Ex Parte Rao et alDownload PDFPatent Trial and Appeal BoardSep 12, 201714200702 (P.T.A.B. Sep. 12, 2017) 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. 14/200,702 03/07/2014 Prakash Rao 6279.128US1 9735 45458 7590 09/14/2017 smwfPtMan t t tndrf.ro & wofnnnfr/rnf EXAMINER PO BOX 2938 GETZOW, SCOTT M MINNEAPOLIS, MN 55402 ART UNIT PAPER NUMBER 3762 NOTIFICATION DATE DELIVERY MODE 09/14/2017 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): uspto@slwip.com SLW @blackhillsip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PRAKASH RAO and SRIDHAR KOTHANDARAMAN Appeal 2016-0076621 Application 14/200,702 Technology Center 3700 Before DONALD E. ADAMS, FRANCISCO C. PRATS, and JOHN E. SCHNEIDER, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims to devices for externally controlling arrays of implanted electrodes that deliver electrical stimulation energy to tissue. The Examiner rejected the claims as anticipated, and for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE The following rejections are before us for review: (1) Claims 17—22, under 35 U.S.C. § 102(b), as anticipated by Goetz (Final Action 2); 1 Appellants state that the real party in interest “is the assignee, Boston Scientific Neuromodulation Corporation.” Appeal Br. 2. Appeal 2016-007662 Application 14/200,702 (2) Claims 25 and 26, under 35 U.S.C. § 103(a), for obviousness over Goetz and Davis2 3 (Final Action 2—3); (3) Claims 1—10, 15, and 16, under 35 U.S.C. § 103(a), for obviousness over Goetz and Kothandaraman4 (Final Action 3); (4) Claims 12—14, under 35 U.S.C. § 103(a), for obviousness over Goetz, Kothandaraman, and Davis (Final Action 3 4); (5) Claim 11, under 35 U.S.C. § 103(a), for obviousness over Goetz, Kothandaraman, and Kim5 (Final Action 4); (6) Claims 23 and 24, under 35 U.S.C. § 103(a), for obviousness over Goetz (Final Action 4); (7) Claims 1—10 and 12—26, under 35 U.S.C. § 103(a), for obviousness over Kothandaraman and Davis (Final Action 5—6); and (8) Claim 11, under 35 U.S.C. § 103(a), for obviousness over Kothandaraman, Davis, and Kim (Final Action 6). Claims 1 and 17, the independent claims on appeal, read as follows (Appeal Br. 28, 30-31): 1. An external control device for use with a two- dimensional array of electrodes implanted within tissue and a neurostimulator capable of delivering electrical stimulation energy to the electrodes to create a volume of activation, comprising: a user interface including a current steering initiation control element and a current steering direction control element capable of being rotated about an axis; 2 US 2008/0163097 A1 (published July 3, 2008). 3 US 2011/0270358 A1 (published Nov. 3, 2011). 4 US 2010/0121409 A1 (published May 13, 2010). 5 US 2012/0041518 A1 (published Feb. 16, 2012). 2 Appeal 2016-007662 Application 14/200,702 a controller/processor configured for, in response to actuation of the initiation control element, generating a series of different combinations of the electrodes in a manner that the volume of activation gradually translates in a specific direction when the electrical stimulation energy is delivered to the different electrode combinations, the controller/processor further configured for, in response to rotation of the direction control element about the axis, defining the specific direction in which the volume of activation is translated; and output circuitry configured for transmitting the different electrode combinations to the neurostimulator. 17. A neurostimulation system, comprising: at least one neurostimulation lead configured for being implanted within tissue, the at least one neurostimulation lead carrying a plurality of electrodes capable of being arranged in a two-dimensional pattern; a neurostimulator configured for delivering electrical stimulation energy to the electrodes to create a volume of activation; and an external control device including a current steering direction control element capable of being rotated about an axis, the external control device configured for prompting the neurostimulator to deliver the electrical stimulation energy to the electrodes in a manner that gradually translates the volume of activation in a specific direction, and for defining the specific direction in which the volume of activation is translated in response to rotation of the direction control element about the axis. ANTICIPATION—GOETZ As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden ... of presenting a prima facie case of unpatentability. . . . After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. 3 Appeal 2016-007662 Application 14/200,702 In the present case, Appellants persuade us that a preponderance of the evidence does not support the Examiner’s finding that Goetz describes a neurostimulation system having all of the features of independent claim 17. As seen above, claim 17 requires the claimed neurostimulation system to have an external control device that includes a current steering direction control element capable of being rotated about an axis. Appeal Br. 31. Claim 17 requires the external control device to be configured to prompt the neurostimulator to deliver electrical stimulation energy to tissue-implantable electrodes “in a manner that gradually translates the volume of activation [of the electrodes in the tissue] in a specific direction, and for defining the specific direction in which the volume of activation is translated in response to rotation of the direction control element about the axis.” Id. Consistent with Appellants’ Specification, “translating] the volume of activation in a specific direction” as required by claim 17 {id.) means that the external control device causes the electrodes in the treated volume of tissue to deliver electrical stimulation to the treated region of tissue in a serial and directional fashion controlled by the rotatable steering device. See Spec. ]]16 (describing external control device as “generating a series of different combinations of the electrodes (e.g., fractionalized electrode combinations) in a manner that the volume of activation gradually translates in a specific direction”) (emphasis added); see also id. at 144 (describing “pulse generation circuitry that delivers electrical stimulation energy in the form of a pulsed electrical waveform (i.e., a temporal series of electrical pulses to the electrodes 26 in an electrode array”) (emphasis added). The Examiner contends that, because Goetz describes a rotatable knob that changes the shape of the field of tissue that is stimulated by electrodes, 4 Appeal 2016-007662 Application 14/200,702 Goetz’s device provides the controlled directional stimulation required by claim 17. See Ans. 2—3 (“When the field shape gets larger, the direction the field changes, or translates, is in the outward direction, and when the field shape gets smaller, the field is considered to translate in the inward direction.”) (citing Goetz 1170). We acknowledge Goetz’s disclosure that a trackball, scroll wheel, or joystick may be used to perform the manipulations of electrode stimulation described in that reference. See Goetz | 81. Nonetheless, we are not persuaded that the Examiner has explained with adequate specificity how simply changing the size of the field of stimulated tissue equates to the delivery of electrical stimulation to the treated region of tissue in a serial and directional fashion, controlled by a rotatable steering element, as claim 17 requires. Because Appellants persuade us, therefore, that the Examiner has not shown that Goetz describes a system having all of the elements required by claim 17, we reverse the Examiner’s rejection of that claim, and its dependent claims 18—22, as anticipated by Goetz. OBVIOUSNESS—GOETZ AND DAVIS In rejecting claims 25 and 26, both of which depend from claim 17 discussed above, over Goetz and Davis, the Examiner cited “paragraphs 93- 97 of Davis which teach adjusting the sensitivity of the wheel, and thus the speed of changing the volume of activation, and using an inertia parameter that will continue changing the field of activation for a set period of time after manipulation of the wheel.” Final Action 2—3. The Examiner concluded that, “[t]o use such features with the device of Goetz would have been obvious since they would merely produce predictable results.” Id. at 3. 5 Appeal 2016-007662 Application 14/200,702 As is evident, the Examiner does not identify teachings in Davis that remedy the deficiencies of Goetz as to claim 17, discussed above, from which claims 25 and 26 depend. Appellants persuade us, therefore, that the Examiner has not shown that the combination of Goetz and Davis teaches or suggests a device having all of the elements required by claims 25 and 26. We, therefore, reverse the Examiner’s rejection of those claims over those references. OBVIOUSNESS— GOETZ AND KOTHANDARAMAN In rejecting claims 1—10, 15, and 16 over Goetz and Kothandaraman, the Examiner concluded that it would have been obvious to use the initiation control element 106 shown in Figure 6 of Kothandaraman with Goetz’s device, “since it would merely yield the predictable result of allowing the programming ability to start or stop.” Final Action 3. Alternatively, the Examiner reasoned, “the on/off button of the programmer of Goetz can also be considered to be an initiation control element in that it functions in the same manner, namely to turn on or off the ability to program the device.” Id. Claim 1, like claim 17 discussed above, recites an external control device that includes a current steering direction control element capable of being rotated about an axis. Appeal Br. 28. Claim 1, like claim 17, requires the external control device to be configured to deliver electrical stimulation to a treated region of tissue in a serial and directional fashion, controlled by the rotatable steering element. See id. (claim 1 reciting a controller/processor configured for “generating a series of different combinations of the electrodes in a manner that the 6 Appeal 2016-007662 Application 14/200,702 volume of activation gradually translates in a specific direction when the electrical stimulation energy is delivered to the different electrode combinations” wherein the controller/processor is “further configured for, in response to rotation of the direction control element about the axis, defining the specific direction in which the volume of activation is translated”). In setting forth the prima facie case of obviousness, the Examiner did not identify where either Kothandaraman or Goetz describes a device that includes the functionality of controllably delivering electrical stimulation to the treated region of tissue in a serial and directional fashion, in the manner required by claim 1. See Final Action 3. In response to Appellants’ arguments in that regard, the Examiner contends that Goetz shows that “the field shapes [of electrically stimulated tissue] can be stretched or shrunk, etc. (par. 73). Thus, the field shape can be translated in the direction the clinician desires. Further, the manipulation tools the clinician uses to change the field shapes can be selection media such as scroll wheels.” Ans. 3. As discussed above, however, we are not persuaded that the Examiner has explained with adequate specificity how simply changing the size of the field of stimulated tissue equates to the delivery of electrical stimulation to the treated region of tissue in a serial and directional fashion, controlled by a rotatable steering element, as claim 1 requires. Because Appellants persuade us, therefore, that the Examiner has not shown that the combination of Goetz and Kothandaraman teaches or suggests a system having all of the elements required by claim 1, we reverse the Examiner’s rejection of that claim, and its dependent claims 2—10, 15, and 16, for obviousness over those references. 7 Appeal 2016-007662 Application 14/200,702 OBVIOUSNESS— GOETZ, KOTHANDARAMAN, AND DAVIS In rejecting claims 12—14 over Goetz, Kothandaraman, and Davis, the Examiner cited “paragraphs 93-97 of Davis which teach[] controlling the speed of the scroll wheel, and thus the manner in which the electrode combinations are generated, as well as an inertia element which continues the changing of the field for a certain time after the wheel has ceased turning.” Final Action 4. The Examiner concluded that “[t]o use such features with the device of Goetz would have been obvious since they would merely produce predictable results.” Id. As is evident, the Examiner does not identify teachings in Davis that remedy the deficiencies of Goetz and Kothandaraman as to claim 1, discussed above, from which claims 12—14 depend. Appellants persuade us, therefore, that the Examiner has not shown that the combination of Goetz, Kothandaraman, and Davis teaches or suggests a device having all of the elements required by claims 12—14. We, therefore, reverse the Examiner’s rejection of those claims over those references. OBVIOUSNESS— GOETZ, KOTHANDARAMAN, AND KIM In rejecting claim 11 over Goetz, Kothandaraman, and Kim, the Examiner stated only that, regarding “the subject matter of claim 11, see office action of 3/30/15.” Final Action 4. Our review of the Non-Final Action entered March 30, 2015 does not show a rejection over the combination of Goetz, Kothandaraman, and Kim. See Non-Final Act., generally. Rather, the only two rejections included in the Non-Final Action are (1) an obviousness rejection of claims 1—10 and 12—26 over the combination of Kothandaraman and Davis (Non-Final Act. 8 Appeal 2016-007662 Application 14/200,702 2—3), and (2) an obviousness rejection of claim 11 over Kothandaraman, Davis, and Kim {id. at 3). Thus, the obviousness rationale advanced in the Final Action does not explain why the combination of Goetz, Kothandaraman, and Kim, asserted as demonstrating the obviousness of claim 11, teaches or suggests all of the claimed elements. In any event, as to the Kim reference, the Non-Final Action states that “Kim teaches using an ideal multipole, par. 59. To use such with the device of Kothandaraman and Davis would have been obvious since such would be a combination of prior art elements yielding a predictable result.” Non-Final Act. 3. As is evident, the Examiner does not identify teachings in Kim that remedy the deficiencies of Goetz and Kothandaraman as to claim 1, discussed above, from which claim 11 depends. Appellants persuade us, therefore, that the Examiner has not shown that the combination of Goetz, Kothandaraman, and Kim teaches or suggests a device having all of the elements required by claim 11. We, therefore, reverse the Examiner’s rejection of that claim over those references. OBVIOUSNESS—GOETZ In rejecting claims 23 and 24, both of which depend from claim 17 discussed above, over Goetz, the Examiner found that “the field shapes, and thus the electrode combinations, of Goetz can be stored for later use, and thus are considered to be defined prior to prompting the neurostimulator to deliver electrical stimulation energy to the electrodes.” Final Action 4. The Examiner concluded, therefore, that, “[ejither way, no unexpected result would occur from defining a specific direction prior to the generation of different electrode combinations or prompting as opposed to defining the 9 Appeal 2016-007662 Application 14/200,702 direction while the device is delivering neurostimulation.” Id. As is evident, the Examiner does not identify additional teachings in Goetz that remedy the deficiencies of Goetz as to claim 17, discussed above, from which claims 23 and 24 depend. Appellants persuade us, therefore, that the Examiner has not shown that Goetz teaches or suggests a device having all of the elements required by claims 23 and 24. We, therefore, reverse the Examiner’s rejection of those claims over Goetz. OBVIOUSNESS— KOTHANDARAMAN AND DAVIS The Examiner’s rationale for rejecting claims 1—10 and 12—26 over Kothandaraman and Davis is set forth in the Non-Final Action entered March 30, 2015. See Final Action 5 (stating “[s]ee office action of 3/30/15”). The Examiner cited Kothandaraman as teaching “user interface (figs. 6-14), and a controller/processor 80 which is capable [of] programming different combinations of electrodes and shifts the current automatically, including fractionalized currents, from electrode to electrode, pars. 33, and 106-120.” Non-Final Act. 2. The Examiner cited Davis as teaching “a directional control element in the form of a scroll wheel 122, 162 which can control the direction of the volume of activation 102.” Id. The Examiner concluded that “[t]o use such with the device of Kothandaraman would have been obvious in that it would be a combination of prior art elements yielding a predictable result.” Id. As the Supreme Court has explained, “rejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to 10 Appeal 2016-007662 Application 14/200,702 support the legal conclusion of obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). We agree with Appellants that, because the Examiner did not explain with any specificity why an ordinary artisan would have combined the prior art elements in the posited manner, the Examiner’s rejection lacks the articulated reasoning, as well as the rationale underpinning, required to sustain an obviousness rejection. We have carefully reviewed the Examiner’s arguments, both in the Final Action (see Final Act. 5—6), and in the Answer (Ans. 4—6), as well as the multiple portions of the references cited therein. Nonetheless, in the absence of a reasoned, specific, evidence-based explanation as to why the particular cited portions of the references would have led an ordinary artisan to the precise combination of elements recited in the claims, we are not persuaded that merely providing a list of multiple teachings alleged as corresponding to claim elements is sufficient to establish that the claimed devices would have been obvious. See Unigene Laboratories, Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011). (“Obviousness requires more than a mere showing that the prior art includes separate references covering each separate limitation in a claim under examination.”). Moreover, similar to the situation in the rejections discussed above, we are not persuaded that the Examiner has explained with adequate specificity why the cited combination of Kothandaraman and Davis teaches or suggests a device having the functionality of delivering electrical stimulation to a treated region of tissue in a serial and directional fashion, controlled by a rotatable steering element, in the manner required by both claims 1 and 17. 11 Appeal 2016-007662 Application 14/200,702 In sum, for the reasons discussed, we reverse the Examiner’s rejection of claims 1—10 and 12—26 for obviousness over Kothandaraman and Davis. OBVIOUSNESS— KOTHANDARAMAN, DAVIS, AND KIM The Examiner’s rationale for rejecting claim 11 over Kothandaraman, Davis, and Kim is set forth in the Non-Final Action entered March 30, 2015. See Final Action 6 (stating “[s]ee office action of 3/30/15”). The Non-Final Action states that “Kim teaches using an ideal multipole, par. 59. To use such with the device of Kothandaraman and Davis would have been obvious since such would be a combination of prior art elements yielding a predictable result.” Non-Final Act. 3. As is evident, the Examiner does not identify teachings in Kim that remedy the deficiencies of Kothandaraman and Davis as to claim 1, discussed above, from which claim 11 depends. Appellants persuade us, therefore, that the Examiner has not shown that the combination of Kothandaraman, Davis, and Kim teaches or suggests a device having all of the elements required by claim 11. We, therefore, reverse the Examiner’s rejection of that claim over those references. SUMMARY For the reasons discussed, we reverse each of the Examiner’s rejections. REVERSED 12 Copy with citationCopy as parenthetical citation