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 .
Response to Amendment
This office action is responsive to the amendment filed on 10/27/2025. As directed by the amendment: claims 1, 3, 8, and 10 have been amended, claims 2, 7, and 12-15 have been cancelled and claim 21 has been added. Thus, claims 1, 3-6, 8-11, 16-21 are presently pending in this application with claims 8-11 and 16-20.
Response to Arguments
Applicant’s arguments, see pg. 6, filed 10/27/2025, with respect to the rejection(s) of claim(s) 1-7 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Macoviak.
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.
Claims 1 and 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Eberhardt et al. (US 5,476,510) in view of Macoviak (US 6,893,459 B1).
Regarding claims 1 and 3 Eberhardt discloses (fig. 1-4) prosthetic valve delivery device (see col. 4 ln. 53-57) comprising
a stationary shaft 22 (shaft is stationary in relation to 12/24, see col. 4 ln. 1-9 and 40-52),
a rotary shaft 24 extending through at least a portion of the stationary shaft 22 (see fig. 1) and rotatable relative to the stationary shaft 22 (see col. 4 ln. 1-9 and 40-52); and
a grasping member (26+28) coupled to the rotary shaft 24 (see fig. 1 and col. 4 ln. 21-31), the grasping member defining a recess (space between 26) within which a prosthetic valve 36 is configured to be received (see fig. 3), the rotary shaft configured to rotate in a first direction, such that the grasping member is configured to radially compress the prosthetic valve (see fig. 4, col. 4 ln. 5 ln. 21-30), and a second direction, such that the grasping member is configured to radially expand the prosthetic valve (the grasping member is capable of rotating in a second direction);
The language “configured to rotate in a… second direction, such that the grasping member is configured to radially expand the prosthetic valve” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Eberhardt meets the structural limitations of the claim, and is capable of rotating in a second direction, such that the grasping member is configured to radially expand the prosthetic valve. If the handle is rotated in the second direction, the friction force would be overcome and the unwinding of the connecting line would expand the finger which would expand the valve.
Eberhardt is silent regarding a handle having the stationary shaft extending therefrom; the rotary shaft rotatable relative to the handle; a rotatable actuator on the handle and coupled to the rotary shaft.
However Macoviak, in the same field of endeavor, teaches (fig. 14-15) a handle 171 having a stationary shaft 173 extending therefrom (see fig. 14-15 and col. 10 ln. 13-32); a rotary shaft 181 rotatable relative to the handle 171 (see col. 10 ln. 45-50); a rotatable actuator 172 on the handle 171 and coupled to the rotary shaft 181 (see fig. 15 and col. 10 ln. 45-50).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Eberhardt to have a handle having the stationary shaft extending therefrom; the rotary shaft rotatable relative to the handle; a rotatable actuator on the handle and coupled to the rotary shaft as taught by Macoviak, for the purpose of having a stationary handle to hold during rotation of the shaft to five the user more leverage and control over the rotation (see col. 10 ln. 45-50).
The language “rotation of the rotatable actuator in the first direction causes the rotary shaft to rotate in the first direction, and rotation of the rotatable actuator in the second direction causes the rotary shaft to rotate in the second direction” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Eberhardt as modified meets the structural limitations of the claim, and rotation of the rotatable actuator in the first direction is capable of causing the rotary shaft to rotate in the first direction, and rotation of the rotatable actuator in the second direction is capable of causing the rotary shaft to rotate in the second direction. The rotatable actuator can be rotated in either direction.
Regarding claim 4, Eberhardt as modified discloses the claimed invention substantially as claimed, as set forth above for claim 3. Eberhardt further discloses (fig. 1-4) the grasping member comprises one or more posts 28 and one or more coil arms 26 (see fig. 1 and col. 4 ln. 21-31), wherein the one or more posts 28 are attached to the stationary shaft 22 (via 26, see fig. 1 and col. 4 ln. 10-31), and wherein the one or more coil arms 26 are attached to the rotary shaft 24 (via 28 see fig. 1 and col. 4 ln. 21-31) and are configured to surround the prosthetic valve 38 such that the one or more coil arms 26 define the recess within which the prosthetic valve is configured to be received (see fig. 3), and wherein rotation of the rotary shaft in the first direction constricts the one or more coil arms 26 (see fig. 4 and col. 4 ln. 31-39), and wherein rotation of the rotary shaft in the second direction expands the one or more coil arms (rotation of the rotary shaft in the second direction is capable of expanding the one or more coil arms).
The language “rotation of the rotary shaft in the second direction expands the one or more coil arms” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Eberhardt meets the structural limitations of the claim, and rotation of the rotary shaft in the second direction is capable of expanding the one or more coil arms. If the handle is rotated in the second direction, the friction force would be overcome and the unwinding of the connecting line would expand the one or more arms.
Regarding claim 5, Eberhardt as modified discloses the claimed invention substantially as claimed, as set forth above for claim 4. Eberhardt further discloses (fig. 1-4) the one or more coil arms 26 comprise a first coil arm and a second coil arm (see fig. 1), the first coil arm attached to the rotary shaft at a first circumferential location of the rotary shaft, and the second coil arm attached to the rotary shaft at a second circumferential location of the rotary shaft that is spaced apart from the first circumferential location (via the corresponding circumferentially positioned wires 28, see fig. 1).
Regarding claim 6, Eberhardt as modified discloses the claimed invention substantially as claimed, as set forth above for claim 4. Eberhardt further discloses (fig. 1-4) the one or more posts 28 extend outwardly from the stationary shaft 22 (see fig. 1, the ends of 28 extend outward of 22) such that the prosthetic valve is configured to abut the one or more posts as the prosthetic valve receives the stationary shaft within a lumen of the prosthetic valve (see fig. 3-4).
Response to Arguments
Applicant’s arguments, see pg. 6, filed 10/27/2025, with respect to the rejection(s) of claim(s) 1-7 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Macoviak.
Allowable Subject Matter
Claim 21 is allowed.
The following is a statement of reasons for the indication of allowable subject matter: the prior art, alone or in combination, fails to teach or render obvious (in addition to the other limitations of claim 21): a diameter of a recess defined by the grasping member increases/decreases with rotation of a rotary shaft in first/second directions, the grasping member comprises one or more coil arms, the rotation of the rotary shaft in the first direction twists the one or more coil arms about the stationary shaft to reduce the diameter of the recess, and wherein rotation of the rotary shaft in the second direction untwists the one or more coil arms from the stationary shaft to increase the diameter of the recess. The closest prior art reference Eberhardt, teaches one or more coil arms having a recess with a diameter that increases/decreases, but fails to teach those coil arms twist/untwist about the stationary shaft.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771