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
Applicant’s amendment to the claims filed May 4, 2026 has been entered. Claims 11-14, 16 and 19 are currently amended. Claims 141-148 are new. Claims 1-10 and 21-140 have been canceled. Claims 11-20 and 141-148 are pending and under examination.
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.
Claims 11-13, 16, 18, 19, 141 and 146 are rejected under 35 U.S.C. 103 as being unpatentable over Ng et al. (US 2019/0060646) in view of any one of Hansen et al. (US 2023/0025428), Ewers et al. (US 2018/0064899), or Nozoe (US 2007/0256595).
Regarding claims 11-13, 16, 18, 19, 141 and 146, Ng et al. teach a method comprising forming a body supporting at least one contact electrode, the body at least partially defining a re-closable lumen and comprising engaging portions, the engaging portions being formed from a silicone material (Abstract; Figure 2 (10) (54) (60); Figures 5-10C showing cuff body (80) with overlapping inner and outer cuff regions/portions that read upon the claimed engaging portions; paragraphs [0013]-[0018], [0054] – silicone; [0055] and [0061]-[0070]; Figure 5 and 6 showing a base structure with distal and proximal portions extending as arms as claimed). Ng et al. further teach implanting the body in a patient and retaining the ability to open/close/expand the body implanted in the patient (Figures 5 and 6; 8 and 9; paragraphs [0010]-[0012], [0017] and [0055]). Ng et al. do not explicitly teach forming a surface contact feature on a surface of at least one of the corresponding engaging portions, wherein the surface-contact feature mitigates or prevents cross-linking of the silicone material of the engaging portion in use or in storage or during transportation; for example, by impacting a surface contact area, adding a plurality of indented or protruding features, texturing the surface with protrusions, indentations or a roughened surface
However, each of Hansen et al. (paragraph [0078] – analogously treat silicone contacting surfaces so that they don’t stick, especially after cleaning or sterilization or in storage), Ewers et al. (paragraph [0140]), and Nozoe (paragraphs [0001], [0002], [0010], [0041] – broadly applicable) disclose analogous methods (e.g. processing silicone polymers into articles) wherein the surface of the silicone is modified by impacting a surface contact area, adding a plurality of indented or protruding features, texturing the surface with protrusions, indentations or a roughened surface in order to reduce tackiness/stickiness/blocking/prevent fusion/prevent bonding of the materials/mitigate or prevent cross-linking between silicone contacting surfaces.
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 Ng et al. and any one of the secondary references and to have formed a surface contact feature on a surface of at least one of the engaging portions, wherein the surface-contact feature mitigates or prevents cross-linking of the silicone material of the engaging portion; for example, by impacting a surface contact area, adding a plurality of indented or protruding features, texturing the surface with protrusions, indentations or a roughened surface, in the method of Ng et al., as suggested by any one of the secondary references, for the purpose, as suggested by the references, of reducing the tendency of the portions of silicone that overlap each other in Ng et al. from sticking together by reducing tackiness/stickiness/blocking/preventing fusion/preventing bonding of the materials/mitigating or preventing cross-linking between silicone contacting surfaces. Ng et al. teach the lumen needs to be able to open/close/expand for both installation and while in use around a nerve (Figures 5 and 6; 8 and 9; paragraphs [0054] and [0055]). If the lumen size of Ng et al. can’t effectively expand due to stickiness/tackiness/bonding/crosslinking/fusion of the overlapping portion, the device of Ng et al. will not work properly. If the overlapping portions stick together, the device cannot be opened/uncurled/unfurled. Ng et al. disclose the cuff is made of silicone and each of the secondary references disclose that silicone polymers have a tendency to stick/bond/fuse together at points of contact and that modifying the surface as set forth in the references reduces this tendency. This is a tendency that one having ordinary skill in the art would have found beneficial in view of the application of Ng et al. Further, to the extent the chosen language regarding the surface contact feature being able to mitigate or prevent crosslinking is different than the language chosen by the secondary references, this ability to mitigate or prevent is done by adding the contact features as claimed. The secondary references suggest forming contact features having the same claimed structure and explicitly focus on the similar/same issues of tackiness/sticking/fusing/bonding language. Different language is used, but the same structure is suggested for substantially similar/the same reasons. The same claimed structure is produced from the same claimed material in the combination. When the same materials are formed into the same structure, the resultant article will have the same claimed properties (e.g. mitigate or prevent cross-linking to the extent required).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ng et al. (US 2019/0060646) in view of any one of Hansen et al. (US 2023/0025428), Ewers et al. (US 2018/0064899), or Nozoe (US 2007/0256595), as applied to claims 11-13, 16, 18, 19, 141 and 146 above, alone or further in view of Kallesoe et al. (US 5,487,756).
As to claim 17, the combination teaches the method set forth above. Ng et al. do not tach a sacrificial material and packaging as claimed. However, in view of the suggestion from the secondary references to reduce stickiness/tackiness, one having ordinary skill would have found it prima facie obvious to have further modified the method of Ng et al. and to have introduced a sacrificial material (e.g. layer of PTFE) between the engaging portions prior to packaging in order to further facilitate a reduction in stickiness/tackiness. Alternatively, Kallesoe et al. teach the inclusion of pins that run between tubes (34) and (36) and further packaging the cuff (20) (col. 7, lines 24-30). 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 Ng et al. and Kallesoe et al. and to have added a sacrificial material and to have packaged the cuff of Ng et al., as suggested by Kallesoe et al., for the purpose, as suggested by the references, of facilitating a safe and sterile delivery of the cuff in a suitable and art recognized manner.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Ng et al. (US 2019/0060646) in view of any one of Hansen et al. (US 2023/0025428), Ewers et al. (US 2018/0064899), or Nozoe (US 2007/0256595), as applied to claims 11-13, 16, 18, 19, 141 and 146 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, the combination teaches the method set forth above. Ng et al. teach the basic claimed structure, 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 Ng 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 Ng 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.
Claims 11, 14, 15, 18, 19, and 141-148 are rejected under 35 U.S.C. 103 as being unpatentable over Ng et al. (US 2019/0060646) in view of either one of Hansen et al. (US 2023/0025428) or Stewart et al. (US 5,593,550).
Regarding claims 11, 14, 15, 18, 19 and 141-148, Ng et al. teach a method comprising forming a body supporting at least one contact electrode, the body at least partially defining a re-closable lumen and comprising engaging portions, the engaging portions being formed from a silicone material (Abstract; Figure 2 (10) (54) (60); Figures 5-10C showing cuff body (80) with overlapping inner and outer cuff regions/portions that read upon the claimed engaging portions; paragraphs [0013]-[0018], [0054] – silicone; [0055] and [0061]-[0070]; Figure 5 and 6 showing a base structure with distal and proximal portions extending as arms as claimed). Ng et al. further teach implanting the body in a patient and retaining the ability to open/close/expand the body implanted in the patient (Figures 5 and 6; 8 and 9; paragraphs [0010]-[0012], [0017] and [0055]). Ng et al. do not explicitly teach forming a surface contact feature on a surface of at least one of the corresponding engaging portions, wherein the surface-contact feature mitigates or prevents cross-linking of the silicone material of the engaging portion in use or in storage or during transportation; for example, by altering a surface chemistry of the surface by a plasma surface treatment or application of a lubricant as claimed.
However, each of Hansen et al. (paragraph [0078] – analogously treat silicone contacting surfaces so that they don’t stick, especially after cleaning or sterilization or in storage by adding barium sulfate – a lubricant in this context) and Stewart et al. (Abstract; col. 1, lines 60-50; col. 3, lines 40-67; col. 5, lines 16-35; col. 6, lines 1-12; col. 6, line 65-col. 7, line 15; col 12, lines 8-42; altering the surface chemistry of the silicone, by plasma treatment – including treatment with a siloxane vapor; to prevent sticking/tackiness/improve slip/reduce friction) disclose analogous methods (e.g. processing silicone polymers into articles) wherein the surface chemistry of the silicone is modified by a plasma surface treatment, including a siloxane vapor treatment, or application of a lubricant 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 Ng et al. and any one of the secondary references and to have formed a surface contact feature on a surface of at least one of the engaging portions, wherein the surface-contact feature mitigates or prevents cross-linking of the silicone material of the engaging portion; for example, by altering a surface chemistry of the engaging portions, as suggested by any one of the secondary references, for the purpose, as suggested by the references, of reducing the tendency of the portions of silicone that overlap each other in Ng et al. from sticking together by reducing tackiness/stickiness/blocking/preventing fusion/preventing bonding of the materials/mitigating or preventing cross-linking between silicone contacting surfaces. Ng et al. teach the lumen needs to be able to open/close/expand for both installation and while in use around a nerve (Figures 5 and 6; 8 and 9; paragraphs [0054] and [0055]). If the lumen size of Ng et al. can’t effectively expand due to stickiness/tackiness/bonding/crosslinking/fusion of the overlapping portion, the device of Ng et al. will not work properly. If the overlapping portions stick together, the device cannot be opened/uncurled/unfurled. Ng et al. disclose the cuff is made of silicone and each of the secondary references disclose that silicone polymers have a tendency to stick/bond/fuse together at points of contact and that modifying the surface chemistry as set forth in the references reduces this tendency. This is a tendency that one having ordinary skill in the art would have found beneficial in view of the application of Ng et al. Further, to the extent the chosen language regarding the surface contact feature being able to mitigate or prevent crosslinking is different than the language chosen by the secondary references, this ability to mitigate or prevent is done by adding the contact features as claimed. The secondary references suggest forming contact features having the same claimed structure and explicitly focus on the similar/same issues of tackiness/sticking/fusing/bonding language. Different language is used, but the same structure is suggested for substantially similar/the same reasons. The same claimed structure is produced from the same claimed material in the combination. When the same materials are formed into the same structure, the resultant article will have the same claimed properties (e.g. mitigate or prevent cross-linking to the extent required). The general disclosure of a siloxane vapor treatment in Stewart et al. renders the more specific trimethylsiloxane treatment prima facie obvious.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ng et al. (US 2019/0060646) in view of either one of Hansen et al. (US 2023/0025428) or Stewart et al. (US 5,593,550), as applied to claims 11, 14, 15, 18, 19 and 141-148 above, alone or further in view of Kallesoe et al. (US 5,487,756).
As to claim 17, the combination teaches the method set forth above. Ng et al. do not tach a sacrificial material and packaging as claimed. However, in view of the suggestion from the secondary references to reduce stickiness/tackiness, one having ordinary skill would have found it prima facie obvious to have further modified the method of Ng et al. and to have introduced a sacrificial material (e.g. layer of PTFE) between the engaging portions prior to packaging in order to further facilitate a reduction in stickiness/tackiness. Alternatively, Kallesoe et al. teach the inclusion of pins that run between tubes (34) and (36) and further packaging the cuff (20) (col. 7, lines 24-30). 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 Ng et al. and Kallesoe et al. and to have added a sacrificial material and to have packaged the cuff of Ng et al., as suggested by Kallesoe et al., for the purpose, as suggested by the references, of facilitating a safe and sterile delivery of the cuff in a suitable and art recognized manner.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Ng et al. (US 2019/0060646) in view of either one of Hansen et al. (US 2023/0025428) or Stewart et al. (US 5,593,550), as applied to claims 11, 14, 15, 18, 19 and 141-148 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, the combination teaches the method set forth above. Ng et al. teach the basic claimed structure, 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 Ng 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 Ng 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.
Response to Arguments
Applicant’s arguments filed May 4, 2026 have been fully considered, but are moot in view of the new grounds of rejection necessitated by the amendment to the claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Schuttler (US 2019/0060641) is understood to be applicable as an alternative primary reference in combination with the secondary references for substantially similar/the same reasons as the Ng et al. reference.
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 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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/JEFFREY M WOLLSCHLAGER/Primary Examiner, Art Unit 1742
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