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 .
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.
Claim(s) 88, 91-94, 96-99, 101, 103, and 118-122 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McWeeney et al. (2020/0214861).
McWeeney discloses the following claimed limitations:
The claims contain a lot of intended use recitations which it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Claim 88: A medical implant for providing access to a body conduit system, the medical implant comprising: a support frame (105-m, 105-l, 105-n) defining a lumen (lumen through the frame as seen in Fig. 1a-b and Fig. 13-15) and having an expanded configuration (Fig. 13-15), the support frame in the expanded configuration being configured to anchor the medical implant in the body conduit system (Fig. 13-15) and to have the lumen in continuity with the body conduit system when the support frame is anchored in the body conduit system (Fig. 13-15); and a barrier membrane (1410, 1505 in [0095], sleeve described in [0051]) configured to coupled to the support frame (Fig. 13-15, [0095], [0051]), the barrier membrane being tensioned by the support frame and penetrable for providing access to the lumen- when coupled to the support frame and when the support frame is in the expanded configuration (Fig. 13-15, [0051], and [0095]), the barrier membrane comprising a tensioned penetrable zone (zone where the catheter enters as seen in Fig. 13-15) when tensioned by the support frame (Fig. 13-15 and [0095]), wherein the tensioned penetrable zone is configured to abut a wall of the body conduit system to be succedently traversed by a catheter (Fig. 13-15), and is configured to (i) permit penetration of the catheter through the barrier membrane in the tensioned penetrable zone into the lumen (Fig. 13-15 and [0095]), and (ii) self- seal around an exterior surface of the catheter when the catheter traverses the wall of the body conduit system and penetrates the tensioned penetrable zone, for reducing outflow of bodily fluid across the wall of the body conduit system at least while the catheter is in place (Fig. 13-15 and [0095]).
Claim 91: wherein the support frame in the expanded configuration has a cylindrical shape defining the lumen longitudinally therethrough, the barrier membrane being circumferentially attached to the support frame (Fig. 13-15, [0051], and [0095]).
Claim 92: wherein the support frame in the expanded configuration has a spherical shape, a spheroidal shape, an ellipsoidal shape, or a conoidal shape (Fig. 13-15), the lumen being centrally arranged relative to the support frame and defining two support frame openings (Fig. 15), the barrier membrane being peripherally attached to the support frame and extending over at least one of the two support frame openings (Fig. 13-15, [0051], and [0095]).
Claim 93: wherein the support frame in the expanded configuration has a shape comprising two spaced-apart discs (discs at the end in Fig. 13-15) connected together by a hollow cylinder defining the lumen longitudinally therethrough (Fig. 13-15), the barrier membrane being attached to the support frame and extending across the lumen (Fig. 13-15, [0051], and [0095]).
Claim 94: wherein the barrier membrane is configured to be fully contained within the body conduit system when the medical implant is implanted therein and the support frame is in the expanded configuration (Fig. 13-15)
Claim 96: wherein the membrane barrier membrane comprises a weakened site (location where the catheter enters as seen in Fig. 13-15 and [0092-95]).
Claim 97: wherein the membrane barrier membrane is made of a material comprising a hemostatic material (Fig. 13-15 and [0092-95]).
Claim 98: wherein the membrane barrier membrane is made of a material comprising a self-sealing material (Fig. 13-15 and [0092-95]).
Claim 99: wherein the membrane barrier membrane is made of a material comprising an elastomeric material (Fig. 13-15 and [0092-95]).
Claim 101: wherein the membrane barrier membrane is made of a material comprising a silicone material ([0062]).
Claim 103: wherein the medical implant is sized and shaped to be implanted transcatheterly (Fig. 13-15).
Claim 118: wherein the tensioned penetrable zone is further configured to self-seal when the catheter is removed from the barrier membrane (Fig. 13-15, [0044], [0092-95]).
Claim 119: wherein the tensioned penetrable zone is repeatedly penetrable and self-sealing (Fig. 15, [0044], [0095]).
Claim 120:, wherein the tensioned penetrable zone is configured to (i) be penetrated by multiple catheters contemporaneously (Fig. 13-15, [0044], [0092-95]), (ii) self-seal around an exterior surface of each of the multiple catheters contemporaneously (Fig. 13-15, [0044], [0092-95]), and (iii) self-seal as each of the multiple catheters is removed from the barrier membrane (Fig. 13-15, [0044], [0092-95]).
Claim 121: wherein the tensioned penetrable zone comprises a self-sealing structure comprising at least one of a valve, a flap, a hinge, and a tortuous pathway (Fig. 13-15 and [0092-95]).
Claim 122: wherein the tensioned penetrable zone extends across the lumen of the hollow cylinder and is configured to self-seal around the exterior surface of the catheter while the catheter contemporaneously traverses a first wall and a second wall of the body conduit system (Fig. 13-15, [0044], [0092-95]).
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.
Claim(s) 89 and 90 is/are rejected under 35 U.S.C. 103 as being unpatentable over McWeeney et al. (2020/0214861) in view of Ohki (2022/0008189)
McWeeney teaches all the claimed limitations discussed above however, McWeeney does not disclose an identifiable marker as claimed.
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), a barrier membrane (7; Fig. 1), tensioned penetrable zone (9; Fig. 1, pp. [0012]); an identifiable marker (19; Fig. 5) for assisting in positioning the medical implant (1) in the body conduit system (pp. [0043]); and 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]).
It would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide McWeeney with identifiable markers in view of the teachings of Ohki, in order to confirm the position of the penetrable zone ([0043]).
Claim(s) 100 is/are rejected under 35 U.S.C. 103 as being unpatentable over McWeeney et al. (2020/0214861) in view of Stevenson et. al. (2019/0307924).
McWeeney teaches the invention as discussed above, however McWeeney 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 McWeeney 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]).
Claim(s) 102 is/are rejected under 35 U.S.C. 103 as being unpatentable over McWeeney et al. (2020/0214861) in view of Purdy ( 2012/0053670).
McWeeney teaches the invention as discussed above, however McWeeney does not explicitly disclose the membrane barrier is made of a material comprising 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 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 McWeeney to incorporate the teachings of Purdy by making the membrane barrier of a material comprising a resorbable material. Doing so would 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.
Response to Arguments
Applicant’s arguments filed on 7/15/26 have been considered but are moot in view of the new grounds of rejection
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
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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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/DIANNE DORNBUSCH/Primary Examiner, Art Unit 3771
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