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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Species A, claims 1-13, in the reply filed on 11/4/25 is acknowledged.
Claims 14-23 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/4/25.
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) 1-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Romero-Ortega (US 2019/0290902).
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Regarding claim 1, Romero-Ortega discloses the same invention as claimed (Figures 1B and 2 shown above for example), including a method stimulating a nerve (abstract), the method comprising: providing a neuromodulation device having a channel that leads to a chamber having an electrode therein (Figure 1B); positioning a nerve at least partially inside the chamber (Figure 2); stimulating the nerve with the electrode using a first set of parameters configured to provide an afferent control signal (Paragraph 135); and stimulating the nerve with the electrode using a second set of parameters configured to provide an efferent control signal (Paragraph 135).
Regarding claim 2, Romero-Ortega discloses treating overactive bladder or fecal incontinence, or stress urinary incontinence as recited (Paragraphs 7-9, 17-18, 133).
Regarding claim 3, Romero-Ortega discloses an afferent stimulation between about 2-20 Hz as recited (Paragraphs 18, 24, 127, 130, 136, 156, 158, 168, 171, 174, 193, 199, 201, 227, 228, 233, 234).
Regarding claim 4, Romero-Ortega discloses afferent stimulation between 0.4-1.0 mA as recited (Paragraphs 16-18, 20, 21, 24, 27, 29, 113, 121, 127, 130, 199, 202, 227-229, 233-235).
Regarding claim 5, Romero-Ortega discloses afferent stimulation pulse duration between 200-300 microseconds as recited (Paragraphs 24, 27, 110, 127, 130, 199, 202, 227-229, 233-235).
Regarding claims 6-7, Romero-Ortega discloses treatment sessions as recited (Paragraphs 18, 114, 137, 174, 227, 228, 233, 234).
Regarding claim 8, Romero-Ortega discloses subthreshold treatment (Paragraphs 113, 127) and treating stress urinary incontinence or fecal incontinence as recited (Paragraphs 7-9, 17-18, 133).
Regarding claim 9, Romero-Ortega discloses an afferent stimulation between about 2-20 Hz as recited (Paragraphs 18, 24, 127, 130, 136, 156, 158, 168, 171, 174, 193, 199, 201, 227, 228, 233, 234).
Regarding claim 10, Romero-Ortega discloses afferent stimulation between 0.4-1.0 mA as recited (Paragraphs 16-18, 20, 21, 24, 27, 29, 113, 121, 127, 130, 199, 202, 227-229, 233-235).
Regarding claim 11, Romero-Ortega discloses afferent stimulation pulse duration between 200-300 microseconds as recited (Paragraphs 24, 27, 110, 127, 130, 199, 202, 227-229, 233-235).
Regarding claim 12, Romero-Ortega discloses treatment sessions as recited (Paragraphs 18, 114, 137, 174, 227, 228, 233, 234).
Regarding claim 13, Romero-Ortega discloses stimulating the perineal nerve (Paragraphs 129-134).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Grill (US 9,446,245) shows afferent and efferent stimulation.
Wei (US 2017/0239470) shows subthreshold stimulation for incontinence.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eugene T Wu whose telephone number is (571)270-5053. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eugene T Wu/Primary Examiner, Art Unit 3796