Ex Parte Parker et alDownload PDFPatent Trial and Appeal BoardMay 22, 201714030399 (P.T.A.B. May. 22, 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. 14/030,399 09/18/2013 Nigel PARKER FKD - 61/670,330 5885 22925 7590 05/24/2017 PHARMACEUTICAL PATENT ATTORNEYS, LLC 55 MADISON AVENUE 4THFLOOR MORRISTOWN, NJ 07960-7397 EXAMINER WEHBE, ANNE MARIE SABRINA ART UNIT PAPER NUMBER 1633 NOTIFICATION DATE DELIVERY MODE 05/24/2017 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 2016-003044 Application 14/030,3991,2 Technology Center 1600 Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and RACHEL H. TOWNSEND, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL This appeal involves claims directed to methods of treating organ cancer comprising administering a chemotherapeutic agent and a recombinant vims, where the recombinant vims comprises a homeomimetic transgene. The Examiner rejected the claims under 35 U.S.C. § 102(b). We have jurisdiction under 35 U.S.C. § 6(b). The rejection is affirmed. 1 The Appeal Brief (“Appeal Br.”) lists FKD Therapies Oy, Kuopio Finland, as the real-party-in-interest. 2 “The ’399 Application.” Appeal 2016-003044 Application 14/030,399 STATEMENT OF THE CASE Appellants appeal from the Examiner’s final rejection of claims 1—9, 11—19, and 21—30 under pre-AIA 35 U.S.C. § 102(b) as anticipated by Sterman (Am. J. Respir. Crit. Care Med., 184:1395—99, 2011; issue ofDec. 15, 2011). Final Action (“Final Act.”; Jan. 14, 2015) 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 to which the ’399 Application claims benefit. Id. at 2—3. 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 [spelled throughout the ’399 Application as “homomimetic”] transgene, said recombinant virus administered to a site remote from said cancerous organ. CLAIM INTERPRETATION There are four independent claims. Claims 1 and 11 are directed to methods of treating a human that has a “cancerous organ.” Claim 21 is directed to a method of treating “organ cancer.” Claim 30 is directed to a method of treating “cancer.” The interpretation of “cancerous organ” and “organ cancer” are in dispute. The Examiner construed “cancerous organ” and “organ cancer” as cancer involving the tissues of an organ (“malignant pleural mesothelioma is 2 Appeal 2016-003044 Application 14/030,399 a malignant cancer which in later stages involves the lung tissue and as such qualifies as a ‘lung cancer’”). Final Act. 4. Appellants contend “internal organs derive from embryonic endoderm .... Organ cancer is cancer of an organ, i.e., endoderm-derived tissue.” Appeal Br. 7.3 Appellants distinguish an “organ cancer” from a cancer of a mesothelioma which is a sac which covers internal organs. Id. Appellants argue that an organ cancer must arise from cancerous cells of the organ (“Lung cancer is a different [sic, cancer?], arising not from cancerous mesothelium cells, but from cancerous lung cells.”). Id. at 8. See also Reply Br. 1—2. Appellants did not provide adequate factual support for the argument that an organ is derived from endodermal cells. It is well-known that not all organs derive from the endoderm. For example, the brain is an organ and it arises from the ectoderm and the spleen and heart, also organs, arise from the mesoderm.4 Nonetheless, regardless of the embryonic origin of an “organ,” the issue is whether the terms “cancerous organ” or “organ cancer” require the cancer to have originated in the organ. During patent examination proceedings, claim terms are given “the broadest reasonable meaning ... in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by 3 Appellants did not number the pages of the Appeal Brief. The numbering used throughout this Decision begins with the title page of the Appeal Brief numbered as page 1. 4 http://discovery.lifemapsc.com/library/review-of-medical- embryology/chapter-25-germ-layers-and-their-derivatives. Accessed April 2, 2017. 3 Appeal 2016-003044 Application 14/030,399 the written description contained in the applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). The Specification does not provide a definition of either term. Thus, we turn to the ordinary usage of these terms. In the term “organ cancer,” “organ” is used as an adjective to describe the type of cancer, namely, the cancer is associated with an organ, namely, the organ has cancerous cells present in it. Neither word requires the cancer of the organ to have originated in the organ. For example, the cancer could have metastasized to, or invaded a particular organ, and the cancerous cells would still would be present in the organ. In the term “cancerous organ,” “cancerous” is an adjective and thus describes the organ as being “affected” with a cancer.5 Again, neither word in the term “cancerous organ” requires the cancer to have a specific history; a “cancerous organ” can result from cells that originated in the organ, or, from cells originating from another location in the body that subsequently invaded the organ. We have not been directed to a definition in the Specification, or an extrinsic definition, that would guide us to a narrower interpretation, particularly the interpretation urged by Appellants that cancer must originate in the organ to qualify as an organ cancer or cancerous organ. Consequently, we adopt the Examiner’s claim construction as the broadest reasonable interpretation of the disputed terms and construe “organ cancer” and “cancerous organ” to mean that cancer is present in the organ. 5 http://www.thefreedictionary.com/cancerous. Accessed April 2, 2017. 4 Appeal 2016-003044 Application 14/030,399 REJECTION The claims are directed to methods of treating cancer comprising administering 1) a chemotherapeutic agent and 2) a recombinant virus to a human, where the recombinant virus comprises a homeomimetic transgene. Appellants elected IFN-alpha as the species of the homeomimetic transgene6 and lung as the species of cancerous organ. Ans. 2. The Examiner found that Sterman teaches “methods of treating malignant pleural mesothelioma (MPM) in human patients by intrapleural catheter infusion of a saline solution comprising an adenoviral vector encoding interferon-alpha 2b, wherein patients receiving the treatment exhibited antitumor immune responses and in some cases stable disease or even tumor regression . . . .” Id. at 3. The patients had also received a chemotherapeutic agent. Id. Because the Examiner found that all limitations of the claim are described by Sterman, the Examiner concluded the claim is anticipated. Id. Appellants contend that mesothelioma is not an organ cancer or a cancerous organ. Appeal Br. 7—8. Appellants state: Organ cancer is cancer of an organ, i. e., endoderm-derived tissue. In contrast, mesothelioma is, as the name implies, cancer of the mesothelium-derived sac that covers many internal organs. The two types of cancers differ in location (one occurs in the organ, the other in the surrounding sac) and biology (endoderm and mesoderm cells differ). Id. 6 A homomimetic transgene is defined in the ’399 Application as “a transgene which codes for a polypeptide which mimics an effect of a naturally-occurring human polypeptide.” ’399 Application 2:18—20. 5 Appeal 2016-003044 Application 14/030,399 Appellants also contend that lung cancer must arise from cancerous lung cells, not mesothelioma cells which migrate into the lung. Id. at 9. Discussion The broadest reasonable interpretation of “organ cancer” and “cancerous organ” is of a cancer that is present in an organ, which in this case would be the elected organ, the lung. Contrary to Appellants’ interpretation, the claims do not require the cancer to originate from the cells of the organ. Accordingly, the issue in the anticipation rejection is whether the mesothelioma described by Sterman is present in lung tissue. The Examiner relied upon an online publication (at https://www. pleuralmesothelioma.com/cancer/staging.php) (“pleuralmesothelioma.com”) describing the staging of mesothelioma to establish that the lung contains mesothelioma cells in Stage T2. Final Act. 4; Ans. 5. According to this publication, at Stage T2: The tumor involves the pleural lining of the chest wall on one side of the chest, as well as the pleural lining of the diaphragm, mediastinum and the lung. The cancer has also grown into at least one of the following: • The diaphragm muscle • Tissue of the lung itself Stage T2 occurs in Stages II through IV of mesothelioma (pleuralmesothelioma.com). Sterman specifically discloses that several of the treated patients were in Stages III and IV (Sterman 1396, Table 1). Stage III and Stage IV patients would have Stage T2 cancer where the mesothelioma is in the lung tissue. Thus, the Examiner had sufficient factual basis to conclude that Sterman treated 6 Appeal 2016-003044 Application 14/030,399 lung cancer. Final Act. 4; Ans. 5. Appellants have not provide adequate arguments or evidence to rebut this fact-based determination. Appellants contend that the migration of cells into the lung is not a lung cancer. Appeal Br. 8. However, such claim construction is not the broadest reasonable interpretation of the claim. Accordingly, this argument does not persuade us that the Examiner erred. Remote Claim 1 requires that the “recombinant virus [is] administered to a site remote from said cancerous organ . . . .” Appeal Br. 7. The Examiner found that Sterman describes “intrapleural catheter infusion of a saline solution comprising an adenoviral vector encoding interferon-alpha 2b.” Ans. 3. The Examiner also found that “intrapleural catheter infusion involves the delivery of the vector to the intrapleural space, the space between the mesothelium and the lung, and as such qualifies as a site ‘remote’ from a cancerous [lung] organ.” Id. Appellants respond that “Sterman’s mesothelium is cancerous, so Sterman teaches administration directly onto cancerous tissue, not ‘remote’ from it.” Reply Br. 5. This argument does not demonstrate error because the rejection is based on administration of the transgene to the intrapleural space which is at a remote location to the lung. 7 Appeal 2016-003044 Application 14/030,399 Is Sterman prior art? Appellants contend that “Sterman (2011) was first published in December 2011 and therefore does not qualify as prior art.” Reply Br. 7. The ’399 Application in this appeal claims benefit to a provisional application filed July If 2012. 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 date and thus constitutes prior art under pre-AIA 35 U.S.C. § 102(a). Consequently, Appellants’ statement that Sterman “does not qualify as prior art” has no factual support in this record. 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 provisionaEfiling date. See Ans. 2. Appellants argue, without providing the Board with any evidence in this proceeding, that the only material published was the abstract. Reply Br. 7. Appellants contend that the DOI document is of record “in the parent case,” but did not identify the “parent case” nor provide the Board, as a courtesy, with such document. Id. Sterman clearly states “Originally Published in Press,” indicating that the article was itself published. Appellants had the opportunity throughout this proceeding to provide evidence to the Examiner that it was only the abstract which was published, but did not. For example, the Sterman rejection was made by the Examiner in a non-final Office Action entered June 11, 2014. Appellants responded to the rejection on Sept. 10, 2014 without making the allegation that Sterman is not prior art to their 8 Appeal 2016-003044 Application 14/030,399 application and without providing evidence that the Examiner erred in finding Sterman’s publication date to be June 3, 2011. Nonetheless, Sterman is prior art under pre-AIA 35 U.S.C. § 102(a). Consequently, even if Sterman was not published more than before the provisional filing date of the ’399 Application, it is still prior art to the application. SUMMARY For the foregoing reasons, the anticipation rejection of independent claims 1, 11,21, and 30 is affirmed. Dependent claims 2—9, 12—19, and 22— 29 were not argued separately and fall with the independent claims. 37 C.F.R. §41.37(c)(iv)(l) TIME PERIOD 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 9 Copy with citationCopy as parenthetical citation