MELCHER, CHRISTOPH et al.Download PDFPatent Trials and Appeals BoardNov 13, 20202020000428 (P.T.A.B. Nov. 13, 2020) 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. 14/937,142 11/10/2015 CHRISTOPH MELCHER MR1035-2463 1089 4586 7590 11/13/2020 ROSENBERG, KLEIN & LEE 3458 ELLICOTT CENTER DRIVE-SUITE 101 ELLICOTT CITY, MD 21043 EXAMINER FISCHER, JOSEPH ART UNIT PAPER NUMBER 1658 NOTIFICATION DATE DELIVERY MODE 11/13/2020 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): ptoactions@rklpatlaw.com ptoactions@yahoo.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CHRISTOPH MELCHER Appeal 2020-000428 Application 14/937,142 Technology Center 1600 Before ERIC B. GRIMES, LINDA M. GAUDETTE, and FRANCISCO C. PRATS, Administrative Patent Judges. GAUDETTE, Administrative Patent Judge. DECISION ON APPEAL1 The Appellant2 appeals under 35 U.S.C. § 134(a) from the Examiner’s decision finally rejecting claims 1, 2, 4–9, and 11–15.3 We AFFIRM. 1 This Decision includes citations to the following documents: Specification filed Nov. 10, 2015, as amended (“Spec.”); Final Office Action dated Dec. 28, 2018 (“Final Act.”); Appeal Brief filed May 21, 2019 (“Appeal Br.”); and Examiner’s Answer dated Aug. 22, 2019 (“Ans.”). 2 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. The Appellant identifies the real party in interest as the inventors. Appeal Br. 1. 3 We have jurisdiction under 35 U.S.C. § 6(b). Appeal 2020-000428 Application 14/937,142 2 CLAIMED SUBJECT MATTER Metallothionein (MT) proteins “are low molecular weight, single chain polypeptides with extraordinarily high content of the amino acid cysteine.” Id. at 2:23–24. The sulfhydryl groups of cysteine residues enable MT proteins to bind metal ions, scavenge reactive species, display antioxidant activity, and respond to changes in intracellular redox potential. Id. at 2:24–26 (citation omitted). “The present invention relates to production of hypo-metallated redox-active [MT] proteins, particularly to production of MT proteins with defined numbers of MT cysteinyl binding sites occupied with physiologically relevant metal ions.” Id. at 1:9–11. Hypo-metallated redox-active MT proteins produced by the inventive method may be used to manufacture medicaments for treating conditions originating from elevated intracellular oxidative stress, dis-balanced intracellular redox-potential, or redox-potential-dependent imbalance of metal ions. Id. at 9:19–23. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A method for producing a hypo-metallated redox- active metallothionein protein, the hypo-metallated redox-active metallothionein protein having 20 cysteine sulfhydryl groups and 7 binding pockets, 2 to 16 of the 20 cysteine sulf[h]ydryl groups being free and reduced, and l to 6 of the 7 binding pockets being occupied by metal ions, comprising: providing a metallothionein protein; fully pre-metallating the metallathionein protein; de-metallating the metallothionein protein; chemically reducing all the 20 cysteine sul[f]hydryl groups of the de-metallated metallothionein protein; and Appeal 2020-000428 Application 14/937,142 3 partially metallating the reduced de-metallated metallothionein protein by providing 1, 2, 3, 4, 5, or 6 metal ions to the 7 binding pockets. Appeal Br. 35 (Claims App.). REJECTIONS 1. Claims 1, 2, and 4–7 are rejected under 35 U.S.C. § 103 as unpatentable over Ngu (Kinetic Analysis of Arsenic-Metalation of Human Metallothionein: Significance of the Two-Domain Structure, JACS, 2008, 130, 17016–17028) in view of Merrifield (J. Inorg. Biochem. 88 (2002) 153–172).4 2. Claims 1, 2, and 4–9 are rejected under 35 U.S.C. § 103 as unpatentable over Ngu in view of Merrifield and Kang (Exp. Biol. Med. 231:1459–1467, 2006). 3. Claims 1, 2, and 4–9 are rejected under 35 U.S.C. § 103 as unpatentable over Ngu in view of Merrifield, Kang, and Maret (Experimental Gerontology 43 (2008) 363–369). 4. Claims 1, 2, 4–7, and 11–13 are rejected under 35 U.S.C. § 103 as unpatentable over Ngu in view of Merrifield and IS (Inoue and Satoh, Current Pharmaceutical Biotechnology, 2013, Vol. 14, No. 4, 391–393). 5. Claims 1, 2, 4–7, and 11–13 are rejected under 35 U.S.C. § 103 as unpatentable over Ngu in view of Merrifield and Datta (Cancer Res. 2007 March 15; 67(6): 2736–2746). 4 Although the Examiner includes claims 1, 2, and 4–7 in each ground of rejection, the Examiner relies solely on the combination of Ngu and Merrifield in rejecting these claims. Appeal 2020-000428 Application 14/937,142 4 6. Claims 1, 2, 4–7, 11, 12, and 14 are rejected under 35 U.S.C. § 103 as unpatentable over Ngu in view of Merrifield and Hozumi (Current Pharmaceutical Biotechnology, 2013, 14(4), 408–413). 7. Claims 1, 2, 4–7, 11, 12, and 15 are rejected under 35 U.S.C. § 103 as unpatentable over Ngu in view of Merrifield and Cai (METALLOTHIONEIN AS AN ADAPTIVE PROTEIN PREVENTS DIABETES AND ITS TOXICITY, Nonlinearity in Biology, Toxicology, and Medicine, 2:89–103, 2004). OPINION The Examiner found that Ngu discloses the claim 1 method except for an explicit teaching of fully pre-metallating the MT protein. See Final Act. 4–6. As to the fully pre-metallating step, the Examiner found that Ngu cites an intermediate reference for a teaching of the recombinant MT production method used in Ngu’s experimental methods. Id. at 4. The Examiner found that the intermediate reference, in turn, cites Merrifield. Id.; see also Ngu 17017 (citing Merrifield). The Examiner found that “Merrifield teaches that the method applied by Ngu, and others in the field, fully metallates at least a portion of the metallothionein protein produced and provided by the cells during preparation from recombinant culture.” Final Act. 5 (finding that Merrifield’s addition of a metal, such as cadmium, at a sufficient concentration to stabilize indicates full metallation). The Appellant suggests that Ngu and Merrifield are nonanalogous art because they describe studies of the MT protein’s binding ability to toxic metals or metalloids such as Cd or As, whereas the present invention’s purpose is to form pharmaceutical compositions that are harmless to Appeal 2020-000428 Application 14/937,142 5 patients. Appeal Br. 16. We agree with the Examiner that this argument is not persuasive. See Ans. 6–7. The Appellant has not identified, nor do we find, any language in the claims or the written description that supports a narrow interpretation of claim 1 as limited to a method of producing a pharmaceutical composition. See, e.g., Spec. 8:12–13 (“The first aspect of the present invention relates to a method for producing a hypo-metallated redox-active metallothionein protein.”), 9:13–15 (“The second aspect of the present invention relates to a pharmaceutical composition, which comprises at least one hypo-metallated redox-active metallothionein protein produced by the method described above.”). The Appellant argues that the applied prior art does not disclose or suggest de-metallating a fully pre-metallated metallathionein protein. See Appeal Br. 14–15. More specifically, the Appellant argues that Merrifield describes adding CdSO4 before the cells are lysed and, therefore, the CdSO4 is not “able to influence the MT protein in cells, let alone ‘fully pre- metallat[e] the metallothionein protein.’” Id. at 15 (citing Merrifield § 2.2). “In contrast, in the present method, the step of fully pre-metallating the MT protein, [is] performed after the native protein [is] separated from host cells.” Id. The Appellant further argues that “in Merrifield, the step of metallating the MT protein, is not an initial pre-metallation, and is not described as being followed by the steps of de-metallating, chemical reduction, or final partial metallating, as provided in the claimed method.” Id. at 17. The Appellant’s arguments are not persuasive for the reasons explained in the Answer. See Ans. 5–7. We add the following: Appeal 2020-000428 Application 14/937,142 6 There is a presumption that method steps need not be performed in the recited order unless the claim specifically provides for such. Interactive Gift Express, Inc. v. Compuserve Inc., 231 F.3d 859, 875–76 (Fed. Cir. 2000). Neither the plain language of the claims nor the written description supports narrowly interpreting the claim 1 method as precluding simultaneous performance of the providing and fully pre-metallating steps. See, e.g., Spec. 16:8–25. Further, the Appellant does not provide persuasive evidentiary support when arguing the drawbacks of adding CdSO4 before cell lysing (see Appeal Br. 15) and has not shown error in the Examiner’s reasoned explanation of why Cd fully occupies all metal binding sites (see Ans. 6). As to the Appellant’s assertion that Merrifield does not describe the claim 1 de- metallating, reducing, and partially metallating steps, this argument is not persuasive of reversible error because the Examiner relies on Ngu for a teaching of these steps. See Ans. 7. The Appellant does not separately argue the patentability of claims 2 and 4–7. See Appeal Br. 18. Accordingly, we sustain the rejections of claims 1, 2, and 4–7 for the reasons stated in the Final Office Action, the Answer, and above. The Examiner cited Kang alone, or in combination with Maret, for teachings of the dependent claim 85 and claim 9 limitations. Final Act. 9–11. As explained by the Examiner (Ans. 8–10), the Appellant’s arguments (see Appeal Br. 18–23) are not persuasive of reversible error because they focus on the teachings of Kang or Maret, individually, and fail to consider what 5 Claim 8, as drafted, depends from claim 8. See Appeal Br. 37 (Claims App.). For purposes of this decision, we have interpreted claim 8 as depending from claim 7. Appeal 2020-000428 Application 14/937,142 7 the ordinary artisan would have understood from the references’ combined teachings. As to the Appellant’s argument that Kang discloses only one of the alternative reducing agents recited in claim 8, we add that the disclosure of one alternative is sufficient for anticipation or obviousness. See Brown v. 3M, 265 F.3d 1349, 1351 (Fed. Cir. 2001) (“When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.”). Therefore, we sustain the rejections of claims 8 and 9 for the reasons stated in the Final Office Action, the Answer, and above. The Examiner found that each of IS and Datta teaches the limitations of dependent claims 11–13. See Final Act. 11–15. The Examiner found that Hozumi teaches the limitations of dependent claims 11, 12, and 14, and Cai teaches the limitations of dependent claims 11, 12, and 15. See id. at 15–18. The Appellant essentially argues that neither IS, Datta, Hozumi, nor Cai cures the deficiencies in the Examiner’s rejection of claim 1 over Ngu and Merrifield. Appeal Br. 23–29. These arguments are not persuasive because the Appellant has not identified error in the rejection of claim 1, the Examiner’s findings as to the secondary references’ teachings, or the Examiner’s reasoning as to why the ordinary artisan would have further modified the method resulting from the Ngu and Merrifield combination in view of the secondary references’ teachings. See Ans. 12–16. Therefore, we sustain the rejections of claims 11–15 for the reasons stated in the Final Office Action, the Answer, and above. Appeal 2020-000428 Application 14/937,142 8 DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 2, 4–7 103 Ngu, Merrifield 1, 2, 4–7 1, 2, 4–9 103 Ngu, Merrifield, Kang 1, 2, 4–9 1, 2, 4–9 103 Ngu, Merrifield, Kang, Maret 1, 2, 4–9 1, 2, 4–7, 11–13 103 Ngu, Merrifield, IS 1, 2, 4–7, 11–13 1, 2, 4–7, 11–13 103 Ngu, Merrifield, Datta 1, 2, 4–7, 11–13 1, 2, 4–7, 11, 12, 14 103 Ngu, Merrifield, Hozumi 1, 2, 4–7, 11, 12, 14 1, 2, 4–7, 11, 12, 15 103 Ngu, Merrifield, Cai 1, 2, 4–7, 11, 12, 15 Overall Outcome: 1, 2, 4–9, 11–15 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED Copy with citationCopy as parenthetical citation