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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any specific references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight; intended use/functional language and/or method of manufacturing is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2113 & 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Claim Rejections - 35 USC § 102/103
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.
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.
Claims 8 and 13-20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Sogard et al. (US PG Pub. 2009/0117334), as disclosed in the IDS dated 07/18/2024, hereinafter Sogard.
Regarding claims 8, 13-15 and 17, Sogard discloses an implantable heart valve leaflet construct (1060/100), illustrated in Figures 1 and 10, comprising a polymeric membrane/first polymer layer (104) comprising a plurality of pores, the polymeric membrane (104) comprising a first portion (1051/1047) configured to promote tissue ingrowth, and a second portion (1053/1049) configured to inhibit tissue ingrowth; a filler material imbibed into pores of the second portion for inhibiting tissue ingrowth onto the second portion of the polymeric membrane; a tissue ingrowth curtain/second polymer layer (104) configured to promote tissue ingrowth and disposed over at least a portion of a first side of the first portion of the polymeric membrane, a second tissue ingrowth curtain/second polymer layer (104) disposed over at least a portion of a second side of the first portion of the polymeric membrane, wherein the first side is configured to be an inflow side of a leaflet of an implantable heart valve, extending from an edge opposite an edge of the polymeric membrane configured to form a free edge of the leaflet toward the edge of the polymeric membrane configured to form the free edge, and the second side is configured to be an outflow side of the leaflet of the implantable heart valve, extending from an edge opposite an edge of the polymeric membrane configured to form a free edge of the leaflet toward the edge of the polymeric membrane configured to form the free edge; wherein the tissue, and second tissue, ingrowth curtains/second polymer layer (104) disposed over the first and second sides, respectively have a common size and material; and an adhesive layer extending along adjoining surfaces between the tissue ingrowth curtain/second polymer layer (104) and the polymeric membrane, illustrated in Figures 1 and 10 ([0057]; [0059], Lines 1-2; [0060], Lines 5-8; [0061]; [0065]; [0091], Lines 1-5; [0101], Lines 5-6; [0141]; [0142] & [0151], Lines 5-6 – to clarify, it is stated that polymer layer 104 can comprise more than one layer/multiple layers and be porous via multiple different techniques such as braiding, weaving, knitting etc., thus the porous polymeric membrane is interpreted as being one/a first layer of the polymer layers 104, and the tissue ingrowth curtain/second tissue ingrowth curtain is interpreted as being another/a second layer of the polymer layers 104; furthermore, it is stated that the first portion 1051/1047 can be formed of porous material to facilitate tissue ingrowth, and as mentioned above, the tissue ingrowth curtains/second layer of the polymer layers 104 is porous thereby being configured to promote tissue ingrowth).
Regarding claim 16, Sogard discloses the implantable heart valve leaflet construct of claim 14, wherein the tissue ingrowth curtain/second polymer layer (104) disposed over the first side and the second tissue ingrowth curtain/third polymer layer (104) disposed over the second side have a different material ([0059], Lines 1-2 & [0061] – to clarify, it is stated that polymer layer 104 can comprise more than one/multiple layers/materials; thus, in the instant case, the second tissue ingrowth curtain is interpreted as being yet another/a third polymer layer of the polymer layers 104).
Regarding claim 18, Sogard discloses the implantable heart valve leaflet construct of claim 8, and though it is not specifically disclosed that there is a fillet transition between the polymeric membrane/first polymer layer (104) and an edge of the tissue ingrowth curtain/second polymer layer (104) terminating over the first side of the polymeric membrane, this parameter is deemed to be a mere matter of normal design choice, not involving a novel inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate shape/form for the transition/abutment between the polymeric membrane/first polymer layer and an edge of the tissue ingrowth curtain/second polymer layer terminating over the first side of the polymeric membrane, including a fillet transition shape/form as claimed, since a change in form/shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04); furthermore, it is to be noted that neither the claim, nor the originally filed specification gave any reason/benefit for, or criticality to the parameter of a fillet transition shape/form, as opposed to any other shape/form, and based on the absence of any unexpected results disclosed in the originally filed disclosure, the above mentioned parameter is considered an obvious matter of design choice within the level of ordinary skill in the art.
Regarding claims 19 and 20, Sogard discloses the implantable heart valve leaflet construct of claim 8, and though it is not specifically disclosed that the tissue growth curtain terminates along a linear boundary or a boundary having a concave shape relative to a free edge of an implantable heart valve leaflet, these parameters are deemed to be a mere matter of normal design choice, not involving a novel inventive step; it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate shape/form for the tissue growth curtain boundary, including a linear boundary or a boundary having a concave shape relative to a free edge of an implantable heart valve leaflet, since a change in form/shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04); furthermore, it is to be noted that neither the claims, nor the originally filed specification gave any reason/benefit for, or criticality to the parameters of the tissue growth curtain terminating along a linear boundary or terminating along a boundary having a concave shape relative to a free edge of an implantable heart valve leaflet, as opposed to any other shape/form for the terminal boundary, and based on the absence of any unexpected results disclosed in the originally filed disclosure, the above mentioned parameters are considered an obvious matter of design choice within the level of ordinary skill in the art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 5-12 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 5-9 of U.S. Patent No. 12,053,374. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims disclose a tissue ingrowth composite material/heart valve leaflet construct comprising a polymeric/fluoropolymer membrane comprising a plurality of pores, a first portion configured to promote tissue ingrowth, and a second portion configured to inhibit tissue ingrowth; a filler material imbibed into pores of the second portion for inhibiting tissue ingrowth onto the second portion of the polymeric/fluoropolymer membrane; and an elastomer/tissue ingrowth curtain imbibed into the first portion for promoting tissue ingrowth on the first portion of the polymeric/fluoropolymer membrane.
Allowable Subject Matter
Claims 1-7 would be allowable if the Double Patenting Rejection, set forth in this Office Action, is overcome by filing an e-Terminal Disclaimer.
Claims 9-12 would be allowable if rewritten to include all of the limitations of the base claim and any intervening claims, and overcome the Double Patenting Rejection, set forth in this Office Action, by filing an e-Terminal Disclaimer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 08/20/2026
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