DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed December 23, 2025 have been fully considered but they are not persuasive.
Applicant argues that “neither of Bennett nor Mann disclose confirming that the monopolar needle electrode is positioned to stimulate the target nerve while minimizing contraction of muscle”(see pages 7-8 of Remarks). However, the examiner respectfully disagrees.
Bennett et al., and thus the modified Bennett et al., disclose “record the stimulation intensity at which the first sensation, first noticeable muscle contraction, and maximum tolerable muscle contraction occurs for both muscle A and muscle B” ([0117]). The first noticeable muscle contraction would be minimal contraction of the muscle prior to delivering increasing stimulation intensity to determine maximum tolerable stimulus intensity ([0115-0119]). As such, determining the stimulation that provides the minimal contraction initially would be “applying electrical stimulation to the monopolar needle electrode while minimizing contraction of muscle”, i.e. first noticeable muscle contraction, prior to “producing strong, visible, and palpable muscle contraction at a tolerable stimulus intensity”([0119]). Therefore, Bennett et al., and thus the modified Bennett et al., disclose “confirming that the monopolar needle electrode is positioned to stimulate the target nerve while minimizing contraction of muscle” and “applying electrical stimulation to the monopolar needle electrode while minimizing contraction of muscle”.
Therefore, for the reasons stated above and previously made of record, the claims remain rejected under the modified Bennett et al. as detailed below.
Terminal Disclaimer
The terminal disclaimer filed on December 23, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 10,668,285 and US 12,076,561 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 12/653029 and 12/653023, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Both applications fail to provide adequate support for the claimed subject matter of placing a monopolar needle electrode prior to the introduction of a coiled lead. However, Application No. 13/605653, a CIP of 12/653029 and 12/653023, does provide adequate support for the claimed subject matter of placing a monopolar needle electrode prior to the introduction of a coiled lead.
The disclosure of the prior-filed application, Application No. 13/294875, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. While the application does provide support for a needle electrode and a monopolar electrode disposed on a lead, the application fails to provide adequate support for “a monopolar needle electrode”.
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 11-30 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 11 recites “confirming that the monopolar needle electrode is positioned to stimulate the target nerve while minimizing contraction of muscle”; Claim 19 recites “applying electrical stimulation to the monopolar needle electrode while minimizing contraction of muscle” and Claim 27 “delivering electrical stimulation through the monopolar needle electrode while minimizing contraction of muscle”.
While there is support in the specification for employing a “monopolar needle electrode” (US 20250269172 A1; [0232, 0236]) and “comfortable paresthesia” which may not evoke muscle contractions (US 20250269172 A1; [0237, 0240]) there is no support for applying stimulation or stimulating “a target nerve while minimizing contraction of muscle”. There are no means or parameters described in the specification for “minimizing contraction of muscle” through electrical stimulation of a target nerve.
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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).
Claims 11, 13-19 and 21-30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bennett et al. (US 20100036454 A1) in view of Mann et al. (US 20020055761 A1).
As to claims 11 and 19, Bennett et al. discloses inserting an introducer needle into tissue ([0050, 0139, 0144]), wherein the introducer needle comprises a proximal end and a distal portion, wherein the distal portion forms a terminal opening ([0129, 0139, 0144, 0151-0152]); inserting a needle electrode into the tissue ([0044]), wherein a distal portion of the needle electrode is positioned to stimulate a target nerve ([0095, 0112-0113]); applying electrical stimulation to the needle electrode ([0044-0045, 0114-0115]); confirming that the needle electrode is positioned to stimulate the target nerve ([0045, 0095, 0115-00119]); and inserting a coiled lead through the introducer needle until an electrode positioned on a distal portion of the coiled lead is in a stimulation position capable of stimulating the target nerve ([0129-0130, 0139]). Bennett et al. discloses the invention substantially as claimed but does not explicitly disclose the needle electrode is a monopolar needle electrode. Mann et al. discloses “monopolar needle electrodes” for test stimulation and location (Mann et al., [0108-0109]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the needle electrodes of Bennett et al. with monopolar needle electrodes as disclosed by Mann et al. in order to provide the predictable results of using medical components and techniques known in the art for perform test stimulation to confirm proper lead and/or catheter location, to confirm response, and/or to determine preliminary stimulator settings (Mann et al. [0108]).
Additionally, as to claims 11 and 19, Bennett et al., and thus the modified Bennett et al., disclose “record the stimulation intensity at which the first sensation, first noticeable muscle contraction, and maximum tolerable muscle contraction occurs for both muscle A and muscle B” ([0117]). The first noticeable muscle contraction would be minimal contraction of the muscle prior to delivering increasing stimulation intensity to determine maximum tolerable stimulus intensity ([0115-0119]). As such, determining the stimulation that provides the minimal contraction initially would be “applying electrical stimulation to the monopolar needle electrode while minimizing contraction of muscle”, i.e. first noticeable muscle contraction, prior to “producing strong, visible, and palpable muscle contraction at a tolerable stimulus intensity”([0119]). Therefore, Bennett et al., and thus the modified Bennett et al., disclose “confirming that the monopolar needle electrode is positioned to stimulate the target nerve while minimizing contraction of muscle” and “applying electrical stimulation to the monopolar needle electrode while minimizing contraction of muscle”.
As to claim 13 and 24, the modified Bennet et al. discloses confirmation that the monopolar needle electrode is positioned to stimulate the target nerve comprises observing muscle responses (Bennett et al., [0095, 0101-0105, 0115-0119]).
As to claim 14 and 25, the modified Bennet et al. discloses the insertion of the coiled lead through the introducer needle until the electrode is positioned to stimulate the target nerve comprises imaging to guide the electrode to the stimulation position (Bennett et al., [0131]).
As to claim 15 and 26, the modified Bennet et al. discloses the insertion of the coiled lead through the introducer needle until the electrode is positioned to stimulate the target nerve comprises observing muscle responses upon application of electrical stimulation through the electrode (Bennett et al., [0130]).
As to claims 16-18, the modified Bennet et al. discloses the invention substantially as claimed but does not explicitly disclose the stimulation to a “nerve trunk of the target nerve” or “nerve branch of the target nerve”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the treatment target location of the modified Bennett et al. to include a nerve trunk or nerve branch in order to provide the predictable results of optimize treatment location to meet specific patient therapeutic needs and requirements.
As to claim 21, the modified Bennet et al. discloses applying electrical stimulation via an external pulse generator to treat pain through the electrode (Bennett et al., [0041, 0047, 0078]).
As to claim 22, the modified Bennet et al. discloses the coiled lead is inserted percutaneously into muscle tissue (Bennett et al., [0036, 0096].
As to claim 23, the modified Bennet et al. discloses replacing the coiled lead with a second coil lead that is implanted; connecting the second coiled lead with an implanted pulse generator; and applying electrical stimulation to the target nerve through the second coiled lead via the implanted pulse generator ([0076-0079, 0090]).
As to claim 27, the modified Bennet et al. discloses inserting monopolar needle electrode (Bennett et al., [0044]; the modified Bennett et al. discloses a monopolar needle electrode, see above) into a target tissue region to stimulate a nerve (Bennett et al., [0095, 0112-0113]); delivering electrical stimulation through the monopolar needle electrode (Bennett et al., [0044-0045, 0114-0115]); confirming stimulation of the nerve (Bennett et al., [0045, 0095, 0115-00119]); installing a coiled lead into an introducer needle (Bennett et al., [0129-0130, 0139]), wherein the introducer needle comprises a proximal end and a distal portion, wherein the distal portion forms a terminal opening (Bennett et al., [0129, 0139, 0144, 0151-0152]); inserting the introducer into the target tissue region (Bennett et al., [0129-0130, 0139]); and depositing the lead into the targeted tissue region as the introducer needle is withdrawn from the target tissue region (Bennett et al., Figures 13-15; [0151, 0153]).
Additionally, the modified Bennett et al., disclose “record the stimulation intensity at which the first sensation, first noticeable muscle contraction, and maximum tolerable muscle contraction occurs for both muscle A and muscle B” (Bennett et al., [0117]). The first noticeable muscle contraction would be minimal contraction of the muscle prior to delivering increasing stimulation intensity to determine maximum tolerable stimulus intensity (Bennett et al., [0115-0119]). As such, determining the stimulation that provides the minimal contraction initially would be “delivering electrical stimulation through the monopolar needle electrode while minimizing contraction of muscle”, i.e. first noticeable muscle contraction, prior to “producing strong, visible, and palpable muscle contraction at a tolerable stimulus intensity”([0119]). Therefore, Bennett et al., and thus the modified Bennett et al., discloses “delivering electrical stimulation to the monopolar needle electrode while minimizing contraction of muscle”.
As to claim 28, the modified Bennet et al. discloses confirmation that the monopolar needle electrode is positioned to stimulate the target tissue region comprises observing muscle responses (Bennett et al., [0095, 0101-0105, 0115-0119]).
As to claim 29, the modified Bennet et al. discloses applying electrical stimulation to a target nerve in the target tissue region; and observing muscle responses upon application of the electrical stimulation confirming that the lead is in a stimulation position relative to the target nerve to treat pain (Bennett et al., [0057-0059, 0096]).
As to claim 30, the modified Bennet et al. discloses applying electrical stimulation via an external pulse generator to treat pain through the lead (Bennett et al., [0041, 0047, 0078]).
Claims 12 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over the modified Bennett et al., as applied to claims 11, 13-19 and 21-30 above, in further view of Lunn et al. (US 5997508 A). The modified Bennet et al. discloses the invention substantially as claimed but does not explicitly disclose the introducer needle includes a Luer hub on the proximal end. Lunn et al. discloses “an introducer sheath contains an access lumen for introduction of interventional devices, a Luer hub for connection to syringes and other peripheral devices” (col. 1, lines 34-36). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the introducer of the modified Bennett et al. to include a Luer hub as disclosed by Lunn et al. in order to provide the predictable results of incorporating a connection to syringes to enable a local anesthetic to be administer subcutaneously to the area in which the lead and/or introducer(s) will be inserted (Bennett et al., [0102]; Lunn et al., col. 1, lines 34-36).
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 ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796