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 .
Election/Restrictions
2. Applicant’s election of Group I in the reply filed on 4/29/2026 is acknowledged. In light of the amendments, the restriction requirement between Group I and Group II, as set forth in the office action mailed on 1/29/2026, is hereby withdrawn. Therefore, claims 1-36 are pending.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-32 and 34-36 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Shahriari et al. (US Pub.: 2021/0016087 A1).
Regarding claim 1, Shahriari discloses a method of controlling an electrical stimulation to a pelvic region of a subject (e.g. abstract), the method comprising of:
receiving, by an Electrical Stimulation System (ESS) (e.g. Fig. 18 – pelvic stimulation system 1800),
one or more inputs for initiating a session (e.g. paragraphs 0150, 0155);
receiving throughout the session, by the ESS (1800), at least one of, an activity level of a plurality of muscles in and around the pelvic region, an orientation of one or more of the plurality of muscles, and a body posture of the subject (e.g. paragraphs 0150, 0155 – EMG sensors detecting muscle contraction);
and controlling, by the ESS (1800), the electrical stimulation to the pelvic region based on at least one of, the activity level of the plurality of muscles, the orientation of one or more of the plurality of muscles, and the body posture of the subject (e.g. paragraphs 0019, 0155, – electrical stimulation is applied based on the amount of muscle contraction).
Regarding claim 2, Shahriari discloses the method as claimed in claim 1 as discussed above, and Shahriari further teaches wherein the one or more inputs are received from at least one of, a User Equipment (UE) (e.g. Fig. 3 – computer 300; paragraphs 0097, 0155) communicatively coupled with the ESS (1800) and a User Interface (UI) (e.g. Fig. 18 – GUI 1816) of the ESS (e.g. paragraph 0155).
Regarding claim 3, Shahriari discloses the method as claimed in claim 1 as discussed above, and Shahriari further teaches wherein the one or more inputs comprises at least one of, initiating the session and selection of one or more operating modes (e.g. paragraphs 0153, 0155).
Regarding claim 4, Shahriari discloses the method as claimed in claim 3 as discussed above, and Shahriari further teaches wherein the one or more operating modes comprise a stimulation mode and an exercise mode (e.g. paragraph 0150).
Regarding claim 5, Shahriari discloses the method as claimed in claim 1 as discussed above, and Shahriari further teaches wherein the plurality of muscles comprises at least one of, pelvic floor muscles and abdominal muscles of the subject (e.g. paragraphs 0026 – abdominal muscles; 0150 – pelvic floor muscles).
Regarding claim 6, Shahriari discloses the method as claimed in claim 1 as discussed above, and Shahriari further teaches wherein the receiving comprises at least one of, receiving at least one of, the activity level of the plurality of muscles, the orientation of one or more of the plurality of muscles, and the body posture of the subject from a determination unit associated with the ESS (e.g. paragraphs 0150, 0155),
wherein the determination unit is configured to determine at least one of, the activity level of the plurality of muscles, the orientation of one or more of the plurality of muscles, and the body posture of the subject (e.g. paragraphs 0150, 0155);
and receiving at least one of, the activity level of the plurality of muscles, the orientation of one or more of the plurality of muscles, and the body posture of the subject from a determination unit associated with the ESS from a machine learning model (e.g. paragraph 0156).
Regarding claim 7, Shahriari discloses the method as claimed in claim 6 as discussed above, and Shahriari further teaches wherein determining at least one of, the activity level of the plurality of muscles, the orientation of one or more of the plurality of muscles, and the body posture of the subject (e.g. paragraphs 0150, 0155) comprises:
determining whether one or more inputs pertains to a stimulation mode (e.g. paragraphs 0155-0156);
monitoring (e.g. paragraph 0149) at least one of:
signals associated with the plurality of muscles by one or more first electrodes to determine the activity level of the plurality of muscles of the subject (e.g. paragraphs 0149, 0155);
orientation of one or more of the plurality of muscles by one or more orientation sensors (e.g. this limitation is in the alternate. Monitoring signals associated with the plurality of muscles is addressed above); and the body posture of the subject by the one or more orientation sensors (e.g. this limitation is in the alternate. Monitoring signals associated with the plurality of muscles is addressed above).
Regarding claim 8, Shahriari discloses the method as claimed in claim 7 as discussed above, and Shahriari further teaches wherein each of the one or more first electrodes placed adjacent to the pelvic region of the subject (e.g. paragraphs 0151-0152).
Regarding claim 9, Shahriari discloses the method as claimed in claim 1 as discussed above, and Shahriari further teaches wherein controlling the electrical stimulation to the pelvic region (e.g. paragraph 0150) comprises:
triggering a pulse generator unit configured in the ESS upon determining that the one or more inputs pertains to a stimulation mode (e.g. paragraphs 0041, 0155);
controlling the pulse generator unit to generate an electrical current based on at least one of, the activity level of the plurality of muscles, the orientation of one or more of the plurality of muscles and the body posture of the subject (e.g. paragraphs 0041, 0155); and providing the electrical stimulation to the pelvic region based on the electrical current through one or more second electrodes configured in the ESS (e.g. paragraphs 0041, 0155).
Regarding claim 10, Shahriari discloses the method as claimed in claim 9 as discussed above, and Shahriari further teaches wherein the pulse generator unit is controlled to maintain the activity level of one or more of the plurality of muscles at a value (e.g. paragraphs 0041, 0155).
Regarding claim 11, Shahriari discloses the method as claimed in claim 9 as discussed above, and Shahriari further teaches wherein each of the one or more second electrodes is a stimulation electrode and is placed in and around at least one of the pelvic, the perineum, the coccyx, the sacrum, the upper thigh, and the abdominal region of the subject (e.g. paragraphs 0151-0152).
Regarding claim 12, Shahriari discloses the method as claimed in claim 6 as discussed above, and Shahriari further teaches further comprises:
determining whether one or more inputs pertains to an exercise mode (e.g. paragraphs 0155-0156);
monitoring the signals associated with the plurality of muscles of the subject by the one or more first electrodes while the subject is performing exercises involving the plurality of muscles in and around the pelvic region (e.g. paragraphs 0149, 0155);
determining the activity level of the plurality of muscles based on the signals (e.g. paragraphs 0149, 0155);
generating a biofeedback indicating contraction of the plurality of muscles based on the activity level (e.g. paragraphs 0153, 0155);
and providing the biofeedback to the UE (e.g. paragraphs 0154-0155).
Regarding claim 13, Shahriari discloses the method as claimed in claim 1 as discussed above, and Shahriari further teaches further comprises:
receiving, by the ESS, one or more electrical stimulation parameter values from one of, a User Equipment (UE) communicatively coupled with the ESS and a User Interface (UI) of the ESS (e.g. paragraphs 0154-0155);
controlling the pulse generator unit to generate the electrical current based on the current intensity value (e.g. paragraphs 0041, 0155); and providing the electrical stimulation to the pelvic region based on the electrical current through the one or more second electrodes (e.g. paragraphs 0151-0152).
Regarding claim 14, Shahriari discloses the method as claimed in claim 1 as discussed above, and Shahriari further teaches further comprises:
transmitting at least one of, information associated with the activity level of the plurality of muscles, information associated with the orientation of one or more of the plurality of muscles, information associated with the body posture of the subject and information associated with the electrical current monitored throughout the session to the UE (e.g. paragraphs 0154-0155).
Regarding claim 15, Shahriari discloses the method as claimed in claim 1 as discussed above, and Shahriari further teaches further comprises:
generating a report for the session comprising at least one of, information associated with the activity level of the plurality of muscles, information associated with the orientation of one or more of the plurality of muscles, information associated with the body posture of the subject and information associated with the electrical current monitored throughout the session (e.g. paragraphs 0037, 0150);
and transmitting the generated report to the UE (e.g. paragraphs 0037, 0150).
Regarding claim 16, Shahriari discloses an Electrical Stimulation System (ESS) (e.g. Fig. 18 – pelvic stimulation system 1800) for controlling an electrical stimulation to a pelvic region of a subject (e.g. abstract), the ESS (1800) comprises:
a processor (e.g. paragraphs 0093, 0155);
and a memory communicatively coupled to the processor (e.g. paragraphs 0093, 0155), wherein the memory stores the processor-executable instructions, which, on execution (e.g. paragraphs 0093, 0155), causes the processor to:
receive one or more inputs for initiating a session (e.g. paragraphs 0150, 0155);
receive throughout the session at least one of, an activity level of a plurality of muscles in and around the pelvic region, an orientation of one or more of the plurality of muscles, and a body posture of the subject (e.g. paragraphs 0150, 0155 – EMG sensors detecting muscle contraction);
and control the electrical stimulation to the pelvic region based on at least one of, the activity level of the plurality of muscles, the orientation of one or more of the plurality of muscles, and the body posture of the subject (e.g. paragraphs 0019, 0155, – electrical stimulation is applied based on the amount of muscle contraction).
Regarding claim 17, Shahriari discloses the ESS as claimed in claim 16 as discussed above, and Shahriari further teaches wherein the one or more inputs are received from at least one of, a User Equipment (UE) (e.g. Fig. 3 – computer 300; paragraphs 0097, 0155) communicatively coupled with the ESS (1800) and a User Interface (UI) of the ESS (e.g. paragraph 0155).
Regarding claim 18, Shahriari discloses the ESS as claimed in claim 16 as discussed above, and Shahriari further teaches wherein the one or more inputs comprises at least one of, initiating the session and selection of one or more operating modes (e.g. paragraphs 0153, 0155).
Regarding claim 19, Shahriari discloses the ESS as claimed in claim 16 as discussed above, and Shahriari further teaches wherein the one or more operating modes comprise a stimulation mode and an exercise mode (e.g. paragraph 0150).
Regarding claim 20, Shahriari discloses the ESS as claimed in claim 16 as discussed above, and Shahriari further teaches wherein the plurality of muscles comprises at least one of pelvic floor muscles and abdominal muscles of the subject (e.g. paragraphs 0026 – abdominal muscles; 0150 – pelvic floor muscles).
Regarding claim 21, Shahriari discloses the ESS as claimed in claim 16 as discussed above, and Shahriari further teaches wherein the processor is configured to, receiving at least one of, the activity level of the plurality of muscles, the orientation of one or more of the plurality of muscles, and the body posture of the subject from a determination unit associated with the ESS (e.g. paragraphs 0150, 0155), wherein the determination unit is configured to determine at least one of, the activity level of the plurality of muscles, the orientation of one or more of the plurality of muscles, and the body posture of the subject (e.g. paragraphs 0150, 0155);
and receiving at least one of, the activity level of the plurality of muscles, the orientation of one or more of the plurality of muscles, and the body posture of the subject from a determination unit associated with the ESS from a machine learning model (e.g. paragraph 0156).
Regarding claim 22, Shahriari discloses the ESS as claimed in claim 21 as discussed above, and Shahriari further teaches wherein the processor is configured to: determine whether the one or more inputs pertains to a stimulation mode (e.g. paragraphs 0155-0156);
monitor (e.g. paragraph 0149) at least one of:
signals associated with the plurality of muscles by one or more first electrodes to determine the activity level of the plurality of muscles of the subject (e.g. paragraphs 0149, 0155);
the orientation of one or more of the plurality of muscles by one or more orientation sensors (e.g. this limitation is in the alternate. Monitoring signals associated with the plurality of muscles is addressed above); and the body posture of the subject by the one or more orientation sensors (e.g. this limitation is in the alternate. Monitoring signals associated with the plurality of muscles is addressed above).
Regarding claim 23, Shahriari discloses the ESS as claimed in claim 22 as discussed above, and Shahriari further teaches wherein each of the one or more first electrodes is placed adjacent to the pelvic region of the subject (e.g. paragraphs 0151-0152).
Regarding claim 24, Shahriari discloses the ESS as claimed in claim 16 as discussed above, and Shahriari further teaches wherein the processor is configured to: trigger a pulse generator configured in the ESS upon determining that the one or more inputs pertains to the stimulation mode (e.g. paragraphs 0041, 0155);
control the pulse generator to generate an electrical current based on at least one of, the activity level of the plurality of muscles, the orientation of one or more of the plurality of muscles and the body posture of the subject (e.g. paragraphs 0041, 0155); and provide the electrical stimulation to the pelvic region of the subject based on the electrical current through one or more second electrodes configured in the ESS (e.g. paragraphs 0041, 0155).
Regarding claim 25, Shahriari discloses the ESS as claimed in claim 24 as discussed above, and Shahriari further teaches wherein the processor controls the pulse generator unit maintain the activity level of one or more of the plurality of muscles at a value (e.g. paragraphs 0041, 0155).
Regarding claim 26, Shahriari discloses the ESS as claimed in claim 24 as discussed above, and Shahriari further teaches wherein each of the one or more second electrodes is a stimulation electrode, and is placed adjacent to the pelvic region of the subject (e.g. paragraphs 0151-0152).
Regarding claim 27, Shahriari discloses the ESS as claimed in claim 16 as discussed above, and Shahriari further teaches wherein the processor is configured to: determine whether the one or more inputs pertains to an exercise mode (e.g. paragraphs 0155-0156);
monitor the signals associated with the plurality of muscles of the subject by the one or more first electrodes while the subject is performing exercises involving the plurality of muscles in and around the pelvic region (e.g. paragraphs 0149, 0155);
determine the activity level of the plurality of muscles based on the signals (e.g. paragraphs 0149, 0155);
generate a biofeedback indicating contraction of the plurality of muscles based on the activity level (e.g. paragraphs 0153, 0155);
and provide the biofeedback to the UE (e.g. paragraphs 0154-0155).
Regarding claim 28, Shahriari discloses the ESS as claimed in claim 16 as discussed above, and Shahriari further teaches wherein the processor is configured: receive one or more electrical stimulation parameter values from one of, a User Equipment (UE) communicatively coupled with the ESS and a User Interface (UI) of the ESS (e.g. paragraphs 0154-0155);
control the pulse generator to generate the electrical current based on the current intensity value (e.g. paragraphs 0041, 0155); and provide the electrical stimulation to the pelvic region based on the electrical current through the one or more second electrodes (e.g. paragraphs 0151-0152).
Regarding claim 29, Shahriari discloses the ESS as claimed in claim 16 as discussed above, and Shahriari further teaches wherein the processor is configured to: transmit at least one of, information associated with the activity level of the plurality of muscles, information associated with the orientation of one or more of the plurality of muscles, information associated with the body posture of the subject and information associated with the electrical current monitored throughout the session to the UE (e.g. paragraphs 0154-0155).
Regarding claim 30, Shahriari discloses the ESS as claimed in claim 16 as discussed above, and Shahriari further teaches wherein the processor is configured to: generate a report for the session comprising at least one of, information associated with the activity level of the plurality of muscles, information associated with the orientation of one or more of the plurality of muscles, information associated with the body posture of the subject and information associated with the electrical current monitored throughout the session (e.g. paragraphs 0037, 0150);
and transmit the generated report to the UE (e.g. paragraphs 0037, 0150).
Regarding claim 31, Shahriari discloses the method of claim 1 as discussed above, and Shahriari further teaches an electronic wearable unit (e.g. Fig. 18 – pelvic stimulation system 1800) for controlling an electrical stimulation to a pelvic region of a subject (e.g. abstract, paragraph 0154), the electronic wearable unit (1800) comprises:
one or more non-electronic wearable parts (e.g. paragraph 0153);
and wherein said one or more electronic wearable parts comprising comprise at least a part of an Electrical Stimulation System (ESS) (e.g. paragraph 0149), wherein the ESS is configured to perform the method as claimed in claim 1 (see rejection of claim 1 above).
Regarding claim 32, Shahriari discloses the electronic wearable unit as claimed in claim 31 as discussed above, and Shahriari further teaches further comprising one or more interlocks for removably attaching the electronic wearable part from the non-electronic wearable part (e.g. paragraph 0153).
Regarding claim 34, Shahriari discloses a method for rehabilitation of pelvic region of a subject by controlling an electrical stimulation to the pelvic region (e.g. abstract, paragraph 0150), the method comprising:
receiving, by an Electrical Stimulation System (ESS) (e.g. Fig. 18 – pelvic stimulation system 1800), one or more inputs for initiating a session (e.g. paragraphs 0150, 0155);
receiving throughout the session, by the ESS (1800), at least one of, an activity level of a plurality of muscles in and around the pelvic region, an orientation of one or more of the plurality of muscles, and a body posture of the subject (e.g. paragraphs 0150, 0155 – EMG sensors detecting muscle contraction);
and controlling, by the ESS (1800), the electrical stimulation to the pelvic region based on at least one of, the activity level of the plurality of muscles, the orientation of one or more of the plurality of muscles, and the body posture of the subject (e.g. paragraphs 0019, 0155, – electrical stimulation is applied based on the amount of muscle contraction).
Regarding claim 35, Shahriari discloses the method of claim 1 as discussed above, and Shahriari further teaches a method of managing a disorder associated with pelvic region of a subject (e.g. paragraphs 0019, 0150), said method comprising rehabilitation of the pelvic region by controlling an electrical stimulation to the pelvic region (e.g. paragraphs 0150, 0155) by method as claimed in claim 1 (see rejection of claim 1 above).
Regarding claim 36, Shahriari discloses the method as claimed in claim 35 as discussed above, and Shahriari further teaches wherein the disorder is selected from a group comprising conditions related to bladder, weak pelvic floor muscles, weak sphincter muscles, nerve injury, requirement of sacral nerve, pudendal nerve, avulsion of a muscle, rupture of connective tissue under the skin of pelvic floor and one or more conditions related to pelvic floor dysfunction comprising, urinary incontinence, anal and fecal incontinence, urinary frequency, weak vaginal muscle tone, pelvic surgeries, pelvic organ prolapse, and sexual dysfunction, or any combination thereof (e.g. paragraph 0019 – urinary incontinence; paragraph 00150, – weak pelvic floor muscles).
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.
Claim 33 is rejected under 35 U.S.C 103 as being unpatentable over Shahriari and further in view of Franklin et al. (US Pub.: 2023/0225898 A1).
Regarding claim 33, Shahriari discloses the electronic wearable unit as claimed in claim 31 as discussed above. However, Shahriari does not explicitly teach that the electronic wearable unit further comprises a crotch part for removably attaching a urine collecting device.
Franklin, in a same field of endeavor of wearable garments pertaining to the pelvic region, discloses a crotch part for removably attaching a urine collecting device (e.g. Fig. 3A – crotch portion 14 and conduit 108; paragraphs 0031-0032).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electronic wearable unit of Shahriari to incorporate a crotch part for removably attaching a urine collecting device, as taught and suggested by Franklin, in order to provide the predictable results of improved hygiene and patient comfort as well as to assist clinicians with monitoring or clinical testing pertaining to urination processes (Franklin, paragraph 0002).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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