CTNF 18/886,646 CTNF 100462 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement The information disclosure statement (IDS) submitted on January 17 th , May 7 th , and October 17 th , 2025 is being considered by the examiner. Priority Acknowledgment is made of applicant’s claim for priority. The current application claims benefit of provisional application 63539774, filed on September 21 st , 2023. Claim Objections 07-29-01 AIA Claim 15 is objected to because of the following informalities: “plurality of the electrode” should read “plurality of the electrodes” . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 4 and 6 are 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. Claim 4, in part, recites “the first and third rows have n electrodes each and the second row has N-n electrodes, wherein N is a total number of electrodes and n is less than N”. Claim 6, in part, recites “the first and third rows have n electrodes each, the fourth and fifth rows have m electrodes each, and the second row has N-n-2m electrodes, wherein N is a total number of electrodes, n is less than N, m is less than N, and n-2m is less than N” The claims limitations recite unclear language in describing the number of electrodes. A claim may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). It is unclear whether the “total number of electrodes” (see line 2 of claim 4 and line 3 of claim 6) is in reference to the entire electrode array or a specific row. Similarly, when the “total number of electrodes” is interpreted as the summation of each row [i.e., the entire electrode array], then these formulas can only be mathematically sound if n and m equal zero. Applicant is encouraged to clarify the total number of electrodes and adjust the equations to correct any mathematical issues. It appears that Applicant intended to recite 4 to cite “N-2n electrodes” in claim 4 and “N-2n-2m electrodes” in claim 6, where the total number of electrodes consists of each electrode contained within the device. For the purposes of applying art, Examiner will interpret these claim limitations to encompass a 3x6 array for both claims, as depicted in page 20, paragraph 2 and page 21, paragraph 2 of Applicant’s specification. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15 AIA Claim s 1-10 and 14-15 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Rondoni et al. (US20220233863) . The following figures from Rondoni’s specification will be referenced for the purposes of applying art. PNG media_image1.png 273 242 media_image1.png Greyscale Regarding claim 1, Rondoni teaches an electrical stimulation lead [i.e., a cuff electrode (300)] comprising: a cuff (300) comprising a cuff body (301) having an exterior surface [i.e., outer electrodes (333B)] and an interior surface [i.e., inner electrodes (313B)], and a plurality of electrodes disposed on the interior surface of the cuff body [i.e., inner electrodes (313A-C)] and arranged into at least three rows of electrodes [i.e., inner electrodes (313A-C), (323A-C), and (333A-C)] , wherein the at least three rows comprises a first row [i.e., inner electrodes (313A-C)] , a second row [i.e., inner electrodes (323A-C) , and a third row [i.e., inner electrodes (333A-C)] , wherein the second row is disposed between the first and third rows [i.e., inner electrodes (323A-C) between (313A-C) and (333A-C)] , wherein each electrode in the first row is electrically coupled to a corresponding electrode in the third row (cuff body (301) couples each electrode to another as seen in [Fig. 8a] above alongside the previously cited labels; see also [0070] “electrically conductive element 170… is electrically coupled relative to each of the respective electrodes” is coupling each electrode) ; a lead body coupled to the cuff; ([0080] “wires extend through/within the lead body 82 up to and through the length of the cuff body 101”) and a plurality of first conductors extending through the lead body and the cuff with the first conductors electrically coupled to the electrodes. (see [0080] above and [0119] “electrodes 323A, 323B, 323C are electrically common with each other” using conducting elements) Regarding claim 2, Rondoni teaches all of the limitations of claim 1. Rondoni also teaches wherein each of the electrodes of the second row are staggered relative to the electrodes of the first and third rows. ([Fig. 25] where pattern of electrodes (4682), (4684), and (4686) are staggered electrode rows; see also [0241] “the array may comprise a greater number or a fewer number of electrodes than shown in FIG. 25”) PNG media_image2.png 397 420 media_image2.png Greyscale Regarding claim 3, Rondoni teaches all of the limitations of claim 1. Rondoni also teaches wherein the first, second, and third rows have four electrodes each or six electrode each. ([0123] “cuff electrode 300 may comprise a 4×4, 3x5, 4×6, etc. electrode matrix”) Regarding claim 4, Rondoni teaches all of the limitations of claim 1. Rondoni also teaches the electrical stimulation lead of claim 1, wherein the first and third rows have n electrodes each and the second row has N-n electrodes, wherein N is a total number of electrodes and n is less than N. ([Fig. 5a] electrodes (250A-C) comprise N-n electrodes while 252B and 254B comprise n electrodes) Regarding claim 5, Rondoni teaches all of the limitations of claim 1. Rondoni also teaches wherein the at least three rows further comprise a fourth row and a fifth row, wherein the first, second, and third rows are all disposed between fourth and fifth rows. ([0123] “cuff electrode 300 may comprise a 4×4, 3x5, 4×6, etc. electrode matrix” where rows are disposed interchangeably) Regarding claim 6, Rondoni teaches all of the limitations of claim 5. Rondoni also teaches wherein the first and third rows have n electrodes each, the fourth and fifth rows have m electrodes each, and the second row has N-n-2m electrodes, wherein N is a total number of electrodes, n is less than N, m is less than N, and n-2m is less than N. ([Fig. 11] electrodes 323A-323C, 313A-313C, 333A-333C and ring electrodes 415A, 415B comprise 5 rows of electrons as limited by this claims interpretation) Regarding claim 7, Rondoni teaches all of the limitations of claim 1. Rondoni also teaches wherein the cuff further comprises a plurality of second conductors, wherein each of the second conductors electrically couples one of the electrodes of the first row to the corresponding one of the electrodes of the third row. ([0120] “the first array 332 of outer electrodes 323A, 323B, 323C are electrically common with each other”; see also [0143] “the elongate electrode 520 is common axially to all of the other electrodes 323B-323C, 313B-313C, and 333B-333C of array 530.”) Regarding claim 8, Rondoni teaches all of the limitations of claim 1. Rondoni also teaches an electrical stimulation system, comprising: the electrical stimulation lead of claim 1 (see [Fig. 8a] above) ; and a control module ([0064] “implantable pulse generator”) configured to receive a portion of the lead body of the electrical stimulation lead and to electrically couple to the electrodes of the cuff. ([0064] “lead extending between the cuff electrode and implantable pulse generator”) Regarding claim 9, Rondoni teaches all of the limitations of claim 1. Rondoni also teaches a method of electrically stimulating a patient, the method comprising ([abstract] “methods of making and using a cuff electrode”) : providing the electrical stimulation lead of claim 1 implanted within the patient (see [Fig. 8a] above) ; and applying electrical current through the patient with at least one of the electrodes of each of the first and third rows having a first polarity and at least one of the electrodes of the second row having a second polarity opposite the first polarity. ([0106-0107] “FIGS. 7A-7K also may be viewed as schematically representing at least an example method of neurostimulation… electrodes 103A, 103C act as anodes while the inner electrode 103B (same as 113B) acts as a cathode” ) The following figure from Rondoni’s specification will be referenced for the purposes of applying art. PNG media_image3.png 485 321 media_image3.png Greyscale Regarding claim 10, Rondoni teaches an electrical stimulation lead [i.e., a cuff electrode (500)] comprising: a cuff (500) comprising a cuff body (501) having an exterior surface [i.e., outer electrodes (333B)] and an interior surface [i.e., inner electrodes (313B)], and a plurality of electrodes disposed on the interior surface of the cuff body [i.e., inner electrodes (313B,323B, 333B)] and arranged into at least three rows of electrodes [i.e., inner electrodes (313B, 323B, 333B), (520) and (339A-C)] , wherein the at least three rows comprises a first row [i.e., inner electrodes (313B, 323B, 333B)] , a second row [i.e., electrode (520) , and a third row [i.e., inner electrodes (339A-C)] , wherein the second row is disposed between the first and third rows [i.e., inner electrode (520) between (313B, 323B, 333B) and (339A-C)] , wherein the first and third rows each comprise a plurality of the electrodes and the second row comprises at least one electrode [i.e., inner electrodes (313A-C), (323A-C), and (333A-C)] , wherein each of the at least one electrode in the second row is at least twice as long as each of the electrodes of the first and third rows [i.e., inner electrode (520) between (313B, 323B, 333B) and (339A-C) in Fig. 12 and 13A] ; a lead body coupled to the cuff; ([0080] “wires extend through/within the lead body 82 up to and through the length of the cuff body 101”) and a plurality of first conductors extending through the lead body and the cuff with the first conductors electrically coupled to the electrodes. (see [0080] above and [0119] “electrodes 323A, 323B, 323C are electrically common with each other” using conducting elements) Regarding claim 14, Rondoni teaches all of the limitations of claim 10. Rondoni also teaches wherein each of the electrodes of the first row is electrically coupled to a corresponding one of the electrodes of the third row. ([0120] “the first array 332 of outer electrodes 323A, 323B, 323C are electrically common with each other”; see also [0143] “the elongate electrode 520 is common axially to all of the other electrodes 323B-323C, 313B-313C, and 333B-333C of array 530.”) Regarding claim 15, Rondoni teaches all of the limitations of claim 10. Rondoni also teaches wherein the second row comprises a) a plurality of the electrode ([0123] “cuff electrode 300 may comprise a 4×4, 3x5, 4×6, etc. electrode matrix”) or b) a single one of the electrodes that is at least as long as a combined length of all of the electrodes of the first row. ([Fig. 13.A] electrode (520)) Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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. 07-21-aia AIA Claim s 11-13 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rondoni et al. (US20220233863) as applied to claims 10 above . Rondoni’s disclosure teaches the variety of electrode arrays in electrical stimulation cuffs, in part, by explaining “it will be understood that size, shape, and/or pattern of electrodes … in FIG. 25 is merely one example, and that the electrodes … may have different sizes, shape, and/or patterns than shown” [para 0241]. “As noted above… a greater number or fewer number of electrodes may comprise the array” [para 0244]. Rondoni indicates that these patterns are dictated by art recognized results since “the various nerve fiber groups may have different diameters from each other and/or may have positions within the nerve casing which vary from the positions shown in FIG. 6A.” Thus, Rondoni indicates the variety of electrode arrays encompasses design choices for the user. PNG media_image4.png 272 310 media_image4.png Greyscale The previous figure from Rondoni’s specification will be referenced for the purposes of applying art. Regarding claim 11, Rondoni teaches all of the limitations of claim 10. Rondoni also teaches wherein the at least three rows further comprises a fourth row ([Fig. 11] where electrodes (415A-B) can either be between electrodes (313A-C), (323A-C), and (333A-C) or outside of it when the cuff is unwrapped) Rondoni does not explicitly teach a fourth row disposed between the first and third rows. Rondoni does illustrate the different arrangements when teaching [0241], “it will be understood that size, shape, and/or pattern of electrodes … is merely one example, and that the electrodes … may have different sizes, shape, and/or patterns than shown”) . Applicant’s specification does not disclose a criticality with any of the arrangements of the electrodes that are illustrated with the figures or consistent with the instant claims. Therefore, it would have been prima facie obvious to have combined various embodiments of Rondoni to have a variety of electrode arrays while accommodating a stimulation device’s necessary array for the different patient’s nerve sizes. Regarding claim 12, Rondoni teaches all of the limitations of claim 11. Rondoni also teaches wherein the at least three rows further comprises a fifth row …wherein the fifth row comprises at least one electrode, wherein each of the at least one electrode of the fifth row is at least twice as long as each of the electrodes of the first and third rows ([Fig. 11] where electrodes (415A-B) can either be between electrodes (313A-C), (323A-C), and (333A-C) or outside of it when the cuff is unwrapped) Rondoni does not explicitly teach a fifth row that is either a) not disposed between the first and third rows… or b) between the second and fourth rows, wherein the fifth row comprises at least one electrode. Rondoni does illustrate the different arrangements when teaching [0241], “it will be understood that size, shape, and/or pattern of electrodes … is merely one example, and that the electrodes … may have different sizes, shape, and/or patterns than shown”) . Applicant’s specification does not disclose a criticality with any of the arrangements of the electrodes that are illustrated with the figures or consistent with the instant claims. Therefore, it would have been prima facie obvious to have combined various embodiments of Rondoni to have a variety of electrode arrays while accommodating a stimulation device’s necessary array for the different patient’s nerve sizes. Regarding claim 13, Rondoni teaches all of the limitations of claim 10. Rondoni also teaches wherein the at least three rows further comprises a fourth row… wherein the fourth row comprises at least one electrode, wherein each of the at least one electrode of the fourth row is at least twice as long as each of the electrodes of the first and third rows. ([Fig. 11] where electrodes (415A-B) can either be between electrodes (313A-C), (323A-C), and (333A-C) or outside of it when the cuff is unwrapped) Rondoni does not explicitly teach a fourth row that is not disposed between the first and third rows. Rondoni does illustrate the different arrangements when teaching [0241], “it will be understood that size, shape, and/or pattern of electrodes … is merely one example, and that the electrodes … may have different sizes, shape, and/or patterns than shown”) . Applicant’s specification does not disclose a criticality with any of the arrangements of the electrodes that are illustrated with the figures or consistent with the instant claims. Therefore, it would have been prima facie obvious to have combined various embodiments of Rondoni to have a variety of electrode arrays while accommodating a stimulation device’s necessary array for the different patient’s nerve sizes. The following figure from Rondoni’s specification will be referenced for the purposes of applying art. PNG media_image3.png 485 321 media_image3.png Greyscale Regarding claim 16, Rondoni teaches an electrical stimulation lead [i.e., a cuff electrode (500)] comprising: a cuff (500) comprising a cuff body (501) having an exterior surface [i.e., outer electrodes (333B)] and an interior surface [i.e., inner electrodes (313B)] , and up to sixteen electrodes ([0123] “cuff electrode 300 may comprise a 4×4, 3x5, 4×6, etc. electrode matrix” where rows are disposed internally) disposed on the interior surface of the cuff body and arranged into at least three rows of electrodes [i.e., inner electrodes (313B, 323B, 333B), (520) and (339A-C)] , wherein the at least three rows comprises a first row [i.e., inner electrodes (313B, 323B, 333B)] , a second row [i.e., electrode (520) , and a third row [i.e., inner electrodes (339A-C)] , wherein the second row is disposed between the first and third rows [i.e., inner electrode (520) between (313B, 323B, 333B) and (339A-C)] ; a lead body coupled to the cuff; ([0080] “wires extend through/within the lead body 82 up to and through the length of the cuff body 101”) and a plurality of first conductors extending through the lead body and the cuff with the first conductors electrically coupled to the electrodes. (see [0080] above and [0119] “electrodes 323A, 323B, 323C are electrically common with each other” using conducting elements) Rondoni does not explicitly teach and comprises more of the electrodes than the first row and more of the electrodes than the third row, wherein each electrode in the first and third rows is at least twice as long as each of the electrodes of the second row. Rondoni does illustrate the different arrangements when teaching [0241], “it will be understood that size, shape, and/or pattern of electrodes … is merely one example, and that the electrodes … may have different sizes, shape, and/or patterns than shown”) . Applicant’s specification does not disclose a criticality with any of the arrangements of the electrodes that are illustrated with the figures or consistent with the instant claims. Therefore, it would have been prima facie obvious to have combined various embodiments of Rondoni to have a variety of electrode arrays while accommodating a stimulation device’s necessary array for the different patient’s nerve sizes. Regarding claim 17, Rondoni teaches all of the limitations of claim 16. Rondoni also teaches wherein the first and third electrodes each comprise a plurality of the electrodes. ([0123] “cuff electrode 300 may comprise a 4×4, 3x5, 4×6, etc. electrode matrix”) Regarding claim 18, Rondoni teaches all of the limitations of claim 16. Rondoni does not explicitly teach wherein the at least three rows further comprises a fourth row that is not disposed between the first and third rows. Rondoni does illustrate the different arrangements when teaching [0241], “it will be understood that size, shape, and/or pattern of electrodes … is merely one example, and that the electrodes … may have different sizes, shape, and/or patterns than shown”) . Applicant’s specification does not disclose a criticality with any of the arrangements of the electrodes that are illustrated with the figures or consistent with the instant claims. Therefore, it would have been prima facie obvious to have combined various embodiments of Rondoni to have a variety of electrode arrays while accommodating a stimulation device’s necessary array for the different patient’s nerve sizes. Regarding claim 19, Rondoni teaches all of the limitations of claim 16. Rondoni does not explicitly teach wherein the at least three rows further comprises a fourth row that is disposed between the first and third rows. Rondoni does illustrate the different arrangements when teaching [0241], “it will be understood that size, shape, and/or pattern of electrodes … is merely one example, and that the electrodes … may have different sizes, shape, and/or patterns than shown”) . Applicant’s specification does not disclose a criticality with any of the arrangements of the electrodes that are illustrated with the figures or consistent with the instant claims. Therefore, it would have been prima facie obvious to have combined various embodiments of Rondoni to have a variety of electrode arrays while accommodating a stimulation device’s necessary array for the different patient’s nerve sizes. Regarding claim 20, Rondoni teaches all of the limitations of claim 16. Rondoni also teaches wherein each of the electrodes of the first row is electrically coupled to a corresponding one of the electrodes of the third row. ([Fig. 11] where electrodes (415A-B) can either be between electrodes (313A-C), (323A-C), and (333A-C) or outside of it when the cuff is unwrapped) Pertinent Prior Art 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. North et al. (US20090326594) discloses a paddle lead with multiple first electrodes disposed entirely on a first major surface of the lead body and multiple second electrodes disposed entirely on a second major surface of the lead body. Govea et al. (US20160296745) discloses a method for improving the contact arrays for electrical stimulation systems. Moffit et al. (Pat. 9216282) also discloses a paddle lead with multiple first electrodes disposed entirely on a first major surface of the lead. Ouchouche et al. (WO2021108810) discloses electrical devices of various shapes and sizes including one or more electrodes have been used for neurostimulation/neuromodulation of target anatomy. Cortec Product information discloses a variety of electrode array patterns . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT ANTHONY SKROBARCZYK whose telephone number is (571)272-3301. The examiner can normally be reached Monday thru Friday 7:30AM -5PM CST. 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, Unsu Jung can be reached at 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /R.A.S/Examiner, Art Unit 3792 /UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792 Application/Control Number: 18/886,646 Page 2 Art Unit: 3792 Application/Control Number: 18/886,646 Page 3 Art Unit: 3792 Application/Control Number: 18/886,646 Page 4 Art Unit: 3792 Application/Control Number: 18/886,646 Page 5 Art Unit: 3792 Application/Control Number: 18/886,646 Page 6 Art Unit: 3792 Application/Control Number: 18/886,646 Page 7 Art Unit: 3792 Application/Control Number: 18/886,646 Page 8 Art Unit: 3792 Application/Control Number: 18/886,646 Page 9 Art Unit: 3792 Application/Control Number: 18/886,646 Page 10 Art Unit: 3792 Application/Control Number: 18/886,646 Page 11 Art Unit: 3792 Application/Control Number: 18/886,646 Page 12 Art Unit: 3792 Application/Control Number: 18/886,646 Page 13 Art Unit: 3792
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