DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Species 1, claims 1-13 in the reply filed on 12/12/2025 is acknowledged.
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/12/2025.
Claim Interpretation
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.
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.
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) 1-8, 10-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tuval et al U.S 2009/0240320.
Claim 1: Tuval et al disclose a valve prosthesis support frame (see fig. 1; the inner support structure/support frame at 12, see paragraph 598) comprising a plurality of cells that form a bottom row of cells, a middle row of cells, and a top row of cells (see fig. 1 with annotated below), the bottom row of cells defining a bottom edge of the support frame, the middle row of cells being circumferentially offset from the bottom row of cells, the top row of cells defining a top edge of the frame having three sets of cells that are circumferentially spaced apart from each other by at least one cell (it is noted that a plurality of major peak portions comprises three pairs of diamond-shaped cells i.e., asymmetric hourglass shape, see paragraph 27 and the prosthesis including a valve prosthesis support, which valve prosthesis support includes a support structure including exactly three engagement arms that meet one another at three respective junctures, and the engagement arms are shaped so as define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes, see paragraph 117 which represent the top row having 3 sets of cells), the top row of cells forming a plurality of major peak portions along the top edge of the frame the middle row of cells defining at least one minor peak portion disposed longitudinally intermediate the bottom edge and the plurality of major peak portions and being configured to allow access to and prevent obstruction to an ostia of a patient (it is noted that valve prosthesis 10 is configured such that when engagement arms 22 are placed properly within aortic sinuses 164, outer strut supports 20 are aligned with commissures 170 (see, for example, FIG. 8A), thus preventing any possible obstruction of coronary ostia 116 by valve prosthesis 10. At this point in the implantation procedure, the distal end of valve prosthesis 10 is free of overtube or trocar 150, and the proximal end of prosthesis 10 remains in overtube or trocar 150 (see figures 6a,b, paragraph 633).
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Claims 2-3: Tuval et al disclose wherein the three sets of cells are
circumferentially spaced apart from each other by two cells (see paragraph 117)., wherein the top row of cells comprises three sets of three cells that are circumferentially spaced apart from each other by at least one cell (see fig. 1 above).
Claims 4-5: Tuval et al disclose wherein each cell of the plurality of cells
has a uniform shape and size (see paragraph 71)., wherein the plurality of major peak portions comprises three pairs of diamond-shaped cells (asymmetric hourglass shape, see paragraph27).
Claims 6-7: Tuval et al disclose wherein each major peak of the plurality
of major peak portions has a longitudinal height defined as a height of two cells of the plurality of cells., wherein each minor peak of the at least one minor peak portion has a longitudinal height defined as a height of one and a half cells of the plurality of cells (it is noted that fig. 4c has different heights of membrane that is varies between the major peaks and the minor peals of the support frame, see paragraph 623).
Claims 8, 10: Tuval et al disclose wherein the at least one minor peak
portion comprises three minor peaks that are each radially intermediate respective major peaks of the plurality of major peak portions (see annotated fig. 1 above; wherein the support frame comprises a shape-memory material (see paragraph 603).
Claims 11-13: Tuval et al disclose wherein the support frame comprises a
laser-cut tubular mesh (the area 206, fig. 12c, see paragraph 660)., wherein the support frame is self- expanding (see paragraph 40)., further comprising a plurality of hooks (move barb 120, fig. 2b) extending from the bottom edge of the support frame.
Allowable Subject Matter
Claim 9 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. Claim 9: the prior arts fail to disclose or reasonably suggest the claimed including the plurality of major peak portions that has three major peaks and one minor peak portion that comprises three minor peaks that are each interposed between major peaks of the plurality of major peak portions.
Conclusion
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/VI X NGUYEN/Primary Examiner, Art Unit 3771