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 .
Claim Objections
Claim 10 is objected to because of the following informalities: the end of the claim does not have a period. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
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 and 10 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 1, line 6 recites a “delivery catheter in a d configuration.” It is unclear what the phrase “in a d configuration” is intending to refer to. Appropriate correction and/or clarification is required. Claim 10 recites the limitation "the intraluminal support structure body" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
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) 1-10 and 12-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pease et al. (US Pub. No. 2003/0055495; hereinafter Pease).
Pease discloses the following regarding claim 1: a method for delivering an intraluminal support structure (e.g., 20, 90) to an implantation site in a human or animal body (para. 0039), wherein the intraluminal support structure has a planar configuration (e.g., Figs. 2A-2D) with a long axis (longitudinal axis) and a short axis (lateral axis), said method comprising: advancing a distal end of a delivery catheter (92, 102, 104, 106a, 106b) through a body lumen to the implantation site (paras. 0041-0042, 0057-0059), wherein the intraluminal support structure is carried on the distal end of the delivery catheter in a d configuration which is elongated along the long axis and has a reduced width along the short axis (Fig. 3A, interpreted as the support structure has a general, rounded d-shape); transitioning the intraluminal support structure from its crimped configuration (e.g., Fig. 3A) to a non-crimped configuration (e.g., Fig. 3B) at the implantation site; folding the non-crimped intraluminal support structure to assume a non-planar folded configuration (e.g., Figs. 1, 3B) at the implantation site (paras. 0053-0055, as the device is folded into its tubular shape); and locking the non-crimped intraluminal support structure in the folded configuration (paras. 0053-0055); wherein the intraluminal support structure is implanted it its locked, folded, non-crimped configuration (paras. 0057-0059).
Pease discloses the following regarding claim 2: the method of claim 1, wherein the implantation site comprises a cardiac valve annulus (para. 0013).
Pease discloses the following regarding claim 3: the method of claim 2, wherein the intraluminal support structure comprises a prosthetic valve assembly (24a, 24b, 24c) coupled to a support structure body (paras. 0019-0021, 0044-0047).
Pease discloses the following regarding claim 4: the method of claim 3, wherein folding the non-crimped intraluminal support structure to assume a non-planar folded configuration at the implantation site comprises forming the support structure body into a cylindrical structure (Figs. 1, 3B; paras. 0053-0055).
Pease discloses the following regarding claim 5: the method of claim 4, further comprising locking ends of the support structure body together to maintain the cylindrical structure (paras. 0053-0055).
Pease discloses the following regarding claim 6: the method of claim 5, wherein individual leaflets of the prosthetic valve assembly are fit together when the support structure body is formed into a cylindrical structure (Fig. 1; para. 0044).
Pease discloses the following regarding claim 7: the method of claim 1, wherein the intraluminal support structure is carried in its crimped configuration inside the distal end of the delivery catheter (Fig. 3A; para. 0059).
Pease discloses the following regarding claim 8: the method of claim 1, wherein locking the non-crimped intraluminal support structure in the folded configuration comprises overlapping and interlocking ends of said intraluminal support structure along the short axis (Figs. 2A-2D; paras. 0053-0055).
Pease discloses the following regarding claim 9: the method of claim 1, wherein said locking members interlocking ends of said intraluminal support structure along the short axis comprises joining any one or combination of pins, hooks, male-female couplers, peg-recess couplers, latches, buckles, sutures, wires, threads, hooks, and loops (Figs. 2A-2D; para. 0053-0055).
Pease discloses the following regarding claim 10: the method of claim 1, wherein the intraluminal support structure body comprises a planar scaffold formed as an arrangement of filaments having interlinking points (Figs. 1-2D, 4A, 5A, 9)
Pease discloses the following regarding claim 12: the method of claim 1, wherein the non-crimped intraluminal support structure is locked, and folded at a final implanted location (paras. 0053-0055, 0057-0059).
Pease discloses the following regarding claim 13: the method of claim 1, wherein further comprising maneuvering the locked, folded, non-crimped intraluminal support structure to a final implanted location (paras. 0041-0042, 0057-0059).
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:
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) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pease in view of Shaw (US Pub. No. 2006/0161251).
Pease discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the filaments of the support structure being arranged by one of braiding, weaving, interlacing, or any combination thereof. Shaw teaches that it is well known in the art that heart valve support structures can be made from a variety of techniques, including weaving filament wires (paras. 0008-0009, 0015-0018), for the purpose of providing the device with the desired strength and mechanical characteristics needed for its implantation site. It would have been obvious to one having ordinary skill in the art to modify the support structure of Pease, to comprise braided or woven filaments, as taught by Shaw, in order to provide the device with the desired strength and mechanical characteristics needed for its implantation site. Such a modification would be made with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
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