DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Claim(s) 1-20 is/are pending.
Response to Arguments
Applicant’s arguments, filed 12/4/2025, with respect to the claim objection have been fully considered and are persuasive. The claim objection of claim 7 has/have been withdrawn due to the Applicant’s amendments.
Applicant’s arguments, filed 12/4/2025, with respect to 35 USC 112, 1st paragraph rejections have been fully considered and are persuasive. The 35 USC 112, 1st paragraph rejections of claims 11-20 has/have been withdrawn due to the Applicant’s amendments.
Applicants arguments, with respect to the prior art, filed on 12/4/2025 have been fully considered, but they are not persuasive as noted below.
With respect to claims 1 and 11, Applicant argues the amended claim language is not taught by the prior art. As broadly claimed, the downstream portion is able to be expanded at the annulus and is configured to engage the annulus because of its larger diameter. The Examiner notes, as broadly claimed, this use is not required to be at the final implantation location and could be another position during delivery of the device. For example, the device could be retracted and repositioned to the final implantation location after the downstream portion engages the annulus.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 USPTO internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application will determine 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3 and 10-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6, 9, 11, 13-16, and 19 of U.S. Patent No. 10,485,660. Although the claims at issue are not identical, they are not patentably distinct from each other because the following prior claims contain the limitations claimed by the current Application as indicated in the following table.
Current Application
Prior Patent ‘660
1-3, 11, 15
1, 19
10
19
12
2, 19
13
6
14
9
16
11
17
13
18
14
19
15
20
16
Claims 1-3, 5-6, 8-9, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 7 of U.S. Patent No. 10,524,901. Although the claims at issue are not identical, they are not patentably distinct from each other because the following prior claims contain the limitations claimed by the current Application as indicated in the following table.
Current Application
Prior Patent ‘901
1-3, 5-6, 8
1
9
4
11
7
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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Functional language and intended use language is presented in italicized font.
Claim(s) 1 and 4-10 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Bradio, et al (Bradio) (WO 2009/042196 A2).
Regarding Claim 1, Bradio teaches a replacement heart valve (e.g. abstract, Figure 1) comprising:
an expandable frame (e.g. Figure 61) configured to engage a native valve annulus (e.g. abstract); and
a valve body mounted onto the expandable frame (e.g. abstract, placement shown as in Figure 35A, [0119], [0116] includes attached buffering layer), the valve body comprising a plurality of valve leaflets (e.g. Figure 35A, leaflets #60) configured to open to allow flow in a first direction and engage one another so as to close and not allow flow in a second direction opposite the first direction (e.g. Figure 35A, the shape of the leaflet closure dictates that blood flow when implanted in from proximal to distal (bottom to top, as shown), wherein the valve body has an upstream end and a downstream end (e.g. Figure 35A; downstream is the end corresponding with #30 of Figure 61 and upstream is the end corresponding with #40 in Figure 61), and a diameter at the downstream end is greater than a diameter at the upstream end (e.g. annotated Figure 35B(1) below);
wherein the replacement heart valve comprises an elongate upstream portion maintaining an inflow diameter (e.g. Figure 61, #40), a transition portion disposed adjacent the upstream portion of the valve body that flares outwardly so that the diameter increases (e.g. Figure 61, axially between #40 and #30), and a downstream portion disposed adjacent the transition portion (e.g. Figure 61, #30), the downstream portion configured to engage the native heart valve annulus (as broadly claimed, the downstream portion is able to be expanded at the annulus and is configured to engage the annulus because of its larger diameter; the Examiner notes, as broadly claimed, this use is not required to be at the final implantation location and could be another position during delivery of the device; for example, the device could be retracted and repositioned to the final implantation location after the downstream portion engages the annulus).
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Annotated Figure 35B(1), Bradio
Regarding Claim 4, the valve body flares outwardly approaching the downstream end of the valve body (e.g. Figure 35B).
Regarding Claim 5, the frame foreshortens as the frame is radially expanded from a collapsed configuration (e.g. Figure 61, the diamond shaped cells are inherently longer when collapsed relative to when expanded, thus the frame foreshortens upon expansion).
Regarding Claim 6, a foreshortening zone generally corresponds with the downstream portion (e.g. Figures 35A-B, 61).
Regarding Claim 7, a non-foreshortening zone upstream from the foreshortening zone, generally corresponding to the upstream portion and the transition portions (e.g. Figure 61, transition portion made of substantially longitudinal struts).
Regarding Claim 8, the valve body is shaped to accommodate the transition portion of the frame (e.g. Figures 35A-B, the valve is able to be seated within the frame and thus is accommodated).
Regarding Claim 9, the valve body is conical (e.g. annotated Figure 35B(1) above, the portion where the dotted lines taper).
Regarding Claim 10, the upstream portion of the valve body has a consistent inflow diameter (e.g. Figure 61, the inflow end is circular and therefore has a consistent inflow diameter).
Claim(s) 2 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Bradio, et al (Bradio) (WO 2009/042196 A2)as evidenced by Tuval, et al (Tuval) (US 2008/0071363).
Regarding Claim 2, the replacement heart valve is designed to replace a diseased native mitral valve (e.g. Bradio, abstract, Figure 1; Tuval teaches in [0632] and Figure 14 that a valve having a shape similar to that of Bradio’s Figure 61 is usable both as an aortic valve device and a mitral valve device; therefore, the Bradio device disclosed as usable in an aortic valve is also usable at a mitral valve location).
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 of this title, 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 negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 3 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bradio, et al (Bradio) (WO 2009/042196 A2) in view of Quadri, et al (Quadri) (WO 2007/058857 A1).
Regarding Claim 3, Bradio discloses the invention substantially as claimed but fails to teach: there are opposing anchors constructed so that their tips are in the downstream portion.
Quadri teaches a support frame having opposing distal and proximal anchors placed on opposing sides of tissue (e.g. Figure 4B).
Bradio and Quadri are concerned with the same field of endeavor, namely support frames for vascular use on opposing sides of tissue.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Bradio by incorporating the anchoring structures as taught by Quadri in order to assist in positioning of the device (e.g. Quadri, page 4, line 24 to page 5, line 2) and as it is a simple substitution of one known element for another to obtain predictable results of anchoring the end portions of the prosthetic device to the implantation site.
The combination of Bradio and Quadri teaches: anchor tips are in the downstream portion (e.g. Bradio, Figure 61 has the Quadri anchors on downstream portion #30; Quadri Figure 4B shows how the anchors extend; thus in the combination the downstream anchors’ tips are in the downstream portion of the Bradio frame).
Claim(s) 11-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bradio, et al (Bradio) (WO 2009/042196 A2) as evidenced by Tuval, et al (Tuval) (US 2008/0071363) in view of Quadri, et al (Quadri) (WO 2007/058857 A1).
Regarding Claim 11, Bradio teaches a replacement heart valve (discussed supra for claim 1) comprising:
an expandable frame (discussed supra for claim 1) configured to radially expand and collapse for deployment within a native heart valve (e.g. abstract), the expandable frame comprising a proximal portion having an inflow end (e.g. Figure 61, end having #40), a distal portion configured to engage an annulus of the native heart valve (discussed supra for claim 1), the distal portion having an outflow end (e.g. Figure 61, end having #30) and a longitudinal axis extending from the inflow end to the outflow end (there is inherently a longitudinal axis present), the inflow end configured to be positioned upstream of the outflow end when the replacement heart valve is deployed within the native heart valve (this is inherently how the device must be placed for the inflow end to be the inflow end and the outflow end to be the out flow end), a cross-sectional dimension perpendicular to the longitudinal axis of the outflow end being greater than a cross-sectional dimension perpendicular to the longitudinal axis of the inflow end when the expandable frame is in an expanded configuration (e.g. Figure 61);
a valve body positioned within a lumen of the expandable frame (discussed supra for claim 1).
Bradio discloses the invention substantially as claimed but fails to teach:
one or more distal anchors extending from the outflow end of the expandable frame,
wherein the one or more distal anchors are sized such that, when the replacement heart valve is expanded and deployed within the native heart valve:
at least one of the one or more distal anchors is positioned radially outwardly from the expandable frame and contacts tissue on a ventricular side of the native heart valve.
Quadri teaches a support frame having opposing distal and proximal anchors placed on opposing sides of tissue (e.g. Figure 4B), such that the support frame has a proximal anchoring portion (e.g. Figure 4B, anchors on one end of the frame), and
one or more distal anchors extending from the outflow end of the expandable frame (e.g. Figure 4B, anchors at the other end of the frame),
wherein the one or more distal anchors are sized such that, when the replacement heart valve is expanded and deployed within the native heart valve: at least one of the one or more distal anchors is positioned radially outwardly from the expandable frame (e.g. Figure 4B).
Bradio and Quadri are concerned with the same field of endeavor, namely support frames for vascular use on opposing sides of tissue.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Bradio by incorporating the anchoring structures as taught by Quadri in order to assist in positioning of the device (e.g. Quadri, page 4, line 24 to page 5, line 2) and as it is a simple substitution of one known element for another to obtain predictable results of anchoring the end portions of the prosthetic device to the implantation site.
The combination of Bradio and Quadri teaches:
the at least one of the one or more distal anchors contacts tissue on a ventricular side of the native heart valve (when placed at the mitral valve location, the distal anchors are on the ventricular side because that is where the outflow end is for the mitral valve; e.g. Tuval teaches in [0632] and Figure 14 that a valve having a shape similar to that of Bradio’s Figure 61 is usable both as an aortic valve device and a mitral valve device; therefore, the Bradio device disclosed as usable in an aortic valve is also usable at a mitral valve location).
Regarding Claim 12, the replacement heart valve further comprises a proximal anchoring portion (discussed supra for claim 11, from Quadri) sized to contact tissue on an atrial side of the native heart valve when the replacement heart valve is deployed within the native heart valve (as discussed supra for claim 11, the distal end is the outflow end, thus the proximal end is the inflow end and is in the atrial side of the annulus when placed at the mitral valve location),
an end of the proximal anchoring portion being positioned radially outwardly from the expandable frame when the expandable frame is in the expanded configuration (e.g. Quadri, Figure 4B).
Regarding Claim 13, the replacement heart valve is sized such that, when the replacement heart valve is expanded and deployed within the native heart valve, a native leaflet of the native heart valve is positioned between at least a first distal anchor of the one or more distal anchors and the expandable frame (e.g. Quadri, Figures 4A-C; Bradio, Figure 61; when the device of Bradio with the anchors of Quadri expands it foreshortens drawing the anchors toward each other, which is exemplified by the Quadri Figures; any tissue place between the anchors will be compressed and some will be between the frame and the anchor; as the leaflets are axially central between the anchors, the native leaflet is able to be placed in the claimed location).
Regarding Claim 14, the distal portion (here, the distal portion is considered to be as indicated below in annotated Figure 61(1)) of the expandable frame further comprises an engagement zone, and wherein the engagement zone is sized such that, when the replacement heart valve is expanded and deployed within the native heart valve, the engagement zone engages an annulus of the native heart valve (e.g. Bradio, [0109], the section having element #30 and in the distal portion is placed at the annulus and thus engages the annulus when implanted).
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Annotated Figure 61(1), Bradio
Regarding Claim 15, the replacement heart valve is designed to replace a diseased native mitral valve (discussed supra for claim 11, where the ventricular placement of the anchors is discussed).
Regarding Claim 16, the engagement zone is sized such that, when the replacement heart valve is expanded, a cross-sectional dimension of the engagement zone is greater than a cross-sectional dimension of a proximal end of the expandable frame (e.g. Bradio, Figure 61, as broadly claimed, the cross-section of the engagement zone that is across diameter of the device and perpendicular to the longitudinal axis is larger than a cross section of a strut diameter at the proximal terminal end).
Regarding Claim 17, the valve body comprises a plurality of valve leaflets (e.g. Bradio, Figures 35A-B).
Regarding Claim 18, there are a plurality of commissures disposed along downstream side edges of the valve leaflets (e.g. Bradio, Figures 35A-B).
Regarding Claim 19, the valve body comprises three valve leaflets (e.g. Bradio, Figures 35A-B).
Regarding Claim 20, the plurality of valve leaflets are configured to open to allow flow in a first direction from an atrium to a ventricle and engage one another so as to close and not allow flow in a second direction opposite the first direction (discussed supra for claim 1).
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 LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 2/6/2026