CTNF 18/915,211 CTNF 86805 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Objections 07-29-01 AIA Claim 20 is objected to because of the following informalities: line 2 should be amended to recite, “a deep brain stimulator (DBS)” and line 6 should be amended to recite, “a peripheral nerve stimulator (PNS)” to remain consistency with the specification ([0003]) . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claims 2, 11 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 2 recites, “at least one wearable sensor… a status of the task ” and “at least one sensor attached… perform the task ”. The emphasized limitation is indefinite because while claim 2 introduces “a task” in line 2, the claim recites limitations in its alternatives and what is recited in line 2 in one alternative does not carry over to other alternatives. Claim 11 recites, “determining timing from available timing selections for sending the signal based on the event and a target of the delivered neuromodulation”. This limitation is indefinite because it is unclear if there is one determined timing for a target of the delivered neuromodulation, this determined timing being sent in the signal that is based on the event; or if there are two separate determined timings- one timing for sending the signal based on the event and one timing for a target of the delivered neuromodulation. Claim 19 recites, “at least one wearable sensor… a status of the task ” and “at least one sensor attached… perform the task ”. The emphasized limitation is indefinite because while claim 19 introduces “a task” in line 3, the claim recites limitations in its alternatives and what is recited in line 3 in one alternative does not carry over to other alternatives. Claim Rejections - 35 USC § 102 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. 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15-aia AIA Claim(s) 17, 19-20 is/are rejected under 35 U.S.C. 102 (a)(1) and/or (a)(2) as being anticipated by Giftakis et al. (US 2009/0264967) . Regarding claim 17, Giftakis et al. discloses a system (fig. 1) comprising: a training system configured for training or improving a nervous system by responding to an event (fig. 7b), wherein the training system includes: a neuromodulator 22 configured for delivering neuromodulation 80 to a nervous system, an event detector 26 (fig. 1) configured for detecting the event ([0120]; “Either sensing module 26 or processor 70 may tune the physiological signal to a particular frequency band that is indicative of the patient's mood state” [0226]) and sending a signal to a neuromodulator when the event is detected 126 ([0146-0147]), a timer configured for timing a predefined time period after receiving the signal ([0147]), wherein the neuromodulator is configured to change neuromodulation to the nervous system at an end of the time period 128 ([0148]). Regarding claim 19, Giftakis et al. discloses wherein the event detector includes: at least one wearable sensor 26 configured to sense a parameter indicative of a status of a task ([0050], [0131], [0240]). Regarding claim 20, Giftakis et al. discloses a deep brain stimulator configured for delivering neuromodulation to a brain ([0050]) . Claim Rejections - 35 USC § 103 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. 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. 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 1-5, 7-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giftakis et al. (US 2009/0264967) as evidenced by Luczak et al. (US 2016/0022168) . Regarding claims 1 and 16, Giftakis et al. discloses a method and a non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to perform a method (fig. 7b), comprising: training or improving a nervous system by responding to an event, wherein the nervous system is trained by detecting the event using at least one event detection criterion ([0120]), sending a signal to a neuromodulator when the event is detected 122, 126 ([0146-0147]), waiting a predefined time period after receiving the signal ([0147]), and then at the end of the predefined time period changing neuromodulation delivered by the neuromodulator to the nervous system 128 ([0148]). Giftakis et al. is concerned with improving the mood of a patient ([0179-0180]) and discloses wherein the nervous system has plasticity for learning to respond to the event, and changed neuromodulation at the end of the time period promotes learning by the nervous system to respond to the event by disclosing this method is directed to a programming session where therapy programs providing efficacious therapy to the patient are trialed and tested ([0100]) to affect the mood of the patient ([0010], [0104], [0120]), interpreted as suggesting the nervous system has plasticity for learning to respond to detected events (undesired moods), and changed neuromodulation promotes learning by the nervous system to respond to the event ([0011], [0202]) by having the mood improve through efficacious therapy programs. Additionally, Luczak et al. teaches it is known in the art that when stimulating an awake brain state, brain plasticity and learning is promoted and may help promote brain recovery from neurological diseases or other traumatic brain trauma ([0008]), example neurological diseases including mood disorders or depressive episodes ([0064]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that by providing electrical stimulation targeted toward a patient in an awake brain state with the intended result of improving the mood of the patient, Giftakis et al. also promotes learning by the nervous system to respond to the event as evidenced by Luczak et al. as this is a known results of delivering electrical stimulation. Regarding claim 2, Giftakis et al. discloses wherein detecting the event includes at least one wearable sensor 26 configured to sense a parameter indicative of a status of a task ([0050], [0131], [0240]). Regarding claim 3, Giftakis et al. discloses wherein detecting the event includes receiving user input indicative of the event ([0073], [0084]). Regarding claim 4, Giftakis et al. discloses wherein the detecting the event includes detecting a state indicative of the event ([0120]). Regarding claim 5, Giftakis et al. discloses wherein the detecting the event includes detecting two or more conditions and using the detected two or more conditions to detect the state ([0172]). Regarding claim 7, Giftakis et al. discloses wherein the event includes a trigger event for implementing a command sequence of one or more preset commands (fig. 7b), the method further comprising implementing the command sequence in response to the detected event 126. Regarding claim 8, Giftakis et al. discloses wherein sending the signal to the neuromodulator includes sending the signal from one process within the neuromodulator used to detect the event 122, 126 to another process within the neuromodulator used to change the neuromodulation 128 (fig. 7b). Regarding claim 9, Giftakis et al. discloses wherein sending the signal includes wirelessly sending the signal to the neuromodulator 22 from another device 26 (fig. 1). Regarding claim 10, Giftakis et al. discloses wherein the signal sent to the neuromodulation includes information used by the neuromodulator to determine information used to change the neuromodulation ([0146-0148]). Regarding claim 11, Giftakis et al. discloses determining timing from available timing selections for sending the signal based on the event and a target of the delivered neuromodulation, wherein the available timing selections include two or more of: 1’s of milliseconds, 10’s of milliseconds, 100’s of milliseconds, 1’s of seconds, 10’s of seconds, minutes or hours (fig. 19; [0054], [0085], [0091], [0105]). Regarding claim 12, Giftakis et al. discloses wherein changing the neuromodulation includes turning stimulation on or off; changing at least one stimulation parameter value ([0111], [0148]). Regarding claim 13, Giftakis et al. is concerned with improving the mood of a patient ([0179-0180]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that with the teachings of Luczak et al., the training or improving the nervous system to respond to the event would include training or improving a brain of the patient to emphasize neutral feeling. Regarding claim 14, Giftakis et al. discloses evaluating the training or improving by monitoring an observed response of the nervous system to the event and comparing the observed response to a desired response (“baseline state” [0017]); and implementing an optimizer algorithm to improve the training of the nervous system to cause the observed response to the event to be closer to the desired response (“evaluate the therapy program… a stimulation period characteristic may be determined for each of the therapy programs and may be used to compare the efficacy of the therapy programs” [0113]; “processor 70 may control the application of a stimulus to actively drive of the physiological signal to a baseline state (124). The physiological signal may be actively driven to the baseline state using any technique that increases the speed at which the physiological signal returns to the baseline state compared to the passive return to the baseline state, i.e., without substantial interference from an external stimulus” [0149]). Regarding claim 15, Giftakis et al. discloses wherein the implementing the optimizer algorithm includes: adjusting a set of neuromodulation parameters (“processor 70 may control the application of a stimulus to actively drive of the physiological signal to a baseline state (124). The physiological signal may be actively driven to the baseline state using any technique that increases the speed at which the physiological signal returns to the baseline state compared to the passive return to the baseline state, i.e., without substantial interference from an external stimulus” [0149]) . 07-21-aia AIA Claim (s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giftakis et al. (US 2009/0264967) as evidenced by Luczak et al. (US 2016/0022168) and further in view of Sison et al. (US 2022/0370810) . Regarding claim 6, Giftakis et al. does not expressly disclose wherein the detecting the event includes detecting a stimulation channel activity as a surrogate for the event. Sison et al. teaches to it is known in the art to consider a detection of a patient event to be equivalent to detection of stimulation therapy being delivered ([0010]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Giftakis et al. to detect a stimulation channel activity as a surrogate for the event as Sison et al. teaches it is known in the art to consider these two types of events as equivalent, the results of such a modification being reasonably predictable . 07-21-aia AIA Claim (s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giftakis et al. (US 2009/0264967) in view of Olsen et al. (US 2011/0257509) . Regarding claim 18, Giftakis et al. does not expressly disclose wherein the neuromodulator and the event detector have synched clocks for use to provide precise timing from a time when the event is detected to a time when the neuromodulation is changed. Olsen et al. teaches it is known in the art for two devices communicating frequently with each other in a therapy delivery system to have synched clocks ([0119]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Giftakis et al. to ensure that the neuromodulator and the event detector have synched clocks in order to ensure timing events within the system occur at exacting times during event sensing and therapy delivery, the results of such a modification being reasonably predictable. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ERICA S LEE/Primary Examiner, Art Unit 3796 Application/Control Number: 18/915,211 Page 2 Art Unit: 3796 Application/Control Number: 18/915,211 Page 3 Art Unit: 3796 Application/Control Number: 18/915,211 Page 4 Art Unit: 3796 Application/Control Number: 18/915,211 Page 5 Art Unit: 3796 Application/Control Number: 18/915,211 Page 6 Art Unit: 3796 Application/Control Number: 18/915,211 Page 7 Art Unit: 3796 Application/Control Number: 18/915,211 Page 8 Art Unit: 3796 Application/Control Number: 18/915,211 Page 9 Art Unit: 3796 Application/Control Number: 18/915,211 Page 10 Art Unit: 3796
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