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 a response to applicant’s arguments and amendment filed 08/18/2025. Claims 1, 32, 34-35, 37-39, 42, 45, 52-54, 57, 61-63 and 65 are amended. Claims 2-30, 33, and 64 are cancelled. Claim 66 is new. Claims 1, 31-32, 34-63 and 65-66 are currently pending.
The objection of claims 32, 34-35, 37-38, 42, 52-54 and 61-63 has been withdrawn due to applicant’s amendment.
The rejection of claim 64 under 35 U.S.C. 112(a) has been withdrawn due to applicant’s amendment.
The rejection of claim 45 under 35 U.S.C. 112(b) has been withdrawn due to applicant’s amendment.
The rejection of claims 1, 31-32 and 34-65 under 35 U.S.C. 101 has been withdrawn due to applicant’s amendment.
Response to Arguments
Applicant’s arguments, see Remarks, filed 08/18/2025, with respect to the rejection(s) of claim(s) 1, 31-32, 35-36, 60 and 63 on the ground of nonstatutory double patenting as being unpatentable over claim 5 of Ratz in view of Cooper; and claims 1, 31-32 and 63 on the ground of nonstatutory double patenting as being unpatentable over claim 22 of Ratz in view of Cooper, have been fully considered but are not persuasive.
Applicant argues the Office’s reliance on Cooper is inaccurate, because a non-statutory double patenting rejection must be based on the claims and may not rely on the disclosure, and further argues Cooper does not teach a device in accordance with the claimed invention (Remarks, pg. 13).
In response to applicant’s argument, it is respectfully submitted MPEP 804(II)(B)(3) states any rejection made under the obviousness analysis should make clear “(B) the reasons why a person of ordinary skill in the art would conclude that the invention defined in the claim at issue would have been an obvious variation of the invention defined in a claim in the patent”, and further states any secondary reference used to support an obviousness analysis must be prior art. The reasons stated in (B) allow the teachings and knowledge of the prior art as a whole to be used as evidence as to why the conflicting claims would be obvious, and therefore a reliance on the disclosure for an obviousness analysis would meet the requirements for the nonstatutory double patenting rejection. Accordingly, the rejection is maintained.
Claim Objections
Claims 34, 36, 39 and 65 are objected to because of the following informalities:
In claim 34, line 4, the phrase “the distal segment of the atrial set of arms” should read “the distal segment of each of the atrial set of arms”.
In claim 36, line 8, the phrase “wherein the distal segment of the atrial set of arms” should read “wherein the distal segment of each of the atrial set of arms”.
In claim 39, line 2, the phrase “the distal segments of the atrial set of arms is configured such that” should read “the distal segments of the atrial set of arms are configured such that”.
In claim 39, lines 4-5, the phrase “at a points of contact” should read “at points of contact” or similar language.
In claim 39, line 6, the phrase “the distal segments of the atrial set of arms is configured such that” should read “the distal segments of the atrial set of arms are configured such that”.
In claim 39, line 9, the phrase “at a points of contact” should read “at points of contact” or similar language.
In claim 65, the phrase “a distal segment of the atrial set of arms” should read “the distal segment of each of the atrial set of arms” or similar language, to remain consistent in referring to the distal segment previously introduced.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 34, 37-51, 54, 56-57, 61-62 and 66 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 34, the claim recites “a distal segment of the ventricular set of arms… the distal segment of each of the ventricular set of arms” in lines 8-11. The first phrase introduces a singular distal segment of the ventricular set of arms, such that it is unclear whether the singular distal segment is being referred to, or multiple distal segments are being introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to at least one distal segment of the ventricular set of arms.
Regarding claim 39, the claim recites “the distal segments of the arms of the ventricular set of arms” in line 6. There is insufficient antecedent basis for this limitation in the claim, since multiple distal segments of the ventricular set of arms have not been previously introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the distal segment previously introduced.
Regarding claim 41, the claim recites “wherein the distal segments of the atrial and ventricular sets of arms” in lines 1-2. As previously discussed, it is unclear how many distal segments of the ventricular set of arms are being introduced, since claim 34 recites a distal segment of the ventricular set of arms. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the distal segment of each of the atrial set of arms, and the distal segment of the ventricular set of arms.
Regarding claim 42, the claim recites “the distal segments of the ventricular set of arms” in line 3. It is unclear whether the phrase is referring to the singular distal segment previously introduced, or introducing new, separate distal segments. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the distal segment previously introduced.
Regarding claim 51, the claim recites “the distal segments of the arms of the ventricular set of arms” in lines 3-4. It is unclear whether the phrase is referring to the singular distal segment previously introduced, or introducing new, separate distal segments. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the distal segment previously introduced.
Regarding claim 57, the claim recites “the initial bend, the secondary bend, and the third bend in each arm of the atrial set of arms and the ventricular set of arms”. Claim 1 introduces an initial bend, a secondary bend and a third bend in each arm of the atrial set of arms, but does not introduce an initial bend, a secondary bend and a third bend of the ventricular set of arms. Therefore, there is insufficient antecedent basis for the initial bend, secondary bend and third bend in each of the ventricular set of arms, and the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to an initial bend, a secondary bend and a third bend in each arm of the ventricular set of arms.
Regarding claim 66, the claim recites “the fenestrations”. It is unclear whether the phrase is referring to the fenestration feature previously introduced, or introducing new, separate fenestrations. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the fenestration feature.
Claims 37-38, 40, 43-50, 54, 56 and 61-62 are indefinite due to their dependencies on indefinite base claim 34.
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.
Claim 1, 31-32, 35-36, 55, 58-60 and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11,324,594 B2 to Ratz in view of Cooper (US 2017/0095328 A1) (previously of record).
Regarding claim 1, Ratz claims the invention of claim 1 (claim 5), but fails to claim wherein each arm of the atrial set of arms of the support structure comprises an initial bend that directs each arm back towards an atrial end of the support structure; a secondary bend that directs a distal segment of each arm away from and perpendicular to a central axis of the elongate central passageway; and an extended segment having a third bend toward the atrial end of the support structure.
Cooper teaches a prosthetic heart valve (fig. 10) comprising an atrial set of arms (at least two ventricular anchors 216, considered to be an atrial set of arms because anchors 216 extend toward the atrial end of the frame), i) an initial bend (intermediate portion 224 having a bend, para. [0107]) that directs each arm back towards an atrial end of the support structure (para. [0107]); ii) a secondary bend (bend formed between sections 252 and 254, paras. [0109]-[0110]; figs. 9-10) that directs a distal segment of each arm away from and perpendicular to a central axis of the elongate central passageway (see fig. 10 depicting section 254 extending away from the central axis of the frame, considered to include a distal segment extending away from and perpendicular to the central axis, since annotated fig. 10 depicts a rounded component falling along a perpendicular line with respect to the central axis); and iii) an extended segment (head portion 228) having a third bend (curved portion of head portion 228) toward the atrial end of the support structure (may be curved/rounded facing atrial end 210, para. [0110]), for the purpose of facilitating wrapping around the native leaflets (para. [0108]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the atrial set of arms including an initial bend, a secondary bend, and an extended segment with a third bend, in order to facilitate wrapping around the native leaflets, based on the teachings of Cooper (para. [0108]).
Regarding claim 31, Ratz (as modified) claims the invention of claim 31 (claim 5), but fails to claim wherein each of the ventricular set of arms of the support structure comprise an initial bend, a secondary bend, and an extended segment having a third bend.
Cooper teaches wherein each the ventricular set of arms of the support structure comprise an initial bend (intermediate portion 234, para. [0105]), a secondary bend (bend forming distal end portion 236, para. [0105]; fig. 10), and an extended segment (terminal portion 240) having a third bend (head portion 238 of terminal portion 240 depicted as curved upward and may also be convex/concave, which is considered to have a bend, para. [0105]; fig. 10), for the purpose of facilitating wrapping around the leaflets (para. [0108]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim each of the ventricular set of arms comprising an initial bend, a secondary bend and an extended segment having a third bend, in order to facilitate wrapping around the leaflets, based on the teachings of Cooper (para. [0108]).
Regarding claim 32, Ratz (as modified) claims the invention of claim 32 (claim 5), but fails to claim wherein the extended segment having the third bend is configured such that each arm of the atrial set of arms exhibits more atraumatic engagement of an atrial surface of the plurality of native leaflets of the native heart valve as compared to an atrial set of arms without an extended segment having a third bend toward the atrial end of the support structure.
Cooper teaches wherein the third bend is configured such that the atrial arm exhibits more atraumatic engagement of an atrial surface of the native leaflets as compared to an atrial arm without a third bend (head portion 228 is curved for contacting tissue and includes an opening through which tissue can protrude; the presence of the third bend is considered to provide more atraumatic engagement of the atrial surface via curved portion, paras. [0107] and [0110]), for the purpose of facilitating wrapping around the leaflets (para. [0108]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the third bend being configured such that the atrial arm exhibits more atraumatic engagement of an atrial surface of the native leaflets as compared to an atrial arm without a third bend, in order to facilitate wrapping around the leaflets, based on the teachings of Cooper (para. [0108]).
Regarding claim 35, Ratz (as modified) claims the invention of claim 35 (claim 5).
Regarding claim 36, Ratz (as modified) claims the invention of claim 36 (claim 5).
Regarding claim 55, Ratz (as modified) claims the invention of claim 55 (claim 5), but fails to claim wherein the prosthetic heart valve comprises at least one additional support structure.
Cooper teaches wherein the prosthetic heart valve comprises at least one additional support structure (skirt 12, para. [0070]), for the purpose of enveloping or covering some or all of the openings in the main body (para. [0070]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the prosthetic heart valve comprises at least one additional support structure, in order to envelop or cover some or all of the openings in the device, based on the teachings of Cooper (para. [0108]).
Regarding claim 58, Ratz (as modified) claims the invention of claim 58 (claim 5), but fails to claim wherein the support structure is configured to biodynamically fix the prosthetic heart valve to the plurality of native leaflets of the native heart valve of the heart such that the prosthetic heart valve is responsive to alternating pressure differentials on either side of the native heart valve during cardiac cycles of the heart.
Cooper teaches wherein the support structure is configured to biodynamically fix the prosthetic heart valve to the plurality of native leaflets of the native heart valve of the heart such that the prosthetic heart valve is responsive to alternating pressure differentials on either side of the native heart valve during cardiac cycles of the heart (anchors 216 and 220 of frame 202 flex relative to each other and the main body, permitting the atrial anchors to independently adjust to and conform to each patient’s particular anatomy; further, prosthetic valve sandwiches tissue to move with tissue in a generally synchronous manner, such that frame 202 is considered to move within the native heart valve during cardiac cycles of the heart and be biodynamically fixed such that frame 202 would be responsive to alternating pressure differentials, since Cooper discloses the prosthetic valve moving with native tissue in a synchronous manner and adjusting and conforming to the patient’s particular anatomy, which is consistent with applicant’s definition of biodynamic, para. [0009] of instant spec., paras. [0078] and [0103], figs. 7-10 of Cooper), for the purpose of permitting the valve to move with tissue in a synchronous manner during use (paras. [0078] and [0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the support structure is configured to biodynamically fix the prosthetic heart valve to the plurality of native leaflets of the native heart valve of the heart such that the prosthetic heart valve is responsive to alternating pressure differentials on either side of the native heart valve during cardiac cycles of the heart, in order to permit the valve to move with tissue in a synchronous manner during use, based on the teachings of Cooper (paras. [0078] and [0108]).
Regarding claim 59, Ratz (as modified) claims the invention of claim 59 (claim 5), but fails to claim wherein the prosthetic heart valve is not rigidly fixed within the native heart valve.
Cooper teaches wherein the prosthetic heart valve is not rigidly fixed within the native heart valve (prosthetic valve moves in generally synchronous manner with native tissue of heart, therefore biodynamic and not rigidly fixed within the native heart valve as discussed above, para. [0078]), for the purpose of permitting the valve to move with tissue in a synchronous manner during use (paras. [0078] and [0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the prosthetic heart valve is not rigidly fixed within the native heart valve, in order to permit the valve to move with tissue in a synchronous manner during use, based on the teachings of Cooper (paras. [0078] and [0108]).
Regarding claim 60, Ratz (as modified) claims the invention of claim 60 (claim 5).
Regarding claim 63, Ratz (as modified) claims the invention of claim 63 (claim 5).
Claims 1, 31-32, 35-36, 55, 58-60 and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. 11,602,433 B2 to Ratz in view of Cooper.
Regarding claim 1, Ratz claims the invention of claim 1 (claim 22), but fails to claim wherein each arm of the atrial set of arms of the support structure comprises an initial bend that directs each arm back towards an atrial end of the support structure; a secondary bend that directs a distal segment of each arm away from and perpendicular to a central axis of the elongate central passageway; and an extended segment having a third bend toward the atrial end of the support structure.
Cooper teaches a prosthetic heart valve (fig. 10) comprising an atrial set of arms (at least two ventricular anchors 216, considered to be an atrial set of arms because anchors 216 extend toward the atrial end of the frame), i) an initial bend (intermediate portion 224 having a bend, para. [0107]) that directs each arm back towards an atrial end of the support structure (para. [0107]); ii) a secondary bend (bend formed between sections 252 and 254, paras. [0109]-[0110]; figs. 9-10) that directs a distal segment of each arm away from and perpendicular to a central axis of the elongate central passageway (see fig. 10 depicting section 254 extending away from the central axis of the frame, considered to include a distal segment extending away from and perpendicular to the central axis, since annotated fig. 10 depicts a rounded component falling along a perpendicular line with respect to the central axis); and iii) an extended segment (head portion 228) having a third bend (curved portion of head portion 228) toward the atrial end of the support structure (may be curved/rounded facing atrial end 210, para. [0110]), for the purpose of facilitating wrapping around the native leaflets (para. [0108]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the atrial set of arms including an initial bend, a secondary bend, and an extended segment with a third bend, in order to facilitate wrapping around the native leaflets, based on the teachings of Cooper (para. [0108]).
Regarding claim 31, Ratz (as modified) claims the invention of claim 31 (claim 22), but fails to claim wherein each of the ventricular set of arms of the support structure comprise an initial bend, a secondary bend, and an extended segment having a third bend.
Cooper teaches wherein each the ventricular set of arms of the support structure comprise an initial bend (intermediate portion 234, para. [0105]), a secondary bend (bend forming distal end portion 236, para. [0105]; fig. 10), and an extended segment (terminal portion 240) having a third bend (head portion 238 of terminal portion 240 depicted as curved upward and may also be convex/concave, which is considered to have a bend, para. [0105]; fig. 10), for the purpose of facilitating wrapping around the leaflets (para. [0108]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim each of the ventricular set of arms comprising an initial bend, a secondary bend and an extended segment having a third bend, in order to facilitate wrapping around the leaflets, based on the teachings of Cooper (para. [0108]).
Regarding claim 32, Ratz (as modified) claims the invention of claim 32 (claim 22), but fails to claim wherein the extended segment having the third bend is configured such that each arm of the atrial set of arms exhibits more atraumatic engagement of an atrial surface of the plurality of native leaflets of the native heart valve as compared to an atrial set of arms without an extended segment having a third bend toward the atrial end of the support structure.
Cooper teaches wherein the third bend is configured such that the atrial arm exhibits more atraumatic engagement of an atrial surface of the native leaflets as compared to an atrial arm without a third bend (head portion 228 is curved for contacting tissue and includes an opening through which tissue can protrude; the presence of the third bend is considered to provide more atraumatic engagement of the atrial surface via curved portion, paras. [0107] and [0110]), for the purpose of facilitating wrapping around the leaflets (para. [0108]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the third bend being configured such that the atrial arm exhibits more atraumatic engagement of an atrial surface of the native leaflets as compared to an atrial arm without a third bend, in order to facilitate wrapping around the leaflets, based on the teachings of Cooper (para. [0108]).
Regarding claim 35, Ratz (as modified) claims the invention of claim 35 (claim 22), but fails to claim wherein the support structure is configured to biodynamically fix the prosthetic heart valve to the plurality of native leaflets of the native heart valve of a heart such that the prosthetic heart valve maintains axial stabilization within the native heart valve of the heart while the support structure moves within the native heart valve during cardiac cycles of the heart.
Cooper teaches (frame 202 accommodates tissue includes native mitral valve leaflets, such that frame is placed between leaflets of mitral valve to grasp leaflets, therefore maintaining axial stabilization since frame 202 is interposed between two opposed points of a native annulus of a native heart valve, which is consistent with applicant’s definition of axial stabilization, para. [0009] of instant spec., paras. [0103] and [0124]; figs. 16a-d of Cooper) while the support structure moves within the native heart valve during cardiac cycles of the heart (anchors 216 and 220 flex relative to each other and the main body, permitting atrial anchors to independently adjust to and conform to each patient’s particular anatomy; further, prosthetic valve sandwiches tissue to move with tissue in a generally synchronous manner, considered to move within native heart valve during cardiac cycles of the heart and be biodynamically fixed, since Cooper discloses the valve moving within native tissue in a synchronous manner and adjusting and conforming to the patient’s particular anatomy, which is consistent with applicant’s definition of biodynamic, para. [0009] of instant spec., paras. [0072]-[0073], [0078] and [0103]; figs. 7-10 of Cooper), for the purpose of providing a valve that moves in a synchronous manner with the tissue (paras. [0072]-[0073], [0078] and [0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the support structure is configured to biodynamically fix the prosthetic heart valve to the plurality of native leaflets of the native heart valve of a heart such that the prosthetic heart valve maintains axial stabilization within the native heart valve of the heart while the support structure moves within the native heart valve during cardiac cycles of the heart, in order to provide a prosthetic heart valve that is able to move in a synchronous manner with the tissue, based on the teachings of Cooper (paras. [0072]-[0073], [0078] and [0103]).
Regarding claim 36, Ratz (as modified) claims the invention of claim 36 (claim 22), but fails to claim wherein: the cylindrical portion of the support structure comprises an atrial end and a ventricular end, the elongate central passageway is defined by the cylindrical portion of the support structure, the support structure comprises the atrial set of arms, and the support structure comprises the ventricular set of arms, each arm of the atrial set of arms comprises a proximal segment that is proximal to the cylindrical portion of the support structure, and wherein the distal segment of the atrial set of arms is distal to the cylindrical portion of the support structure, and each arm of the ventricular set of arms comprises a proximal segment that is proximal to the cylindrical portion of the support structure and a distal segment that is distal to the cylindrical portion of the support structure.
Cooper teaches wherein the support structure comprises the cylindrical portion (cylindrical portion of frame 202, figs. 7-10) comprising an atrial end (210) and a ventricular end (212), the elongate central passageway is defined by the cylindrical portion of the support structure (figs. 7-10), the support structure comprises an atrial set of arms (at least two ventricular anchors 216, considered to be an atrial set of arms because anchors 216 extend toward the atrial end of the frame), and the support structure comprises a ventricular set of arms (at least two atrial anchors 220, considered to be a ventricular set of arms because anchors 220 extend toward the ventricular end of the frame, para. [0103]; fig. 10), each arm of the atrial set of arms and the ventricular set of arms comprises a proximal segment (proximal end portion 222 of ventricular anchors 216, and proximal end portion 232 of atrial anchors 220, paras. [0105] and [0107]) that is proximal to the cylindrical portion of the support structure (figs. 7-10) and a distal segment (distal end portion 226 of ventricular anchors 216 and distal portion 236 of atrial anchors 220, paras. [0105] and [0107]) that is distal to the cylindrical portion of the support structure (figs. 7-10), for the purpose of providing specific portions of the anchor to contact tissue (paras. [0105] and [0107]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein: the cylindrical portion of the support structure comprises an atrial end and a ventricular end, the elongate central passageway is defined by the cylindrical portion of the support structure, the support structure comprises the atrial set of arms, and the support structure comprises the ventricular set of arms, each arm of the atrial set of arms comprises a proximal segment that is proximal to the cylindrical portion of the support structure, and wherein the distal segment of the atrial set of arms is distal to the cylindrical portion of the support structure, and each arm of the ventricular set of arms comprises a proximal segment that is proximal to the cylindrical portion of the support structure and a distal segment that is distal to the cylindrical portion of the support structure, in order to provide specific portions of the valve to contact tissue, based on the teachings of Cooper (paras. [0105] and [0107]).
Regarding claim 55, Ratz (as modified) claims the invention of claim 55 (claim 22), but fails to claim wherein the prosthetic heart valve comprises at least one additional support structure.
Cooper teaches wherein the prosthetic heart valve comprises at least one additional support structure (skirt 12, para. [0070]), for the purpose of enveloping or covering some or all of the openings in the main body (para. [0070]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the prosthetic heart valve comprises at least one additional support structure, in order to envelop or cover some or all of the openings in the device, based on the teachings of Cooper (para. [0108]).
Regarding claim 58, Ratz (as modified) claims the invention of claim 58 (claim 22, responsive to systolic and/or diastolic pressure loads).
Regarding claim 59, Ratz (as modified) claims the invention of claim 59 (claim 22, biodynamic movement of valve).
Regarding claim 60, Ratz (as modified) claims the invention of claim 60 (claim 22, attached at locations radially inward from annulus).
Regarding claim 63, Ratz (as modified) claims the invention of claim 63 (claim 22).
Prior Art
It is noted claims 1, 31-32, 34-63 and 65-66 are currently free of prior art.
Allowable Subject Matter
Claims 52-53 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 65 would be allowable if rewritten or amended to overcome the objections set forth in this Office action.
Conclusion
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/BRIGID K BYRD/Examiner, Art Unit 3771