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 10/2/25. As directed by the amendment: 30, 31, and 33 have been amended, 1-29 and 34-61 have been cancelled, and new claims 62-77 have been added. Thus, claims 30-33 and 62-77 are presently pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group III (claims 30-33 and 62-77) in the reply filed on 10/2/25 is acknowledged.
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.
Conclusion
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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/NATHAN R PRICE/Primary Examiner, Art Unit 3783