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 .
Information Disclosure Statement
2. Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action. There is no requirement that applicants explain the materiality of English language references, however the cloaking of a clearly relevant reference in a long list of references may not comply with applicants’ duty to disclose; see Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, aff’d 479 F. 2d. 1338.
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 (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 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.
Claims 1, 4, 7-17 are rejected under 35 U.S.C. 103 as being unpatentable over Cooper et al (2019/0262129) in view of Rolando et al (9,895,225).
Cooper et al teaches a prosthetic heart valve for implantation in a native valve of a heart, the prosthetic heart valve comprising:
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a plurality of prosthetic valve leaflets 1662 positioned within a flow channel of the prosthetic heart valve;
an expandable and compressible inner frame 1620 supporting the plurality of prosthetic valve leaflets;
an expandable and compressible sealing body for sealing with a portion of the heart (frame 1640 and skirt 1680), the sealing body positioned radially outward of the inner frame,
and a plurality of ventricular anchors 1624 extending from an outflow end of the prosthetic heart valve for capturing leaflets of the native valve between the ventricular anchors and the outer surface of the sealing body.
However, Cooper et al fails to teach at least a portion of the sealing body includes a plurality of friction bodies along an outer surface thereof; wherein the friction bodies contact the captured leaflets of the native valve for enhancing securement of the prosthetic heart valve in the native valve.
Rolando et al teaches a prosthetic heart valve a plurality of friction bodies 200 along an outer surface thereof.
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It would have been obvious to one having ordinary skill in the art to have used the friction bodies of Rolando et al on the sealing body of Cooper et al to penetrate (e.g., harpoon-like) into the natural tissue, e.g., into the native valve leaflets and/or into the native valve annulus increasing anchoring (column 5, lines 53-64). The captured leaflets of the native valve are interpreted as not being positively claimed.
Claim 4, wherein each friction bodies include a protrusion (four as shown above) coupled to a wire in between.
Claim 7, wherein the sealing body comprises a skirt 1680 and wherein the outer surface of the sealing body is the outer surface of the skirt. See 7:25-28.
Claim 8, Rolando et al teaches the friction bodies are stitched onto the skirt interpreted as being embedded in the skirt. Also see figure 2 mounted to intermediate sheet 210.
Claim 9, wherein the friction bodies include protrusions extending from the outer surface of the skirt is self-evident.
Claim 10, wherein the sealing body is a metallic (par. 0180) outer frame coupled to the inner frame and wherein the skirt is wrapped around the outer frame as described above.
Claim 11, referring to at least figure 19, wherein the outer frame 1640 is coupled to the inner frame 1620 at an inflow end of the prosthetic heart valve.
Claim 12, wherein each of the plurality of ventricular anchors has a hook shape (see the figure above) for hooking around a leaflet of the native valve.
Claim 13, it would have been obvious to one skilled in the art to have placed to the friction bodies is at a location (directly) opposed to one of the ventricular anchors to clamp the native valve leaflets increasing anchoring. Just incorporating the friction bodies anywhere maybe interpreted as being “opposed”.
Claim 14, par. 0140 of Cooper et al teaches the prosthetic heart valve is sized for replacing a native mitral valve or a native tricuspid valve.
Claim 15, the limitation are addressed in the claims above. The protrusions are the frictional bodies 200.
Claim 16, the distal direction can be either direction.
Claim 17, the protrusion 200 are barbs.
Allowable Subject Matter
Claims 18-20 are allowed.
Claims 2-3 and 5-6 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.
The following is a statement of reasons for the indication of allowable subject matter: The closes prior art of record is believed to be Cooper et al (2019/0262129) in view of Rolando et al (9,895,225). The combination fails to teach all limitations including:
Claim 2, the friction bodies include a fabric having a honeycomb weave pattern and wherein the honeycomb weave pattern is formed by fibers that have been heat treated to increase a thickness of the honeycomb weave pattern.
Claim 3, the friction bodies include a patch having a plurality of loops.
Claim 5, the friction bodies include barbed sutures.
Claim 6, further comprising a fabric coupled to the plurality of ventricular anchors, wherein the fabric has a honeycomb weave pattern formed by wavy fibers that have been heat treated to increase a thickness of the honeycomb weave pattern.
Claim 18 is interpreted as follows and the underlined portion is not taught in the combination rejection: A prosthetic heart valve for implantation in a native valve of a heart, the prosthetic heart valve comprising: a frame supporting a plurality of prosthetic valve leaflets; an anchor (see applicant’s figure 9, anchor 56) coupled to the frame and adapted to anchor the frame to the native valve; and a pad 25 coupled to the anchor, the pad adapted to cushion the anchor against a portion of the native valve and including a fabric having a honeycomb weave pattern, wherein the honeycomb weave pattern is formed by fibers that are wavy and have been heat treated to increase a thickness of the honeycomb weave pattern.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRUCE E SNOW/Primary Examiner, Art Unit 3774