DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 5/04/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/04/2026 was filed after the mailing date of the Notice of Allowance on 2/04/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The information provided in the IDS has raised new issues. Accordingly, a new rejection is made in view of Lutter (DE 10 2006 052 564 B3) as discussed below.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0043] of the specification filed 10/18/2023 recites “FIG. 1” twice. However, there is no Fig. 1 and it is unclear as to which of Figs. 1A-1C, Fig. 1 is referring to.
Paragraph [0047] recites “FIG. 3”. It is unclear as to which of Figs. 3A-3F, Fig. 3 is referring to.
Paragraph [0050] recites “FIG. 4”. It is unclear as to which of Figs. 4A-4B, Fig. 4 is referring to.
Paragraph [0065] recites “FIG. 5”. It is unclear as to which of Figs. 5A-5B, Fig. 5 is referring to.
Paragraph [0069] recites “FIG. 6”. It is unclear as to which of Figs. 6A-6B, Fig. 6 is referring to.
Paragraph [0099] recites “FIGS. 7-9”. It is unclear as to which of Figs. 7A-7D, 8A-8C, and/or 9A-9C, Figs. 7-9 are referring to.
Paragraph [0106] recites “FIG. 7”. It is unclear as to which of Figs. 7A-7D, Fig. 7 is referring to.
Paragraph [0109] recites “FIGS. 8-9”. It is unclear as to which of Figs. 8A-8C and 9A-C, Figs. 8-9 are referring to.
Paragraph [0110] recites “FIG. 9A-9C depicts” which should read “FIGS. 9A-9C depict”.
Paragraph [0112] recites “FIG. 10” and “FIG. 9”. It is unclear as to which of Figs. 10A-10D and Figs. 9A-9C, Fig. 10 and Fig. 9 are referring to.
Appropriate correction is required.
EXAMINER’S AMENDMENT
An examiner’s amendment to the record appears below. Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
Authorization for this examiner’s amendment was given in an interview with Mark R. Hull (Reg. No. 54,753) on 1/08/2026.
The application has been amended as follows:
Claim 1, lines 2-3: “axis; a middle” has been amended to read --axis, wherein the stent includes a middle--.
Claim 18, line 15: “portion are configured to a radial force” has been amended to read --portion configured to exert a radial force--.
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 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-2, 4, 9-12, 18-19 and 21-25 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Lutter (DE 10 2006 052 564 B3).
Regarding claim 1, Lutter discloses a mitral valve prosthesis (mitral valve stent 10 for a mitral valve; [0043]; see translation provided by applicant on 5/04/2026) comprising: a stent (stent bracket 20) having an expanded (Figs. 13-14) and an unexpanded state (Fig. 9) and that includes a long axis (longitudinal axis through stent bracket 20); wherein the stent (20) includes a middle region (first section 20a) having first (towards 20’) and second (towards 30) ends and comprising a framework that defines inner and outer surfaces (Fig. 2); a lower flange portion (second section 20b/20’, wherein 20’ is the second section 20b of a particularly preferred embodiment of 10; [0057]) at the first end of the middle region that comprises a plurality of flange elements (20’; Figs. 2-3, 7), each of the flange elements of the lower flange portion having a first end that is attached to the middle region and an opposed second end that is spaced from the first end of the flange elements of the lower flange portion (Figs. 7, 12-14); and a valve (valve of valve stent 10; Fig. 1B; [0044]) that is attached to the inner surface of the middle region of the stent (Fig. 1B), wherein, when the stent is in the unexpanded state, the lower flange portion is oriented substantially along the long axis of the stent (20b/20’ are aligned with the stent longitudinal axis when comparing the relative sizes of the flanges and the deployment catheter of Figs. 9-12. The emerging flanges that can be seen in Figs. 10-11 also indicate the direction of the flanges during deployment. 20b/20’ have the ability to be aligned with the long axis of the stent when in the collapsed state with the right outer constraint since the stent is self-expanding; [0050]); and wherein, when the stent (20) is in the expanded state (Figs. 12-14), the flange elements of the lower flange portion are configured to exert a radial force in a direction of the middle region such that leaflets and chordae of a native mitral valve interposed between the flange elements of the lower flange portion and the middle region will be clamped therebetween so as to anchor the stent within a mitral annulus (The second section 20b is designed for ventricular anchoring of the stent 10; [0043]. The nitinol flange 20’ state to the right in Fig. 7 is suitable to grasp, i.e. clamp, leaflets and chordae of a native mitral valve of unspecified size/thickness. The border between the middle region and the lower flange of the claim can be arbitrarily defined in Lutter since no specific feature is assigned to the lowest part of the middle region bordering the lower flange. Any gap formed by a nitinol construction is suitable to apply inward force depending on what is inserted into the gap, e.g. the thickness and elasticity of the inserted tissue. Thus, depending on how the stent is implanted, a grasping/clamping force can be exerted between the flange and the middle region in the fully expanded state of Figs. 13-14. The flange 20’ is rolled inwards trapping the leaflet and chordae; [0057]. Paragraph [0057] discloses that the stent is fixed to the native valve. The fact that Fig. 14 shows a space between the rolled up leaflet, chordae and the middle section cannot be interpreted as unambiguous disclosure of a lack of exerted force since the images are schematic non-technical drawings. Even if Figs. 13-14 would be deemed technical drawings with accurate relative dimensions, the grasping of thick tissue from the subvalvular apparatus would still result in a force between the flange and the middle region. Moreover, the exerted upward and outward movement on the leaflets does not rule out a force between the flange and the middle region, since the expansion of the middle region of the stent is implicitly causing this leaflet movement. Thus, fixing the native leaflet to the middle section would be enough to create the disclosed movement; [0054]).
Regarding claim 2, Lutter discloses wherein when the stent (20) transitions from the unexpanded state to the expanded state, the lower flange portion transitions in space so that it is no longer oriented substantially along the long axis of the stent (Figs. 9-14).
Regarding claim 4, Lutter discloses an upper flange portion (anchoring elements 30) at the second end of the middle region (Figs. 2-3, 7).
Regarding claim 9, Lutter discloses wherein the lower flange portion (20’) is adapted to anchor the stent (20) within the mitral annulus by grasping a subvalvular apparatus at a ventricular side of the mitral annulus (Figs. 12-14; [0057]).
Regarding claim 10, Lutter discloses wherein the lower flange portion comprises an irregularly spaced array (stent brackets 20b may be asymmetric around the stent 10; Fig. 3; [0044]).
Regarding claim 11, Lutter discloses wherein the lower flange portion (20’) is adapted to anchor the stent within the mitral annulus by grasping a left ventricular wall (Figs. 12-14; [0057]).
Regarding claim 12, Lutter discloses wherein when the stent transitions from the unexpanded state to the expanded state, the second ends of the flange elements of the lower flange portion move towards the middle region of the stent (Figs. 12-14).
Regarding claim 18, Lutter discloses a valve prosthesis (mitral valve stent 10 for a mitral valve; [0001]; see translation provided by applicant on 5/04/2026) configured to be deployed in a mitral valve or a tricuspid valve comprising: a stent (stent bracket 20) having an expanded (Figs. 12-14) and an unexpanded state (Fig. 9) and that includes a long axis (longitudinal axis of 20); and a valve (valve of valve stent 10; Fig. 1B; [0044]) configured to be attached to the stent, wherein the stent includes a middle region (first section 20a) having a first end portion (towards 20b/20’) and a second end portion (towards 30) and comprising a framework that defines an inner surface and an outer surface (Fig. 2); wherein the stent includes a lower flange portion (second section 20b/20’, wherein 20’ is the second section 20b of a particularly preferred embodiment of 10; [0057]) at the first end portion of the middle region that comprises a plurality of flange elements (Figs. 7, 12-14), each of the flange elements of the lower flange portion having a first end that is attached to the middle region and an opposed second end that is spaced from the first end of the flange elements of the lower flange portion (Fig. 7), wherein the valve is configured to be attached to the inner surface of the middle region ([0044]), wherein, when the stent (20) is in the unexpanded state, the lower flange portion is oriented substantially along the long axis of the stent (20b/20’ are implicitly aligned with the stent longitudinal axis when comparing the relative sizes of the flanges and the deployment catheter of Figs. 9-12. The emerging flanges that can be seen in Figs. 10-11 also indicate the direction of the flanges during deployment. 20b/20’ have the ability to be aligned with the long axis of the stent when in the collapsed state with the right outer constraint since the stent is self-expanding; [0050]); and wherein, when the stent is in the expanded state (Figs. 12-14), the flange elements (20’) of the lower flange portion are configured to exert a radial force in a direction of the middle region such that leaflets and chordae of a native mitral or tricuspid valve interposed between the flange elements of the lower flange portion and the middle region will be clamped therebetween so as to anchor the stent within a native valve annulus (The second section 20b is designed for ventricular anchoring of the stent 10; [0043]. The nitinol flange 20’ state to the right in Fig. 7 is suitable to grasp, i.e. clamp, leaflets and chordae of a native mitral valve of unspecified size/thickness. The border between the middle region and the lower flange of the claim can be arbitrarily defined in Lutter since no specific feature is assigned to the lowest part of the middle region bordering the lower flange. Any gap formed by a nitinol construction is suitable to apply inward force depending on what is inserted into the gap, e.g. the thickness and elasticity of the inserted tissue. Thus, depending on how the stent is implanted, a grasping/clamping force can be exerted between the flange and the middle region in the fully expanded state of Figs. 13-14. The flange 20’ is rolled inwards trapping the leaflet and chordae; [0057]. Paragraph [0057] discloses that the stent is fixed to the native valve. The fact that Fig. 14 shows a space between the rolled up leaflet, chordae and the middle section cannot be interpreted as unambiguous disclosure of a lack of exerted force since the images are schematic non-technical drawings. Even if Figs. 13-14 would be deemed technical drawings with accurate relative dimensions, the grasping of thick tissue from the subvalvular apparatus would still result in a force between the flange and the middle region. Moreover, the exerted upward and outward movement on the leaflets does not rule out a force between the flange and the middle region, since the expansion of the middle region of the stent is implicitly causing this leaflet movement. Thus, fixing the native leaflet to the middle section would be enough to create the disclosed movement; [0054]).
Regarding claim 19, Lutter discloses wherein when the stent (20) transitions from the unexpanded state (Fig. 9) to the expanded state (Figs. 12-14), the lower flange portion (20’) is configured to transition in space so that it is no longer oriented substantially along the long axis of the stent (Figs. 12-14).
Regarding claim 21, Lutter discloses an upper flange portion (anchoring elements 30) at the second end portion of the middle region (Figs. 2-3, 7).
Regarding claim 22, Lutter discloses wherein the lower flange portion (20’) is adapted to anchor the stent (20) within the native valve annulus by grasping a subvalvular apparatus at a ventricular side of the native valve annulus (Figs. 12-14; [0057]).
Regarding claim 23, Lutter discloses wherein the lower flange portion comprises an irregularly spaced array (stent brackets 20b may be asymmetric around the stent 10; Fig. 3; [0044]).
Regarding claim 24, Lutter discloses wherein the lower flange portion (20’) is adapted to anchor the stent (20) within the native valve annulus by grasping a left ventricular wall (Figs. 12-14; [0057]).
Regarding claim 25, Lutter discloses wherein when the stent (20) transitions from the unexpanded state to the expanded state, the second ends of the flange elements of the lower flange portion move towards the middle region of the stent (Figs. 12-14).
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 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.
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.
Claims 14 and 26 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lutter (DE 10 2006 052 564 B3) in view of Navia et al. (US 2006/0195183 A1).
Regarding claims 14 and 26, Lutter fails to disclose wherein at least one flange element of the lower flange portion is fitted with webbing.
However, Navia teaches a mitral valve prosthesis (apparatus 10 for a mitral valve; [0023]; Figs. 9 and/or 10; while the embodiment of Figs. 9 and/or 10 are being relied upon in the rejection for the positioning of the lower portion, reference is made with respect to Figs. 1-8 for common elements) comprising: a stent (expandable support member 40; [0024]) having an expanded (Fig. 5) and unexpanded state (Fig. 1) that includes a long axis (longitudinal axis of 40); a middle region (body portion 46 of stent 40) having first (44) and second (42) ends (Fig. 1; [0025]) and comprising a framework (lattice of stent) that defines inner and outer surfaces (Fig. 2); a lower flange portion at the first end (44) of the middle region that comprises a plurality of flange elements (lower wing members 70), wherein at least one flange element of the lower flange portion (70) is fitted with a webbing (woven biocompatible material covering 50; [0027]; Fig. 4).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the lower flange portions of Lutter to be fitted with a webbing as taught by Navia in order to allow the flange portions to be coated with therapeutics to induce healing.
Allowable Subject Matter
Claims 3, 16-17, 20 and 27-28 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Lutter, does not disclose or fairly suggest, either singly or in combination of any of the prior art of record, “wherein the lower flange portion is oriented substantially parallel relative to the long axis of the stent when the stent is in the expanded state” as recited in claims 3 and 20 and/or “wherein at least some of the flange elements of the lower flange portion include a central portion…that has a linear configuration when the stent is in the expanded state” as recited in claims 16 and 27.
Instead, the lower flange portion (20’) of Lutter is curled outward in a spiral-like manner when the stent is unfolded and fully deployed ([0048]; Figs. 13-14) i.e., in the expanded state. Modifying the spiral-like curl of the lower flange portion of Lutter to be linear would render the prior art unsatisfactory for its intended purpose of rolling up the anterior mitral valve leaflet and displacing and/or wrapping the leaflet laterally and basally, which pushes the anterior mitral valve leaflet to the side and folds it in ([0054]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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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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/SARAH A LONG/Primary Examiner, Art Unit 3771
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