Ex Parte Young et al

Patent Trials and Appeals BoardApr 22, 2019

14377498 - (D) (P.T.A.B. Apr. 22, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/377,498 08/07/2014 71996 7590 04/24/2019 SHUMAKER & SIEFFERT, P.A 1625 RADIO DRIVE, SUITE 100 WOODBURY, MN 55125 FIRST NAMED INVENTOR Edward Willem Albert Young 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 ATTORNEY DOCKET NO. CONFIRMATION NO. l 123-237US01/C00011058.US 3206 EXAMINER GRAND, JENNIFER LEIGH-STEW AR ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 04/24/2019 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): pairdocketing@ssiplaw.com rs.patents.five@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte EDWARD WILLEM ALBERT YOUNG and EGBERTUS JOHANNES MARIA BAKKER 1 Appeal2018-005433 Application 14/377,498 Technology Center 3700 Before ERIC B. GRIMES, FRANCISCO C. PRATS, and JEFFREY N. FREDMAN, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134 involving claims relating to a deep brain stimulation system, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We reverse. STATEMENT OF THE CASE "Deep brain stimulation (DBS), the mild electrical stimulation of sub- cortical structures ... , has been shown to be therapeutically effective for 1 Appellants identify the Real Parties in Interest as Medtronic Bakken Research Center B.V. and Medtronic plc. Appeal Br. 3. Appeal2018-005433 Application 14/377,498 Parkinson's disease, dystonia, and tremor." Spec. 1:6-8. Some DBS "systems consist of a lead made from a thin film .... As the thin film wires and traces for the lead are relatively thin and long in these leads, the electrical resistance gives rise to substantial differences between the driving voltage at the current source and the driving voltage at the distal end." Id. at 1:19-25. For therapeutic applications that require potential control at the distal end, active voltage monitoring at the distal end is required. For safety reasons voltage monitoring can be beneficial too. Sensing near the electrode can be also beneficial to create an active feedback loop to compensate for pulse to pulse variation between various drivers in the electronic circuit. Id. at 1 :27-31. Claims 1, 4--10, 13, 15-20, and 22-27 are on appeal. Claim 1 is illustrative and reads as follows ( emphasis added): 1. A deep brain stimulation system comprising: a lead comprising at least one distal section, at least one electrode, a first connecting trace, and a second connecting trace, wherein the at least one electrode is arranged in the distal section and wherein the at least one electrode is connected to the first connecting trace and the second connecting trace; an electrical power supply, wherein the first connecting trace is configured to supply electrical power from the electrical power supply to the at least one electrode; and a controller configured to monitor voltage of the at least one electrode via the second connecting trace, and to control the electrical power supplied to the at least one electrode via the electrical power supply based on the monitored voltage. Claims 18 and 24 are the other independent claims. Claim 18 is directed to a method that includes "monitoring a voltage at a distal end of 2 Appeal2018-005433 Application 14/377,498 the lead via a second connecting trace of the lead that is coupled to the at least one electrode; and controlling electrical power supplied to the at least one electrode via an electrical power supply based on the monitored voltage." Claim 24 is directed to a system that includes "means for monitoring a voltage at a distal end of the lead via a second connecting trace of the lead that is coupled to the at least one electrode; and means for controlling electrical power supplied to the at least one electrode via an electrical power supply based on the monitored voltage." The claims stand rejected as follows: Claims 1, 4, 7-10, 18-20, 22, and 24--27 under 35 U.S.C. Â§ I03(a) based on Neves2 and Mercanzini '361 3 (Ans. 2); Claims 5 and 6 under 35 U.S.C. Â§ I03(a) based on Neves, Mercanzini '361, and Bluger4 (Ans. 5); and Claims 13, 15, and 16 under 35 U.S.C. Â§ I03(a) based on Neves, Mercanzini '361, and Mercanzini '665 5 (Ans. 6). DISCUSSION The Examiner has rejected all of the claims as obvious based on Neves and Mercanzini '361, by themselves or combined with either Bluger of Mercanzini '665. The same issue is dispositive for all of the rejections. The Examiner finds that Neves discloses a system meeting most of the limitations of the independent claims "but does not explicitly teach the 2 Neves et al., US 2011/0313270 Al, published Dec. 22, 2011. 3 Mercanzini et al., US 2013/0085361 Al, published Apr. 4, 2013. 4 Bluger et al. US 2004/0147992 Al, published July 29, 2004. 5 Mercanzini et al., US 2011/0301665 Al, published Dec. 8, 2011. 3 Appeal2018-005433 Application 14/377,498 controller configured to monitor a voltage via the second connecting trace and using the monitored voltage to control the electrical power supplied to at least one electrode." Ans. 2-3. The Examiner finds that Mercanzini '361 discloses a device comprising a lead; an electrode; and first and second connecting traces; and "a controller ... configured to monitor voltage via the second connecting trace ( e.g. detecting electric voltage between the electrode element ... )." Id. at 3. The Examiner reasons that it is well known within the art of stimulation to monitor the current/voltage being delivered to detect any conditions within the electrodes that might indicate damage/fault within the lead of electrode resulting in excessive or unbalance stimulation being delivered to the tissue and turning off or modifying stimulation in order to prevent excessive or unbalance stimulation being delivered to the tissue. Id. The Examiner concludes that, [t]herefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to further modify the system of Neves modified by Mercanzini [ '3 61] to include monitoring the current/voltage being delivered to detect any conditions within the electrodes that might indicate damage/fault within the lead or electrode resulting in excessive or unbalance stimulation being delivered to the tissue and turning off or modifying stimulation in order to prevent excessive or unbalance stimulation being delivered to the tissue. Id. at 3--4. Appellants argue that "[t]he applied references, alone or in any combination, fail to disclose or suggest the features defined by Appellant's claims, and there is no apparent reason that would cause one of ordinary skill in the art to modify the applied references to arrive at the claimed 4 Appeal2018-005433 Application 14/377,498 features." Appeal Br. 8. Appellants note that the Examiner "acknowledged that Neves fails to disclose" (id. at 13) "'a controller configured to monitor voltage of the at least one electrode via the second connecting trace, and to control the electrical power supplied to the at least one electrode via the electrical power supply based on the monitored voltage,' as recited by independent claim 1" ( id. at 12). Appellants argue that "Mercanzini [' 3 61] similarly fails to disclose this element." Id. at 13. Appellants argue, therefore, that "the Examiner has failed to show that that the cited references disclose or suggest" this limitation. Id. at 12. We agree with Appellants that the Examiner has not provided evidence to show that the claimed system-which includes a controller configured to control electrical power supplied to an electrode based on voltage monitored by a second trace connected to the electrode-would have been obvious to a person of ordinary skill in the art based on the cited references. The Examiner finds that Neves does not disclose the above limitation, and relies on Mercanzini '3 61 to disclose or suggest the elements of the claimed invention that are missing from Neves. Ans. 2-3. Specifically, the Examiner finds that Mercanzini '3 61 discloses a deep brain stimulation system comprising a lead ( e.g. 100, Fig. 1) comprising at least one distal section ( e.g. 150, Fig. 4A) and at least one electrode ( e.g. 160/260, Figs. 4A and 6) a first connecting trace and a second connecting trace ( e.g. plurality of conductive traces, Fig. 6; paragraphs [0039],[0049], [0159] at least one between 265Pb and 265Pc and at least another connecting trace between 265Pb and 265Pa) and a controller (e.g. 122, Fig. 2) configured to monitor voltage via the second 5 Appeal2018-005433 Application 14/377,498 connecting trace ( e.g. detecting electric voltage between the electrode element, paragraphs [0037], [0038], [0060],[0070]). Id. at 3 ( emphasis added). However, the Examiner does not point to any description in Mercanzini '361 of the controller as being "configured to ... to control the electrical power supplied to the at least one electrode via the electrical power supply based on the monitored voltage," as required by the claims on appeal. Rather, the Examiner states that "it is well known within the art of stimulation to monitor the current/voltage being delivered" in order to detect conditions that could "result[] in excessive or unbalance stimulation being delivered" and to "tum[] off or modify[] stimulation in order to prevent excessive or unbalance stimulation being delivered to the tissue." Ans. 3. The Examiner reasons that the claim limitation missing from Neves and Mercanzini '361 would therefore have been obvious to a skilled artisan. Id. "[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418 (2007) (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). "Motivation to combine is a factual determination as to whether there is a known reason a skilled artisan would have been motivated to combine elements to arrive at a claimed combination." Arctic Cat, Inc. v. Bombardier Recreational Prods., Inc., 876 F.3d 1350, 1359 (Fed. Cir. 2017). "In rejecting an application, factual determinations by the PTO must be based on a preponderance of the evidence." In re Oetiker, 977 F.2d 1443, 1449 (Fed. Cir. 1992) (J. Plager, concurring). 6 Appeal2018-005433 Application 14/377,498 Here, the Examiner does not point to any evidence showing that it was well-known in the relevant art to monitor the voltage being delivered to an electrode, in a DBS system, via a connecting trace connected to the electrode, and to then control the electrical power supplied to the electrode based on the monitored voltage. Thus, the Examiner's conclusion that this limitation, and therefore the claimed invention as a whole, would have been obvious to a person of ordinary skill in the art is not supported by a preponderance of the evidence of record. We reverse the rejection of claims 1, 18, and 24, and dependent claims 4, 7-10, 19, 20, 22, and 25-27, under 35 U.S.C. Â§ 103(a) based on Neves and Mercanzini '3 61. For the same reason, we also reverse the rejection of claims 5 and 6 under 35 U.S.C. Â§ 103(a) based on Neves, Mercanzini '361, and Bluger, and the rejection of claims 13, 15, and 16 under 35 U.S.C. Â§ 103(a) based on Neves, Mercanzini '361, and Mercanzini '665. SUMMARY We reverse all of the rejections on appeal. REVERSED 7