CTNF 18/775,287 CTNF 94002 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 Claim 11 and 12 should have consistent terminology with regards to “first amplitude” and “first pulse amplitude” along with “second amplitude” and “second pulse amplitude”. The claim elements reciting “neural tissue” and “targeted neural tissue” should be named consistently. Claim Rejections - 35 USC § 103 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 (s) 1-2, 4-5, 7-18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman (US 2022/0387799 A1) in view of Harkema (US 11691016 B2) . Regarding claims 1, 16, and 17, Feldman discloses a method, comprising: delivering an electrical waveform using at least one electrode contact (eg. Abstract, Para. 26-34 Fig 1 electrodes 26), wherein the electrical waveform includes first phases of a first polarity and second phases of a second polarity opposite the first polarity (eg. Abstract, Fig. 2, 3A, 34-47), wherein the delivering the electrical waveform includes therapeutically stimulating neural tissue using both the first phases and the second phases of the electrical waveform (eg. Para. 34-47), and using the second phases to reduce built up charge from the at least one electrode contact caused by the first phases and using the first phases to reduce built up charge from the at least one electrode contact caused by the second phases (eg. Para. 34-47). Feldman does not explicitly using charges to reduce built up charge. Harkema teaches a neural stimulation device charge imbalanced bi-phasic waveforms teaches imbalanced biphasic charge for reduce risk of residual charge buildup (eg. Col. 6, Ln. 55 – Col. 7, Ln. 50). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Feldman with the charge imbalance correction feature as taught by Harkema to maintain balance and minimize irreversible reactions that may lead to tissue or electrode damage (eg. Harkema, Col. 6, Ln. 55 – Col. 7, Ln. 50). Regarding claims 2 and 18, the combined invention of Feldman and Harkema discloses the electrical waveform includes a plurality of interphase intervals, each of the plurality of interphase intervals separating individual ones of the first phases and individual ones of the second phases (eg. Feldman, Para. 37, Fig. 2, injection phase 240 stimulation pulse 246 and recovery phase 247 with delay between). Regarding claim 4, the combined invention of Feldman and Harkema discloses the plurality of interphase intervals includes equal intervals (eg. Feldman, Para. 35, 47). Regarding claim 5, the combined invention of Feldman and Harkema discloses the plurality of interphase intervals includes different intervals (eg. Feldman, Para. 48). Regarding claims 7 and 20, the combined invention of Feldman and Harkema discloses the delivering the electrical waveform includes delivering a series of therapeutic pulses within a window of time by delivering both one or more pulses of the first phase and one or more pulses of the second phase for balancing a net charge on the at least one electrode contact in the window of time (eg. Feldman, Fig. 3B, Para. 39-41). Regarding claim 8, the combined invention of Feldman and Harkema discloses intermittently performing extra charge balancing beyond the series of therapeutic pulses according to predefined charge balance rules (eg, Feldman, Para. 6, Claims 1 and 3-4, Para. 42-49 and Harkema Col. 6, Ln. 55 – Col. 7, Ln. 50). Regarding claim 9, the combined invention the combined invention of Feldman and Harkema discloses the predefined charge balance rules include rules for performing extra charge balancing at predefined times, after delivering a predefined number of therapeutic pulses, after delivering a predefined charge, after a predefined charge per unit of time, or based on an estimated instantaneous charge accounting for slow charge diffusion (eg. Feldman, Para. 48). Regarding claim 10, the combined invention the combined invention of Feldman and Harkema discloses the extra charge balancing is performed by inserting at least one non-therapeutic pulse to reduce a residual net charge within the window of time (eg. Feldman, Para. 41-46). Regarding claim 11, the combined invention the combined invention of Feldman and Harkema discloses the therapeutic pulses have a first amplitude and a first pulse width and the non-therapeutic pulse has a second amplitude and a second pulse width, wherein the second amplitude is smaller than the first amplitude and is less than a depolarization threshold for the neural tissue, and the second pulse width is larger than the first pulse width (eg. Feldman, Para. 41-46). Regarding claim 12, the combined invention the combined invention of Feldman and Harkema discloses a proportion that the second pulse width is larger than the first pulse width is larger than a proportion that the first pulse amplitude is larger than the second pulse amplitude such that a charge provided by the non-therapeutic pulse is more than a charge provided by one of the therapeutic pulses such that a charge provided by the non-therapeutic pulse is more than a charge provided by one of the therapeutic pulses (eg. Feldman, Para. 42). Regarding claim 13, the combined invention the combined invention of Feldman and Harkema discloses the neurostimulator is configured to perform extra charge balancing by monitoring a net charge and inserting charge to reduce the monitored net charge below the predefined threshold (eg. Harkema, Col. 5, Ln. 50 – Col. 6, Ln. 12). Regarding claim 14, the combined invention the combined invention of Feldman and Harkema discloses the delivering the electrical waveform includes using three or more electrode contacts, distributing the first phases over at least one of the three or more electrode contacts, and distributing the second phases over at least one of the three or more electrode contacts (eg. Feldman, Para. 28-29). Regarding claim 15, the combined invention the combined invention of Feldman and Harkema discloses the delivering the electrical waveform includes delivering a first electrical waveform over a first timing channel to a first set of electrode contacts that includes the at least one electrical contact, the method further including delivering a second electrical waveform over a second timing channel to a second set of electrode contacts, wherein the second electrical waveform includes first phases of a first polarity and second phases of a second polarity opposite the first polarity, and wherein at least one shared electrode contact is in both the first and second sets of electrode contacts, wherein at least one of the first and second phases of the second electrical waveform removes built up charge at the at least one shared electrode contact from the first electrical waveform (eg. Feldman, Para. 28, Harkema, Col. 1, Ln. 45-67 Col. 3, Ln. 65-Col. 4, Ln. 13) . 07-21-aia AIA Claim (s) 3, 6, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman (US 2022/0387799 A1) in view of Harkema (US 11691016 B2) further in view of Doan (US 11944816 B2) . Regarding claims 3 and 19, the combined invention of Feldman and Harkema discloses the invention of claim 2, but does not disclose the plurality of interphase intervals includes about an 11ms interphase interval to stimulate the targeted neural tissue with a stimulation frequency of about 90 Hz. Doan teaches a neural stimulation device that uses a biphasic pulse with an interphase that can be (eg. Col. 2, Ln. 50 – Col. 3, Ln. 5, Col. 20, Ln. 4-22, Col. 25, Ln. 5-15). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Feldman and Harkema with the biphasic frequency and interphase as taught by Doan as known parameters for use in helping treat patient’s pain (eg. Col. 20, Ln. 4-22). While Doan teaches 0-3 ms as an example and not explicitly mentioning 11 ms interphases, one of ordinary skill would have been able to arrive at 11 ms via routine experimentation to arrive at 11 ms since the ranges are close and the Doan range of 0-3 was merely given as an example that is open to adjustment. (See MPEP 2144.05) Regarding claim 6, the combined invention of Feldman, Harkema, and Doan discloses each of the plurality of interphase intervals includes at least 1ms between successive ones of the first and second phases (eg. Doan Col. 20, Ln. 4-22). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM. 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, Carl Layno can be reached at 571-272-4949. 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. /MICHAEL J LAU/Examiner, Art Unit 3796 Application/Control Number: 18/775,287 Page 2 Art Unit: 3796 Application/Control Number: 18/775,287 Page 3 Art Unit: 3796 Application/Control Number: 18/775,287 Page 4 Art Unit: 3796 Application/Control Number: 18/775,287 Page 5 Art Unit: 3796 Application/Control Number: 18/775,287 Page 6 Art Unit: 3796 Application/Control Number: 18/775,287 Page 7 Art Unit: 3796
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