13051776 (P.T.A.B. Dec. 12, 2016)

Ex Parte McMichael

Patent Trial and Appeal BoardDec 12, 2016

13051776 (P.T.A.B. Dec. 12, 2016)

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. 13/051,776 03/18/2011 John McMichael 13024/44934A 5180 4743 7590 12/14/2016 MARSHALL, GERSTEIN & BORUN LLP 233 SOUTH WACKER DRIVE 6300 WILLIS TOWER CHICAGO, IL 60606-6357 EXAMINER CHONG, YONG SOO ART UNIT PAPER NUMBER 1627 NOTIFICATION DATE DELIVERY MODE 12/14/2016 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): mgbdocket@marshallip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOHN McMICHAEL1 Appeal 2015-000590 Application 13/051,776 Technology Center 1600 Before ERIC B. GRIMES, JOHN E. SCHNEIDER, and TIMOTHY G. MAJORS, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a method for treating viral infections which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE The present invention is directed a method for treating viral infections using ethyl mercury or a thiol derivative or salt thereof. Spec. 113. The preferred thiol derivative of ethyl mercury is thimerosal. Spec. 115. 1 Appellant identifies the Real Party in Interest as Beech Tree Labs, Inc. App. Br. 2. Appeal 2015-000590 Application 13/051,776 Claims 1—5 and 7—9 are on appeal. Claim 1 is illustrative and reads as follows: 1. A method of treating a viral infection selected from the group consisting of an adenoviral infection, a human papilloma virus infection, a polyoma virus infection and a pox virus infection in a subject comprising systemically administering ethyl mercury or thiol derivative thereof to the subject at a dosage range of about 0.05gg to about 500gg effective to treat the viral infection. The claims stand rejected as follows: Claims 1—5 and 7—9 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Keller2 or Nabel3 in view of Manfuso.4 DISCUSSION Issue The Examiner finds that Keller teaches the treatment of viral infections such as adenovirus in humans by systemically administering an antiviral agent. Final Act.5 4. The Examiner finds that the antiviral agent is combined with a bactericidal agent such as thimerosal. Id. The Examiner finds that Nabel also teaches a method for treating a viral infection by systemically administering an antiviral agent. Id. The Examiner finds that Nabel teaches the use of thimerosal as an antibacterial agent for use with the antiviral agent. Id. The Examiner finds that Manfuso teaches topically administering thimerosal to treat a viral infection in the eyes. Final Act. 5. 2 Keller, US 2005/0245502 Al, published Nov. 3, 2005 (“Keller”). 3 Nabel et al., US 2009/0214510 Al, published Aug. 27, 2009 (“Nabel”). 4 Manfuso, US 4,083,991, issued Apr. 11, 1978 (“Manfuso”). 5 Final Action mailed Feb. 5, 2014. 2 Appeal 2015-000590 Application 13/051,776 The Examiner finds that it would have been prima facie obvious to optimize the thimerosal formulation of either Keller or Nabel to a dose of 0.2pg. Appellant contends that Manfuso in limited to the topical application of thimerosal to treat epithelial herpes infections and does not teach or suggest the systemic administration of thimerosal. Appeal Br. 5. With respect to Nabel and Keller, Appellant argues that the teaching of the use of thimerosal as a bactericidal preservative does not teach the use of thimerosal to treat viral infections when administered systemically. Appeal Br. 4. Appellant argues that one skilled in the art would not expect a topically administered agent to possess similar efficacy when administered systemically. The issue with respect to this rejection is whether the Examiner has established by a preponderance of the evidence that claims 1—5 and 7—9 would have been obvious over Keller or Nabel combined with Manfuso under 35 U.S.C. § 103(a). Findings of Fact FF1. Keller discloses a composition for treatment of viral infections comprising therapeutically effective amounts of an anticonvulsant component, such as phenytoin, with at least one calcium channel blocker component (or metabolites thereof), a quinoline component, quinoline-quinone component or intermediates or derivatives such as chloroquine, in combination with a multivitamin component. Keller 115. FF2. Keller teaches that the anti-viral compositions “ordinarily contain in addition to the basic solvent or suspending liquid, preservatives in 3 Appeal 2015-000590 Application 13/051,776 the nature of bactericidal and fungicidal agents, for example, parabens, chlorobutanol, benzyl alcohol, phenol, thimerosal, and the like.” Keller 196. FF3. Nabel discloses an antiviral agent comprising “a biologically active, e.g., an enzymatically active, phospholipase, or biologically active fragment thereof, attached to a viral binding polypeptide, e.g., a polypeptide that recognizes a viral polypeptide or a carbohydrate, and optionally containing a linker.” Nabel 1 6. FF4. Nabel teaches that the antiviral composition may also include various antibacterial and antifungal agents including thimerosal. Nabel 1111. FF5. Manfuso teaches the topical application of thimerosal to the eye to treat a herpes simplex virus infection. Manfuso col. 1,11. 30—54. Principles of Law “Obviousness requires more than a mere showing that the prior art includes separate references covering each separate limitation in a claim under examination.” Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011). “Rather, obviousness requires the additional showing that a person of ordinary skill at the time of the invention would have selected and combined those prior art elements in the normal course of research and development to yield the claimed invention.” Id- Analysis We agree with Appellant that the Examiner did not establish a prima facie case of obviousness. While Keller and Nabel teach the inclusion of 4 Appeal 2015-000590 Application 13/051,776 thimerosal in an antiviral composition, in each reference, thimerosal is used only as a preservative. FF2 and 4. Neither reference teaches use of thimerosal for the systemic treatment of a viral infection. Manfuso teaches the use of thimerosal to treat a viral infection but only as a topical application. FF5. The Examiner has provided insufficient credible evidence or scientific reasoning to show that one skilled in the art would expect thimerosal to have the same efficacy when used systemically as when applied topically. Thus, the Examiner did not show why one skilled in the art would have been motivated to use thimerosal for treating a viral infection systemically. Conclusion of Law We conclude that the Examiner did not establish by a preponderance of the evidence that the present claims would have been obvious over either Keller or Nabel combined with Manfuso. SUMMARY We reverse the rejection under 35 U.S.C. § 103(a). REVERSED 5