CTNF 18/939,885 CTNF 95002 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. Information Disclosure Statement 2. The Information Disclosure Statement submitted on 07 November 2024 and 05 December 2024 have been considered by the Examiner. Claim Objections 3. Claim 11 is objected to because of the following informalities. Claim 11 contains a minor typographical error. - Claim 11, line 3: The Examiner suggests changing “the method comprising” to “the medical device comprising”. Appropriate correction is required. Claim Rejections - 35 USC § 103 07-20-aia AIA 4. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA 5. Claim s 1, 9-11, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Giftakis et al. (US 2018/0071530 A1) in view of Torgerson et al. (US 2020/0054879 A1) . Regarding claim 1, Giftakis teaches a method of providing deep brain stimulation (DBS) in a patient having one or more electrode leads implanted in their brain (the deep brain stimulation system 10 comprises leads 20A and 20B having respective sets of electrodes 24 and 26 [0003, 0031, 0113]), each of the one or more electrode leads comprising a plurality of electrodes (the leads 20A and 20B include respective sets of electrodes 24 and 26 [0031, 0113, FIG. 1, FIG. 3]. Specifically, the set of electrodes 24 consist of electrodes 24A-24D and the set of electrodes 26 consist of electrodes 26A-26D [0113, FIG. 3]), the method comprising: providing stimulation to the patient’s brain using a first one or more of the plurality of electrodes implanted in the patient’s brain (the leads 20A and 20B include respect sets of electrodes 24 and 26 that are implanted within the patient’s brain to provide deep brain stimulation [0031, 0113, FIG. 1, FIG. 3]. Specifically, the set of electrodes 24 consist of electrodes 24A-24D and the set of electrodes 26 consist of electrodes 26A-26D [0113, FIG. 3]), wherein the stimulation is configured to provide therapy to the patient ([0031, 0033]), upon an indication of a decline in therapeutic efficacy of the stimulation (the clinician may receive an indication from the programmer 14 which indicates that the patient has experienced a loss in therapy efficacy due to a potential system fault [0086, 0093-0094, 0190]): determining impedances at one or more of the plurality of electrodes, sensing evoked potentials evoked by the stimulation using one or more of the plurality of electrodes (as stated previously above, the clinician may receive an indication from the programmer 14 which indicates that the patient has experienced a loss in therapy efficacy due to a potential system fault [0086, 0093-0094, 0190]. In response, a system fault analysis is performed which consist of collecting impedance measurements and evoked response measurements (also referred to as “evoked potentials”) [0035, 0079, 0086, 0190]. Specifically, the impedance of the electrodes 24A-24D and 26A-26D are measured [0092, 0113]. Furthermore, the evoked responses are caused by the delivery of stimulation using the electrodes 24A-24D and 26A-26D [0059, 0101, 0113]). Giftakis does not explicitly teach using both the impedances and the evoked potentials to adjust the stimulation. The prior art by Torgerson is analogous to Giftakis, as they both teach deep brain stimulation devices ([0066]). Torgerson teaches using both the impedances and the evoked potentials to adjust the stimulation (the stimulation therapy parameters (e.g., amplitude) may be adjusted based on a detected change in electrode impedance and/or a detected change in the evoked compound action potential [0006, 0081, 0122]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the Giftakis method to consist of using both of the impedances and the evoked potentials to adjust stimulation, as taught by Torgerson. The advantage of such modification will allow for adjusting the stimulation amplitude in response to the impedance measurements and the evoked potential measurements. Specifically, the adjustment of stimulation amplitude will improve effectiveness of therapy while minimizing patient discomfort (see paragraphs [0006, 0040, 0081, 0122] by Torgerson). Regarding claim 9, Giftakis teaches using the impedances and evoked potentials to determine a cause of the decline in therapeutic efficacy (the impedance measurements and the evoked potential measurements are used to confirm the presence of a fault within the system [0079, 0106, 0131-0132, 0167]. Specifically, a fault in system (e.g., an electrical short) may cause a decline or degradation in the therapeutic efficacy [0086]). Regarding claim 10, Giftakis teaches comprising communicating an indication of the cause of the decline in therapeutic efficacy to a remote location via an internet connection (as stated previously in claim 9, a fault in system (e.g., an electrical short) may cause a decline or degradation in the therapeutic efficacy [0086]. Specifically, the IMD 16 may wirelessly communicate the fault data to a remote programming device 14 (e.g., computer, workstation, tablet, or cell phone) for further analysis by the clinician [0089, 0091, 0128]. Furthermore, the IMD 16 may communicate with the programming device 14 via a wireless connection based on 802.11 protocol (e.g., Wi-Fi) [0097]). Regarding claim 11, Giftakis teaches a medical device for providing deep brain stimulation (DBS) to a patient having one or more electrode leads implanted in their brain (the deep brain stimulation system 10 comprises leads 20A and 20B having respective sets of electrodes 24 and 26 [0003, 0031, 0113]), each of the one or more electrode leads comprising a plurality of electrodes (the leads 20A and 20B include respective sets of electrodes 24 and 26 [0031, 0113, FIG. 1, FIG. 3]. Specifically, the set of electrodes 24 consist of electrodes 24A-24D and the set of electrodes 26 consist of electrodes 26A-26D [0113, FIG. 3]), the medical device comprising: control circuitry (the processor 60 [0101, 0103, 0109]) configured to: cause stimulation circuitry of the medical device to provide stimulation to the patient’s brain using a first one or more of the plurality of electrodes implanted in the patient’s brain ([0109]), wherein the stimulation is configured to provide therapy to the patient ([0109]), upon an indication of a decline in therapeutic efficacy of the stimulation (the clinician may receive an indication from the programmer 14 which indicates that the patient has experienced a loss in therapy efficacy due to a potential system fault [0086, 0093-0094, 0190]): determine impedances at one or more of the plurality of electrodes, sense evoked potentials evoked by the stimulation using one or more of the plurality of electrodes (as stated previously above, the clinician may receive an indication from the programmer 14 which indicates that the patient has experienced a loss in therapy efficacy due to a potential system fault [0086, 0093-0094, 0190]. In response, a system fault analysis is performed which consist of collecting impedance measurements and evoked response measurements (also referred to as “evoked potentials”) [0035, 0079, 0086, 0190]. Specifically, the impedance of the electrodes 24A-24D and 26A-26D are measured [0092, 0113]. Furthermore, the evoked responses are caused by the delivery of stimulation using the electrodes 24A-24D and 26A-26D [0059, 0101, 0113]). Giftakis does not explicitly teach using both the impedances and the evoked potentials to adjust the stimulation. The prior art by Torgerson is analogous to Giftakis, as they both teach deep brain stimulation devices ([0066]). Torgerson teaches using both the impedances and the evoked potentials to adjust the stimulation (the stimulation therapy parameters (e.g., amplitude) may be adjusted based on a detected change in electrode impedance and/or a detected change in the evoked compound action potential [0006, 0081, 0122]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the Giftakis medical device to use both of the impedances and the evoked potentials to adjust stimulation, as taught by Torgerson. The advantage of such modification will allow for adjusting the stimulation amplitude in response to the impedance measurements and the evoked potential measurements. Specifically, the adjustment of stimulation amplitude will improve effectiveness of therapy while minimizing patient discomfort (see paragraphs [0006, 0040, 0081, 0122] by Torgerson). Regarding claim 19, Giftakis teaches wherein the control circuitry is configured to use the impedances and evoked potentials to determine a cause of the decline in therapeutic efficacy (the impedance measurements and the evoked potential measurements are used to confirm the presence of a fault within the system [0079, 0106, 0131-0132, 0167]. Specifically, a fault in system (e.g., an electrical short) may cause a decline or degradation in the therapeutic efficacy [0086]). Regarding claim 20, Giftakis teaches wherein the control circuitry is configured to communicate an indication of the cause of the decline in therapeutic efficacy to a remote location via an internet connection (as stated previously in claim 19, a fault in system (e.g., an electrical short) may cause a decline or degradation in the therapeutic efficacy [0086]. Specifically, the IMD 16 may wirelessly communicate the fault data to a remote programming device 14 (e.g., computer, workstation, tablet, or cell phone) for further analysis by the clinician [0089, 0091, 0128]. Furthermore, the IMD 16 may communicate with the programming device 14 via a wireless connection based on 802.11 protocol (e.g., Wi-Fi) [0097]) . 07-21-aia AIA 6. Claim s 2-8 and 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over Giftakis et al. in view of Torgerson et al., further in view of Bradley et al. (US 2006/0224222 A1) . Regarding claims 2 and 12, Giftakis in view of Torgerson suggests the method of claim 1 and the medical device of claim 11. Giftakis teaches comparing the impedances to baseline impedances to confirm a presence of fault in the system ([0167]). However, Giftakis and Torgerson do not explicitly teach wherein adjusting the stimulation comprises comparing the impedances to baseline impedances. The prior art by Bradley is analogous to Giftakis, as they both teach neurostimulation systems, such as deep brain stimulation systems (the neurostimulation system may positioned relative to the dura of the patient’s brain [0002, 0004, 0009]). Bradley teaches wherein adjusting the stimulation comprises comparing the impedances to baseline impedances (the system will compare the baseline impedance measurement and the subsequent impedance measurement to determine if the lead has migrated [0009, 0048]. If the lead has migrated, the system may be manually or automatically reprogrammed by adjusting the delivery of the stimulation pulses to one or more selected electrodes that are still in contact with the target tissue [0048, 0067-0068]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the method and the medical device suggested by Giftakis in view of Torgerson to compare the impedances to baseline impedances for adjusting the stimulation, as taught by Bradley. The advantage of such modification will allow for detecting lead migration and further adjusting the delivery of the stimulation pulses to one or more selected electrodes that are still in contact with the target tissue (see paragraphs [0048, 0067-0068]). Regarding claims 3 and 13, Giftakis teaches wherein the baseline impedances are impedances determined during implantation of the electrode lead into the patient’s brain (the baseline impedance data may be measured during the implantation of leads 20A and 20B into the brain [0031, 0171]. Specifically, the baseline impedance data of the electrodes 24 and 26 is measured immediately during implantation when it is known that a fault does not exist within the system [0092, 0171]. As stated previously in claims 1 and 11, the leads 20A and 20B include the respective sets of electrodes 24 and 26 [0031, 0092, FIG. 1, FIG. 3]). Regarding claims 4 and 14, Giftakis teaches wherein the baseline impedances are impedances determined during a fitting procedure (the baseline impedance data may be measured during the implantation or fitting of the leads 20A and 20B into the brain [0031, 0171, FIG. 1, FIG. 3]. Specifically, the baseline impedance data of the electrodes 24 and 26 is measured immediately during implantation or fitting procedure when it is known that a fault does not exist within the system [0092, 0171, FIG. 1, FIG. 3]. As stated previously in claims 1 and 11, the leads 20A and 20B include the respective sets of electrodes 24 and 26 [0031, 0092, FIG. 1, FIG. 3]). Regarding claims 5 and 15, Giftakis in view of Torgerson suggests the method of claim 1 and the medical device of claim 11. Giftakis teaches comparing the sensed evoked potentials to a baseline evoked potential confirm a presence of fault in the system ([0106, 0131-0132]). Giftakis and Torgerson do not explicitly teach wherein adjusting the stimulation comprises comparing the sensed evoked potentials to a baseline evoked potential. However, Bradley teaches wherein adjusting the stimulation comprises comparing the sensed evoked potentials to a baseline evoked potential (the system will compare the baseline evoked potential measurements and subsequent evoked potential measurements to determine if the lead has migrated [0059-0060]. If the lead has migrated, the system may be manually or automatically reprogrammed by adjusting the delivery of the stimulation pulses to one or more selected electrodes that are still in contact with the target tissue [0059-0060, 0067-0068]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the method and the medical device suggested by Giftakis in view of Torgerson to compare the sensed evoked potentials to a baseline evoked potential for adjusting the stimulation, as taught by Bradley. The advantage of such modification will allow for detecting lead migration and further adjusting the delivery of the stimulation pulses to one or more selected electrodes that are still in contact with the target tissue (see paragraphs [0059-0060, 0067-0068]). Regarding claims 6 and 16, Giftakis in view of Torgerson and Bradley suggests the method of claim 5 and the medical device of claim 15. Bradley teaches wherein the comparing the sensed evoked potentials to a baseline evoked potential comprises determining one or more features of the sensed evoked potentials and comparing the determined features to corresponding features of the baseline evoked potentials (the system is configured to determine the positions of the lead from the baseline evoked potential measurements and the subsequent evoked potential measurements [0060, 0062-0063]. Specifically, the positions of the lead are compared to determine if the lead has migrated or shifted [0060, 0062-0063, FIGS. 8A-8B]. For example, figures 8A-8B illustrates the lead 102 shifting or migrating from the original baseline position [0063, FIGS. 8A-8B]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the method and the medical device suggested by Giftakis in view of Torgerson and Bradley to compare one or more features of the sensed evoked potentials to corresponding features of the baseline evoked potentials, as further taught by Bradley. The advantage of such modification will allow for determining if the lead has shifted or migrated from the original baseline position (see paragraphs [0060, 0062-0063] by Bradley). Regarding claims 7 and 17, Giftakis teaches wherein the baseline evoked potentials are evoked potentials determined during implantation of the electrode lead into the patient’s brain (the baseline evoked potentials may be measured during the implantation of leads 20A and 20B into the brain [0031, 0131-0132]. Specifically, the baseline evoked potentials are measured immediately during implantation when it is known that a fault does not exist within the system [0131-0132, claim 11]. As stated previously in claims 1 and 11, the leads 20A and 20B include the respective sets of electrodes 24 and 26 [0031, FIG. 1, FIG. 3]). Regarding claims 8 and 18, Giftakis teaches wherein the baseline evoked potentials are evoked potentials determined during a fitting procedure (the baseline evoked potentials may be measured during the implantation or fitting of leads 20A and 20B into the brain [0031, 0131-0132]. Specifically, the baseline evoked potentials are measured immediately during implantation or fitting procedure when it is known that a fault does not exist within the system [0131-0132, claim 11]. As stated previously in claims 1 and 11, the leads 20A and 20B include the respective sets of electrodes 24 and 26 [0031, FIG. 1, FIG. 3]). Statement on Communication via Internet 7. 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If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792 Application/Control Number: 18/939,885 Page 2 Art Unit: 3792 Application/Control Number: 18/939,885 Page 3 Art Unit: 3792 Application/Control Number: 18/939,885 Page 4 Art Unit: 3792 Application/Control Number: 18/939,885 Page 5 Art Unit: 3792 Application/Control Number: 18/939,885 Page 6 Art Unit: 3792 Application/Control Number: 18/939,885 Page 7 Art Unit: 3792 Application/Control Number: 18/939,885 Page 8 Art Unit: 3792 Application/Control Number: 18/939,885 Page 9 Art Unit: 3792 Application/Control Number: 18/939,885 Page 10 Art Unit: 3792 Application/Control Number: 18/939,885 Page 11 Art Unit: 3792 Application/Control Number: 18/939,885 Page 12 Art Unit: 3792 Application/Control Number: 18/939,885 Page 13 Art Unit: 3792 Application/Control Number: 18/939,885 Page 14 Art Unit: 3792 Application/Control Number: 18/939,885 Page 15 Art Unit: 3792
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