Patrick L. Mcgeer et al.Download PDFPatent Trials and Appeals BoardJul 25, 201914537611 - (D) (P.T.A.B. Jul. 25, 2019) 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. 14/537,611 11/10/2014 Patrick L. McGeer A637 0009/DHT 4719 720 7590 07/25/2019 OYEN, WIGGS, GREEN & MUTALA LLP 480 - THE STATION 601 WEST CORDOVA STREET VANCOUVER, BRITISH COLUMBIA V6B 1G1 CANADA EXAMINER MCMILLIAN, KARA RENITA ART UNIT PAPER NUMBER 1627 NOTIFICATION DATE DELIVERY MODE 07/25/2019 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): mail@patentable.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte PATRICK L. MCGEER and MOONHEE LEE ____________ Appeal 2018-006120 Application 14/537,6111 Technology Center 1600 ____________ Before JEFFREY N. FREDMAN, TAWEN CHANG, and DAVID COTTA, Administrative Patent Judges. COTTA, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of treating age related macular degeneration. The Examiner rejected the claims on appeal as obvious under 35 U.S.C. § 103(a). We reverse. 1 According to Appellants, the real party in interest is Aurin Biotech Inc. App. Br. 1. Appeal 2018-006120 Application 14/537,611 2 STATEMENT OF THE CASE The Specification states “this invention relates to treatment of age- related macular degeneration.” Spec. ¶ 2. Claims 1–9 are on appeal. Claim 1 is illustrative and reads as follows: 1. A method of treating age-related macular degeneration, the method comprising administering orally or parenterally an effective amount of aurin tricarboxylic acid, aurin quadracarboxylic acid, and/or aurin hexacarboxylic acid, wherein the method excludes administration of components of aurin tricarboxylic acid complex of greater than or equal to 1 kilodalton in molecular weight. App. Br. 12. The Examiner rejected claims 1–9 rejected under 35 U.S.C. § 103(a) as obvious over the combination of Bernstein,2 Wang,3 and Fung.4 OBVIOUSNESS Claim 1 recites a method for treating age-related macular degeneration by administering aurin tricarboxylic acid, aurin quadracarboxylic acid, and/or aurin hexacarboxylic acid. The Specification expressly defines aurin tricarboxylic acid to be a compound having a molecular weight of 422 kDa, aurin quadracarboxylic acid to be a compound having a molecular weight of 572 kDa, and aurin quafracarboxylic acid to be a compound having a molecular weight of 858 kDa. Spec. ¶ 15. 2 Bernstein et al., US Patent No. 4,007,270, issued Feb. 8, 1977 (“Bernstein”). 3 Wang et al., Isolation and Structure Elucidation of Low Molecular Weight Components of Aurintricarboxylic Acid (ATA), 57 J. Org. Chem. 3861–3866 (1992) (“Wang”). 4 Fung et al., US Patent Publication No. 2009/0214538 A1, published Aug. 27, 2009 (“Fung”). Appeal 2018-006120 Application 14/537,611 3 The express definition of aurin tricarboxylic acid (“ATA”) provided by Appellants differs from how the term “aurin tricarboxylic acid” was used in the art. For example, Wang discloses “ATA is actually a heterogeneous mixture of polymers.” Wang, 3862. Similarly, Gonzalez5 discloses that “aurintricarboxylic acid is a mixture of polymers of the phenol- formaldehyde type.” Gonzalez, 535. This is consistent with the teaching in the Specification that aurin tricarboxylic acid having a molecular weight of 422 kDa, aurin quadracarboxylic acid having a molecular weight of 572 kDa, and aurin quadracarboxylic acid having a molecular weight of 858 kDa, were obtained by separating “commercially purchased ‘aurin tricarboxylic acid’ from Sigma-Aldrich, or from Aluminon . . . into high and low molecular weight components.” Spec. ¶ 15. In finding the claimed method obvious, the Examiner found that Fung disclosed the use of complement inhibitors for the treatment of ocular conditions including age-related macular degeneration. Ans. 8. The Examiner found that Bernstein disclosed “inhibiting complement with a heterogeneous mixture of polymers that include aurin tricarboxylic acid, aurin quadracarboxylic acid and other components of the aurin tricarboxylic acid complex of less than 1 kDa in molecular weight.” Id. at 6. The Examiner concluded: [I]t would have been obvious to a person of ordinary skill in the art to combine the teachings of Bernstein et al. which teaches a 5 Gonzalez et al., Fractionation and Structural Elucidation of the Active Components of Aurintricarboxylic Acid, a Potent Inhibitor of Protein Nucleic Acid Interactions, 562 Biochimica et Biophysica Acta 534–545 (1979) (“Gonzalez”). Gonzalez was cited by Appellants as evidence that commercially available “aurin tricarboxylic acid” is a mixture “dominated by components over 1kDa in molecular weight.” App. Br. 8. Appeal 2018-006120 Application 14/537,611 4 method of inhibiting complement comprising the administration of aurin tricarboxylic acid with the teachings of Fung et al. which teaches a method of treating both the dry and wet forms of age- related macular degeneration comprising the administration of inhibitors of complement including inhibitors of the classical complement pathway. Id. at 16. With respect to the requirement of claim 1 that the method “exclude[] administration of components of aurin tricarboxylic acid complex of greater than or equal to 1 kilodalton in molecular weight,” the Examiner concluded that since commercially available aurin tricarboxylic acid was known to be impure – i.e. was known to be a heterogeneous mixture of polymers – it would have been obvious to “use procedures well-known in the art as taught by Wang et al. to purify or fractionate the composition such that only ATA which is the triphenylmethane dye is present resulting in the use of the ATA component of less than 1 kDa for inhibiting complement.” Ans. 12. We are not persuaded. We acknowledge that it is often obvious to purify a composition known to be impure. We further acknowledge that the prior art discloses an impure composition known as “aurin tricarboxylic acid” that included the low-molecular weight compounds recited in the claim – i.e., aurin tricarboxylic acid, aurin quadracarboxylic acid, and aurin quadracarboxylic acid. However, the Examiner does not identify in the cited art any teaching that the claimed low-molecular-weight compounds are the compounds in the heterogeneous mixture that have, or would have been expected to have, complement inhibiting activity. Moreover, Gonzalez suggests that compounds in the heterogeneous mixture having a high molecular weight have greater potency than compounds having a lower molecular weight. Appeal 2018-006120 Application 14/537,611 5 Gonzalez, 535 (“Evidence will be presented that aurintricarboxylic acid is a mixture of polymers of the phenol-formaldehyde type whose inhibitory potency increases with the average molecular weight of the fraction.”); see also, Wang, 3865 (“All of these low molecular weight components were considerably less potent in preventing the cytopathic effect of HIV-1 than unfractionated ATA. This is not surprising because prior investigations of the anti-HIV activities of ATA fractions have shown that the antiviral potency increases with the molecular weight of the ATA fraction.”) (internal citations omitted). The current record thus does not support the Examiner’s finding that it would have been obvious to purify the heterogeneous mixture of polymers known in the art as ATA by excluding compounds having a molecular weight greater than or equal to 1 kilodalton because the evidence of record shows that purification would have been expected to remove active compound, not concentrate it. Accordingly, we reverse the Examiner’s rejection of claims 1–9. SUMMARY For the reasons set forth herein, we reverse the Examiner’s rejection of claims 1–9 under 35 U.S.C § 103(a) as obvious over the combination of Bernstein, Wang, and Fung. REVERSED Copy with citationCopy as parenthetical citation