By Stephen G. Kunin
| May 10, 2010
stemOn April 28, 2010, The USPTO’s Board of Patent Appeals and Interferences (BPAI) rejected claims 1-3 of Wisconsin Alumni Research Foundation’s (WARF) “Primate Embryonic Stem Cells” Patent (U.S. Patent No. 7,029,913, the ’913 patent).  The WARF patent is licensed to Geron Corporation and is subject to Inter partes Reexamination as Control No. 95/000,154.  The BPAI reversed the Examiner’s decision to allow the claims. The claims cover pluripotent human embryonic stem cells (ES) cultured in vitro. The request for inter partes reexamination of the ’913 patent was filed on July 17, 2006 by the Public Patent Foundation (PubPat) on behalf of The Foundation for Taxpayer & Consumer Rights (FTCR), now known as Consumer Watchdog. The BPAI decision does not affect two other WARF embryonic stem cell patents (U.S. Patent Nos. 5,843,780 and 6,200,806) that were challenged by FTCR in reexamination proceedings resulting in confirmation of the patentability of their claims in reexamination certificates. However, the rejection of the ’913 patent claims may have a reverberating effect on the stem cell industry. Following an order granting inter partes reexamination of the ’913 patent on September 29, 2006, the Examiner rejected claims 1-3 based on anticipation and obviousness rejections. However, in the Action Closing Prosecution of February 25, 2008 and the Right of Appeal Notice of June 8, 2008, the Examiner withdrew the rejections and found claims 1-3 allowable. On appeal the Third Party Requester (TPR) contended that the Examiner committed reversible error in improperly withdrawing the rejections of claims 1-3 made in the Examiner’s initial Office Action and in failing to adopt a rejection that had been proffered by the TPR in the request for inter partes reexamination. Claim 1 of the ’913 patent was amended several times during the reexamination proceeding. Claims 2 and 3 depend from claim 1 and were not separately argued for patentability on appeal. The narrowing of claim 1 by amendment, should the rejection of claim 1 be reversed on appeal, may result in intervening rights applying to these claims in any enforcement proceeding against a third party. There were two issues to be decided by the BPAI in determining whether the claims should be properly rejected. 1) Whether the Williams patent (U.S. Patent No. 5,166,065) described and enabled the claimed embryonic stem cells derived from a pre-implementation embryo? 2) Whether the Williams patent disclosure of human ES cells is negated by the facts in the Cherny (Robert A. Cherny, Strategies for the Isolation and Characterization of Bovine Embryonic Stem Cells, 6 Reprod. Fertil. Dev. 569, 571 (1994)) article? The BPAI found that the Williams patent did describe and enable the claimed embryonic stem cells derived from a pre-implementation embryo and that Cherny did not negate the Williams patent disclosure of human ES cells. As a consequence, the BPAI reversed the Examiner’s decision to withdraw the obviousness rejections of claims 1-3 based on the Williams patent alone and in combination with other prior art references. However, they affirmed the Examiner’s decision not to adopt proposed obviousness rejections of claims 1-3 based on the other prior art references without the Williams patent. In addition, the BPAI designated as new grounds of rejection the rejection of claims 1-3, as amended, based on the Williams patent alone and in combination with the same other prior art references comparable to the rejections withdrawn by the Examiner during the inter partes reexamination proceedings. By designating the adoption of TPR proposed rejections as new grounds of rejection under 37 C.F.R. § 41.77, the patent owner may either request that prosecution of the reexamination proceedings be reopened before the Examiner or rehearing by the BPAI on the same record. Interestingly, in making its decision the BPAI interpreted § 41.77 to cover the situation where the examiner withdrew a rejection after the patent owner amended a claim rather than never having adopted the third party requesters proposed rejection as literally stated in the rule. Of course, once the patent owner amended claim 1 and the Examiner allowed claims 1-3, the TPR proposed that the claim be rejected, thus reserving its right to independently appeal the Examiner’s allowance of claims 1-3. So in essence, the Examiner decided not to make or adopt a rejection of the amended claims as proposed by the TPR, albeit by his withdrawal of his earlier rejection of the claims prior to amendment as of the time of the appeal. According to Teddy Gron, who is of Counsel at Oblon Spivak and a former Administrative Patent Judge at the BPAI, “[o]nce the Board has jurisdiction under 35 U.S.C. 134(a),(b), or (c), it has jurisdiction to resolve patentability issues relating to the claimed subject matter and may act accordingly. New grounds of rejection may be raised and entered by the Board itself, e.g. 37 CFR §§ 41.50(b) or 41.77(a). The new grounds of rejection may be based on new evidence or, as in this case, based on new rationale (KSR) relating to evidence of record. The Board in this case acted well within its jurisdiction and raised a new, non-final ground of rejection based on the rationale in the Supreme Court’s decision in KSR.” Reopening of prosecution before the Examiner permits the filing of an amendment and/or new evidence, whereas a rehearing before the BPAI to challenge the correctness of the decision is limited to the same record. In either case, expect that the patent owner will continue its fight against these rejections in order to obtain a favorable reexamination certificate at the end of the proceedings.
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