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 .
Terminal Disclaimer
The terminal disclaimer filed on 03 February 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,642,530 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s arguments, see Applicant Arguments/Remarks Made in an Amendment, filed 15 June 2026, with respect to the rejection(s) of claim(s) 34 – 37 and 39 – 41 under 35 U.S.C. § 102(a)(1) 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 Therefore, the rejection has been withdrawn.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 Naritoku et al. (US PGPUB 2002/0099418 – previously cited) in view of Tweden et al. (US PGPUB 2014/0316478).
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.
Claim(s) s 34 – 37 and 39 – 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naritoku et al. (US PGPUB 2002/0099418 – previously cited) in view of Tweden et al. (US PGPUB 2014/0316478).
Regarding claim 34¸ Naritoku teaches a system for modulating the plasticity and/or memory of the autonomic cardiac nervous system comprising a control unit communicatively connected to one or more components for delivering energy to a nerve (e.g. ¶ 76 – 77), wherein the control unit is configured to delivering of energy to a nerve via the one or more components (e.g. ¶ 76). Naritoku does not explicitly recite the target as a nerve or ganglion of the autonomic cardiac nervous system or that delivering energy comprises producing scalable block of efferent projecting axons to the heart.
Tweden teaches it is know to use a neuroregulatory to deliver electrical treatment signals to at least partially down-regulate neural activity on the nerve, including activity that affects heart rate and blood pressure (e.g. ¶ 58 – 59 and 64 – 65). In doing so, the control unit delivers energy comprising a scalable block of vagral fibers, including efferent fibers that project to the heart.
It would have been obvious to one having ordinary skill in the art to modify the invention as taught by Naritoku with the partial conduction block as taught by Tweden, since such a modification would provide the predictable results of titrating heart rate/blood pressure effect.
Regarding claims 35 – 37, Naritoku discloses one or more electrodes for measuring the activity of the nerve, measure biomarker levels, and stimulating electrodes for applying an electrical stimulus (e.g. ¶ 27 – 29 and 76 – 77).
Regarding claim 39, Naritoku discloses the delivered energy is selected from the group consisting of electrical energy, electromagnetic energy, acoustic energy, and thermal energy (¶ 27 – 29).
Regarding claims 40 – 42, Naritoku discloses the claimed invention except for the evaluation of block efficacy is done manually and/or done in a close looped fashion. Tweden teaches it is known that the evaluation of block efficacy is done manually and/or done in a close looped fashion (e.g. ¶ 38). It would have been obvious to one having ordinary skill in the art to modify the invention as taught by Naritoku with the partial conduction block as taught by Tweden, since such a modification would provide the predictable results of titrating heart rate/blood pressure effect.
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 JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3792
