DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
CLAIM INTERPRETATION
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term (e.g., ‘a covering’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
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 6, 7, 14, and 15 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.
Claim 6 recites the limitation "the two or more lower coil" in in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the two or more lower coils" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the two or more lower coil" in in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the two or more lower coils" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-2, 8, 12, 16, and 17 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Yaron (US 2013/0006352A1).
Regarding claims 1, 8 and 16, Yaron discloses a helical anchor for docking a mitral valve prosthesis including a plurality of coils having a preformed, coiled configuration [0044] after being delivered from a coil guide catheter [0056; it is noted that the guide catheter does not appear to be positively recited] and adapted to support the mitral valve prosthesis upon being fully delivered from the coil guide catheter. The helical anchor is capable of being implanted with coil portions above and below a mitral valve annulus of a native mitral valve of a heart, wherein the plurality of coils includes an upper coil and at least two lower coils (Fig. 4). The upper coil is spaced axially apart from the at least two lower coils, and wherein the upper coil is configured to engage a wall of an atrium of the heart at a position superior to and spaced axially from the mitral valve annulus after the plurality of coils have been fully delivered from the coil guide catheter. A covering in the form of a coating [0049] extending along at least a portion of the plurality of coils.
Regarding claim 2, Yaron discloses that the helical anchor is a solid wire [0044, Fig. 4].
Regarding claims 12 and 17, Yaron discloses that the upper coil is capable of engaging ga wall of an atrium of the heart at a position superior to and spaced axially from the valve annulus (Fig. 4).
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.
Claims 3 and 10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Yaron in view of Bolling et al. (US 2012/0053680A1, “Bolling”).
Regarding claims 3 and 10, Yaron does not disclose that the covering is formed of polyester. In the same field of endeavor, valve repair, Bolling teaches a plurality of coils including a covering (963; Fig. 9P; [0140]) formed of polyester (polyethylene terephthalate). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have formed the covering of the helical anchor of Yaron of polyester, as taught by Bolling, for the predictable result of providing means to allow tissue growth such that heart tissue will attach thereto [0140].
Claims 3-5, 9-11, 13, and 18-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Yaron in view of Tremulis et al. (US 7,101,395, “Tremulis”).
Regarding claims 3-5, 9-11, 13, and 18-20, Yaron does not disclose that the covering is formed of fabric. In the same field of endeavor, valve repair, Tremulis teaches a plurality of coils including a covering (64) that is in the form of a sleeve formed of a mesh fabric (Fig. 10a; C6;L22-63). The cover may be made of a variety of material such as Dacron (polyester) or any other suitable material. To promote endothelialization, the anchor or mesh may be formed of nitinol or polyester (C16;L46-60). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have formed the covering of the helical anchor of Yaron of polyester or nitinol fabric or sleeve, as taught by Tremulis, for the predictable result of providing means for endothelialization which allows tissue growth such that tissue will attach thereto (C6;L60-63).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Keranen (US 2008/0208330A1) discloses a heart repair device including a plurality of coils.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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