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America Invents Act, Patent Law Treaty Referenced Items (255, 256, 257, 258, 259, 260, 261, 262, 263)
(261)                       Department of Commerce
                   United States Patent and Trademark Office
                             37 CFR Parts 1 and 41
                         [Docket No.: PTO-P-2011-0073]
                                 RIN 0651-AC67

              Changes To Implement the Preissuance Submissions by
                        Third Parties Provision of the
                       Leahy-Smith America Invents Act;
                                  Final Rule

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Final rule.

SUMMARY: The United States Patent and Trademark Office (Office) is
revising the rules of patent practice to implement the preissuance
submissions by third parties provision of the Leahy-Smith America
Invents Act (AIA). This provision provides a mechanism for third
parties to contribute to the quality of issued patents by submitting to
the Office, for consideration and inclusion in the record of a patent
application, any patents, published patent applications, or other
printed publications of potential relevance to the examination of the
application. A preissuance submission may be made in any non-
provisional utility, design, and plant application, as well as in any
continuing application. A third-party preissuance submission must
include a concise description of the asserted relevance of each
document submitted, and must be submitted within a certain statutorily
specified time period. The third party must submit a fee as prescribed
by the Director, and a statement that the submission complies with the
statutory provision. The Office has also revised the rules of patent
practice to make related aspects of the existing protest rule more
consistent with the new rule implementing the preissuance submissions
by third parties provision. Further, the Office is eliminating the
provision providing for public use proceedings.

DATES: Effective Date: The changes in this final rule take effect on
September 16, 2012.
    Applicability Date: The changes in this final rule apply to any
application filed before, on, or after September 16, 2012.

FOR FURTHER INFORMATION CONTACT: Nicole Dretar Haines, Legal Advisor
((571) 272-7717), Brian E. Hanlon, Director ((571) 272-5047), or Hiram
H. Bernstein, Senior Legal Advisor ((571) 272-7707), Office of Patent
Legal Administration, Office of the Deputy Commissioner for Patent
Examination Policy.

SUPPLEMENTARY INFORMATION:

   Executive Summary: Purpose: Section 8 of the AIA amends the patent
laws to provide a mechanism for third parties to submit to the Office,
for consideration and inclusion in the record of a patent application,
any patents, published patent applications, or other printed
publications of potential relevance to the examination of the
application. The changes in section 8 of the AIA take effect on
September 16, 2012. This final rule revises the rules of practice to
implement the provision of section 8 of the AIA.

   Summary of Major Provisions: This final rule specifies the
requirements for third parties to file a preissuance submission of
patents, published patent applications, or other printed publications
of potential relevance to the examination of an application. A
preissuance submission must be timely filed, in writing, and contain:
(1) A list identifying the items being submitted; (2) a concise
description of the relevance of each item listed; (3) a legible copy of
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each non-U.S. patent document listed; (4) an English language
translation of any non-English language item listed; (5) a statement by
the party making the submission that the submission complies with the
statute and the rule; and (6) the required fee.

   The Office is revising the rules of practice to harmonize, where
appropriate, the practice regarding protests with the practice
regarding preissuance submissions. The Office is also revising the
rules of practice to eliminate the former practice for making third-
party submissions in published patent applications and to eliminate the
practice regarding public use proceedings.

   Costs and Benefits: This rulemaking is not economically significant
as that term is defined in Executive Order 12866 (Sept. 30, 1993).

   Background: The AIA was enacted into law on September 16, 2011. See
Public Law 112-29, 125 Stat. 284 (2011). This final rule changes the
rules of practice to implement section 8 of the AIA, which provides a
mechanism for third parties to submit to the Office, for consideration
and inclusion in the record of a patent application, any patents,
published patent applications, or other printed publications of
potential relevance to the examination of the application.

   Section 8 of the AIA amends 35 U.S.C. 122 by adding 35 U.S.C.
122(e), which enumerates certain conditions that apply to a third-party
preissuance submission to the Office in a patent application. Pursuant
to 35 U.S.C. 122(e), preissuance submissions of patents, published
patent applications, or other printed publications must be made in
patent applications before the earlier of: (a) The date a notice of
allowance under 35 U.S.C. 151 is given or mailed in the application; or
(b) the later of (i) six months after the date on which the application
is first published under 35 U.S.C. 122 by the Office, or (ii) the date
of the first rejection under 35 U.S.C. 132 of any claim by the examiner
during the examination of the application. 35 U.S.C. 122(e) also
requires a concise description of the asserted relevance of each
document submitted, a fee as prescribed by the Director, and a
statement by the person making the third-party preissuance submission
that the submission was made in compliance with 35 U.S.C. 122(e).

   The preissuance submissions by third parties provision of the AIA
takes effect on September 16, 2012. This provision applies to any
patent application filed before, on, or after September 16, 2012.

   This final rule implements 35 U.S.C. 122(e) in a new rule, 37 CFR
1.290, and revises the rules of practice in title 37 of the Code of
Federal Regulations (CFR) concerning other related third-party
practices. This final rule eliminates 37 CFR 1.99, which provided for
third-party submissions of patents, published patent applications, or
printed publications in published patent applications, but did not
permit an accompanying concise description of the relevance of each
submitted document and limited the time period for such submissions to
up to two months after the date of the patent application publication
or the mailing of a notice of allowance, whichever is earlier. By
contrast, new 35 U.S.C. 122(e) and 37 CFR 1.290 permit third parties to
submit the same types of documents, but with an accompanying concise
description of relevance of each document submitted, and provide third
parties with the same or more time to file preissuance submissions with
the Office when compared with former 37 CFR 1.99. Third-party
submissions under 37 CFR 1.290 provide an enhanced opportunity for
third parties to identify and describe potentially relevant
publications to the Office.

   This final rule also eliminates the public use proceeding provisions
of 37 CFR 1.292. Because section 6 of the AIA makes available a post-
grant review proceeding in which prior public use may be raised, the
pre-grant public use proceeding previously set forth in 37 CFR 1.292 is
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no longer necessary. Additionally, information on prior public use may
continue to be submitted by third parties via a protest in a pending
application when the requirements of 37 CFR 1.291 have been met, and
utilization of 37 CFR 1.291 will promote Office efficiency with respect to
treatment of these issues. Such requests for a public use proceeding under
37 CFR 1.292 were very rare, and the few public use proceedings conducted
each year were a source of considerable delay in the involved applications
and seldom led to the rejection of claims on the basis of public use.

   In view of the elimination of 37 CFR 1.99 and 37 CFR 1.292, this
final rule amends 37 CFR 1.17 to eliminate the document submission fees
pertaining to 37 CFR 1.292 and to add the document submission fee
pertaining to new 37 CFR 1.290. This final rule also amends 37 CFR 41.202
to remove a reference to 37 CFR 1.99.

   Additionally, this final rule amends 37 CFR 1.8 to add, among other
items, third-party submissions filed under 37 CFR 1.290 to the list of
items to which no benefit of a certificate of mailing or transmission
will be given, and amends 37 CFR 1.6 to provide that facsimile
transmissions are not permitted for third-party submissions, to which
no benefit of a certificate of mailing or transmission will be given
pursuant to 37 CFR 1.8.

   In the notice of proposed rulemaking, the Office proposed to permit
third-party submissions directed to reissue applications. See Changes
to Implement the Preissuance Submissions by Third Parties Provision of
the Leahy-Smith America Invents Act, 77 FR 448, 449 and 451 (Jan. 5,
2012). After reviewing the public comments received and revisiting this
proposal, the Office has decided not to adopt its previously proposed
position. Instead, the Office will continue to maintain its position
that a reissue application is a post-issuance proceeding, as set forth
in the Manual of Patent Examining Procedure (MPEP) § 1441.01 (8th
ed. 2001) (Rev. 8, July 2010) ("a reissue application is a post-
issuance proceeding"). Accordingly, a preissuance submission under 35
U.S.C. 122(e) is not permitted to be filed in a reissue application
since 35 U.S.C. 122(e) is limited to preissuance submissions by third
parties in patent applications. Third parties who have a need to submit
information in a reissue application are advised to avail themselves of
the protest provisions of 37 CFR 1.291. See MPEP § 1441.01
(providing that "the prohibition against the filing of a protest after
publication of an application under 35 U.S.C. 122(c) is not applicable
to a reissue application").

   Third-party submissions also are not permitted in reexamination
proceedings because reexamination proceedings are post-issuance
proceedings. See 35 U.S.C. 302 and 35 U.S.C. 311.

   In the notice of proposed rulemaking, the Office proposed
amendments to 37 CFR 1.291 to make the requirements for submitting
protests against pending patent applications clearer and, where
appropriate, more consistent with the requirements of new 37 CFR 1.290.
See Changes to Implement the Preissuance Submission by Third Parties
Provision of the Leahy-Smith America Invents Act, 77 FR 451. While this
final rule amends some aspects of 37 CFR 1.291 to streamline the
requirements for submitting protests, as proposed, this final rule
retains some of the original language of 37 CFR 1.291 because, in view
of comments submitted by the public, the Office recognizes that its
proposed attempt to harmonize the language of 37 CFR 1.291 with new 37
CFR 1.290 may have resulted in some confusion.

   Comments questioned the necessity for maintaining 37 CFR 1.291 in
view of new 37 CFR 1.290 if both provided for the same type of third-
party submissions. For example, if the concise explanation requirement
of 37 CFR 1.291(c)(2) is no different than the concise description of
relevance required by 35 U.S.C. 122(e)(2)(A), then a question is raised
as to whether it is necessary to maintain 37 CFR 1.291. See Changes to
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Implement the Preissuance Submission by Third Parties Provision of the
Leahy-Smith America Invents Act, 77 FR 454.

   Protests pursuant to 37 CFR 1.291 are supported by a separate
statutory provision, 35 U.S.C. 122(c), which implies the availability
of submitting a protest in an application prior to publication, absent
the applicant's consent. Further, 37 CFR 1.291 is not deemed
duplicative or unnecessary because it permits the submission of
information that is not permitted in a third-party submission under 37
CFR 1.290. Specifically, 37 CFR 1.291 provides for the submission of
information other than publications, including any facts or information
adverse to patentability, and arguments to that effect. See MPEP
§§ 1901, 1901.02 and 1901.06(VII). That Congress provided for
35 U.S.C. 122(e), which permits concise descriptions of relevance to be
submitted after publication, without rescinding 35 U.S.C. 122(c)
evidences Congressional intent to supplement, not eviscerate, protests
under 35 U.S.C. 122(c).

   To eliminate any confusion, this final rule retains the language of
37 CFR 1.291(c)(2) requiring a protest to include a "concise
explanation of the relevance" of each item of information submitted as
opposed to the proposed "concise description of the asserted
relevance" and highlights a distinction between the concise
explanation required under 37 CFR 1.291 for protests and the concise
description required by 35 U.S.C. 122(e) for preissuance submissions.
Unlike the concise description of relevance required by 35 U.S.C.
122(e) for a preissuance submission, which is limited to a description
of a document's relevance, the concise explanation for a protest under
37 CFR 1.291 allows for arguments against patentability.

   Additionally, the proposed addition of a reference to 35 U.S.C.
122(b) in the 37 CFR 1.291(b) requirement that a protest be filed prior
to the date the application was published under 37 CFR 1.211 has not
been retained in this final rule in view of comments regarding whether
the inclusion of 35 U.S.C. 122(b) suggested that an earlier publication
by the World Intellectual Property Organization (WIPO) of an
international application designating the U.S. could trigger the end of
the 37 CFR 1.291(b) time period for an application which entered the
national stage from the international application after compliance with
35 U.S.C. 371. Because there has been no change in Office policy that a
publication by the Office under 37 CFR 1.211 triggers the end of the
time period under 37 CFR 1.291(b) for filing a protest, absent an
earlier notice of allowance, the proposed reference to 35 U.S.C. 122(b)
has not been retained, thereby confirming and clarifying current Office
practice that an earlier publication of the application by WIPO would
not prevent a protest from being filed in accordance with 37 CFR
1.291(b).

   General Discussion of Implementation: A third-party submission
under 37 CFR 1.290 may be made in any non-provisional utility, design,
or plant application, as well as in any continuing application. These
submissions may not be made in reissue applications or reexamination
proceedings.

   The Office has developed a dedicated Web-based interface to permit
third-party submissions under new 37 CFR 1.290 to be filed
electronically. Third parties can access the preissuance submissions
Web-based interface by selecting the preissuance submissions filing
option in the Office's electronic filing system - Web (EFS-Web).
Additionally, third-party submissions may be filed in paper via first-
class mail, United States Postal Service (USPS) Express Mail service
pursuant to 37 CFR 1.10, or delivery by hand. Facsimile transmission of
third-party submissions is not permitted. See 37 CFR 1.6(d)(3).

   When filing a third-party submission electronically, a third party
will receive immediate, electronic acknowledgment of the Office's
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receipt of the submission. When filing a third-party submission in
paper, a third party may include a self-addressed postcard with the
submission to receive an acknowledgment by return receipt postcard that
a third-party submission has been received. In either case, the
electronic acknowledgment or return receipt postcard is not an
indication that the third-party submission is compliant or has been
entered; rather, it merely shows Office receipt of the submission.

   Third-party submissions, whether submitted in paper or
electronically via the dedicated Web-based interface, will not be
automatically entered into the electronic image file wrapper (IFW) of
an application, i.e., will not be made of record in the application.
Instead, third-party submissions submitted by third parties will be
reviewed by the Office to determine compliance with 35 U.S.C. 122(e)
and 37 CFR 1.290 before being entered into the IFW. Third parties are
encouraged to file third-party submissions electronically via the
dedicated Web-based interface because the Office plans to automatically
verify the timeliness of a submission, as well as some of the content
of a submission (e.g., U.S. patent and published patent application
data). Electronic filing via the dedicated Web-based interface will be
the most efficient means of making compliant third-party submissions
available to an examiner for consideration, as compliant third-party
submissions filed in paper will experience a delay in entry due to the
additional processing required for scanning and indexing of paper
submissions into electronic form. Additionally, third parties filing
third-party submissions electronically via the dedicated Web-based
interface will receive immediate, electronic acknowledgment of the
Office's receipt of the submission, instead of waiting for the Office
to mail a return receipt postcard when provided with a paper submission.

   The EFS-Web Legal Framework previously prohibited third-party
submissions under 37 CFR 1.99 from being filed electronically in patent
applications because documents filed electronically via EFS-Web were
instantly loaded into the IFW. See Legal Framework for Electronic
Filing System - Web (EFS-Web), 74 FR 55200, 55202, 55206-7 (October 27,
2009). Because third-party submissions filed electronically in EFS&-Web
via the dedicated Web-based interface for preissuance submissions will
be screened for compliance with the requirements of 35 U.S.C. 122(e)
and 37 CFR 1.290 before being entered into the IFW of an application,
the EFS-Web Legal Framework will be revised to permit such submissions.
Third parties are cautioned that electronically filing a third-party
submission other than via the dedicated Web-based interface for
preissuance submissions is prohibited (i.e., a third party must select
the "Third-Party Preissuance Submission under 37 CFR 1.290" option in
EFS-Web). Additionally, the EFS-Web Legal Framework continues to
prohibit protests under 37 CFR 1.291 from being filed electronically in
patent applications.

   The Office has established procedures to complete its compliance
determination, for both paper and electronic submissions, promptly
following receipt of the submission so that compliant third-party
submissions will be quickly entered into the IFW and made available to
the examiner for consideration. Third-party submissions filed in paper,
however, will incur more processing delay than submissions filed
electronically via the dedicated Web-based interface for preissuance
submissions due to the scanning and indexing process.

   Third-party submissions that are not compliant with the statute
will not be entered into the IFW of an application or considered, and
will be discarded. Also, the Office will not refund the required fees
in the event a third-party submission is determined to be non-
compliant. The statutory time period for making a third-party
submission will not be tolled by an initial non-compliant submission.
The Office will not set a time period for a third party to file a
corrected third-party submission. Additionally, the Office will not
accept amendments to a non-compliant submission that was previously
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filed. Instead, a third party who previously filed a non-compliant
submission may file another complete submission, provided the statutory
time period for filing a submission has not closed.

   If the third party provides an electronic mail message (email)
address with a third-party submission, whether filed electronically or
in paper, the Office intends to notify the third-party submitter of
such non-compliance at the email address provided and to include the
reason(s) for non-compliance (e.g., a document was listed improperly, a
copy of a document was not submitted, a concise description was not
provided for a document, etc.). No notification will be issued where a
third party does not provide an email address with the submission.
Neither the notification nor the non-compliant third-party submission
will be made of record in the application. The Office intends to
provide such notification as a result of numerous comments the Office
received regarding the Office's proposal to not notify a third party of
a non-compliant third-party submission.

   Third parties are not required to serve the applicant with a copy
of the third party submission. However, the Office intends to notify
the applicant upon entry of a compliant third-party submission in their
application file where the applicant participates in the Office's e-
Office Action program. Such notification is being provided as a result
of numerous comments the Office received regarding the Office's
proposal to not directly notify applicants of the entry of a third-
party submission in an application. In order to receive such
notification, the applicant must participate in the Office's e-Office
Action program, as such notification will only be provided via email to
program participants. The contents of a compliant third-party
submission will be made available to the applicant via its entry in the
IFW of the application. An applicant may view non-patent documents
identified in a third-party submission document list via the Office's
private Patent Application Information Retrieval (PAIR) system. By not
requiring service of third-party submissions on the applicant, the
Office is underscoring that such third-party submissions will not
create a requirement on the part of the applicant to independently file
the submitted documents with the Office in an information disclosure
statement (IDS). Additionally, the Office is seeking to prevent
challenges regarding whether service of a third-party submission was
proper from negatively impacting the pendency of the application.

   35 U.S.C. 122(e) does not limit third-party preissuance submissions
to pending applications. A third-party submission made within the
statutory time period, and otherwise compliant, will be entered even if
the application to which the submission is directed has been abandoned.
An examiner will not consider such third-party submission unless the
application resumes a pending status (e.g., the application is revived,
the notice of abandonment is withdrawn, etc.). The abandonment of an
application will not, however, toll the statutory time period for making
a third-party submission. For example, if prior to publication an
application goes abandoned because the applicant fails to timely
respond to a first rejection of any claim, and the application is later
revived, the time period for making a third-party submission will run
until the earlier of the date of a notice of allowance or the date that
is six months after the application's publication date. Additionally, a
third-party submission made within the statutory time period, and
otherwise compliant, will be entered even if the application to which
the submission is directed has not been published, for example, due to
a non-publication request filed under 35 U.S.C. 122(b)(2)(B)(i) and
§ 1.213.

   Compliant third-party submissions will be considered by the
examiner when the examiner next takes up the application for action
following the entry of the third-party submission into the IFW. An
examiner will consider the documents and concise descriptions submitted
in a compliant third-party submission in the same manner that the
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examiner considers information and concise explanations of relevance
submitted as part of an IDS. Similarly, examiner consideration of a
document and its accompanying concise description of relevance in a
third-party submission does not mean that the examiner agrees with the
third party's position regarding the document, only that the examiner
considered the publication and its accompanying description. Generally
with the next Office action, a copy of the third party's listing of
documents with an indication of the examiner's consideration (e.g., an
initialed form PTO/SB/429) will be provided to the applicant. Documents
from a third-party submission that were considered by the examiner will
be printed on the patent, similar to the way documents from an IDS that
were considered by the examiner are printed on the patent. Accordingly,
an applicant need not file an IDS to have the same documents that were
previously submitted by a third party as part of a compliant third-
party submission considered by the examiner in the application. The
Office is updating its existing information technology (IT) systems to
distinguish considered third-party submission documents on an issued
patent from documents cited by the applicant and by the examiner.

   Examiners will acknowledge in the record of the patent application
the examiner's consideration of the documents submitted. This
acknowledgment will be made in a manner similar to that of the
examiner's consideration of applicant-submitted documents filed as part
of an IDS. For example, the examiner may indicate at the bottom of each
page of a third-party submission "All documents considered except
where lined through," along with the examiner's electronic initials
and the examiner's electronic signature on the final page of the
submission. See, e.g., MPEP § 609.05(b). Such indication by the
examiner placed at the bottom of each page of a third-party submission
will mean that the examiner has considered the listed documents and
their accompanying concise descriptions. While every effort will be
made to ensure that only compliant third-party submissions are entered
for an examiner's consideration, in the unlikely event an examiner
cannot consider a listed document, the examiner will strike through the
document to indicate that the examiner did not consider either the
document or its accompanying concise description. If the examiner does
not cite the stricken document on a form PTO-892, the applicant may
file an IDS to have the document considered, if deemed necessary.
Because the prosecution of a patent application is an ex parte
proceeding, no response from a third party with respect to an
examiner's treatment of the third-party submission will be permitted or
considered.

   Since it would be advantageous for examiners to have the best art
before them prior to issuing the first Office action on the merits, and
because a first action allowance in the application could close the
time period for making a preissuance submission under 35 U.S.C. 122(e),
third parties should consider providing any third-party submission at
the earliest opportunity. Additionally, because highly relevant
documents can be obfuscated by voluminous submissions, third parties
should limit any third-party submission to the most relevant documents
and should avoid submitting documents that are cumulative in nature.
Third parties need not submit documents that are cumulative of each
other or that are cumulative of information already under consideration
by the Office. Nonetheless, in some instances, third parties may deem
it necessary to submit a document in an application that was previously
made of record in the application, where the third party has additional
information regarding a document that was not previously considered.
Third parties are reminded that 35 U.S.C. 122(e) requires that the
documents submitted be "of potential relevance to the examination of
the application" and that the relevance of each document submitted
must be provided in an accompanying concise description.

   The Director has set the fees for third-party submissions to
recover costs to the Office for third-party submissions to the Office.
35 U.S.C. 122(e) expressly provides for "such fee as the Director may
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prescribe." The Office is setting fees for third-party submissions in
this final rule pursuant to its authority under 35 U.S.C. 41(d)(2),
which provides that fees for all processing, services, or materials
relating to patents not specified in 35 U.S.C. 41 are to be set at
amounts to recover the estimated average cost to the Office of such
processing, services, or materials. See 35 U.S.C. 41(d)(2). The prior
practice (37 CFR 1.99) provided for a third-party submission of up to
ten documents for the fee set forth in 37 CFR 1.17(p) (currently
$180.00). The Office expects the processing costs to the Office for
third-party submissions under new 37 CFR 1.290 to be equivalent to the
processing costs to the Office for submissions under former 37 CFR
1.99. Accordingly, the Office has determined that the fee set forth in
37 CFR 1.17(p) will also be applicable to third-party submissions under
37 CFR 1.290 such that the fee set forth in 37 CFR 1.17(p) will be
required for every ten documents, or fraction thereof, listed in each
third-party submission.

   The Office is providing an exemption from this fee requirement
where a third-party submission lists three or fewer total documents and
is the first third-party submission by a third party or a party in
privity with the third party, in a given application. The Office is
providing this fee exemption for the first third-party submission in an
application by a third party containing three or fewer total documents
because the submission of a limited number of documents is more likely
to assist in the examination process and thus offset the cost of
processing the submission. Moreover, keeping the size of the fee
exempted submission to three or fewer total documents will help to
focus the attention of third parties on finding and submitting only the
most relevant art to the claims at hand. Where one third party takes
advantage of the fee exemption in an application, another third party
is not precluded from also taking advantage of the fee exemption in the
same application provided that the third parties are not in privity
with each other.

   The fees set or adjusted in this notice will subsequently be
revisited and may be proposed to be set or adjusted in a notice of
proposed rulemaking under section 10 of the AIA.

Discussion of Specific Rules

   The following is a discussion of the amendments to Title 37 of the
Code of Federal Regulations, part 1, that are implemented in this final
rule:

   Section 1.6: Section 1.6(d)(3) is amended to provide that facsimile
transmissions are not permitted for third-party submissions under §
1.290, to which no benefit of a certificate of mailing or transmission
will be given pursuant to § 1.8(a)(2)(i)(I).

   Section 1.8: Section 1.8(a)(2)(i)(C) is amended to replace the
reference to the "Board of Patent Appeals and Interferences" with
"Patent Trial and Appeal Board." Sections 1.8(a)(2)(i)(B) and
§§ 1.8(a)(2)(i)(G) through 1.8(a)(2)(i)(J) are added to
identify additional situations where the procedure of § 1.8(a) does
not apply. For instance, the procedure of § 1.8(a) does not apply
to papers filed in trials before the Patent Trial and Appeal Board
governed by § 42.6(b); the filing of a written declaration of
abandonment under § 1.138; the filing of any of the papers required
for a submission under § 1.217 for publication of a redacted copy
of an application; the filing of the papers required for making a
third-party submission under § 1.290; and the calculation of any
period of adjustment, as specified in § 1.703(f).

   Section 1.17: Section 1.17(j) is removed to eliminate the document
submission fee pertaining to § 1.292 and is reserved. Section
1.17(p) is amended to replace the reference in the document submission
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fee to former § 1.99 with a reference to new § 1.290.

   Section 1.99: Section 1.99 is removed and reserved. Section 1.99 is
unnecessary because § 1.290 provides for third-party submissions of
patents, published patent applications, and other printed publications
to the Office for consideration and inclusion in the record of a patent
application, with a concise description of the relevance of each
document being submitted and within time periods that are the same or
greater than those permitted under former § 1.99.

   Section 1.290: Section 1.290(a) provides that a third party may
submit, for consideration and entry in the record of a patent
application, any patents, published patent applications, or other
printed publications of potential relevance to the examination of the
application if the submission is made in accordance with 35 U.S.C.
122(e) and § 1.290. Any member of the public, including private
persons, corporate entities, and government agencies, may file a third-
party submission under § 1.290. A third-party submission may also
be filed by an attorney or other representative on behalf of an unnamed
real party in interest, because § 1.290 does not require that the
real party in interest be identified as such identification might
discourage some third parties from making a third-party submission or
invite challenges based on allegations of misidentification that could
delay the prosecution of an application. The submitter of a third-party
submission, however, will be identified in view of the signature
requirement in § 1.4 for papers filed in a patent application,
which require a person's signature. Third-party submissions are
required to be signed because §§ 1.290(d)(5) and (g) require
statements by the party making the submission.

   Because § 1.290(a) requires that third-party submissions be
directed to patent applications, the Office will not accept third-party
submissions directed to issued patents. Such submissions should be
filed in accordance with § 1.501. Third-party submissions under
§ 1.290 may be directed to non-provisional utility, design, and
plant applications, as well as to continuing applications. Because 35
U.S.C. 122(e) is limited to preissuance submissions, a third party may
not file a submission under § 1.290 in post-issuance proceedings,
such as reexamination proceedings and reissue applications. Where a
submission is filed under § 1.290 in a reissue application, the
Office will process the submission as a protest under § 1.291
because, while a concise explanation of relevance under § 1.291
allows for arguments against patentability, such as proposed rejections
of the claims, it does not require that such arguments be raised.
Therefore, a third-party submission that would otherwise be compliant
under § 1.290 will be entered into the record of a reissue
application as a protest under § 1.291.

   35 U.S.C. 122(e) provides for preissuance submissions to be made
for consideration and inclusion "in the record of a patent
application" and does not preclude third parties from making
preissuance submissions in unpublished applications. Therefore,
§ 1.290(a) does not require that the application to which a submission
is directed be published. For example, the Office will enter a
compliant third-party submission directed to an application in which
a nonpublication request has been filed pursuant to 35 U.S.C.
122(b)(2)(B)(i) and § 1.213. Further, because 35 U.S.C. 122(e) does
not preclude third parties from making submissions in abandoned
applications, § 1.290(a) does not require that the application be
pending and, therefore, permits third-party submissions to be filed in
an abandoned application.

   Section 1.290(a) limits the type of information that may be
submitted to patents, published patent applications, and other printed
publications of potential relevance to the examination of a patent
application. For example, a submission under § 1.290 could include
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litigation papers and court documents not subject to a court-imposed
protective or secrecy order, if they qualify as publications, but must
not include documents that are subject to a court-imposed protective or
secrecy order or include trade secret information, unpublished internal
documents, or other non-patent documents which do not qualify as
"printed publications." See MPEP § 2128.

   Because 35 U.S.C. 122(e) does not limit the type of information
that may be submitted to only that which is prior art, there is no
requirement in § 1.290(a) that the information submitted be prior
art documents in order to be considered by the examiner. Further,
§ 1.290(a) does not require a third party to indicate whether a listed
document is or is not asserted to be prior art. For those documents
where the date of publication is not apparent from a review of the
document, the third party may provide information regarding the
publication date of the document in its accompanying concise
description of relevance.

   Similarly, 35 U.S.C. 122(e) does not limit submissions to
publications that are not already of record in a patent application.
As a result, § 1.290(a) does not prohibit third-party submissions
including patents, published patent applications, or other printed
publications that are already of record in an application where the
submission is otherwise compliant.

   Further, while it would be a best practice for third parties not to
submit documents that are cumulative of each other or that are
cumulative of information already under consideration by the Office,
§ 1.290(a) does not explicitly prohibit cumulative submissions
because it has been the Office's experience that identifying purely
cumulative submissions is difficult where a submission includes both a
publication and a description of the publication's relevance. For
example, a document submitted may appear on its face to be cumulative
of information already of record, but the description of relevance may
provide additional information with respect to the document such that
the submission of the document, together with the concise description
of relevance, is not cumulative of information already of record.

   The standard under § 1.290(a) for the documents submitted to be
of "potential relevance to the examination of the application" is
imposed by 35 U.S.C. 122(e)(1). This standard requires the submitter to
believe the documents being submitted are relevant to the extent that
the submitter can provide the concise description of the asserted
relevance of each document submitted as required by 35 U.S.C. 122(e).

   Section 1.290(a) also provides that a third-party submission may
not be entered or considered by the Office if any part of the
submission is not in compliance with 35 U.S.C. 122(e) and § 1.290.
The Office will enter a third-party submission that is compliant with
both 35 U.S.C. 122(e) and § 1.290; however, any part of a third-
party submission that is non-compliant with respect to the requirements
of 35 U.S.C. 122(e), whether or not the third-party submission is
otherwise compliant with § 1.290, will prevent entry of the entire
third-party submission into the record. By contrast, a third-party
submission that is compliant with 35 U.S.C. 122(e), but non-compliant
with some requirement of § 1.290, may be entered into the record if
the error is of such a minor character that, in the opinion of the
Office, it does not raise an ambiguity as to the content of the
submission. In any event, the Office will either enter or not enter the
entire submission and will not attempt to enter portions of partially
compliant submissions. The determination of whether to enter or not to
enter a submission that partially complies with respect to a
requirement of § 1.290 will be at the sole discretion of the
Office. The Office will not set a time period for a third party to file
a corrected third-party submission. Additionally, the Office will not
accept amendments to non-compliant submissions that were previously
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filed. Instead, a third party who previously filed a non-compliant
submission may file another complete submission, provided the statutory
time period for filing a submission has not closed.

   Section 1.290(b) sets forth the time periods in which a third party
may file a third-party submission. Under § 1.290(b), any third-
party submission must be filed prior to the earlier of: (1) The date a
notice of allowance under § 1.311 is given or mailed in the
application; or (2) the later of: (i) Six months after the date on
which the application is first published by the Office under 35 U.S.C.
122(b) and § 1.211, or (ii) the date the first rejection under
§ 1.104 of any claim by the examiner is given or mailed during the
examination of the application.

   The time periods provided for in § 1.290(b) are statutory and
cannot be waived. Thus, the Office cannot grant any request for
extension of the § 1.290(b) time periods. Also, third-party
submissions must be filed prior to, not on, the dates identified in
§§ 1.290(b)(1) and (b)(2). A third-party submission under § 1.290
is filed on its date of receipt in the Office as set forth in
§ 1.6. Pursuant to § 1.290(i), the certificate of mailing or
transmission provisions of § 1.8 do not apply to a third-party
submission under § 1.290; however, the USPS Express Mail service
provisions of § 1.10 do apply to a third-party submission under
§ 1.290. Additionally, facsimile transmission of third-party
submissions is not permitted. See § 1.6(d)(3). Third-party
submissions that are not timely filed will not be entered or considered
and will be discarded.

   The § 1.290(b)(2)(i) time period will be initiated only by
publications "by the Office" under 35 U.S.C. 122(b) and § 1.211,
and will not be initiated by a publication by WIPO. Thus, an earlier
publication by WIPO of an international application designating the
U.S. will not be considered a publication that will initiate the
§ 1.290(b)(2)(i) time period for an application which entered the
national stage from the international application after compliance with
35 U.S.C. 371.

   The § 1.290(b)(2)(ii) time period will be initiated by the date
the first rejection under § 1.104 of any claim by the examiner is
given or mailed during the examination of the application. "Given"
refers to the electronic notification of an Office action that replaces
postal mailing of an Office action for applicants participating in the
Electronic Office Action Notification (e-Office Action) program. The
§ 1.290(b)(2)(ii) time period will not be initiated, for example,
by a first Office action that only contains a restriction requirement
or where the first Office action is an action under Ex parte Quayle,
1935 Dec. Comm'r Pat. 11 (1935). The filing of a request for continued
examination (RCE) does not preclude a third-party submission from being
filed, if the filing of the third-party submission would otherwise be
within the time periods set forth in § 1.290(b)(2). Nor does the
filing of an RCE reset the § 1.290(b)(2)(ii) time period for filing
a third-party submission.

   Section 1.290(c) requires a third-party submission to be made in
writing. In the notice of proposed rulemaking, the Office proposed to
require under § 1.290(c) that each page of a third-party submission
identify the application to which the third-party submission is
directed by application number, except for the copies of the documents
being submitted. See Changes to Implement the Preissuance Submission by
Third Parties Provision of the Leahy-Smith America Invents Act, 77 FR
452. In view of comments submitted by the public expressing concern
that such a requirement would be overly burdensome, § 1.290(e) of
this final rule relaxes the requirement for identifying the application
number of the application to which the submission is directed by only
requiring the identification on each page of the document list, as
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opposed to every page of the submission.

   Section 1.290(d) identifies the required content of a third-party
submission. Section 1.290(d)(1) provides that any third-party
submission under § 1.290 must include a document list identifying
the documents, or portions of documents, being submitted in accordance
with § 1.290(e). Section 1.290(e) sets forth the requirements on
how to identify the items in the § 1.290(d)(1) document list.
Because § 1.290(d)(1) provides for an item identified in the
document list to be either an entire document or a portion of a
document, in the case where a lengthy document contains both
information of potential relevance to the examination of the
application and other information that is not of potential relevance, a
third party may choose to identify only the relevant portion of the
document (e.g., one chapter of a textbook) in lieu of the entire
document where it is practical to do so. Otherwise, the third party
should identify the entire document.

   The Office is providing a form PTO/SB/429 that is similar to forms
PTO/SB/08A and 08B to assist third parties in preparing the document
list in accordance with §§ 1.290(d)(1) and (e). Use of this
form is recommended for paper submissions. Use of this form will not be
necessary for third-party submissions filed electronically via the
Office's dedicated Web-based interface for preissuance submissions, as
this interface will prompt the third party to complete the fields that
are provided on the form and will automatically format the entered
information into an electronic version of the form PTO/SB/429.

   Section 1.290(d)(2) requires a concise description of the asserted
relevance of each item identified in the document list in view of the
statutory requirement of 35 U.S.C. 122(e)(2)(A) that each third-party
preissuance submission be accompanied by a "concise description of the
asserted relevance of each submitted document." A concise description
of relevance for an item is a statement of facts regarding the submitted
evidence (i.e., the patent, published patent application, or other
publication) and will not, itself, be treated as evidence. The concise
description should set forth facts, explaining how an item listed is of
potential relevance to the examination of the application in which the
third-party submission has been filed.

   The third party should present the concise description in a format
that would best explain to the examiner the relevance of the
accompanying document, such as in a narrative description or a claim
chart. The statutory requirement for a concise description of relevance
should not be interpreted as permitting a third party to participate in
the prosecution of an application, as 35 U.S.C. 122(c) prohibits the
initiation of a protest or other form of pre-issuance opposition for
published applications without the consent of the applicant. Therefore,
while a concise description of relevance may include claim charts
(i.e., mapping various portions of a submitted document to different
claim elements), the concise description of relevance is not an
invitation to a third party to propose rejections of the claims or set
forth arguments relating to an Office action in the application or to
an applicant's reply to an Office action in the application.

   The Office is interpreting the requirement for a concise
description of relevance liberally because the Office anticipates that
third parties will be motivated to provide complete concise
descriptions of relevance so as to effectively draw the examiner's
attention to the potential relevance of a submitted document to the
examination of an application. At a minimum, a concise description of
relevance must be more than a bare statement that the document is
relevant as such a statement does not amount to a meaningful concise
description. As a best practice, each concise description should point
out the relevant pages or lines of the respective document,
particularly where the document is lengthy and complex and the third
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party can identify a highly relevant section, such as a particular
figure or paragraph. Third parties should refrain from submitting a
verbose description of relevance, not only because the statute calls
for a "concise" description, but also because a focused description
is more effective in drawing the examiner's attention to the relevant
issues.

   For example, a description that includes an introductory paragraph
describing the field of technology of a document and a claim chart that
maps portions of the document to different claim elements would likely
be considered "concise." On the other hand, descriptions that merely
repeat in narrative format the same information that is also depicted
in a claim chart or that approach the length of the documents
themselves will not likely be considered "concise.

   A third party using the Office's dedicated Web-based interface to
electronically file a third-party submission may fill in the concise
description of relevance field for an item or upload a separate paper
with the concise description for the item in lieu of entering the
concise description in the field. When filing in paper, a third party
should provide the concise description of relevance for an item as a
separate paper (as opposed to combining the concise descriptions of
relevance for all items into a single paper). Providing, for each
concise description of relevance, a separate paper that prominently
identifies the item in the document list to which the concise
description pertains will help ensure that the screener and the
examiner can readily identify it.

   Section 1.290(d)(3) requires submission of a legible copy of each
item identified in the document list, other than U.S. patents and U.S.
patent application publications. See § 1.98(a)(2) and MPEP § 609.04(a).
Where only a portion of a document is listed as an item in
the document list, the third party must only submit a copy of that
portion and not a copy of the entire document (e.g., where a particular
chapter of a book is listed and not the entire book). Further, when a
copy of only a portion of a document is submitted, the third party
should also submit copies of pages of the document that provide
identifying information (e.g., a copy of the cover, the title page, the
copyright information page, etc.). Under § 1.290(d)(3), a third
party need not submit copies of U.S. patents and U.S. patent
application publications because such documents are readily accessible
to examiners. The proposed language "unless required by the Office"
has not been retained in this final rule as the Office will not be
communicating with third parties other than where a return receipt
self-addressed postcard is mailed, acknowledging receipt of a third-
party submission, and/or an email notification is given to a third
party indicating that a third-party submission was found to be non-
compliant.

   Section 1.290(d)(4) requires an English language translation of any
non-English language item identified in the document list. A
translation submitted pursuant to § 1.290(d)(4) may be a reliable
machine translation and need not be certified. Section 1.290(d)(4) has
been clarified in this final rule in view of comments submitted by the
public expressing concern regarding a situation where a third party
cites and provides a translation for only a portion of a non-English
language document but submits a copy of the entire non-English language
document. The comments questioned whether an applicant would have a
duty to cite and translate the remaining portions of the non-English
language document in this situation. Section 1.290(d)(1) provides for
the listing of either entire documents or portions of documents, and
§§ 1.290(d)(3) and (4) require a copy and translation,
respectively, of each item listed pursuant to § 1.290(d)(1). Thus,
where only a portion of a non-English language document is listed, a
third party must not submit a copy of the entire non-English language
document. Rather, the third party must submit a copy of the listed
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portion of the non-English language document and a translation of only
this portion.

   Whether filing a third-party submission under § 1.290 in paper
or electronically, it would be a best practice for third parties to
include an identifying label for each item in the document list and
place the identifying label on the accompanying concise description of
relevance for the item, on the copy of the item (if submitted), and on
the translation of the item (if submitted) so that screeners and
examiners can more quickly identify the descriptions of relevance,
copies, and translations that correspond to each item in the document
list.

   Section 1.290(d)(5)(i) requires a statement by the party making the
submission that the party is not an individual who has a duty to
disclose information with respect to the application (i.e., each
individual associated with the filing and prosecution of the patent
application) under § 1.56. Such statement is intended to avoid
potential misuse of third-party submissions by applicants (e.g., by
employing a third-party "straw man") to attempt to circumvent the IDS
rules.

   Section 1.290(d)(5)(ii) requires a statement by the party making
the submission that the submission complies with the requirements of 35
U.S.C. 122(e) and § 1.290. To facilitate compliance by third parties, the
form PTO/SB/429 and the dedicated Web-based interface for preissuance
submissions include the statements required by §§ 1.290(d)(5)(i) and (ii).

   Section 1.290(e) sets forth the requirements for identifying the
items in the document list pursuant to § 1.290(d)(1). Section
1.290(e) requires the document list include a heading that identifies
the list as a third-party submission under § 1.290. The dedicated
Web-based interface for electronically filing preissuance submissions
will automatically generate a document list that complies with these
two requirements of § 1.290(e).

   Section 1.290(e) also requires that the document list required by
§ 1.290(d)(1) identify on each page of the list, the application
number (i.e., the series code and serial number) of the application in
which the submission is being filed. This requirement is consistent
with the requirement set forth in § 1.98(a)(1)(i) for applicant IDS
listings. In view of public comments received, this requirement
modifies the previously proposed requirement of § 1.290(c) to be
less burdensome to the submitter, while achieving the same goals. See
Changes to Implement the Preissuance Submission by Third Parties
Provision of the Leahy-Smith America Invents Act, 77 FR 452.

   Section 1.290(e) further requires that U.S. patents and U.S. patent
application publications be listed in a separate section from other
items in the document list. Separating the listing of U.S. patents and
U.S. patent application publications from the listing of other items in
the document list will facilitate printing the U.S. patents and U.S.
patent application publications considered by the examiner in a third-
party submission on the face of the patent.

   Sections 1.290(e)(1) through (e)(4) set forth the requirements for
identifying the items in the § 1.290(d)(1) document list. Section
1.290(e)(1) requires that each U.S. patent be identified by patent
number, first named inventor, and issue date. Section 1.290(e)(2)
requires that each U.S. patent application publication be identified by
patent application publication number, first named inventor, and
publication date. Section 1.290(e)(3) requires that each foreign patent
or published foreign patent application be identified by the country or
patent office that issued the patent or published the application; the
applicant, patentee, or first named inventor; an appropriate document
number; and the publication date indicated on the patent or published
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application. The requirement for U.S. patents and patent application
publications to be identified by first named inventor, and for foreign
patents and published patent applications to be identified by the
applicant, patentee, or first named inventor, is intended to aid in
identifying the items in the document list in the event the application
number, publication number, or other appropriate document number data
is in error, for example, inadvertently transposed. In view of comments
submitted by the public expressing concern that the identity of the
first named inventor of a foreign patent/published patent application
may not be known in some instances, § 1.290(e)(3) of this final
rule offers more flexibility in permitting identification of foreign
patents and published patent applications by expanding the
identification to also include the applicant or patentee, in addition
to the first named inventor. See Changes to Implement the Preissuance
Submission by Third Parties Provision of the Leahy-Smith America
Invents Act, 77 FR 452.

   Section 1.290(e)(4) requires that each non-patent publication be
identified by author (if any), title, pages being submitted,
publication date, and where available, publisher and place of
publication. Section 1.290(e)(4) does not preclude a third party from
providing additional information not specified in § 1.290(e)(4)
(e.g., journal title and volume/issue information for a journal
article). In view of comments submitted by the public expressing
concern that publisher and place of publication information may not be
available in some instances, § 1.290(e)(4) of this final rule
emphasizes that such information need only be provided where it is
available.

   Further, in view of comments submitted by the public that the
Office should be more critical as to whether a document submitted is
actually a publication, the qualifier "where available" no longer
applies to each item of information specified in § 1.290(e)(4) in
this final rule. See Changes to Implement the Preissuance Submission by
Third Parties Provision of the Leahy-Smith America Invents Act, 77 FR
452-53. In order for a submission to be compliant under 35 U.S.C.
122(e) and § 1.290, each item submitted for consideration and
inclusion into the file of a patent application must be a publication.
Thus, § 1.290(e)(4) requires that, if no publication date is known,
the third party must provide evidence of publication. As a result, a
third-party submission must either include items that are prima facie
publications, or evidence that establishes that they are publications.

   Where the actual publication date of a non-patent document is not
known, a third party must, at a minimum, provide a date of retrieval or
a time frame (e.g., a year, a month and year, a certain period of time)
when the document was available as a publication for purposes of
identifying the document by publication date pursuant to
§ 1.290(e)(4), in addition to including evidence that establishes the
document as a publication. In such situations, the third party may
submit evidence in the form of affidavits, declarations, or any other
appropriate format. For example, a third party might submit as evidence
of publication a printout from a Web site showing that the content of
the Web site was publicly available at least as of the date retrieved
shown on the printout, or screenshots from a Web site that establish
the content of the Web site on a particular date. In another example, a
third party might submit a company's undated marketing brochure with a
declaration from an employee of the company stating that the brochure
was publicly distributed at a trade show on a particular date. Such
evidence will not be counted toward the item count for fee purposes,
unless the evidence is in the form of a patent document or other
printed publication and the evidence, itself, is listed and submitted
for consideration by the examiner. In some instances, the copy of the
document provided pursuant to § 1.290(d)(3) may itself be the
evidence, such as where a printout from the Web site showing the date
the document was retrieved is provided to satisfy the copy requirement.
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Further, if the patent applicant has evidence that a document filed by
a third party is, in fact, not a publication, the applicant can
challenge the determination by the Office that a document is a
publication in a response to a rejection applying the document in
question.

   Section 1.290(f) requires payment of the fee set forth in § 1.17(p)
for every ten items or fraction thereof listed in the document
list, except where the submission is accompanied by the statement set
forth in proposed § 1.290(g). The Office will determine the item
count based on the § 1.290(d)(1) document list. Thus, if a U.S.
patent or a U.S. patent application publication is identified in the
document list, but a copy of the item is not submitted (i.e., because a
copy is not required), the listed U.S. patent or U.S. patent
application publication will be counted toward the document count. If a
copy of an item is submitted but the item is not identified in the
document list, the item will not be counted or considered and
will be discarded. Additionally, if a third party identifies an item in
the § 1.290(d)(1) document list that is only a portion of a
publication, the portion of the publication will be counted as one
item. Further, while a third party is permitted to cite different
publications that are all available from the same electronic source,
such as a Web site, each such publication listed will be counted as a
separate item.

   Section 1.290(g) provides an exemption from the § 1.290(f) fee
requirement where a third-party submission listing three or fewer total
items is the first third-party submission by a third party, or a party
in privity with the third party, in a given application. Where one
third party takes advantage of the fee exemption in an application,
another third party is not precluded from also taking advantage of the
fee exemption in the same application as long as the third parties are
not in privity with each other. For example, applying the current 37
CFR 1.17(p) fee of $180.00 in accordance with §§ 1.290(f) and
(g): (1) No fee would be required for the first third-party submission
by a third party containing three or fewer total items; (2) a $180.00
fee would be required for the first third-party submission by a third
party containing more than three, but ten or fewer total items; and (3)
a $360.00 fee would be required for the first third-party submission by
a third party containing more than ten, but twenty or fewer total
items. For a second or subsequent third-party submission by the same
third party: (1) A $180.00 fee would be required where the second or
subsequent third-party submission by the third party contains ten or
fewer total items; and (2) a $360.00 fee would be required where the
second or subsequent third-party submission by the same third party
contains more than ten, but twenty or fewer total items. Note that fees
set or adjusted in this notice will subsequently be revisited and may
be proposed to be set or adjusted in a notice of proposed rulemaking
under section 10 of the AIA.

   To implement the fee exemption in § 1.290(g) and avoid
potential misuse of such exemption, exemption-eligible third-party
submissions must be accompanied by a statement of the third party that,
to the knowledge of the person signing the statement after making
reasonable inquiry, the submission is the first and only third-party
submission in the application by the third party or a party in privity
with the third party. To preclude a third party from making multiple
third-party submissions in the same application on the same day and
asserting that each such submission is the first third-party submission
in the application by the third party, the § 1.290(g) statement
requires that the submission be the "first and only" third-party
submission. This statement will not, however, preclude the third party
from making more than one third-party submission in an application,
where the need for the subsequent submissions was not known at the time
the earlier submission, including the § 1.290(g) statement, was
filed with the Office. Such additional submissions would not be exempt
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from the § 1.290(f) fee requirement.

   The Office will not entertain challenges to the accuracy of such
third-party statements because, pursuant to § 11.18(b), whoever
knowingly and willfully makes any false, fictitious, or fraudulent
statements or representations to the Office shall be subject to the
penalties set forth under 18 U.S.C. 1001. Section 11.18(b) applies to
any paper presented to the Office, whether by a practitioner or non-
practitioner.

   Section 1.290(h) provides that in the absence of a request by the
Office, an applicant need not reply to a third-party submission under
§ 1.290. Where the Office believes information from applicant is
needed, the Office may issue a requirement for information pursuant to
§ 1.105. In view of public comments received regarding
misinterpretations of the Office's use of the term "duty" in the
proposed requirement, § 1.290(h) has been revised in this final
rule to delete its use. While the comments interpreted the use of the
term "duty" in the proposed requirement as an intent to incorporate a
statement relative to the duty of disclosure under § 1.56, the use
of the term "duty" was in keeping with the general concept that
applicants need not comment on third-party submissions based solely on
the presence of such submissions.

   Section 1.290(i) provides that the provisions of § 1.8 do not
apply to the time periods set forth in § 1.290. Third parties may
not use a certificate of mailing or transmission in filing a third-
party submission under § 1.290. By not according a third-party
submission filed by first class mail the benefit of its date of deposit
with the USPS pursuant to a § 1.8 certificate of mailing, the
Office reduces the potential for papers crossing in the mail. That is,
the requirement of § 1.290(h) reduces the risk that a third-party
submission, if it was permitted to rely on a certificate of mailing to
be timely, would not be identified and entered until after an Office
action is mailed. The requirement of § 1.290(h) also encourages
third parties to file third-party submissions at their earliest
opportunity. Additionally, because facsimile transmission of third-
party submissions under § 1.290 is not permitted, the use of a
certificate of transmission pursuant to § 1.8 is not applicable.
Facsimile transmissions, although not subject to the delay associated
with first class mail, are often received in poor quality, which may
result in illegible content and cause the submission to be found non-
compliant. The use of USPS Express Mail service pursuant to § 1.10
is permitted for third-party submissions under § 1.290 as it
carries with it the risk of little, if any, delay. Nonetheless, the
fastest and most legible means for transmitting a third-party
submission is electronically via the dedicated Web-based interface the
Office has developed for these submissions.

   Section 1.291: This final rule amends portions of § 1.291 for
clarity and also for consistency with new 35 U.S.C. 122(e) and
§ 1.290, where appropriate.

   The proposed addition of a reference to 35 U.S.C. 122(b) in the
§ 1.291(b) requirement that a protest be filed prior to the date
the application was published under § 1.211 has not been retained
in this final rule in view of public comments received. See Changes to
Implement the Preissuance Submission by Third Parties Provision of the
Leahy-Smith America Invents Act, 77 FR 451. The comments questioned
whether the inclusion of 35 U.S.C. 122(b) suggested that an earlier
publication by WIPO of an international application designating the
U.S. could trigger the end of the § 1.291(b) time period for an
application which entered the national stage from the international
application after compliance with 35 U.S.C. 371. Because there has been
no change in Office policy that a publication by the Office under
§ 1.211 triggers the end of the time period under § 1.291(b) for
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filing a protest, absent an earlier notice of allowance, the proposed
reference to 35 U.S.C. 122(b) has not been retained, thereby clarifying
that an earlier publication of the application by WIPO would not
prevent a protest from being filed in accordance with § 1.291(b).

   Section 1.291(b) is amended by including "given or" before
"mailed" to provide for electronic notification of the notice of
allowance (i.e., via the e-Office action program).

   Section 1.291(b)(1) is amended to more clearly define the time
period for submitting protests under § 1.291 that are accompanied
by applicant consent. Specifically, § 1.291(b)(1) is amended to
provide that, if a protest is accompanied by the written consent of the
applicant, the protest will be considered if the
protest is filed prior to the date a notice of allowance under
§ 1.311 is being given or mailed in the application. This amendment
provides a definite standard for both the Office and third parties and
gives more certainty as to when a protest under § 1.291 that is
accompanied by applicant consent would or would not be accepted by the
Office. Moreover, it is reasonable that the time period for submission
ends when a notice of allowance is given or mailed in the application
in view of the current publication process. Under the current
publication process, final electronic capture of information to be
printed in a patent will begin as soon as an allowed application is
received in the Office of Data Management, which occurs immediately
after the notice of allowance has been given or mailed. See MPEP § 1309.

   Section 1.291(c) identifies required content of a protest. Section
1.291(c)(1) is amended to provide that any protest under § 1.291
must include an information list identifying the documents, portions of
documents, or other information being submitted. Unlike § 1.290(d)(1),
which refers to a "document list" because a third-party submission under
§ 1.290 is limited to publications, § 1.291(c)(1) now refers to an
"information list" because § 1.291 provides for the submission of
information other than publications, including any facts or information
adverse to patentability. See MPEP §§ 1901 and 1901.02. Like § 1.290(d)(1),
§ 1.291(c)(1) provides for the listing of either entire documents or
portions of documents, as deemed appropriate by the protestor.
Additionally, § 1.291(c)(1) also provides for the listing of other
information.

   Sections 1.291(c)(1)(i) through (c)(1)(v) are added to set forth
the requirements on how to identify the items in the § 1.291(c)(1)
information list, consistent with the requirements set forth in
§§ 1.290(e)(1) through (e)(4), where appropriate. Section
1.291(c)(1)(i) requires that each U.S. patent be identified by patent
number, first named inventor, and issue date. Section 1.291(c)(1)(ii)
requires that each U.S. patent application publication be identified by
patent application publication number, first named inventor, and
publication date. Section 1.291(c)(1)(iii) requires that each foreign
patent or published foreign patent application be identified by the
country or patent office that issued the patent or published the
application; the applicant, patentee, or first named inventor; an
appropriate document number; and the publication date indicated on the
patent or published application. The requirement for U.S. patents and
patent application publications to be identified by first named
inventor, and for foreign patents and published patent applications to
be identified by the applicant, patentee, or first named inventor, is
intended to aid in identifying the items in the information list in the
event the application number, publication number, or other appropriate
document number data is, for example, inadvertently transposed.

   In view of comments submitted by the public expressing concern that
the identity of the first named inventor of a foreign patent/published
patent application may not be known in some instances,
§ 1.291(c)(1)(iii) of this final rule offers more flexibility in
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permitting identification of foreign patents and published patent
applications by the applicant, patentee, or first named inventor. See
Changes to Implement the Preissuance Submission by Third Parties
Provision of the Leahy-Smith America Invents Act, 77 FR 454.

   Section 1.291(c)(1)(iv) requires that each non-patent publication
be identified by author (if any), title, pages being submitted,
publication date, and where available, publisher and place of
publication. Section 1.291(c)(1)(iv) does not preclude a protestor from
providing additional information not specified in § 1.291(c)(1)(iv)
(e.g., journal title and volume/issue information for a journal
article). In view of comments submitted by the public expressing
concern that publisher and place of publication information may not be
available in some instances, § 1.291(c)(1)(iv) of this final rule
emphasizes that such information need only be provided where it is
available. The qualifier "where such information is available" no
longer applies to each item of information specified in
§ 1.291(c)(1)(iv), as proposed, because at least a minimum amount of
identifying information must be provided to establish the listed item
as a non-patent publication.

   Section 1.291(c)(1)(v) requires that each item of "other
information" be identified by date, if known. This requirement
accounts for the submission of information other than patents and
publications, including any facts or information adverse to
patentability. See MPEP §§ 1901 and 1901.02. For example, if a
publication date for a document is not known and the document is not
being relied upon as a publication, the protestor may list such
document as "other information" pursuant to 1.291(c)(1)(v).

   Section 1.291(c)(2) requires a concise explanation of the relevance
of each item identified in the information list. Comments questioned
the necessity for maintaining § 1.291 in view of new § 1.290 if
both require the third party to comment on the relevance of the items
being submitted. For example, if the concise explanation requirement of
§ 1.291(c)(2) is no different than the concise description of
relevance required by 35 U.S.C. 122(e)(2)(A) and § 1.290(d)(2),
then a question is raised as to whether it is necessary to maintain
§ 1.291. See Changes to Implement the Preissuance Submission by
Third Parties Provision of the Leahy-Smith America Invents Act, 77 FR
454. Unlike the concise description of relevance required by 35 U.S.C.
122(e)(2)(A) and § 1.290(d)(2) for a preissuance submission, the
concise explanation for a protest under § 1.291(c)(2) allows for
arguments against patentability. To eliminate any confusion, this final
rule retains the language of § 1.291(c)(2) in requiring that a
protest must include a "concise explanation of the relevance" of each
item of information submitted as opposed to the proposed "concise
description of the asserted relevance," and highlights a distinction
between the concise explanation required under § 1.291(c)(2) for
protests and the concise description required by 35 U.S.C. 122(e)(2)(A)
and § 1.290(d)(2) for preissuance submissions.

   Section 1.291(c)(3) requires a legible copy of each item identified
in the information list, other than U.S. patents and U.S. patent
application publications. Section 1.291(c)(3) is amended to clarify
that copies of information submitted must be legible. See
§ 1.98(a)(2) and MPEP § 609.04(a). Section 1.291(c)(3) is also
amended to provide that copies of U.S. patents and U.S. patent
application publications need not be submitted because such documents
are readily accessible to examiners. The proposed language "unless
required by the Office" has not been retained in this final rule as
the Office will not be communicating with protestors other than where a
return receipt self-addressed postcard acknowledging receipt of a
protest is mailed. Where only a portion of a document is listed as an
item in the information list, the protestor must only submit a copy of
that portion and not a copy of the entire document (e.g., where a
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particular chapter of a book is listed and not the entire book).
Further, when a copy of only a portion of a document is submitted, the
protestor should also submit copies of pages of the document that
provide identifying information (e.g., a copy of the cover, the title
page, the copyright information page, etc.).

   Section 1.291(c)(4) requires an English language translation of any
non-English language item identified in the information list. A
translation submitted pursuant to § 1.291(c)(4) may be a reliable
machine translation and need not be certified. Section 1.291(c)(4) has
been clarified in this final rule in view of comments submitted by the
public expressing concern regarding a situation where a protestor cites
and provides a translation for only a portion of a non-English language
document but submits a copy of the entire non-English language
document. The comments questioned whether an applicant would have a
duty to cite and translate the remaining portions of the non-English
language document in this situation. Section 1.291(c)(1) provides for
the listing of entire documents or portions of documents, and
§§ 1.291(c)(3) and (4) require a copy and translation,
respectively, of each item listed pursuant to § 1.291(c)(1). Thus,
where only a portion of a non-English language document is listed, a
protestor must not submit a copy of the entire non-English language
document. Rather, the protestor must submit a copy of the listed
portion of the non-English language document and a translation of only
this portion.

   Section 1.291(f) is amended to provide that in the absence of a
request by the Office, an applicant need not reply to a protest under
§ 1.291. In view of public comments received regarding
misinterpretations of the Office's use of the term "duty" in the
proposed requirement for § 1.290(h), both § 1.290(h) and
§ 1.291(f) have been revised in this final rule to delete its use. While
the comments interpreted the use of the term "duty" in the proposed
requirement for § 1.290(h) as an intent to incorporate a statement
relative to the duty of disclosure under § 1.56, the use of the
term "duty" in § 1.291(f) was in keeping with the general concept
that applicants need not comment on a protest solely because one has
been entered into the application.

   Section 1.292: Section 1.292 is removed and reserved. The practice
of providing a pre-grant public use proceeding as set forth in
§ 1.292 is no longer considered necessary, and is inefficient as compared
to alternative mechanisms available to third parties for raising prior
public use, for example, as provided for by § 1.291 protests, where
appropriate, and also by section 6 of the AIA which makes available a
post-grant review proceeding. Petitions to institute public use
proceedings filed under former § 1.292 on or after the effective
date of this final rule will not be entered or otherwise treated by the
Office. Instead, they will be discarded.

   Section 41.202: Section 41.202 is amended to remove a reference to
§ 1.99 for consistency in view of the removal of § 1.99.

   Comments and Response to Comments: As discussed previously, the
Office published a notice on January 6, 2012, proposing to change the
rules of practice to implement the preissuance submissions by third
parties provisions of section 8 of the AIA. See Changes to Implement
the Preissuance Submission by Third Parties Provision of the Leahy-
Smith America Invents Act, 77 FR 448-457. The Office received thirty-
six written comments (from intellectual property organizations,
academia, industry, law firms, individual patent practitioners, and the
general public) in response to this notice. The comments and the
Office's responses to the comments follow:

A. Submission Requirements

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1. Identification of Documents

   Comment 1: A number of comments suggested revising some of the
requirements for identifying documents set forth in proposed
§§ 1.290(e) and 1.291(c)(1). These suggestions are detailed with the
Office's response to this comment.
   Response: In response to the comments, the proposed requirements
for identifying foreign patents or published foreign patent
applications pursuant to §§ 1.290(e)(3) and 1.291(c)(1)(iii)
and for identifying non-patent publications pursuant to
§§ 1.290(e)(4) and 1.291(c)(1)(iv) have been modified in this final rule.
For example, when identifying foreign patents or published foreign
patent applications pursuant to §§ 1.290(e)(3) and
1.291(c)(1)(iii), at least one of the applicant, patentee, or first
named inventor must be identified. This requirement offers flexibility
in identification, such as where a foreign jurisdiction does not
require inventors be named or allows inventors to remain anonymous.

   Additionally, § 1.290(e)(4) and 1.291(c)(1)(iv) require
identification of non-patent publications by publisher and place of
publication only where such information is available. With the
increasing use of the Internet for publication, many non-patent
publications do not identify a publisher or place of publication, so
such information need only be provided where it is available. Sections
1.290(e)(4) and 1.291(c)(1)(iv) do not, however, preclude additional
identifying information, not specified in the rules, from being
provided (e.g., journal title and volume/issue information for a
journal article). Section 1.290(e)(4) also requires evidence
establishing publication if the date of publication is not available.
For example, such evidence might establish a date the document was
publicly available.

   2. English language translation of listed non-English language
documents:

   Comment 2: A number of comments suggested revising the requirements
set forth in proposed §§ 1.290(d)(4) and 1.291(c)(4) requiring
a translation of "all relevant portions" and "all the necessary and
pertinent parts," respectively, of any non-English language document.
One comment suggested a third party be required to provide a
translation of all portions, or to redact any non-translated portions.
The comment stated that if a third party submits a copy of an entire
non-English language document and only translates and cites a portion
of the document, the applicant may have a duty to translate and cite
the remaining portions. Other comments suggested that a full
translation of any non-English language document be required so the
examiner can determine if the document as a whole stands for the
proposition for which it is cited. Alternatively, it was suggested a
third party be required to submit any translation in its possession.
   Response: Sections 1.290(d)(4) and 1.291(c)(4) have been modified
from the proposed rule to clarify that an English language translation
of any non-English language item identified in the document or
information list, respectively, is required. Sections 1.290(d)(1) and
1.291(c)(1) provide for the listing of entire documents or portions of
documents. Sections 1.290(d)(3) and (4) require a copy and translation,
respectively, of each item listed pursuant to § 1.290(d)(1), and
§§ 1.291(c)(3) and (4) require a copy and translation,
respectively, of each item listed pursuant to § 1.291(c)(1). Thus,
where only a portion of a non-English language document is listed, a
third party or protestor must not submit a copy of the entire non-
English language document. Rather, the third party or protestor must
submit only a copy of the listed portion of the non-English language
document and only a translation of this portion. Where an entire non-
English language document is listed, a third party or protestor should
submit a copy and a translation of the entire non-English language
document.
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   Any translations submitted pursuant to §§ 1.290(d)(4) and
1.291(c)(4) may be a reliable machine translation and need
not be certified. The requirements of §§ 1.290(d)(4) and
1.291(c)(4) are different from the requirement of § 1.98(a)(3)(ii),
which requires a copy of any translation of a non-English language
document cited in an IDS that is "within the possession, custody, or
control of, or is readily available to any individual designated in
§ 1.56(c)."

3. Application Number

   Comment 3: A number of comments asserted that the requirement of
proposed § 1.290(c) to identify the application number on each page
of the submission (except for the copies of documents) is unnecessary
and burdensome. Several comments stated that the application number
should appear on at least the first page of the submission and that,
while it may be a best practice to include the application number on
each page of the submission, it should not be required.
   Response: Based on the comments, the Office understands that the
requirement in proposed § 1.290(c) that the application number of
the application to which the submission is directed be identified on
every page of the submission was overly burdensome. Accordingly, the
final rule does not include this requirement. Instead, § 1.290(e)
only requires that the document list set forth in § 1.290(d)(1)
identify on each page of the list, the application number of the
application in which the submission is being filed. This requirement
is consistent with the requirement set forth in § 1.98(a)(1)(i) for
applicant IDS listings.

B. Documents

1. Corroboration of Documents

   Comment 4: One comment suggested the examiner should objectively
corroborate submitted documents and be permitted to ignore any
documents that cannot be corroborated (e.g., as a publication). The
comment suggested the Office should not blindly accept submissions as
true and accurate and should entertain challenges to the accuracy of
third-party statements that are not objectively verifiable (e.g., a
journal article might be verifiable, whereas a marketing pamphlet
might be less so).
   Response: Submissions filed pursuant to § 1.290 will be
reviewed before being forwarded to an examiner for consideration.
During this review, the Office will determine if the documents
submitted for consideration appear on their faces to be publications.
If any of the submitted documents are found not to be a publication,
the entire submission will be found not to comply. In such a situation,
the submission will not be entered into the patent application file or
considered by the examiner and will be discarded. If the submission is
determined to be compliant, the publications will be considered by the
examiner and entered into the file, as required by 35 U.S.C. 122(e). If
the patent applicant, however, has evidence that a document filed by a
third party is, in fact, not a publication, then the applicant can
challenge the determination by the Office that the document is a
publication in response to a rejection applying the document in
question.

   Comment 5: One comment questioned whether an examiner can request
additional information from a third party under § 1.105. The
comment suggested it should be at the option of the third party to
respond to any such request and that there should be no effect on the
original submission if the third party does not comply with the
request.
   Response: Section 1.105 provides an examiner or other Office
employee with the authority to require the submission, from individuals
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identified under § 1.56(c), or any assignee, of such information as
may be reasonably necessary to properly examine or treat a matter.
Section 1.290(d)(5)(i) does not permit a third party to be a
§ 1.56(c) party. An examiner cannot therefore request additional
information from a party who makes a third-party submission. The Office
does not believe there is a need for a similar mechanism to require
further information from third-party submitters as the third parties
will be motivated to provide complete submissions that would not likely
require further information.

   Comment 6: A number of comments suggested evidence should be
required to establish the relevant date of documents not in print, such
as documents only published electronically on the Internet. One comment
suggested the rules explicitly provide for the submission of
screenshots from Web sites, such as "www.archive.org," that evidence
the content of Web pages at specified dates in the past because such
screenshots are relevant to novelty considerations under 35 U.S.C. 102
and can be readily verified.
   Response: Section 1.290(e)(4) requires non-patent publications be
identified by author (if any), title, pages being submitted,
publication date, and where available, publisher and place of
publication. Section 1.290(e)(4) further requires that, if no
publication date is known, the third party must provide evidence of
publication. This requirement recognizes that some documents, such as
the content of a Web site, may not indicate a date of publication. See
MPEP 2128. Section 1.290(e)(4) does not require the evidence of
publication be submitted in a particular format. For example, the third
party might submit as evidence of publication a printout from the Web
site showing that the content of the Web site was publicly available at
least as of the date retrieved shown on the printout, or screenshots
from a Web site that establish the content of the Web site on a
particular date (like www.archive.org). In some instances, the copy of
the document provided pursuant to § 1.290(d)(3) may itself be the
evidence, such as where a printout from the Web site showing the date
the document was retrieved is provided to satisfy the copy requirement.
Each item of evidence submitted will be evaluated with respect to both
its authenticity and its persuasiveness.

2. Prior Art Documents

   Comment 7: A number of comments requested clarification as to
whether the proposed rules allow submissions of documents that are not
prior art to the patent application. These comments also suggested the
rules not permit submission of non-prior art documents. A number of
comments also proposed adding a requirement that the third party
indicate whether the documents submitted are prior art or are not prior
art.
   Response: Pursuant to 35 U.S.C. 122(e), "[a]ny third party may
submit for consideration and inclusion in the record of a patent
application, any patent, published patent application, or other printed
publication of potential relevance to the examination of the
application." The statute does not limit the publications that can be
submitted to prior art publications. Accordingly, § 1.290(a) does
not require that publications be prior art in order to be considered by
an examiner. Additionally, the Office is not requiring a third party to
indicate whether a listed document is or is not asserted to be prior
art because a mistake in complying with such a requirement could cause
a submission to be found not in compliance with § 1.290. The Office
believes the benefit of such a statement is outweighed by the potential
that the submission will be found not to comply should the Office
disagree with the third party.

   Comment 8: A number of comments requested further clarification on
what documents would be admitted or excluded as "other printed
publications" under proposed § 1.290(a). These comments also requested
that publicly accessible documents of potential relevance to the
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examination of the application be permitted, such as litigation papers
not subject to a protective order and otherwise available to the public.
   Response: Section 1.290(a) does not limit the type of printed
publications that can be filed as part of a compliant submission.
Litigation papers and court documents not subject to a court-imposed
protective or secrecy order can be submitted for consideration and
entry under § 1.290(a) if they qualify as publications. See MPEP
§ 2128. Documents that are subject to a court-imposed protective or
secrecy order, documents that include trade secret information,
unpublished internal documents, or other non-patent documents that do
not qualify as publications should not be submitted for consideration
and entry under § 1.290(a).

   Comment 9: A number of comments suggested amending proposed
§ 1.290(e)(4) to clarify what is required to establish the date of a
non-patent publication asserted to be prior art if the date is "not
apparent from the document."
   Response: This final rule revises the requirement of proposed
§ 1.290(e)(4) that the third party bears the burden of establishing the
date of a non-patent publication asserted to be prior art if the date
is not apparent from the document. A compliant submission pursuant to
§ 1.290 requires that all documents for consideration and inclusion
into the file of an application be publications. Thus,
§ 1.290(e)(4) requires a third party to provide evidence of publication
where the publication date of a document is not known, regardless of
whether the document is asserted to be prior art. As a result, third
parties making such a submission must either submit documents that are
prima facie publications or evidence that establishes that they are
publications. The Office is not requiring specific types of evidence to
prove publication, but where the actual publication date of a non-
patent document is not known, a third party should, at a minimum,
provide a date of retrieval or a timeframe (e.g., a year, a month and
year, a certain period of time) when the document was available as a
publication for purposes of identifying the document by publication
date pursuant to § 1.290(e)(4), in addition to including evidence
that establishes the document as a publication. In such situations, the
evidence that may be submitted by a third party includes affidavits or
declarations, or may be present on the copy of the document itself
submitted pursuant to § 1.290(d)(3).

3. Submissions Related to Documents Already of Record

   Comment 10: A number of comments requested clarification as to
whether the proposed rules allow submissions and descriptions of
relevance in connection with patents, published patent applications, or
other printed publications that are already of record in a patent
application.
   Response: 35 U.S.C. 122(e) states: "Any third party may submit for
consideration and inclusion in the record of a patent application, any
patent, published patent application, or other printed publication of
potential relevance to the examination of the application." The
statute does not limit submissions to publications that are not already
of record in a patent application. Accordingly, new § 1.290 does
not place this limitation on the publications that can be submitted. As
a result, third-party submissions pursuant to § 1.290 can include
patents, published patent applications, or other printed publications
that are already of record in an application where the submission is
otherwise compliant.

   Comment 11: Some comments suggested amending proposed § 1.290
to prohibit cumulative submissions. One comment suggested that where
more than three documents are submitted, the third party should be
required to explain which documents, up to three, are most relevant and
why any other submitted documents are not merely cumulative.
   Response: While it would be a best practice for third parties not
to submit documents that are cumulative of each other or that are
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cumulative of information already under consideration by the Office,
§ 1.290 does not explicitly prohibit cumulative submissions because
it has been the Office's experience that identifying purely cumulative
submissions is difficult, such as where the submission includes both a
publication and a description of the publication's relevance. Where a
concise description of relevance is not identical to another party's
concise description of relevance, and the submission is otherwise
compliant, the submission will be entered into the file of the
application. Thus, while a document submitted may appear on its face to
be cumulative of information already of record, its accompanying
concise description of relevance may provide additional information
with respect to the document, such that the submission of the document,
together with the concise description of relevance of the document, is
not cumulative of information already of record. For example, a
submission including documents cited in the background section of an
application would not be considered cumulative if accompanied by
concise descriptions of relevance that provide additional information
regarding the documents.

4. Limits on Submissions

   Comment 12: Several comments raised concerns regarding the
potential for third parties to "flood" an application with third-
party submissions. One comment suggested that, with no contemplated
limit on the number of third-party submissions that may be made in an
application, an examiner could become "buried" and, as a result,
potentially miss highly relevant art. Another comment asserted that the
fee structure alone may not go far enough to prevent harassment where
the third party is allowed to remain anonymous.
   Response: Third-party submitters are subject to § 11.18(b)(2),
which provides that a party presenting a paper to the Office, whether a
practitioner or non-practitioner, is certifying that "to the best of
the party's knowledge, information and belief, formed after an inquiry
reasonable under the circumstances, [t]he paper is not being presented
for any improper purpose, such as to harass someone or to cause
unnecessary delay or needless increase in the cost of any proceeding
before the Office." Accordingly, Office rules already prohibit third
parties from purposely "flooding" an application with third-party
submissions in order to cause unnecessary delay in the prosecution of
the application. Moreover, the statute does not impose any limit on the
number of third-party submissions that may be filed in an application.
The Office, in turn, has not imposed any limit on the number of third-
party submissions that may be filed in applications so as not to
preclude examiners from having all relevant information before them
when examining applications. To limit the number of third-party
submissions in an application might preclude some third parties from
filing potentially relevant information. Further, because highly
relevant documents can be obfuscated by voluminous submissions, third
parties should be motivated to limit any third-party submission to only
the most relevant documents and should not be motivated to "flood"
the Office with irrelevant submissions.

   Comment 13: Some comments suggested the Office limit the number of
pages in a third-party submission thatwill be considered by an examiner.
For example, one comment suggested amending § 1.290(f) to require a third
party to identify up to 50 of the most relevant pages of the submitted
documents where the cumulative number of pages of the submitted documents,
other than patents or published patent applications, exceeds 50 pages.
   Response: The Office has not imposed any limit on the total number
of pages that may be submitted in a third-party submission because, to
do so, could prevent an examiner from considering all of the relevant
information submitted. Further, if a third party deems more than 50
pages in a submission to be relevant to the examination of an
application, an examiner should not be precluded from reviewing all of
the pages of information deemed to be relevant. Nevertheless, a third
party should avoid making a submission unnecessarily voluminous as
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voluminous submissions tend to obfuscate the most relevant information.

5. Electronic Sources

   Comment 14: One comment requested clarification regarding what is
considered a separate document on a Web site. The comment questioned
whether each page of a single Web site would constitute a separate
document.
   Response: What constitutes a separate document on a Web site will
vary case-by-case. For example, if a single article posted on a Web
site spans multiple Web pages, each such Web page would not constitute
a separate document. On the other hand, if a Web site includes
different articles and each appears on a different Web page, then each
such Web page would constitute a separate document, even though each
article is available from the same Web site.

6. Third Party Participation

   Comment 15: One comment suggested the Office not permit third-party
submissions of documents that were prepared by the third party solely
to address patentability issues in an application. The comment
suggested the Office require a statement that the third party or its
privies did not draft the cited documents after the application was
filed to contest patentability.
   Response: Third parties are cautioned that submission of documents
drafted after the application was filed solely to contest patentability
may result in non-entry of an entire third-party submission. A concise
description of relevance under § 1.290 is not an invitation for
third-party participation in the examination of an application. Thus,
the concise description of relevance of a document, which was prepared
by a third party after an application was filed solely to contest the
patentability of the application, would likely be deemed an improper
attempt by the third party to impermissibly participate in the
examination of the application because the relevance of the document
being described is its discussion of the patentability of the
application. As a result of the improper concise description, the
entire third-party submission that includes such document would not be
entered.

C. Consideration of Documents

1. Consideration by an Examiner

   Comment 16: A number of comments requested clarification as to how
examiners will consider documents and concise descriptions of relevance
submitted in third-party submissions pursuant to the guidance set forth
in the MPEP at §§ 609.05(b), 904.03, 2256, and 2656.
   Response: Examiners will consider documents and concise
descriptions of relevance submitted in compliant third-party
submissions in the same manner that examiners consider information and
concise explanations of relevance submitted as part of IDSs in patent
applications. Generally with the next Office action following the entry
of third-party submission, a copy of the third party's listing of
documents, with an indication of which documents were considered by the
examiner, will be provided to the applicant. The indication that a
document has been considered by the examiner will mean that the
examiner has considered both the listed document and its accompanying
concise description. The examiner will apply the information in a
compliant third-party submission as the examiner deems necessary, but
will not be expected to comment on each submitted document and concise
description of relevance.

   Parties should keep in mind that examiner consideration of a
document and its accompanying concise description of relevance does not
mean that the examiner agrees with the third party's position regarding
the document, only that the examiner considered the publication and its
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accompanying description. For example, a third party might assert that
a particular document is prior art but the examiner might determine
that the assertion is incorrect in view of the application's earliest
effective filing date. In such a situation, the examiner will still
consider the document and the concise description of relevance even
though the examiner determined that the document is not prior art.

2. Distinguish Third-Party Submitted Documents

   Comment 17: Several comments suggested the Office print considered
third-party submitted documents on the patent with a font or symbol
that distinguishes them from applicant-submitted documents and
examiner-cited documents. One comment also suggested the Office
similarly distinguish references entered into the image file wrapper
(IFW) of an application.
   Response: The Office is updating its existing information
technology (IT) systems to permit considered third-party submission
documents to be distinguished on an issued patent from documents cited
by the applicant and by the examiner, and also to distinguish third-
party submission papers from other papers in the IFW of an application.
The Office intends to have these updates completed prior to or shortly
after the effective date of this final rule.

D. Concise Description of Relevance

   Comment 18: One comment suggested that the Office indicate that the
standard set forth in proposed § 1.290(a) for documents to be of
"potential relevance to the examination of the application" is
intended to be a low threshold so that third parties are encouraged to
submit potentially relevant documents.
   Response: The standard under § 1.290(a) for the documents
submitted to be of "potential relevance to the examination of the
application" is specified by 35 U.S.C. 122(e)(1). This standard
requires the submitter to believe the documents being submitted are
relevant to the extent that the submitter can provide the statutorily
required concise description of the asserted relevance of each document
submitted. See 35 U.S.C. 122(e)(2)(A).

   Comment 19: Some comments requested the Office clarify the
threshold for non-compliance for concise descriptions of relevance. One
comment suggested the Office make the concise description requirement a
low threshold that can be easily satisfied so that third parties are
encouraged to participate. A number of comments requested more guidance
and examples on concise descriptions. Several comments requested
further guidance regarding what would be considered non-compliant
(e.g., bare statements) and what would be considered "concise." One
comment further recommended the Office publish samples of third-party
submission filing documents and Office communications concerning
third-party submissions.
   Response: The Office is interpreting the requirement for a concise
description of relevance liberally because the Office anticipates third
parties will be motivated to provide complete concise descriptions of
relevance to draw the examiner's attention to the potential relevance
of a submitted document to the examination of an application. At a
minimum, a concise description of relevance must be more than a bare
statement that the document is relevant. For example, the statements
"Document 1 is relevant," "See Document 1," and "Document 1
discloses/may disclose the invention" would not be considered anything
more than bare statements of relevance that do not rise to the level of
meaningful concise descriptions. Additionally, merely highlighting or
otherwise annotating the copy of the submitted document itself will not
be deemed a proper concise description of relevance. Further, concise
descriptions of relevance that appear to be mere form paragraphs/
letters in opposition to a general class of invention or technology
will not be deemed proper concise descriptions of relevance.

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   The statutory requirement for a concise description of relevance
should not be interpreted as permitting a third party to participate in
the prosecution of an application. 35 U.S.C. 122(c) prohibits the
initiation of a protest or other form of pre-issuance opposition for
published applications without the consent of the applicant. Therefore,
while a concise description of relevance may include claim charts
(i.e., mapping various portions of a submitted document to different
claim elements), the concise description of relevance is not an
invitation to a third party to propose rejections of the claims, or set
forth arguments relating to an Office action in the application or to
an applicant's reply to an Office action in the application. Further,
while third parties should refrain from submitting verbose descriptions
of relevance, not only because the statute calls for a "concise"
description but also because a focused description is more effective in
drawing the examiner's attention to the relevant issues, the Office has
not established an upper limit on the size of a concise description at
this time.

   Any sample third-party submission filing documents that the Office
provides may not be appropriate in all situations; however, the Office
intends to provide additional guidance on filing third-party
submissions on its Web site, www.uspto.gov.

   Comment 20: One comment suggested a third party need only explain
"how" a document is of potential relevance, and suggested that it is
unnecessary to explain both "how and why" a document is relevant, as
discussed in the proposed rule package. See Changes to Implement the
Preissuance Submission by Third Parties Provision of the Leahy-Smith
America Invents Act, 77 FR 452 (stating that "[t]he concise
description should explain why the document has been submitted and how
it is of potential relevance to the examination of the
application * * *.").
   Response: The Office did not intend to suggest that two separate
statements are required in order to comply with § 1.290(d)(2) as
the statute only requires one statement of the asserted relevance of
each submitted document. Accordingly, the third party need only provide
for each document submitted one concise description setting forth the
asserted relevance of the document.

   Comment 21: One comment recommended the Office amend the rules to
explicitly exclude declarations, such as expert declarations, as
concise descriptions of relevance because applicants would not be able
to readily contest such testimonial evidence during prosecution.
   Response: 35 U.S.C. 122(e) provides for the submission of evidence
in the form of patents, published patent applications, and other
printed publications. A concise description of relevance for a
submitted document is not considered evidence but, rather, a statement
of facts regarding the submitted evidence. Accordingly, the Office will
not consider a declaration as evidence, where such declaration is
submitted as a concise description of relevance for a document. Third
parties relying on declarations as concise descriptions of relevance
should ensure the concise description of relevance does not amount to
an attempt at third-party participation in the examination of the
application.

E. Third Party

1. Anonymity

   Comment 22: One comment expressed concern that preserving the
anonymity of the third party could negatively impact small entities
where large competitors seek out third parties to file excessive third-
party submissions against small start-up companies, which might not
have the funds, or be able to acquire the funds from their financial
backers, to address such submissions.
   Response: Section 1.290(h) makes clear, and its related preamble
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further explains, that the Office believes there is no need for
applicants in general to address third-party submissions. The examiner
will review the submissions, and should an issue arise where
information from the applicant is desired, the Office will frame the
issue and request information from the applicant under § 1.105.
Such requests are envisioned to be rare and limited in scope and
therefore well within the ability of any applicant to reply, including
small start-up companies.

   Additionally, the Office believes that providing anonymity would
encourage small entity third parties to submit prior art. Without such
anonymity, there are situations where potential third-party small
start-ups would be hesitant to make a third-party submission, such as
where the third party would be concerned with damaging a valuable
relationship with the larger applicant. Anonymity helps small start-ups
in supplying prior art against applications submitted by large entities
(not necessarily competitors) with whom they may have a relationship.

   Comment 23: A number of comments suggested making explicit in the
rules that the real party in interest need not be identified and that
the submitter may also remain anonymous where the submitter is not the
real party in interest. Several comments asserted that the identity of
the party making the submission for the real party in interest should
also be protected because the identity of the submitter (e.g., a
particular attorney or law firm) could, in some instances, implicitly
give away the identity of the real party in interest and that such
protection would likely encourage more third-party submissions. Some
comments have suggested ways for the Office to protect the identity of
a party making a third-party submission for a real party in interest.
   Response: The absence of an identification requirement in § 1.290
makes clear that there is no requirement to identify a real party
in interest. The absence of such requirement is reinforced by the
explanation of such in the preamble.

   The Office cannot permit a third-party submission to be presented
unsigned by the submitter in view of the signature requirement in
§ 1.4 for papers filed in a patent application, which require a person's
signature. Third-party submissions are required to be signed because
§§ 1.290(d)(5) and (g) require statements by the party making
the submission. Therefore, to permit anonymity of the submitter, the
Office would need a special procedure to hide the submitter's identity,
which would impose an unjustifiable burden in view of the ease with which
the real party in interest can be shielded notwithstanding identification
of a submitter.

   Comment 24: To the extent the Office collects identifying
information regarding the submitter, some comments have suggested ways
of collecting the information and means of keeping such identifying
information confidential and preventing its entry into the IFW.
   Response: The Office, at this time, does not intend to collect
identifying information from submitters who utilize § 1.290. In
view of the signature requirement in § 1.4 for all papers filed in
a patent application, which require a person's signature, only the name
of the submitter will be identified upon entry of a compliant third-
party submission into the IFW of an application.

2. Registered Practitioners

   Comment 25: Some comments suggested that only registered patent
practitioners should be able to file third-party submissions. One
comment suggested that registered practitioners are presumed qualified
to have sufficient knowledge of patent law necessary to make the
concise descriptions of relevance, and distinguished ex parte
reexamination which may be filed by "[a]ny person at any time."
Another comment stated that the independent inventor community is
concerned that potential harassment could result if any third party can
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file a third-party submission under proposed § 1.290.
   Response: New 35 U.S.C. 122(e)(1) provides for "[a]ny third
party" to file a preissuance submission. Any member of the public,
including private persons, corporate entities, and government agencies,
may file a third-party submission under § 1.290. An attorney or
other representative on behalf of an unnamed real party in interest
likewise may file a third-party submission since § 1.290 does not
require that the real party in interest be identified. To limit the
filing of third-party submissions to registered practitioners would be
contrary to the express language of the statute and potentially exclude
parties that may not have the resources to hire registered
practitioners to file third-party submissions for them. Further, the
Office's experience with pilot programs, such as the Peer Review Pilot
2011, has demonstrated the capabilities of non-practitioners to make
appropriate submissions to the Office. To describe the relevance of a
submitted document to an application, submitters need not be as well-
versed in the patent laws as they should be in the field or technology
described in the application and the document being submitted.

   Regardless of who files a third-party submission, the Office will
screen the third-party submission for compliance before entering it
into the record so as to limit the potential for patent applicants to
be harassed by third parties filing non-compliant third-party
submissions. Moreover, third-party submitters are subject to
§ 11.18(b)(2), which provides that a party presenting a paper to the
Office, whether a practitioner or non-practitioner, is certifying that
"to the best of the party's knowledge, information and belief, formed
after an inquiry reasonable under the circumstances, [t]he paper is not
being presented for any improper purpose, such as to harass someone or
to cause unnecessary delay or needless increase in the cost of any
proceeding before the Office." Accordingly, Office rules already
prohibit third parties from purposely filing a third-party submission
to harass the applicant.

3. Compliance

   Comment 26: One comment asserted that given the requirements of 35
U.S.C. 122(e)(2)(C) for making a statement affirming that a submission
was made in compliance with the statute, and the requirements of
§ 11.18(b), for presenting a paper to the Office after making reasonable
inquiry that the paper is not being presented for any improper purpose,
the Office should provide explicit guidance regarding what is a
"reasonable inquiry" so far as ascertaining whether a first rejection
or notice of allowance has been issued and how a third party would be
able to demonstrate such reasonable inquiry.
   Response: What is reasonable will vary on a case-by-case basis.
However, at a minimum, third parties wishing to determine whether an
Office action rejecting any claim or a notice of allowance has been
issued in a published application should avail themselves of the
Office's public Patent Application Information Retrieval (PAIR) system
to obtain the application's status prior to making a third-party
submission.

F. Proposed Fees

1. Proposed Fee Schedule

   Comment 27: A number of comments suggested that proposed § 1.290(f)
be amended to charge a fee on a per-document basis as opposed
to in increments of ten documents.
   Response: Because the Office expects the processing costs to the
Office for third-party submissions under § 1.290 to be equivalent
to the processing costs to the Office for submissions under prior
§ 1.99, the Office has determined that the fee set forth in § 1.17(p)
for submissions under prior § 1.99 is also applicable to third-
party submissions under § 1.290. Thus, § 1.290(f) provides that
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any third-party submission filed under § 1.290 must be accompanied
by the fee set forth in § 1.17(p) for every ten documents or
fraction thereof being submitted.

2. Fee Exemption

   Comment 28: Several comments suggested the fee exemption provided
for in proposed § 1.290(g) could encourage abuse, which will result
in the Office being overburdened by documents for consideration by an
examiner. These comments also favored the $180 fee and suggested that
the $180 fee set forth in proposed § 1.290(f) would not discourage
a third party from filing documents that will enhance the quality of
the application's examination. Another comment proposed an alternate
fee schedule intended to balance the needs of the Office and third
parties.
   Response: Because the fee exemption provided under § 1.290(g)
only applies to a third party's first submission of three or fewer
documents in an application, the Office does not anticipate it will
become overburdened by submissions in any one application. While the
$180 fee set forth under § 1.290(f) may not be burdensome to some
third parties, the Office believes it may discourage or prevent some
third parties from making a third-party submission if even the first
document submitted incurred the $180 fee. The Office believes the fee
structure implemented in this final rule strikes a balance between
encouraging submissions so that examiners have the best documents
before them when examining applications and, at the same time,
discouraging third parties from making excessive submissions.

   Comment 29: A number of comments suggested the Office not rely on
the concept of "privity" to administer the fee exemption. One comment
suggested it will be difficult for third parties with limited legal
experience and large entities, such as corporations and universities,
to determine if privity exists. This comment also suggested that a
"privity test" in the fee exemption is not necessary to avoid abuse
because the Office's experience with the Peer-to-Patent pilot program
shows that third parties did not flood applications with documents even
though the submissions were free and could be made anonymously. This
comment further asserted that the required statement regarding privity
is likely to "chill collaboration" among third-party submitters which
might be necessary for third parties to avoid making cumulative
submissions.
   Response: The Office believes that the concept of "privity" is
well established since it is already employed in other contexts before
the Office, such as inter partes reexamination. See, e.g., § 1.907
(providing that "[o]nce an order to reexamine has been issued under
§ 1.931, neither the third party requester, nor its privies, may
file a subsequent request for inter partes reexamination of the patent
until an inter partes reexamination certificate is issued under
§ 1.997, unless authorized by the Director."). Additionally, third
parties who are concerned about not being able to make the "privity"
statement under § 1.290(g) to take advantage of the fee exemption
when making a submission in an application are not precluded from
making the submission because such parties have the option of simply
paying the required fee under § 1.290(f) instead of evaluating
whether it is appropriate to make the "privity" statement pursuant to
§ 1.290(g).

   Comment 30: One comment questioned whether a third party who made a
first third-party submission that included the statement set forth in
proposed § 1.290(g) would need to make a similar statement in each
subsequent submission (e.g., that it was previously unaware of the
documents at the time of the first submission).
   Response: Where a third party takes advantage of the fee exemption
pursuant to § 1.290(g) in a first submission, the third party is
not required to make any statement in each subsequent submission
indicating that the third party was previously unaware of the need to
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file the subsequent submission at the time the third party made the
first submission.

   Comment 31: Several comments suggested that the number of fee-
exempt documents under proposed § 1.290(g) should be changed. Some
comments suggested that the number be reduced, while others suggested
it be increased.
   Response: The Office is providing a fee exemption for the first
third-party submission in an application by that third party containing
three or fewer total documents because the submission of three or fewer
documents is more likely to assist the examiner in the examination
process than no third-party submissions. Moreover, keeping the size of
the fee exempted submission to three or fewer total documents will help
to focus the attention of third parties on finding and submitting only
the most relevant art to the claims at hand. Submission of voluminous
documents costs the Office more in processing the submission and that
cost outweighs the benefit to the examiner in having access to third-
party submissions. Thus, the provision of § 1.290(g) strikes a
balance between encouraging third parties to make focused third-party
submissions of perhaps highly relevant documents to the examination of
an application and discouraging third parties from making unnecessarily
voluminous submissions.

G. Time Periods for Submission

1. Statutory Time Periods

   Comment 32: One comment questioned whether the filing of a request
for continued examination (RCE) resets the time period for filing a
third-party submission under proposed § 1.290(b)(2)(ii).
   Response: The filing of an RCE does not reset the time period for
filing a third-party submission under § 1.290(b)(2)(ii). However,
the filing of an RCE does not preclude a third-party submission from
being filed after the RCE, if the filing of the third-party submission
would otherwise be within the time periods set forth in §1.290(b)(2).

   Comment 33: One comment asserted that the only deadline for making
a third-party submission should be the issuance date of a notice of
allowance because, among other reasons, third parties may not
immediately be aware of their competitors' patent applications.
   Response: The time period for making a third-party submission is
set by statute in 35 U.S.C. 122(e) and cannot be modified by the
Office, as the Office regulations must conform to the requirements of
the statute.

   Comment 34: A number of comments recommended amending proposed
§§ 1.290(b) and 1.291(b)(1) to state that the third-party
submission/protest must be filed "prior to" the specified date or
event instead of "before" because the meaning of the term "before"
can vary depending on the context.
   Response: Sections 1.290(b) and 1.291(b)(1) have been modified
relative to the proposed rule to require that any third-party
submission/protest must be filed "prior to" the specified date or
event.

   Comment 35: One comment requested clarification regarding whether a
third-party submission could be timely submitted after prosecution is
reopened in an application subsequent to a notice of allowance where
the publication of the application or the mailing of a first rejection
of any claim has not occurred.
   Response: The time period for making a third-party submission is
set by statute in new 35 U.S.C. 122(e), which states that a third-party
submission must be made before "a notice of allowance * * * is given
or mailed in the application." Thus, the statute does not permit a
third-party submission to be filed after a notice of allowance has been
given or mailed in an application, regardless of whether that notice of
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allowance is subsequently withdrawn.

2. "First Published"

   Comment 36: One comment suggested that the republication of an
application under § 1.221(b) should not be considered the first
publication under 35 U.S.C. 122(b) for purposes of proposed § 1.290(b)
as third parties will be given a windfall of time to file documents.
This comment also suggested that this additional time could result
in submissions not receiving timely consideration before a first
Office action is mailed.
   Response: The republication of an application under § 1.221(b)
is not the first publication by the Office under 35 U.S.C. 122(b) for
purposes of 35 U.S.C. 122(e). Accordingly, the first publication of the
application will trigger the § 1.221(b)(2)(i) time period where
appropriate.

   Comment 37: One comment suggested that publication of an
application by the World Intellectual Property Organization (WIPO)
should be considered a publication of the application for purposes of
proposed § 1.290(b).
   Response: The third-party submission timing requirement based on
the publication of the application is set forth in new 35 U.S.C.
122(e)(1)(B), which is expressly limited to the publication of the
application for patent "by the Office." This statutory provision does
not account for the publication of the application by organizations
other than the Office, such as WIPO. The timing requirement of
§ 1.290(b)(2)(i) conforms to that of the statute and, likewise, is not
triggered by the publication of the application by WIPO.

   Comment 38: One comment questioned how a third party could make a
third-party submission before a date of first rejection that is earlier
than the date the application publishes, where the existence of the
application, and its contents, is only available to that third party
after the publication date.
   Response: A third-party submission could be made before a first
rejection that is earlier than the date the application publishes where
a third party otherwise knows of the application. The time periods for
submission are set forth in new 35 U.S.C. 122(e) and cannot be modified
by the Office. The AIA included provisions for prioritization of
examination, as well as for preissuance submissions by third parties,
and the details of any individual provision, such as for preissuance
submissions, can be understood to represent a balance among the
benefits of the individual provisions of the Act.

   Comment 39: Several comments requested that the Office consider
amending the provisions of 35 U.S.C. 122(b)(2)(B)(i), which permit
applicants to make non-publication requests in their applications, to
ensure that all applications publish without condition so examiners
will have the benefit of third-party submissions during examination.
   Response: The statutory provisions of 35 U.S.C. 122(b)(2)(B)(i) are
not subject to amendment by the Office. Where the Office does not
publish an application, the date that is six months after the
publication date would not occur and, therefore, by default would be
considered later than both the date of a first rejection of any claim
and the date the notice of allowance is given or mailed in the
application. Accordingly, the date that a notice of allowance is given
or mailed in the application would control the timing of a third-party
submission in an application which has not been published, not the date
of the first rejection of any claim.

3. Certificate of Mailing/Transmission

   Comment 40: Several comments suggested amending § 1.8 to
include the exception listed in proposed § 1.290(i). One comment
suggested the Office permit use of the certificate of mailing or
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transmission under § 1.8. The comment further suggested that the
problem of papers crossing in the mail can also occur with use of
"Express Mail" service under § 1.10.
   Response: Section 1.8(a)(2)(i) has been amended to include the
exception listed in § 1.290(i). Not according a third-party
submission filed by first class mail the benefit of its date of deposit
with the USPS pursuant to a § 1.8 certificate of mailing reduces
the potential for papers crossing in the mail. This requirement reduces
the risk that a third-party submission, if it was permitted to rely on
a certificate of mailing to be timely, would not be identified and
entered until after an Office action is mailed, and encourages third
parties to file a third-party submission at their earliest opportunity.
It is desirable for papers filed under § 1.290 to be included in
the record of the patent application, and considered by the Office, at
the earliest possible point in prosecution.

   Additionally, the use of a certificate of transmission pursuant to
§ 1.8 is not applicable to third-party submissions under § 1.290
because facsimile transmission of third-party submissions is not
permitted. Facsimile transmissions, although not subject to delay, are
often received in poor quality. Errors in optical character
recognition, or lack of clarity of symbols or figures, present
potential issues with providing a "legible copy" as required by
§ 1.290(d)(3), and could cause a submission to be found non-compliant.
Further, because a submission under § 1.290 is made by a third
party, the Office will not have an opportunity to contact the third
party for clarification of any illegible content.

   The use of United States Postal Service (USPS) Express Mail service
pursuant to § 1.10 carries with it the risk of little, if any,
delay. This risk is minimal as compared to the possible delay that
could be experienced with first class mail for which a certificate of
mailing is used. The fastest and most legible means for transmitting a
third-party submission is electronically via the dedicated Web-based
interface the Office has developed for these submissions. As a
practical matter, any third-party submission should be submitted as
soon as possible after the third party becomes aware of the existence
of the application to which the submission is to be directed. By
submitting a third-party submission early in the examination process,
i.e., before the Office acts on the application if possible, the third
party ensures that the submission will be of the most benefit to the
Office in its examination of the application and increases the
likelihood that the submission will meet the statutory timing
requirements.

H. Entry of Third-Party Submissions

1. Notification to Applicant of Entry

   Comment 41: A number of comments recommended the Office directly
notify applicants of third-party submissions directed to their
applications, either when the third-party submissions are filed or when
compliant third-party submissions are entered into the applications.
   Response: The Office plans to electronically message applicants
upon entry of compliant third-party submissions directed to their
applications. In order to receive notification, however, applicants
must participate in the e-Office Action program, as such notification
will only be provided via electronic mail message (email) to program
participants.

2. Service on Applicant

   Comment 42: As an alternative to the Office directly notifying
applicants, several comments recommended requiring third parties to
serve third-party submissions on applicants. These comments suggested
that service would alleviate the burden on applicants to monitor their
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application files for third-party submissions.
   Response: Service on applicants will not be necessary in view of
the opportunity for applicants to receive electronic notification of
the entry of a third-party submission from the Office by participating
in the e-Office action program. Further, not requiring service of
third-party submissions should reduce the possibility that applicants
will gain knowledge of non-compliant third-party submissions and, as a
result, deem it necessary to independently file the submitted documents
with the Office in an IDS. Additionally, the Office is seeking to
prevent challenges regarding whether service of a third-party
submission was proper from negatively impacting the pendency of the
application.

3. Notification to Third Party of Non-Compliance

   Comment 43: A number of comments urged the Office to notify third
parties of non-compliant third-party submissions to provide those
parties an opportunity to make a resubmission if the statutory time
period has not yet expired. Several comments suggested that such notice
include the reason(s) for non-compliance. Other comments suggested the
notice of non-compliance provide procedures for curing the defect(s)
and not be made of record in the application. One comment suggested
that such notice be provided where the third party includes a
correspondence address with the submission, while another comment
suggested the Office also notify third parties when third-party
submissions are accepted.
   Response: As a courtesy, the Office intends to notify third parties
of non-compliant third-party submissions via electronic mail message
(email) where the third-party submitter includes an email address in
the third-party submission, whether the submission is filed
electronically or in paper. An issued notice of non-compliance will
indicate why the third-party submission was found to be non-compliant.
Neither the notification nor the non-compliant third-party submission
will be made of record in the application. Further, if the submission
is deemed compliant, the Office does not intend to enter the email
address provided for notification of non-compliance into the record of
the patent application.

   The Office will not notify the third-party submitter of entry of a
compliant third-party submission into the record. However, for an
electronic filing, the third party will receive immediate, electronic
acknowledgment of the Office's receipt of the submission. For a paper
filing, the third party may include a self-addressed postcard with the
third-party submission to receive an acknowledgment by the Office that
a third-party submission has been received. In either case, the
electronic acknowledgment or return receipt postcard is not an
indication that the third-party submission is compliant or has been
entered. In a published application, third parties may access public
PAIR to confirm that their submission has been entered.

   Where a third-party submission is filed in an unpublished
application, a returned postcard acknowledging receipt will not
indicate whether such application in fact exists or the status of any
such application because original applications are required by 35
U.S.C. 122 to be kept in confidence unless published pursuant to 35
U.S.C. 122(b) or available to the public pursuant to § 1.14(a)(1)(iv),
(v), or (vi). Thus, unless a third party has been granted access to an
original application, the third party is not entitled to obtain from
the Office any information concerning the same, including the mere fact
that such an application exists.

4. Non-Compliant Submissions

   Comment 44: Some comments raised the issue of applicant's duty to
disclose any documents cited in a third-party submission that make it
through an initial review but are not considered by the examiner for
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failure to comply with some formality. One of these comments urged the
Office to conduct a thorough initial review to ensure submitted
documents can be considered by examiners. Several comments suggested
the Office consider alternative ways of processing partially compliant
third-party submissions, such as by redacting the non-compliant parts
of the submission so that the other documents and their concise
descriptions may be entered and considered by the examiner, or by
preparing a clean or redacted list of only the documents that were
considered, and discarding any paper that references any documents that
were not considered by the examiner.
   Response: The Office has established procedures to screen third-
party submissions for compliance with the requirements of 35 U.S.C.
122(e) and § 1.290 before entering the submissions into the IFW of
an application for consideration. Non-compliant and partially compliant
submissions will not be entered into the record, as the Office's intent
is that only compliant third-party submissions will be entered for
consideration by examiners. The Office does not intend to redact or
correct non-compliant portions of a third-party submission as the
third-party submitter is in the best position to make any necessary
revisions to its submission and make a resubmission if the statutory
time period has not yet expired.

   Comment 45: A number of comments questioned whether minor defects
in a third-party submission would result in the entire submission not
being entered, and requested guidance regarding what types of
informalities, if any, in a third-party submission would not cause the
Office to deem the entire submission non-compliant.
   Response: Section 1.290(a) provides that a third-party submission
may not be entered or considered by the Office if any part of the
submission is not in compliance with 35 U.S.C. 122(e) and § 1.290.
The Office will enter a third-party submission that is compliant with
both 35 U.S.C. 122(e) and § 1.290; however, any non-compliance in a
third-party submission with respect to the requirements of 35 U.S.C.
122(e), whether or not the third-party submission is otherwise
compliant with § 1.290, will prevent entry of the entire third-
party submission into the record. A third-party submission that is
compliant with 35 U.S.C. 122(e) but non-compliant with some requirement
of § 1.290 may be entered if the error is of such a minor character
that, in the opinion of the Office, it does not raise an ambiguity as
to the content of the submission. In any event, the Office will either
enter or not enter the entire submission and will not attempt to enter
portions of partially compliant submissions.

   Ideally, only compliant third-party submissions will come before an
examiner for consideration. Nonetheless, the Office, in certain
circumstances, may be able to exercise some latitude in its screening
of third-party submissions for non-compliance with the requirements of
§ 1.290 so that errors of only a minor character that, in the
opinion of the Office, do not raise an ambiguity as to the content of
the submission do not prevent entry of the entire submission. For
example, if an error with respect to a requirement of § 1.290 is of
such a nature that the content of the third-party submission can still
be readily ascertained (e.g., a U.S. patent is identified by the
correct patent number and issue date but the name of the first named
inventor is clearly misspelled), the Office may have enough information
to be able to enter the third-party submission into the record despite
the error. However, the determination of whether to enter or not to
enter a partially compliant submission with respect to a requirement of
§ 1.290 will be on a case-by-case basis and at the sole discretion
of the Office (e.g., the Office may decline to enter a third-party
submission listing a U.S. patent whose patent number does not match
Office records with respect to that patent number's issue date and/or
first named inventor). The Office's dedicated Web-based interface for
filing third-party submissions electronically permits third parties to
verify the accuracy of some of the information in the submission prior
to its filing. Thus, third parties are strongly encouraged to avail
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themselves of this feature to better ensure compliance with 35 U.S.C.
122(e) and § 1.290.

   Comment 46: Several comments suggested the Office waive any
informality in a third-party submission, or give the submitter an
opportunity, such as a non-extendable one-month period, to either
explain why the submission was not defective or to correct the
submission. One comment stated that the Office has authority to
consider the statutory period to be tolled by an initial non-compliant
submission, as it does under the provisions of § 1.135(c).
   Response: Where a third-party submitter is notified of a non-
compliant third-party submission, the party will have an opportunity to
make a resubmission if the statutory time period for making a third-
party submission has not yet expired. The Office will not provide the
third-party submitter a non-extendable time period in which to make a
correction as such a practice would delay the prosecution of the
application and could potentially be used by third parties as a
mechanism for delaying prosecution. Similarly, the filing of a non-
compliant third-party submission will not toll the statutory time
period for making submissions. The Office cannot toll the statutory
time period for third-party submissions that fail to comply with
statutory requirements. Further, the Office will not toll the time
period for making a third-party submission where a submission complies
with the statute but does not comply with a requirement of § 1.290
because the Office does not want to introduce a delay in the prosecution
of an application to wait for a third party who may, or may not, make
the necessary correction. Accordingly, third parties are advised not to
delay in making third-party submissions to increase the likelihood of
having sufficient time to make a resubmission should the original
submission be found non-compliant. The Office intends to notify third
parties of non-compliant submissions as soon as reasonably practicable.

   Comment 47: Several comments favored eliminating the Office's
proposed "gatekeeper function" (i.e., screening third-party
submissions for compliance) and instead relying upon "self-policing"
pursuant to the statement of compliance under proposed § 1.290(d)(5)(ii),
as being subject to § 11.18(b), to discourage unauthorized filings. These
comments also asserted that overly strict screening may prevent an
examiner from considering relevant documents, and that screening will not
fully protect applicants from obtaining knowledge of non-compliant
submissions. Instead of a costly review process, one comment suggested
limiting the number of third-party submissions that a single party (or
parties in privity with the third party) may submit to promote prompt
entry of third-party submissions while preventing individual third parties
from making excessive submissions.
   Response: By screening third-party submissions for compliance
before entry into the record of an application, the Office is affording
some protection to applicants against entry of non-compliant
submissions that might trigger a duty of disclosure on the part of the
applicant to independently file such information in an IDS. Such
screening is merely an extension of the screening the Office already
performs for submissions under § 1.291 (and previously performed
for submissions under § 1.99). Further, such screening should
encourage third parties to file better quality third-party submissions,
with fewer errors, than under the proposed "self-policing" approach.

5. Submissions in Abandoned Applications

   Comment 48: One comment suggested the Office should give more
consideration to requests to revive applications that were abandoned
during the time period when third parties could make third-party
submissions because some applicants might abandon their applications to
discourage third-party submissions.
   Response: The statute does not preclude third parties from making
submissions in abandoned applications. Third parties having documents
relevant to an abandoned application, therefore, should cite these
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documents to the Office via a compliant third-party submission since
the application eventually may be revived and the submission considered.

   Comment 49: One comment suggested the Office not permit entry of
third-party submissions into the record of abandoned applications
because it wastes Office resources to screen such submissions for
compliance and places too much burden on applicants to monitor
abandoned application records if the Office does not notify them when
compliant submissions are entered. Another comment suggested the Office
only enter third-party submissions into the record of abandoned
applications under certain circumstances, such as when the Office's
Patent Application Information Retrieval (PAIR) system indicates that a
continuing application or a petition to revive has been filed, thereby
shifting the burden to third parties to monitor the application in that
regard.
   Response: 35 U.S.C. 122(e) permits preissuance submissions to be
filed in an application, whether the application is pending or
abandoned. Because the Office intends to notify applicants
participating in the e-Office action program of the entry of compliant
third-party submissions into an application, whether pending or
abandoned, these applicants should not need to monitor their abandoned
application files for entry of such submissions.

   Comment 50: One comment requested clarification regarding examiner
consideration of third-party submissions made in abandoned
applications. While the notice of proposed rulemaking states that an
examiner would not consider such submission until the abandoned
application resumes a pending status, the comment questioned whether,
in reviewing an abandoned parent application for pertinent prior art
with respect to a pending child application pursuant to MPEP
§ 707.05, an examiner would be required to consider any third-party
submission that was entered into the parent application after it was
abandoned.
   Response: In reviewing an abandoned parent application for
pertinent prior art with respect to a pending child application
pursuant to MPEP § 707.05, an examiner should consider any third-
party submission that was entered into the parent application after it
was abandoned.

I. Duty on Applicant

1. Duty of Disclosure

   Comment 51: Several comments suggested deleting any references in
proposed § 1.290(h) to an applicant's duty under § 1.56 because
such references could be interpreted as waiving the duty of disclosure
or, alternatively, revising proposed § 1.290(h) to make it clear
that applicants are not relieved of their duty under § 1.56.
Several of these comments gave examples of where non-compliant third-
party submissions may trigger an applicant's duty under § 1.56.
Another comment suggested the rule explicitly provide that a third-
party submission imposes no duty on an applicant (e.g., to correct or
otherwise review its contents). Further, to the extent proposed
§ 1.290(h) implies that applicants may be required to reply to a third-
party submission under some circumstances, several comments suggested
amending proposed § 1.290(h) to reflect that applicants are not
required to reply to a third-party submission.
   Response: Section 1.290(h), as proposed, states that in the absence
of any request by the Office, an applicant has no duty to, and need
not, reply to a third-party submission under § 1.290 by a third
party. The Office's intent in utilizing the term "duty" in proposed
§ 1.290(h) was not to incorporate a statement relative to the duty
of disclosure under § 1.56. Rather, the Office's use of the term
"duty" was in keeping with the general concept that applicants need
not comment on third-party submissions based solely on the presence of
such submissions. This concept was articulated in the rule by providing
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that there is no general requirement that applicants reply to third-
party submissions. In view of the controversy generated by the use of
the term "duty" in the proposed rule, the section has been revised in
this final rule to delete its use.

   Comment 52: One comment suggested amending the statement under
proposed § 1.290(d)(5)(i) to include individuals who are in privity
with an individual who has a duty to disclose information with respect
to the application under § 1.56. Another comment recommended
providing instructions to the general public regarding the statement
under proposed § 1.290(d)(5)(i) because non-practitioners may be
unfamiliar with the duty of disclosure.
   Response: Section 1.290(d)(5)(i) requires a statement by the third-
party submitter that the submitter is not a § 1.56(c) party with a duty
to disclose information with respect to the application for which the
third-party submission is intended. The requirement is present to exclude
applicants and other § 1.56(c) parties from filing information in the
application via § 1.290 rather than using the required means of an
information disclosure statement under §§ 1.97 and 1.98. The Office
declines the invitation to extend the prohibition beyond those parties
who already have a duty to disclose material information to the Office
under § 1.56.

   Guidance regarding who has a duty to disclose, i.e., a § 1.56(c)
party, can be found in MPEP § 2001.01, and the use of the rule section is
itself self-defining.

J. Information Technology (IT) Issues

1. Electronic Filing

   Comment 53: One comment suggested requiring that all third-party
submissions be filed electronically.
   Response: While it would be most efficient for third parties to
file third-party submissions electronically, the Office is not
requiring all third-party submissions be filed electronically, as doing
so would be contrary to Article 8 of the Patent Law Treaty (PLT), which
requires an Office to accept a filing in paper for purposes of
complying with a time limit.

   Comment 54: One comment suggested the Office separate the listing
of documents from the copies of submitted documents so that identifying
bibliographical information in the listing of documents is visible in
the IFW even when the copies of submitted non-patent literature (NPL)
documents are not visible in the IFW.
   Response: The Office will separate the § 1.290(d)(1) document
list from the copies of the documents in the IFW when entering
compliant third-party submissions under § 1.290. The Office
currently employs such a practice when entering IDS submissions under
§ 1.98.

2. Protect Applicants From Unauthorized Submissions

   Comment 55: Several comments urged the Office to exercise
precautions to protect applications from unauthorized third-party
submissions in applications. Another comment asserted that third
parties should be encouraged to use EFS-Web to make third-party
submissions, but the Office should alter the EFS software to prevent
third-party submissions from being directly entered into the IFW
without first being reviewed for compliance.
   Response: The Office has developed a dedicated Web-based interface
for third parties to submit third-party submissions electronically.
This dedicated electronic interface is available as an option in EFS-
Web and is designed so that third-party submissions under § 1.290
are first screened for compliance with the statute and the rule before
being entered into an application file. While this interface will
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identify submissions for screening before the submissions are sent to
the examiner, the Office cannot guarantee that such a system will
entirely prevent parties from making unauthorized submissions. Further,
while the Office could limit third-party submissions to paper and
perform manual screening of each incoming paper to determine whether it
is a proper paper, such a system would require intensive resources, and
lack the efficiencies and benefits of electronic filing using the
Office's dedicated interface. Additionally, limiting submissions to
paper only would not entirely eliminate the risk of an unauthorized
submission being entered into an application due to inadvertent human
error in a manual screening process.

3. Reduce Untimely Third-Party Submissions

   Comment 56: A number of comments suggested IT enhancements to
prevent or drastically reduce the possibility of untimely third-party
submissions. Several of these comments suggested the Office include a
feature in EFS-Web or the Office's Patent Application Information
Retrieval (PAIR) system that automatically notifies third parties when
an application is no longer eligible to receive third-party
submissions. One comment suggested providing notice to the examiner
when a third-party submission is made in the time period between the
posting of an Office action to be mailed and the actual mailing date of
the Office action.
   Response: As a feature of its dedicated Web-based interface for
electronically filing preissuance submissions, the Office plans to
automatically prevent a third party from making a third-party
submission in an application after the time periods for submission have
expired for that application. With respect to providing notice to
examiners, examiners will be notified upon entry of a compliant third-
party submission in an application that they are examining. On the rare
occasion of a third-party submission being filed after preparation of
an Office action but before the mailing of the Office action,
notification of the entry of a compliant third-party submission in the
application will not necessarily delay the mailing of the Office
action. Such submissions will be handled the same way IDS submissions
are handled under similar circumstances.

4. Other Proposed System Enhancements

   Comment 57: One comment suggested making available in the Office's
Patent Application Information Retrieval (PAIR) system a "first action
prediction" estimate of when the first Office action is expected to be
issued, and that such estimate might be provided only after the six-
month window from publication has elapsed.
   Response: The Office already provides a tool that permits third
parties and applicants to check current estimates on how long it will
take for a first Office action to issue in a patent application according
to the Group Art Unit in which the application has been docketed or by
class and subclass associated with the application. This "First Office
Action Estimator" tool is available on the Office's Web site at
http://www.uspto.gov/patents/stats/first_office_action_estimator.jsp.
Accordingly, the Office does not plan to implement an additional feature
in PAIR at this time to specifically address third-party submissions under
§ 1.290. Additionally, third parties are encouraged to file third-party
submissions as early as possible rather than delay a submission based upon
a predicted first Office action date. Any first Office action prediction
for an application would merely operate as an estimate and would not be a
binding date or otherwise provide assurance to a third party that a
submission would be accepted if an Office action was mailed before the
estimated date.

   Comment 58: One comment suggested EFS-Web identify the earliest-
claimed priority date of an application so an interested third party
can identify whether a document is prior art.
   Response: In general, the Office does not make a determination
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regarding earliest effective filing date until such determination is
necessary to evaluate the patentability of the claims. Additionally,
the determination of the earliest-claimed priority date of an
application is a highly fact-specific inquiry that is not fully
amenable to performance by an automated algorithm. Furthermore, it
would not be desirable for third parties to delay submissions until the
Office would provide such a date, which is subject to change if, for
instance, applicant introduces new priority or benefit claims or amends
the claims in such a manner as to affect whether the claims are
supported by the disclosures of the claimed priority or benefit
documents. Also, determination of the earliest-claimed priority date of
an application would not be necessary where a third-party is submitting
a document that is not prior art. For these reasons, the Office has no
plans at this time to modify EFS-Web to identify the earliest-claimed
priority or benefit date of an application for third-party submission
purposes.

   Comment 59: One comment suggested the Office provide an automated
means for third parties to check whether a document has been made of
record in an application, making it convenient for the third party to
review any associated descriptions of relevance so the third party can
avoid making a cumulative submission. The comment also suggested the
Office automatically flag documents in the IFW that have been submitted
more than once in an application and make the associated descriptions
of relevance for these documents easily accessible to examiners.
   Response: Since an interested third party can review a published
application's file history using the Office's public Patent Application
Information Retrieval (PAIR) system (e.g., to view a document list
previously submitted in a third-party submission by another third
party), the Office does not deem an automated system that would
identify whether a particular document was previously made of record in
the application to be necessary at this time. Further, third parties
may use the concise description of relevance to bring to the examiner's
attention whether a particular document being submitted was previously
made of record in the application.

L. Other Rules

1. 37 CFR 1.99

   Comment 60: Some comments suggested the Office retain § 1.99 because
some third parties might still want to make a submission without providing
a concise description of relevance as required by proposed §§ 1.290(d)(2)
and 1.291(c)(2). In this regard, one of these comments recommended the time
for making a submission under § 1.99 be amended to be the same as that for
proposed § 1.290.
   Response: In implementing new 35 U.S.C. 122(e), Congress provided that
preissuance submissions by third parties must set forth a concise
description of relevance of each document submitted. Thus, to maintain
§ 1.99, which does not require concise descriptions of relevance, would be
in conflict with the statute.

2. 37 CFR 1.291

   Comment 61: One comment proposed removing § 1.291 along with §§ 1.99 and
1.292 on the basis that § 1.291 is unnecessary and contrary to Congressional
intent. The comment asserted that § 1.291 is ultra vires because it permits
submission of evidence concerning inequitable conduct that is not
statutorily authorized under 35 U.S.C. 122(e), which refers solely to
submission of printed publications. The comment further asserted that
§ 1.291 imposes obligations that conflict with those under § 1.290 because
35 U.S.C. 122(e) will require a concise description of relevance
regardless of whether the application has been published, yet 35 U.S.C.
122(c) still does not allow post-publication protests without the
applicant's consent.
   Response: Protests pursuant to § 1.291 are supported by a
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separate statutory provision, 35 U.S.C. 122(c), which implies the
availability of submitting a protest in an application prior to
publication, absent the applicant's consent. Further, § 1.291 is
not deemed duplicative or unnecessary because it permits the submission
of information that is not permitted in a third-party submission under
§ 1.290. For example, in addition to printed publications, under
§ 1.291, a third party can submit information other than printed
publications, as well as present arguments regarding the patentability
of the claims of the application.

Rulemaking Considerations

   A. Administrative Procedure Act: This final rule changes the rules
of practice concerning the procedure for filing third-party
submissions. The changes in this final rule concern the patent
application process and do not change the substantive criteria of
patentability. Therefore, the changes in this final rule are merely
procedural and/or interpretive. See Bachow Communs., Inc. v. FCC, 237
F.3d 683, 690 (DC Cir. 2001) (rules governing an application process
are procedural under the Administrative Procedure Act); Inova
Alexandria Hosp. v. Shalala, 244 F.3d 342, 350 (4th Cir. 2001) (rules
for handling appeals were procedural where they did not change the
substantive standard for reviewing claims); Nat'l Org. of Veterans'
Advocates v. Sec'y of Veterans Affairs, 260 F.3d 1365, 1375 (Fed. Cir.
2001) (rule that clarifies interpretation of a statute is
interpretive).

   Accordingly, prior notice and opportunity for public comment are
not required pursuant to 5 U.S.C. 553(b) or (c) (or any other law) and
are not required pursuant to 5 U.S.C. 553(d) (or any other law). See
Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 2008)
(stating that 5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), does not
require notice and comment rulemaking for "interpretative rules,
general statements of policy, or rules of agency organization,
procedure, or practice.") (quoting 5 U.S.C. 553(b)(A)). The Office,
however, published proposed changes and a Regulatory Flexibility Act
certification for comment as it sought the benefit of the public's
views on the Office's proposed implementation of this provision of the
AIA. The Office received no comments on the Regulatory Flexibility Act
certification.

   B. Regulatory Flexibility Act: For the reasons set forth herein,
the Deputy General Counsel for General Law of the United States Patent
and Trademark Office has certified to the Chief Counsel for Advocacy of
the Small Business Administration that changes in this final rule will
not have a significant economic impact on a substantial number of small
entities. See 5 U.S.C. 605(b). This final rule changes the rules of
practice to implement section 8 of the AIA, which provides a mechanism
for third parties to submit to the Office, for consideration and
inclusion in the record of a patent application, any patents, published
patent applications, or other printed publications of potential
relevance to the examination of the application.

   The changes in this final rule concern requirements for third
parties submitting patents, published patent applications, or other
printed publications in a patent application. The burden to all
entities, including small entities, imposed by these rules is a minor
addition to that of the current regulations for third-party submissions
under § 1.99. Consistent with the current regulations, the Office
will continue to require third parties filing submissions to, for
example, file a listing of the documents submitted along with a copy of
each document, with minor additional formatting requirements.
Additional requirements in this final rule are requirements of statute
(e.g., the concise explanation) and thus the sole means of
accomplishing the purpose of the statute. Because of the expanded scope
of submissions under this rulemaking and additional requirements by
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statute, the Office believes this will take a total of 10 hours at a
cost of $3710 per submission. Furthermore, the Office estimates that no
more than 730 small entity third parties will make third-party
submissions per year. Therefore, the changes in this final rule will not
have a significant economic impact on a substantial number of small
entities.

   C. Executive Order 12866 (Regulatory Planning and Review): This
rulemaking has been determined to be not significant for purposes of
Executive Order 12866 (Sept. 30, 1993).

   D. Executive Order 13563 (Improving Regulation and Regulatory
Review): The Office has complied with Executive Order 13563.
Specifically, the Office has, to the extent feasible and applicable:
(1) Made a reasoned determination that the benefits justify the costs
of the rule; (2) tailored the rule to impose the least burden on
society consistent with obtaining the regulatory objectives; (3)
selected a regulatory approach that maximizes net benefits; (4)
specified performance objectives; (5) identified and assessed available
alternatives; (6) involved the public in an open exchange of
information and perspectives among experts in relevant disciplines,
affected stakeholders in the private sector, and the public as a whole,
and provided on-line access to the rulemaking docket; (7) attempted to
promote coordination, simplification, and harmonization across
government agencies and identified goals designed to promote
innovation; (8) considered approaches that reduce burdens and maintain
flexibility and freedom of choice for the public; and (9) ensured the
objectivity of scientific and technological information and processes.

   E. Executive Order 13132 (Federalism): This rulemaking does not
contain policies with federalism implications sufficient to warrant
preparation of a Federalism Assessment under Executive Order 13132
(Aug. 4, 1999).

   F. Executive Order 13175 (Tribal Consultation): This rulemaking
will not: (1) Have substantial direct effects on one or more Indian
tribes; (2) impose substantial direct compliance costs on Indian tribal
governments; or (3) preempt tribal law. Therefore, a tribal summary
impact statement is not required under Executive Order 13175 (Nov. 6,
2000).

   G. Executive Order 13211 (Energy Effects): This rulemaking is not a
significant energy action under Executive Order 13211 because this
rulemaking is not likely to have a significant adverse effect on the
supply, distribution, or use of energy. Therefore, a Statement of
Energy Effects is not required under Executive Order 13211 (May 18,
2001).

   H. Executive Order 12988 (Civil Justice Reform): This rulemaking
meets applicable standards to minimize litigation, eliminate ambiguity,
and reduce burden as set forth in sections 3(a) and 3(b)(2) of
Executive Order 12988 (Feb. 5, 1996).

   I. Executive Order 13045 (Protection of Children): This rulemaking
does not concern an environmental risk to health or safety that may
disproportionately affect children under Executive Order 13045 (Apr.
21, 1997).

   J. Executive Order 12630 (Taking of Private Property): This
rulemaking will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630 (Mar. 15, 1988).

   K. Congressional Review Act: Under the Congressional Review Act
provisions of the Small Business Regulatory Enforcement Fairness Act of
1996 (5 U.S.C. 801 et seq.), the United States Patent and Trademark
Office will submit a report containing this final rule and other
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required information to the United States Senate, the United States
House of Representatives, and the Comptroller General of the Government
Accountability Office. The changes in this final rule are not expected
to result in an annual effect on the economy of 100 million dollars or
more, a major increase in costs or prices, or significant adverse
effects on competition, employment, investment, productivity,
innovation, or the ability of United States-based enterprises to
compete with foreign-based enterprises in domestic and export markets.
Therefore, this final rule is not a "major rule" as defined in 5
U.S.C. 804(2).

   L. Unfunded Mandates Reform Act of 1995: The changes in this final
rule do not involve a Federal intergovernmental mandate that will
result in the expenditure by State, local, and tribal governments, in
the aggregate, of 100 million dollars (as adjusted) or more in any one
year, or a Federal private sector mandate that will result in the
expenditure by the private sector of 100 million dollars (as adjusted)
or more in any one year, and will not significantly or uniquely affect
small governments. Therefore, no actions are necessary under the
provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C.
1501 et seq.

   M. National Environmental Policy Act: This rulemaking will not have
any effect on the quality of environment and is thus categorically
excluded from review under the National Environmental Policy Act of
1969. See 42 U.S.C. 4321 et seq.

   N. National Technology Transfer and Advancement Act: The requirements
of section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (15 U.S.C. 272 note) are not applicable because this rulemaking
does not contain provisions which involve the use of technical standards.

   O. Paperwork Reduction Act: The Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.) requires that the Office consider the impact of
paperwork and other information collection burdens imposed on the
public. This final rule makes changes to the rules of practice that
impact existing information collection requirements previously approved
by the Office of Management and Budget (OMB) under OMB Control Number
0651-0062. Accordingly, the Office submitted a proposed revision to the
information collection requirements under 0651-0062 to OMB for its
review and approval when the notice of proposed rulemaking was
published. The Office also published the title, description, and
respondent description of the information collection, with an estimate
of the annual reporting burdens, in the notice of proposed rulemaking
(See Changes to Implement the Preissuance Submission by Third Parties
Provision of the Leahy-Smith America Invents Act, 77 FR 455-56). The
Office did not receive any comments on the proposed revision to the
information collection requirements under 0651-0062. The changes
adopted in this final rule do not require any further change to the
proposed revision to the information collection requirements under
0651-0062. Accordingly, the Office has resubmitted the proposed
revision to the information collection requirements under 0651-0062 to
OMB. The proposed revision to the information collection requirements
under 0651-0062 is available at OMB's Information Collection Review Web
site (www.reginfo.gov/public/do/PRAMain).

   Notwithstanding any other provision of law, no person is required
to respond to, nor shall a person be subject to a penalty for failure
to comply with, a collection of information subject to the requirements
of the Paperwork Reduction Act, unless that collection of information
displays a currently valid OMB control number.

List of Subjects

37 CFR Part 1

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   Administrative practice and procedure, Courts, Freedom of information,
Inventions and patents, Reporting and recordkeeping requirements, Small
businesses, and Biologics.

37 CFR Part 41

   Administrative practice and procedure, Inventions and patents, Lawyers.

   For the reasons set forth in the preamble, 37 CFR parts 1 and 41
are amended as follows:

PART 1 - RULES OF PRACTICE IN PATENT CASES

.1. The authority citation for 37 CFR part 1 continues to read as follows:

   Authority: 35 U.S.C. 2(b)(2).

.2. Section 1.6 is amended by revising paragraph (d)(3) to read as follows:

§ 1.6  Receipt of correspondence.

* * * * *

   (d) * * *
   (3) Correspondence which cannot receive the benefit of the certificate of
mailing or transmission as specified in § 1.8(a)(2)(i)(A) through (D), (F),
and (I), and § 1.8(a)(2)(iii)(A), except that a continued prosecution
application under § 1.53(d) may be transmitted to the Office by facsimile;

* * * * *

.3. Section 1.8 is amended by revising paragraph (a)(2)(i)(C), and by
adding new paragraphs (a)(2)(i)(B) and (a)(2)(i)(G) through (a)(2)(i)(J),
to read as follows:

§ 1.8  Certificate of mailing or transmission.

   (a) * * *
   (2) * * *
   (i) * * *
   (B) Papers filed in trials before the Patent Trial and Appeal Board,
which are governed by § 42.6(b) of this title;
   (C) Papers filed in contested cases before the Patent Trial and
Appeal Board, which are governed by § 41.106 (f) of this title;

* * * * *

   (G) The filing of a written declaration of abandonment under § 1.138;
   (H) The filing of a submission under § 1.217 for publication of
a redacted copy of an application;
   (I) The filing of a third-party submission under § 1.290; and
   (J) The calculation of any period of adjustment, as specified in
§ 1.703(f).

* * * * *

.4. Section 1.17 is amended by removing and reserving paragraph (j) and
revising paragraph (p) to read as follows:

§ 1.17  Patent application and reexamination processing fees.

* * * * *

   (j) [Reserved]

* * * * *
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   (p) For an information disclosure statement under § 1.97(c) or
(d) or for the document fee for a submission under § 1.290 - $180.00

* * * * *

§ 1.99  [Removed and reserved]

.5. Section 1.99 is removed and reserved.

.6. An undesignated center heading before § 1.290 is added to read
as follows:

PREISSUANCE SUBMISSIONS AND PROTESTS BY THIRD PARTIES

.7. Section 1.290 is added to read as follows:

§ 1.290  Submissions by third parties in applications.

   (a) A third party may submit, for consideration and entry in the
record of a patent application, any patents, published patent
applications, or other printed publications of potential relevance to
the examination of the application if the submission is made in
accordance with 35 U.S.C. 122(e) and this section. A third-party
submission may not be entered or considered by the Office if any part
of the submission is not in compliance with 35 U.S.C. 122(e) and this
section.
   (b) Any third-party submission under this section must be filed
prior to the earlier of:
   (1) The date a notice of allowance under § 1.311 is given or
mailed in the application; or
   (2) The later of:
   (i) Six months after the date on which the application is first
published by the Office under 35 U.S.C. 122(b) and § 1.211, or
   (ii) The date the first rejection under § 1.104 of any claim by
the examiner is given or mailed during the examination of the application.
   (c) Any third-party submission under this section must be made in
writing.
   (d) Any third-party submission under this section must include:
   (1) A document list identifying the documents, or portions of
documents, being submitted in accordance with paragraph (e) of this
section;
   (2) A concise description of the asserted relevance of each item
identified in the document list;
   (3) A legible copy of each item identified in the document list,
other than U.S. patents and U.S. patent application publications;
   (4) An English language translation of any non-English language
item identified in the document list; and
   (5) A statement by the party making the submission that:
   (i) The party is not an individual who has a duty to disclose
information with respect to the application under § 1.56; and
   (ii) The submission complies with the requirements of 35 U.S.C.
122(e) and this section.
   (e) The document list required by paragraph (d)(1) of this section
must include a heading that identifies the list as a third-party
submission under § 1.290, identify on each page of the list the
application number of the application in which the submission is being
filed, list U.S. patents and U.S. patent application publications in a
separate section from other items, and identify each:
   (1) U.S. patent by patent number, first named inventor, and issue
date;
   (2) U.S. patent application publication by patent application
publication number, first named inventor, and publication date;
   (3) Foreign patent or published foreign patent application by the
country or patent office that issued the patent or published the
application; the applicant, patentee, or first named inventor; an
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appropriate document number; and the publication date indicated on the
patent or published application; and
   (4) Non-patent publication by author (if any), title, pages being
submitted, publication date, and, where available, publisher and place
of publication. If no publication date is known, the third party must
provide evidence of publication.
   (f) Any third-party submission under this section must be
accompanied by the fee set forth in § 1.17(p) for every ten items
or fraction thereof identified in the document list.
   (g) The fee otherwise required by paragraph (f) of this section is
not required for a submission listing three or fewer total items that
is accompanied by a statement by the party making the submission that,
to the knowledge of the person signing the statement after making
reasonable inquiry, the submission is the first and only submission
under 35 U.S.C. 122(e) filed in the application by the party or a party
in privity with the party.
   (h) In the absence of a request by the Office, an applicant need
not reply to a submission under this section.
   (i) The provisions of § 1.8 do not apply to the time periods
set forth in this section.

.8. The undesignated center heading before § 1.291 is removed.

.9. Section 1.291 is amended by revising paragraphs (b) introductory
text, (b)(1), (c)(1) through (c)(4), and (f) to read as follows:

§ 1.291  Protests by the public against pending applications.

* * * * *

   (b) The protest will be entered into the record of the application
if, in addition to complying with paragraph (c) of this section, the
protest has been served upon the applicant in accordance with § 1.248,
or filed with the Office in duplicate in the event service is
not possible; and, except for paragraph (b)(1) of this section, the
protest was filed prior to the date the application was published under
§ 1.211, or the date a notice of allowance under § 1.311 was
given or mailed, whichever occurs first:
   (1) If a protest is accompanied by the written consent of the
applicant, the protest will be considered if the protest is filed prior
to the date a notice of allowance under § 1.311 is given or mailed
in the application.

* * * * *

   (c) * * *
   (1) An information list of the documents, portions of documents, or
other information being submitted, where each:
   (i) U.S. patent is identified by patent number, first named
inventor, and issue date;
   (ii) U.S. patent application publication is identified by patent
application publication number, first named inventor, and publication
date;
   (iii) Foreign patent or published foreign patent application is
identified by the country or patent office that issued the patent or
published the application; an appropriate document number; the
applicant, patentee, or first named inventor; and the publication date
indicated on the patent or published application;
   (iv) Non-patent publication is identified by author (if any),
title, pages being submitted, publication date, and, where available,
publisher and place of publication; and
   (v) Item of other information is identified by date, if known.
   (2) A concise explanation of the relevance of each item identified
in the information list pursuant to paragraph (c)(1) of this section;
   (3) A legible copy of each item identified in the information list,
other than U.S. patents and U.S. patent application publications;
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   (4) An English language translation of any non-English language
item identified in the information list; and

* * * * *

   (f) In the absence of a request by the Office, an applicant need
not reply to a protest.

* * * * *

§ 1.292  [Removed and reserved]

.10. Section 1.292 is removed and reserved.

PART 41 - PRACTICE BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES

.11. The authority citation for 37 CFR Part 41 continues to read as
follows:

   Authority: 35 U.S.C. 2(b)(2), 3(a)(2)(A), 21, 23, 32, 41, 132,
133, 134, 135, 306, and 315.

.12. Section 41.202 is amended by revising paragraph (b) to read as
follows:

§ 41.202  Suggesting an interference.

* * * * *

   (b) Patentee. A patentee cannot suggest an interference under this
section but may, to the extent permitted under § 1.291 of this
title, alert the examiner of an application claiming interfering
subject matter to the possibility of an interference.

* * * * *

June 21, 2012                                               DAVID J. KAPPOS
                  Under Secretary of Commerce for Intellectual Property and
                  Director of the United States Patent and Trademark Office

                                [1381 OG 49]