DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The disclosure is objected to because, in para. [0001] of the filed specification, U.S. Pat. No. 12,109,116 is not cited as being issued from U.S. Pat. App. No. 18/296,043.
Appropriate correction is required.
Claim Objections
Claims 21, 26, 31, and 37 are objected to because of informalities, which can be corrected as follows: In claim 21, line 7, between “coaptation and “body,” –assist-- should be inserted. In claim 26, lines 1 and 2, between “comprises” and “plurality,” –a-- should be inserted. In claim 31, line 7, “coaptation and “body,” –assist-- should be inserted. In claim 37, line 7, “coaptation and “body,” –assist-- should be inserted. Appropriate correction is required.
Claim Interpretation - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
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 21 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,109,116. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of U.S. Patent No. 12,109,116 encompasses subject matter of claims of the present application.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 21, 23-28, and 30-40 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Gabbay (2003/0199975). Gabbay discloses, in figures 11-14 and para. [0081], [0086], and [0087]-[0094]; a coaptation assist system for treating mal-coaptation of a heart valve of a heart, the heart valve comprising a valve annulus, the coaptation assist system comprising: a coaptation assist body (combination of 400 or 430, and 470) comprising a first surface and a second surface extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body and longitudinally between an upstream end and a downstream end of the coaptation assist body; a primary anchor (472) configured to secure the coaptation body to the valve annulus of the heart, wherein the coaptation assist body is configured to move and/or deform to facilitate maintaining natural movement of tissues of the heart (according to para. [0090]); wherein the system further comprises a secondary anchor (another 472); wherein the primary anchor is configured to maintain positioning engagement with a target location of the heart before the secondary anchor is moved into alignment with a different target location of the heart; wherein the coaptation assist body is configured to curve laterally across an opening of the heart valve to mimic a natural geometry of a coaptation zone between leaflets of the heart valve (as shown in fig. 11, 12, and 15); wherein the coaptation assist body comprises a plurality of members (wires or filaments of the mesh of 400 or 430) comprising Nitinol (according to para. [0081]); wherein the coaptation assist body is configured to accommodate lateral flexing and/or axial resilient elongation of the coaptation assist body during beating of the heart (according to para. [009]); wherein the coaptation assist body is configured to be laterally offset from a centroid of the heart valve (as shown in fig. 11 and 12); wherein the coaptation assist body is configured to allow leaflets to coapt with axially offset regions of opposed coaptation surfaces of the coaptation assist body (as shown in fig. 11 and 12).
Gabbay also discloses a coaptation assist system for treating mal-coaptation of a heart valve of a heart, the heart valve comprising a valve annulus, the coaptation assist system comprising: a coaptation assist body (combination of 400 or 430, and 470) comprising a first surface and a second surface extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body and longitudinally between an upstream end and a downstream end of the coaptation assist body; a primary anchor (472) configured to secure the coaptation body to the valve annulus of the heart, wherein the coaptation assist body is configured to structurally float during the beating of the heart (as shown in fig. 11 and 12, and according to para. [0075] for a similar coaptation assist body); wherein the system further comprises a pair of secondary anchors (472) configured to facilitate accurate positioning and support of the coaptation assist body; wherein the system further comprises a secondary anchor (472) configured to be separately deployed from the deployment of the primary anchor; wherein the coaptation assist body comprises a non-thrombogenic material (e.g., collagen or animal tissue material, according to para. [0072]); wherein the coaptation assist body comprises a shape memory frame (400 or 430, according to para. [0081]); wherein the coaptation assist body tapers inward toward the downstream end.
Gabbay further discloses a coaptation assist system for treating mal-coaptation of a heart valve of a heart, the heart valve comprising a valve annulus, the coaptation assist system comprising: a coaptation assist body (combination of 400 or 430, and 470) comprising a first surface and a second surface extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body and longitudinally between an upstream end and a downstream end of the coaptation assist body; and a primary anchor (472) configured to secure the coaptation body to tissue, wherein the coaptation assist body is configured to move with blood flow and/or with movement of the tissue to which the coaptation assist body is secured (according to para. [0075] for a similar coaptation assist body); wherein the system further comprises a pair of additional anchors (472); wherein the coaptation assist body is configured to be disposed between leaflets to fill gaps between coapting leaflet surfaces (as shown in fig. 11 and 12); and wherein the coaptation assist body comprises a nitinol frame (400 or 430, according to para. [0081]) covered with a biocompatible material (according to para. [0093]).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 22 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gabbay (2003/0199975) in view of Navia (8,216,303). Gabbay discloses the invention substantially as claimed, wherein the coaptation assist body may comprise a synthetic, cloth-like or fabric material (according to para. [0092]). However, Gabby does not explicitly disclose that the coaptation assist body comprises ePTFE. Navia teaches, in figures 1A-1E and col. 7, lines 37-41; a device for treating a heart valve, wherein a body (combination of 32 and 52) of the device comprises ePTFE. It would have been obvious to one having ordinary skill in the art at the time the invention was made, in view of Navia, to modify the coaptation assist body of Gabbay, so that it comprises ePTFE. Such a material is resilient, biocompatible, and suitable for use in a cardiac chamber.
Allowable Subject Matter
Claim 29 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.
The following is a statement of reasons for the indication of allowable subject matter: None of the prior art of record, alone or in combination, discloses a coaptation assist system for treating mal-coaptation of a heart valve of a heart, the heart valve comprising a valve annulus, the coaptation assist system comprising, inter alia: a coaptation assist body comprising a first surface and a second surface extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body and longitudinally between an upstream end and a downstream end of the coaptation assist body; a primary anchor configured to secure the coaptation body to the valve annulus of the heart, wherein the coaptation assist body is configured to move and/or deform to facilitate maintaining natural movement of tissues of the heart, and wherein the coaptation assist body comprises a triangular configuration.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
Any inquiry concerning this communication should be directed to Julian W. Woo at telephone number (571)272-4707. Normal office hours are: M-Th, 8-5:30 ET, 1st Fri. of biweek OFF; 2nd Fri., 8-4:30 ET.
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/JULIAN W WOO/Primary Examiner, Art Unit 3771