Ex Parte SiberDownload PDFBoard of Patent Appeals and InterferencesJul 22, 201010441059 (B.P.A.I. Jul. 22, 2010) 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. 10/441,059 05/20/2003 George R. Siber 38523.000031 1066 21967 7590 07/22/2010 HUNTON & WILLIAMS LLP INTELLECTUAL PROPERTY DEPARTMENT 1900 K STREET, N.W. SUITE 1200 WASHINGTON, DC 20006-1109 EXAMINER STOICA, ELLY GERALD ART UNIT PAPER NUMBER 1647 MAIL DATE DELIVERY MODE 07/22/2010 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte GEORGE R. SIBER __________ Appeal 2010-003908 Application 10/441,059 Technology Center 1600 __________ Before ERIC GRIMES, LORA M. GREEN, and STEPHEN WALSH, Administrative Patent Judges. WALSH, Administrative Patent Judge. DECISION ON APPEAL1 This is an appeal under 35 U.S.C. § 134(a) involving claims to a method for treating Severe Acute Respiratory Syndrome (SARS). The Patent Examiner rejected the claims on the ground of obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE” (paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery mode) shown on the PTOL-90A cover letter attached to this decision. Appeal 2010-003908 Application 10/441,059 2 STATEMENT OF THE CASE Claims 36-41 and 48-50, which are all the pending claims, are on appeal. Claim 38 is representative and reads as follows: 38. A method for treating a patient having Severe Acute Respiratory Syndrome (SARS) comprising: administering to the patent [sic] a therapeutically effective amount of an inhibitor of TNF. The Examiner rejected the claims under 35 U.S.C. § 103(a) as unpatentable over Nicholls2, Cheung3, Pluenneke4, and Tobinick5. Appellant requested an oral hearing in this appeal. We find an oral hearing unnecessary and have decided the appeal on the basis of the written record, as authorized by 37 C.F.R. § 41.47(f). OBVIOUSNESS The Issue The Examiner reviewed the prior art and concluded: It would have been obvious for a person of ordinary skill in the art . . . to have used the critical observations of Nicholls et al. that the macrophages are present in the dead SARS patients, combined with the teachings of Cheung et al., that viruses are potent inducers of TNFα in macrophages, to come to the conclusion that the TNFα likely explains the etiology and 2 John M Nicholls et al., Lung pathology of fatal severe acute respiratory syndrome, 361 LANCET 1773-78 (2003). 3 C Y Cheung et al., Induction of proinflammatory cytokines in human macrophages by influenza A (H5N1) viruses: a mechanism for the unusual severity of human disease?, 360 LANCET 1831-37 (2002). 4 Patent Appl. Pub. No. US 2001/0021380 A1, by John D. Pluenneke, Sep. 13, 2001. 5 Patent No. US 6,419,934 B1, issued to Edward L. Tobinick, Jul. 16, 2002. Appeal 2010-003908 Application 10/441,059 3 severity of the SARS and would lead the person of ordinary skill in the art to treat SARS with TNFα inhibitors. . . . The motivation to do so would have come from the constant desire of a person of ordinary skill in the art to find solutions to the problems which are posed in the art by employing methodologies that are well within her or his skills and chosen from a finite number of options. (Ans. 6.) Appellant contends that “[c]lose inspection of the cited references exposes critical deficiencies,” and that “[a]pplication of the appropriate legal standard to the facts compels reversal.” (App. Br. 10.) Appellant argues that the rejection did not state a specific rationale to support the conclusion of obviousness (id. at 10-11); that the rejection is based on an incorrect “obvious to try” standard (id. at 11-12); and that a prima facie case of obviousness was not established (id. at 12-27, analyzing the references). The issue with respect to this rejection is whether the rejection is supported by the evidence. Findings of Fact 1. Nicholls disclosed that “SARS is associated with epithelial-cell proliferation and an increase in macrophages in the lung.” (Nicholls p. 1773, “Interpretation”.) 2. According to Nicholls, “[a] virus from the family Coronaviridae has been identified as the cause, but the pathogenesis is still unclear.” (Id., “Background”.) 3. Cheung disclosed that “[t]he H5N1/97 [influenza] viruses are potent inducers of proinflammatory cytokines in macrophages, the most notable being TNF α.” (Cheung p. 1831, “Interpretation”.) Appeal 2010-003908 Application 10/441,059 4 4. Tobinick disclosed “administering a TNF antagonist for reducing the inflammation of neuronal tissue.” (Tobinick, col. 4, ll. 23-27.) 5. Tobinick disclosed that for viral-associated neurological disorders, also administering an antiviral agent with the TNF antagonist to reduce the inflammation of the neuronal tissue. (Id. at col. 4, ll. 37- 43.) 6. Pluenneke disclosed treating disorders “characterized by abnormal or excessive TNFα levels by administering a TNFα antagonist.” (Pluenneke [0002].) Principles of Law “[K]nowledge of a problem and motivation to solve it are entirely different from motivation to combine particular references to reach the particular claimed method.” Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1373 (Fed. Cir. 2008). “Obviousness does not require absolute predictability of success. . . . [A]ll that is required is a reasonable expectation of success.” In re O'Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988). Analysis The record evidences that at the time the Appellant made the invention, SARS was a known problem, but there was little guidance to an effective treatment. Given the facts in evidence, we find that too little was known at the time to conclude that the invention would have been obvious. Nicholls did not disclose that abnormal TNFα levels were implicated in SARS, nor did Cheung, Tobinick, or Pluenneke. We agree with the Appeal 2010-003908 Application 10/441,059 5 Examiner that those of skill in the art would have been motivated to look for an effective treatment. But we agree with Appellant, that the existing motivation to solve the problem was not sufficient to render Appellant’s solution obvious. (App. Br. 15, citing Innogenetics.) Assuming the “macrophage” link was enough to combine the Nicholls and Cheung disclosures concerning different viruses, we do not see evidence that their combined teachings provided more than a promising field of experimentation. We agree with Appellant that the Examiner’s “obvious to try” rationale does not support the obviousness conclusion. (Id. at 11-12; Reply Br. at 5, discussing In re Kubin.) The fact pattern in this case is the kind of “impermissible” obvious to try situation where the prior art provided only a general, exploratory approach insufficient to render a specific, defined invention obvious. See, e.g., In re Kubin, 561 F.3d 1351, 1359-60 (Fed. Cir. 2008) (contrasting prior art that contained detailed enabling methodology with prior art that gave no direction on which of many possible choices were likely to be successful, or gave only a promising field of exploration), quoting In re O’Farrrell, 853 F.2d 894, 903 (Fed. Cir. 1988). CONCLUSION The prior art of record contained insufficient guidance to have rendered it obvious to treat SARS by administering a TNF inhibitor. Appeal 2010-003908 Application 10/441,059 6 SUMMARY We reverse the rejection of claims 36-41 and 48-50 under 35 U.S.C. § 103(a) as unpatentable over Nicholls, Cheung, Pluenneke, and Tobinick. REVERSED alw HUNTON & WILLIAMS LLP INTELLECTUAL PROPERTY DEPARTMENT 1900 K STREET, N.W. SUITE 1200 WASHINGTON DC 20006-1109 Copy with citationCopy as parenthetical citation