Source: https://bitlaw.com/source/mpep/2642.html
Timestamp: 2019-04-25 04:06:05+00:00

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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 legislative history and 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.
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 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 if reexamination is denied, requester may obtain reconsideration only pursuant to MPEP § 2648. If reexamination is granted, the decision that a reference raises a SNQ is final and non-appealable by the patent owner. See 35 U.S.C. 312(c).
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 or was 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 to be merely cumulative to similar prior art already fully considered by the Office in an earlier concluded examination or review of the claim or a pending reexamination or supplemental examination of the claim.
(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 anticipated by, or obvious in view of, the prior art patents or printed publications. The difference between "a substantial new question of patentability" and a "prima facie" case of unpatentability is important. 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 § 2616. It should be also noted that the "substantial new question of patentability" standard for granting reexamination on a request for an inter partes reexamination is the same as the "substantial new question of patentability" standard for granting reexamination on a request for an ex parte reexamination.
"The threshold for initiating an inter partes review is elevated from ‘significant new question of patentability’--a standard that currently allows 95% of all requests to be granted--to a standard requiring petitioners to present information showing that their challenge has a reasonable likelihood of success." H.R. Rep. No. 112-98 (Part 1), at 47.
Thus, the reasonable likelihood standard requires a showing that is "elevated" from that of the substantial question of patentability question standard.
If a reexamination proceeding was terminated/vacated without resolving the "reasonable likelihood" question, it can be re-presented in a new reexamination request (but note that for an ex parte reexamination request, a substantial new question of patentability must be raised).
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.
A "substantial new question of patentability" is not raised by the prior art if the Office has previously considered (in an earlier concluded examination or review of the patent or in a pending reexamination or supplemental examination 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 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 Co., 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.
MPEP § 2258.01 provides a discussion of the use of "old art" in the examination stage of an ordered reexamination (as a basis for rejecting patent claims).
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 arise from a reissue application which was abandoned after rejection of the claim and without disclaiming the patent claim.
Any prior adverse final decision by the Director of the Office, 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. To the extent that such a prior adverse final decision was based upon grounds other than patents or printed publications, the prior adverse final decision will not be considered in determining whether or not a "substantial new question of patentability" is present.
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 given to such decisions will depend upon the circumstances.
As to A - C which follow, see Ethicon v. Quigg, 849 F.2d 1422, 7 USPQ2d 1152 (Fed. Cir. 1988).
When the initial question as to whether the prior art raises a substantial new question of patentability (SNQ) or there is a reasonable likelihood that the requester will prevail (RLP) as to a patent claim is under consideration, the existence of a final court decision that a patent claim is not invalid in view of the same or different prior art does not necessarily mean that no SNQ/RLP is present, because of the different standards of proof and different standards of claim construction applied by the federal district courts and the Office. While the Office may accord deference to factual findings made by the court, the determination of whether a SNQ/RLP exists will be made independently of the court’s decision on validity, because it is not binding on the Office. See, e.g., In re Swanson et al., 540 F.3d 1368, 1378 (Fed. Cir. 2008) (Federal Circuit approved of the Office’s interpretation in MPEP § 2242). Note, where the requester was a party to the prior litigation resulting in the final court decision that a patent claim is not invalid, see MPEP § 2686.04, subsection II(B) for a discussion of the application of the estoppel provisions of the inter partes reexamination statute.
A non-final holding of claim invalidity or unenforceability will not be controlling on the question of whether a substantial new question of patentability/a reasonable likelihood that the requester will prevail is present.
However, a final holding of claim invalidity or unenforceability, after all appeals, binds the Office. In such cases, a substantial new question of patentability/a reasonable likelihood that the requester will prevail would not be present as to any claims finally held invalid or unenforceable.
Note: Any situations requiring clarification should be brought to the attention of the Office of Patent Legal Administration.

References: § 2648
 v. 
 § 2616
 § 2258
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 § 2242
 § 2686