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 .
Status of Claims
The amendments and remarks filed on 14APR2026 have been entered and considered.
Claims 1, 7, 10, 31, 39, 44, 46-48, & 68-76 are currently pending and under examination.
Claims 1, 44, 68, & 70 have been amended.
Claims 2-6, 8-9, 11-30, 32-38, 40-43, 45, & 49-67 have been canceled.
Claims 72-76 have been added.
Response to Arguments
The previous 35 USC 112(b) rejections as made in the previous Non-Final Rejection Office Action mailed February 24th 2026 have been withdrawn due to the amendments made in the claims, submitted April 14th 2026, which obviates the rejections.
The previous 35 USC 103(a) rejections as made in the previous Non-Final Rejection Office Action mailed February 24th 2026 have been withdrawn due to the amendments made in the claims, submitted April 14th 2026, which obviates the rejections.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 7, 10, 31, 39, 44, 46-48, 68, 69, 71, & 73 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 1:
The claim recites “the positive result indicative of a reduced frequency of voiding episodes of the subject” in line 32. The term “reduced” is not found within the specification, nor is there any indication of a reference to a reduction in frequency of voiding episodes indicating a positive event. The application has not shown possession of the claimed invention and therefore the claims are rejectable under 112a, written description for new matter.
Claims 1, 7, 10, 31, 39, 44, 46-48, 68, 69 & 71 are further rejected for depending upon rejected Claim 1.
Regarding Claim 39:
Claim 1, from which claim 39 depends, is a computer-implemented process (“using an electronic processor” in line 5 of claim 1). MPEP 2161.01 states the following:
When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing.
For the limitation of determining “quality-of-life score” in claim 39, the specification discloses that a quality-of-life score may be calculated based on sensor/activity data to indicate a subject’s level of recovery from OAB in [0067], [0141], and [0159]–[0160]. However, the specification does not appear to provide sufficient detail regarding how the claimed “quality-of-life score” is calculated from the first set of data. For example, the specification does not appear to disclose an algorithm, scoring scale, mathematical relationship, weighting scheme, thresholds, classification rules, or other objective methodology for converting the received distance/activity data into a “quality-of-life score indicative of a level of recovery of the subject from OAB.” Accordingly, the disclosure may not reasonably convey possession of the full scope of the claimed step of calculating the quality-of-life score.
Regarding Claims 44 & 73:
The claim recites “second number different from the first number” in line 6. The specification does not provide a disclosure of a “second number different from the first number as claimed in claims 44 & 73. The application has not shown possession of the claimed invention and therefore the claims are rejectable under 112a, written description for new matter.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 39 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “quality-of-life score” in claim 39 is a relative term which renders the claim indefinite. The term “quality-of-life score” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what factors are considered to determine “quality-of-life score” that would be indicative of a level of recovery of the subject from OAB.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: Claim 1 recites “wherein performing the first assessment of the characteristic of the response of the subject to the stimulation based on the first set of data comprises: comparing (a) a post-treatment-initiation distance traveled by the subject subsequently to the first time that the tibial nerve is stimulated using the implant to (b) a predetermined threshold distance; identifying a positive result of the stimulation based at least in part on the post- treatment-initiation distance being greater than the predetermined threshold distance during a given time period,”. Claim 70 recites “wherein performing the first assessment of the characteristic of the response of the subject to the stimulation based on the first set of data comprises comparing (a) a post- treatment-initiation distance traveled by the subject subsequently to the first treatment of the subject by stimulating the tibial nerve using the implant to (b) a baseline distance traveled by the subject prior to the first treatment of the subject by stimulating the tibial nerve using the implant”
The closest relevant art does not disclose tracking the progress of therapy by comparing a distance traveled by the patient to a threshold or baseline distance traveled by the patient to determine changes.
Therefore, claims 1, 7, 10, 31, 39, 44, 46-48, & 68-76 contain allowable subject matter once the 112(a) rejections have been overcome.
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 extension fee 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 date of this final action.
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/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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