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 01/26/2026. As directed by the amendment: claims 5, 10, 17 and 18 have been amended, no claims have been cancelled and no new claims have been added. Thus, claims 1-20 are presently pending in this application, and currently examined in the Office Action.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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 1, 2, 4 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ratz et al. (US PG Pub. 2014/0277427), as previously disclosed, hereinafter Ratz, in view of Letac et al. (US PG Pub. 2001/0007956), as previously disclosed, hereinafter Letac, Karapetian et al. (US PG Pub. 2015/0148896), as previously disclosed, hereinafter Karapetian, and Raanani et al. (US PG Pub. 2015/0173897), as previously disclosed, hereinafter Raanani.
Regarding claims 1, 2 and 9, Ratz discloses a replacement heart valve prosthesis (10), illustrated in Figures 4, 6A and 6B, comprising a valve body (60) including a plurality of flexible leaflets (62); and a self-expanding, shape-memory metal support structure (20) surrounding and supporting the valve body (60), the support structure (20) sized for deployment in a native heart valve, illustrated in Figures 6A, 6B and 10 ([0008], Lines 1-3; [0034], Lines 1-6; [0035], Lines 2-6; [0036], Lines 1-4; [0056], Lines 1-4; [0057], Lines 1-3 & [0070], Lines 1-5), the support structure (20) comprising a cylindrical valve frame (comprised of struts 12, 14, 50 & 52) comprising an upper portion (16) including tabs with enlarged heads (at top portion/proximal end of strut 12), an intermediate portion (18) comprising at least two circumferential rows of closed cells, and a lower portion comprising a plurality of anchors (24) extending radially outwardly and upwardly and ending in a flared tip (28), illustrated in Figure 4 ([0038]); and a sealing frame (22) comprising an upper portion including a plurality of struts (36&38), an intermediate portion (40), and a lower portion (at tips 26), the sealing frame (22) disposed radially outwardly of the cylindrical valve frame and the upper portion (struts 36&38) of the sealing frame (22) is coupled to the upper portion (16) of the cylindrical valve frame, wherein a clearance is provided between the sealing frame (22) and the cylindrical valve frame when the prosthesis is in an expanded configuration, and wherein the flared tips (28) of the plurality of anchors (24) of the cylindrical valve frame are disposed radially outwardly of the sealing frame (22) when the prosthesis is in the expanded configuration, illustrated in Figures 4 and 6A ([0054]); but does not specifically teach the leaflets being made from pericardium, at least some of the flared tips of the anchors having cushions, the sealing frame being separate from the cylindrical valve frame, the two frames coupled by/via sutures, and the upper portion of the sealing frame having eyelets.
However, Letac teaches a prosthetic heart valve, in the same field of endeavor, wherein the leaflets, of the prosthetic heart valve, can be made from numerous different materials, including pericardium (Letac: [0034]). Additionally, Karapetian teaches a prosthetic heart valve, in the same field of endeavor, wherein a plurality of anchoring features (3840/3842) are covered with a cushion, in order to absorb/cushion the load applied to natural tissue and promote ingrowth of surrounding tissue, illustrated in Figure 121 (Karapetian: [0370]). Furthermore, Raanani teaches a prosthetic heart valve (10), in the same field of endeavor, comprising an inner frame/atrial part (35) and an outer frame/ventricular part (32), illustrated in Figures 1-2B, wherein the two frames/parts are connected/fixed to one another by/via eyelets and sutures (Raanani: [0134] & [0181]).
In view of the teachings of Letac, Karapetian and Raanani, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention: for the leaflets, of the prosthesis of Ratz, to being made from pericardium, since this is a well-known material used for replacement heart valve leaflets, as taught by Letac, and 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 (see MPEP 2144.07); for at least some of the flared tips of the anchors, of the prosthesis of Ratz, to have cushions, in order to absorb/cushion the load applied to natural tissue and promote ingrowth of surrounding tissue, as taught by Karapetian; and for the sealing frame, of the prosthesis of Ratz, to be separate from the cylindrical valve frame, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art (see MPEP 2144.04), and for the upper portion of the sealing frame to have eyelets such that the sealing frame and the cylindrical valve frame are connected/coupled via the eyelets and sutures, since this is a well-known way to connect/couple two frames/parts of a prosthetic heart valve, as taught by Raanani.
Regarding claim 4, Ratz in view of Letac, Karapetian and Raanani disclose the prosthesis of claim 1, wherein Ratz further teaches the support structure (20) is adapted to capture native heart valve leaflets (90) between the sealing frame (22) and the anchors (24), illustrated in Figure 10A (Ratz: [0048], Last 4 Lines & [0070]).
Regarding claim 8, Ratz in view of Letac, Karapetian and Raanani disclose the prosthesis of claim 1, wherein Ratz further teaches the lower portion (at tips 26) of the sealing frame (22) has a larger diameter than the upper portion (36&38) of the sealing frame (22), illustrated in Figures 4 and 6A.
Regarding claim 10, Ratz in view of Letac, Karapetian and Raanani disclose the prosthesis of claim 1, wherein Ratz further teaches the plurality of anchors (24) extend upwards beyond a lowermost end of the lower portion of the sealing frame (22), illustrated in Figures 6A and 7.
Regarding claim 11, Ratz in view of Letac, Karapetian and Raanani disclose the prosthesis of claim 1, wherein Ratz states the prosthesis is “configured for use in the vasculature of a patent, such as for replacement of natural heart valves” (Ratz: [0034], Lines 1-6) and further iterates that a tricuspid valve is one type of human heart valve (Ratz: [0005], Lines 1-2); thus, it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate use/location for the prosthesis, of Ratz in view of Letac, Karapetian and Raanani, including being a replacement tricuspid valve, based on patient need.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Ratz in view of Letac, Karapetian and Raanani as applied to claim 1 above, and further in view of Wallace et al. (US PG Pub. 2016/0158001), as previously disclosed, hereinafter Wallace.
Regarding claim 3, Ratz in view of Letac, Karapetian and Raanani disclose the prosthesis of claim 1, but do not specifically disclose the sealing frame is more flexible than the cylindrical valve frame.
However, Wallace teaches a prosthetic heart valve, in the same field of endeavor, wherein atrial anchors/sealing frame is more flexible than ventricular anchors/cylindrical valve frame, in order to provide better confirmability and sealing in the atrium, the stiffer ventricular anchors/cylindrical valve frame provide sufficient resistance to ventricular pressure (Wallace: [0074], Lines 1-12).
In view of the teachings of Wallace, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the sealing frame, of the prosthesis of Ratz in view of Letac, Karapetian and Raanani, to be more flexible than the cylindrical valve frame, in order for the sealing frame to provide better confirmability and sealing in the atrium, while the stiffer cylindrical valve frame provides sufficient resistance to ventricular pressure, as taught by Wallace.
Regarding claim 5, Ratz in view of Letac, Karapetian and Raanani disclose the prosthesis of claim 1, wherein Ratz further teaches an exterior of the intermediate portion of the sealing frame is configured to contact a native valve annulus, illustrated in Figure 10 (Ratz: [0071]); but does not specifically disclose the intermediate portion has a diameter in a range of 35 mm to 55 mm when the prosthesis is in the expanded configuration.
However, Wallace teaches a prosthetic heart valve, in the same field of endeavor, comprising an inner/cylindrical valve frame (5) and an outer/sealing frame (2&4), wherein the outer/sealing frame (2&4) has a diameter in a range of 35 mm to 55 mm when the prosthesis is in the expanded configuration (Wallace: [0047], Lines 10-12).
In view of the teachings of Wallace, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the sealing frame, of the prosthesis of Ratz in view of Letac, Karapetian and Raanani, to have a diameter in a range of 35 mm to 55 mm, when the prosthesis is in the expanded configuration, since this is a well-known diameter range for heart valves, as taught by Wallace; and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 3255.05).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Ratz in view of Letac, Karapetian and Raanani as applied to claim 1 above, and further in view of Ratz et al. (US PG Pub. 2014/0277422), as previously disclosed, hereinafter Ratz;422.
Regarding claims 6 and 7, Ratz in view of Letac, Karapetian and Raanani disclose the prosthesis of claim 1, but does not specifically disclose a fabric extending along, and covering, at least a portion of an exterior of the sealing frame and at least a portion of the fabric extends between the sealing frame and the cylindrical valve frame.
However, Ratz’422 teaches a prosthetic heart valve (10), in the same field of endeavor, comprising a fabric (30) which extends along, and covers, at least a portion of an exterior of a sealing frame (22), and at least a portion of the fabric (30) extends between the sealing frame (fabric portion 66) and the cylindrical valve frame (fabric portion 64), illustrated in Figure 1A (Ratz’422: [0042]); the fabric (30) aids in preventing axial flow of fluid around the exterior of the prosthesis and can additionally encourage tissue ingrowth to further prevent blood flow leakage (Ratz’422: [0052]).
In view of the teachings of Ratz’422, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the prosthesis, of Ratz in view of Letac, Karapetian and Raanani, to further comprise a fabric extending along, and covering, at least a portion of an exterior of the sealing frame and at least a portion of the fabric extending between the sealing frame and the cylindrical valve frame, in order to aid in preventing fluid/blood flow around the exterior of the prosthesis and can additionally encouraging tissue ingrowth to further prevent blood flow leakage, as taught by Ratz’422.
Claims 12 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ratz in view of Raanani.
Regarding claims 12, 14 and 16, Ratz discloses a replacement heart valve prosthesis (10), illustrated in Figures 4, 6A and 6B, comprising a valve body (60) including a plurality of flexible leaflets (62); and a self-expanding, shape-memory metal support structure (20) surrounding and supporting the valve body (60), the support structure (20) sized for deployment in a native heart valve, illustrated in Figures 6A, 6B and 10 ([0008], Lines 1-3; [0034], Lines 1-6; [0035], Lines 2-6; [0036], Lines 1-4; [0056], Lines 1-4; [0057], Lines 1-3 & [0070], Lines 1-5), the support structure (20) comprising a valve frame (comprised of struts 12, 14, 50 & 52) comprising an upper portion (16) including tabs with enlarged heads (at top portion/proximal end of strut 12), an intermediate portion (18) comprising at least two circumferential rows of closed cells, and a lower portion comprising a plurality of anchors (24) extending radially outwardly and upwardly and ending in a flared tip (28), illustrated in Figure 4 ([0038]); and a sealing frame (22) comprising an upper portion including a plurality of struts (36&38), an intermediate portion (40), and a lower portion (at tips 26), the sealing frame (22) disposed radially outwardly of the valve frame and the upper portion (struts 36&38) of the sealing frame (22) is coupled to the upper portion (16) of the valve frame, wherein a clearance is provided between the intermediate portion (40) of the sealing frame (22) and the intermediate portion (18) of the valve frame when the prosthesis is in an expanded configuration, and wherein the flared tip (28) of each of the plurality of anchors (24) of the valve frame is disposed radially outwardly of the sealing frame (22) when the prosthesis is in the expanded configuration, illustrated in Figures 4 and 6A ([0054]); but does not specifically teach the sealing frame being separate from the valve frame and the upper portion of the sealing frame having eyelets, wherein the upper portion of the sealing frame is sutured to the upper portion of the valve frame through the eyelets.
However, Raanani teaches a prosthetic heart valve (10), in the same field of endeavor, comprising an inner frame/atrial part (35) and an outer frame/ventricular part (32), illustrated in Figures 1-2B, wherein the two frames/parts are connected/fixed to one another via eyelets and sutures (Raanani: [0134] & [0181]).
In view of the teachings Raanani, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the sealing frame, of the prosthesis of Ratz, to be separate from the valve frame, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art (see MPEP 2144.04), and for the upper portion of the sealing frame to have eyelets such that the sealing frame and the valve frame are connected/coupled via the eyelets and sutures, since this is a well-known way to connect/couple two frames/parts of a prosthetic heart valve, as taught by Raanani.
Regarding claim 15, Ratz in view of Raanani disclose the prosthesis of claim 12, wherein Ratz further teaches the lower portion (at tips 26) of the sealing frame (22) has a larger diameter than the upper portion (36&38) of the sealing frame (22), illustrated in Figures 4 and 6A.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ratz in view of Raanani as applied to claim 12 above, and further in view of Karapetian.
Regarding claim 13, Ratz in view of Raanani disclose the prosthesis of claim prosthesis of claim 12, but do not specifically disclose the flared tip of at least some of the plurality of anchors being covered by a cushion.
However, Karapetian teaches a prosthetic heart valve, in the same field of endeavor, wherein a plurality of anchoring features (3840/3842) are covered with a cushion, in order to absorb/cushion the load applied to natural tissue and promote ingrowth of surrounding tissue, illustrated in Figure 121 (Karapetian: [0370]).
In view of the teachings of Karapetian, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for at least some of the flared tips of the anchors, of the prosthesis of Ratz in view of Raanani, to have cushions, in order to absorb/cushion the load applied to natural tissue and promote ingrowth of surrounding tissue, as taught by Karapetian.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ratz in view of Raanani as applied to claim 12 above, and further in view of Wallace.
Regarding claim 17, Ratz in view of Raanani disclose the prosthesis of claim 12, wherein Ratz further teaches an exterior of the intermediate portion of the sealing frame is configured to contact a native valve annulus, illustrated in Figure 10 (Ratz: [0071]); but does not specifically disclose the intermediate portion has a diameter in a range of 35 mm to 55 mm when the prosthesis is in the expanded configuration.
However, Wallace teaches a prosthetic heart valve, in the same field of endeavor, comprising an inner/cylindrical valve frame (5) and an outer/sealing frame (2&4), wherein the outer/sealing frame (2&4) has a diameter in a range of 35 mm to 55 mm when the prosthesis is in the expanded configuration (Wallace: [0047], Lines 10-12).
In view of the teachings of Wallace, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the sealing frame, of the prosthesis of Ratz in view of Raanani, to have a diameter in a range of 35 mm to 55 mm, when the prosthesis is in the expanded configuration, since this is a well-known diameter range for heart valves, as taught by Wallace; and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 3255.05).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Ratz in view of Raanani as applied to claim 12 above, and further in view of Ratz’422.
Regarding claim 18, Ratz in view of Raanani disclose the prosthesis of claim 12, but does not specifically disclose at least a portion of the sealing frame is covered by fabric.
However, Ratz’422 teaches a prosthetic heart valve (10), in the same field of endeavor, comprising a fabric (30) which extends along, and covers, at least a portion of an exterior of a sealing frame (22), illustrated in Figure 1A (Ratz’422: [0042]); the fabric (30) aids in preventing axial flow of fluid around the exterior of the prosthesis and can additionally encourage tissue ingrowth to further prevent blood flow leakage (Ratz’422: [0052]).
In view of the teachings of Ratz’422, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the prosthesis, of Ratz in view of Raanani, to further comprise a fabric extending along, and covering, at least a portion of an exterior of the sealing frame and at least a portion of the fabric extending between the sealing frame and the cylindrical valve frame, in order to aid in preventing fluid/blood flow around the exterior of the prosthesis and can additionally encouraging tissue ingrowth to further prevent blood flow leakage, as taught by Ratz’422.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ratz in view of Karapetian and Raanani.
Regarding claims 19 and 20, Ratz discloses a replacement heart valve prosthesis (10), illustrated in Figures 4, 6A and 6B, comprising a valve body (60) including a plurality of flexible leaflets (62); and a self-expanding support structure (20) surrounding and supporting the valve body (60), the support structure (20) sized for deployment in a native heart valve, illustrated in Figures 6A, 6B and 10 ([0008], Lines 1-3; [0034], Lines 1-6; [0035], Lines 2-6; [0036], Lines 1-4; [0056], Lines 1-4; [0057], Lines 1-3 & [0070], Lines 1-5), the support structure (20) comprising a valve frame (comprised of struts 12, 14, 50 & 52) comprising an upper portion (16) including tabs with enlarged heads (at top portion/proximal end of strut 12), an intermediate portion (18), and a lower portion comprising a plurality of anchors (24) extending radially outwardly and upwardly and ending in a flared tip (28), illustrated in Figure 4; and a sealing frame (22) comprising an upper portion including a plurality of struts (36&38), an intermediate portion (40), and a lower portion (at tips 26), the sealing frame (22) disposed radially outwardly of the valve frame and the upper portion (struts 36&38) of the sealing frame (22) is coupled to the upper portion (16) of the valve frame, and wherein the flared tip (28) of at least one of the plurality of anchors (24) of the valve frame is disposed radially outwardly of the sealing frame (22) when the prosthesis is in the expanded configuration, illustrated in Figures 4 and 6A ([0054]); but does not specifically teach at least some of the flared tips of the anchors are covered by a cushion, the sealing frame being separate from the valve frame and the upper portion of the sealing frame having eyelets, wherein the upper portion of the sealing frame is sutured to the upper portion of the valve frame through the eyelets.
However, Karapetian teaches a prosthetic heart valve, in the same field of endeavor, wherein a plurality of anchoring features (3840/3842) are covered with a cushion, in order to absorb/cushion the load applied to natural tissue and promote ingrowth of surrounding tissue, illustrated in Figure 121 (Karapetian: [0370]). Furthermore, Raanani teaches a prosthetic heart valve (10), in the same field of endeavor, comprising an inner frame/atrial part (35) and an outer frame/ventricular part (32), illustrated in Figures 1-2B, wherein the two frames/parts are connected/fixed to one another via eyelets and sutures (Raanani: [0134] & [0181]).
In view of the teachings of Karapetian and Raanani, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention: for at least some of the flared tips of the anchors, of the prosthesis of Ratz, to have cushions, in order to absorb/cushion the load applied to natural tissue and promote ingrowth of surrounding tissue, as taught by Karapetian; for the sealing frame, of the prosthesis of Ratz, to be separate from the valve frame, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art (see MPEP 2144.04), and for the upper portion of the sealing frame to have eyelets such that the sealing frame and the valve frame are connected/coupled via the eyelets and sutures, since this is a well-known way to connect/couple two frames/parts of a prosthetic heart valve, as taught by Raanani.
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 1-6, 8, 12-15 and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,639,143, hereinafter ‘143, in view of Letac and/or Raanani. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims disclose a replacement heart valve prosthesis comprising a valve body including a plurality of leaflets and a self-expanding, metallic support structure surrounding and supporting the valve body, the support structure comprising a first/inner/cylindrical valve frame comprising an upper portion including tabs with enlarged heads, an intermediate portion comprising at least two circumferential rows of closed cells, and a lower portion comprising a plurality of anchors extending radially outwardly and upwardly and ending in a flared tip, at least some flared tips having cushions; and a second/outer/sealing frame separate from, coupled to by sutures, and disposed radially outwardly of the first/inner/cylindrical valve frame, the second/outer/sealing frame comprising an upper portion including a plurality of struts, an intermediate portion, and a lower portion, wherein a clearance is provided between the sealing frame and the cylindrical valve frame when the prosthesis is in an expanded configuration, and wherein the flared tips of the plurality of anchors of the cylindrical valve frame are disposed radially outwardly of the sealing frame when the prosthesis is in the expanded configuration; but '143 does not specifically disclose the leaflets being made from pericardium and the upper portion of the sealing frame having eyelets, wherein the upper portion of the sealing frame is sutured to the upper portion of the valve frame through the eyelets. However, Letac teaches a prosthetic heart valve, in the same field of endeavor, wherein the leaflets, of the prosthetic heart valve, can be made from numerous different materials, including pericardium (Letac: [0034]). Furthermore, Raanani teaches a prosthetic heart valve (10), in the same field of endeavor, comprising an inner frame/atrial part (35) and an outer frame/ventricular part (32), illustrated in Figures 1-2B, wherein the two frames/parts are connected/fixed to one another via eyelets and sutures (Raanani: [0134] & [0181]). Thus, in view of the teachings of Letac and Raanani, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention: for the leaflets, of the prosthesis of '143, to being made from pericardium, since this is a well-known material used for replacement heart valve leaflets, as taught by Letac, and 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 (see MPEP 2144.07); and for the upper portion of the sealing frame to have eyelets such that the sealing frame and the valve frame are connected/coupled via the eyelets and sutures, since this is a well-known way to connect/couple two frames/parts of a prosthetic heart valve, as taught by Raanani.
Response to Arguments
Applicant's arguments filed 01/26/2026 have been fully considered but they are not persuasive. Applicant argues the combination(s) of the prior art giving examples of specific structure of each device of each piece of art and thereby stating since they are different and/or may have different intended use/function “a person having ordinary skill in the art would not have been motivated to” combine/modify said prior art. Examiner respectfully disagrees with Applicant’s assertions. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Furthermore, Applicant is reminded that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference, nor is it that the claimed invention must be expressly suggested in any one or all of the references; rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Thus, in the instant case, the prior art of Letac, Karapetian and/or Raanani were used to teach that it is well known in the art to have specific structure, which wasn’t specifically disclosed in the primary reference of Ratz, along with motivation/reasons for having including such structure. Specifically, the prior art of Letac was used to teach that it is well known, in the art of prosthetic heart valves, for the valve to comprise pericardium (Letac: [0034]); and 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 (see MPEP 2144.07). Moreover, the prior art of Karapetian was used to teach that it is known, in the art of prosthetic heart valves, for anchoring features to be covered with a cushion, in order to absorb/cushion the load applied to natural tissue and promote ingrowth of surrounding tissue, as disclosed by Karapetian, for example in paragraph [0370]. Lastly, the prior art of Raanani was used to teach that it is known, in the art of prosthetic heart valves, for the prosthetic heart valve to comprise two parts/frames which are connected/fixed to one another by an eyelet and suture mechanism (Raanani: [0134] & [0181]); and it is to be noted that it has been held that forming a formerly integral structure in various elements involves only routine skill in the art (see MPEP 2144.04). Hence, the rejection of independent claims 1, 12 and 19, and all the claims that depend from them, are deemed to be proper since all the structural limitations set forth in the claims are taught by the prior art; therefore, the rejections stand.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774
03/25/2026