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 .
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.
Election/Restrictions
Applicant’s election without traverse of Invention I, drawn to an improved guidewire for delivering a replacement heart valve implant of claims 1-8 in the reply filed on 8/8/25 is acknowledged.
Claim(s) 9-20 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/8/25.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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) 1-2 and 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2017/0209671 to Ring.
For claim 1, Ring discloses an improved guidewire for delivering a replacement heart valve implant (Abstract) (also see para [0006]), comprising:
an elongate shaft (unlabeled, but as can be seen in Figs. 18 and/or 21) including a distal section (as can be seen in Figs. 18 and/or 21) and a proximal section extending proximally from the distal section (as can be seen in Figs. 18 and/or 21);
wherein the elongate shaft includes a coiled portion (i.e., 801 in Fig. 21) disposed within the distal section (as can be seen in Figs. 18 and/or 21, but unlabeled in Fig. 18);
wherein the coiled portion is curved in a first direction in a first plane (as can be seen in Figs. 18 and/or 21);
wherein the elongate shaft includes a reverse curve portion curved in a second direction opposite the first direction (unlabeled, but as can be seen in Figs. 18 and/or 21);
wherein the reverse curve portion is disposed proximal of the coiled portion (as can be seen in Figs. 18 and/or 21).
For claim 2, Ring further discloses wherein the reverse curve portion is curved in the second direction within the first plane (as can be seen in Figs. 18 and/or 21).
For claim 7, Ring further discloses wherein the reverse curve portion is at least partially disposed in the proximal section of the elongate shaft (as can be seen in Figs. 18 and/or 21).
For claim 8, Ring further discloses wherein the reverse curve portion extends from a distal portion of the proximal section into the distal section (as can be seen in Figs. 18 and/or 21).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ring in view of U.S. Patent Application Publication No. 2023/0042352 to Urbanski et al. (hereinafter “Urbanski”).
For claim 3, Ring does not expressly disclose wherein the proximal section of the elongate shaft is laterally stiffer than the distal section of the elongate shaft.
However, Urbanski teaches wherein the proximal section of the elongate shaft is laterally stiffer than the distal section of the elongate shaft (para [0072]) (also see para [0009]).
It would have been obvious to a skilled artisan to modify Ring wherein the proximal section of the elongate shaft is laterally stiffer than the distal section of the elongate shaft, in view of the teachings of Urbanski, for the obvious advantage of a “predictable, consistent deployment of the … distal section of the guidewire” (see para [0009] of Urbanski).
For claim 4, Ring does not expressly disclose wherein the distal section of the elongate shaft is tapered in a distal direction.
However, Urbanski teaches wherein the distal section of the elongate shaft is tapered in a distal direction (as can be seen in Figs. 3-4) (also see para [0045]).
It would have been obvious to a skilled artisan to modify Ring wherein the distal section of the elongate shaft is tapered in a distal direction, in view of the teachings of Urbanski, for the obvious advantage of making the distal end atraumatic (see para [0045] of Urbanski).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ring in view of U.S. Patent No. 5,772,609 to Nguyen et al. (hereinafter “Nguyen”).
For claims 5-6, Ring does not expressly disclose wherein the elongate shaft includes a polymeric coating disposed on the coiled portion, wherein the proximal section of the elongate shaft is devoid of the polymeric coating.
However, Nguyen teaches wherein an elongate shaft (101) includes a polymeric coating (116 and/or 180, Figs. 1 and 5-6) (alternatively, see 276 and/or 278 in Fig. 11) disposed on a distal portion, wherein the proximal section of the elongate shaft is devoid of the polymeric coating (see Figs. 1, 5-6, and/or 11).
It would have been obvious to a skilled artisan to modify Ring wherein the elongate shaft includes a polymeric coating disposed on the coiled portion, wherein the proximal section of the elongate shaft is devoid of the polymeric coating, in view of the teachings of Nguyen, for the obvious advantage of reducing friction at the distal section so that is moves smoothly through a body lumen, but not making the proximal section slippery so that it can’t be grasped and maneuvered.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791