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 .
Response to Arguments
Applicant’s amendment and arguments filed 11/13/2025, with respect to the claim rejections set forth in the Non-Final Rejection dated 8/13/2025 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Galvani Bioelectronics Limited (WO 2021/116674) which is the WIPO publication of the previously applied Sridhar et al. (2023/0021801).
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 12 and 16-19 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.
Claim 1 has been amended to include the specific target site of “a terminal perineal branch of a pudendal nerve at a location where the terminal perineal nerve branch innervates an external urethral sphincter”. Applicant has disclosed targeting one or more terminal perineal branches this as a single embodiment in par. [0078] of the specification: “In other examples, systems and methods of the present disclosure are configured to apply stimulation to the perineal branch of the pudendal nerve 44 (e.g., targeting the terminal perineal branches of the pudendal nerve where they innervate the external urethral sphincter).”
Applicant discloses stimulating the base of the pudendal nerve as a separate embodiment as well, see par. [0079], with the key point being the word “OR”: “As a point of reference, some benefits of functional stimulation (e.g., at levels sufficient to cause muscular contraction) of the pudendal nerve base or posterior pudendal nerve (proximal the pudendal nerve branches, such as location A in FIGS. 4A-4E)” (emphasis added)
Applicant also discloses stimulation of the posterior pudendal nerve target as an alternative to stimulating the branches, see par. [0078], “With this anatomy in mind, in some examples, systems and methods of the present disclosure can include applying stimulation to a posterior region of the pudendal nerve 44 (e.g., targeting the pudendal nerve 44 posterior to where it enters Alcock's canal, for example by delivering a lead or the like through the buttocks). In other examples, systems and methods of the present disclosure are configured to apply stimulation to the perineal branch of the pudendal nerve 44 (e.g., targeting the terminal perineal branches of the pudendal nerve where they innervate the external urethral sphincter).” (emphasis added)
The same applies to the nerve root of the sphincter and directly to the sphincter muscle itself. Applicant has not provided a disclosure that combines stimulation form the various embodiments into a single embodiment.
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 1 and 15-19 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.
Claim 1 requires stimulation of a terminal perineal nerve branch. Claim 15 introduces applying stimulation to two terminal perineal nerve branches. It is unclear if one of these branches is the branch form Claim1 or if they are two additional branches, different from that of Claim 1.
Claims 12 and 16-19 are unclear in that the disclosure only targets terminal perineal nerve branch(es) OR any one of the other claimed locations. Therefore, it is unclear if the locations in claims 12 and 16-19 supersede and replace the target nerve as claimed in claim 1 or if Applicant is intending to target multiple nerves with a single embodiment.
Claim Rejections - 35 USC § 103
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 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 1, 12 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Galvani Bioelectronics Limited (WO 2021/116674), herein Galvani.
Regarding Claims 1 and 16-19, Galvani discloses causing contraction of the external urethral sphincter by stimulating the pudendal nerve and/or any of its branches (p. 11, lines 15-25), such as the perineal nerve in order to address a potential urinary stress incontinence (p. 16). Galvani does not explicitly mention “a terminal perineal nerve branch of the pudendal nerve at a location where the terminal perineal; nerve branch innervates an external urethral sphincter” as presently claimed. However, Galvani does disclose targeting the pudendal nerve (which as defined by Galvani also could include the perineal nerve) to selectively stimulate the external urethral sphincter (EUS) thus clearly targeting a part of the perineal nerve that innervates the EUS (p. 11, lines 20-31). Galvani also discloses that optimizing the placement of the electrodes along the pudendal nerve (which would include the perineal nerve as disclosed by Galvani) to obtain the desired effect can be a trial and error process performed by a skilled clinician (p. 12, lines 21-31).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to try and target a terminal perineal nerve at a location where the terminal perineal nerve branch innervates an external urethral sphincter since Galvani has provided a finite number of solutions (the perineal nerve dorsal genital nerve, sacral roots, se p. 11, lines 15-20) each having a reasonable expectation of success of selectively stimulating the EUS.
Galvani also discloses a routine optimization process of the target nerve (the perineal nerve) such that the location that provides the desired stimulation can be selected through a trial and error fitting process (pp. 35-37). Testing the claimed location of “a terminal perineal nerve at a location where the terminal perineal nerve branch innervates an external urethral sphincter” is well within the scope of the nerve area and stimulation result disclosed by Galvani, which is the same result claimed by Applicant. The claimed invention is an obvious variation of a routine optimization fitting process disclosed by Galvani.
This also applies to the other locations claimed for stimulation the EUS.
In regard to Claim 12, Galvani also discloses the inferior rectal nerve and/or the distal branch of the pudendal nerve such as the dorsal genital nerve can be targeted (p. 11, lines 15-20).
Regarding Claim 15, Galvani discloses multiple perineal locations can be tested and used (p. 12, lines 20-30
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 ALLEN PORTER whose telephone number is (571)270-5419. The examiner can normally be reached Mon - Fri 9:00-6:00 EST.
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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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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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