2242 Criteria for Deciding Request Filed under 35 U.S.C. 302 [R-10.2019]

I. SUBSTANTIAL NEW QUESTION OF PATENTABILITY

The presence or absence of “a substantial new question of patentability” determines whether or not reexamination is ordered. The meaning and scope of the term “a substantial new question of patentability” is not defined in the statute and must be developed to some extent on a case-by-case basis, using the case law to provide guidance as will be discussed in this section.

If the prior art patents and printed publications raise a substantial question of patentability of at least one claim of the patent, then a substantial new question of patentability as to the claim is present, unless the same question of patentability has already been: (A) decided in a final holding of invalidity by a federal court in a decision on the merits involving the claim, after all appeals; (B) decided in an earlier concluded examination or review of the patent by the Office; or (C) raised to or by the Office in a pending reexamination or supplemental examination of the patent. If the request for reexamination includes issues involving 35 U.S.C. 325(d), the examiner must bring such issues to the attention of the appropriate SPRS or the Director of the CRU. Inquiries from the public regarding the treatment of issues involving 35 U.S.C. 325(d) in ex parte reexaminations should be referred to OPLA.

An earlier concluded examination or review of the patent is: (A) the original examination of the application which matured into the patent; (B) the examination of the patent in a reissue application that has resulted in a reissue of the patent; (C) the examination of the patent in an earlier concluded reexamination or supplemental examination; (D) the review of the patent in an earlier concluded trial by the Patent Trial and Appeal Board, such as a post-grant review, inter partes review, or covered business method review of the patent; or (E) any other contested Office proceeding which has been concluded and which involved the patent. The answer to the question of whether a “substantial new question of patentability” exists, and therefore whether reexamination may be had, is decided by the examiner, and the examiner’s determination may be reconsidered:

(a) If reexamination is denied – as set forth in MPEP § 2248.

(b) If reexamination is granted – as set forth in MPEP § 2246, subsection II.

A prior art patent or printed publication raises a substantial question of patentability where there is a substantial likelihood that a reasonable examiner would consider the prior art patent or printed publication important in deciding whether or not the claim is patentable. If the prior art patents and/or publications would be considered important, then the examiner should find “a substantial new question of patentability” unless the same question of patentability has already been decided as to the claim in a final holding of invalidity by a federal court or by the Office in an earlier concluded examination or review of the patent, or unless the same question of patentability has been raised to or by the Office in a pending reexamination or supplemental examination of the patent. For example, the same question of patentability may have already been decided by the Office where the examiner finds the additional (newly provided) prior art patents or printed publications are merely cumulative to similar prior art already fully considered by the Office in an earlier concluded examination or review of the claim.

For “a substantial new question of patentability” to be present, it is only necessary that: (A) the prior art patents and/or printed publications raise a substantial question of patentability regarding at least one claim, i.e., the teaching of the (prior art) patents and printed publications is such that a reasonable examiner would consider the teaching to be important in deciding whether or not the claim is patentable; and (B) the same question of patentability as to the claim has not been decided by the Office in an earlier concluded examination or review of the patent, raised to or by the Office in a pending reexamination or supplemental examination of the patent, or decided in a final holding of invalidity (after all appeals) by a federal court in a decision on the merits involving the claim. If a reexamination proceeding was terminated/vacated without resolving the substantial question of patentability question, it can be re-presented in a new reexamination request. It is not necessary that a "prima facie" case of unpatentability exist as to the claim in order for “a substantial new question of patentability” to be present as to the claim. Thus, “a substantial new question of patentability” as to a patent claim could be present even if the examiner would not necessarily reject the claim as either fully anticipated by, or obvious in view of, the prior art patents or printed publications. As to the importance of the difference between “a substantial new question of patentability” and a "prima facie" case of unpatentability see generally In re Etter, 756 F.2d 852, 857 n.5, 225 USPQ 1, 4 n.5 (Fed. Cir. 1985).

Note that the clarification of the legal standard for determining obviousness under 35 U.S.C. 103 in KSR International Co. v. Teleflex Inc.(KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007) does not alter the legal standard for determining whether a substantial new question of patentability exists. See the discussion in MPEP § 2216.

Where a second or subsequent request for reexamination of a patent is made before the conclusion of an earlier filed reexamination proceeding pending (ongoing) for that patent, the second or subsequent request for reexamination may provide information raising a substantial new question of patentability with respect to any new or amended claim which has been proposed under 37 CFR 1.530(d) in the ongoing pending reexamination proceeding. However, in order for the second or subsequent request for reexamination to be granted, the second or subsequent requester must independently provide a substantial new question of patentability which is different from that raised in the pending reexamination for the claims in effect at the time of the determination. The decision on the second or subsequent request is based on the claims in effect at the time of the determination (37 CFR 1.515(a)). Thus, the second or subsequent request must be directed to the claims of the patent, as modified by any disclaimer, or by any reexamination certificate that has issued as of the time of the determination. If a “different” substantial new question of patentability is not provided by the second or subsequent request for the claims in effect at the time of the determination, the second or subsequent request for reexamination must be denied since the Office is only authorized by statute to grant a reexamination proceeding based on a substantial new question of patentability “affecting any claim of the patent.” See 35 U.S.C. 303. Accordingly, there must be at least one substantial new question of patentability established for the existing claims in the patent in order to grant reexamination.

Once the second or subsequent request has provided a “different” substantial new question of patentability based on the claims in effect at the time of the determination, the second or subsequent request for reexamination may also provide information directed to any proposed new or amended claim in the pending reexamination, to permit examination of the entire patent package. The information directed to a proposed new or amended claim in the pending reexamination is addressed during the later filed reexamination (where a substantial new question is raised in the later reexamination for the existing claims in the patent), in order to permit examination of the entire patent package. When a proper basis for the subsequent reexamination is established, it would be a waste of resources to prevent addressing the proposed new or amended claims, by requiring parties to wait until the certificate issues for the proposed new or amended claims, and only then to file a new reexamination request challenging the claims as revised via the certificate. This also prevents a patent owner from simply amending all the claims in some nominal fashion to preclude a subsequent reexamination request during the pendency of the reexamination proceeding.

II. POLICY IN SPECIFIC SITUATIONS

In order to further clarify the meaning of “a substantial new question of patentability” certain situations are outlined below which, if present, should be considered when making a decision as to whether or not “a substantial new question of patentability” is present. Any issues involving 35 U.S.C. 325(d) raised in the request must be referred to the examiner's SPRS or the director of the CRU. Any questions from the public regarding procedures in regard to issues involving 35 U.S.C. 325(d) should be referred to the Office of Patent Legal Administration (OPLA).

A. Prior Favorable Decisions by the U.S. Patent and Trademark Office (Office) on the Same or Substantially Identical Prior Art in Relation to the Same Patent

A “substantial new question of patentability” is not raised by prior art presented in a reexamination request if the Office has previously considered (in an earlier concluded examination or review of the patent) the same question of patentability as to a patent claim favorable to the patent owner based on the same prior art patents or printed publications. In re Recreative Technologies, 83 F.3d 1394, 38 USPQ2d 1776 (Fed. Cir. 1996).

In deciding whether to grant a request for reexamination of a patent, the examiner should check the patent’s file history to ascertain whether any of the prior art now advanced by requester was previously cited/considered in an earlier concluded examination or review of the patent or has been raised to or by the Office in a pending reexamination or supplemental examination of the patent. For the sake of expediency, such art is referred to as “old art” throughout, since the term “old art” was coined by the Federal Circuit in its decision of In re Hiniker, 150 F.3d 1362,1365-66, 47 USPQ2d 1523, 1526 (Fed. Cir. 1998).

In a decision to order reexamination made on or after November 2, 2002, reliance on old art does not necessarily preclude the existence of a substantial new question of patentability that is based exclusively on that old art. See Public Law 107-273, 116 Stat. 1758, 1899-1906 (2002), which expanded the scope of what qualifies for a substantial new question of patentability upon which a reexamination may be based. Determinations on whether a substantial new question of patentability exists in such an instance shall be based upon a fact-specific inquiry done on a case-by-case basis. For example, a substantial new question of patentability may be based solely on old art where the old art is being presented/viewed in a new light, or in a different way, as compared with its use in the earlier examination(s), in view of a material new argument or interpretation presented in the request. Such material new argument or interpretation may be based solely on claim scope of the patent being reexamined.

When it is determined that a substantial new question of patentability based solely on old art is raised, form paragraph 22.01.01 should be included in the order for reexamination.

See MPEP § 2258.01 for a discussion of the use of “old art” in the examination stage of an ordered reexamination (as a basis for rejecting the patent claims).

B. Prior Adverse Decisions by the Office on the Same or Substantially Identical Prior Art in the Same Patent

A prior decision adverse to the patentability of a claim of a patent by the Office based upon prior art patents or printed publications would usually mean that “a substantially new question of patentability” is present. Such an adverse decision by the Office could, for example, arise from a reissue application which was abandoned after rejection of the claim and without disclaiming the patent claim.

C. Prior Adverse Reissue Application Final Decision by the Director of the USPTO or the Board Based Upon Grounds Other Than Patents or Printed Publications

Any prior adverse final decision by the Director of the USPTO or the Patent Trial and Appeal Board or Board of Patent Appeals and Interferences (Board), on an application seeking to reissue the same patent on which reexamination is requested will be considered by the examiner when determining whether or not a “substantial new question of patentability” is present. However, to the extent that such prior adverse final decision was based upon grounds other than patents or printed publications, the prior adverse final decision will not be a basis for determining whether or not a “substantial new question of patentability” is present.

D. Prior Favorable or Adverse Decisions on the Same or Substantially Identical Prior Art Patents or Printed Publications in Other Cases not Involving the Patent

While the Office would consider decisions involving substantially identical patents or printed publications in determining whether a “substantial new question of patentability” is raised, the weight to be given such decisions will depend upon the circumstances.

III. POLICY WHERE A FEDERAL COURT DECISION HAS BEEN ISSUED ON THE PATENT

A. Final Holding by Court that a Patent Has Not Been Proven Invalid

When the initial question as to whether the prior art raises a substantial new question of patentability as to a patent claim is under consideration, the existence of a final court decision that a claim has not been proven invalid in view of the same or different prior art does not necessarily mean that no new question is present, because of the different standards of proof employed by the federal district courts and the Office. While the Office may accord deference to factual findings made by the district court, the determination of whether a substantial new question of patentability exists will be made independently of the court’s decision on validity, because it is not controlling on the Office. See In re Swanson et al., 540 F.3d 1368, 1378 (Fed. Cir. 2008), where the Federal Circuit approved of the Office’s interpretation in MPEP § 2242. See also In re Baxter International Inc., 678 F.3d 1357, 102 USPQ2d 1925 (Fed. Cir. 2012) (patent reexamination should take notice of a court decision but the Office need not come to the same conclusion as the court).

B. Nonfinal Holding of Invalidity or Unenforceability by the Courts

A nonfinal holding of claim invalidity or unenforceability will not be controlling on the question of whether a substantial new question of patentability is present.

C. Final Holding of Invalidity or Unenforceability by the Courts

A final holding of claim invalidity or unenforceability, after all appeals, is controlling on the Office. In such cases, a substantial new question of patentability would not be present as to the claims finally held invalid or unenforceable because such claims no longer exist in the patent.

As to subsections A, B, and C above, see Ethicon v.Quigg, 849 F.2d 1422, 7 USPQ2d 1152 (Fed. Cir. 1988).

Any situations requiring clarification should be brought to the attention of the Office of Patent Legal Administration.

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