CTNF 18/774,100 CTNF 101401 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 Rejections - 35 USC § 101 07-04-01 AIA 07-04 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. Claims 1-19 are rejected under 35 U.S.C 101 because the claimed invention is directed to non-statutory subject matter of abstract ideas under the mental processes grouping, without significantly more. The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception. Step (1) The claimed invention in claims 1-19 are directed to a method, and thus, the claims all fall under one of the four patent eligible categories. Step (2a) Prong 1 (Judicial Exception) Regarding claims 1-19, the recited steps are directed towards mental processes of performing concepts in a human mind or by a human using a pen and paper (See MPEP 2106.04(a)(2) subsection (III)). Independent claim 1 recites: A method of determining one or more stimulation parameters for a patient…, the method comprising: (iii) classifying each of the recorded electrical signals according to one or more classification criteria to determine if each of the recorded electrical signals contain evoked resonant neural activity (ERNA), (iv) for each electrical signal containing ERNA, extracting one or more features of the ERNA…, and (vi) using the extracted features to determine the one or more stimulation parameters. Under the broadest reasonable interpretation, these limitations classifying electrical signals to determine if they contain ERNA, extracting features of the ERNA if present, and determining stimulation parameters based on the extracted features. These limitations are processes that, as drafted, cover that which can be wholly performed in a person’s mind via a series of mental observations and judgements. In particular, a person can review a dataset representing recorded electrical signals, determine if they contain ERNA and features of the ERNA, and determine stimulation based on the features. These are data gathering and processing steps (classify, determine, extract) that reflect mental processes. Accordingly, claim 1 is directed to a judicial exception including one or more abstract ideas, specifically mental processes. Independent claim 1 recites the corresponding apparatus associated with the method, including electrode leads/electrodes. Under the broadest reasonable interpretation, these claims also recite a judicial exception including one or more abstract ideas under the mental processes bucket. The additional limitations in claims 2-19 (electrode configuration types, graphing/modeling techniques, signal analysis techniques) comprise additional abstract ideas and/or further limit the abstract ideas of claim 1. Step (2a) Prong 2 (Integration into a Practical Application) This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d). For claims 1-19, the judicial exception is not integrated into a practical application. Regarding claim 1, the additional elements of electrode leads/electrodes amount to recitation of a generic electrode. Under the broadest reasonable interpretation, these elements are nothing more than the pre-solution activity of mere data gathering using generic components. Step (2b) (Inventive Concept) The claims also 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 judicial exception into a practical application, the additional elements of electrode leads/electrodes in the field of deep brain stimulation are well-understood, routine and conventional activities previously known in the industry as indicated in the following references: Wu et al. (US Pre-Grant Publication 2012/0271375) teaches electrode leads (leads 520A, 520B, Fig. 6) and electrodes (electrodes 524A-D, 526A-D, Fig. 6) for stimulating/recording signals ([0097-0098]). Esteller et al. (US Pre-Grant Publication 2019/0099602) teaches electrode leads (lead 14, Fig. 8A) and electrodes (electrodes E3-E8, Fig. 8A) for stimulating/recording signals ([0043]). Accordingly, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Claims 1-19 are thus rejected under 35 USC 101 for reciting patent-ineligible subject matter- abstract ideas. 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. 07-15 AIA Claim s 1-2, 4, 7-19 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Wu et al. (US Pre-Grant Publication 2012/0271375), hereinafter ‘Wu’ . Regarding claim 1, Wu teaches a method of determining one or more stimulation parameters (abstract, setting stimulation frequency parameter) for a patient having one or more electrode leads in the patient’s brain, each electrode lead comprising a plurality of electrodes (Fig. 5, electrodes 524, 526), the method comprising: (i) providing stimulation using one or more of the electrodes as stimulating electrodes ([0068], one or more electrodes 524, 526 deliver stimulation, [0097], sets of electrodes on leads 520A, 520B receive stimulation signals from stimulation generator 542, Fig. 6), (ii) recording electrical signals at a plurality of electrodes as recording electrodes ([0068], one or more electrodes 524, 526 sense bioelectrical brain signals, [0098], sets of electrodes on leads 520A, 520B sense brain signals via sensing module 544, Fig. 6), (iii) classifying each of the recorded electrical signals according to one or more classification criteria to determine if each of the recorded electrical signals contain evoked resonant neural activity (ERNA) ([0101-0103], processor 540 determines/recognizes bioelectrical resonance response based on characteristics), (iv) for each electrical signal containing ERNA, extracting one or more features of the ERNA ([0103], processor 540 compares characteristics of sensed signals including amplitude, frequency, power level), (v) iteratively repeating steps (i) – (iv) with a different one or more electrodes as the stimulating electrodes with each iteration (Fig. 4, change a stimulation parameter 440, [0054], changing electrode combination used in stimulation), and (vi) using the extracted features to determine the one or more stimulation parameters ([0059], select or change electrode combination based on bioelectric resonance response). Regarding claim 2, Wu teaches the method of claim 1, further comprising: wherein the one or more stimulation parameters comprise an electrode configuration for a multi-electrode stimulation paradigm ([0054], changing electrode combination used in stimulation). Regarding claim 4, Wu teaches the method of claim 1, further comprising: wherein determining the one or more stimulation parameters comprises determining a neural coupling between two or more of the electrodes and selecting the two or more of the electrodes to provide therapeutic stimulation based on the neural coupling ([0063], providing stimulation to an area of the brain associated with the target area). Regarding claim 7, Wu teaches the method of claim 1, further comprising: wherein determining if each of the recorded electrical signals contain ERNA comprises determining if each of the electrical signal comprises peaks with a prominence exceeding a predetermined threshold value ([0071], amplitude spike). Regarding claim 8, Wu teaches the method of claim 1, further comprising: wherein determining if each of the recorded electrical signals contain ERNA comprises determining if each of the electrical signal comprises a number of peaks meeting or exceeding a predetermined threshold number of peaks within a predetermined time window ([0031-0032], resonance response includes a significant increase in bioelectrical oscillation, [0055], number of peaks detected in monitoring 470 may be compared to a threshold). Regarding claim 9, Wu teaches the method of claim 1, further comprising: wherein determining if each of the recorded electrical signals contain ERNA comprises determining if each of the electrical signal comprises one or more peaks with amplitudes meeting or exceeding a predetermined amplitude threshold ([0032], increase in amplitude indicates increased oscillatory content and potentially a resonant response, [0071], amplitude is a percentage of the maximum amplitude value). Regarding claim 10, Wu teaches the method of claim 1, further comprising: wherein determining if each of the recorded electrical signals contain ERNA comprises determining if each of the electrical signal comprises one or more components within a range of predetermined frequencies and exceeding a predetermined threshold ([0055], number of peaks detected in monitoring 470 may be compared to a threshold). Regarding claim 11, Wu teaches the method of claim 1, further comprising: wherein determining if each of the recorded electrical signals contain ERNA comprises converting the recorded electrical signal from a time domain signal to a frequency domain signal ([0029], signal received during monitoring 120 can be converted to the frequency domain). Regarding claim 12, Wu teaches the method of claim 11, further comprising: wherein determining if each of the recorded electrical signals contain ERNA further comprises determining if a relative band power in a predetermined frequency range of the frequency domain signal meets or exceeds a predetermined threshold ([0035], highest relative band power indicates resonance response). Regarding claim 13, Wu teaches the method of claim 1, further comprising: wherein determining if each of the recorded electrical signals contain ERNA further comprises determining a confidence value that ERNA is present ([0033], requirements to ensure only meaningful differences indicate a bioelectrical resonance response, [0055-0057], monitoring therapy efficacy parameter, Fig. 4) and rejecting the recorded electrical signal unless the confidence value meets or exceeds a predetermined threshold ([0056], parameter threshold 480 assesses whether the resonant bioelectrical response is present or not, Fig. 4, yes/no response). Regarding claim 14, Wu teaches the method of claim 1, further comprising: wherein the one or more features of the ERNA comprises one or more of a band power, a peak power, a full width at half max (FWHM), or a decay constant ([0035], highest relative band power indicates resonance response, [0047], change in power level of frequency spectrum). Regarding claim 15, Wu teaches the method of claim 1, further comprising: wherein the one or more features of the ERNA comprises one or more of a peak amplitude or a number of peaks ([0042], measuring frequency of signal peaks). Regarding claim 16, Wu teaches the method of claim 1, further comprising: wherein the recorded electrical signal is a time domain signal, and wherein the method further comprises determining a frequency domain signal corresponding to the time domain signal ([0033], transforming signal to frequency domain). Regarding claim 17, Wu teaches the method of claim 16, further comprising: wherein the step of classifying the electrical signal is performed on the frequency domain signal ([0071], metrics used to recognize resonance response episodes include frequency domain characteristics). Regarding claim 18, Wu teaches the method of claim 17, further comprising: wherein the step of extracting one or more features of the ERNA is performed on the frequency domain signal ([0071], power level in one or more frequency bands). Regarding claim 19, Wu teaches the method of claim 17, further comprising: wherein the step of extracting one or more features of the ERNA is performed on the time domain signal ([0071], metrics used to recognize resonance response episodes include time domain characteristics) . 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-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. 07-23-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. 07-21-aia AIA Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (US Pre-Grant Publication 2012/0271375) in view of Steinke et al. (US Pre-Grant Publication 2017/0189689), hereinafter ‘Steinke’ . Regarding claim 3, Wu teaches the method of claim 2, further comprising treating Parkinson's disease by suppressing dominant beta band oscillatory frequencies ([0112]), but does not teach a coordinated reset stimulation electrode configuration. Steinke teaches a system for programming a neurostimulator (abstract), further comprising: wherein the multi-electrode stimulation paradigm comprises coordinated reset stimulation ([0112], coordinated reset types of stimulation). It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Wu to incorporate the teachings of Steinke to include electrodes configured for coordinated reset stimulation. Doing so would optimize patterns of neurostimulation, as recognized by Steinke [0112] . 07-21-aia AIA Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (US Pre-Grant Publication 2012/0271375) in view of John (US Patent No. 11,779,775), hereinafter ‘John’ . Regarding claim 5, Wu teaches the method of claim 4, further comprising generating plots to present patterns in resonance responses ([0047]), but does not specifically teach modeling electrodes as vertices and features of the response as edges. John teaches a method of targeting neurostimulation (abstract), further comprising: wherein determining the neural coupling comprises using graph theory analysis (GTA) (para. 8, model shows influence that two or more brain structures have on each other) comprising: modeling each of the plurality electrodes as vertices of a graph (Figs. 3B-3G, brain regions A, B, C, stimulation areas), modeling the extracted one or more features of the neural response as edges of the graph (Figs. 3B-3G, para. 119, solid lines represent positive correlations where stimulation in one brain structure increases activity at another structure), and determining therapeutic stimulation parameters based on weights of the edges (para. 119, thickness of line indicates strength of relationship, para. 120, stimulation protocols incorporate these interactions). It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Wu to incorporate the teachings of John to include modeling electrodes as vertices and features of the response as edges. Doing so would allow for a more accurate and efficient treatment method, as recognized by John (para. 120) . 07-21-aia AIA Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (US Pre-Grant Publication 2012/0271375) in view of Esteller et al. (US Pre-Grant Publication 2019/0099602) , hereinafter ‘Esteller’ . Regarding claim 6, Wu teaches the method of claim 1, further comprising generating plots to present patterns in resonance responses ([0047]), but does not specifically teach modeling the neural features in three-dimensions. Esteller teaches a system for adjusting a stimulation program based on an evoked action potential (abstract), further comprising: modeling the extracted neural features in three-dimensions (Fig. 8B) wherein a first dimension represents time (Fig. 8B, time on x-axis), a second dimension represents the stimulating electrodes (Fig. 8B, E3-E5 plots), and a third dimension represents the recording electrodes (Fig. 8B, E8 plot) ([0038]), using independent components analysis to determine dominant components of the modeled extracted neural features ([0066-0076], determine ECAP features, step 148, Fig. 11) determining the stimulation configuration based on the dominant components ([0045], ECAP speed calculation is useful in deciding how stimulation might be adjusted). It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Wu to incorporate the teachings of Esteller to include modeling neural features in three dimensions. Doing so would allow for the determination of a stimulation program that is useful in treating patient symptoms, as recognized by Esteller ([0086]) . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sinclair et al. (US 2019/0143120) teaches a method of detecting a resonant response evoked by electrical stimuli. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5. 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. 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. /E.L.O./Examiner, Art Unit 3792 /Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792 Application/Control Number: 18/774,100 Page 2 Art Unit: 3792 Application/Control Number: 18/774,100 Page 3 Art Unit: 3792 Application/Control Number: 18/774,100 Page 4 Art Unit: 3792 Application/Control Number: 18/774,100 Page 5 Art Unit: 3792 Application/Control Number: 18/774,100 Page 6 Art Unit: 3792 Application/Control Number: 18/774,100 Page 7 Art Unit: 3792 Application/Control Number: 18/774,100 Page 8 Art Unit: 3792 Application/Control Number: 18/774,100 Page 9 Art Unit: 3792 Application/Control Number: 18/774,100 Page 10 Art Unit: 3792 Application/Control Number: 18/774,100 Page 11 Art Unit: 3792 Application/Control Number: 18/774,100 Page 12 Art Unit: 3792 Application/Control Number: 18/774,100 Page 13 Art Unit: 3792 Application/Control Number: 18/774,100 Page 14 Art Unit: 3792
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