Ex Parte Crockford et al

Patent Trial and Appeal BoardAug 4, 2017

13219394 (P.T.A.B. Aug. 4, 2017)

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. 13/219,394 08/26/2011 David CROCKFORD 2600-255 9759 6449 7590 08/08/2017 ROTHWELL, FIGG, ERNST & MANBECK, P.C. 607 14th Street, N.W. SUITE 800 WASHINGTON, DC 20005 EXAMINER ALSTRUM ACEVEDO, JAMES HENRY ART UNIT PAPER NUMBER 1675 NOTIFICATION DATE DELIVERY MODE 08/08/2017 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): PTO-PAT-Email @rfem. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DAVID CROCKFORD and ALLAN L. GOLDSTEIN Appeal 2015-0073421 Application 13/219,3942 Technology Center 1600 Before DONALD E. ADAMS, FRANCISCO C. PRATS, and DAVID COTTA, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims 1—6, 8—12, 16, and 18 (see August 4, 2014 Notice of Panel Decision from Pre-Appeal Brief Review 12). Examiner entered a rejection under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Oral Hearing held August 1, 2017. 2 Appellants identify the real party in interest as “Regenerx Biopharmaceuticals Incorporated” (App. Br. 1). Appeal 2015-007342 Application 13/219,394 STATEMENT OF THE CASE Appellants’ claims are directed to a method of treating dry eye syndrome in a subject suffering from dry eye syndrome (see App. Br. 17— 18). Appellants’ independent claims 1,16, and 18 are representative and reproduced below: 1. A method of treating dry eye syndrome in a subject suffering from dry eye syndrome, comprising administering to the subject an ophthalmically acceptable composition twice per day, wherein said composition has a pH of about 6.8-8.1 and comprises an isolated peptide agent comprising amino acid sequence LKKTET (SEQ ID NO.: 1) or Thymosin 04 (T04), wherein said peptide agent is present in said aqueous medium at a concentration within a range of about 0.001 — 1,000 mg/ml. (App. Br. 17.) 16. A method of treating dry eye syndrome in a subject suffering from dry eye syndrome, comprising administering to the subject an ophthalmically acceptable composition twice per day, wherein said composition comprises an isolated peptide agent comprising amino acid sequence LKKTET (SEQ ID NO.: 1) or Thymosin 04 (T04), wherein said ophthalmically acceptable composition has a pH of about 6.8-7.4, and wherein said peptide agent is present in said aqueous medium at a concentration within a range of about 0.001 — 1,000 mg/ml. (Id. at 18.) 18. A method of treating dry eye syndrome in a subject suffering from dry eye syndrome, comprising administering to the subject an ophthalmically acceptable composition twice per day, wherein said composition comprises an isolated peptide agent comprising Thymosin 04 (T04), wherein said ophthalmically acceptable composition has a pH of about 6.8- 7.4, wherein said T04 is present at a concentration within a range of about 1 — 10 mg/ml. (Id.) 2 Appeal 2015-007342 Application 13/219,394 The claims stand rejected as follows: Claims 1—6, 8—12, 16, and 183 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Goldstein.4 CLAIM INTERPRETATION Appellants’ independent claims recite a method of treating dry eye syndrome in a subject suffering from dry eye syndrome (App. Br. 17 and 18 (claims 1,16, and 18). Appellants’ claimed method comprises the twice daily administration of an ophthalmically acceptable composition to a subject (id.). The ophthalmically acceptable composition required by Appellants’ claims: 1. has a pH of about: a. 6.8—8.1 (App. Br. 17 (claim 1)) or b. 6.8—7.4 (App. Br. 18 (claims 16 and 18)); and 2. comprises an isolated peptide agent comprising: a. amino acid sequence LKKTET (SEQ ID NO.: 1) or Thymosin P4 (Tp4) (App. Br. 17 (claim 1) and App. Br. 18 (claim 16)) or b. Thymosin p4 (Tp4) (App. Br. 18 (claim 18)) Appellants’ method claims further require that the peptide agent is present in the “ophthalmically acceptable composition1'’ at a concentration within a range of about: A. 0.001 — 1,000 mg/ml (App. Br. 17 (claim 1) and App. Br. 18 (claim 16)) or B. 1 — 10 mg/ml (App. Br. 18 (claim 18)). 3 Examiner included Appellants’ cancelled claim 17 in the statement of rejection (Ans. 2; see Appellants’ July 3, 2014 Amendment 4; see also August 4, 2014 Notice of Panel Decision from Pre-Appeal Brief Review 12 (identifying claims 1—6, 8—12, 16, and 18 as rejected)). We did not include Appellants’ claim 17 in our deliberations. 4 Goldstein, US 2004/0131626 Al, published July 8, 2004. 3 Appeal 2015-007342 Application 13/219,394 We recognize that Appellants’ independent claims 1 and 18 refer to “said aqueous medium” (see App. Br. 17 and 18). There is, however, no other recitation of “aqueous medium” in either of Appellants’ independent claims 1 and 18 (see id.). Therefore, for this Appeal, we interpret the phrase “said aqueous medium” as said ophthalmically acceptable composition (