BAXTER INTERNATIONAL INC. et al.

Patent Trials and Appeals Board

Jan 14, 2022

2021000744 (P.T.A.B. Jan. 14, 2022)

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. 15/457,802 03/13/2017 Yves A. Delmotte 3712044.05107 4555 29200 7590 01/14/2022 K&L Gates LLP-Chicago Baxter P.O. Box 1135 Chicago, IL 60690-1135 EXAMINER SORKIN, DAVID L ART UNIT PAPER NUMBER 1774 NOTIFICATION DATE DELIVERY MODE 01/14/2022 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): USpatentmail@klgates.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte YVES A. DELMOTTE Appeal 2021-000744 Application 15/457,802 Technology Center 1700 Before JEFFREY T. SMITH, MERRELL C. CASHION, JR, and SHELDON M. MCGEE, Administrative Patent Judges. MCGEE, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 13-21. We have jurisdiction. 35 U.S.C. § 6(b). We reverse. 1 Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Baxter International Inc. Appeal Br. 2. Appeal 2021-000744 Application 15/457,802 2 CLAIMED SUBJECT MATTER The claims are directed to fibrin foams comprising a reaction product of fibrinogen and thrombin, where that reaction product has air bubbles entrained therein. Appeal Br. 3. Claim 13 is illustrative of the claimed subject matter and is reproduced below with the key limitations on appeal italicized: 13. A fibrin foam comprising (1) a three-dimensional reaction product of fibrinogen and thrombin having a percent crosslinking of about 23% to about 36%, and (2) air bubbles entrained within the reaction product, the air bubbles having a volume of about 50% to about 70% of the fibrin foam. Appeal Br. 18 (Claims App.). THE REJECTION The Examiner rejects claims 13-21 under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Bering2 and Seelich.3 Final Act. 2-3. OPINION The dispositive issue on appeal is whether the Examiner has established that the prior art foam contains air bubbles entrained within the reaction product of fibrinogen and thrombin at “a volume of about 50% to about 70% of the fibrin foam” as recited in sole independent claim 13. Because the Examiner failed to do so on this record, we do not sustain the rejection. 2 US 2,492,458 issued December 27, 1949. 3 US 4,816,251 issued March 28, 1989. Appeal 2021-000744 Application 15/457,802 3 The Examiner finds, inter alia, that Bering discloses a fibrin foam having “about 55% air.” Final Act. 2 (citing Bering 3:20-50). This finding is based on the Examiner’s calculation of the percentage of air in Bering’s fibrinogen solution prior to the addition of thrombin. Id.; see Bering 3:17- 34 (disclosing that the fibrinogen solution is aerated to 2.3 times its original volume, and after the desired volume increase is produced, the clotting agent, e.g., thrombin, is added). This disclosure is insufficient to establish that Bering’s reaction product of fibrinogen and thrombin has the claimed volume of air bubbles. As correctly argued by Appellant, Bering discloses aerating the fibrinogen solution--not the reaction product of fibrinogen and thrombin as claimed--to 2.3 times its original volume. Appeal Br. 9; Bering 3:17-24. Only “[a]fter the agitation has produced the desired increased volume, a clotting agent is added.” Id. at 3:28-30. At best, the Examiner’s finding regarding the percentage of air bubbles in Bering’s fibrin foam amounts to a speculative assumption that the initial 55% volume of air bubbles is maintained after the thrombin is added to the aerated fibrinogen solution. Such speculative assumptions cannot take the place of findings based on factual evidence. In re Warner, 379 F.2d 1011, 1017 (CCPA 1967) (“The Patent Office has the initial duty of supplying the factual basis for its rejection. It may not . . . resort to speculation, unfounded assumptions or hindsight reconstruction to supply deficiencies” in the cited references.). The Examiner’s response in the Answer fares no better because it amounts to a de facto finding that the air bubble percentage in Bering’s aerated fibrinogen solution would not be capable of decreasing during a span of 18-25 seconds after the addition of the clotting agent, e.g., thrombin. Appeal 2021-000744 Application 15/457,802 4 Ans. 4. That, too, is speculative and unsupported. Warner, 379 F.2d at 1017. For this reason, the rejection cannot be sustained. CONCLUSION The Examiner’s rejection is reversed. DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s) / Basis Affirmed Reversed 13-21 103(a) Bering, Seelich 13-21 REVERSED