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 .
Double Patenting
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 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-7, 15-20 and 22 of U.S. Patent No. 11,617,644. Although the claims at issue are not identical, they are not patentably distinct from each other because the Patent discloses:
Regarding Claim 1, the Patent discloses an implant comprising: a conduit (column 20, line 44) including a distal portion having a distal end and a proximal portion having a proximal end (column 20, lines 45-50), the proximal portion comprising one or more sinuses having a concave shape relative to an inner surface of the proximal portion (column 21, lines 64-67 and column 22, lines 1-3); and a valve structure including at least one leaflet (column 20, lines 53-55) disposed adjacent to at least one of the one or more sinuses (column 21, lines 64-67), each of the at least one leaflet having a free edge and a leaflet attachment edge coupled between the distal end and the proximal end (column 20, lines 53-60).
Regarding Claim 2, the Patent discloses wherein the one or more sinuses are more rigid relative to other areas of the proximal portion (column 22, lines 4-6).
Regarding Claim 3, the Patent discloses wherein the distal end and the proximal end have a complementary shape (column 20, lines 61-63).
Regarding Claim 4, the Patent discloses wherein the distal end defines a plurality of parabolic valleys, and wherein the proximal end defines a plurality of complementary conduit parabolic hills (column 20, lines 64-67).
Regarding Claim 5, the Patent discloses wherein the valve structure is a leaflet construct comprising a plurality of leaflets that are joined together by a bridge region between adjacent leaflets (column 21, lines 13-16).
Regarding Claim 6, the Patent discloses wherein the valve structure comprises a leaflet construct defining a contiguous annular ring comprising a plurality of leaflets and a bridge region between each leaflet of the plurality of leaflets, each leaflet of the plurality of leaflets extending radially inward from the distal end, each leaflet of the plurality of leaflets defining an attachment region (column 21, lines 17-22).
Regarding Claim 7, the Patent discloses wherein the leaflet attachment edge of each of the at least one leaflet extends between the distal end and the proximal end and coupled thereto with means selected from a list consisting of suture, adhesive, and thermal bonding (column 21, lines 59-63).
Regarding Claim 8, the Patent discloses wherein the proximal portion further comprises a plurality of sinuses adjacent the proximal end, and wherein each leaflet is adjacent a sinus of the plurality of sinuses (column 21, lines 64-67).
Regarding Claim 9, the Patent discloses further comprising a support frame coupled to the distal end, the support frame having a generally annular shape (column 22, lines 8-10).
Regarding Claim 10, the Patent discloses wherein the support frame has a complementary shape relative to the distal end (column 22, lines 11-14).
Regarding Claim 11, the Patent discloses wherein the support frame is at least partially composed of a radiopaque material (column 22, lines 18-20).
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-7, 11-15 and 17 of U.S. Patent No. 10,504,101. Although the claims at issue are not identical, they are not patentably distinct from each other because the Patent discloses:
Regarding Claim 1, the Patent discloses an implant comprising: a conduit (column 20, line 47) including a distal portion having a distal end and a proximal portion having a proximal end (column 20, lines 47-49), the proximal portion comprising one or more sinuses having a concave shape relative to an inner surface of the proximal portion (column 21, lines 57-60 and column 21, lines 61-63); and a valve structure including at least one leaflet (column 20, line 52) disposed adjacent to at least one of the one or more sinuses (column 21, lines 57-60), each of the at least one leaflet having a free edge and a leaflet attachment edge coupled between the distal end and the proximal end (column 20, lines 52-53).
Regarding Claim 2, the Patent discloses wherein the one or more sinuses are more rigid relative to other areas of the proximal portion (column 21, lines 64-67).
Regarding Claim 3, the Patent discloses wherein the distal end and the proximal end have a complementary shape (column 21, lines 9-11).
Regarding Claim 4, the Patent discloses wherein the distal end defines a plurality of parabolic valleys, and wherein the proximal end defines a plurality of complementary conduit parabolic hills (column 21, lines 12-15).
Regarding Claim 5, the Patent discloses wherein the valve structure is a leaflet construct comprising a plurality of leaflets (column 21, lines 27-29) that are joined together by a bridge region between adjacent leaflets (column 21, lines 29-30).
Regarding Claim 6, the Patent discloses wherein the valve structure comprises a leaflet construct defining a contiguous annular ring comprising a plurality of leaflets and a bridge region between each leaflet of the plurality of leaflets, each leaflet of the plurality of leaflets extending radially inward from the distal end, each leaflet of the plurality of leaflets defining an attachment region (column 21, lines 31-36).
Regarding Claim 7, the Patent discloses wherein the leaflet attachment edge of each of the at least one leaflet extends between the distal end and the proximal end and coupled thereto with means selected from a list consisting of suture, adhesive, and thermal bonding (column 21, lines 1-6).
Regarding Claim 8, the Patent discloses wherein the proximal portion further comprises a plurality of sinuses adjacent the proximal end, and wherein each leaflet is adjacent a sinus of the plurality of sinuses (column 21, lines 57-60).
Regarding Claim 9, the Patent discloses further comprising a support frame coupled to the distal end, the support frame having a generally annular shape (column 22, lines 1-3).
Regarding Claim 10, the Patent discloses wherein the support frame has a complementary shape relative to the distal end (column 22, lines 4-7).
Regarding Claim 11, the Patent discloses wherein the support frame is at least partially composed of a radiopaque material (column 22, lines 12-13).
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) 1-4, 8-10, 12-15 and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Murad et al. WO 2014/145811.
Regarding Claim 1, Murad et al. discloses an implant 400 comprising: a conduit 428 having a distal portion having a distal end 410 (see Figures 30- 31A) and a proximal portion having a proximal end (above 402), the proximal portion comprising one or more sinuses 402 having a concave shape relative to an inner surface of the proximal portion (see Figures 16A-16B and 29-30); and a valve structure 404 including at least one leaflet (paragraphs [0105-], [0107- 0109]) disposed adjacent to at least one of the one or more sinuses 402, each of the at least one leaflet having a free edge and a leaflet attachment edge coupled between the distal end and the proximal end (as seen in Figure 27B).
Regarding Claim 2, Murad et al. discloses wherein the one or more sinuses 402 are more rigid relative to other areas of the proximal portion (paragraph [0099] and as seen in Figures 30, 30A, the sinuses includes additional layer of material formed by the valve leaflets and wireform stent, see hashed line, therefore the sinuses would be more rigid than the tubular portion extending above the sinuses 402).
Regarding Claim 3, Murad et al. discloses wherein the distal end 410 and the proximal end have a complementary shape (as seen in Figures 30A-31B).
Regarding Claim 4, Murad et al. discloses wherein the distal end 410 defines a plurality of parabolic valleys, and wherein the proximal end 429a defines a plurality of complementary conduit parabolic hills (as seen in Figures 30A-31B).
Regarding Claim 8, Murad et al. discloses wherein the proximal portion further comprises a plurality of sinuses 402 adjacent the proximal end, and wherein each leaflet is adjacent a sinus of the plurality of sinuses 402 (as seen in Figure 30A, 36A).
Regarding Claim 9, Murad et al. discloses further comprising a support frame 26, 412 coupled to the distal end, the support frame 26, 304, 454 having a generally annular shape (as seen in Figure 1, 15, 17-17A, 33A-33B and see hashed curve of the support frame in Figure 30A and paragraphs [0060], [0065], [0093] and [0118]).
Regarding Claim 10, Murad et al. discloses wherein the support frame 26, 412 has a complementary shape relative to the distal end (as seen in Figures 30, 30A, 30C, see paragraph [0103] the heart valve 404 has crown shaped upper and lower edges 429a, 429b so called double crown ring which is attached to the conduit graft).
Regarding Claim 12, Murad et al. discloses an implant 400 comprising: a conduit 428 including a distal portion having a distal end 410 (see Figures 30- 31A) and a proximal portion having a proximal end (above 402), the proximal portion comprising a cylindrical tube and one or more sinuses 402 extending from the cylindrical tube (see Figures 16A-16B and 29-30); the proximal portion having an increased diameter at the one or more sinuses 402 relative to other portions of the cylindrical tube (as seen in Figure 30); and a valve structure 404 including at least one leaflet (paragraphs [0105-], [0107- 0109]) disposed adjacent to at least one of the one or more sinuses 402, each of the at least one leaflet having a free edge and a leaflet attachment edge coupled between the distal end and the proximal end (as seen in Figure 27B).
Regarding Claim 13, Murad et al. discloses wherein the one or more sinuses are more rigid relative to other areas of the proximal portion (paragraph [0099] and as seen in Figures 30, 30A, the sinuses includes additional layer of material formed by the valve leaflets and wireform stent, see hashed line, therefore the sinuses would be more rigid than the tubular portion extending above the sinuses 402).
Regarding Claim 14, Murad et al. discloses wherein the distal end 410 and the proximal end have a complementary shape (as seen in Figures 30A-31B).
Regarding Claim 15, Murad et al. discloses wherein the distal end 410 defines a plurality of parabolic valleys, and wherein the proximal end 429a defines a plurality of complementary conduit parabolic hills (as seen in Figures 30A-31B).
Regarding Claim 18, Murad et al. discloses wherein the proximal portion further comprises a plurality of sinuses 402 adjacent the proximal end, and wherein each leaflet is adjacent a sinus of the plurality of sinuses 402 (as seen in Figure 30A, 36A).
Regarding Claim 19, Murad et al. discloses further comprising a support frame 26, 412 coupled to the distal end, the support frame 26, 304, 454 having a generally annular shape (as seen in Figure 1, 15, 17-17A, 33A-33B and see hashed curve of the support frame in Figure 30A and paragraphs [0060], [0065], [0093] and [0118]).
Regarding Claim 20, Murad et al. discloses wherein the support frame 26, 412 has a complementary shape relative to the distal end (as seen in Figures 30, 30A, 30C, see paragraph [0103] the heart valve 404 has crown shaped upper and lower edges 429a, 429b so called double crown ring which is attached to the conduit graft).
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.
Claim(s) 5-7 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murad et al. WO 2014/145811 in view of Duran et al. U.S. Patent 5,489,297.
Regarding Claim 5, 6, 16, 17, Murad et al. discloses wherein the valve structure comprises a leaflet construct (as seen in Figure 27) defining a contiguous annular ring comprising a plurality of leaflets, each leaflet of the plurality of leaflets extending radially inward from the distal end, each leaflet of the plurality of leaflets defining an attachment region (the leaflets are attached to each other, see Figures 17, 23A, 27B, 33A-33B). However, Murad et al. does not expressly disclose wherein the valve structure is a leaflet construct comprising a plurality of leaflets that are joined together by a bridge region between adjacent leaflets. Duran et al. teaches an implant 17 comprising: a conduit 20 and a valve structure 110 having a plurality of leaflets 112, wherein the leaflets are joined together by a bridge region 119 between adjacent leaflets (as seen in Figures 16b-16C) to form a single strip of biocompatible membrane (column 12, lines 23-30). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Murad’s leaflet to further include a bridge region between adjacent leaflets as taught by Duran et al. for the purpose of forming a single strip of biocompatible membrane forming commissural “bridge” regions.
Regarding Claim 7, Murad et al. discloses wherein the leaflet attachment edge of each of the at least one leaflet extends between the distal end and the proximal end (as seen in Figures 17, 23A, 27B, 33A-33B). However, Murad et al. does not expressly disclose the leaflet attachment coupled thereto with means selected from a list consisting of suture, adhesive, and thermal bonding. Duran et al. teaches an implant 17 comprising: a conduit 20 and a valve structure 110 having a plurality of leaflets 112, wherein the leaflets comprises a leaflet attachment edge 118 coupled via suture 124 or adhesive (column 12, lines 59-67 and column 13, lines 1-9) for the purpose of attaching the valve structure having a stent and a plurality of leaflets together forming a bioprosthetic heart valve (column 12, lines 14-30 and column 13, lines 35-46). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Murad’s leaflet attachment edge to be coupled with a suture or adhesive as taught by Duran et al. for the purpose of attaching the valve structure having a stent and a plurality of leaflets together forming a bioprosthetic heart valve.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murad et al. WO 2014/145811 in view of Guttenberg et al. U.S. Publication 2015/0366664 A1.
Regarding Claim 11, Murad et al. does not expressly disclose wherein the support frame is at least partially composed of a radiopaque material. Guttenberg et al. teaches a support frame in the same field of endeavor for forming a prosthetic heart valve configured to replace a native heart valve (abstract and as seen in Figures 1A-1D), the frame 40 includes radiopaque material forming the band and valve size indicators 50 formed by cutting holes or voids through the radiopaque outer band for the purpose of allowing the identifying the surgical heart valve in terms of size and type (paragraph [0047]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Murad’s support frame to further include a radiopaque material or radiopaque cut outs in the support frame as taught by Guttenberg et al. for the purpose of allowing the identifying the surgical heart valve in terms of size and type.
Conclusion
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
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