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 6/3/26. As directed by the amendment: claims 32, 63, 65, and 66 have been amended, claims 1-29 and 34-61 have been cancelled, and no new claims been added. Thus, claims 30-33 and 62-77 are presently pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 30-33 and 62-77 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, the specification and disclosure as a whole does not provide adequate description of any particular methodology for causing the inward collapse/contraction of the implant, and does not establish how displacing a central portion of an implant would be performed such that it causes an outer perimeter of the implant to contract and collapse, as claimed in independent claim 30 and its dependent claims. The disclosure as a whole does not elaborate beyond what is claimed, with arguably the most detailed description of this methodology being found in par. 1061, which states that “the tool member 1650 traverses an entire length of the implant 1100 to create a tunnel (not shown) such that an outer surface of the implant 1100 collapses inwards towards the tunnel and an effective outer diameter of the implant is smaller than an inner diameter of the body lumen BL.” Additionally, levels of ordinary skill in the art would not have permitted the ordinary artisan to immediately envisage the claimed effect of contraction and collapse of the implant to result from displacing a central portion of the implant. For example, Lee-Sepsick et al. (US 20130220335) discloses in examples in fig. 6B and 6D advancing an instrument into/through an occlusion to displace some of the occlusion, but does not correlate this activity to collapsing or contracting the occlusion. Elsewhere, Efremkin (US 20190142453) discloses a methodology for removing a central portion of an occlusion using an ablative element 20 (see fig. 6-7A), but notes that since this element only removes a central portion of the occlusion, an additional element 65 must also be used to remove remaining outer portions of the occlusion adjacent to the vessel wall (see fig. 7A). Thus, the disclosure as a whole appears to lack sufficient particularity of description with regard to this methodology such that one having ordinary skill in the art would recognize that the inventor had possession of the claimed invention at the time of filing.
Claims 30-33 and 62-77 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Independent claim 30 and its dependent claims broadly recite a cause and effect relationship between displacing a central portion of an implant and contracting and collapsing the implant toward a center. Neither the specification nor the claims provide direction for how displacing a central portion as claimed will cause the claimed central contraction/collapse, and fail to direct any particular methodology for causing the contraction or collapse. In contrast, the state of the prior art which would inform one having ordinary skill in the art appears to envision removal of material centrally from an implant without particularly associating such removal with collapse or contraction of the implant centrally; see in particular Lee-Sepsick et al. (US 20130220335) in the examples of fig. 6B and 6D where an instrument is advanced into/through an implant thereby displacing a central portion of the implant without correlating the activity to a collapse or contraction of the implant. See also Efremkin (US 20190142453) which discloses a methodology for removing a central portion of an occlusion using an ablative element 20 (see fig. 6-7A), but notes that since this element only removes a central portion of the occlusion, an additional element 65 must also be used to remove remaining outer portions of the occlusion adjacent to the vessel wall (see fig. 7A; par. 0075). Thus, it does not appear based on the state of the prior art that one having ordinary skill in the art would inherently correlate removal of central material of an implant to the inward contraction/collapse of the implant, as claimed and disclosed, and further would not understand implementing this claimed relationship without further direction from the inventor.
Response to Arguments
Applicant's arguments filed 6/3/26 have been fully considered but they are not persuasive.
Applicant argues, on pg. 7 of the Remarks, that par. 1061 of the specification provides sufficient written description for the limitation of “displacing the central portion of the implant to cause at least a portion of an outer perimeter of the implant to contract and collapse towards a center of the vas deferens” from claim 30, restating language from par. 1061 and stating that it identifies a structure, an action, and a resulting configuration. Examiner maintains that the relationship between the action and the resulting configuration is not sufficiently described in cited par. 1061 or elsewhere in the specification. It is not described, in par. 1061 how creating a tunnel via the tool member is performed such that it collapses inwards the outer surface of the implant.
Regarding the argument at the top of pg. 8 of the Remarks that usage of the phrase “immediately envisage” is not an accurate statement of the legal standard for assessing written description requirement, Examiner maintains that such an analysis is appropriate regarding evidence for or against written description support as discussed in MPEP 2163(I)(A).
Applicant’s arguments directed to requiring working examples, detailed mechanical explanations, or proof of operation in the lower half of pg. 8 – pg. 9 is moot since no such requirements have been made by the Examiner.
Regarding the arguments on pg. 9 of the Remarks regarding the prior art, Examiner maintains that the prior art examples provided are relevant to the assessment of whether the specification reasonably conveys to those skilled in the art that Applicant had possession of the claimed invention. As noted, Applicant has not sufficiently described the relationship/methodology between displacing the central portion of the implant and causing the outer perimeter to contract and collapse toward the center. The prior art assists in formulating the person of ordinary skill in the art’s perspective on this issue.
Applicant argues, on pg. 10-11 of the Remarks, that the same limitation is enabled based on the same disclosure in par. 1061. Examiner does not agree that the phrasing of par. 1061 provides sufficient disclosure for one having ordinary skill in the art regarding how the act of displacing the central portion of the implant should be performed to specifically cause the outer perimeter of the implant to contract and collapse toward the center, only stating that the tunnel is created such that an outer surface of the implant collapses inwards, and lacks any details of how that methodology is to be performed to cause the effect of inward collapse of the outer surface. Examiner has not required “every conceivable embodiment” to be disclosed as argued by Applicant, but it appears that no embodiment of how this relationship is achieved is disclosed.
Regarding Applicant’s arguments directed to the cited prior art on pg. 11-12, Examiner points to MPEP 2164.01(a), specifically Wands factor (C) which pertains to the state of the prior art. The cited references are provided to establish the state of the prior art with regards to this Wands factor. Additionally, the Examiner has not asserted or assumed that “all implants within any bodily lumen will react the same to the traversal of the implant length using a tool member to form a tunnel”.
Conclusion
THIS ACTION IS MADE FINAL. 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 NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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