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 arguments, see Applicant Arguments/Remarks Made in an Amendment, filed 13 June 2025, with respect to the rejection(s) of claim(s) 18 and 21 – 26 under 35 U.S.C. § 102/103 have been fully considered and are persuasive, in light of the amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Bhadra et al. (US PGPUB 2016/0101286 – previously cited) in view of Vallejo et al. (USPN 11,607,548).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 19, 20, and 27 – 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16 – 20 of U.S. Patent No. 11,027,126. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present application and the ‘126 patent claim a method for nerve block of a patient utilizing a capacitive chargeable electrode and dynamically sensing the amount of charge of the at least one implantable electrode, wherein the controller is further configured to receive data from the sensor and discontinue at least one of the first current or the second current when an amount of water is being electrolyzed. The claims of the ‘126 patent anticipated the claims of the present application.
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) 18 and 21 – 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bhadra et al. (US PGPUB 2016/0101286 – previously cited) in view of Vallejo et al. (USPN 11,607,548).
Regarding claim 18, 21, and 22¸ Bhadra discloses a method for nerve block of a patient utilizing a rechargeable electrode (e.g. ¶ 8), comprising: generating a first current of a first polarity through a titanium nitride implanted electrode (e.g. ¶ 58 – 60) proximate a nerve sufficient to at least partially block conduction in the nerve (e.g. ¶ 38 and 58), wherein the electrode generates current in an ionic component proximate the at least one electrode (e.g. ¶ 43 and 47) sufficient to create at least a partial block in the nerve and decrease the amount of stored charge in the implanted electrode (e.g. ¶ 38 and 58); and generating a second current of a second polarity opposite the first polarity through the implanted electrode, wherein the second current increases the amount of the stored charge of the implanted electrode to recharge the implanted electrode (e.g. ¶ 38 and 58). Bhadra further discloses the decrease and increase in amount of stored charge on the at least one electrode are not equal (e.g. ¶ 58; the biphasic current may not be fully balanced) and/or the decrease and increase in amount of stored charge on the at least one electrode are equal (e.g. ¶ 58; a balanced charge). Bhadra fails to teach that the transition from the first current to the second current comprises a smooth trapezoidal waveform. Vallejo teaches it is known to use a method for nerve block that include trapezoidal pulses having increasing or decreasing ramps in a continuous function (e.g. column 22, lines 42 – 55). The continuous function with a trapezoidal pulse would read on the smooth trapezoidal waveform. It would have been obvious to one having ordinary skill in the art to modify the trapezoidal waveforms as taught by Bhadra with the trapezoidal waveforms having a continuous function (i.e. smoot trapezoidal waveforms) as taught by Vallejo, since such a modification would provide the predictable results of avoiding unwanted generation of action potentials.
Regarding claim 23¸ Bhadra discloses the claimed invention except for specifically reciting the insulated enclosure. However, insulated enclosures are well known in the art. It would have been obvious to one having ordinary skill in the art to modify the invention of Bhadra with the insulated enclosure, since such a modification would provide the predictable results of preventing unwanted stimulation to surrounding tissue.
Regarding claim 24, Bhadra discloses titanium nitride as previously mentioned, but fails to explicitly recite porous or fractal titanium nitride. However, both porous and fractal titanium nitride are well known in the art. It would have been obvious to one having ordinary skill in the art to modify the titanium nitride as taught by Bhadra with the porous or fractal titanium nitride, since such a modification would provide the predictable results of generating more surface area for the electrochemical reactions to occur.
Regarding claims 25 and 26¸ Bhadra discloses the claimed invention except for delivering at least about 5,000µC or at least about 25,000 µC of charge into excitable tissue without damaging the excitable tissue. However, it is reminded that finding the optimal workable ranges requires only routine skill in the art. One of ordinary skill would have arrived at the claimed parameters through merely routine testing.
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