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PGPUB Comments - BIO

From: msharma@BIO.ORG
Sent: Friday, May 26, 2000 1:38 PM
To: Pre Grant Pub
Subject: BIO comments

The Honorable Q. Todd Dickinson
Under Secretary of Intellectual Property and 
  Director of the United States Patent and Trademark Office
Box Comments - Patents
Assistant Commissioner for Patents
Washington, DC 20231

ATTENTION: 	Robert Bahr
				Comments on Proposed Changes to Implement
18-Month Publication of Patent Applications (65 FR 17946)

Dear Director Dickinson:

	These comments are offered on behalf of the Biotechnology Industry
Organization (BIO), a trade association representing over 900 entities doing
business in the biotechnology sector.

BIO members were strongly supportive of the legislative effort to require
publication of patent applications.  The final form of the legislation
mandating publication falls somewhat short of our goals, but we believe that
practices under the new system will meet the expectations of our industry.  

We are generally supportive of the proposed system by which the PTO has
proposed to implement 18-month publication.  In particular, we support the
decision of the PTO to publish applications electronically, rather than
using a paper-based model integrated into the Official Gazette cycle form.
We are also supportive of developments that will make feasible electronic
filing of patent applications and to use these systems to modernize the
means by which we can communicate and do business with the PTO. 

Our suggestions in respect of the system and the proposed rule package can
be divided into three general categories.

1.	Comments on Proposed Operating Principles for the Publication System

BIO Members recognize the need for fixed deadlines for application
requirements as a condition for operation of a publication system.  The
deadlines articulated in the guidelines (other than in respect of
publication of redacted copies of applications upon which we express no
opinion) are acceptable in principle to our industry.  These deadlines will
require that elements of a patent application that are needed to put it in
condition for publication be received prior to the date that is the later of
sixteen months from the effective filing date or four months after the
actual filing date. 
	Notwithstanding our support for these deadlines, we believe it is
necessary for certain issues to be addressed.

	(a)	Sequence listing formalities

The issues regarding sequence listing deposits are not adequately addressed
in the notice or the rules.  We believe the PTO should make absolutely clear
the following issues regarding sequence listing deposits:

		-	the latest date upon which a sequence listing
deposit must be submitted or perfected to avoid delay of transfer of the
application to the examining corps;

		-	whether applications containing listings that have
not complied with the formality requirements associated with those deposits
will be forwarded to the examiner for substantive examination;

		-	whether the sequence listing deposit will be
subjected to the new standards and policies on compliance to be applied to
drawings (i.e., no flexibility on non-compliance), and if so, what changes
will be implemented to reduce the complications associated with use of the
sequence listing authoring and submission software; and

		-	precisely how parties are to make references to
sequences previously deposited.

Explicit and clear requirements relating to deposits of sequence information
is critical to the ability of our members to comply with the new publication
system.  We urge the PTO to take note of the past difficulties that have
been associated with the use of the authoring software and compliance by
patent applications with this system in developing its position on such

(b)	Access to file wrappers following publication 

	The PTO has indicated that it intends to provide full access to
patent application file wrappers following publication of the application.
While this approach seems to endorse a model of openness and maximum public
access, BIO members are concerned that it cannot be implemented by the PTO
in way that will not prove extremely disruptive to the examination process.
The experience of our Members with obtaining copies of file wrappers from
the PTO is unfortunately very negative.  All too frequently, file wrappers
are lost, misplaced and often the contents of file wrappers are compromised
(i.e., items lost, mutilated or put out of order).  A system that presumes
that file wrappers will not be lost and will not have their integrity
compromised, unfortunately, is not one that the PTO seems capable of

	We accordingly urge the PTO to defer providing access to the public
to file wrappers until the date when it is able to produce copies of such
file wrapper histories from a digital, rather than physical, copy of the
documents that make up the file wrapper.  Any system that would require
additional and unnecessary handling of the file wrappers by PTO staff
pursuant to a copy of file request is likely to significantly increase the
likelihood of loss or corruption of the file wrapper contents.  If the PTO
can extend the document capture system used for applications that are to be
filed on paper or can implement a new system that would allow copies of the
file wrapper to be produced while it is still pending, our concerns about
public access to the contents of the file wrapper while applications are
still pending will be mitigated.  Until the PTO can provide copies from
digital records rather than physical paper records, we urge that the policy
on access be reconsidered and no access provided to the public. The risks
associated with corruption and loss of physical contents of the file
wrappers while applications are still pending are simply too great to be

(c)	Use of title of invention for correlation of EFS filings

	The PTO has indicated that it intends to rigorously enforce title of
invention requirements to ensure that it can implement its Electronic Filing
System (EFS) system.  In the description of the EFS system, the PTO has
indicated in particular that it will use the title of the application to
correlate a later-filed substitute specification to an original file record
associated with the application.  We are puzzled by this decision to use the
title of the invention as the key for data to be handled and processed by
the PTO's EFS system in view of the fact that (a) titles are not usually
unique identifiers of applications and (b) each patent application does have
a unique identifier (i.e., the application serial number) that is the
logical reference point for use in database systems like these.  We
encourage the PTO to use the serial number rather than the title for data
handling steps such as these.

2.	Third party prior art submission procedure

The PTO is proposing to establish a procedure by which third parties may,
within two months following the publication date, submit prior art that will
be entered into the file wrapper of pending applications.  Certain points
associated with this process should be reconsidered and revised to ensure
that it does not prove unworkable or become a means by which third parties
can harass or disrupt the examination process.

In this regard, BIO recommends the following changes be made:

		-	The PTO is proposing to require that the information
provided by a third party be served on the patent applicant.  The rule to
implement this requirement, however, does not specify whether it is the
party submitting the information or the PTO that must serve the information
on the patent applicant.  We believe the only acceptable approach would be
for the party submitting the information to provide evidence that it has
served the information on the patent application.

		-	The PTO must implement this procedure in a way that
forecloses the possibility of third parties abusing this process to delay or
harass patent applicants.  One step that could be implemented to do this
would be for the PTO to require that the party submitting the information to
declare whether they are submitting the information pursuant to an agency
relationship, and if so, to identify the real party in interest (i.e., the
principal) that is making the submission.  Requiring parties to properly
identify themselves will help minimize the frequency of situations where
third parties submit information to harass or impede the examination

		-	The PTO should adopt an approach that will not allow
third parties to file large amounts of irrelevant or redundant prior art.
The current approach of allowing twenty references per submission will allow
a tremendous volume of information to come into the file wrapper that is
likely to be irrelevant to examination.  The twenty-reference standard will
also encourage parties to not rigorously consider and forward the most
relevant prior art.  To prevent this practice from evolving into an
unmanageable process, we encourage the PTO to limit the total number per
filing to no more than five per submission. We also suggest that the PTO
screen the submitted prior art to eliminate references provided in a
submission that have already been cited in the application. 

3.	Other Issues

	A number of other specific issues were identified that merit

		-	The law permits third parties to expressly abandon
an application to prevent its publication.  The PTO has properly indicated
that its ability to suppress publication depends on when it receives notice
of an express abandonment.  Recognizing the immense volume of paper coming
into the PTO each day, we recommend that the PTO set up a special box for
notifying the PTO of an express abandonment that was made to avoid
publication.  This will segregate mail coming in to the PTO to allow last
minute abandonments to achieve their goal of suppressing publication.

		-	Proposed rule 1.215(b) will allow patent applicants
to identify their ownership interest on the face of the published patent
application.  We encourage the PTO to provide a form or sample format for
this separate paper that is to be included with applications to avoid
confusion as to the requirements for this procedure.

		-	The transition to a publication system will result
in a number of situations later this year where applications having an
effective filing date more than 18 months earlier than November 29, 2000
will be subjected to an immediate requirement for publication under the law
(i.e., where the application is filed after November 29, 2000, and claims
priority to an application filed earlier than 18 months before this date).
Given the strict posture the PTO is taking with regard to compliance with
formalities, and in view of the potential loss of patent term due to
non-compliance with formalities, we believe it is essential for the PTO to
set up a transitional procedure for these applications.  One approach could
be to set a specified period for compliance with formalities for
applications filed having this profile for a set period of time, where
compliance within a four to five month period will not be treated as
non-diligent prosecution. Without a transitional period, the PTO's approach
will unfairly punish applicants just as the new system is being implemented.

In conclusion, we believe the rule package and the general operating model
being adopted by the PTO is sound, and should be improved as recommended
above.  We look forward to working with you to build a viable and
user-friendly system.


				L. Val Giddings, PhD.
				Vice President for Food and Agriculture

United States Patent and Trademark Office
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Last Modified: 7/4/2009 4:40:17 PM