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 .
Election/Restrictions
Applicant's election with traverse of claims 35, 37-39, 41-42, 44, and 46-49 in the reply filed on 06/22/2026 is acknowledged. The traversal is on the ground(s) that claim 42 read on elected species and generic to the identified species. This is found persuasive and will be examiner below.
The rest of the requirement is still deemed proper and is therefore made FINAL.
Claims 36, 40, 43, 45, and 50-56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species and invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/22/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/11/2024 and 06/22/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 37-39, 41-42, 44, and 46-49 objected to because of the following informalities: the phrase “The method of Claim 35” should have the term “Claim” is lowercase letters and should be amended to recite “The method of claim X”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 39 is 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.
Regarding claim 39, it is unclear of the “EMG response” of line 2 is the same or different than the “EMG response” of claim 35 line 5.
Claim Rejections - 35 USC § 103
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.
Claim(s) 35, 37-39, 41, and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siegel et al. (US 20070173900)(Hereinafter Siegel) in view of Jiang et al. (US 20160045747)(Hereinafter Jiang).
Regarding claim 35, Siegel teaches A method for securing an electrode lead to a tissue near a pudendal nerve of a patient (Abstract “The disclosure is directed to a method and tool for implanting a stimulation lead or other medical device adjacent a pudendal nerve.”), the method comprising:
inserting a needle toward an ischial spine ([0042] “Inserting needle 30 into pelvis 10 with a transobturator procedure may be beneficial over other methods to reach pudendal nerve 40.” Examiner notes that although the ischial spine is found posterior (back) side, accessing the ischial spine anterior (front) side, via the transobturator procedure is inserting the needle toward the ischial spine, as the physical direction is still towards the ischial spine, just the opposite side of the location of the ischial spine.);
applying stimulation through the needle ([0044] “Needle 30 may include an electrode near the tip of the needle to deliver electrical pulses to pudendal nerve 40.”);
locating the pudendal nerve by measuring an EMG response to the stimulation applied through the needle ([0044] “Upon delivery of stimulation energy to the electrode, the physician may identify muscle movement associated with appropriate pudendal nerve stimulation to correctly place needle 30. Alternatively, electromyography may be performed with the test stimulator or another device to observe a sphincter compound muscle action potential (CMAP) which aids in correct needle 30 placement.”);
after locating the pudendal nerve, advancing … along a path of the needle ([0034] “Once needle 30 is appropriately positioned near the pudendal nerve, the needle is removed from the cannula so that the cannula remains positioned adjacent to the pudendal nerve. A stylet and a lead are then inserted into the cannula which serves as a lead introducer to guide the lead to the location adjacent the pudendal nerve.” [0074] “As needle 30 is completely removed from cannula 64, the cannula remains in the second shape. A stylet and lead is then inserted into cannula 64. In particular, the stylet is inserted into an inner lumen defined by the lead, and the combined lead and stylet are then inserted into the inner lumen of cannula 64.”);
advancing the electrode lead through the introducer ([0074] “As needle 30 is completely removed from cannula 64, the cannula remains in the second shape. A stylet and lead is then inserted into cannula 64. In particular, the stylet is inserted into an inner lumen defined by the lead, and the combined lead and stylet are then inserted into the inner lumen of cannula 64.”); and
anchoring the electrode lead into the tissue surrounding the pudendal nerve ([0048] “The cannula may be removed from lead 46 when the lead 46 provides good capture of pudendal lead 40. Lead 46 is disposed within a tunnel created by needle 30 and the cannula. Lead 46 may include tines or other structure to anchor the lead within tissue of pelvis 10.”).
However, Siegel teaches that the stylet is within the lumen of the lead where both are advanced through the cannula together ([0039] and [0074]), and not that the lead is advanced through the introducer. Jiang, although directed to PNE procedure, where the needle is inserted at the S3 foreman (which is further away from the ischial spine) ([0061]), solves the common problem of improving the positioning of implantable lead in a patient (Abstract). Jiang further teaches after locating the pudendal nerve, advancing an introducer along a path of the needle ([0099] “After the target nerve is successfully located, the direction guide, introducer and dilator are used to prepare a path along which the lead can be implanted.”);
advancing the electrode lead through the introducer ([0099] “The introducer sheath and dilator is a tool that increases the diameter of the hole through the foramen to allow introduction of the permanent lead. The lead stylet is a stiff wire that is inserted into the lead to increase its stiffness during lead placement and may be configured with a straight or curved tip.”) to provide more accurate and robust neural localization while improving ease of use by the physician and the patient ([0099]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Siegel, with the advancing an introducer along a path of the needle and advancing the electrode lead through the introducer of Jiang, because such a modification would allow to provide more accurate and robust neural localization while improving ease of use by the physician and the patient.
Regarding claim 37, claim 35 is obvious over Siegel and Jiang. Siegel does not teach adjusting a location of the introducer based on an anal sphincter EMG response. Jiang, although directed to PNE procedure, where the needle is inserted at the S3 foreman (which is further away from the ischial spine) ([0061]), solves the common problem of improving the positioning of implantable lead in a patient (Abstract). Jiang further teaches further comprising adjusting a location of the introducer based on an anal sphincter EMG response ([0019] “The second pair of EMG sensing electrodes are positionable within the inner area of the patient buttocks near the anal sphincter, with positioning targeted over the levator ani muscles.” [0025] “Method further include delivering the test stimulation to the sacral nerve tissue via a foramen needle and recording the stimulation-induced EMG motor response for each test stimulation delivered to the foramen needle so as to provide for initial positioning of the implantable lead at the target stimulation region. Similarly, user input may be received related to an adjustment of a stimulation amplitude level of the test stimulation for the foramen needle in proportional increments to achieve a desired stimulation-induced EMG motor response via the graphical user interface of the integrated clinician programmer. Optionally, automatic adjustments to the stimulation amplitude level of the test stimulation for the foramen needle may be made by the integrated clinician programmer until a desired stimulation-induced EMG motor response is detected.” [0069] “determination of whether or not an implantable lead and neurostimulation electrode is located in a desired or correct location can be accomplished through use of electromyography (“EMG”), also known as surface electromyography.”) to provide more accurate and robust neural localization while improving ease of use by the physician and the patient ([0099]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Siegel, with the adjusting a location of the introducer based on an anal sphincter EMG response of Jiang, because such a modification would allow to provide more accurate and robust neural localization while improving ease of use by the physician and the patient.
Regarding claim 38, Siegel teaches further comprising applying stimulation through the electrode lead to confirm a position of the electrode lead in the tissue ([0035] “Once the lead is in place, the stylet and cannula are removed and the lead is left in place to provide electrical stimulation to the pudendal nerve.”).
Regarding claim 39, claim 35 is obvious over Siegel and Jiang. Siegel does not teach adjusting the position of the electrode lead based on an EMG response to the stimulation applied through the electrode lead. Jiang, although directed to PNE procedure, where the needle is inserted at the S3 foreman (which is further away from the ischial spine) ([0061]), solves the common problem of improving the positioning of implantable lead in a patient (Abstract). Jiang further teaches further comprising adjusting the position of the electrode lead based on an EMG response to the stimulation applied through the electrode lead ([0108] “The neurostimulation lead can be re-positioned along various differing paths within the three-dimensional space of the implantation site to an optimal location and alignment by advancing or retracting the lead along the insertion axis and/or steering the lead in a lateral direction from the insertion axis as needed.” [0109] “the system provides improved lead placement by determining lead position of a multi-electrode lead relative the target nerve with EMG using an electrode sweeping process.”) to provide more accurate and robust neural localization while improving ease of use by the physician and the patient ([0099]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Siegel, with the adjusting the position of the electrode lead based on an EMG response to the stimulation applied through the electrode lead of Jiang, because such a modification would allow to provide more accurate and robust neural localization while improving ease of use by the physician and the patient.
Regarding claim 41, claim 35 is obvious over Siegel and Jiang. Siegel does not teach adjusting a location of the introducer based on an anal sphincter EMG response. Jiang, although directed to PNE procedure, where the needle is inserted at the S3 foreman (which is further away from the ischial spine) ([0061]), solves the common problem of improving the positioning of implantable lead in a patient (Abstract). Jiang further teaches wherein the EMG response is measured at an anal sphincter ([0019] “The second pair of EMG sensing electrodes are positionable within the inner area of the patient buttocks near the anal sphincter, with positioning targeted over the levator ani muscles.”) to provide more accurate and robust neural localization while improving ease of use by the physician and the patient ([0099]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Siegel, with the adjusting a location of the introducer based on an anal sphincter EMG response of Jiang, because such a modification would allow to provide more accurate and robust neural localization while improving ease of use by the physician and the patient.
Regarding claim 48, claim 35 is obvious over Siegel and Jiang. Siegel does not teach implanting an implantable pulse generator. Jiang, although directed to PNE procedure, where the needle is inserted at the S3 foreman (which is further away from the ischial spine) ([0061]), solves the common problem of improving the positioning of implantable lead in a patient (Abstract). Jiang further teaches further comprising implanting an implantable pulse generator ([0059] “Electrodes are placed next to a sacral nerve, usually at the S3 level, by inserting the electrode leads into the corresponding foramen of the sacrum. The electrodes are inserted subcutaneously and are subsequently attached to an implantable pulse generator (IPG).”) to provide more accurate and robust neural localization while improving ease of use by the physician and the patient ([0099]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Siegel, with the implanting an implantable pulse generator of Jiang, because such a modification would allow to provide more accurate and robust neural localization while improving ease of use by the physician and the patient.
Claim(s) 42 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siegel et al. (US 20070173900)(Hereinafter Siegel) in view of Jiang et al. (US 20160045747)(Hereinafter Jiang) and DeMarchi et al. (US 20140088348)(Hereinafter DeMarchi).
Regarding claim 42, claim 35 is obvious over Siegel and Jiang. Siegel in view of Jiang do not teach marking a buttocks to indicate a greater trochanter and ischial tuberosity to locate a surface position of the ischial spine. Although DeMarchi is directed to the treatment of rectal prolapse, Siegel and DeMarhi solve a common problem of incontinence in patients via surgical access ([0003]-[0007]). DeMarchi further teaches further comprising marking a buttocks to indicate a greater trochanter and ischial tuberosity to locate a surface position of the ischial spine ([0035] “Next, the buttocks is marked approximately 3 cm lateral and 3 cm posterior to the anus and a small stab incision is made at each of the marks. A long curved introducer needle 60 can be passed through the ischiorectal fossa to pierce the levator muscle at the ischial spine.”) to accurately insert the needle at the location of interest ([0034]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Siegel in view Jiang, with the marking a buttocks to indicate a greater trochanter and ischial tuberosity to locate a surface position of the ischial spine of DeMarchi, because such a modification would allow to provide more accurate and robust neural localization while improving ease of use by the physician and the patient.
Regarding claim 44, claim 35 is obvious over Siegel and Jiang. Siegel in view of Jiang do not teach inserting the needle by ischiorectal approach. Although DeMarchi is directed to the treatment of rectal prolapse, Siegel and DeMarhi solve a common problem of incontinence in patients via surgical access ([0003]-[0007]). DeMarchi further teaches further comprising inserting the needle by ischiorectal approach ([0035] “Next, the buttocks is marked approximately 3 cm lateral and 3 cm posterior to the anus and a small stab incision is made at each of the marks. A long curved introducer needle 60 can be passed through the ischiorectal fossa to pierce the levator muscle at the ischial spine.”) to accurately insert the needle at the location of interest ([0034]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Siegel in view Jiang, with the inserting the needle by ischiorectal approach of DeMarchi, because such a modification would allow to provide more accurate and robust neural localization while improving ease of use by the physician and the patient.
Claim(s) 46 and 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siegel et al. (US 20070173900)(Hereinafter Siegel) in view of Jiang et al. (US 20160045747)(Hereinafter Jiang) and Rondoni et al. (US 20240149064)(Hereinafter Rondoni).
Regarding claim 46, claim 35 is obvious over Siegel and Jiang. However, Siegel in view of Jiang do not teach the placing the electrode lead on an anterior branch of the pudendal nerve. Rondoni, in the same field of endeavor, teaches the targeting and stimulating of target sites for users suffering incontinence (Abstract and [0001]), and further teaches further comprising placing the electrode lead on an anterior branch of the pudendal nerve ([0087] “percutaneous introducer needle stick/puncture thorough the gluteus maximus muscle followed by tunneling may be required, the ischiorectal fossa target site of some examples of the present disclosure is readily accessible via a laparoscopic approach (e.g., incision made inferior to the gluteus maximus); muscle cutting and tunneling are not necessary in some embodiments, promoting a faster healing time for the patient. Furthermore, access to the pudendal nerve and its branches in the ischiorectal fossa could allow selective intraoperative stimulation using nerve monitoring methods to determine the most effective stimulation location to maximize the evoked response to improve continence and minimize or prevent unwanted sensations from electrical stimulation.” Examiner notes that the ischiorectal fossa contains the divide of the following anterior branches: inferior rectal nerve, perineal nerve, and dorsal nerve of the penis or clitoris.) to maximize evoked response and improve incontinence ([0087]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Siegel in view Jiang, with the placing the electrode lead on an anterior branch of the pudendal nerve of Rondoni, because such a modification would allow to maximize the evoked response to improve continence.
Regarding claim 49, claim 35 is obvious over Siegel and Jiang. Siegel does not teach tunnelling to direct the electrode lead to an implanted pulse generator. Jiang, although directed to PNE procedure, where the needle is inserted at the S3 foreman (which is further away from the ischial spine) ([0061]), solves the common problem of improving the positioning of implantable lead in a patient (Abstract). Jiang further teaches further comprising tunnelling to direct the electrode lead to an implanted pulse generator ([0059] “Electrodes are placed next to a sacral nerve, usually at the S3 level, by inserting the electrode leads into the corresponding foramen of the sacrum. The electrodes are inserted subcutaneously and are subsequently attached to an implantable pulse generator (IPG).”) to provide more accurate and robust neural localization while improving ease of use by the physician and the patient ([0099]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Siegel, with the tunnelling to direct the electrode lead to an implanted pulse generator of Jiang, because such a modification would allow to provide more accurate and robust neural localization while improving ease of use by the physician and the patient.
However, Siegel in view of Jiang do not teach the tunneling the lead. Rondoni, in the same field of endeavor, teaches the targeting and stimulating of target sites for users suffering incontinence (Abstract and [0001]), and further teaches tunnelling to direct the electrode lead ([0087] “percutaneous introducer needle stick/puncture thorough the gluteus maximus muscle followed by tunneling may be required”) to maximize the evoked response to improve continence ([0087]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Siegel in view Jiang, with the tunneling of the lead of Rondoni, because such a modification would allow to maximize the evoked response to improve continence.
Claim(s) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siegel et al. (US 20070173900)(Hereinafter Siegel) in view of Jiang et al. (US 20160045747)(Hereinafter Jiang) and Pianca et al. (US 20180296827)(Hereinafter Pianca).
Regarding claim 47, claim 35 is obvious over Siegel and Jiang. Siegel teaches an anchoring system of tines for the leads ([0048]). However, Siegel in view of Jiang fail to teach fixing the lead using fins. Pianca, in the same field of endeavor, teaches an electrical stimulation lead and IPG (Abstract) to target the pudendal nerve ([0052]), and further teaches further comprising fixing the electrode lead to the tissue using one or more fins ([0057] “FIGS. 3 and 4 show several different embodiments of lead anchoring units utilizing a cone, and FIGS. 5-8 show several different embodiments of lead anchoring units utilizing fins. FIG. 9 shows one embodiments of a lead anchoring unit utilizing a combination of cones and fins. FIGS. 10A-10A show several different embodiments of lead anchoring units mounted to a distal portion of a stimulation lead.”) to avoid migration of electrodes from the desired target ([0005]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Siegel in view Jiang, with the fixing the electrode lead to the tissue using one or more fins of Pianca, because such a modification would allow to avoid migration of electrodes from the desired target.
Conclusion
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/MOUSSA HADDAD/Examiner, Art Unit 3796
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