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 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:
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.
3. Claim(s) 1-3, 6-7, 10-11, 13-14, 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Vidlund et al.2018/0271653 in view of Alkhatib 2015/0032206.
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Noting figures 6A-7B, Vidlund discloses a system for replacing the function of a defective native heart valve, the system comprising: a prosthetic heart valve (300) including: an inner frame (350) having a proximal portion and a distal portion (top and bottom), the inner frame surrounding a flow channel, wherein the proximal portion (344) comprises an inflow portion of the prosthetic heart valve (see fig. 6B) and the distal portion comprises an outflow portion (e.g. 347) of the prosthetic heart valve, an outer frame (320) surrounding the inner frame, the outer frame having a proximal portion coupled to the proximal portion of the inner frame, wherein the outer frame includes a hinge (see [0055] which states that joints 146 can include a living hinge) for allowing a first region of the outer frame to pivot relative to a second region of the outer frame, thereby allowing the outer frame to conform to a shape of an annulus of the defective native heart valve (this is functional language see MPEP 2114. See [0055] which discloses the pivotal coupling), and a plurality of prosthetic valve leaflets (e.g. 670 see [0071]) positioned within the flow channel of the inner frame; and a delivery sheath catheter for delivering the prosthetic heart valve to the defective native heart valve; and a metallic frame [0028; 0043].
However Vidlund et al. does not state that the hinge is longitudinal or a catheter. It would have been obvious to one having ordinary skill in the art to modify the invention of Vidlund et al. and utilize a longitudinal hinge because [0055] envisions various shapes for the coupling member.
Regarding claim 2-3, MPEP 2114 states:
II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART
"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (The preamble of claim 1 recited that the apparatus was "for mixing flowing developer material" and the body of the claim recited "means for mixing ..., said mixing means being stationary and completely submerged in the developer material." The claim was rejected over a reference which taught all the structural limitations of the claim for the intended use of mixing flowing developer. However, the mixer was only partially submerged in the developer material. The Board held that the amount of submersion is immaterial to the structure of the mixer and thus the claim was properly rejected.).
The limitations of claim 2 “…wherein the longitudinal hinge allows for radially inward and radially outward rotation of the first region relative to the second region” and claim 3 “…wherein the longitudinal hinge allows for rotation of the first region relative to the second region in only a single direction”, this is functional language. See MPEP 2114 supra. .
4. Regarding claim 19, although Vidlund et al. disclose metal Vidlund et al. does not specifically recite stainless steel. Alkhatib teaches the use of stainless steel and the use of a delivery catheter (See [0048]). It would have been obvious to modify the invention of Vidlund and utilize stainless steel that delivery sheaths and catheters are utilized for minimally invasive delivery of implants.
5. Regarding claim 6 see mark-up which indicates the clearance region below.
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6. Regarding claims 7, 16 Vidlund et al. does not specifically state “..one or more distal anchors adapted to hook over one or more native leaflets of the defective native heart valve to anchor the prosthetic heart valve to the defective native heart valve.” Vidlund et al. does however discloses that an anchoring mechanism and/or an attachment point for a separate anchoring mechanism to anchor the valve to the native heart valve apparatus, a support to carry inner valve assembly 240, and/or a seal to inhibit paravalvular leakage between prosthetic heart valve 200 and the native heart valve apparatus (see [0042]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Vidlund et al. and provide one or more distal anchors adapted to hook over one or more native leaflets of the defective native heart valve to anchor the prosthetic heart valve to the defective native heart valve because Vidlund et al. envisions an anchoring attachment feature.
7. Regarding claims 9 and 20, see [0050; 0059].
8. Regarding claims 10, 13-14 Vidulund discloses coupling joints 346 which are configured to “rotate” about the coupling joint. The limitation of “…to rotate relative to the second portion in a plane extending transverse to the central axis, to thereby allow the outer frame to conform to a shape of an annulus of the defective native heart valve…allows for radially inward and radially outward rotation of the first portion relative to the second portion….allows for rotation of the first portion relative to the second portion in only a single direction” is functional language. See MPEP 2114 as discussed supra.
Allowable Subject Matter
9. Claims 4-5, 8, 12, 15 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.
10. The following is a statement of reasons for the indication of allowable subject matter: The closest prior art has been disclosed above including a prosthetic heart valve (300) including: an inner frame (350) having a proximal portion and a distal portion (top and bottom), the inner frame surrounding a flow channel, wherein the proximal portion (344) comprises an inflow portion of the prosthetic heart valve (see fig. 6B) and the distal portion comprises an outflow portion (e.g. 347) of the prosthetic heart valve, an outer frame (320) surrounding the inner frame, the outer frame having a proximal portion coupled to the proximal portion of the inner frame, wherein the outer frame includes a hinge.
11. The prior art fails to teach or disclose the first region comprises a first axially extending column of the outer frame, and the second region comprises a second axially extending column of the outer frame that is adjacent to the first axially extending column;
a first axially extending column includes a first strut cell of the outer frame, and the second axially extending column includes a second strut cell of the outer frame, and the longitudinal hinge couples a first strut of the first strut cell with a second strut of the second strut cell that is non-integral with the first strut; a micropattern applied to at least a portion of the prosthetic heart valve; wherein the suture joint includes a shear-lashing knot;
a first portion comprises a first axially extending column of the outer frame including a first strut cell, and the second portion comprises a second axially extending column of the outer frame including a second strut cell that is adjacent to the first strut cell, and the at least one rotation joint couples a first strut of the first strut cell with a second strut of the second strut cell that is non-integral with the first strut.
Conclusion
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 June 27, 2026
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