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 .
Information Disclosure Statement
The claims of the instant invention are specifically directed to an anchoring system of a valve treatment system for placement within a native valve using a tether. A review of the citations and their apparent relevance as they relate to the claimed invention has been evaluated for the numerous IDS submissions and particularly that filed 9/24/25. This IDS was found to have at least 30 documents irrelevant to the claims, not even close to the field of endeavor. Applicant is advised that in submitting information relevant to the claimed invention, to supply information that caused it to be submitted. It is noted that failing to provide the factual basis for each reference cited in any IDS might be held to be a non bona fide submission when large numbers of references or total IDS submissions are presented before the office.
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 1-20 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.
The term “near” in claims 1,5,7 is a relative term which renders the claims indefinite. The term “near” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not evident in claim 1 as to how far away from the native valve annulus the recited annular support member can be as it can encompass within a chamber of the heart and not even be in contact with the native valve annulus. Thus what is near meant to mean with defining how close it is to a native valve annulus? It is also not evident how far a distance a “coil” is placed near a distal end as recited in claim 5. Also it is not evident how far an “expandable region” is from a distal end as recited in claim 7. Dependent claims carry the same issue as the claim they depend on.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4,10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Migliazza et al. (2013/0079873). Fig. 10D shows a system for treating a diseased heart, the system comprising: an annular support member 40 that is shaped and sized for placement near a native valve annulus. Migliazza et al. also disclose (paragraph 21) an anchor member comprising at least one anchor portion configured for implantation in tissue within a ventricle; and at least one tether 50a that is configured for extension from the at least one anchor portion to the support member, the at least one tether configured to apply a tensioning force (paragraphs 53,54) between the support member and the at least one anchor portion. With respect to claim 2, Migliazza discloses (paragraph 21) the anchor can be implanted in a ventricle wall or a papillary muscle. Regarding claim 3, it can be construed the support member is configured to alter a dimension of the native valve annulus, see paragraph 48, having expandable structure, but corrects the annulus distortion, see paragraph 11. With respect to claim 4, Migliazza further discloses (paragraph 48) the at least one tether is configured to secure the support member to the native valve annulus. Regarding claims 10,11 Migliazza et al. further disclose (paragraph 48) a prosthetic valve that is sized and shaped to be placed within the support member and also there can be expandable stent structure. With respect to claim 12, Migliazza also disclose (paragraph 71) that the native leaflets can be present and thus the prosthetic valve is fully capable of being positioned to displace the native valve leaflets, see Fig. 5.
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.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Migliazza et al. (2013/0079873) in view of Ketai et al. (WO 2011/024973). Migliazza et al. is explained supra. However, Migliazza et al. did not disclose the anchor portion comprises a coil near a distal end thereof. Ketai et al. teach (Fig. 47) an anchor portion 4075 with a coil near a distal end for engagement with a wall of a ventricle, paragraph 145. It would have been obvious to one of ordinary skill in the art to utilize an anchor with a coil near its distal end as taught by Ketai et al. for the anchor of the valve repair device of Migliazza et al. such that it assures penetration at the desired depth.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Migliazza et al. (2013/0079873) in view of Gilmore et al. (9307980). Migliazza et al. is explained supra. However, Migliazza et al. did not disclose the anchor portion comprises a taper that reduces to a point at a distal end thereof. Gilmore et al. teach (Fig. 10D) an anchor portion 40 with a taper reducing to a point at a distal end for engagement with tissue, col. 50. It would have been obvious to one of ordinary skill in the art to utilize an anchor with a taper that reduces to a point at a distal end as taught by Gilmore et al. for the anchor of the valve repair device of Migliazza et al. such that it assures penetration into tissue so it is inserted deep enough and maintains a tension on the tether.
Claim(s) 7,8 are rejected under 35 U.S.C. 103 as being unpatentable over Migliazza et al. (2013/0079873) in view of Ortiz et al. (2007/0078302). Migliazza et al. is explained supra. However, Migliazza et al. did not disclose the at least one anchor portion includes an elongate tube having a first circumference, and wherein the at least one anchor portion comprises an expandable region configured to expand to a second circumference that is larger than the first circumference, wherein the expandable region is near a distal end of the at least one anchor portion. Ortiz et al. teach (Fig. 2) an anchor portion including an elongate tube 10 having a first circumference, and wherein the at least one anchor portion comprises an expandable region 22 configured to expand to a second circumference that is larger than the first circumference, see Fig. 3 wherein the expandable region is near a distal end of the at least one anchor portion. It would have been obvious to one of ordinary skill in the art to utilize the at least one anchor portion includes an elongate tube having a first circumference, and wherein the at least one anchor portion comprises an expandable region configured to expand to a second circumference that is larger than the first circumference, wherein the expandable region is near a distal end of the at least one anchor portion as taught by Ortiz et al. on the valve repair device support of Migliazza et al. such that it provides the to secure the anchor in the tissue of the patient. Regarding claim 8, it can be seen Fig. 5 that Ortiz teaches the at least one anchor portion comprises at least two expandable regions 22,24 configured to expand to circumferences larger than the first circumference.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Migliazza et al. (2013/0079873) in view of Meiri et al. (CN 102869321). Migliazza et al. is explained supra. However, Migliazza et al. did not disclose the support member comprises a self- expanding material. Meiri et al. teach (Fig. 15) support member 310 that comprises a self- expanding material., paragraph 117 of translation. It would have been obvious to one of ordinary skill in the art to utilize a support member that comprises a self- expanding material as taught by Meiri et al. for the material of the valve repair device support of Migliazza et al. such that it provides the necessary properties of self-expansion to retain a structure with its dimension deployed in a constrained configuration.
Claim(s) 13,14 are rejected under 35 U.S.C. 103 as being unpatentable over Migliazza et al. (2013/0079873) in view of Alderman et al. (2005/0277839). Migliazza et al. is explained supra. However, Migliazza et al. did not disclose the support member comprises first and second flow meters. Alderman et al. teach (Figs. 8,13) support member that comprises flow meters at ends, paragraphs 36,54. It would have been obvious to one of ordinary skill in the art to utilize flow meters with the support member as taught by Alderman et al. on the valve repair device support of Migliazza et al. such that it provides the necessary flow information through the valve to monitor its effectiveness in the patient.
Claim(s) 15,16 are rejected under 35 U.S.C. 103 as being unpatentable over Migliazza et al. (2013/0079873) in view of Spence et al. (10034749). Migliazza et al. is explained supra. However, Migliazza et al. did not disclose the support member is expandable and includes wires arranged to form an annular shape. Spence et al. teach (Figs. 4C,4D) an annular support member that comprises wires and is expandable, abstract. It would have been obvious to one of ordinary skill in the art to utilize coils made of wires for the annular support member as taught by Spence et al. on the valve repair device support of Migliazza et al. such that it provides the ability to expand as needed to secure at the annulus and attach about the valve. Further regarding claim 16, it can be construed the wires 32 define an inner wall and an outer wall to dispose about the native leaflets, see (Figs. 4C,D) how they are placed about the two sides of a leaflet.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Migliazza et al. (2013/0079873) in view of Yaron (WO 2013/001339). Migliazza et al. is explained supra. However, Migliazza et al. did not disclose the annular support member is conically shaped. Yaron teaches (Fig. 4) an annular support member that can be defined with a conical shape, paragraph 32. It would have been obvious to one of ordinary skill in the art to utilize an annular support member that defines a conical shape as taught by Yaron for the support in the valve repair device of Migliazza et al. such that it provides the necessary configuration to match anatomy and properly affix in a tapered location of a patient.
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Migliazza et al. (2013/0079873) in view of Keidar et al. (2014/0031930). Migliazza et al. is explained supra. However, Migliazza et al. did not disclose the annular support member is half-dome shaped. Keidar et al. teach (Figs. 13A,B) an annular support member 1090 that can be defined with a half-dome shape, paragraph 129. It would have been obvious to one of ordinary skill in the art to utilize an annular support member that defines a half-dome shape as taught by Keidar et al. for the support in the valve repair device of Migliazza et al. such that it provides the necessary configuration to match anatomy and properly affix in a repair location of a patient.
Claim(s) 19,20 are rejected under 35 U.S.C. 103 as being unpatentable over Migliazza et al. (2013/0079873) in view of Miller et al. (WO 2009/082479). Migliazza et al. is explained supra. However, Migliazza et al. did not disclose the at least one anchor includes an expandable portion that is configured to expand from a first diameter to a second diameter. Spence et al. teach (Figs. 31A-C) at least one anchor 300 includes an expandable portion that is configured to expand from a first diameter to a second diameter. It would have been obvious to one of ordinary skill in the art to utilize at least one anchor includes an expandable portion that is configured to expand from a first diameter to a second diameter as taught by Miller et al. on the valve repair device support of Migliazza et al. such that it provides the ability to expand as needed to secure at the tissue site and remain affixed therein. Further regarding claim 20, it can be construed the at least one anchor includes a collapsible tube having a pattern of cutouts (please note this can be considered a product by process limitation) that is configured to collapse the tube since they are disposed about the pusher and the collapsible cut outs form radially extending arms 301.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799