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 .
Claim Rejections - 35 USC § 112
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.
Claims 5-14 are 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.
Regarding claim 5, it is unclear what distinction, if any, the applicant is making between the terms “likelihood” and “probability.” The two terms appear to be synonymous, making claim 5 read as if one were saying “establishing a slip likelihood by computing a slip likelihood based on at least one likelihood of slippage.” It is unclear how else one would compute slip likelihood if not based on likelihood of slippage.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1, 4-8, 18 and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hamacher et al. (Pub. No. 2018/0243560).
Regarding claim 1, with related comments applying to patentably indistinct claims 18 and 20, Hamacher discloses a system comprising: at least one processor 24; and memory 60 storing instructions (inherently required in any computerized system) that, when executed by the at least one processor, configure the at least one processor to perform operations comprising: processing values comprising at least one of measurements by one or more sensors of an intra-body device (par. 0013: ECAP signals measured), power levels of wireless data transmissions transmitted by one or more antennas of the intra-body device, or power levels of wireless data transmissions received by the one or more antennas of the intra-body device; establishing a slip likelihood based on the processed values (par. 0040: previously stored/historical baseline values or weighted average of the ECAP signals determined for each electrode, wherein divergence from the reference value is indicative of the likelihood of electrode migration), the slip likelihood being a likelihood of the intra-body device having slipped out from a cavity of a person (electrode migration out of the cochlea); detecting that the slip likelihood has reached or exceeded a predetermined level (pars. 0013, 0040: measured ECAP signal compared to previously determined ECAP threshold); in response to detecting that the slip likelihood has reached or exceeded the predetermined level, identifying that the intra-body device has slipped out from the cavity of the person (electrode migration out of the cochlear cavity determined); and controlling a tracking procedure of the system based on identifying that the intra-body device has slipped out from the cavity of the person (par. 0047: electrode migration unit issues alarm).
Regarding claim 4, see par. 0047.
Regarding claim 5, note the rejection under §112 above. The slip likelihood is computed based on at least one probability of existence of slippage. A slip is more likely, for example, when the measured signal compared to a calculated weighted average baseline value significantly diverges from the baseline value (par. 0040).
Regarding claim 6, Hamacher associates at least one predetermined relationship between some or all processed values (weighted average of measured ECAP values) and the probability of slippage (the divergence between the weighted baseline and measured/processed values of the ECAP signals/data indicating the probability of slippage).
Regarding claim 7, the probability of slippage of each electrode or a plurality of electrodes (e.g., at least the basal electrodes) is determined (see Fig. 5) wherein both a shift in electrode response and an increase in neural response threshold may indicate probabilities that the electrodes have shifted, as well as grounding effects and impedance measurements (see pars. 0041-0045). Hamacher teaches that impedance measurements alone may not be reliable (par. 0045), and thus includes additional measures of probabilities. The combination of probabilities is considered an aggregate probability establishing slip likelihood.
Regarding claim 8, Hamacher teaches that significant deviations from the baseline may indicate electrode migration out of the body cavity. A significant deviation is thus given more weight than a comparatively small deviation in determining the existence of slippage. It is further noted that claim 8 includes the weighing of a single probability.
Allowable Subject Matter
Claims 2, 3, 15-17 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
There is no suggestion in the art of record for modifying the Hamacher invention to comprise a pelvic floor muscle tracking system for a vagina or anus of a person (claims 2, 3, 15, 19). Nor is there a teaching in the art of record for, prior to detecting that the slip likelihood has reached or exceeded the predetermined level, causing a notification indicating that the intra-body device will potentially slip out from the cavity (claim 16). There is further no teaching to modify Hamacher to include a motion sensor and a pressure sensor to process acceleration values (claim 17).
Claims 9-14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
There is no motivation to modify Hamacher to include: adjusting a maximum limit for one or more probabilities based on at least one of the exercise to be performed or the person to perform the exercise (claim 9); a motion sensor for processing angular velocity values wherein the probability of the existence of slippage relates to the processed angular velocity values (claim 10); a pressure sensor wherein the probability of existence of slippage relates to the processed pressure values (claim 11); an acceleration sensor wherein the probability of the existence of slippage relates to the processed acceleration values (claim 12); or, a temperature sensor wherein the probability of the existence of slippage relates to the processed temperature values (claims 13 and 14).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ishikawa ‘247 discloses an anatomic position sensing system determining relative position between transmitter and receiver structure. Sample ‘238 discloses a pressure sensor for vaginal contractions. Maurer ‘577 discloses a pelvic reflex stimulator including means for preventing movement of the stimulating electrodes out of the body.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached 2nd Monday of the biweek and W-F.
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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
June 18, 2026
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