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 § 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.
Claims 1-6, 23, 25-29, 33-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maimon et al. (Pub. No.: US 2018/0153689).
Maimon et al. (hereinafter, Maimon) discloses a medical assembly comprising:
a prosthetic heart valve (para. 4), comprising:
a radially expandable annular frame 22, wherein the frame comprises at least one frame portion 94 defining an axially extending channel (e.g., fig. 9);
a valvular structure 14 disposed within the frame and configured to regulate flow of blood through the frame in one direction (functioning as a prosthetic valve);
at least one actuation member 86 coupled to the frame and configured to apply an axially directed force to the frame;
wherein the prosthetic heart valve is configured to self-expand from a radially compressed state to at least a partially radially expanded state (e.g., 102
para. 162); a delivery device comprising:
at least one delivery system actuator 76 releasably coupled to the actuation member 86 and extending through the axially extending channel of the frame (e.g., fig. 10A, 11);
wherein one of an exterior surface of the delivery system actuator and an inner surface the axially extending channel comprises a friction surface 312 and the other of the exterior surface of the delivery system actuator and the inner surface of the axially extending channel comprises an opposing surface 102 that can engage the friction surface (e.g., para. 147), wherein the exterior surface of the delivery system actuator and the inner surface of the axially extending channel have a first coefficient of friction when the friction surface and the opposing surface engage each other (friction fit) and a second coefficient of friction when the friction surface and the opposing surface do not engage each other (free movement allowed), wherein the first coefficient of friction is greater than the second coefficient of friction;
wherein, when the prosthetic heart valve self-expands from the radially compressed state to the partially radially expanded state, the delivery system actuator can slide relative to the axially extending channel and the friction surface slides against the opposing surface to control a rate of expansion of the prosthetic heart valve (e.g., para. 162);
wherein the delivery system actuator is configured to move the actuation member in an axial direction to further expand the prosthetic heart valve from the partially radially expanded state to a further radially expanded state (e.g., para. 163).
For claim 2, Maimon discloses the medical assembly of claim 1, wherein the friction surface is configured to disengage from the opposing surface when the prosthetic heart valve reaches the partially radially expanded state (e.g., para. 163).
For claim 3, Maimon discloses the medical assembly of claim 1, wherein the frame comprises a proximal end portion and a distal end portion, wherein the proximal end portion comprises a plurality of frame apices, wherein the axially extending channel extends through one of the frame apices (e.g., fig. 8).
For claim 4, Maimon discloses the medical assembly of claim 1, wherein the friction surface is on the delivery system actuator and the opposing surface is on the inner surface of the axially extending channel (fig. 8-12A).
For claim 5, Maimon discloses the medical assembly of claim 1, wherein the friction surface 102 is on the inner surface of the axially extending channel (e.g., fig. 11) and the opposing surface 86 is on the delivery system actuator (e.g., fig. 12A).
For claim 6, Maimon discloses the medical assembly of claim 1 wherein the friction surface is configured to disengage completely from the frame and to provide no resistance to axial motion of the delivery system actuator when the prosthetic heart valve has self-expanded to the partially radially expanded state (e.g., para. 163).
For claim 23, Maimon discloses the medical assembly of claim 1, wherein the delivery device comprises a sheath 82 configured to retain the prosthetic heart valve in the radially compressed state and to deploy the prosthetic heart valve from the sheath to allow the prosthetic heart valve to self- expand (e.g., para. 162).
For claim 25, Maimon discloses the medical assembly of claim 1, wherein the delivery system actuator is configured to exert a proximally directed force on the actuation member to radially expand the prosthetic heart valve from the partially radially expanded state to the further radially-expanded state (e.g., para. 163).
For claim 26, Maimon discloses the medical assembly of claim 3, wherein the actuation member 86 is configured to pass through the axially extending channel when the prosthetic heart valve is fully expanded (e.g., para. 166).
For claim 27, Maimon discloses the medical assembly of claim 1, wherein the frame comprises at least one locking member configured to engage the actuation member and prevent radial compression of the prosthetic heart valve after the prosthetic heart valve is expanded to the further radially expanded state (e.g., para. 166-167).
For claim 28, Maimon discloses the medical assembly of claim 1, wherein the frame is made of Nitinol (e.g., para. 118).
For claim 29, Maimon discloses the medical assembly of claim 1, wherein the opposing surface comprises another friction surface 102.
For claim 33. Maimon discloses the medical assembly of claim 1, wherein the at least one actuation member comprises a plurality of actuation members and the at least one delivery system actuator comprises a plurality of delivery system actuators releasably coupled to respective actuation members and extending through respective channels of the frame (e.g., fig. 8).
For claim 34, Maimon discloses the medical assembly of claim 33, wherein each delivery system actuator and corresponding channel has a friction surface and an opposing surface (e.g., fig. 8, 12A).
For claim 35, Maimon discloses the medical assembly of claim 33, wherein the delivery device comprises a plurality of support tubes 76 that abut the frame, wherein each delivery system actuator extends through one of the support tubes (e.g., fig. 11).
For claim 36, Maimon discloses the medical assembly of claim 1, wherein the delivery system actuator is configured to be de-coupled from the actuation member after the prosthetic heart valve is expanded to the further radially expanded state so that the delivery device can be removed from a patient's body (e.g., para. 166).
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.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Maimon et al. (Pub. No.: US 2018/0153689) in view of Rothstein (Pub. No.: US 2017/0165066).
Maimon is explained supra, however, Maimon lacks a delivery device which comprises an adjustable loop circumferentially disposed around an exterior of the prosthetic heart valve to retain the prosthetic heart valve in the radially compressed state and to allow the prosthetic heart valve to self-expand when slack is introduced in the adjustable loop. Rothstein teaches a delivery device with an adjustable loop 20 circumferentially disposed around an exterior of a prosthetic heart valve (e.g., fig. 5A) to control expansion and contraction of the prosthetic heart valve (abstract). It would have been obvious to have utilized the adjustable loop 20 of Rothstein with the delivery device of Maimon for the purpose of controlling the natural elastic expansion of the prosthetic valve frame once it is removed from the delivery sheath (e.g., para. 162) providing greater control over the deployment. This modification would have occurred using known methods and would have yielded predictable results.
Claims 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Maimon et al. (Pub. No.: US 2018/0153689).
For claim 30, Maimon does not expressly disclose the friction surface comprises an elastomeric polymer which is silicone, flouroelastomer, perflouroelastomer, ethylene propylene, nitrile rubber, or a combination thereof, however, Maimon discloses the actuation member 86 is made of suture material (para. 141), and it is known in the art that sutures may be fabricated from flouroelastomer, perflouroelastomer, and/or ethylene propylene. It would have been obvious to one of ordinary skill in the art to have selected these particular materials for the friction surface as an obvious selection of a known biocompatible material suitable for use as a filamentous suture-type material. This selection would have occurred using known methods and would have yielded predictable results.
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774
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