Haritha Samaranayake et al.

Patent Trials and Appeals BoardSep 4, 2019

13877246 - (R) (P.T.A.B. Sep. 4, 2019)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 13/877,246 08/07/2013 Haritha Samaranayake GB11/00804.2 1025 22925 7590 09/04/2019 Pharmaceutical Patent Attorneys, LLC 801 Brickell Avenue 9th Floor #9101 Miami, FL 33131-4924 EXAMINER SGAGIAS, MAGDALENE K ART UNIT PAPER NUMBER 1632 NOTIFICATION DATE DELIVERY MODE 09/04/2019 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): administration@LicensingLaw.net docket@LicensingLaw.net mark.pohl@licensinglaw.net PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte HARITHA SAMARANAYAKE, JERE PIKKARAINEN, ANN-MARIE MAATTA, SEPPO YLA-HERTTUALA1 ____________ Appeal 2018-001996 Application 13/877,246 Technology Center 1600 ____________ Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and DAVID COTTA, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. REQUEST FOR REHEARING This is a request for rehearing under 37 C.F.R. 41.79 (“Req. Reh’g”) of the Decision on Appeal entered May 30, 2019 (“Dec. App.”). Appellants argue that three erroneous factual findings were made in the Decision on Appeal. Req. Reh’g 1. We have considered Appellants’ arguments, but we are not persuaded to change the outcome of the Decision. Each of three arguments made by Appellants are discussed below. 1 The Appeal Brief (“Appeal Br.” entered July 27, 2016) lists Trizell Limited as the Real Party in Interest. Appeal Br. 1. Appeal 2018-001996 Application 13/877,246 2 Is Hegi (2008) of record? Appellants contend that Hegi (J. Clin. Oncol. 26: 4189–4199, 2008) (“Hegi (2008)”) is not of record. Req. Reh’g 1. Hegi (2008) was cited in the Answer, but not in the Final Office Action, as part of a new ground of rejection.2 Ans. 14, 19. The Examiner stated that Hegi (2008) was cited in an Information Disclosure statement (“IDS”). Ans. 14, 19. The Decision on Appeal agreed that Hegi was of record because it was cited in an IDS. Dec. App. 18. However, as pointed out by Appellants, the “Hegi” publication listed in the IDS is not the same Hegi (2008) publication cited in the Answer. Req. Reh’g 1. Thus, the statement that Hegi (2008) was listed on the IDS is an error. Nonetheless, we do not agree with Appellants that Hegi (2008) is not of record. Hegi (2008) was made of record in the Examiner’s Answer because the Examiner provided a full citation to it. Even if the publication was not listed by the Examiner on a disclosure form, this deficiency does not mean it is not “of record.” The Manual of Patent Examining Procedures (“MPEP”) (Ninth Edition, Last Revised January 2018) explains the purpose of listing a publication on a disclosure form: MPEP 707.05(a) Copies of Cited References . . . To assist in providing copies of, or access to, references, the examiner should: (A) Type the citation of the references on form PTO-892, “Notice of References Cited” using OACS; 2 Appellants had the option to reopen prosecution in response to the new ground, but did not do so and addressed the Hegi (2008) reference in the Reply Brief (see Reply Br. 12). Appeal 2018-001996 Application 13/877,246 3 (B) Include in the eRed Folder all of the references cited by the examiner which are to be furnished to the applicant. The MPEP does not indicate that the failure to list a publication on form PTO-892 establishes that a publication is “not of record” as stated by Appellants. Rather, the purpose is to assist in providing a copy or access to the publication. The Answer provided Appellants with the complete citation to Hegi (2008) in the Answer and thus Hegi (2008) is recorded in the examination record. Appellants did not provide legal basis for the assertion Hegi (2008) is not of record, that they lacked access to the reference, or that they were prejudiced in any way. Antibody detection in the ’855 patent In the Decision on Appeal, Appellants’ statement that “certain cancer therapies should not be given to immunocompetent patients” was addressed. Dec. App. 9. In addressing this argument, the declaration by Mr. Seppo Yla- Herttuala describing results reported in U.S. Pat. 6,579,855 (“the ’855 patent”) was discussed. Mr. Yla-Herttuala is a co-inventor of the ’855 patent and also a co-inventor of the application involved in this appeal. It was stated in the Decision on Appeal: The declaration [describing the results in U.S. Pat. 6,579,855] does not say patients were “only” treated “if” antivirus antibody was below the detectable level as asserted by Appellants. Instead, Mr. Yla-Herrtuala [Yla-Herttuala] states that antibody was not measured before gene transfer because it would have been below detection levels. The apparent reason for this is because the patients had not yet been exposed to the viral vector and had not yet developed an immune reaction it. Dec. App. 10. Appeal 2018-001996 Application 13/877,246 4 Appellants state the Decision erred in finding that antibody was not measured in the ’855 patent before gene transfer. Req. Reh’g 3. We agree this is an error, but the error does not change our conclusion that patients having a normal immune response were treated in the cited prior art publication. Dec. App. 9. The reasoning set forth in the Decision on Appeal is unchanged. We clarify that the ’855 patent states that antibodies were measured before and after gene therapy. ’855 patent, col. 4: 9–10, 53–54. However, Mr. Yla-Herttuala makes the following statement in his declaration: The patent does not disclose the measure of anti-virus antibodies measured before gene transfer. This is because as measured before gene transfer, anti-virus antibody was below detectable limits for all patients. Yla-Herttuala ¶ 3. Thus, antibody was measured, but not reported in the ’855 patent before gene transfer because it was “below detectable limits.” Does Ulasov teach a transgene? Claim 1 recites a step of “administering to said human patient a viral gene therapy vector having a transgene.” As explained in the Decision on Appeal, the Examiner found that Ulasov describes introducing the E1A gene into a viral vector and driving its expression with a survivin promoter, which the Examiner determined met the claimed requirement of a “transgene.” As explained in the Decision: Ulasov discloses “CRAd-Survivin-pk7 (CRAd-S-pk7), a novel oncolytic adenoviral vector that utilises the survivin promoter to drive E1A expression and binds to heparan sulphate proteoglycans expressed on malignant glioma.” Ulasov 1155. Appeal 2018-001996 Application 13/877,246 5 The E1A gene, normally present in the virus, was not the copy that was used in Ulasov’s experiment. Instead, Ulasov teaches that “the survivin-controlled E1 expression cassette was placed in the native E1 region of the Ad genome to avoid nonspecific viral replication.” Id. For this reason, we do not agree with Appellants that reading the term “transgene” on the E1 expression cassette would “read” the limitation out of the claim, allegedly because all the viral DNA would be considered a transgene. Reply Br. 3. Rather, the Examiner correctly found that the E1A expression cassette is a “transgene” because it was introduced into the adenovirus and is not native to it. The E1A expression cassette is an E1 gene operably connected to the non-native survivin promoter. Dec. App. 7–8. Appellants contend that the Examiner erred in finding that Ulasov describes a “transgene,” and that such finding was made only after prosecution had been closed (“She raised it only after she had closed the record to the introduction of rebuttal evidence.”). Req. Reh’g 3–4. Appellants also state that the Board invited Appellants to provide rebuttal evidence, and “[i]n response to the Board’s kind invitation to do so, however, Appellant here provides the rebuttal evidence you request: a Declaration (July 2019) from Professor Yla-Herttuala explaining how the voluminous evidence of record contradicts the Examiner's incorrect interpretation of the term ‘transgene.’” Req. Reh’g 4. While the Examiner did not raise the transgene issue with respect to Ulasov until the Answer, Appellants had the opportunity to reopen prosecution (Ans. 33) and introduce new evidence at that time. Appellants chose not to reopen prosecution, but instead filed a Reply Brief. The Declaration was not provided at this time. The Decision on Appeal did not subsequently “invite” Appellants to provide rebuttal evidence. New Appeal 2018-001996 Application 13/877,246 6 evidence is not permitted in a Request for Rehearing “except as permitted by paragraphs (a)(2) through (a)(4) of” 37 C.F.R § 41.52(a). Appellants did not establish that such conditions were met, and thus the new Declaration is not permitted and has not been considered. The term “transgene” does not appear in the Specification as originally filed. In the Appeal Brief, Appellants identified page 1, line 6 of the Specification as providing support for the term. Appeal Br. 1. The complete sentence spanning line 6 of the Specification is reproduced below: Herpes simplex virus type 1, thymidine kinase (HSV-tk) gene therapy is based on the prodrug activating enzyme that converts a non-toxic compounds such as ganciclovir, (GCV) into a toxic metabolite. Spec. 1:6–8. This disclosure does not elucidate the meaning of “transgene.” In the Reply Brief, Appellants defined a “transgene” as “foreign genetic material.” Reply Br. 2. Appellants further state that the transgene must code for a polypeptide. Req. Reh’g 4. Appellants also argue that the E1 gene is native to adenovirus and therefore not a foreign gene. Id. at 3. The E1A gene utilized in Ulasov codes for a protein and is not the same copy that is present in the vector, but instead was introduced into the vector. Ulasov 1155. The E1A gene is therefore “foreign” to the adenoviral genome present in the vector because it is not the “native” copy present in the adenoviral genome. Accordingly, we decline to change our determination that Ulasov describes a transgene consistent with the broadest reasonable interpretation of that term as it would have been understood by an ordinary artisan. “[D]uring patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language Appeal 2018-001996 Application 13/877,246 7 explored, and clarification imposed.” In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989). REHEARING DENIED