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 .
Detailed Action
This is in response to the non-provisional application filed 11/20/2024.
Allowable Subject Matter
Claims 8-19 are allowed.
Claims 4 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.
Claims 6, 7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 4 recites wherein the inner surface of the body at the extended outflow portion further comprises a recess, and wherein the tissue compressor is disposed in the recess. Claim 6 recites wherein the thickness of the ring is greater than a depth of the recess. Claim 8 recites the tissue compressor comprising a plurality of ports through the extended outflow portion of the body configured to provide pressurized fluid to the lumen of the body. Claim 11 recites applying a radially inward force to tissue of the prosthetic valve as the transcatheter heart valve prosthesis is advanced through the extended outflow portion such that the tissue is moved radially inward with respect to the frame
The Office agrees the art of record fails to teach or suggest these features.
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 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 refers to the recess. There is insufficient antecedent basis for this limitation. The recess is recited in claim 4 and claim 6 is dependent on claim 5 (which is dependent on claim 1)
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) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication Number 2010/0057185 (Melsheimer et al.)
Regarding claims 1-3, Melsheimer et al. discloses as shown in Figure 2, a funnel crimper (compressor 30, see paragraph [0021]) comprising: a body having a first end, a second end, and a lumen extending from the first end to the second end, the lumen being defined by an inner surface of the body, the body including a tapered portion and an extended outflow portion, wherein the lumen in the tapered portion tapers from a first diameter at the first end to a second diameter smaller than the first diameter, and wherein the extended outflow portion extends from the tapered portion to the second end of the body; and a tissue compressor (sleeves 52, see paragraph [0033]) coupled to the body such that the tissue compressor extends into the lumen relative to the inner surface of the body, wherein the tissue compressor comprises a relatively soft material softer than a relatively hard material of the body, and wherein the tissue compressor is capable of applying a radially inward force to tissue of a prosthetic valve of a transcatheter heart valve prosthesis disposed on an inner surface of a frame of the transcatheter heart valve prosthesis as the transcatheter heart valve prosthesis is advanced through the lumen of the body, wherein the relatively soft material of the tissue compressor has a Shore A hardness in the range of 20 A-80 A, wherein the relatively soft material of the tissue compressor is selected from the group consisting of closed cell foam, rubber, modified polyurethane, silicone, ethylene propylene diene monomer rubber (EDPM), nitrile, fluorocarbon-based fluoroelastomers (FKM), polychloroprene (neoprene), and/or combinations thereof.
To be clear, claim 1 does not require a prosthetic valve or a frame of the transcatheter heart valve prosthesis. Only a tissue compressor capable of working with one.
Claim(s) 1-3, 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Number 5,972,028 (Rabneau et al.)
Regarding claims 1-3, 5 Rabneau et al. discloses as shown in Figure 13, a funnel crimper (instrument 20, see col. 4, lines 27-41) comprising: a body having a first end, a second end, and a lumen extending from the first end to the second end, the lumen being defined by an inner surface of the body, the body including a tapered portion and an extended outflow portion, wherein the lumen in the tapered portion tapers from a first diameter at the first end to a second diameter smaller than the first diameter, and wherein the extended outflow portion extends from the tapered portion to the second end of the body; and a tissue compressor (ring 140, see col. 12, lines 36-50) coupled to the body such that the tissue compressor extends into the lumen relative to the inner surface of the body, wherein the tissue compressor comprises a relatively soft material softer than a relatively hard material of the body, and wherein the tissue compressor is capable of applying a radially inward force to tissue of a prosthetic valve of a transcatheter heart valve prosthesis disposed on an inner surface of a frame of the transcatheter heart valve prosthesis as the transcatheter heart valve prosthesis is advanced through the lumen of the body, wherein the tissue compressor is a ring having an outer surface, an inner surface, a thickness defined between the inner surface and the outer surface, a width, and a ring lumen defined by the inner surface of the ring.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771
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