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 Group II, claims 11-20, in the reply filed on October 27, 2025 is acknowledged. The traversal is on the grounds that the requirement does not specify the species/groups that lack unity with each other and why there would be a burden to examine the alleged species/groups, noting that the groups overlap and that there would not be an undue burden and that claim 20 provides overlap between Groups I and II. These arguments are not persuasive. As set forth in the requirement, the analysis in a 371 application is based on unity of invention. The inventions of claims 1 and 11 do not share the same or corresponding technical feature. There is nothing in claims 1 and 11 that is required in both of the claims. An analysis of the independent claims is appropriate for a unity of invention analysis. Further, to the extent there is any conceivable shared technical feature between the groups, it was addressed in the restriction requirement and demonstrates that unity of invention is lacking for that additional reason set forth in the requirement. Further, as evidenced by the prior art rejections set forth below in this Office action, all the technical features of the elected invention are known in the art. It follows that there is no special technical feature linking the different inventions. Further, the standard for unity of invention is not an undue burden, but that the lack of unity is not raised based on a narrow, literal or academic approach. The standard has been met. The different inventions have a vastly different scope and lack of unity clearly exists under a reasonable approach. Further, to the extent one would want to apply an undue burden standard, the differences in scope between the different inventions makes clear that a different search would be required and that this different search would create an undue search and examination burden if restriction were not required.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 19 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.
As to claim 19, the claim recites “bonding the engaging portions, via cross-linking between the silicone material”. The limiting effect of the recitation is unclear. As set forth in claim 11, only one of the engaging portions is necessarily formed from a silicone material. It is not clear in claim 19, whether each of the engaging portions is made of silicone are intended or required within the scope of the claim. If each of the engaging portions are made of silicone in order to achieve the bonding through crosslinking, this should be clarified. If this is not required, it should be clarified how the bonding as claimed is able to take place in a manner supported by the original disclosure. Appropriate correction and clarification are required.
Claim Rejections - 35 USC § 102
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 –
(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.
Claims 11-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kallesoe et al. (US 5,487,756).
Regarding claim 11, Kallesoe et al. teach a method, comprising: forming a body supporting at least one contact electrode (Abstract; Figures 1-9 (20) (70) (71) (72); col. 4, line 59-col. 5, line 60; col. 7, line 65-col. 8, line 42), the body at least partially defining a re-closable lumen and comprising engaging portions (Figures 1-9; multiple elements are reasonably understood to form the claimed engaging portions: edges (28) and (30) can be understood to be engaging portions; tubes (34) and (36) can be understood to be engaging portions; flaps (50) and (50A) can be understood to be engaging portions; col. 4, line 59-col. 5, line 60; col. 6, lines 46-col. 7, line 24), at least one of the engaging portions being formed from a silicone material (col. 4, line 59-col. 5, line 37; col. 7, line 3-11; col. 8, lines 44-62).
As to claims 12-14 and 16, Kallesoe et al. teach the inclusion of interdigitating tubes (34) and (36) as surface contact features that read upon the claims. Similarly, flaps (50) protrude from the surface. These impact a surface contact area between the engaging portions with indented/protruding/textured as claimed (Figures 1-9).
As to claim 15, the rejection of claim 14 relies upon the limitation directed to adding texture. As such, the further limitations in claim 15 are not necessary since the altering a surface chemistry limitation of claim 14 was not part of the rejection.
As to claim 17, Kallesoe et al. teach the inclusion of pins that run between tubes (34) and (36) and packaging the cuff (20), which reads upon the claimed adding a sacrificial material between the engaging portions and packaging the body (col. 7, lines 24-30).
As to claim 18, Kallesoe et al. teach the inclusion of flaps (50) and (50A) which read upon the claimed arms configured as claimed (Figures 1-9).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kallesoe et al. (US 5,487,756), as applied to claims 11-18 above, and further in view of Ashe et al. (US 2019/0366079).
As to claim 19, Kallesoe et al. teach the method set forth above. Kallesoe et al. teach utilizing the nerve cuff while implanted in a patient (col. 7, line 65-col. 8, line 42), but do not teach crosslinking between the silicone material of the engaging portions to bond them while implanted. However, Ashe et al. teach an analogous method wherein the silicone material is crosslinked to bond the assembly together while implanted (Abstract; paragraphs [0006], [0068], [0069] and [0074]).
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Kallesoe et al. and Ashe et al. and to have bonded the engaging portions by crosslinking the silicone material while implanted in a patient in the method of Kallesoe et al., as suggested by Ashe et al., for the purpose, as suggested by Ashe et al., of effectively securing and positioning the device to its nerve target.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kallesoe et al. (US 5,487,756), as applied to claims 11-18 above, and further in view of either one of Bolea (US 2014/0228905) or Cross, Jr. et al. (US 2007/0282410).
As to claim 20, Kallesoe et al. teach the method set forth above. Kallesoe et al. teach utilizing the nerve cuff while implanted in a patient (col. 7, line 65-col. 8, line 42), but do not teach the lead portion of a medical lead body is in a non-linear configuration and formed from a thermoset material and that it is coupled to a proximal end of a base of the body. However, each of Bolea (Abstract; Figure 1 (60) (62) (64) (50) (52); Figure 2 paragraphs [0127]-[0134], [0141], [0142], [0176]; sigmoid configuration) and Cross, Jr. et al. (Abstract; paragraphs [0057] and [0058]; Figures 1, 6, 13, 15, 18, 19, 20, 22, 23, 24) teach and suggest an analogous method wherein the lead portion of a medical lead body is in a non-linear configuration and formed from a thermoset material and that it is coupled to a proximal end of a base of the body as claimed.
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Kallesoe et al. and either one of Bolea and Cross, Jr. et al. and to have included a lead portion of a medical lead body in a non-linear configuration and formed from a thermoset material and that it is coupled to a proximal end of a base of the body as claimed in the method of Kallesoe et al., as suggested by either one of the secondary references, for the purpose, as suggested by the references, of reducing strain in the lead, facilitating extensibility of the lead, and accommodating movement.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Each of Su (US 2020/0094050; Figures 1-6B; paragraphs [0005], [0010], [0017], [0018], and [0022]); Schuttler et al. (US 2019/0060641; Figures 1 and 2; paragraphs [0097]-[0120]); Ng et al. (US 2019/0060646; Figures 1, 2, 4-11; paragraphs [0034]-[0036] and [0051]-[0054]); Mrva et al. (US 2006/0030919; Figures 1-2B; paragraphs [0035] and [0041]) are understood to disclose analogous and applicable methods as claimed. These references should be considered prior to responding to this Office Action. Further, each of Cantwell et al. (US 2019/0261875; Figure 11A) and Cowley et al. (US 2012/0277819; Figures 9A; 10A, 11A, 11B) are understood to disclose analogous and applicable modifications to analogous engaging portions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeff Wollschlager whose telephone number is (571)272-8937. The examiner can normally be reached M-F 7:00-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christina Johnson can be reached at 571-272-1176. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEFFREY M WOLLSCHLAGER/Primary Examiner, Art Unit 1742