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Home > Nanotechnology Columns > Magda Carvalho PhD, JD > Inter Partes Reexamination: Substantial New Questions of Patentability Attaches to a Particular Rejection.

Magda Carvalho
Patent Attorney
Patent Law at M. Carvalho

In the area of reexamination, presentation of a substantial new question of patentability (SNQ) is still a hot topic. A recent BPAI decision reiterated the rule about jurisdiction to review an Examiner's denial of SNQ. The invention pertains to diabetes care involving electrochemical sensors.

May 15th, 2011

Inter Partes Reexamination: Substantial New Questions of Patentability Attaches to a Particular Rejection.

After a patent is granted, its validity can be tested in litigation, reexamination, interference and reissue. In reexamination proceedings, both inter partes and ex parte statutes require that at least one SNQ is included in the request. (1) The issue of SNQ is separate and distinct from the proposed ground of rejection. The SNQ was created to prevent serial reexamination proceedings on the same references and to prevent harassment of the patent owner. (2)

If the PTO denies a SNQ then the claims at issue are not reexamined for the proposed ground of rejection (for lack of the required SNQ). Denied SNQs can be disputed by either appeal or petition. Notably, the reviews procedures are different between inter partes and ex parte reexamination. A determination by the PTO in an inter partes either that no SNQ has been raised or that a reference raises a SNQ is final and non-appealable. (3) Regarding ex parte reexamination this issue is appealable but the right of appeal is not interlocutory. For an ex parte reexamination ordered before June 25, 2010, the patent owner may include a challenge to the finding of a SNQ as a separate ground in an appeal to the Board of Patent Appeals and Interferences (BPAI), even if the patent owner did not request that the Examiner reconsider the finding of the SNQ during prosecution. For ex parte reexaminations proceedings ordered on or after June 25, 2010, the patent owner must request that the Examiner reconsider the grant of the SNQ as part of a full response to the Office action in order to preserve the issue for appeal. (4)

As seen in inter partes reexamination procedure, denial of a SNQ by the PTO is of concern to third party requesters. Under statutory law, the third party is estopped from asserting in litigation the "invalidity of any claim finally determined to be valid and patentable on any ground which the third-party requester raised or could have raised during the inter partes reexamination proceedings."(5)

BPAI decision in inter partes reexamination of U.S. Patent No. 6,931,327 (Abbot Diabetes Care, Inc., v. DexCom, Inc.). (6)

On May 2011 the BPAI dealt again with the issue of was "whether the BPAI has "jurisdiction to review the Examiner's decision that proposed Rejection VI does not raise a substantial new question of patentability?" In this case before the BPAI, the PTO determined that some of the proposed grounds of rejections were SNQs and some were not. As such, a reexamination was ordered only against the claims were SNQ were found.

The patent 6,931,327 under reexamination is directed to diabetes care monitoring system involving transcutaneous analyte sensors. Specifically, it concerns a method for calibrating glucose sensors including evaluating received reference and sensor data, and evaluating the calibration for the analyte sensor. The method includes evaluating the clinical acceptability of reference data and/or time corresponding sensor data. Analyte sensors produce a raw data signal that is indicative of the analyte concentration of a user.

The Examiner did not adopt a proposed ground of rejection for certain claims since it was determined that there is no SNQ in first place. The Examiner explained that "there does not appear to be any evidence that the Say reference is considered in a different light over the manner in which it was considered by the Examiner [during prosecution]." The Requester did not petition the denial to the Director.

Under appeal to the BPAI, the Requester tried to appeal the denial of the SNQ asserting that "once any SNQ is found and the inter partes reexamination is granted, there is no longer any reason to limit the patentability analysis to the SNQ issue. Instead, the focus shifts to the proposed rejections and whether they should be adopted or not. To limit patentability analysis solely as to whether an SNQ issue exists or not and therefore simply ignore a prior art reference that directly bears on patentability would contravene a very reason behind reexamination which is patent validity." The Patent Owner successfully contended that an appeal was not a proper venue to challenge determinations that a reference fails to raise a SNQ because, a determination by the Director that a substantial question of patentability does not exist is final and non-appealable.

The Board made it clear that the denial of SNQs affecting certain claims is properly pursued by petition to the Director, "under 35 U.S.C. 312(c), the Director's determination in an inter partes reexamination as to the existence of a substantial new question of patentability is "final and non-appealable." The decision continues on to explain the March 2011ruling on Belkin International, Inc. et al v. Optimumpath, LLC, in which an expanded panel considered whether the Board has jurisdiction to decide SNQ matters in the context of inter partes reexamination. (7) In Belkin, the Examiner had found an SNQ over a proposed rejection but did not find SNQ affecting certain claims. The expanded panel held that the Board did not have jurisdiction to decide an appeal on the non-appealable issue of whether a substantial new question of patentability exists. Although, the Examiner found some SNQ for a reference, the expanded panel concluded that the Board did not have jurisdiction to review the Examiner's determination that substantial questions of patentability did not exist with respect to the other proposed rejections. As the Board explained Belkin's holding stands for that an "SNQ attaches to a particular rejection" and thus, "the determination that an SNQ exists with respect to a particular rejection does not necessarily permit a third party requestor to pursue proposed rejections not found to raise an SNQ outside of the attached rejection, regardless of whether or not the additional rejections are directed to the same claims."

The Board concluded that an Appeal is not a proper venue for challenging the Examiner's determination that a particular reference does not raise a SNQ. Therefore, the Requester should have sought relief by filing a timely petition rather than an appeal.

In summary, the Board decision was consistent with Belkin that in inter partes reexamination proceeding a review of SNQ is a petitionable matter. For this reason, third parties must dispute such denials internal to the PTO.

(1) 35 U.S.C. 303 and 312.
(2) H.R. Rep. No. 96-1307 (1980).
(3) 35 U.S.C. 312(c).
(4)75 Fed. Reg. 36357 (June 25, 2010).
(5) 75 Fed. Reg. 36357 (June 25, 2010).
(6) Reexamination Control 95/001,039.
(7) Belkin International v Optimumpath, Reexamination Control No. 95/001,089.

Please send your comments to Magda Carvalho at

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