DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Terminal Disclaimer
The terminal disclaimer filed on 22 January 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent Nos. 8,805,512; 8,938,297; 8,942,816; 8,965,511; 9,314,399; 9,566,213; 9,566,212; 9,949,893; 10,299,987; 10,792,219 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 October 2025, with respect to the rejection(s) of claim(s) 1 – 20 under 35 U.S.C. § 102/103 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 Therefore, the rejection has been withdrawn.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 the rejections under 35 U.S.C. § 103 below.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 1 – 4, 6, 7, 11 – 14, 16, and 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cox et al. (USPN 6,141,588 – previously cited) in view of Hastings et al. (US PGPUB 2011/0307034).
Regarding claims 1 and 11, Cox discloses a method and an implantable stimulator (e.g. 200 in Figs.1, 6 – 7), comprising: a housing (e.g. 254 in Figs. 6 – 7); a central electrode (e.g. 203 in Fig. 6) of a first polarity and centrally located on a first surface of the housing (e.g. 254); a single annular electrode (e.g. 202) of a second polarity and that surrounds the central electrode (e.g. 203) on the first surface of the housing (e.g. 254), the singular annular electrode being spaced apart from the central electrode (e.g. Fig. 6); and pulse generation circuitry (e.g. 206 in Fig.7) located within the housing, the pulse generation circuitry configured to apply the-stimulation sessions by way of the central electrode and the annular electrode to a location, within the patient (Col.13, lines 44 – 56). Cox fails to teach that the central electrode is a smooth surface electrode without any sharp or pointed edges.
Hastings teaches it is known to use an implantable stimulator having a central electrode that is a smooth surface electrode without any sharp or pointed edges (e.g. 54 in Fig. 6C). It would have been obvious to one having ordinary skill in the art to modify the central electrode as taught by Cox with the smooth electrode as taught by Hastings, since such a modification would provide the predictable results of allowing the central electrode to effectively contact the target tissue.
Regarding claims 2 and 12, Cox discloses a rechargeable battery within the housing and configured to provide power to the pulse generation circuitry (Col.10, lines 66 – 67 and col. 11, lines 1 – 6).
Regarding claims 3 and 13, Cox discloses a receiver circuit (222 in Fig.5) within the housing and configured to receive, from an external controller (300 in Fig.1), a power signal configured to recharge the rechargeable battery (Col.10, lines 66 - 67 & col. 11, lines 1 – 6).
Regarding claims 4 and 14, Cox discloses a primary battery within the housing and configured to provide power to the pulse generation circuitry (Col. 10, lines 66 - 67 and col. 11, lines 1 – 6).
Regarding claims 6 and 16, Cox discloses wherein the housing of the implantable stimulator is coin-sized and coin-shaped (e.g. element 200 in Fig.1).
Regarding claims 7 and 17, Cox discloses the annular electrode (e.g. 200 in fig.6-7) is located on the first surface of the housing (e.g. 254 in fig.6 – 7 and col. 14, lines 13 – 15).
Claims 5, 9 – 10, 15 and 19 – 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cox et in view of Hastings et al. al as applied to claims 1 and 11 above, and further in view of Gelfand et al (USPN 7,373,204 – previously cited).
Regarding claims 5, 9 – 10, 15 and 19 – 20, Cox in view of Hastings discloses substantially the invention as claimed but failed to disclose wherein the primary battery has an internal impedance greater than 5 ohms, wherein the implantable stimulator is configured to be implanted at an acupoint PC6 and wherein the location comprises a median nerve of the patient.
However, Gelfand discloses a small implantable electroacupuncture device (IEAD) powered by a small disc primary battery (col. 11, lines 36-49), and having an internal impedance of at least 5 ohms (col. 10, lines 62-65); Gelfand discloses implanting the IEAD below the skin surface of the patient at or near an acupoint selected from at least PC6, ST36 and LI11 (col. 14, lines 1-22). Gelfand discloses that treatment is performed by periodically stimulating a nerve such as a median nerve [abstract].
Thus, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify Cox in view of Hastings to have the primary battery with an internal impedance greater than 5 ohms, wherein the implantable stimulator is configured to be implanted at an acupoint PC6 and wherein the location comprises a median nerve of the patient in view of Gelfand teachings in order to provide electrical stimulation therapy.
Claims 8 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cox et al in view of Hastings et al. as applied to claims 1 and 11 above, and further in view of Gliner et al (US PGPUB 2003/0125786).
Regarding claims 8 and 18, Cox in view of Hastings discloses substantially the invention as claimed but fails to disclose wherein the annular electrode comprises a ring electrode located around a perimeter edge of the housing. However, Gliner discloses a stimulator 600 in fig.6 comprises a ring electrode (660b) located around a perimeter edge of the housing 612 [see fig.6;[0104]].
Thus, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify Cox in view of Hastings to have an annular electrode comprises a ring electrode located around a perimeter edge of the housing in view of Gliner teachings as such is a design choice.
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.
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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 3796