Applied Cardiovascular Solutions, LLC et al.

Patent Trials and Appeals BoardJun 1, 2020

2019006188 (P.T.A.B. Jun. 1, 2020)

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. 14/208,338 03/13/2014 F. Javier Otero 10046-040US1 5369 96039 7590 06/01/2020 Meunier Carlin & Curfman LLC 999 Peachtree Street NE Suite 1300 Atlanta, GA 30309 EXAMINER TEMPLETON, CHRISTOPHER L ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 06/01/2020 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): docketing@mcciplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte F. JAVIER OTERO, JOSEPH J. BEAMAN, KRISHNENDU ROY, and ANDREW ZIMBROFF Appeal 2019-006188 Application 14/208,338 Technology Center 3700 Before BRETT C. MARTIN, MICHAEL J. FITZPATRICK, and LEE L. STEPINA, Administrative Patent Judges. STEPINA, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–10, 12–14, 16, 18, 19, and 24–27.2 We have jurisdiction under 35 U.S.C. § 6(b). 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Applied Cardiovascular Solutions, Inc. and the Board of Regents, the University of Texas System. Appeal Br. 3. 2 Claims 11, 15, 17, 20–23, 28, and 29 have been cancelled. Appeal Br. 30– 33 (Claims App.). Appeal 2019-006188 Application 14/208,338 2 We reverse. CLAIMED SUBJECT MATTER The claims are directed to methods of occluding a left atrial appendage (LAA) of a patient by injecting an amount of crosslinkable biomaterial to decrease a rate of thromboembolic events associated with atrial fibrillation (AF). Spec. 2:14–25. Claim 1, reproduced below, is illustrative of the claimed subject matter. 1. A method of occluding a left atrial appendage (LAA) of a patient comprising: (a) providing a delivery catheter comprising: a proximal region; a distal region comprising a distal tip; a first lumen extending from the proximal region to the distal region; and an occluding element positioned in proximity to the distal tip; (b) advancing the delivery catheter percutaneously through vasculature of the patient such that the distal tip of the delivery catheter reaches a left atrium of the patient; (c) advancing the distal tip of the delivery catheter into the LAA of the patient, such that the occluding element transitorily occludes the LAA; (d) withdrawing blood from the patient’s LAA; (e) measuring a volume of the blood withdrawn from the patient’s LAA to determine an amount of a crosslinkable biomaterial to be injected into the LAA of the patient; and (f) injecting the amount of the crosslinkable biomaterial into the LAA of the patient, wherein the crosslinkable biomaterial comprises a first precursor molecule and a second precursor molecule; and wherein the first precursor molecule and the second precursor molecule crosslink in situ in the LAA to form a biocompatible polymeric matrix that occupies a cavity in the Appeal 2019-006188 Application 14/208,338 3 LAA of the patient, thereby preventing stagnation of blood within the cavity in the LAA of the patient. Appeal Br. 30 (Claims App.). REFERENCES3 The prior art relied upon by the Examiner is: Name Reference Date Gnanou US 4,644,033 Feb. 17, 1987 McCormick US 2005/0245891 A1 Nov. 3, 2005 Beckman US 2007/0014755 A1 Jan. 18, 2007 Rehor US 2008/0253987 A1 Oct. 16, 2008 Shalaby US 2009/0264555 A1 Oct. 22, 2009 Gemeinhart US 2009/0291115 A1 Nov. 26, 2009 Dye US 2009/0324719 A1 Dec. 31, 2009 Kassab US 2010/0191279 A1 July 29, 2010 Sheardown US 2010/0303911 A1 Dec. 2, 2010 West US 2012/0255124 A1 Oct. 11, 2012 Chau US 2014/0212373 A1 July 31, 2014 Jose R. Lopez-Minguez et al., Immediate and One-year Results in 35 Consecutive Patients After Closure of Left Atrial Appendage With the Amplatzer Cardiac Plug, Rev Esp Cardiol. 66(2):90–97 (2013) (“Lopez Minguez”). REJECTIONS I. Claims 1–5, 8, 12, 16, 18, and 26 are rejected under 35 U.S.C. § 103(a) as unpatentable over Kassab, Rehor, and McCormick. II. Claim 9 is rejected under 35 U.S.C. § 103(a) as unpatentable over Kassab, Rehor, McCormick, and Dye or Gnanou. 3 The evidence submitted by Appellant is a declaration under 37 CFR 1.132 executed by Joeseph J Beaman, one of the inventors named in the present Application, made of record on March 28, 2018. Appeal 2019-006188 Application 14/208,338 4 III. Claim 6 is rejected under 35 U.S.C. § 103(a) as unpatentable over Kassab, Rehor, McCormick, and Chau. IV. Claims 7 and 25 are rejected under 35 U.S.C. § 103(a) as unpatentable over Kassab, Rehor, McCormick, and Beckman. V. Claim 10 is rejected under 35 U.S.C. § 103(a) as unpatentable over Kassab, Rehor, McCormick, and Sheardown. VI. Claims 13 and 14 are rejected under 35 U.S.C. § 103(a) as unpatentable over Kassab, Rehor, McCormick, and Lopez-Minguez. VII. Claim 19 is rejected under 35 U.S.C. § 103(a) as unpatentable over Kassab, Rehor, McCormick, and West. VIII. Claim 24 is rejected under 35 U.S.C. § 103(a) as unpatentable over Kassab, Rehor, McCormick, and Gemeinhart. IX. Claims 1 and 27 are rejected under 35 U.S.C. § 103(a) as unpatentable over Kassab, Shalaby, and McCormick. OPINION Rejection I (Kassab, Rehor, and McCormick) The Examiner finds that Kassab discloses all of the elements recited in claim 1, except for the use of a cross-linkable biomaterial and the step of measuring the volume of blood withdrawn to determine an amount of biomaterial to be injected. Non-Final Act. 2–3. The Examiner finds that McCormick teaches the step of withdrawing blood from a patient, measuring the volume of the blood withdrawn to determine an amount of biomaterial to be injected, and injecting the amount of the biomaterial. Id. at 4 (citing McCormick ¶ 68). The Examiner finds McCormick teaches this step is “for the purpose of determining the volume of the void to be filled, estimating the Appeal 2019-006188 Application 14/208,338 5 amount of agent required to fill the void, not overfilling or under filling the void, and reducing the risk of rupturing the void.” Id. (citing McCormick ¶ 68). The Examiner determines that a person of ordinary skill in the art would have found it obvious to implement this step in the method disclosed by Kassab to achieve the same benefits this step provides in McCormick. Id. at 4–5. Appellant argues that, although Kassab teaches injecting an adhesive or biological glue into the LAA of a patient in order to occlude it, Kassab performs this step only after causing the LAA to completely collapse. See Appeal Br. 9–12. According to Appellant, if a surgeon were to measure the volume of blood withdrawn before injection of biological glue, as suggested by the Examiner, one would necessarily obtain a measurement of the internal volume of the patient’s unmanipulated LAA. Id. at 11. Thus, Appellant contends, the Examiner’s proposed modification would offer no benefit to a surgeon practicing Kassab’s method. Id. In other words, Appellant contends that the measurement disclosed by McCormick provides information that is not pertinent to the method disclosed by Kassab. In response, the Examiner contends, “[t]he amount of blood withdrawn in McCormick is used to determine an amount of agent to be injected (see para. 68 of McCormick)[, and t]he amount injected correlates to the determined amount.” Ans. 3. The Examiner finds that Appellant’s argument rests on an unrecited requirement in claim 1 for the volume measured and the amount of biomaterial injected to be equal, i.e., for there to be a 1 to 1 ratio of measured blood to injected biomaterial. Id. As claim 1 has no such requirement, the Examiner concludes Appellant’s argument is unpersuasive. Id. The Examiner also reiterates the finding that the proposed Appeal 2019-006188 Application 14/208,338 6 modification to Kassab’s method would provide the benefit of the measurement disclosed in McCormick, e.g., prevention of overfilling/underfilling. Id. at 3–4 (citing McCormick ¶ 68). Although we agree with the Examiner that (i) claim 1 does not require a 1 to 1 ratio of measured volume to injected biomaterial, and (ii) McCormick discloses a benefit of measuring an amount of blood withdrawn before injecting an amount of biomaterial based on the measured amount, for the following reasons, we do not agree that McCormick’s disclosed benefit would apply in the context of Kassab’s method. As Appellant asserts (Appeal Br. 11), Kassab’s method requires collapsing the LAA before injecting biomaterial (adhesive 47). See McCormick ¶¶ 34–36. Despite the fact that claim 1 does not require a 1 to 1 ratio of the measured volume to the injected biomaterial, claim 1 requires a relationship between these two quantities. Specifically, claim 1 recites “measuring a volume of the blood withdrawn from the patient's LAA to determine an amount of a crosslinkable biomaterial to be injected into the LAA of the patient.” Appeal Br. 30 (Claims App.). In light of this fact, the Examiner does not adequately explain how a measurement of the volume of blood or other material removed from the unaltered LAA bears any relationship to (and, therefore would assist in determining) the amount of adhesive 47 required to attach the walls of the collapsed LAA. In other words, the rejection of claim 1 leaves unaddressed how the volume of a fully inflated LAA informs the amount of adhesive required to seal a collapsed LAA. Accordingly, we agree with Appellant that the Examiner relied on impermissible hindsight in rejecting claim 1, and claims 2–5, 8, 12, 16, 18, and 26 depending therefrom, as unpatentable over Kassab, Rehor, and McCormick. Appeal 2019-006188 Application 14/208,338 7 Rejections II–VIII (Kassab, Rehor, McCormick, Dye, Gnanou, Chau, Beckman, Sheardown, Lopez-Minguez, West, and Gemeinhart) The Examiner does not use the teachings of Dye, Gnanou, Chau, Beckman, Sheardown, Lopez-Minguez, West, and Gemeinhart in any manner that would remedy the deficiency discussed above regarding Rejection I and the combination of the teachings of Kassab, Rehor, and McCormick. See Non-Final Act. 5–9. Accordingly, for the same reasons, we do not sustain Rejections II–VIII. Rejection IX (Kassab, Shalaby, McCormick) In Rejection IX, the Examiner rejects claim 1 based on the same findings of fact regarding Kassab and McCormick, but replaces Rehor with Shalaby to address the recited characteristics of the biomaterial. Non-Final Act. 10–11. For the same reasons discussed above regarding Rejection I, we do not sustain the rejection of claim 1, and claim 27 depending therefrom, as unpatentable over Kassab, Shalaby, and McCormick. CONCLUSION The Examiner’s rejections are reversed. DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–5, 8, 12, 16, 18, 26 103(a) Kassab, Rehor, McCormick 1–5, 8, 12, 16, 18, 26 9 103(a) Kassab, Rehor, McCormick, (Dye or Gnanou) 9 Appeal 2019-006188 Application 14/208,338 8 Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 6 103(a) Kassab, Rehor, McCormick, Chau 6 7, 25 103(a) Kassab, Rehor, McCormick, Beckman 7, 25 10 103(a) Kassab, Rehor, McCormick, Sheardown 10 13, 14 103(a) Kassab, Rehor, McCormick, Lopez- Minguez 13, 14 19 103(a) Kassab, Rehor, McCormick, West 19 24 103(a) Kassab, Rehor, McCormick, Gemeinhart 24 1, 27 103(a) Kassab, Shalaby, McCormick 1, 27 Overall Outcome 1–10, 12– 14, 16, 18, 19, 24–27 REVERSED