Barry O'Connell et al.

Patent Trials and Appeals BoardNov 4, 2019

14306997 - (D) (P.T.A.B. Nov. 4, 2019)

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. 14/306,997 06/17/2014 Barry O'Connell C00006316.USU1 7737 28390 7590 11/04/2019 MEDTRONIC VASCULAR, INC. IP LEGAL DEPARTMENT 3576 UNOCAL PLACE SANTA ROSA, CA 95403 EXAMINER OUYANG, BO ART UNIT PAPER NUMBER 3794 NOTIFICATION DATE DELIVERY MODE 11/04/2019 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): rs.patents.five@medtronic.com rs.vasciplegal@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BARRY O’CONNELL, CORMAC DELANEY, ANGELA DUFFY, and EOGHAN TWOHIG Appeal 2018-003703 Application 14/306,997 Technology Center 3700 Before EDWARD A. BROWN, BRETT C. MARTIN, and RICHARD H. MARSCHALL, Administrative Patent Judges. MARSCHALL, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 22 and 24–35.2 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(a). Appellant identifies the real party in interest as Medtronic Ardian Luxembourg S.a.R.l. Appeal Br. 1. 2 Claims 1–11 and 15–21 are withdrawn, and claims 12–14 and 23 are cancelled. Appeal Br. 16–19 (Claims App.) Appeal 2018-003703 Application 14/306,997 2 CLAIMED SUBJECT MATTER The invention relates to an implantable catheter-delivered neuromodulation devices. Spec. ¶ 1. Claims 22 and 27 are independent. Claim 22, reproduced below, is illustrative of the claimed subject matter: 22. An implantable neuromodulation device, comprising: a bioabsorbable electrode electrically energizable to modulate a nerve of a human patient within tissue at or otherwise proximate to a wall of a naturally occurring lumen of the patient; and a bioabsorbable elongate support structure carrying the electrode, wherein the support structure is configured to expand in a direction perpendicular to its length such that the electrode moves into contact with the wall of the lumen. Appeal Br. 19 (Claims App.). REJECTIONS ON APPEAL 1. Claims 22 and 24–32 are rejected under 35 U.S.C. § 103 as unpatentable over Hastings,3 Falkenberg,4 Rudakov,5 and Young.6 2. Claim 33 is rejected under 35 U.S.C. § 103 as unpatentable over Hastings, Falkenberg, Rudakov, Young, and Weber.7 3 U.S. Patent Pub. No. 2011/0307034 A1, published December 15, 2011 (“Hastings”). 4 U.S. Patent Pub. No. 2004/0116965 A1, published June 17, 2004 (“Falkenberg”). 5 U.S. Patent Pub. No. 2014/0371777 A1, published December 18, 2014 (“Rudakov”). 6 U.S. Patent Pub. No. 2009/0131855 A1, published May 21, 2009 (“Young”). 7 U.S. Patent Pub. No. 2008/0086201 A1, published April 10, 2008 (“Weber”). Appeal 2018-003703 Application 14/306,997 3 3. Claims 34 and 35 are rejected under 35 U.S.C. § 103 as unpatentable over Hastings, Falkenberg, Rudakov, Young, and Boutry.8 ANALYSIS Claim 22 Claim 22 requires a “bioabsorbable electrode” and a “bioabsorbable elongate support structure.” Appeal Br. 19 (Claims App.). The Examiner finds that Hastings discloses an electrically energizable electrode and Falkenberg discloses a support structure that expands perpendicular to its length. Final Act. 3. The Examiner determines that it would have been obvious to modify Hastings to include the features of Falkenberg to move the energy delivery element into contact with the lumen wall. Id. at 4. As to bioabsorbability, the Examiner further finds that Rudakov discloses bioabsorbable support structure in a stent and Young teaches a bioabsorbable electrode. Id. at 3. The Examiner determines that it further would have been obvious “to modify Hastings with the support structure being bioabsorbable, as in Rudakov,” and “to modify Hastings with the energy delivery element being a bioabsorbable electrode, as in Young,” “to allow for absorption of the foreign object from the patient after all treatments have been performed.” Id. at 3–4. Appellant argues that claim 22 would not have been obvious because “nothing in the applied art or in the common knowledge would have motivated a person of ordinary skill in the art to further combine the teachings of Hastings and Falkenberg regarding an expandable and 8 C.M. Boutry et al., Towards biodegradable wireless implants, Phil. Trans. R. Soc. A 370, 2418–2432 (The Royal Society 2012). Appeal 2018-003703 Application 14/306,997 4 implantable neuromodulation device with the teachings of Rudakov and Young regarding bioabsorbability.” Appeal Br. 10. According to Appellant, “a person of ordinary skill in the art would not have found either of these [bioabsorbability] teachings to have been relevant to any known problem or objective in the context of implantable neuromodulation devices.” Id. at 11. Appellant argues that nothing in the references suggests the desirability of bioabsorbability for implantable neuromodulation devices, and that both “Hastings and Falkenberg actually emphasize the permanence of their respective implants, which is incompatible with modifying the implants to be bioabsorbable.” Id. In a related argument, Appellant contends that Hastings and Falkenberg emphasis on treating “chronic fixation” within an artery (Hastings) and leaving a stent “in position” (Falkenberg) amounts to teaching away from bioabsorbability. Id. at 12 (emphasis removed). In response, the Examiner finds that the term “chronic,” as used in Hastings, encompasses conditions that last 3 months or more, and that “Rudakov discusses bioabsorbable material having a controlled degradation between 3 months to 3 years.” Ans. 3 (citing Rudakov ¶ 713, MedicineNet.com dictionary definition). Based on the overlapping timeframes, the Examiner finds that one of ordinary skill in the art would appreciate that Rudakov’s materials are configured to degrade within the timeframe contemplated by Hastings and “would not be at odds with the desire for a chronic fixation as in Hastings.” Id. The Examiner further finds that one of ordinary skill in the art would desire failure of the device within a similar timescale, and that “other bioabsorbable materials such as that of Young would also fall within this chronic timescale.” Id. Appeal 2018-003703 Application 14/306,997 5 We are not apprised of error in the Examiner’s findings. We initially note that Appellant does not argue that, once combined, the prior art fails to disclose any of the limitations of claim 22. Appellant first argues the lack of applicability of bioabsorbable materials to implantable neuromodulation devices. See Appeal Br. 10. Although Rudakov and Young are not implanted neuromodulation devices, Appellant does not present any argument that claim 22 does not encompass other medical devices, given that the term “neuromodulation device” only appears in the preamble to the claim. See Appeal Br. 19 (Claims App.). Moreover, the neuromodulation devices of Hastings/Falkenberg need not make any specific reference to bioabsorbable materials to support the proposed combination. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (“The analysis need not seek out precise teachings [in the prior art] directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ”). Rudakov discloses an endoluminal vessel implant, while Young discloses a tissue ablation probe. See Rudakov, code (57); Young, code (57). Appellant has not persuasively argued that the Examiner erred in determining that the bioabsorbable materials found useful in these medical applications would be useful in neuromodulation devices. See Final Act. 3–4. Appellant’s second argument against the Examiner’s proposed combination stems from the alleged permanence of the Hastings/Falkenberg devices compared to the impermanent bioabsorbable materials of Rudakov and Young. Appeal Br. 11–12. Appellant does not address the Examiner’s additional findings and explanation in the Answer that address those arguments and point out the apparent overlap in the period of treatment Appeal 2018-003703 Application 14/306,997 6 contemplated by Hastings and Rudakov. See Ans. 3. We discern no error in the Examiner’s unrebutted findings in the Answer. Rudakov discusses leaving in its bioabsorbable material for 3 months to 3 years, which undermines Appellant’s teaching away argument based on the assumption that Hastings and Falkenberg require longer treatments than the bioabsorbable materials can achieve. Ans. 3; Rudakov ¶ 713. Hastings and Falkenberg do not address the potential use of bioabsorbable implants and whether they would work in their contemplated applications. This silence as to the use of bioabsorbable materials does not amount to a teaching away or undermine the basis for the proposed combination when weighed against the advantages of bioabsorbability the Examiner relies upon. Moreover, even if Hastings and Falkenberg prefer a longer treatment time frame, that preference does not conclusively teach away from the use of bioabsorbable materials with a shorter treatment time. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (finding no teaching away when reference did not “criticize, discredit or otherwise discourage” alternative approach). Based on the foregoing, we sustain the rejection of claim 22. Claims 34 and 35 Dependent claims 34 and 35 require a bioabsorbable inductor. Appeal Br. 20–21 (Claims App.). The Examiner finds that Boutry discloses an inductor made from bioabsorbable materials, and determines that it would have been obvious “to modify the combination such that the inductor is bioabsorbable, as taught by Boutry, . . . to avoid a second surgery to remove the implanted device.” Final Act. 9. Appellant argues against the motivation for the combination, given that Boutry is directed to implantable Appeal 2018-003703 Application 14/306,997 7 sensors and neurostimulators, not neuromodulation devices, which do not need to be removed. Br. 14–15. In response, the Examiner finds that given implant devices with electronics would have similar considerations such as duration of function of the implant, a similar device environment (the body of the patient), and flexibility to deal with stress (from body movement, blood flow, and the like), among other considerations, a neurostimulator implant and neuromodulator implant would have similar considerations, such that one of ordinary skill in the art would look to prior art regarding either implant type in determining factors such as how long the implant would function, and materials for biodegradation. Ans. 3–4. As to Boutry’s statement that a second surgery can be avoided by using bioabsorbable materials, the Examiner further finds that the statement shows the desirability of using such materials “so as to not require surgery to remove the device at the end of its life cycle.” Id. at 4. We are not apprised of error in the Examiner’s findings or reasoning in support of the rejection of claims 34 and 35. Similar to the discussion above, the Examiner made further findings and provided further reasoning in support of the rejection in the Answer, which Appellant chose not to rebut in a Reply Brief. We are not persuaded that the Examiner erred in those unrebutted findings. Even if we accepted Appellant’s argument that there is no need to remove a neuromodulation device, that argument does not address the Examiner’s findings that the considerations in the respective medical applications are similar enough overall that one of ordinary skill in the art would look to Boutry’s disclosure of bioabsorbable inductors for use in neuromodulation devices. See Ans. 3–4. Based on the foregoing, we sustain the rejection of claims 34 and 35. Appeal 2018-003703 Application 14/306,997 8 Remaining Claims For the remaining claims 24–33, Appellant relies on the same arguments addressed above in the context of claim 22. Accordingly, we sustain the rejections of claims 24–33 for the same reasons discussed above. CONCLUSION We affirm the Examiner’s rejection of claims 22 and 24–35. DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 22, 24–32 103 Hastings, Falkenberg, Rudakov, Young 22, 24–32 33 103 Hastings, Falkenberg, Rudakov, Young, Weber 33 34, 35 103 Hastings, Falkenberg, Rudakov, Young, Boutry 34, 35 Overall Outcome 22, 24–35 FINALITY AND RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED