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 Amendment
This Office Action is responsive to the amendment filed on 23 July 2025. As directed by the amendment: Claims 1-8 have been amended, no claims have been cancelled, and no claims have been added. Thus, Claims 1-8 are presently pending in this application.
The amendments to the Specification have been reviewed and accepted by the Examiner.
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.
Claims 1-8 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.
Regarding Claim 1, the claim recites, “a reflowed implantable lead body…comprising an assembled lead body” and “the assembled lead body comprising a pre-reflowed coiled cable assembly….wherein the pre-reflowed coiled cable assembly is substantially free of stored mechanical energy… wherein each of the plurality of terminals is electrically coupled to at least one of the plurality of electrodes through the pre-reflowed coiled cable assembly.” However, it is unclear as to how “a reflowed implantable lead body” can comprise “an assembled lead body” with multiple pre-reflowed components. It appears from the instant Specification (e.g., Paragraphs [0049], [0051], [0060], [0064]) that the lead is subjected to a reflow process during assembly. Therefore, it is unclear as to what elements are being claimed (post-reflowed vs. pre-reflowed) in the claimed stimulation lead. Therefore, these limitations are indefinite. For purposes of examination, the Examiner is interpreting the “assembled lead body” as “a pre-reflowed assembled lead body”, and interpreting Claim 1 as including the limitation “wherein the pre-reflowed assembled lead body is subjected to a reflow process by applying heat to form the reflowed implantable lead body” (e.g., see Paragraphs [0049], [0051], [0060], [0064] of the instant Specification), in order to clarify that the pre-reflowed elements undergo the heated reflow process to form the stimulation lead as claimed. Appropriate correction or clarification is required. Claims 2-5 are rejected for depending on rejected Claim 1.
Regarding Claim 6, the claim recites, “a reflowed implantable lead body…comprising an assembled lead body” and “the assembled lead body comprising a pre-reflowed coiled cable assembly … wherein each of the plurality of terminals is electrically coupled to at least one of the plurality of electrodes through the pre-reflowed coiled cable assembly...wherein the pre-reflowed coiled cable assembly is substantially free of stored mechanical energy.” However, it is unclear as to how “a reflowed implantable lead body” can comprise “an assembled lead body” with multiple pre-reflowed components. It appears from the instant Specification (e.g., Paragraphs [0049], [0051], [0060], [0064]) that the lead is subjected to a reflow process during assembly. Therefore, it is unclear as to what elements are being claimed (post-reflowed vs. pre-reflowed) in the claimed stimulation lead. Therefore, these limitations are indefinite. For purposes of examination, the Examiner is interpreting the “assembled lead body” as “a pre-reflowed assembled lead body”, and interpreting Claim 6 as including the limitation “wherein the pre-reflowed assembled lead body is subjected to a reflow process by applying heat to form the reflowed implantable lead body” (e.g., see Paragraphs [0049], [0051], [0060], [0064] of the instant Specification), in order to clarify that the pre-reflowed elements undergo the heated reflow process to form the stimulation lead as claimed. Appropriate correction or clarification is required. Claims 7 and 8 are rejected for depending on rejected Claim 6.
Regarding Claim 6, the claim recites, “wherein a portion of each conductive wire” in Lines 11-12 of the claim. However, it is unclear as to whether “each conductive wire” is included in the “plurality of conductive wires”, or if these elements are intended to be separate conductive wires. Therefore, this limitation is indefinite. For purposes of examination, the Examiner is interpreting this limitation as “wherein a portion of each conductive wire of the plurality of conductive wires”. Appropriate correction or clarification is required. Claims 7 and 8 are rejected for depending on rejected Claim 6.
Prior Art
The prior art made of record and not relied upon is considered pertinent to the Applicant's disclosure:
Pianca (US Publication No. 2003/0105505) discloses a stimulation lead comprising a conductive coil wound over a mandrel (Paragraph 0032-0033), wherein the stimulation lead is subjected to heat and reflowed to allow for the insulation to flow around the conductor winding (Paragraph 0039, 0041; Claims 7, 21, 24).
Swoyer et al. (US Publication No. 2008/0147155) discloses a stimulation lead comprising conductive strands braided over a mandrel (Paragraph 0034, 0041, 0042), wherein the braided strands are placed within a tubing and a reflowed operation is performed to reduce the profiled of the lead body (Paragraph 0041, 0042)
Allowable Subject Matter
Claims 1-8 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112(b), set forth in this Office action. It is noted that Claims 1-8 have been interpreted by the Examiner as described in the 35 U.S.C. 112(b) Rejection section above.
Response to Arguments
The previous Objection to the Specification as made in the previous Non-Final Rejection Office Action mailed 23 April 2025 has been withdrawn due to the amendments to Paragraph [0001] of the Specification which adds in the issued US Patent number for the related DIV application.
The Applicant’s arguments with respect to the previous 35 USC 102(a)(1) and 35 USC 103 rejections of Claims 1-8 have been fully considered. The Examiner agreed that none of the previously cited Altman (US Patent No. 5,845,396) and Williams (US Publication No. 2014/0031911), nor the additional prior art references cited above explicitly discloses or teaches all of the claimed elements of independent Claims 1 and 6 as currently amended. In particular, the prior art does not disclose a reflowed implantable lead body extending from a proximal end to a distal end and comprising an assembled lead body, the assembled lead body comprising a pre-reflowed coiled cable assembly including at least one cable helically wound about a central longitudinal axis of the reflowed implantable lead body, the at least one cable including at least one conductive wire and an insulative coating, wherein a portion of the at least one conductive wire is exposed through the insulative coating, wherein the pre-reflowed coiled cable assembly is substantially free of stored mechanical energy” and “a plurality of terminals located at the proximal end of the lead body, wherein at least one terminal of the plurality of terminals is connected to the exposed portion of the at least one conductive wire of the pre-reflowed coiled cable assembly; and a plurality of electrodes located at the distal end of the lead body, wherein each of the plurality of terminals is electrically coupled to at least one of the plurality of electrodes through the pre-reflowed coiled cable assembly”, as required by Claim 1 as amended, and similar limitations in Claim 6 as amended. It is noted that the Examiner is interpreting the “assembled lead body” as “a pre-reflowed assembled lead body”, and interpreting Claim 1 as including the limitation “wherein the pre-reflowed assembled lead body is subjected to a reflow process by applying heat to form the reflowed implantable lead body” (e.g., see Paragraphs [0049], [0051], [0060], [0064] of the instant Specification), in order to clarify that the pre-reflowed elements undergo the heated reflow process to form the stimulation lead as claimed. See the 35 U.S.C. 112(b) Rejection section above
Therefore, Claims 1-8 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112(b), set forth in this Office action. Claims 1-8 have been interpreted by the Examiner as described in the 35 U.S.C. 112(b) Rejection section above.
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 PAMELA M BAYS whose telephone number is (571)270-7852. The examiner can normally be reached 9:00am - 6:00pm EST.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796
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