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.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burkin et al (US 2023/0080070).
Burkin et al discloses the following limitations:
Claim 1. A prosthetic heart valve delivery system (Figs. 16-17) comprising:
a handle (302) ([0066]);
a delivery catheter (304) extending distally from the handle *[0066]);
an inflatable balloon (318) positioned at a distal end portion of the delivery catheter ([0073]);
a prosthetic heart valve (370) configured to be collapsed onto the inflatable balloon for transcatheter delivery of the prosthetic heart valve to a native heart valve of a patient ([0073]);
an axial adjustment actuator (362) positioned on the handle, wherein actuation of the axial adjustment actuator causes the prosthetic heart valve to translate distally or proximally relative to the handle when the prosthetic heart valve is collapsed onto the inflatable balloon ([0081] discloses “the adjustment mechanism 361 can be configured to adjust the axial position of the intermediate shaft 306 relative to the outer shaft 304” and [0066] discloses “the delivery apparatus 300 can further comprise an intermediate shaft 306 (which can also be referred to as a balloon shaft) that extends proximally from the handle 302 (FIG. 16) and distally from the handle 302”. Therefore, axial movement of the intermediate/balloon shaft results in axial movement of the prosthetic heart valve mounted onto the balloon) and
a commissure alignment actuator (314) positioned on the handle (Fig. 16; positioned indirectly on the handle via intermediate shaft 306 which is extended through the handle), wherein actuation of the commissure alignment actuator causes the prosthetic heart valve to rotate about a central longitudinal axis of the prosthetic heart valve when the prosthetic heart valve is collapsed onto the inflatable balloon ([0068], [0074]);
wherein the axial adjustment actuator and the commissure alignment actuator are configured to be independently actuated so that actuation of the axial adjustment actuator does not cause the prosthetic heart valve to rotate about the central longitudinal axis of the prosthetic heart valve, and actuation of the commissure alignment actuator does not cause the prosthetic heart valve to translate distally or proximally relative to the handle (the cited axial adjustment actuator 362 and commissure alignment actuator 314 do not interact with one another. Therefore, actuation of one actuator does not result in movement of the other actuator and they are therefore considered configured to be independently actuated).
Claim 2. The prosthetic heart valve delivery system of claim 1, wherein the delivery catheter includes an outer catheter (304), and an inner catheter (306) radially inward of the outer catheter ([0066]).
Allowable Subject Matter
Claims 3-20 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 closest prior art of record, Burkin et al, discloses the invention substantially as claimed above. Burkin et al does not disclose or fairly suggest either singly or in combination the claimed prosthetic heart valve delivery system comprising, inter alia, a catheter hub positioned at least partially within the handle, the catheter hub being axially and rotatably fixed to the inner catheter.
Additionally, Lee et al (US 2013/0030520) discloses a prosthetic heart valve delivery system (10) comprising: a handle (20) ([0085]); a delivery catheter (16) extending distally from the handle ([0085]); an inflatable balloon (28) positioned at a distal end portion of the delivery catheter ([0086]); a prosthetic heart valve (12) configured to be collapsed onto the inflatable balloon for transcatheter delivery of the prosthetic heart valve to a native heart valve of a patient ([0086]); an axial adjustment actuator (82) positioned on the handle, wherein actuation of the axial adjustment actuator causes the prosthetic heart valve to translate distally or proximally relative to the handle when the prosthetic heart valve is collapsed onto the inflatable balloon ([0101]) and a commissure alignment actuator (98) positioned on the handle (Fig. 16; positioned indirectly on the handle via intermediate shaft 306 which is extended through the handle), wherein actuation of the commissure alignment actuator causes the prosthetic heart valve to rotate about a central longitudinal axis of the prosthetic heart valve when the prosthetic heart valve is collapsed onto the inflatable balloon ([0101]);
wherein the delivery catheter includes an outer catheter (22), and an inner catheter (26) radially inward of the outer catheter ([0085]); and further comprising a catheter hub (88) positioned at least partially within the handle (Fig. 2A), the catheter hub being axially and rotatably fixed to the inner catheter ([0101]). Lee et al does not disclose or fairly suggest either singly or in combination the claimed prosthetic heart valve delivery system comprising, inter alia, the axial adjustment actuator and the commissure alignment actuator are configured to be independently actuated so that actuation of the axial adjustment actuator does not cause the prosthetic heart valve to rotate about the central longitudinal axis of the prosthetic heart valve, and actuation of the commissure alignment actuator does not cause the prosthetic heart valve to translate distally or proximally relative to the handle. Instead, the cited commissure alignment actuator (98) allows both rotational and axial movement to occur simultaneously ([0102]).
Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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