Ex Parte Miyagawa et al

Patent Trial and Appeal BoardMar 14, 2017

12532547 (P.T.A.B. Mar. 14, 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. 12/532,547 11/03/2009 Shinichi Miyagawa 347967US0PCT 8498 22850 7590 03/16/2017 OBLON, MCCLELLAND, MAIER & NEUSTADT, L.L.P. 1940 DUKE STREET ALEXANDRIA, VA 22314 EXAMINER TSAY, MARSHA M ART UNIT PAPER NUMBER 1656 NOTIFICATION DATE DELIVERY MODE 03/16/2017 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): patentdocket @ oblon. com oblonpat @ oblon. com tfarrell@oblon.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SHINICHIMIYAGAWA, TATSUYA ARAKI, TSUTOMU HAMURO, MIKA OKUDA, and HIROSHI KAETSU1 Appeal 2015-000544 Application 12/532,547 Technology Center 1600 Before ERIC B. GRIMES, ULRIKE W. JENKS, and RACHEL H. TOWNSEND, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims directed to fibrinogen composition. The Examiner rejects the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 According to Appellants, the Real Party in Interest is the Chemo-Sero- Therapeutic Research Institute. App. Br. 2. Appeal 2015-000544 Application 12/532,547 STATEMENT OF THE CASE “Fibrinogen is a very important coagulation factor.” Spec. 1:16. “[FJibrinogen in admixture with thrombin is used in a surgery as an adhesive for substitute of suture of soft organs such as the liver and the spleen or as an auxiliary agent for the suture.” Id. at 2:2—6. The problem is that commercially available preparations take “a lot of time to rehydrate . . . and hence further improvement in the dissolution time [of fibrinogen products] is desired.” Id. at 4:22—25. Claims 28—47 are on appeal, and can be found in the Claims Appendix of the Appeal Brief. Claim 28 is representative of the claims on appeal, and reads as follows: Claim 28: A solid fibrinogen composition comprising fibrinogen, albumin, a non-ionic surfactant and a combination of amino acid or amino acid salts selected from the group consisting of: isoleucine, glycine, arginine, and glutamic acid, or salts thereof (IGRE); glycine, arginine, and glutamic acid, or salts thereof (GRE); isoleucine, glycine, and arginine, or salts thereof (IGR); leucine, glycine, arginine, and glutamic acid, or salts thereof (LGRE); isoleucine, alanine, arginine, and glutamic acid, or salts thereof (IARE); isoleucine, serine, arginine, and glutamic acid, or salts thereof (ISRE); isoleucine, threonine, arginine, and glutamic acid, or salts thereof (ITRE); isoleucine, glutamine, arginine, and glutamic acid, or salts thereof (IQRE); and isoleucine, glycine, lysine and glutamic acid, or salts thereof (IGKE). 2 Appeal 2015-000544 Application 12/532,547 Claims 35 and 42, the only other independent claims, recite a composition that includes amino acid salts selected from the following group: IGRE, GRE, and IRE. Appellants seek review of the following rejections: I claims 28, 29, 32—36, 39-43, 46, and 47 under 35 U.S.C. § 103(a) as unpatentable over Heimburger2 in view of Seelich3 as evidenced by Metzner;4 and II. claims 30, 31, 37, 38, 44, and 45 under 35 U.S.C. § 103(a) as unpatentable over Heimburger in view of Seelich in view of Uchida5 as evidenced by Metzner. Because both of the rejections turn on the same issues, we will consider them together. The issues with respect to these rejections are: (i) Does the evidence of record support the Examiner’s conclusion that the prior art renders the claims prima facie obvious? (ii) If so, have Appellants presented evidence of secondary considerations, that when weighed with the evidence of obviousness, is sufficient to support a conclusion of non obviousness? Findings of Fact FF1. Heimburger discloses the production of a fibrinogen adhesive that contains a mixture of compounds “in the form of a solid, preferably a 2 Heimburger et al., US 5,407,671, issued Apr. 18, 1995 (“Heimburger”). 3 Seelich, US 4,909,251, issued Mar. 20, 1990. 4 Metzner et al., US 7,550,567 B2, issued Jun. 23, 2009 (“Metzner”). 5 Uchida et al., EP 1 588 722 Al, published Oct. 26, 2005. 3 Appeal 2015-000544 Application 12/532,547 lyophilizate.” Id. 3: 39-41. Example 1 discloses a mixture as set out in the table below: human fibrinogen 2.0 g/100 ml human albumin 033 g/100 ml arginine 03 g/100 ml Ha glutamate 2.5 g/1 isoleucine 33 S/1 factor XIII 20,000 U/f aprotinin 250,000 KIWI prothrombin 5,000 U/l (calculated as F II) antithrombin III 50 U/I NaCl 0.05 raol/1 trisodium citrate 0.005 mol/1 calcium chloride 0.15 mmol/1. The table shows the components that are included in the solution that is then filter sterilized and freeze-dried. See id. 4:55 —5:3. FF2. The Examiner acknowledges that Heimburger does “not teach a non ionic surfactant or explicitly teach [the addition of the] amino acid glycine (G)” in the fibrinogen composition. Ans. 3. FF3. Metzner teaches that there are many known lyophilization aids for proteins, including “amino acids (for example glycine, arginine, aspartic acid, glutamic acid, histidine, lysine, isoleucine )” as well as “detergents (for example poloxamers or polysorbates).” Metzner 17:53-57. FF4. Example 45 of Seelich teaches the production of a lyophilized fibrinogen composition containing a tenside, specifically, Triton WR 1339. See id. 12:17—20. The comparative sample in Seelich contains fibrinogen dissolved to a concentration of 30 mg/ml in a buffer containing NaCl, Na3-citrate 2H20, aprotinin, glycine, human albumin, fibronectin, as well as factor XIII. See id. 12:29-42. In the 4 Appeal 2015-000544 Application 12/532,547 tenside test solution Triton WR 1339 was added at a concentration of 0.15 mg/ml. See id. 12:43—46. Both the comparative and tenside test sample were lyophilized. The reconstitution times measured “were 15 min for the comparative preparation without tenside, but only 4 min for the tenside-containing preparation.” Id. 12:57—60. FF5. Figure 2 of the Specification is reproduced below. Fig. 2 shows measurements of rehydration time for each of the test samples: As a result, it was demonstrated that IGRE-AlDe, GRE- AlDe, IRE-AlDe and IGR-AlDe were rehydrated in a shorter time than the prior art (Prior art 1 to 3) with IGRE- AlDe showing the shortest rehydration time. On the other hand, the rehydration time of IGRE-De, IGE-AlDe and IGRE-A1 was similar to that of the preparation using the prior art. Spec. 22:23—23:5. “AlDe” indicates that the samples contained human serum albumin and Tween 80. Id. at 22:6-7. 5 Appeal 2015-000544 Application 12/532,547 FF6. Table 2, reproduced below, lists the components in the samples shown in Figure 2 (above). ftBposhian twpKttS«fi AtMitisre S«-AJ0® K*D» itm OMi m) iftt-Aiit. UW -JiM.. UHUfe thm m# Prior *rtt Prior art! Prior »rt3 til __m__ ...M,.T m 17-5... ...m is.... 3trisodiim flitrate|jn*/mU —tt... -.. R..J n 12 ....ii...,,, 12 il 12 5 .. 8 Aliwinww ■ h io - IS 10 10 SO IS IS IS 18 IS0l8!»i!ttW«"U : J 4 4 >♦ 4 4 4 4 - S3 3 3 3 - 3 3 3 13 * .... 25 '' Afgtnifi# B^ii¥tSmhliFid5ln«/#iiy; H n 12 12 12 *# 12 12 - 12 "Mim glutwtfliMMj: E n is IQ to 10 * !B - » IwhoiWsiJ - - - ~ - ~ - 40 - AproiifiifiSiRit/Bt} - * - - - - * 80 ; Cl 01 02 02 02 02 - ~ - lyioxapolHw i o* * - - - - - 0.3 Croiwt of Cwalstsle PreteiAfM) 88 81 n tt 33 83 81 -JL. IS 84 Spec. 24. FF7. Figure 3 of the Specification is reproduced below. £ 350 <5 ■§ fSft I’m I Q R E-AID© m , 5 S|| m JtlL g| ill ...m, n>s ill M. V2G S&SiS m. 380 S;3S': iiW ii ?y;;;r >}: : ■iW 3S0 3SS £50 jjy m *<*$> "38