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 without traverse of Invention I, claims 88-103 in the reply filed on October 03, 2025 is acknowledged.
Applicant has canceled claims 104-117 drawn to the non-elected invention.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 88-91, 93-96, and 98-99 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ohki (U.S. Pub. No. 2022/0008189)(priority to November 11, 2019).
Regarding claim 88, Ohki teaches a medical implant (1; Fig. 1) for providing access to a body conduit system, the medical implant comprising:
a support frame (5; Fig. 1) defining a lumen and having an expanded configuration (pp. [0028]), the support frame (5) in the expanded configuration being configured to anchor the medical implant in the body conduit system (pp. [0044]) and to have the lumen in continuity with the body conduit system when the support frame (5) is anchored in the body conduit system (pp. [0004]); and
a barrier membrane (7; Fig. 1) configured to couple to the support frame (5), the barrier membrane (7) being tensioned by the support frame (5) and penetrable for providing access to the lumen (pp. [0012]), when coupled to the support frame (5) and when the support frame is in the expanded configuration.
Regarding claim 89, Ohki teaches the invention as discussed above in claim 88. Ohki further teaches an identifiable marker (19; Fig. 5) for assisting in positioning the medical implant (1) in the body conduit system (pp. [0043]).
Regarding claim 90, Ohki teaches the invention as discussed above in claim 88. Ohki further teaches an identifiable marker (19; Fig. 5) for assisting in positioning the barrier membrane (7) in the body conduit system to penetrate the barrier membrane (pp. [0043]).
Regarding claim 91, Ohki teaches the invention as discussed above in claim 88. Ohki further teaches the support frame (5) in the expanded configuration has a cylindrical shape defining the lumen longitudinally therethrough (pp. [0029]), the barrier membrane (7) being circumferentially attached to the support frame (5).
Regarding claim 93, Ohki teaches the invention as discussed above in claim 88. Ohki further teaches the support frame (5) in the expanded configuration has a shape comprising two spaced-apart discs (11; Fig. 2) connected together by a hollow cylinder defining the lumen longitudinally therethrough (pp. [0039]), the barrier membrane (7) being attached to the support frame (5) and extending across the lumen.
Regarding claim 94, Ohki teaches the invention as discussed above in claim 88. Ohki further teaches the barrier membrane (7) is configured to be fully contained within the body conduit system (e.g., the aorta, pp. [0037]) when the medical implant (1) is implanted therein and the support frame (5) is in the expanded configuration.
Regarding claim 95, Ohki teaches the invention as discussed above in claim 88. Ohki further teaches the membrane barrier (7) comprises a tensioned penetrable zone (9; Fig. 1, pp. [0012]).
Regarding claim 96, Ohki teaches the invention as discussed above in claim 88. Ohki further teaches the membrane barrier (7) comprises a weakened site (9; Fig. 1, pp. [0012]).
Regarding claim 98, Ohki teaches the invention as discussed above in claim 88. Ohki further teaches the membrane barrier (7) is made of a material comprising a self-sealing material (pp. [0036]).
Regarding claim 99, Ohki teaches the invention as discussed above in claim 88. Ohki further teaches the membrane barrier (7) is made of a material comprising an elastomeric material (pp. [0036]).
Claim(s) 88, 91-92, 94-96, 98-99, 101, and 103 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nugent et. al. (U.S. Pub. No. 2005/0234546), hereinafter, “Nugent.”
Regarding claim 88, Nugent teaches a medical implant (110; Fig. 11A) for providing access to a body conduit system (see Fig. 10), the medical implant comprising:
a support frame (“mesh 112”; not shown, pp. [0082]) defining a lumen and having an expanded configuration (pp. [0085]), the support frame (mesh 112) in the expanded configuration being configured to anchor the medical implant in the body conduit system (see Fig. 10) and to have the lumen in continuity with the body conduit system (see Fig. 10) when the support frame (mesh 112) is anchored in the body conduit system; and
a barrier membrane (56; Fig. 11A) configured to couple to the support frame (mesh 112), the barrier membrane (56) being tensioned by the support frame (mesh 112) and penetrable for providing access to the lumen (“cover” 56 is sutured to “valve assembly” 110 such that blood flow can penetrate the mesh cover, pp. [0084]), when coupled to the support frame (mesh 112) and when the support frame is in the expanded configuration.
Regarding claim 91, Nugent teaches the invention as discussed above in claim 88. Nugent further teaches the support frame (mesh 112) in the expanded configuration has a cylindrical shape defining the lumen longitudinally therethrough (see pp. [0089] discussing how “valve assembly” 110 can be any geometric shape previously described and pp. [0072] describing a cylindrical shape), the barrier membrane (56) being circumferentially attached to the support frame (mesh 112).
Regarding claim 92, Nugent teaches the invention as discussed above in claim 88. Nugent further teaches the support frame (mesh 112) in the expanded configuration has a spherical shape (see Fig. 11C. See also pp. [0089] discussing how “valve assembly” 110 can be any geometric shape previously described and pp. [0072] describing a spherical shape), the lumen being centrally arranged relative to the support frame and defining two support frame openings (the top opening and the bottom opening in Fig. 11C), the barrier membrane (56) being peripherally attached to the support frame and extending over at least one of the two support frame openings (e.g., the bottom opening, see Fig. 11A).
Regarding claim 94, Nugent teaches the invention as discussed above in claim 88. Nugent further teaches the barrier membrane (56) is configured to be fully contained within the body conduit system (see Fig. 10) when the medical implant (110) is implanted therein and the support frame (mesh 112) is in the expanded configuration.
Regarding claim 95, Nugent teaches the invention as discussed above in claim 88. Nugent further teaches the membrane barrier (56) comprises a tensioned penetrable zone (pp. [0084]).
Regarding claim 96, Nugent teaches the invention as discussed above in claim 88. Nugent further teaches the membrane barrier (56) comprises a weakened site (pp. [0084]).
Regarding claim 98, Nugent teaches the invention as discussed above in claim 88. Nugent further teaches the membrane barrier (56) is made of a material comprising a self-sealing material (pp. [0084]).
Regarding claim 99, Nugent teaches the invention as discussed above in claim 88. Nugent further teaches the membrane barrier (56) is made of a material comprising an elastomeric material (pp. [0084]).
Regarding claim 101, Nugent teaches the invention as discussed above in claim 88. Nugent further teaches the membrane barrier (56) is made of a material comprising a material having silicone material (pp. [0084]).
Regarding claim 103, Nugent teaches the invention as discussed above in claim 88. Nugent further teaches the medical implant (110) is sized and shaped to be implanted transcatheterly (pp. [0085]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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(s) 97 and 102-103 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohki in view of Purdy (U.S. Pub. No. 2012/0053670).
Regarding claims 97 and 102, Ohki teaches the invention as discussed above in claim 88. However, Ohki does not explicitly disclose the membrane barrier is made of a material comprising a hemostatic material and a resorbable material.
Purdy teaches a medical implant stent graft (20; Fig. 1A) with a membrane barrier (50; Fig. 1A) made of a material comprising a hemostatic material and a resorbable material (“collagen,” pp. [0047], which is known for being both hemostatic and resorbable) .
Purdy is considered to be analogous to the claimed invention because it is in the same field of stent grafts. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the membrane barrier of Ohki to incorporate the teachings of Purdy by making the membrane barrier of a material comprising a hemostatic material and a resorbable material. Doing so would help stop bleeding at the implant site and allow the membrane barrier to safely break down and be absorbed by the body to alleviate the need to remove the barrier at a later time.
Regarding claim 103, Ohki teaches the invention as discussed above in claim 88. Ohki further teaches the medical implant (1) is sized and shaped to be implanted into the aorta (pp. [0037]) but does not explicitly disclose delivering it transcatheterly.
Purdy teaches delivering a medical implant stent graft (20; Fig. 12) to a blood vessel (175; Fig. 18) using a catheter (30; Fig. 12).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ohki to incorporate the teachings of Purdy by delivering the medical implant transcatheterly. Doing so would provide a safe and efficient way of delivering the implant into the aorta.
Claim(s) 100-101 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohki in view of Stevenson et. al. (U.S. Pub. No. 2019/0307924), hereinafter, “Stevenson.”
Regarding claims 100 and 101, Ohki teaches the invention as discussed above in claim 88. Ohki further teaches the membrane barrier is made of a material comprising a material having high elasticity (pp. [0036]) but does not explicitly disclose a material comprising a silicone material and a Shore A Durometer of less than 90.
Stevenson teaches a membrane barrier (10; Fig. 1a) for use with a support member (pps. [0155] & [0156]) can be made of a material comprising a silicone material (pp. [0449]) with a Shore A Durometer of less than 90 (pp. [0449]).
Stevenson is considered to be analogous to the claimed invention because it is in the same field of [2]. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the barrier member of Ohki to incorporate the teachings of Stevenson by making the barrier membrane from a silicone material and a having Shore A Durometer of less than 90. Doing so would provide a material having high elasticity as desired by Ohki and would also provide the barrier membrane with suitable flexibility and handling characteristics for use within vessels (see pps. [0449] & [0160]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. (McWeeney)(US-11207172-B2), (Cully)(US-20150265391-A1), (Ginn)(US-20140364899-A1), (Gonzalez)(US-20140330309-A1), (Tabor)(US-20140114391-A1), (Jonsson)(US-20140066979-A1), and (Teichman)( US-20120253387-A1) all teach body cavity sealing devices with support frames and barrier membranes as claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL A. ICET whose telephone number is (571)272-0488. The examiner can normally be reached M-F: 8:00-5:00 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL ICET/ Examiner, Art Unit 3771
/ELIZABETH HOUSTON/ Supervisory Patent Examiner, Art Unit 3771