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 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., ‘outer skirt,’ ‘leaflet structure,’ ‘annular frame’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.”
Claim Rejections - 35 USC § 103
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 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 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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi et al. (US 2012/0123529A1, “Levi”) in view of Carlson et al. (US 2008/0228028A1, “Carlson”).
Regarding claims 1-15 and 18-20, Levi discloses a prosthetic valve that includes an annular frame (12; Fig. 1) that is capable of radially collapsing and expandable between a radially collapsed configuration and a radially expanded configuration. A leaflet structure (14; [0009,0011, 0020]) is positioned within the frame and secured thereto [0097, 0099]. An outer skirt (18) is positioned around an outer surface of the frame. The outer skirt includes an inflow edge and an outflow edge [0016]. The outer skirt is formed of woven (interlaced) PET (polyethylene terephthalate) material [0084] between the inflow and outflow edges (Fig. 41). Levi discloses that the inner skirt is formed multiple rows of woven yarns. A weave is known to be formed of interlaced yarns from first and second sets. However, Levi does not disclose that one or more of the multiple rows include groups of floating yarns.
In the same field of endeavor, woven material for implants [0044, 0045], Carlson teaches a woven fabric that includes shape memory strands and textile strands (non-shape memory material). The woven fabric may include fibers (strands, fibers) made of self-expandable shape memory material, e.g. nitinol [0040], that extend in the axial direction [0029, 0032-0036, 0039-0040]. The textile strands may include PET (polyethylene terephthalate;[0037] ) and extend perpendicular to the shape memory strands. The woven fabric includes multiple rows of first and second sets of interlaced yarns [0020]. The multiple rows include groups of floating yarns [0034]. The first rows of the multiple rows include a first set of interlaced yarns and alternate with second rows including a second set of interlaced yarns (Figs. 3). The first rows include a groups of floating yarns, e.g. over-27/under-3 configuration [0031, 0034], wherein the groups of floating yarns include at least two, five, and eight adjacent floating yarns within a same row. Each row formed by the first set of interlaced yarns may have a satin weave pattern or a plain weave [0027]. The first set of interlaced yarns include warp yarns made of non-shape memory material and weft yarns made of shape memory material [0051], wherein each group of floating yarns includes eight adjacent floating yarns between outwardly exposed weft yarns made of the shape memory material. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the fabric of outer skirt of Levi with the woven fabric of Carlson including groups of floating yarns in satin or plan weave patterns, as taught by Carlson, as this modification involves the simple substitution of one biocompatible material for another for the predictable result of maintaining low porosity, providing desirable shape memory characteristics and distributing stress across the fabric. With this modification, the weave pattern includes yarns that extend in a circumferential direction.
Regarding claim 16, the combination of Levi and Carlson discloses that the outer skirt includes an inflow edge secured to the frame at a first location and an outflow edge secured to the frame at a second location, wherein the plurality of rows is arrayed from the inflow edge to the outflow edge [0016; Levi].
Regarding claim 17, the combination of Levi and Carlson discloses that the frame defines an axial direction extending between an inflow end and an outflow end of the frame, wherein the floating yarns extend in the axial direction. It is noted that Carlson teaches that the woven fabric includes shape memory element strands aligned in a first direction and textile strands aligned in a second direction [0007], thus the floating yarns may extend in the axial direction when the warp fibers are aligned in the axial direction.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Schmitt (US 5,178,630) discloses groups of floating yarns within a woven pattern.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571)272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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