Ex Parte Parker et alDownload PDFPatent Trial and Appeal BoardSep 25, 201713932202 (P.T.A.B. Sep. 25, 2017) Copy Citation 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. 13/932,202 07/01/2013 Nigel PARKER FKD - 61/670,330 7140 22925 7590 09/27/2017 PHARMACEUTICAL PATENT ATTORNEYS, LLC 55 MADISON AVENUE 4THFLOOR MORRISTOWN, NJ 07960-7397 EXAMINER MONTANARI, DAVID A ART UNIT PAPER NUMBER 1632 NOTIFICATION DATE DELIVERY MODE 09/27/2017 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): docket @ LicensingLaw. net administration @LicensingLaw.net PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte NIGEL PARKER and SEPPO YLA-HERTTUALA Appeal 2016-008089 Application 13/932,2021,2 Technology Center 1600 Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and RICHARD J. SMITH, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL This appeal involves claims directed to methods of treating a cancerous organ comprising administering a chemotherapeutic agent and a recombinant virus, where the recombinant virus comprises a homeomimetic transgene. The Examiner rejected the claims under 35 U.S.C. §§ 102(b) and 103. We have jurisdiction under 35 U.S.C. § 6(b). The rejections are affirmed. 1 The Appeal Brief (“Appeal Br.”) identifies FKD Therapies as the real- party-in-interest. 2 “The ’202 Application.” Appeal 2016-008089 Application 13/932,202 STATEMENT OF THE CASE The claims stand rejected by the Examiner as follows: 1. Claims 1-9, 11-19 and 21-30 under pre-AIA 35 U.S.C. § 102(b) as anticipated by Sterman (A Trial of Intrapleural Adenoviral-mediated Interferon-a2b Gene Transfer for Malignant Pleural Mesothelioma, 184 Am. J. Respir. Crit. Care Med. 1395-99 (2011)); issue of Dec. 15, 2011). Ans. 2. The Examiner found that Sterman was originally published as DOI: 10.1164/rccm.201103-0554CR on June 3, 2011, which is more than a year before the provisional application 61/670,330 filing date of July 11, 2012, and the provisional application 61/692,828 filing date of August 24, 2012, to which the ’202 Application claims benefit. 2. Claim 10 under pre-AIA 35 U.S.C. § 103(a) as obvious over Sterman in view of Giaccone {Pleural mesothelioma: combined modality treatments 13, Suppl. 4 Eur. Soc. Med. Oncol. 217-25, (2002)). Ans. 3^1. 3. Claims 11, 12 and 20 under pre-AIA 35 U.S.C. § 103(a) as obvious over Sterman in view of Lengyel (Ovarian Cancer Development and Metastasis 177(3) Amer. J. Pathol. 1053—64. (Sep. 2010)). Ans. 5. The ’202 Application is the parent application of continuation application 14/030,399 which was the subject of Appeal 2016-003044 to the PTAB. A decision on the appeal was decided on May 24, 2017, affirming the Examiner’s rejection. The decision has been appealed to the Federal Circuit Court of Appeals. Appellants did not list this related appeal in their Appeal Brief. 2 Appeal 2016-008089 Application 13/932,202 CLAIMED SUBJECT MATTER Independent claim 1 is representative and reads as follows: 1. In a method of treating a human diagnosed as having cancerous organ by administering chemotherapeutic agent, the improvement comprising administering to said human a recombinant virus, said recombinant virus comprising a homeomimetic transgene. REJECTIONS Appellants contend that Sterman “does not qualify as prior art” because it was published December 15, 2011, which “is less than one year before the priority date of the instant application.” Appeal Br. 1. Appellants have presented no other patentability argument for Rejections 1,2, and 3. Consequently, the appeal from all three rejections turns on the issue of whether Sterman is prior art to the rejected claims. The ’202 Application in this appeal claims benefit to a provisional applications filed July 11, 2012 and August 24, 2012, respectively. Sterman was published in the issue of American Journal of Respiratory and Critical Care Medicine dated Dec. 15, 2011, which is less than a year before the provisional filing dates and thus constitutes prior art under pre-AIA 35 U.S.C. § 102(a) (“(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent”). Because Appellants did not establish that the authors of Sterman were not “others,” Appellants’ statement that Sterman “does not quality as prior art” is not factually correct. A rejection under § 102(a), however, was not made by the Examiner. 3 Appeal 2016-008089 Application 13/932,202 The Examiner found that Sterman is prior art under pre-AIA 35 U.S.C. § 102(b) based on the statement in Sterman that it was “Originally Published in Press as DOI: 10.1164/rccm.201103-0554CR on June 3, 2011” which is more than a year before the July 11, 2012 provisional application filing date. Final Act. 6. Because the complete journal article was published in December of 2011, it is reasonable that the phrase “Originally Published” refers to this complete article, rather than just a part of it, such as an abstract only. We find that such statement constitutes sufficient evidence that the manuscript and the experiments therein relied upon by the Examiner to establish unpatentability of the claimed subject matter was available on June 3,2011. Appellants argue that the only material from Sterman that was published on June 3, 2011 was the abstract. Reply Br. 4. Appellants contend that the Examiner conceded that only the abstract was available. Id., 5. The Examiner made no such concession. Rather, the Examiner directed Appellants’ attention to the publisher’s guidelines which expressly states “Manuscripts accepted for publication will immediately (within 48 hours of acceptance) be published online in the Articles in Press section of the A.JRCCM.” Ans. 8. Appellants contend that the “publisher's previous publication guidelines could potentially be legally relevant here. In contrast, the publisher’s current guidelines provide no information on how the publisher in fact treated the Sterman manuscript six years ago.” Reply Br. 5. We disagree. There is no evidence that the policy has changed.3 The 3 It seemed rather simple to confirm with the publisher of the journal that the manuscript was available as indicated in the printed statement that 4 Appeal 2016-008089 Application 13/932,202 journal guidelines reproduced by the Examiner stating that manuscripts are “published online in the Articles in Press section” is fully consistent with the statement in Sterman, published Dec. 15, 2011, that the complete journal article was “Originally Published in Press ... on June 3, 2011” containing the experiments relied upon by the Examiner to establish unpatentability. Appellants have not provided evidence that the statement in the Dec. 15, 2011 journal article about being originally published in press on June 3, 2011 is any less than what it says to be true. Appellants’ allegation that the guidelines are not of record is not persuasive. The Examiner’s citation to the guidelines is responsive to the new argument made by Appellants in the Appeal Brief for apparently the first time concerning the editing and creation of the PDF file for the Dec. 15 2011 journal article. See Ans. 7—8. We could not find this argument made earlier, e.g., in Appellants’ Remarks filed July 13, 2015. The Examiner clearly identified where the information concerning the guidelines appeared. Ans. 8. Appellants had the opportunity to respond to the Examiner’s finding in their Reply Brief, and did. Reply Br. 5. Appellants did not explain why Examiner’s response to Appellants’ new argument is improper and should be ignored when it is of record in the Answer and Appellants are on notice of it. Indeed, Appellants introduced new evidence in this appeal regarding the creation of the Sterman pdf file. accompanied the publication on December 15, 2011. We did just that, and as indicated in the attached email, the publisher advised us that “just abstracts” are not posted. However, it is unnecessary to rely on this email because, as explained in this Decision, Appellants did not establish that the statement “Originally Published in Press ... on June 3, 2011” means that only the abstract of the journal article was published. 5 Appeal 2016-008089 Application 13/932,202 Under 37 C.R.F. § 41.37(c)(2), the “brief shall not include any new or non- admitted amendment, or any new or non-admitted affidavit or other Evidence.” Appellants further argue that the pdf of the Sterman publication is freely available to download from the publisher’s website and that “[t]he ‘Document Properties’ for that pdf file says the file was created on Nov. 24, 2011 — shortly before the Dec. 15 edition was published.” Appeal Br. 3. Based on this date, Appellants contend the metadata on the article pdf file shows that publisher created that file on Nov. 24, 2011, after the critical date. That file could not possibly have been published before the critical date because it did not exist before the critical date. Id., 6. We do not see the relevance of the date of when the final publication was created to the finding by the Examiner that an earlier manuscript was published online on June 4, 2011. To the contrary, the fact that the final version was created months later is consistent with the statement in the Sterman publication that an earlier manuscript was available online after acceptance. Appellants appear to have confused the pdf available today with the online manuscript availability on June 4, 2011; these are not the same. Appellants also contend: What was published on June 3, 2011, however, appears to have been merely the Abstract only, not the entire paper. Searching “Sterman 2011” on the www.atsjoumals.org website identifies six articles, including the instant one. Clicking on the link to “10.1164/rccm.201103-0554CR” leads to a page with only the Abstract: Id., 7. 6 Appeal 2016-008089 Application 13/932,202 Appellants’ argument is not persuasive. The “link” directs to a page with the abstract and tabs for “Full Text”, “References”, “Suppl. Materials”, “Cited by”, and “PDF.” Consequently, we find Appellants’ argument that the aforementioned “link” establishes that only the abstract was available on the disputed date is unavailing because the link contains the complete publication as published on Dec. 15, 2011. There is no evidence that this is the same link available on June 3, 2011. In sum, there is no persuasive evidence before us that the disclosure in Sterman’s December 15, 2011 publication indicating it was “Originally Published in Press as DOI: 10.1164/rccm.201103-0554CR on June 3, 2011” was not the complete, albeit unedited for publication, manuscript and the disclosure of the experiments relied by the Examiner to reject the claims. To the extent we have considered Appellants’ new argument and new evidence regarding the creation of the December 15, 2011 pdf file, we find it unpersuasive because such argument and new evidence do not rebut the finding that an earlier manuscript was publicly available on the journal website at the cited DOI number. SUMMARY For the foregoing reasons, Rejections 1, 2, and 3 of all pending claims are affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 7 Copy with citationCopy as parenthetical citation