CTNF 18/639,063 CTNF 88681 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. Election/Restrictions 08-25-01 AIA Applicant’s election without traverse of Invention IV (original claims 19-20 as well as new claims 21-31) in the reply filed on May 8, 2026 is acknowledged. Drawings 06-21 AIA New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the drawings filed April 18, 2024 fail to comply with line and shading requirements of 37 C.F.R. 1.84 (1 and m) and thus do not possess satisfactory reproduction characteristics as required by those sections. See MPEP 608.02. Specifically, nearly all of the drawings contain excessive and unnecessary grey shading and/or backgrounds as a result of reproduction from earlier images; these characteristics will only worsen with each subsequent reproduction . Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance 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. 07-20-02-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 Claim s 19-22, 24-27 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Yousif et al. (see NPL Item Number 52 on Applicant’s IDS dated 07/11/2024 for full citation) (hereinafter “Yousif”) in view of US 2021/0346695 A1 to Grill et al. (hereinafter “Grill”) . Regarding Claims 19-20 and 31 , Yousif teaches a method of selecting a desired lead configuration to treat or prevent at least one symptom associated with a disease or condition in a subject in need thereof (see generally the abstract and Introduction sections; see e.g. “In this study, we looked specifically at implanted electrodes for clinical SNS and at the comparison of two of the common models of electrodes, as well as contact configuration. By allowing the clinician to visualise the impact of each parameter setting, this approach has the potential to tailor therapy for each individual patient, and maximise the therapeutic effect whilst minimising adverse events such as pain and discomfort” in the Introduction) , the method comprising: generating a three-dimensional model of a pelvis (see Section 2.2 “Anatomical FEM model”) and a sacral nerve (see Section 2.4 “Biophysical axon models”) based on imaging from a subject (see Section 2.2) ; adding an electrode model to the three-dimensional model in a position relative to the sacral nerve; wherein the position is based on imaging from the subject (see Section 2.2) ; simulating neural activation of the sacral nerve in the three-dimensional model for a plurality of candidate lead configurations of the electrode model (see Sections 2.3 “Theoretical analysis of SNS settings”, 3.2 “Monopolar settings” and 3.3 “Bipolar settings”) ; and selecting the desired lead configuration from one of the plurality of candidate lead configurations based on simulated neural activation (this is implicitly taught in e.g. Introduction: “By allowing the clinician to visualise the impact of each parameter setting, this approach has the potential to tailor therapy for each individual patient, and maximise the therapeutic effect whilst minimising adverse events such as pain and discomfort.”) Concerning the limitation of “selecting the desired lead configuration …” above, although Yousif implicitly teaches that this step would ultimately be done in a clinical setting (such as the quoted language of “potential to tailor therapy for each individual patient”), it is noted that due to Yousif’s nature as a research article, there is no explicit disclosure of the actual clinical implementation step in which the desired lead configuration is selected and implemented. However, taking this step would have been clearly obvious since the entire purpose of Yousif’s article is to help enable an improved real-world clinical therapy. To show an example of how this would have been obvious, attention is directed to the Grill reference which teaches evaluating different stimulation locations which leads to actually selecting a location (i.e. a lead configuration) and implementing that configuration (see e.g. Para. 57: “In some embodiments, placing an electrode lead adjacent to the target nerve determined to have the strongest representation and/or strongest subject perception associated with a peripheral nerve, and delivering electrical stimulation to the target nerve treats and/or prevents at least one symptom associated with overactive bladder, urge urinary incontinence, urinary urgency frequency, underactive bladder, urinary retention, fecal incontinence, constipation and/or sexual dysfunction”) . Grill further teaches delivering the stimulation with a programmed pulse generator (see e.g. Paras. 58-61 of Grill) . It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Yousif to take the final steps of selecting the desired/most optimal lead configuration and then implementing it in a real clinical setting with a programmed pulse generator since that is ultimately the purpose of Yousif’s research into this topic and it would allow the real therapeutic benefits to be realized. Regarding Claims 21-22 and 25 , see e.g. Section 2.2 of Yousif. Regarding Claim 24 , see Section 1: “SNS involves implanting electrodes into the patient’s sacral foramen” and Section 2.2 of Yousif. Regarding Claim 26 , see e.g. Sections 3.2 and 3.3. Regarding Claim 27 , see e.g. Section 2.4: “We used the potential distribution from the FEM model convolved with a time dependent square wave (14 Hz frequency, 1 V amplitude [18]) for 1000ms as the extracellular stimulus delivered by SNS.” 07-22-aia AIA Claim s 23 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Yousif in view of Grill as applied to claim 19 above, and further in view of Ciotti et al. (see NPL Item Number 7 on Applicant’s IDS dated 07/11/2024 for full citation) (hereinafter “Ciotti”) . Regarding Claim 23 , Yousif as modified teaches modeling the sacral nerve as noted above but fails to specifically teach wherein the sacral nerve includes a plurality of fascicles and an epineurium modeled based on at least one of histology nerve cross sections and imaging data. However, this was a known methodology for modeling a nerve for simulating lead configurations for stimulation. Ciotti teaches this same methodology in an analogous nerve stimulation (see e.g. Section II(A): “Starting from four pudendal histological cross-sections along a 2 cm length [15] we extracted the contours of each fascicle and of the epineurium with an ad-hoc designed assisted segmentation tool, implemented in MATLAB R2020a (The MathWorks, Inc.), the result of which is shown in Fig. 1.”) . It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Yousif to model the sacral nerve in this same manner because it would yield the predictable advantages associated with that modeling methodology, e.g. more accurate simulation of the nerve response to stimulation, and/or because it would merely involve adapting a known modeling methodology from one type of nerve stimulation into another to achieve the same predictable results and improvements. Regarding Claim 28 , Ciotti further teaches how simulating neural activation of a nerve can be achieved by solving for an extracellular potential along a path of the nerve in a 3-D model (see e.g. Sections II(B) and II(C)). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Yousif to incorporate this methodology of simulating neural activation for a sacral nerve because it would yield the predictable advantages associated with that modeling methodology, e.g. more accurate simulation of the nerve response to stimulation and/or because it would merely involve adapting a known modeling methodology from one type of nerve stimulation into another to achieve the same predictable results and improvements. Regarding Claims 29-30 , Ciotti further teaches how simulating neural activation of a nerve can include determining an activation threshold for nerve fibers in fascicles and selecting a desired lead configuration based on at least fascicle selectivity (see e.g. Sections II(C) and III) . It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Yousif to incorporate this methodology of simulating neural activation for a sacral nerve because it would yield the predictable advantages associated with that modeling methodology, e.g. more accurate simulation of the nerve response to stimulation and/or because it would merely involve adapting a known modeling methodology from one type of nerve stimulation into another to achieve the same predictable results and improvements. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET. 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, NIKETA PATEL can be reached at (571)-272-4156. 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. /JOHN R DOWNEY/Primary Examiner, Art Unit 3792 Application/Control Number: 18/639,063 Page 2 Art Unit: 3792 Application/Control Number: 18/639,063 Page 3 Art Unit: 3792 Application/Control Number: 18/639,063 Page 4 Art Unit: 3792 Application/Control Number: 18/639,063 Page 5 Art Unit: 3792 Application/Control Number: 18/639,063 Page 6 Art Unit: 3792 Application/Control Number: 18/639,063 Page 7 Art Unit: 3792 Application/Control Number: 18/639,063 Page 8 Art Unit: 3792 Application/Control Number: 18/639,063 Page 9 Art Unit: 3792
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