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 .
Response to Amendment
This office action is responsive to the amendment filed on 06/26/2025. As directed by the amendment: claims 1, 14 and 18 have been amended, claim 21 has been cancelled and new claims 22-24 have been added. Thus, claims 1, 2, 5-9, 11-14, 16-20 and 22-24 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 § 102/103
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)(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.
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 14, 16, 17 and 23 are rejected under 35 U.S.C. 102(a) as anticipated by Rabito et al. (US PG Pub. 2015/0238315), as previously disclosed, hereinafter Rabito, or, in the alternative, under 35 U.S.C. 103 as obvious over Rabito in view of Ratz et al. (US PG Pub. 2014/0277390), as previously disclosed, hereinafter Ratz, and Quadri et al. (US Patent No. 8,403,983), as previously disclosed, hereinafter Quadri.
Regarding claims 14, 16 and 17, Rabito discloses an assembly comprising a self-expandable prosthetic heart valve for implantation within a native heart valve/mitral valve, between an atrium and a ventricle, and a delivery apparatus ([0009]), wherein the prosthetic heart valve can take any number of form including that as described by Ratz et al. (2014/0277390), hereinafter Ratz, the entirety of which is incorporated by reference and made part of Rabito (Rabito: [0070]); wherein Ratz further teaches the prosthetic heart valve (10) comprising a radially collapsible and expandable annular body (20) defining a central axis and a lumen extending therethrough from an inlet/proximal end portion (32) to an outlet/distal end portion (34), the annular body (20) comprising a network of struts (12/14) made from nitinol and interconnected at a plurality of nodes to form a plurality of open cells (16/18), illustrated in Figure 1 (Ratz: [0021], Lines 3-4 & [0023], Lines 1-5); a plurality of radially extending atrial protrusions (22) coupled to the annular body (20), wherein the atrial protrusions (22) are connected to a first set of nodes (1N) of the plurality of nodes, wherein the first set of nodes are located at the inlet/proximal end portion (32) of the annular body (20); a plurality of radially extending ventricular protrusions (24) coupled to the annular body (20), wherein the ventricular protrusions (24) are connected to a second set of nodes (2N) of the plurality of nodes, and wherein the second set of nodes (2N) are axially spaced from the first set of nodes (1N) toward the outlet/distal end portion (34) of the annular body (20), illustrated in Figures 1, 5 and modified figure 1, below (Ratz: [0019], Lines 1-6; [0028], Lines 1-4; [0035], 6th – 2nd to Last Lines & [0061]);
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a valve member (60) comprising a plurality of leaflets disposed within the lumen of the annular body (20), the valve member configured to enable flow of blood in a direction from the inlet end toward the outlet end of the annular body, and prevent flow of blood in an opposing direction; a layer of fabric (30) covering at least a portion of the annular body (30), the plurality of atrial protrusions (22) covered by another layer of fabric (68) to form an atrial sealing flange, illustrated in Figures 3 and 4, wherein the valve can be similar to and include features similar to those as described by Quadri et al. (8,403,983), hereinafter Quadri, the entirety of which is incorporated by reference and made part of Ratz (Ratz: [0019], Lines 7-5; [0020]; [0040]; [0048]; [0049]; [0052] & [0053]), wherein Quadri further teaches the valve comprising three leaflets made of pericardium (Quadri: Column 6, Lines 9-12 & 26); and Rabito further teaches a delivery apparatus (100), illustrated in Figures 9 and 10, comprising a first capsule portion (118) and a second capsule portion (116/124) along a distal end portion of the delivery apparatus, wherein the first and second capsule portions are in a closed, delivery configuration with the prosthetic heart valve retained in a radially compressed state within the first and second capsule portions, wherein the first capsule portion (118) is distal relative to the second capsule portion (116), wherein the radially compressed ventricular protrusions are disposed within a recess of the first capsule portion (118) and the radially compressed atrial protrusions are disposed within the second capsule portion (116); wherein the first capsule portion (118) is configured to move distally, relative to the second capsule portion, to deploy, and expand, the ventricular protrusions while the atrial protrusions are still disposed within the second capsule portion; and wherein the second capsule portion (116) is configured to move proximally, relative to the first capsule portion, to deploy, and expand, the atrial protrusions, illustrated in Figures 9 and 10 (Rabito: [0080]; [0091], Last 4 Lines; [0103], Lines 1-7; [0108], Last 2 Lines & [0141], Lines 1-5 – it is to be noted that which one of the ventricular or atrial protrusions are disposed in which one of the first or second capsule portion depends on the intended use of the delivery assembly, i.e. if the implant is delivered transapically or transeptally, however, Rabito teaches all the structure set forth in the claim(s) and is capable of functioning in either delivery option, specifically in a transeptal delivery, wherein the ventricular protrusions would be disposed in the first capsule portion and the atrial protrusions would be disposed in the second capsule portion).
Regarding claim 23, Rabito in view Ratz and Quadri disclose the assembly of claim 14, wherein Rabito further teaches a distal end portion of an inner sheath (124) of the second capsule portion extends into the recess (119) of the first capsule portion (118), illustrated in Figures 11-13 (Rabito: [0094]).
Claims 18-20 are rejected under 35 U.S.C. 102(a) as anticipated by Ratz, or, in the alternative, under 35 U.S.C. 103 as obvious over Ratz in view of Quadri and Quadri et al. (US PG Pub. 2010/0298931), hereinafter Quadri’931.
Regarding claim 18, Ratz discloses an assembly comprising a self-expandable prosthetic heart valve (10), illustrated in Figures 1-5, for implantation within a native heart valve between an atrium (78) and a ventricle (86), illustrated in Figure 5 ([0060]) the prosthetic heart valve (10) comprising a radially collapsible and expandable annular body (20) defining a central axis and a lumen extending therethrough from an inlet/proximal end portion (32) to an outlet/distal end portion (34), the annular body (20) being made from nitinol, and therefore self-expanding, and comprising a network of interconnected struts (12/14), illustrated in Figure 1 ([0021], Lines 3-4 & [0023], Lines 1-5); an atrial flange, disposed at the inlet/proximal end portion (32) of the annular body (20), comprising a plurality of radially extending atrial protrusions (22) coupled to the annular body (20) and covered by a first fabric layer (68); a plurality of radially extending ventricular protrusions (24) coupled to the annular body (20) and axially spaced apart from the atrial flange (22) toward the outlet/distal end portion (34) of the annular body, illustrated in Figures 1 and 5 ([0019], Lines 1-6; [0028], Lines 1-4; [0035], 6th – 2nd to Last Lines; [0048]; [0049]; [0052]; [0053] & [0061]); and a valve member (60) comprising a plurality of leaflets disposed within the annular body (20), the valve member configured to enable flow of blood in a direction from the inlet end toward the outlet end of the annular body, and prevent flow of blood in an opposing direction, wherein the prosthetic heart valve can be similar to and include features similar to those as described by Quadri et al. (US Patent No. 8,403,983), hereinafter Quadri, the entirety of which is incorporated by reference and made part of Ratz (Ratz: [0019], Lines 7-5; [0020] & [0040]), wherein Quadri further teaches valve comprising three leaflets made of pericardium (Quadri: Column 6, Lines 9-12 & 26); and a delivery apparatus/device for retaining the prosthetic heart valve in a radially compressed state, wherein the ventricular protrusions of the radially compressed prosthetic heart valve are distal relative to the atrial protrusions, and deploying the ventricular protrusions/distal anchors to extend away from the annular body, while the atrial protrusions/proximal anchors are disposed within the delivery apparatus/device, and deploying the atrial protrusions/proximal anchors to extend away from the annular body, wherein the atrial flange is configured to engage an atrial side of a native annulus the native heart valve and the ventricular protrusions are configured to engage a ventricular side of the native annulus, such that the native annulus is captured between the atrial flange and the ventricular protrusions, illustrated in Figures 1, 5 and 6 ([0039], Lines 1-8 & [0059] – [0061]); but does not specifically disclose the delivery apparatus/device comprising a first capsule portion and a second capsule portion; however Ratz states that the heart valve can be deployed in manners similar to that as disclosed by Quadri et al. (US PG Pub. 2010/0298931), hereinafter Quadri’931, the entirety of which is incorporated by reference and made part of Ratz (Ratz: [0059], Last 6 Lines); wherein Quadri’931 teaches a delivery apparatus/device (238), illustrated in Figures 14K and 14L, comprising a first capsule portion (276) and a second capsule portion (300), wherein the prosthetic heart valve (128) is retained in a radially compressed state within the first and second capsule portions in a closed, delivery configuration, wherein the first capsule portion (276) is distal relative to the second capsule portion (300), illustrated in Figure 14L, wherein the ventricular protrusions (190), of the radially compressed prosthetic heart valve, are distal relative to the atrial protrusions and disposed within a recess (286) of the first capsule portion (276) and the atrial protrusions of the radially compressed prosthetic heart valve are disposed within the second capsule portion (300), wherein a distal end portion (302) of a sheath of the second capsule portion (300) extends into the recess (286) of the first capsule portion (276), illustrated in Figures 14K and 14 L (Quadri’931: [0080], Lines 1-4; [0088]; [0095] & [0097]);wherein the first capsule portion is configured to move distally relative to the second capsule portion to deploy the ventricular protrusions to extend away from the annular body, while the atrial protrusions are disposed within the second capsule portion; and wherein the second capsule portion is configured to retract proximally relative to the first capsule portion to deploy the atrial protrusions to extend away from the annular body, wherein the atrial flange is configured to engage an atrial side of a native annulus the native heart valve and the ventricular protrusions are configured to engage a ventricular side of the native annulus, such that the native annulus is captured between the atrial flange and the ventricular protrusions (Quadri’931: [0067]; [0073] – [0075] & [0097], Last 3 Lines).
Regarding claim 19, Ratz in view of Quadri and Quadri’931 disclose the assembly of claim 18, wherein Ratz further teaches the interconnected struts (12/14) are joined at a plurality of nodes, wherein the atrial protrusions (22) are connected to a first set of nodes (1N), of the plurality of nodes; wherein the first set of nodes (1N) form inlet apices of the annular body (20), illustrated in Figure 1 and modified figure 1, above.
Regarding claim 20, Ratz in view of Quadri and Quadri’931 disclose the assembly of claim 18, and though it is not specifically disclosed that the plurality of atrial and ventricular protrusions includes twelve protrusions each; Ratz does state that there can be any number of atrial/proximal and ventricular/distal protrusions (Ratz: [0037], Lines 2-3); therefore, 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 number of atrial and ventricular protrusions, including twelve protrusions each, since doing to amount to a mere duplication of the essential working parts of a device, which involves only routine skill in the art (see MPEP 2144.04). Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the atrial and ventricular protrusions includes twelve protrusions each, as opposed to any other number/amount.
Claims 1, 2, 5-9, 11-13 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (US Patent No. 9,393,111), as previously disclosed, hereinafter Ma, in view of Rabito.
Regarding claims 1 and 11-13, Ma discloses an assembly comprising a self-expandable prosthetic heart valve (20) for implantation within a native heart valve, specifically a mitral valve, between an atrium and a ventricle, illustrated in Figures 1-5B, the prosthetic heart valve (20) comprising a radially collapsible and expandable annular body (28) defining a central axis and a lumen extending therethrough from an inlet end to an outlet end, the annular body being made from nitinol and comprising a network of struts interconnected at a plurality of nodes to form a plurality of open cells, illustrated in Figures 1 and 4 (Column 5, Lines 56-64 & Column 6, Lines 1-7); a plurality of radially extending atrial protrusions (22) coupled to the annular body (28), wherein the atrial protrusions are sized and shaped to engage an atrial side of the native heart valve when the prosthetic heart is in a fully radially expanded state within the mitral valve; a plurality of radially extending ventricular protrusions (24) coupled to the annular body (28), wherein the ventricular protrusions (24) are angularly offset from the atrial protrusions (22), wherein the ventricular protrusions (24) are sized and shaped to engage a ventricular side of the native heart valve when the prosthetic heart is in the fully radially expanded state within the mitral valve, wherein the ventricular protrusions (24) are axially spaced from the atrial protrusions (22) toward the outlet end of the annular body (28), and the atrial protrusions (22) and the ventricular protrusions (24) are closer to the inlet end than to the outlet end of the annular body (28), illustrated in Figures 1-5B (Column 6, Lines 7-10, 16-23 & Column 8, Lines 27-35); and a valve member comprising three leaflets (48) made of pericardium and disposed within the lumen of the annular body (28), the valve member configured to enable flow of blood in a direction from the inlet end toward the outlet end of the annular body, and prevent flow of blood in an opposing direction, illustrated in Figures 5B, 7A and 7B (Column 2, Line 66; Column 5, Lines 17-19 & Column 8, Lines 40-44); and a delivery apparatus/system for retaining the prosthetic heart valve in a radially compressed state, configured for transeptal delivery of the prosthetic heart valve, and enabling the ventricular and atrial protrusions to deploy and extend radially away from the annular body to achieve the fully radially expanded state (Column 6, Lines 1-7 & 28-30); but does not specifically disclose the delivery apparatus/system comprising first and second capsule portions, wherein the first capsule portion comprises a recess in which the ventricular protrusions in a radially compressed state are disposed, the first capsule portion configured to move distally, relative to the second capsule portion, to deploy the ventricular protrusions while the atrial protrusions are disposed within the second capsule portion, and the second capsule portion configured to retract proximally, relative to the first capsule portion, to deploy the atrial protrusions.
However, Rabito teaches an assembly, in the same field of endeavor, comprising an implant/prosthesis and a delivery apparatus (100), illustrated in Figures 9 and 10, for transeptal delivery of the implant, the delivery apparatus (100) comprising a first capsule portion (118) and a second capsule portion (116/124), for retaining the implant/prosthesis in a radially compressed state therewithin, wherein the first capsule portion (118) comprises a recess, wherein protrusions of the implant/prosthesis in the radially compressed state are disposed, and is distal relative to the second capsule portion (116), wherein other protrusions of the implant/prosthesis in the radially compressed state are disposed; wherein the first capsule portion (118) is configured to move distally, relative to the second capsule portion, to deploy the protrusions while the other protrusions are still disposed within the second capsule portion, and the second capsule portion (116) is configured to retract proximally, relative to the first capsule portion, to deploy the other protrusions, illustrated in Figures 9 and 10 (Rabito: [0080]; [0091], Last 4 Lines; [0103], Lines 1-7; [0108], Last 2 Lines & [0141], Lines 1-5).
In view of the teachings of Rabito, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for delivery apparatus/system, of the assembly of Ma, to comprise first and second capsule portions, wherein the first capsule portion comprises a recess, in which the ventricular protrusions in the radially compressed state are disposed, and the first capsule is distal relative to the second capsule portion, in which the atrial protrusions in the radially compressed state are disposed; wherein the first capsule portion is configured to move distally, relative to the second capsule portion, to deploy the ventricular protrusions while the atrial protrusions are still disposed within the second capsule portion, and the second capsule portion is configured to retract proximally, relative to the first capsule portion, to deploy the atrial protrusions, since this includes known structure(s) for a delivery apparatus/system used in the delivery of a prosthetic heart valve/prosthesis to a mitral valve, as taught by Rabito.
Regarding claim 2, Ma in view of Rabito disclose the assembly of claim 1, wherein Ma further teaches, when the prosthetic heart valve is in the fully radially expanded state, the ventricular protrusions (24) and the atrial protrusions (22) extend radially outward from the annular body (28) and form a gap (26) therebetween, the gap sized and shaped to retain a portion of a native annulus of the native heart valve therein, illustrated in Figures 1-5B.
Regarding claim 5, Ma in view of Rabito disclose the assembly of claim 1, wherein Ma further teaches the plurality of atrial protrusions (22) includes twelve atrial protrusions, illustrated in Figure 1 (Ma: Column 5, Lines 61-62; Column 6, Lines 43-44 & Column 8, Lines 55-56).
Regarding claim 6, Ma in view of Rabito disclose the assembly of claim 1, wherein Ma further teaches the plurality of ventricular protrusions (24) includes twelve ventricular protrusions, illustrated in Figure 1 (Ma: Column 7, Line 36).
Regarding claim 7, Ma in view of Rabito disclose the assembly of claim 1, wherein Ma further teaches the prosthetic heart valve further comprises a first fabric layer, wherein the atrial protrusions (22) are covered by the first fabric layer and form an atrial flange (Ma: Column 6, Lines 11-13 & 47-49).
Regarding claim 8, Ma in view of Rabito disclose the assembly of claim 7, wherein Ma further teaches the prosthetic heart valve further comprises a second fabric layer, the second fabric layer covering at least a portion of the annular body (Ma: Column 7, Lines 2-4).
Regarding claim 9, Ma in view of Rabito disclose the assembly of claim 7, wherein Ma further teaches at least a portion of the atrial flange (22) is orthogonal relative to the central axis (Ma: Column 6, Lines 45-47).
Regarding claim 22, Ma in view of Rabito disclose the assembly of claim 1, wherein Rabito further teaches a distal end portion of an inner sheath (124) of the second capsule portion extends into the recess (119) of the first capsule portion (118), illustrated in Figures 11-13 ([0094]).
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, 2, 5-9, 11-14, 16-20 and 22-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,058,424 in view of Quadri’931. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims disclose a self-expandable prosthetic heart valve comprising an expandable annular body having an inlet end and an outlet end, a plurality of radially extending atrial protrusions, coupled to the annular body, being sized and shaped to engage an atrial side of the native heart valve, a plurality of radially extending ventricular protrusions, coupled to the annular body, angularly offset from the atrial protrusions, and sized/shaped to engage a ventricular side of the native heart valve, and a valve member disposed within the lumen of the annular body, the valve member configured to enable flow of blood in a direction from the inlet end toward the outlet end of the annular body, and prevent flow of blood in an opposing direction; but does not disclose the delivery apparatus as claimed. However, Quadri’931 teaches an assembly, in the same field of endeavor, comprising an implant/prosthesis and a delivery apparatus (238), illustrated in Figures 14K and 14L, comprising a first capsule portion (276) and a second capsule portion (300), wherein the prosthetic heart valve (128) is retained in a radially compressed state within the first and second capsule portions in a closed, delivery configuration, wherein the first capsule portion (276) is distal relative to the second capsule portion (300), illustrated in Figure 14L, wherein the ventricular protrusions (190), of the radially compressed prosthetic heart valve, are distal relative to the atrial protrusions and disposed within a recess (286) of the first capsule portion (276) and the atrial protrusions of the radially compressed prosthetic heart valve are disposed within the second capsule portion (300), wherein a distal end portion (302) of a sheath of the second capsule portion (300) extends into the recess (286) of the first capsule portion (276), illustrated in Figures 14K and 14 L (Quadri’931: [0080], Lines 1-4; [0088]; [0095] & [0097]); wherein the first capsule portion is configured to move distally relative to the second capsule portion to deploy the ventricular protrusions to extend away from the annular body, while the atrial protrusions are disposed within the second capsule portion; and wherein the second capsule portion is configured to retract proximally relative to the first capsule portion to deploy the atrial protrusions to extend away from the annular body, wherein the atrial flange is configured to engage an atrial side of a native annulus the native heart valve and the ventricular protrusions are configured to engage a ventricular side of the native annulus, such that the native annulus is captured between the atrial flange and the ventricular protrusions (Quadri’931: [0067]; [0073] – [0075] & [0097], Last 3 Lines). Thus it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the self-expandable prosthetic heart valve, of the above mentioned US Patent No., to include a delivery apparatus comprising first and second capsule portions, wherein the first capsule portion comprises a recess, in which the ventricular protrusions in the radially compressed state are disposed, and the first capsule is distal relative to the second capsule portion, in which the atrial protrusions in the radially compressed state are disposed; wherein the first capsule portion is configured to move distally, relative to the second capsule portion, to deploy the ventricular protrusions while the atrial protrusions are still disposed within the second capsule portion, and the second capsule portion is configured to retract proximally, relative to the first capsule portion, to deploy the atrial protrusions, since this includes known structure(s) for a delivery apparatus/system used in the delivery of a prosthetic heart valve/prosthesis to a mitral valve, as taught by Quadri’931.
Allowable Subject Matter
Claim 24 is 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.
Response to Arguments
Applicant’s arguments with respect to independent claim 18 have been considered but are moot because the arguments do not apply to the current rejections presently used in the Office Action. Specifically, in response to Applicant’s amendment independent claim 18 is now rejected as being unpatentable over Ratz in view of Quadri and Quadri’931.
Applicant's arguments filed 06/26/2025, regarding independent claims 1 and 14, have been fully considered but they are not persuasive. Applicant argues the rejections of independent claim 1, as being unpatentable over the prior art of Ma in view of Rabito, and independent claim 14, as being unpatentable over the prior art of Rabito in view Ratz and Quadri, stating that the newly amended parameter of “the ventricular protrusions of the radially compressed prosthetic heart valve are contained within recess of the first capsule portion” is not taught by the prior art; and further states that “the term “contain” refers to something that is entirely inside of the thing containing it”. Examiner respectfully disagrees with Applicant’s assertion. As Applicant states, the plain meaning/definition of “contain” is “to have an amount of something inside or within it” (emphasis added); nowhere in the definition, or in the originally filed disclosure of the current application at hand, does it state that an entirety of something has to be inside/within. Furthermore, nowhere in the originally filed disclosure is it stated and/or illustrated that the entire ventricular protrusion is contained within the recess; in fact, Figures 20 and 21 (which illustrate the embodiment where the ventricular protrusion is within the recess of the first capsule) show it to be virtually impossible for the entire ventricular protrusion (124) to be contained within the recess of the first capsule/nosecone (410). To further address Applicant’s concern regarding claim 14, mentioned in the interview summary, of it being “unclear how the delivery device of Rabito could function if the nose cone (118) was sized to receive the both the inner retention member (132) and the atrial anchors (22) of the valve on Ratz, as the inner retention member (132) retains the longitudinally extending struts of a valve between the teeth of the inner retention member via a tight fit between the inner retention member (132) and the interior wall of the nose cone (118)”; Rabito clearly states “In some embodiments, the first end of the prosthesis can be received within a proximally-facing opening 119 (see FIG. 11) and covered by the nose cone 118. The first end of the prosthesis can also be engaged with the inner retention member 132” (emphasis added – Rabito [0091]), Rabito also states “The implant or prosthesis can take any number of different forms. A particular example of frame for a prosthesis is shown herein, though it will be understood that other designs can also be used. Additional example designs for a prosthesis are described in U.S. Pat. Nos. 8,403,983, 8,414,644, 8,652,203 and U.S. Patent Publication Nos. 2011/0313515, 2012/0215303, 2014/0277390, 2014/0277422, 2014/0277427” (emphasis added – Rabito [0070] – to clarify, 2014/0277390 is the US PG Pub. for Ratz). Thus, the implant of Ratz would clearly be able to be used with the delivery device of Rabito since it is specifically mentioned by Rabito. Also, regarding Applicant’s concern of claim 1, mentioned in the interview summary, of how the annulus support/ventricular protrusions (22) could be contained within the nosecone (118) of Rabito due to the U-shaped tails (36) of the valve; it can be argued that this issue is taught to the same extent that the current application at hand teaches/that it is understood how the ventricular protrusions could be contained within a recess in the nosecone when the ventricular protrusions are axially spaced from the atrial protrusions toward the outlet end of the annular body, and the atrial protrusions and the ventricular protrusions are closer to the inlet end than to the outlet end of the annular body, as set forth in claim 1. Specifically, in this scenario the annular body extends substantially distal to the ventricular protrusions, as illustrated in Figures 1, 2, 4 and 5, and the originally filed disclosure does not detail and/or illustrate how exactly the ventricular protrusions could be contained within the nosecone with the heart valve having the shape/scenario as described above; thus it is assumed to be a matter of obviousness to one having ordinary skill in the art, just as in the rejection of Ma in view of Rabito, for such a heart valve to be delivered by a delivery apparatus as set forth in the claim. Hence, the rejections of independent claim 1, as being unpatentable over the prior art of Ma in view of Rabito, and independent claim 14, as being unpatentable over the prior art of Rabito in view Ratz and Quadri, are deemed to be proper since all the structural limitations set forth in the claims are taught by the prior art; thus, 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.
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/DINAH BARIA/Primary Examiner, Art Unit 3774