Ein-Gal, MosheDownload PDFPatent Trials and Appeals BoardApr 30, 202013756556 - (D) (P.T.A.B. Apr. 30, 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. 13/756,556 02/01/2013 Moshe Ein-Gal 2261EIN-US 9249 32964 7590 04/30/2020 DEKEL PATENT LTD., DAVID KLEIN BEIT HAROF'IM 18 MENUHA VENAHALA STREET, ROOM 27 REHOVOT, 76209 ISRAEL EXAMINER DAVIS, AMELIE R ART UNIT PAPER NUMBER 3793 MAIL DATE DELIVERY MODE 04/30/2020 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte MOSHE EIN-GAL Appeal 2019-005460 Application 13/756,556 Technology Center 3700 ____________ Before HUBERT C. LORIN, MICHAEL C. ASTORINO, and KENNETH G. SCHOPFER, Administrative Patent Judges. ASTORINO, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–16. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 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 inventor. See Appeal Br. 1. Appeal 2019-005460 Application 13/756,556 2 STATEMENT OF THE CASE Claimed Subject Matter Claims 1 and 7 are the independent claims on appeal. Claim 1, reproduced below, is illustrative of the claimed subject matter. 1. A method for pressure-assisted irreversible electroporation of tissue cells, comprising: placing one or more electrodes near tissue cells to be treated; positioning a pressure source configured to apply pressure pulses to said tissue cells; and applying to said tissue cells a combination of electrical pulses through said one or more electrodes and pressure pulses from said pressure source such that the combination is sufficient to induce irreversible electroporation of said tissue cells, and wherein said electrical pulses have a pulse duration and a pulse voltage gradient that are insufficient to induce irreversible electroporation of said tissue cells without said pressure pulses, and wherein the pulse duration is less than 5 μsec and the pulse voltage gradient is less than 100 V/cm. Appeal Br. 16, Claims App. References The prior art relied upon by the Examiner is: Name Reference Date Unger et al. (“Unger”) US 6,627,421 B1 Sept. 30, 2003 Ferek-Petric US 2005/0096584 A1 May 5, 2005 Hagio et al. (“Hagio”) US 2006/0188992 A1 Aug. 24, 2006 May et al. (“May”) US 2007/0095648 A1 May 3, 2007 Bonutti et al. (“Bonutti”) US 2007/0141106 A1 June 21, 2007 Hyde et al. (“Hyde”) US 2012/0330284 A1 Dec. 27, 2012 Makin et al. (“Makin”) US 2012/0330223 A1 Dec. 27, 2012 Soikum et al. (“Soikum”) US 2013/0108667 A1 May 2, 2013 Appeal 2019-005460 Application 13/756,556 3 Rejections The Appellant requests our review of the Examiner’s rejections in the Final Office Action, mailed October 10, 2018. All of the Examiner’s rejections are under 35 U.S.C. § 103(a): claim 1 is rejected as unpatentable over May and Hagio; claim 2 is rejected as unpatentable over May, Hagio, and Bonutti; claim 3 is rejected as unpatentable over May, Hagio, and Ferek-Petric; claim 4 is rejected as unpatentable over May, Hagio, and Soikum; claims 5 and 6 are rejected as unpatentable over May, Hagio, and Hyde; claims 7, 12, 14, and 16 are rejected as unpatentable over May, Unger, Makin, and Hagio; claim 8 is rejected as unpatentable over May, Unger, Makin, Hagio, and Bonutti; claim 9 is rejected as unpatentable over May, Unger, Makin, Hagio, and Ferek-Petric; claim 10 is rejected as unpatentable over May, Unger, Makin, Hagio, and Soikum; claims 11 and 15 are rejected as unpatentable over May, Hagio, and Makin; and claim 13 is rejected as unpatentable over May, Hagio, and Unger. ANALYSIS Independent Claim 1 and Dependent Claims 2, 3, 5, 6, 11, 13, and 15 The Appellant argues that the Examiner’s rejection of claim 1 is in error because the combined teachings of May and/or Hagio fail to provide Appeal 2019-005460 Application 13/756,556 4 the incentive or instructions to perform the method of claim 1, and, more particularly, the “applying” step of claim 1. See Appeal Br. 10–11. The “applying” step of claim 1 recites: applying to said tissue cells a combination of electrical pulses through said one or more electrodes and pressure pulses from said pressure source such that the combination is sufficient to induce irreversible electroporation of said tissue cells, and wherein said electrical pulses have a pulse duration and a pulse voltage gradient that are insufficient to induce irreversible electroporation of said tissue cells without said pressure pulses, and wherein the pulse duration is less than 5 μsec and the pulse voltage gradient is less than 100 V/cm. Id. at 16, Claims App. (emphasis added). The Appellant supports this argument with the assertion that “lightweight” electrical and pressure pulse tools “will not cause irreversible electroporation of tissue cells,” whereas “heavyweight” tools of the same kind “will cause irreversible electroporation of tissue cells.” Id. at 10. According to the Appellant, assuming a skilled artisan desired as a goal “to cause irreversible electroporation of tissue cells,” then the skilled artisan would have no incentive to choose electrical and pressure pulse tools that are lightweight. Id. Rather, the skilled artisan “would naturally choose” the heavyweight tools. Id. at 11. Moreover, the Appellant asserts that using a combination of electrical and pressure pulse tools that each are “lightweight” to cause irreversible electroporation would have been counterintuitive, and not taught by May and Hagio, either singly or in combination. Id. The Appellant’s argument is not persuasive of Examiner error. We determine that the Examiner’s rejection of claim 1 is adequately supported. See Final Act. 6–9 (citing May ¶¶ 28, 35, 45, 48–49, Fig. 5; Hagio ¶ 91); In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections Appeal 2019-005460 Application 13/756,556 5 on obviousness grounds . . . [require] some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”) (cited with approval in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)). We also agree with the explanations in the Examiner’s Answer that respond to the Appellant’s argument and we adopt them as our own. Ans. 3–11. Of particular note is the Examiner’s explanations that “claim 1 does not recite ‘lightweight’ pressure pulse tools that will not cause irreversible electroporation of tissue,” that the support for the Appellant’s argument is based on attorney argument and not evidence, and that May teaches the emphasized portion of the “applying” step of claim 1 in paragraphs 48 and 49. See id. at 5–8. Additionally, we note that the Appellant fails to address: the Examiner’s findings particular to the individual teachings of May or Hagio; or how the Examiner’s proposed combination of teachings from May and Hagio lacks some articulated reasoning with some rational underpinning. Further, the Appellant fails to address, with any detail, how the combined teachings of May and Hagio fail to result in the subject matter of the method of claim 1, including the “applying” step. Thus, we sustain the Examiner’s rejection of claim 1. The Appellant provides separate headings titled as Issues 2 (claim 2), 3 (claim 3), 5 (claims 5 and 6), 10 (claims 11 and 15), and 11 (claim 13). Appeal Br. 11–12, 14. However, the Appellant does not provide separate arguments for the rejections of any of these claims (id.), each of which depends directly or indirectly from claim 1 (id. at 16, 17, Claims App.). More specifically, the Appellant relies on the arguments presented for the rejection of claim 1, as discussed above, for the rejections of claims 2, 3, 5, Appeal 2019-005460 Application 13/756,556 6 6, 11, 13, and 15. Id. Thus, we sustain the Examiner’s rejections of claims 2, 3, 5, 6, 11, 13, and 15. Independent Claim 7 and Dependent Claims 8, 9, 12, 14, and 16 The Appellant provides separate headings titled as Issues 6 (claims 7, 12, 14, and 16), 7 (claim 8), and 8 (claim 9). Appeal Br. 13. However, the Appellant does not provide separate arguments for the rejections of any of these claims (id.); claims 8, 9, 12, 14, and 16 depend directly from independent claim 7 (id. at 16–17, Claims App.). For the rejection of independent claim 7, the Appellant refers back to the argument for the rejection of claim 1 while acknowledging the additional prior art references, i.e., Makin and Unger. Id. at 13. As discussed above, the Appellant’s argument is not persuasive for the rejection of claim 1. For similar reasons, we determine that the Appellant’s argument for rejection of claim 7 is likewise not persuasive. Thus, we sustain the Examiner’s rejection of independent claim 7 as well as the rejections of dependent claims 8, 9, 12, 14, and 16. Dependent Claims 4 and 10 Claim 4, which depends from claim 1, recites “further comprising adjusting an angle between an electrical field of said electrical pulses and a pressure propagation of said pressure pulses.” Appeal Br. 16, Claims App. The Appellant argues that the Examiner’s rejection of claim 4 is in error. Id. at 12. Outside of the Appellant’s reliance on the unpersuasive arguments presented for the rejection of claim 1, the Appellant argues that May teaches away from the subject matter of claim 4 because “[i]n May it is Appeal 2019-005460 Application 13/756,556 7 essential not to change this angle because the pressure must be presented as a force perpendicular to the polar axis of the cell membrane.” Id. The Appellant’s argument is not persuasive of Examiner error. Initially, we determine that the Examiner’s rejection of claim 4 as unpatentable over May, Hagio, and Soikum is adequately supported. See Final Act. 11–13 (citing May ¶ 49; Soikum ¶¶ 125, 149, 304, 306–308, 331, 385, Figs. 12A–D, 17C–D). In response to the Appellant’s argument, we note that the Appellant does not cite to any particular portion of May that describes that “pressure must be presented as a force perpendicular to the polar axis of the cell membrane.” Id. at 12. The Examiner appears to understand that the Appellant’s argument refers to May’s disclosure in paragraph 49. See Ans. 13. We agree. The Examiner explains, “[a]lthough May discusses the angle between the polar axis of the cell membrane and the radiation force vector generated by the pressure pulses, May does not discuss that the angle ‘must be’ perpendicular.” Id. We agree. In this case, the Appellant’s argument is not persuasive at least because the Appellant does not explain –– using evidence and/or technical reasoning –– how May teaches that pressure must be presented as a force perpendicular to the polar axis of the cell membrane. Further, we note that the Examiner acknowledges that May describes that “the incident angle between the radiation vector and portions of the membrane radial to the polar axis progressively decrease” (May ¶ 49), but explains that “the angle of the radiation force vector relative to the ‘polar axis of the cell membrane’ is not the angle between ‘an electrical field of said electrical pulses and a pressure propagation of said pressure pulses.’ May does not discuss such an angle.” Ans. 13. In view of the Appeal 2019-005460 Application 13/756,556 8 foregoing, the Examiner determines that “May does not disparage, discredit, or otherwise discourage the proposed modification to adjust the claimed angle. Consequently, May does not ‘teach away’ from the proposed modification.” Id. We agree. Thus, we sustain the Examiner’s rejection of claim 4. The Appellant argues that the Examiner’s rejection of claim 10, which depends from claim 7, is in error for substantially the same reason the rejection of claim 4 is in error. See Appeal Br. 13–14. For the rejection of independent claim 10, the Appellant refers back to the argument for the rejection of claims 7 and 4 while acknowledging the additional prior art references, i.e., Makin and Unger. See id. As discussed above, the Appellant’s argument is not persuasive for the rejections of claims 7 and 4. For similar reasons, we determine that the Appellant’s argument for rejection of claim 10 is likewise not persuasive. Thus, we sustain the Examiner’s rejection of claim 10. CONCLUSION In summary: Claims Rejected 35 U.S.C. § References/Basis Affirmed Reversed 1 103(a) May, Hagio 1 2 103(a) May, Hagio, Bonutti 2 3 103(a) May, Hagio, Ferek- Petric 3 4 103(a) May, Hagio, Soikum 4 5, 6 103(a) May, Hagio, Hyde 5, 6 7, 12, 14, 16 103(a) May, Unger, Makin, Hagio 7, 12, 14, 16 8 103(a) May, Unger, Makin, Hagio, Bonutti 8 Appeal 2019-005460 Application 13/756,556 9 Claims Rejected 35 U.S.C. § References/Basis Affirmed Reversed 9 103(a) May, Unger, Makin, Hagio, Ferek-Petric 9 10 103(a) May, Unger, Makin, Hagio, Soikum 10 11, 15 103(a) May, Hagio, Makin 11, 15 13 103(a) May, Hagio, Unger 13 Overall Outcome 1–16 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation