DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 6/30/2026 have been fully considered but they are not persuasive. Applicant argues that the limitation “wherein at least a portion of the sealing member is disposed on an outside of the stent and has an inflow edge disposed at the inflow end of the stent and a free floating edge that is axially spaced apart from the inflow edge and extends toward the outflow end” is absent in Salahieh because the free edge extends towards the inflow end of the stent. Examiner disagrees, as annotated below, Salahieh discloses a free floating edge which is axially spaced apart from the inflow edge and extends toward the outflow end. Regarding the rejection of claim 11 under Section 103, the sealing member is considered both the covering on the stent and the sac 200, as both cooperate to provide a sealing function.
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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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,896,482. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are merely broader than the patent claims. All of the elements of application claims 1, 11, 19 are found in patent claims 1, 8, 13. The differences between the claims are that the patent claim includes many more elements and thus is much more specific. Thus the invention of claims 1-17 of the patent is in effect a “species” of the “generic” invention of application claims 1-20. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims 1-20 are anticipated by patent claims 1-17, the claims are not patentably distinct.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1, 4-9, 19 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Salahieh (Pub. No.: US 2007/0244552).
Salahieh discloses a prosthetic heart valve (abstract), comprising:
a stent 30 having a first end region defining an inflow end (fig. 13, bottom of figure) and a second end region defining an outflow end (fig. 13, top of figure);
a plurality of leaflets 20 coupled to the stent 30 (fig. 13); and
a sealing member 34 coupled to the first end region;
wherein at least a portion of the sealing member is disposed on an outside of the stent and has an inflow edge disposed at the inflow end of the stent (e.g., covering on the stent, fig. 5F, 15A-E) and a free floating edge 202 (fig. 16A) that is axially spaced apart from the inflow edge and extends toward the outflow end (fig. 16A).
For claim 4, Salahieh discloses the prosthetic heart valve of claim 1, wherein the first end region is flared (e.g., fig. 2B).
For claim 5, Salahieh discloses the prosthetic heart valve of claim 1, further comprising a plurality of longitudinal cuts disposed along the free floating edge (e.g., fig. 16A).
For claim 6, Salahieh discloses the prosthetic heart valve of claim 5, wherein the plurality of longitudinal cuts defines a plurality of alternating projections and recesses in the sealing member (e.g., fig. 16A).
For claim 7, Salahieh discloses the prosthetic heart valve of claim 1, wherein the stent comprises an annular groove (e.g., fig. 13, narrowed central area).
For claim 8, Salahieh discloses the prosthetic heart valve of claim 7, wherein the free floating edge of the sealing member is positioned within the annular groove (fig. 13, 16A).
For claim 9, Salahieh discloses the prosthetic heart valve of claim 7, wherein the sealing member includes a plurality of flaps within the annular groove (fig. 13, 16A).
For claim 19, Salahieh discloses a prosthetic heart valve, comprising:
a stent 30 having a first end region defining an inflow end (fig. 13, bottom of figure) and a second end region defining an outflow end (fig. 13, top of figure), the stent further defining an annular groove (fig. 13, narrowed central area);
a plurality of leaflets 20 coupled to the stent 30; and
a sealing member 34 coupled to the first end region;
wherein at least a portion of the sealing member is disposed on an outside of the stent and has an inflow edge disposed at the inflow end of the stent (e.g., covering on the stent, fig. 5F, 15A-E) and a free floating edge 202 that is axially spaced apart from the inflow edge and extends toward the outflow end (fig. 16A).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 10-18, 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Salahieh (Pub. No.: US 2007/0244552).
For claim 2, Salahieh discloses the prosthetic heart valve of claim 1, wherein the first end region includes a first ring of cells adjacent the inflow end (e.g., fig. 1B) and the sealing member covers the first ring of cells. As provided in italicized text, it is unclear whether the sealing member covers the first ring of cells. In figures 5F, 15A-E, the cover does appear to extend to over the first ring of cells. Additionally, figures 32-33 teach a cover which wraps around the inflow end of the stent. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the sealing member of Salahieh as covering the first ring of cells as in figures 32-33 in order to provide an atraumatic inflow end.
For claim 10, Salahieh discloses the prosthetic heart valve of claim 1, wherein the sealing member is folded over the inflow end of the stent. As provided in italicized text, it is unclear whether the sealing member is folded over the inflow end of the stent. In figures 5F, 15A-E, the cover does appear to extend to the end of the stent. Additionally, figures 32-33 teach a cover which is folded over the inflow end of the stent. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the sealing member of Salahieh as folded over the inflow end of the stent as in figures 32-33 in order to provide an atraumatic inflow end.
For claim 11, Salahieh discloses a prosthetic heart valve, comprising:
a stent 30 having a first end region (fig. 13, bottom of figure) and a second end region (fig. 13, top of figure), the first end region including a first ring of cells defining a first end of the stent (e.g., fig. 1A-B);
a plurality of valve leaflets 20 coupled to the stent30 (fig. 13); and
a sealing member 34 coupled to the first end region;
wherein a portion of the sealing member is disposed on an outside of the stent and covers the first end of the stent (e.g., covering on the stent, fig. 5F, 15A-E) and the first ring of cells (not disclosed), the sealing member having and a free floating edge 202 that is axially spaced apart from the first end and extends toward the second end region of the stent (fig. 16A). As provided in italicized text, it is unclear whether the sealing member covers the first ring of cells. In figures 5F, 15A-E, the cover does appear to extend to over the first ring of cells. Additionally, figures 32-33 teach a cover which wraps around the inflow end of the stent. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the sealing member of Salahieh as covering the first ring of cells as in figures 32-33 in order to provide an atraumatic inflow end.
For claim 12, Salahieh discloses the prosthetic heart valve of claim 11, wherein the first end region defines an inflow end of the stent and the second end region defines an outflow end of the stent (fig. 13), wherein the sealing member is folded over the inflow end of the stent. As provided in italicized text, it is unclear whether the sealing member is folded over the inflow end of the stent. In figures 5F, 15A-E, the cover does appear to extend to the end of the stent. Additionally, figures 32-33 teach a cover which is folded over the inflow end of the stent. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the sealing member of Salahieh as folded over the inflow end of the stent as in figures 32-33 in order to provide an atraumatic inflow end.
For claim 13, Salahieh discloses the prosthetic heart valve of claim 11, further comprising one or more attachment elements disposed at the second end region, the one or more attachment elements being designed to attach the stent to a delivery catheter (e.g., fig. 3A).
For claim 14, Salahieh discloses the prosthetic heart valve of claim 11, wherein the first end region is flared (e.g., fig. 2B).
For claim 15, Salahieh discloses the prosthetic heart valve of claim 11, further comprising a plurality of longitudinal cuts disposed along the free floating edge (e.g., fig. 16A).
For claim 16, Salahieh discloses the prosthetic heart valve of claim 15, wherein the plurality of longitudinal cuts defines a plurality of flaps (e.g., fig. 16A).
For claim 17, Salahieh discloses the prosthetic heart valve of claim 11, wherein the stent comprises an annular groove (e.g., fig. 13, narrowed central area).
For claim 18, Salahieh discloses the prosthetic heart valve of claim 17, wherein the free floating edge of the sealing member is positioned within the annular groove (fig. 13, 16A).
For claim 20, Salahieh discloses the prosthetic heart valve of claim 19, wherein the first end region includes a first ring of cells adjacent the inflow end and the sealing member covers the first ring of cells. As provided in italicized text, it is unclear whether the sealing member covers the first ring of cells. In figures 5F, 15A-E, the cover does appear to extend to over the first ring of cells. Additionally, figures 32-33 teach a cover which wraps around the inflow end of the stent. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the sealing member of Salahieh as covering the first ring of cells as in figures 32-33 in order to provide an atraumatic inflow end.
Conclusion
THIS ACTION IS MADE FINAL. 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 SUBA GANESAN whose telephone number is (571)272-3243. The examiner can normally be reached Monday-Friday, 8 AM - 5 PM Mountain Time.
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/SUBA GANESAN/Primary Examiner, Art Unit 3774
