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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/10/2025 has been entered.
Response to Arguments
The previous objection of claim 16 due to minor informalities has been withdrawn in light of applicant’s amendments made 7/10/2025.
The terminal disclaimer filed on 7/10/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent no. 11,864,993 and 9,288,291 has been reviewed and is accepted. The terminal disclaimer has been recorded and the double patenting rejections have been withdrawn.
The rejection of claims 1-5, 7-9, 11, 13, 16 and 17 under 35 U.S.C. 102(a)(1) as being anticipated by Jaramillo (US 2009/0112309) has been withdrawn in light of applicant’s amendment made 7/10/2025. Specifically, Jaramillo does not teach when the stent is in the expanded state, the flange elements are configured to exert a radial force in a direction of the middle region such that leaflets and chordae of a native mitral valve are trapped between the flange elements and the middle region so as to anchor the stent within a mitral annulus.
Applicant’s arguments with respect to claims 1-5, 7-9, 11, 13, 16 and 17 have been considered but are moot because the new ground of rejection does not rely on any reference in the prior art rejection of record for any teaching or matter specifically challenged in the argument. However, as discussed below, the newly added reference Berreklouw (6,790,229) teaches said limitation.
Applicant's arguments filed 7/10/2025 have been fully considered but they are not persuasive. Applicant argues Berreklouw fails to disclose the deficiencies of Jaramillo. The examiner respectfully disagrees. Berreklouw teaches wherein, when said valve prosthesis is in the unexpanded state (Fig. 11a), the upper and lower flange portions are oriented substantially along the long axis of the valve prosthesis (Fig. 11a); when said valve prosthesis transitions from the unexpanded state to the expanded state, the upper and lower flange portions transition in space so that they are no longer oriented substantially along the long axis of the valve prosthesis and move towards the middle region of the stent (Fig. 11b; column 29, lines 4-17). This particular movement would cause the flange elements of the lower flange portion to exert a radial force in a direction of the middle region as the flange elements expand from the long axis within the catheter to the position against the mitral annulus. Accordingly, arguments over Berreklouw are not found persuasive.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “the flange elements” in lines 15 and 17 which should read “the flange elements of the lower flange portion” for consistency purposes. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: Claim 18 recites “having first end portion” in line 6 which should read “having a first end portion” for grammatical purposes, claim 18 recites “the flange elements” in lines 17 and 19 which should read “the flange elements of the lower flange portion” for consistency purposes, and claim 18 recites “the native valve” in line 20 which should read “a native valve annulus” for consistency purposes. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: Claim 21 recites “the second end” in line 2 which should read “the second end portion” for consistency purposes. Appropriate correction is required.
Claim 27 is objected to because of the following informalities: Claim 27 recites “the elements” in line 3 which should read “the flange elements” for consistency purposes. Appropriate correction is required.
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.
Claim 1-4, 9, 11-12, 16-22, 24-25 and 27-28 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jaramillo et al. (US 2009/0112309A1) in view of Berreklouw et al. (US 6,790,229 B1).
Regarding claims 1, 12, 18 and 25, Jaramillo discloses a mitral valve prosthesis (catheter based heart valve 10, which can be used in a mitral valve; [0121]-[0123]; further, the stent of the valve has a length of 1.8 cm and a diameter of 2.4 cm; [0068]; which is within applicant’s disclosed sizing of the mitral valve (length: 0.5 cm - 5 cm, diameter: 2 cm - 5 cm; [0033]); therefore, capable of being positioned in a native mitral valve) comprising: a stent (stent 12) having an expanded (Fig. 1) and an unexpanded state (radially deformable and partially collapsible into a catheter; [0066]) and that includes a long axis (longitudinal axis of stent 12); a middle region (body of stent 12) having first (towards retainers 22) and second ends (towards retainers 20) and comprising a framework (framework of 12) that defines inner and outer surfaces (Figs. 1-2); a lower flange portion (at retainers 22) at the first end of the middle region that comprises a plurality of flange elements (retainers 22), each of the flange elements of the lower flange portion having a first end (towards body of 12) that is attached to the middle region and an opposed second end (free end of 22) that is spaced from the first end of the flange elements of the lower flange portion (Figs. 1-2); and, a valve (leaflets 14) that is attached to the inner surface of the middle region of the stent (Fig. 1), wherein, when the stent is in the unexpanded state, the lower flange portion is oriented substantially along the long axis of the stent (due to the radial collapsing of the body of the stent 12 along with the retainers 22 which are substantially along the long axis of the stent when expanded; thus, when inserted into a catheter, due to their spring-like configuration and with 10 being made of nitinol, the retainers 22 will deform against the inner surface of the catheter along the long axis of the stent; [0067], [0068]); and, wherein the lower flange portion is adapted to grasp leaflets and chordae of a native mitral valve by enfolding the leaflets and chordae between the lower flange portion (22) and the outer surface of the middle region in order to anchor the stent within a mitral annulus when the stent is in the expanded state (see for example, Fig. 3, in which tissue such as leaflets and chordae of the native mitral valve can be grasped between the body of the stent 12 and the retainers 22).
Jaramillo fails to disclose when the stent is in the expanded state, the flange elements are configured to exert a radial force in a direction of the middle region such that leaflets and chordae of a native mitral valve are trapped between the flange elements and the middle region so as to anchor the stent within a mitral annulus.
However, Berreklouw teaches a heart valve prosthesis (Figs. 11a-11b) comprising: an expanded (Fig. 11b) and an unexpanded state (Fig. 11a), a long axis (axis through heart valve fixing device 170); a middle region (tubular element 171); a lower flange portion (bottom flange fingers 172) at a first end of the middle region that comprises a plurality of flange elements (Figs. 11a-11b), each of said elements having a first end that is attached to the middle region and an opposed second end that is spaced from the first end of said elements (Figs. 11a-11b); an upper flange portion (top flange fingers 173) at a second end of the middle region that comprises a plurality of flange elements (Figs. 11a-11b), each of said elements having a first end that is attached to the middle region and an opposed second end that is spaced from the first end of said elements of the upper flange portion (Figs. 11a-11b); wherein, when said valve prosthesis is in the unexpanded state (Fig. 11a), the upper and lower flange portions are oriented substantially along the long axis of the valve prosthesis (Fig. 11a); when said valve prosthesis transitions from the unexpanded state to the expanded state, the upper and lower flange portions transition in space so that they are no longer oriented substantially along the long axis of the valve prosthesis and move towards the middle region of the stent (Fig. 11b; column 29, lines 4-17).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the upper and lower flange portions of Jaramillo to be oriented substantially along the long axis of the stent, similar to that of Berreklouw, when the stent is in the unexpanded state and when the stent transitions from the unexpanded state to the expanded state, the upper and lower flange portions transition in space so that they are no longer oriented substantially along the long axis of the stent as taught by Berreklouw in order to reduce the profile of the stent during the delivery process. The particular orientation would cause the flange elements to exert a radial force in a direction of the middle region due to the expansion of the flange elements from the long axis, inside the catheter in the unexpanded state, to the expanded state in which the flange elements are forcefully moved toward the mitral annulus due to shape memory properties.
Regarding claims 2 and 19, Jaramillo modified discloses the invention as claimed above, and Jaramillo further discloses wherein when the stent 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 (because the retainers 22 are made of nitinol and are radially collapsible and deformable into a catheter, the retainers 22 can be bent to a smaller profile to lie against the inner surface of the catheter when collapsed, which would make them substantially parallel relative to the long axis of the stent; [0067], [0068]; when the retainers 22 are expanded they may be either expanded away from the long axis of the stent as shown in Fig. 2 or along the long axis of the stent as shown in Fig. 3).
Regarding claims 3 and 20, Jaramillo modified discloses the invention as claimed above, and Jaramillo further discloses wherein the lower flange portion (22) is oriented substantially parallel relative to the long axis of the stent when the stent is in the expanded state (Fig. 3).
Regarding claims 4 and 21, Jaramillo modified discloses the invention as claimed above, and Jaramillo further discloses an upper flange portion (at retainers 20) at the second end of the middle region (Fig. 2).
Regarding claims 9 and 22, Jaramillo modified discloses the invention as claimed above, and Jaramillo further discloses wherein the lower flange portion (22) is adapted to anchor the stent within the mitral annulus by grasping a subvalvular apparatus at a ventricular side of the mitral annulus (retainers 22 are capable of grasping a subvalvular apparatus, due to their shape, size, flexibility and ability of the valve being implanted in a mitral annulus).
Regarding claims 11 and 24, Jaramillo modified discloses the invention as claimed above, and Jaramillo further discloses wherein the lower flange portion is adapted to anchor the stent within the mitral annulus by grasping a left ventricular wall (retainers 22 are capable of grasping a left ventricular wall, due to their shape, size, flexibility and ability of the valve being implanted in a mitral annulus).
Regarding claims 16 and 27, Jaramillo modified discloses the invention as claimed above, and Jaramillo further discloses wherein at least some of the flange elements of the lower flange portion include a central portion that extends between the first end of the at least some of the elements of the lower flange portion and the second end of the at least some of the flange elements of the lower flange portion and that has a linear configuration (straight sides of retainers 22; Fig. 2) when the stent is in the expanded state and when the stent is in the unexpanded state (Figs. 2-3).
Regarding claims 17 and 28, Jaramillo modified discloses the invention as claimed above, and Jaramillo further discloses wherein the second end (free ends) of the at least some of the flange elements (22) of the lower flange portion comprises an arc (curved tip at free end of 22 between straight sides) that extends from the central portion (Fig. 2).
Claim(s) 10, 14, 23 and 26 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jaramillo et al. (US 2009/0112309A1) in view of Berreklouw et al. (US 6,790,229 B1), as applied to claims 1 and 18 above, and further in view of Navia et al. (US 2006/0195183 A1).
Regarding claims 10 and 23, Jaramillo modified fails to disclose wherein the lower flange portion comprises an irregularly spaced array.
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) forming an irregularly spaced array (as lower wing members 70 are unevenly spaced about the circumference of the stent; therefore, “irregularly spaced”; Figs. 9-10; [0029]). The uneven spacing of the two pairs of lower wing members allows for positioning directly over respective central portions of the native leaflets ([0029]).
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 portion of modified Jaramillo to comprise an irregularly spaced array as taught by Navia in order to position the lower flange portion directly over respect central portions of the native leaflets.
Regarding claims 14 and 26, Jaramillo modified fails to disclose wherein at least one flange element of the lower flange portion is fitted with a webbing and wherein the upper flange portion is fitted with a webbing.
However, Navia teaches wherein at least one flange element of one or both of the lower flange portion (70) and an upper flange portion (60) 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 and upper flange portions of modified Jaramillo 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.
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 on (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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