Prosecution Insights
Last updated: October 16, 2026
Application No. 19/548,249

DEVICES, SYSTEMS, AND METHODS FOR INCONTINENCE CONTROL

Final Rejection §102§103§DOUBLEPATENT
Filed
Feb 24, 2026
Priority
Mar 12, 2021 — provisional 63/160,322 +5 more
Examiner
VOORHEES, CATHERINE M
Art Unit
3792
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Amber Therapeutics Holdings Limited
OA Round
2 (Final)
84%
Grant Probability
Favorable
3-4
OA Rounds
1y 11m
Est. Remaining
98%
With Interview

Examiner Intelligence

Grants 84% — above average
84%
Career Allowance Rate
737 granted / 882 resolved
+13.6% vs TC avg
Moderate +14% lift
Without
With
+14.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
26 currently pending
Career history
916
Total Applications
across all art units

Statute-Specific Performance

§101
3.1%
-36.9% vs TC avg
§103
38.2%
-1.8% vs TC avg
§102
17.8%
-22.2% vs TC avg
§112
26.7%
-13.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 882 resolved cases

Office Action

§102 §103 §DOUBLEPATENT
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Priority Claims 1-20 are deemed to have an effective filing date of March 12, 2021. Response to Amendment This Action is in response to the Office Action dated September 4, 2026. In view of the amendments, items 3 and 4 of the drawing objections, set forth in the Office Action dated 06/05/3036, are withdrawn. Claims 1, 4, 6, 11, and 14-15 are amended. Claims 1-20 are pending. Response to Arguments Applicant's arguments filed 09/04/2026 have been fully considered but they are not persuasive. In response to Applicant’s comments regarding item 5 of the drawing objection set forth in the Office Action dated 06/05/2026, the examiner requires descriptive legends on the respective drawing sheets so that a review of the drawings indicates what the figures are indented to convey. With respect to the added limitations to the claimed invention, US Patent Application Publication No. 2012/0197338 to Su et al. teaches that in addition to or instead of physiological conditions sensed by a bladder contractions, the sensor can be an accelerometer that detects patient activity level (e.g., indication of the level of motion or movement of one or more of the patient’s limbs or trunk) by generating a signal that changes as patient activity level changes; compares the detected patient activity level to a threshold (analyzes the detected signal) and provides a stimulation intensity adapted to the circumstances that may increase patient incontinence and provides an additional layer of therapy to help prevent the occurrence of an involuntary voiding event while the patient is engaging in the detected activity (e.g. paragraphs [0067]-[0069] of Su). That is, Su teaches an alternative type of sensor for preventing occurrences of an involuntary voiding event by monitoring a user’s physical movement to detect a parameter/activity level, analyzing a signal intensity of the detected physical activity level in order to provide a second temporary electrical stimulation pattern of a higher level/intensity (e.g., paragraph [0062]) where the duration of the stimulation lasts as long as the sensor detects the parameter indicative of the user’s physical movement and the intensity of the detected parameter. Drawings The drawings are objected to under 37 CFR 1.84 (o) because a legend is required for the boxes designated by reference numeral “103 (Fig. 1)”; “123” (Fig. 2), “152”, “154”, “156”, “160”, and “214” (Fig. 5); “801”, “802”, “804”, “806”, “808” “820”, “810”, “812”, “814” and “816” (Fig. 8); “902”, “904”, “906”, and “908” (Fig. 9); and “1010” (Fig. 10). CFR 1.84 (o) Legends. Suitable descriptive legends may be used subject to approval by the Office, or may be required by the examiner where necessary for understanding of the drawing. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Rejections - 35 USC § 102 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 – (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. Claims 1-3, 5-9, 11-14, and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2012/0197338 to Su et al. (hereinafter referred to as “Su”). Regarding claim 1, Su discloses a system for ameliorating an episode of incontinence (e.g., paragraphs [0002]-[0003] and [0018]:implantable medical device/system of treatment of bladder dysfunction that includes incontinence), the system comprising: an implantable sensor configured to detect a parameter indicative of a user’s physical movement (e.g., paragraph [0069]: motion sensor 22 may comprise an accelerometer or other sensor that generates a signal that changes as patient activity level changes and Fig. 1); a processor configured to analyze a signal intensity of the detected parameter (e.g., paragraph [0129]: In examples in which sensor 22 is a motion sensor that generates a signal that changes as a function of patient activity level, processor 40 determines an activity level of patient 12 by sampling the signal from sensor 22 and determining a number of activity counts during a sample period, where a plurality of activity levels are associated with respective activity counts. In one example, processor 40 compares the signal generated by sensor 22 to one or more amplitude thresholds stored within memory 44, and identifies each threshold crossing as an activity count); at least one implantable stimulator electrode configured to apply an electrical stimulation at or near a nerve (e.g., paragraph [0037]: IMD 14 delivers electrical stimulation therapy to a patient 12 by generating and delivering a programmable electrical signal to target therapy sites including nerves proximate electrodes of leads 16, 18; and Fig. 1); and an implantable pulse generator operably coupled to the at least one stimulator electrode (e.g., paragraphs [0037]: IMD 14 is coupled to electrodes of each lead 16, 18; [0090]: IMD 14 includes a processor 40 and stimulator generator; Fig. 3; [0096]: stimulation generator 32 generates and delivers electrical stimulation in the form of electrical pulses); wherein the implantable pulse generator is configured to provide a base electrical stimulation pattern having one or more of a constant frequency, a constant amplitude, or a constant current (e.g., Abstract: IMD delivers a first electrical stimulation therapy to a patient; [0045]: first stimulation therapy delivers stimulation at a stimulation intensity substantially equal to a threshold stimulation level that implies an intensity/amplitude that is constant); wherein in response to detecting the parameter indicative of the user’s physical movement, the implantable pulse generator is configured to provide a temporary electrical stimulation pattern configured to ameliorate the episode of incontinence (e.g., paragraph [0069]:the IMD 14 controls the delivery of the second stimulation therapy to patient 12 upon detecting a patient activity level exceeding a particular threshold based on the signal from the signal from the motion sensor); wherein the temporary electrical stimulation pattern is at a higher level than the base electrical stimulation pattern (e.g., paragraphs [0069]:the IMD 14 controls the delivery of the second stimulation therapy to patient 12 upon detecting a patient activity level exceeding a particular threshold based on the signal from the signal from the motion sensor), and wherein a duration of the temporary electrical stimulation pattern is based on at least the following: the signal intensity of the detected parameter (e.g., paragraph [0069]: see above), or a duration of the implantable sensor detecting the parameter indicative of the user’s physical movement (e.g., paragraph [0069]: patient activity level that is greater than or equal to a threshold (which may be stored in a memory of IMD 14, programmer 20 or another device) may indicate that patient 12 is engaging in an activity that may increase in the possibility of an occurrence of an involuntary voiding event, and, therefore, the greater inhibition of bladder contraction frequency provided by the second stimulation therapy may be desirable while patient 12 is engaging in the activity). Referring to claim 11, Su discloses a system for ameliorating an episode of incontinence (e.g., paragraphs [0002]-[0003] and [0018]: implantable medical device/system of treatment of bladder dysfunction that includes incontinence), the system comprising: an implantable sensor configured to detect a parameter indicative of a user’s physical movement (e.g., paragraph [0069]: motion sensor 22 may comprise an accelerometer or other sensor that generates a signal that changes as patient activity level changes and Fig. 1); a processor configured to analyze a signal intensity of the detected parameter (e.g., paragraph [0129]: In examples in which sensor 22 is a motion sensor that generates a signal that changes as a function of patient activity level, processor 40 determines an activity level of patient 12 by sampling the signal from sensor 22 and determining a number of activity counts during a sample period, where a plurality of activity levels are associated with respective activity counts. In one example, processor 40 compares the signal generated by sensor 22 to one or more amplitude thresholds stored within memory 44, and identifies each threshold crossing as an activity count); at least one implantable stimulator electrode configured to apply an electrical stimulation at or near a nerve (e.g., paragraph [0037]: IMD 14 delivers electrical stimulation therapy to a patient 12 by generating and delivering a programmable electrical signal to target therapy sites including nerves proximate electrodes of leads 16, 18; and Fig. 1); and an implantable pulse generator operably coupled to the at least one stimulator electrode (e.g., paragraphs [0037]: IMD 14 is coupled to electrodes of each lead 16, 18; [0090]: IMD 14 includes a processor 40 and stimulator generator; Fig. 3; [0096]: stimulation generator 32 generates and delivers electrical stimulation in the form of electrical pulses); wherein the implantable pulse generator is configured to provide a base electrical stimulation pattern (e.g., Abstract: IMD delivers a first electrical stimulation therapy to a patient; [0045]: first stimulation therapy delivers stimulation at a stimulation intensity substantially equal to a threshold stimulation level); wherein in response to detecting the parameter indicative of the user’s effort to ameliorate the episode of incontinence, the implantable pulse generator is configured to provide a temporary electrical stimulation pattern configured to ameliorate the episode of incontinence (e.g., paragraphs [0062]: IMD delivers first stimulation over an extended period of time and delivers a second stimulation therapy to a patient when a stronger therapy is needed or desirable; [0069]: the IMD 14 controls the delivery of the second temporary stimulation therapy to patient 12 upon detecting a patient activity level exceeding a particular threshold based on the signal from the signal from the motion sensor) and wherein the temporary electrical stimulation pattern is at a higher level than the base electrical stimulation pattern (e.g., paragraphs [0062] and [0069]: see above). With respect to claims 2 and 12, Su discloses the system of claims 1 and 11, wherein an intensity of the temporary electrical stimulation pattern is higher than an intensity of the base electrical stimulation pattern (e.g., paragraph [0182]: delivering the second stimulation upon detection of a trigger event/detected motion over threshold helps reduce muscle fatigue by limiting the amount of the second stimulation therapy, which has a higher intensity than the first stimulation therapy). As to claims 3 and 13, Su discloses the system of claims 1 and 11, wherein the implantable sensor comprises an accelerometer (e.g., paragraph [0069]: motion sensor may be an accelerometer). With respect to claims 5 and 16, Su discloses the system of claims 1 and 11, wherein a first lead and a second lead configured to be implanted bilaterally at or near a pudendal nerve, wherein the first lead comprises a first stimulator electrode and the second lead comprises a second stimulator electrode (e.g., paragraph [0084]: Leads 16, 18 of the IMD 14 are implanted bilaterally near the pudendal nerves; see Fig 2). As to claim 6, Su discloses the system of claims 1, wherein in response to detecting the parameter indicative of the user’s physical movement, the temporary electrical stimulation pattern changes one or more of a pulse width of electrical stimulation, a frequency of electrical stimulation, or an amplitude of electrical stimulation (e.g., paragraph [0182]: the second stimulation therapy has a higher intensity than the first stimulation therapy – changes the amplitude/intensity of the first stimulation therapy). With respect to claims 7 and 18, Su discloses the system of claims 1 and 11, wherein at least one of the base electrical stimulation pattern or the temporary electrical stimulation pattern is programmable by a healthcare provider (e.g., paragraphs [0095]: clinician may select stimulation therapy programs from a list using programmer 20; and [0143]: programmer 20 may be a hand-held computing device). As to claims 8 and 19, Su discloses the system of claims 1 and 11, wherein a frequency, an amplitude, and a pulse width of the at least one of the base stimulation pattern or the temporary electrical stimulation patter is adjustable by a healthcare provider (e.g., paragraph [0076]: clinician may interact with programmer 20 to set values for the stimulation parameter values with which IMD 14 generates and delivers stimulation and/or other operational parameters). With respect to claims 9 and 20, Su discloses the system of claims 1 and 11, further comprising an external input device configured to adjust parameters of the temporary electrical stimulation pattern (e.g., paragraphs [0135]: processor 40 can receive the patient input via telemetry module 46; and [0183]: the duration of the first time period maybe adjusted based on an input received by processor 40 via a telemetry module 46) is configured to adjust parameters). As to claim 14, Su discloses the system of claim 11, wherein the parameter comprises a voluntary physical movement of the user intended to ameliorate the episode of incontinence (e.g., paragraph [0129]: In examples in which sensor 22 is a motion sensor that generates a signal that changes as a function of patient activity level, processor 40 determines an activity level of patient 12 by sampling the signal from sensor 22 and determining a number of activity counts during a sample period, where a plurality of activity levels are associated with respective activity counts). With respect to claim 17, Thor discloses the system of claim 11, wherein the base electrical stimulation pattern has one or more of a constant frequency, a constant amplitude, or a constant current (e.g., paragraph [0182]: the second stimulation therapy has a higher intensity than the first stimulation therapy – changes the amplitude/intensity of the first stimulation therapy). Claim Rejections - 35 USC § 103 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. 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. Claims 4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Su in view of US Patent No. 5,782,885 to Andersson. Su discloses the system of claims 1 and 11, comprising a processor, but does not expressly disclose providing a signal from its implantable sensor to a trained classifier. However, Andersson, in a related art: stimulation device using neural network and classifier, teaches that in order to classify sensed signals indicating the workload of the patient, the stimulation implant includes a classifying device for classification of the sense signals (IEGM) (e.g., Abstract), where the classifying device is trained using sensed IEGM data (e.g., Abstract and column 4, lines 33-55, column 6, lines 21-54 and column 7, lines 15-25 of Andersson). Accordingly, one of ordinary skill in the art would have recognized the benefits of providing a signal from an implantable sensor to a trained classifier in view of the teachings of Andersson. Consequently, one of ordinary skill in the art would have modified the system of Su to provide a signal from the implantable motion sensor to determine/classify the signal to determine how much physical activity is being performed in view of the teachings of Andersson that using a trained classifier to determine an optimal adjustment was a well-known protocol in the medical stimulation art, and because the combination would have yielded a predictable result. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Su in view of US Patent Application Publication No. 2016/0263376 to Yoo et al. (hereinafter referred to as “Yoo”). Su discloses the system of claim 1, but does not expressly disclose that the temporary electrical stimulation pattern is based at least in part on a real-time clock scheduler. However, Yoo, in a related art: systems and method for improved treatment of overactive bladder, teaches that therapy for overactive bladder can be in response to time data such as a clock time or a time interval such as the time since last voiding (e.g., paragraph [0210] of Yoo). Accordingly, one of ordinary skill in the art would have recognized the benefits of employing a real-time clock scheduler for the temporary electrical stimulation pattern in view of the teachings of Yoo. Consequently, one of ordinary skill in the art would have modified the system of Su to base the temporary electrical stimulation pattern at least in part on a real-time clock scheduler in view of the teachings of Yoo that such was a well-known engineering expedient in the stimulation of the pudendal nerve art, and because the combination would have yielded a predictable result. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 1-3, 5-14, and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 68-70, 72-75 of U.S. Patent No. 12,397,156 (hereinafter referred to as “patent ‘156”) in view of Su. Instant claim 1 is encompassed by and conflicts with claim 13 of the ‘156 patent, except for the recitation of the processor for analyzing a signal intensity of the detected physical activity/movement and the duration of the temporary stimulation pattern being based on the signal intensity of the detected parameter or a duration of the implantable sensor detecting the parameter indicative of the user’s physical movement. However, as discussed above with respect to the rejection of claim 1 under 35 USC 102, Su teaches that such features were known to those skilled in the stimulation therapy art for incontinence. Consequently, one of ordinary skill in the art would have modified the system of claim 13 of the ‘156 patent to have an implantable sensor to detect a parameter indicative of a user’s movement, a processor for analyzing a signal intensity of the detected parameter, and basing a duration of a temporary electrical stimulation pattern on either the signal intensity of the detected parameter or a duration of the implantable sensor detecting the movement in view of the teachings of Su that such was a well-known protocol in the stimulation device for incontinence control art, and because the combination would have yielded a predictable result. Instant claim 2 is encompassed by and conflicts with claim 17 of the ‘156 patent, as modified by Su. Instant claim 3 is encompassed by and conflicts with claim 21 of the ‘156 patent, as modified by Su. Instant claim 5 is encompassed by and conflicts with claim 13 of the ‘156 patent, as modified by Su, and further modified by Su to meet the features of claim 5 as discussed above w/r/t the rejection of claim 5. Instant claim 6 is encompassed by and conflicts with claim 20 of the ‘156 patent, as modified by Su, and further modified by Su to meet the features of claim 6 as discussed above w/r/t the rejection of claim 6. Instant claims 7-8 are encompassed by and conflicts with claim 13 of the ‘156 patent, as modified by Su, further modified by Su to meet the features of claim 7-8 as discussed above w/r/t the rejection of claim 7-8. Instant claim 9 is encompassed by and conflicts with claim 13 of the ‘156 patent, as modified by Su where Su further teaches an external input device configured to adjust parameters of the temporary electrical stimulation pattern as discussed above w/r/t the rejection of claim 9. Instant claim 10 is encompassed by and conflicts with claim 22 of the ‘156 patent, as modified by Su. Instant claims 11 and 16 are encompassed by and conflict with claims 1 and 23 of the ‘156 patent, except for the recitation of the processor for analyzing a signal intensity of the detected physical activity/movement and the duration of the temporary stimulation pattern being based on the signal intensity of the detected parameter or a duration of the implantable sensor detecting the parameter indicative of the user’s physical movement. However, as discussed above with respect to the rejection of claim 11 under 35 USC 102, Su teaches that those features were known in a stimulation device for incontinence control stimulation. Consequently, one of ordinary skill in the art would have modified the systems of claims 1 and 23 of the ‘156 patent to change one or more of the recited parameters in a second stimulation pattern in view of the teachings of Su that such was a well-known protocol in the stimulation device for incontinence control art, and because the combination would have yielded a predictable result. Instant claim 12 is encompassed by and conflicts with claims 5 and 27 of the ‘156 patent, as modified by Su. Instant claim 13 is encompassed by and conflicts with claim 31 of the ‘156 patent, as modified by Su. Instant claim 14 is encompassed by and conflicts with claim 30 of the ‘156 patent, as modified by Su. Instant claim 17 is encompassed by and conflicts with claim 24 of the ‘156 patent, as modified by Su. Instant claims 18-19 are encompassed by and conflicts with claims 1 and 23 of the ‘156 patent, as modified by Su, and further modified by Su to meet the features of claim 18-19 as discussed above w/r/t the rejection of claim 18-19. Instant claim 20 is encompassed by and conflicts with claim 6 of the ‘156 patent, as modified by Su. Claims 4 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims and 23 of U.S. Patent No. 12,397,156 in view of Su and Andersson. Claims 4 and 15 are encompassed by and conflict with claims 13 and 23 of the ‘156 patent respectively, except for the features of claims 4 and 15. However, as discussed above with respect to the rejection of claims 4 and 15 under 35 USC 103, Andersson, in a related art: stimulation device using neural network and classifier, teaches that in order to classify sensed signals indicating the workload of the patient, the stimulation implant includes a classifying device for classification of the sense signals (IEGM) (e.g., Abstract), where the classifying device is trained using sensed IEGM data (e.g., Abstract and column 4, lines 33-55, column 6, lines 21-54 and column 7, lines 15-25 of Andersson). Accordingly, one of ordinary skill in the art would have recognized the benefits of providing a signal from an implantable sensor to a trained classifier in view of the teachings of Andersson. Consequently, one of ordinary skill in the art would have modified the system of claims 68 or 23 of the ‘156 patent, as modified by Su, to provide the signal from the implantable sensor of the ‘156 patent to a trained classifier in view of the teachings of Andersson that using a trained classifier to determine a signal was a well-known protocol in the medical stimulation art, and because the combination would have yielded a predictable result. Claims 7-8 and 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 68 and 23 of U.S. Patent No. 12,397,156 in view of Thor and Yoo. Claims 7-8 and 18-19 are encompassed by and conflict with claims 68 and 23 of the ‘156 patent respectively, except for the features of claims 7-8 and 18-19. However, Yoo, in a related art, teaches that the therapy program may be implemented partially or fully by one or more processors of a medical system including a fully implantable neurostimulator where the therapy program can be adjusted according to control by, or therapy plan implemented by a doctor, remote medical service or caregiver (e.g., paragraph [00040] of Yoo). Accordingly, one of ordinary skill in the art would have recognized the benefits of a healthcare provider programming /implementing and adjusting at least one of the stimulation modes in view of the teachings of Yoo. Consequently, one of ordinary skill in the art would have modified the system of claims 68 or 23 of the ‘156 patent to be programmed by a healthcare provider on a remote computing device in view of the teachings of Yoo that such was a well-known engineering expedient in the stimulation of the pudendal nerve art, and because the combination would have yielded a predictable result. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 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, Unsu Jung can be reached at 571 272-8506. 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. /CATHERINE M VOORHEES/ Primary Examiner, Art Unit 3792
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Prosecution Timeline

Show 1 earlier event
Jun 05, 2026
Non-Final Rejection mailed — §102, §103, §DOUBLEPATENT
Sep 04, 2026
Response Filed
Sep 10, 2026
Examiner Interview Summary
Sep 10, 2026
Applicant Interview (Telephonic)
Sep 23, 2026
Final Rejection mailed — §102, §103, §DOUBLEPATENT
Oct 13, 2026
Applicant Interview (Telephonic)
Oct 13, 2026
Examiner Interview Summary
Oct 14, 2026
Response after Non-Final Action

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Prosecution Projections

3-4
Expected OA Rounds
84%
Grant Probability
98%
With Interview (+14.0%)
2y 7m (~1y 11m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 882 resolved cases by this examiner. Grant probability derived from career allowance rate.

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