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 .
Status of Claims
This office action is responsive to the amendment filed on 01/23/2026. As directed by the amendment: claims 1 and 12-13 have been amended. Thus, claims 1-13 are presently pending in this application.
Response to Arguments
Applicant's arguments with respect to claims 1, 7 and 9-11 rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Fish et al. (2018/0185143) “Fish”; claims 2-6 and 12-13 rejected under 35 U.S.C. 103 as being unpatentable over Fish et al. (2018/0185143) “Fish” in view of Kheradvar et al. (2021/0137676) “Kheradvar” and claim 8 rejected under 35 U.S.C. 103 as being unpatentable over Fish et al. (2018/0185143) “Fish” in view of Lelkes et al. (2013/0018454) “Lelkes” have been fully considered but they are not persuasive.
On page 6 of the response, the applicants argue “Fish does not teach or suggest that when the flexible substrate is in a folded configuration, the plurality of outer-wall defining regions of the flexible substrate form a cylindrical outer wall. Rather, Fish describes a flat sheet membrane template 100 that, when folded into a folded configuration, creates a leaflet structure 130 that includes cuff wall sections 118, 128 that form only the outer wall of a sector shape, not a cylindrical outer wall. Fish, [0110]. Fish explicitly states that, to form an operating heart valve (e.g., a cylindrical heart valve), "three completed folded cusp and leaflet structures 130 are typically mounted to a frame." Fish, [0105]. Fish is, therefore, clear that its membrane template 100, when folded, forms only a subcomponent of a complete and operative prosthetic heart valve; namely, one single leaflet structure 130 of the three needed to form a functional heart valve. To this end, Fish requires multiple membrane templates 100 to be folded into corresponding leaflet structures 130, which are then coupled to an outer frame to form the completed prosthetic heart valve”.
This is not found to be persuasive because claim 1 requires “the flexible substrate is folded into a folded configuration the plurality of outer wall-defining regions form a cylindrical outer wall”. Fig. 5 and par. 0040 of the specification of the present invention discloses when the substrate 20 is folded to form the heart valve 10, the cylindrical outer wall is formed by the plurality of wall-defining regions 32 form the outer wall portions 16 and par. 0034 discloses the plurality of the outer wall portions 16 collectively form the outer cylindrical wall. Similarly, as shown in Fig. 1G for Fish, the plurality of outer wall-defining regions 118/128 collectively form the cylindrical outer wall. Fish requires multiple or plurality of membranes similar to the plurality of outer wall-defining regions. When placed in the frame, it’s the structure of the plurality of outer wall-defining regions 118/128 that “form a cylindrical outer wall”.
Therefore, Fish discloses the claimed invention of claim 1 including “the flexible substrate is folded into a folded configuration the plurality of outer wall-defining regions form a cylindrical outer wall”.
Regarding claim 13, the claim requires “when in a folded configuration the first edge line and the second edge line of each leaflet-defining portion meet in a seam region such that the plurality of wall- defining regions circumscribe a cylindrical volume and define an outer wall”. The applicants argue that Fish does not disclose “a cylindrical volume that define an outer wall” and Fish does not teach a “singular” flexible substrate. This is not persuasive because the claim is silent regarding a “singular flexible substrate”, instead claim 13 requires a plurality of wall-defining regions having first and second edge lines that meet in a seam region to collectively form an outer wall. Fish also teaches a plurality of wall-defining regions with edges 117/127 that meet in a seam 132 to collectively circumscribe a cylindrical volume defining an outer wall.
Therefore, Fish discloses the claimed limitations of claim 13 including “when in a folded configuration the first edge line and the second edge line of each leaflet-defining portion meet in a seam region such that the plurality of wall- defining regions circumscribe a cylindrical volume and define an outer wall”.
Rejection under 35 USC 112 (b) of claim 13 has been withdrawn.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 7 and 9-11 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Fish et al. (2018/0185143) “Fish”.
Regarding claim 1, Fish discloses a prosthetic heart valve 130 (abstract; Fig. 1G), comprising: a flexible substrate 100 (Fig. 1A and pars. 0101-0102 discloses a sheet membrane made of flexible and pliable materials) having a plurality of leaflet-defining regions 111/121 (par. 0106 and Fig. 1B disclose left and right halves of leaflets) and a plurality of outer wall-defining regions 118/128 (Fig. 1C and par. 0110 disclose left and right cuff wall sections), such that when the flexible substrate is folded into a folded configuration the plurality of outer wall-defining regions form a cylindrical outer wall (Fig. 1G and par. 0113 disclose the folded membrane is folded into cylindrical configurations 130A-C using the edge segments 113/123 of the plurality of wall-defining regions 118/128) and the plurality of leaflet-defining regions form a corresponding plurality of flexible leaflets arranged within a lumen of the cylindrical outer wall (Fig. 1G and par. 0116 disclose the leaflet-defining regions 111/121 form the valve leaflets structures 130).
Regarding claims 7 and 9-11, Fish discloses wherein the flexible substrate is composed of a biocompatible material and a biomaterial; wherein the biomaterial is a decellularized membrane and wherein the flexible substrate is composed of a tissue (par. 0085 discloses the substrate is made of biocompatible pericardium tissue).
Claim Rejections - 35 USC § 103
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.
Claims 2-6 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Fish et al. (2018/0185143) “Fish” in view of Kheradvar et al. (2021/0137676) “Kheradvar”.
Fish discloses a prosthetic heart valve device (abstract), comprising: a flexible substrate 100 (Fig. 1A and pars. 0101-0102 discloses a sheet membrane made of flexible and pliable materials) comprising: an outer periphery that circumscribes the flexible substrate (the outer periphery comprising sections 112/122/113/123/111/121; Fig. 1C); an inner periphery (inner periphery comprising sections 115/125) that defines an aperture of the flexible substrate (the gap between sections 115/125 defines an aperture); a plurality of leaflet-defining regions 111/121 (Fig. 1D), each defined by: a segment extending along the outer periphery from a first point to a second point (segments 112/111/121/122 extend along the outer periphery from left end point to right end point); a first edge line 117 extending from the first point to a nadir point 133 on the inner periphery (Fig. 1E shows the first edge line 117 extends from section 112 to nadir point 133 which is located at the inner periphery defined by intersection of sections 115/125); a second edge line 127 extending from the second point to the nadir point on the inner periphery (Fig. 1C shows the second edge line 127 extends from section 122 to nadir point 133 which is located at the inner periphery defined by intersection of sections 115/125); a plurality of wall-defining regions 118/128 (Fig. 1D), each defined as a portion of the flexible substrate opposed by the first edge line 117 of a first leaflet- defining region 111 and the second edge line 127 of a second leaflet-defining region 121 that is adjacent the first leaflet-defining region (as shown in Fig. 1D); wherein when in a folded configuration (Fig. 1D) the first edge line 117 and the second edge line 127 of each leaflet-defining portion meet in a seam region 132 (Fig. 1D and par. 0111 disclose seam 132) such that the plurality of wall- defining regions circumscribe a cylindrical volume and define an outer wall (Fig. 1G and par. 0113 disclose the folded membrane is folded into cylindrical configurations 130A-C using the outer wall edge segments 113/123 of the plurality of wall-defining regions 118/128), and such that each leaflet-defining region 130A-C extends from its nadir point 133 at an inflow end of cylindrical volume to at least a free edge lying in a transverse plane at an outflow end of the cylindrical volume (pars. 0119-0120 and Fig. 1G disclose the leaflet-defining regions 130A-C extend from the point 133 to free edges 111/121 which are transverse to the outflow end); wherein the flexible substrate has a flat shape that is discontinuous at a cut region defined by opposing first and second cut edges of the flexible substrate (Fig. 1A discloses the cut region 102 defined by edges 115 an 125; Fig. 1C),
Fish discloses the claimed invention including the flexible substrate is made of polygonal shapes having rounded edges (par. 0120 and Fig. 2) and has a conical frustum annular shape (abstract) but is silent regarding the substrate having an annular shape; leaflet-defining regions defined by an arcuate segment; wherein the flexible substrate has a flat annular shape; wherein the annular shape is a triangular annular shape; wherein the triangular annular shape has rounded corners on its outer periphery; and wherein the flexible substrate has a curved annular shape; and wherein when the first cut edge is coupled to the second cut edge the flexible substrate forms a curved annular shape.
However, Kheradvar teaches a similar prosthetic heart valve (abstract; Fig. 4) comprising a flexible substrate 120 having an annular shape (annular or curved edge 124) and forming arcuate leaflets (edges 121/122 form leaflets; Fig. 3A); wherein the flexible substrate has a flat annular shape 124 (Fig. 4); wherein the annular shape is a triangular annular shape (par. 0050); wherein the triangular annular shape has rounded corners on its outer periphery (as shown in Fig. 4); wherein the flexible substrate has a curved annular shape (Figs. 3A and 4, curved edge 124). The combination of the curved annular shape of Kheradvar with the cut edges 115/125 of Fish would arrive at wherein when the first cut edge is coupled to the second cut edge the flexible substrate forms a curved annular shape.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polygonal flexible substrate in Fish to include the substrate having an annular shape; leaflet-defining regions defined by an arcuate segment; wherein the flexible substrate has a flat annular shape; wherein the annular shape is a triangular annular shape; wherein the triangular annular shape has rounded corners on its outer periphery; and wherein the flexible substrate has a curved annular shape; and wherein when the first cut edge is coupled to the second cut edge the flexible substrate forms a curved annular shape, as taught and suggested by Kheradvar, for using a rounded shape that would better conform to and contact adjacent edges once the substrate is folded.
Furthermore, it would have been an obvious matter of design choice to modify the polygonal flexible substrate in Fish to include the substrate having an annular shape; leaflet-defining regions defined by an arcuate segment; wherein the flexible substrate has a flat annular shape; wherein the annular shape is a triangular annular shape; wherein the triangular annular shape has rounded corners on its outer periphery; and wherein the flexible substrate has a curved annular shape, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Fish et al. (2018/0185143) “Fish” in view of Lelkes et al. (2013/0018454) “Lelkes”.
Fish discloses the claimed invention of claims 1 and 7; except for the biocompatible material comprises electrospun polyurethane. However, Lelkes teaches a similar biocompatible valve material comprising electrospun polyurethane (par. 0005 discloses synthetic vascular scaffolds made of electrospun polyurethane).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biocompatible material in Fish to include electrospun polyurethane, as taught and suggested Lelkes, for using a material that closely resembles the native valve leaflets (par. 0005).
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the material since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07.
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 extension fee 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 comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri. If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774