CTNF 18/904,394 CTNF 97721 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 Rejections - 35 USC § 101 07-04-01 AIA 07-04 2. 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. 3. Claims 1-20 are rejected under 35 U.S.C 101 because the claimed invention is directed to an abstract idea (i.e. mental process) without significantly more. Step 1: The claimed invention in claims 1-20 are directed to statutory subject matter as the claims recite a method (i.e. a process), a non-transitory computer-readable medium, and a system (i.e. a machine). Thus, they are directed to statutory categories of invention (See MPEP 2106.03). Step 2A – (Prong 1): Independent claim 1 (and similarly independent claims 17 and 20) recites a judicial exception by reciting the limitations of “delivering electrostimulation to a neural target of a patient in accordance with a stimulation setting…; sensing evoked responses (ERs) to the electrostimulation…; determining at least one parameter associated with the electrostimulation or an affect of the electrostimulation to the neural target; and associating at least one feature of a first set of the sensed ERs with the at least one parameter to classify the at least one parameter”. These limitations, as drafted, is a process that, under its broadest reasonable interpretation covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) or by a person using a pen and paper. For example, these limitations are nothing more than a clinician receiving a print-out of evoked responses data of a subject from a therapy session. The clinician can then use the print-out of evoked responses data to determine at least one parameter associated with the electrostimulation or determine an affect of the electrostimulation had to the neural target. Finally, the clinician can associate at least one feature of a first set of the sensed evoked responses from the print-out with the at least one parameter in order to classify the at least one parameter. Therefore, the claims are directed to a judicial exception (see MPEP 2106.04(a)(2)). Step 2A – (Prong 2): Regarding claim 1 (and similarly claims 17 and 20), the judicial exception is not integrated into a practical application. Claim 1 (and similarly claims 17 and 20) recites the steps of “delivering electrostimulation to a neural target of a patient in accordance with a stimulation setting via a stimulating electrode” and “sensing evoked responses (ERs) to the electrostimulation using at least one sensing electrode” which amounts to nothing more than pre-solution activity of data gathering. In addition, claim 17 recites a processor and claim 20 recites a controller at a high-level of generality and amounts to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of delivering electrostimulation to a neural target of a patient in accordance with a stimulation setting via a stimulating electrode followed by sensing evoked responses (ERs) to the electrostimulation using at least one sensing electrode is nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, applying electrical stimulation to a neural target via a stimulating electrode/electrostimulator and measuring/sensing evoked responses to the electrical stimulation using a sensing electrode/sensing circuit is well-understood, routine, and conventional as shown in Gribetz et al. (US Pub.: 2020/0023189 A1), Bouton et al. (US Pub.: 2018/0178013), and Cardinal et al. (US Pub.: 2010/0268311 A1). 4. Regarding dependent claims 2-16 and 18-19, the limitations of claim 2-16 and 18-19 further define the limitations already indicated as being directed to the abstract idea. While the dependent claims further define the abstract idea, it does not set forth any additional elements that integrate the claims into a practical application or add any additional elements that amount to significantly more than the abstract idea. Thus, when considered as a whole and in combination, claims 1-20 are directed to an abstracted idea and are therefore rejected. 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 Claim s 1-20 are rejected under 35 U.S.C. 102( a)(1) and 102(a)(2 ) as being anticipated by Moffitt et al. (US Pub.: 2022/0040486 A1) . Regarding claim 1, Moffitt discloses a method, comprising: delivering electrostimulation to a neural target of a patient in accordance with a stimulation setting via a stimulating electrode (e.g. paragraph 0078 – the electrodes of lead 902 perform electrostimulation) ; sensing evoked responses (ERs) to the electrostimulation using at least one sensing electrode (e.g. paragraph 0078 – the electrodes of lead 902 perform both electrical stimulation and sense evoked responses; paragraph 0100, – sensing/feedback algorithm of the IPG analyzes the evoked resonant neural activity (ERNA) response) ; determining at least one parameter associated with the electrostimulation or an affect of the electrostimulation to the neural target (e.g. paragraph 0100, – IPG extracts one or more ERNA parameters from the ERNA response) ; and associating at least one feature of a first set of the sensed ERs with the at least one parameter to classify the at least one parameter (e.g. paragraphs 0100-0101, – the ERNA algorithm determines if the ERNA parameter(s) are commensurate with a desirable patient state) . Regarding claim 2, Moffitt discloses the method of claim 1 as discussed above, and Moffitt further teaches wherein associating the at least one feature with the at least one parameter comprises determining a relative or absolute state of the patient based on the at least one feature (e.g. paragraph 0094) . Regarding claim 3, Moffitt discloses the method of claim 1 as discussed above, and Moffitt further teaches comprising determining whether to perform an action based on the association of the at least one feature with the at least one parameter (e.g. paragraph 0100) . Regarding claim 4, Moffitt discloses the method of claim 1 as discussed above, and Moffitt further teaches wherein the at least one feature comprises at least one of a frequency of the sensed ERs, an amplitude of the sensed ERs, an area under curve, peak to peak differences, or a latency of one or more peaks (e.g. paragraph 0099, – amplitude and frequency of the sensed ERNA responses) . Regarding claim 5, Moffitt discloses the method of claim 1 as discussed above, and Moffitt further teaches comprising determining a state of the patient based on whether a value for the at least one feature is within a defined range of values (e.g. paragraphs 0083, 0099) . Regarding claim 6, Moffitt discloses the method of claim 5 as discussed above, and Moffitt further teaches wherein: the state is determined to be a high state in response to the value being within a first threshold range of values (e.g. paragraph 0083) ; the state is determined to be a low state in response to the value being within a second threshold range of values (e.g. paragraph 0083) ; the state is determined to be an optimal state in response to the value being associated with a particular patient outcome (e.g. paragraph 0084) ; and the state is determined to be an average state in response to the value being within a third threshold range associated with a most common range of the at least one feature for a set period of time (e.g. paragraph 0084) . Regarding claim 7, Moffitt discloses the method of claim 6 as discussed above, and Moffitt further teaches wherein the high state, the low state, the optimal state, and the average state are each patient specific (e.g. paragraph 0101) . Regarding claim 8, Moffitt discloses the method of claim 1 as discussed above, and Moffitt further teaches comprising: comparing the at least one feature of the sensed ERs to a medication schedule associated with the patient (e.g. paragraphs 0086, 0101) ; and determining a medication parameter of the patient (e.g. paragraphs 0086, 0101) ; wherein the medication parameter comprises one of: a shift in a medication schedule of the patient; a high medication state of the patient; or a decrease in a medication state of the patient (e.g. paragraph 0101 – decrease in medication state) . Regarding claim 9, Moffitt discloses the method of claim 1 as discussed above, and Moffitt further teaches comprising estimating a medication state of the patient by using a particular feature of the sensed ERs and a medication schedule of the patient (e.g. paragraph 0101) . Regarding claim 10, Moffitt discloses the method of claim 9 as discussed above, and Moffitt further teaches comprising: determining when a decrease in medication in the patient exceeds a particular medication threshold based on the association (e.g. paragraph 0101) ; and determining when to adjust a medication schedule based on the estimated medication state and a previously determined medication schedule (e.g. paragraph 0101) . Regarding claim 11, Moffitt discloses the method of claim 1 as discussed above, and Moffitt further teaches wherein determining the at least one parameter of the patient comprises determining when a medication schedule has shifted (e.g. paragraph 0101) . Regarding claim 12, Moffitt discloses the method of claim 1 as discussed above, and Moffitt further teaches wherein determining the at least one parameter of the patient comprises determining an average pattern of response to medication administered to the patient (e.g. paragraph 0101) . Regarding claim 13, Moffitt discloses the method of claim 1 as discussed above, and Moffitt further teaches comprising: determining a state of the patient based on the association (e.g. paragraph 0101) ; comparing the determined state of the patient to an expected state of the patient based on a time of medication dose taken (e.g. paragraph 0101) ; and in response to the determined state and the expected state being different, determining that an administration of the medication is being affected by an additional parameter (e.g. paragraphs 0101-0102) . Regarding claim 14, Moffitt discloses the method of claim 1 as discussed above, and Moffitt further teaches wherein: the association indicates a disease severity of the patient (e.g. paragraphs 0010, 0099) ; the method comprises: in response to the sensed ERs stabilizing faster, determining that the disease severity is low (e.g. paragraph 0099) ; and in response to the sensed ERs stabilizing slower, determining that the disease severity is high (e.g. paragraph 0099) . Regarding claim 15, Moffitt discloses the method of claim 1 as discussed above, and Moffitt further teaches wherein: the association indicates an amount of brain fatigue of the patient; the method comprises (e.g. paragraph 0099) : in response to the sensed ERs stabilizing faster, determining that the amount of brain fatigue is low (e.g. paragraph 0099) ; and in response to the sensed ERs stabilizing slower, determining that the amount of brain fatigue is high (e.g. paragraph 0099) . Regarding claim 16, Moffitt discloses the method of claim 15 as discussed above, and Moffitt further teaches comprising: collecting a first set of sensed ERs toward an earlier portion of a day (e.g. paragraphs 0099, 0101) ; collecting a second set of sensed ERs toward a later portion of a day (e.g. paragraphs 0099, 0101) ; comparing the first set to the second set (e.g. paragraphs 0099-0100) ; in response to the first set stabilizing faster and the second set stabilizing slower, determining that the amount of brain fatigue is high (e.g. paragraph 0099) ; and in response to the first set stabilizing slower and the second set stabilizing slower, determining that an amount of brain fatigue is low and a disease severity is high (e.g. paragraph 0099) . Regarding claim 17, Moffitt discloses a non-transitory computer-readable medium storing instructions executable by a processor (e.g. paragraph 0016) to: deliver electrostimulation to a neural target of a patient, wherein the electrostimulation is delivered to the neural target of the patient via a medical-device system that comprises an electrostimulator (e.g. Fig. 6 – system 900; paragraph 0078 – the electrodes of lead 902 perform electrostimulation) ; sense evoked responses (ERs) to the electrostimulation using sensing electrodes connected to a sensing circuit (e.g. paragraph 0078 – the electrodes of lead 902 perform both electrical stimulation and sense evoked responses; paragraph 0100, – sensing/feedback algorithm of the IPG analyzes the evoked resonant neural activity (ERNA) response) ; determine at least one feature for a first set of the sensed ERs (e.g. paragraph 0100, – IPG extracts one or more ERNA parameters from the ERNA response) ; determine a state of the patient based on the at least one feature (e.g. paragraph 0094) ; and determine whether to perform an action based on the state of the patient (e.g. paragraph 0100) . Regarding claim 18, Moffitt discloses the non-transitory computer-readable medium of claim 17 as discussed above, and Moffitt further teaches wherein the instructions are executable by the processor to notify a physician to perform an assessment in response to the determined state being a state to use for performing the assessment (e.g. paragraphs 0067, 0100) . Regarding claim 19, Moffitt discloses the non-transitory computer-readable medium of claim 17 as discussed above, and Moffitt further teaches wherein the instructions are executable by the processor to: in response to the determined state indicating an affect on the patient from medication is decreasing, adjusting electrostimulation to compensate for the affect (e.g. paragraphs 0100-0101) ; or in response to the determined state indicating a reduced response to therapy, setting a limit on a rate of adjustment of the electrostimulation to avoid overtreatment (e.g. paragraphs 0100-0101) . Regarding claim 20, Moffitt discloses a system, comprising: an electrostimulator configured to provide electrostimulation to a neural target of a patient (e.g. Fig. 9 – evoked response stimulation and recording programmer (ER) 906 and lead 902; paragraph 0078 – the electrodes of lead 902 perform electrostimulation) ; a sensing circuit configured to sense evoked responses (ERs) to the electrostimulation (e.g. Fig. 6 – sensing circuitry 115; paragraphs 0064, 0078 – the electrodes of lead 902 perform both electrical stimulation and sense evoked responses; paragraph 0100, – sensing/feedback algorithm of the IPG analyzes the evoked resonant neural activity (ERNA) response) ; and a controller circuit operably connected to the electrostimulator and the sensing circuit (e.g. paragraph 0078 – control circuitry) , the controller circuit configured to: determine at least one parameter associated with the electrostimulation or an affect of the electrostimulation to the neural target (e.g. paragraph 0100, – IPG extracts one or more ERNA parameters from the ERNA response) ; and associate at least one feature of a first set of the sensed ERs with the at least one parameter to classify the at least one parameter (e.g. paragraphs 0100-0101, – the ERNA algorithm determines if the ERNA parameter(s) are commensurate with a desirable patient state) . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm. 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, Benjamin Klein can be reached at 571-270-5213. 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /D.T./Examiner, Art Unit 3792 /Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792 Application/Control Number: 18/904,394 Page 2 Art Unit: 3792 Application/Control Number: 18/904,394 Page 3 Art Unit: 3792 Application/Control Number: 18/904,394 Page 4 Art Unit: 3792 Application/Control Number: 18/904,394 Page 5 Art Unit: 3792 Application/Control Number: 18/904,394 Page 6 Art Unit: 3792 Application/Control Number: 18/904,394 Page 7 Art Unit: 3792 Application/Control Number: 18/904,394 Page 8 Art Unit: 3792 Application/Control Number: 18/904,394 Page 9 Art Unit: 3792 Application/Control Number: 18/904,394 Page 10 Art Unit: 3792 Application/Control Number: 18/904,394 Page 11 Art Unit: 3792
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