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 .
Election/Restrictions
Applicant’s election without traverse of Group II (claims 15-18 and 21-36) in the reply filed on 08/06/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 02/12/2025 and 10/06/2025, have been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22-24 and 26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
[Claims 22-24 and 26] The claims all recite the limitation of “the leaflet.” There is a lack of antecedent basis for this limitation in the claims. Further, the examiner is unable to determine the metes and bounds of the claims, since it is unclear if these limitations refer to the previously recited “calcified leaflet,” or if a new structure is being introduced into the claim limitations. For purposes of examination, it is interpreted that “the leaflet” refers to the previously recited “calcified leaflet.”
Claim Rejections - 35 USC § 102
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.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 15, 18, 21-23 and 25, are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hartman et al. (PGPub 2023/0113185).
[Claim 15] Hartman teaches a method for advancing a primary guidewire (figure 5c, item 1500) past a calcified leaflet (figure 5c, item 12; paragraph [0063]), the method comprising:
advancing a catheter (figure 5a, item 1504) configured to surround (figure 1a) the primary guidewire (figure 5c, item 1500) and a secondary guidewire (figure 5c, item 1400; paragraph [0088]);
attaching a leaflet anchor (figure 5a, item 1402; paragraph [0073]) of the secondary guidewire (figure 5c, item 1400) to the calcified leaflet (figure 5c, item 12) of a valve (figure 5a, item 26) (figures 5a and 5b; paragraph [0095]);
retracting the secondary guidewire (figure 5c, item 1400) attached to the calcified leaflet (figure 5c, item 12) to open the valve (figure 5a, item 26) (figure 5b; paragraph [0095]); and
advancing the primary guidewire (figure 5c, item 1500) through the open valve (figure 5a, item 26) (figure 5c).
[Claim 18] Hartman teaches the limitations of claim 15, upon which claim 18 depends. In addition, Hartman discloses retracting the secondary guidewire (figure 5c, item 1400) comprises retracting the secondary guidewire (figure 5c, item 1400) through a first lumen (figure 1b, item 1702) of the catheter (figure 5a, item 1504) and advancing the primary guidewire (figure 5c, item 1500) comprises advancing the primary guidewire (figure 5c, item 1500) through a second lumen (figure 1b, item 1700) of the catheter (figure 5a, item 1504) (figure 1b; paragraph [0068]).
[Claim 21] Hartman teaches the limitations of claim 15, upon which claim 21 depends. Hartman further discloses the primary guidewire (figure 5c, item 1500) is independently actuatable from the secondary guidewire (figure 5c, item 1400) (figures 5a-5c; paragraph [0076]).
[Claims 22, 23, and 25] Hartman teaches the limitations of claims 15 and 21, upon which claims 22, 23, and 25, depend. Hartman also teaches the leaflet anchor (figure 5a, item 1402) comprises a needle (“projections”) (“sharp tip”) configured to pierce through a proximal surface of the leaflet (see 112b interpretation above) (figure 5c, item 12) (paragraph [0073]), a hook configured to attach to a distal surface of the leaflet (see 112b interpretation above) (figure 5c, item 12) (paragraph [0073]), or a screw (paragraph [0073]).
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 24 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Hartman et al. (PGPub 2023/0113185), in view of Cohen et al. (WO 2013/049734 A1).
[Claim 24] Hartman teaches the limitations of claim 15, upon which claim 24 depends. Although teaching multiple potential structures for the leaflet anchor, Hartman does not specifically disclose the leaflet anchor comprises a suction cup.
However, Cohen teaches a system and method comprising valve manipulation of the heart (paragraph [0002]) utilizing a leaflet anchor (“gripping arrangement”) comprising a suction cup configured to couple with a proximal surface of a leaflet (paragraph [0040]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the leaflet anchor taught by Hartman, to have utilized a suction cup, as taught by Cohen, in order to provide increased functionality and versatility, by allowing for an alternative, yet equivalent means, of valve manipulation.
[Claim 28] Hartman teaches the limitations of claim 15, upon which claim 28 depends. Although teaching multiple potential structures for the leaflet anchor, including multiple prongs (paragraph [0073]), Hartman does not specifically disclose the leaflet anchor comprises a joint connecting first and second prongs.
However, Cohen teaches a system and method comprising valve manipulation of the heart (paragraph [0002]) utilizing a leaflet anchor (“gripping arrangement”) comprising
a first prong (figure 3, item 22) actuatable to a first configuration (figure 4) and a second configuration (figure 3);
a second prong (figure 3, item 24); and
a joint (figure 3; near item 64) joining the first prong (figure 3, item 22) and the second prong (figure 3, item 24) at a point away from distal ends (figure 4, item 66) of the first prong (figure 3, item 22) and the second prong (figure 3, item 24) (figure 3; paragraph [0036]);
wherein in the first configuration (figure 4), the first prong (figure 3, item 22) presses against the second prong (figure 3, item 24), and
in the second configuration (figure 3) the first prong (figure 3, item 22) is separated from the second prong (figure 3, item 24).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the leaflet anchor taught by Hartman, to have utilized a joint-connected first and second prong configuration, as taught by Cohen, in order to provide increased functionality and versatility, by allowing for an alternative, yet equivalent means, of valve manipulation.
Allowable Subject Matter
Claims 29-36 are allowed.
Claims 16, 17, and 27, 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.
Claim 26 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: The claims in this application have been allowed because the prior art of record fails to disclose or render obvious the method recited in independent claims 29 and 33, as well as dependent claims 16, 17, 26, and 27.
The closest prior art of record is Hartman et al. (PGPub 2023/0113185); and Cohen et al. (WO 2013/049734 A1).
The claims in this application have been allowed because the closest prior art of record fails to teach among all the limitations or render obvious a method comprising advancing a primary guidewire past a calcified leaflet, the method comprising:
advancing a catheter configured to surround the primary guidewire and a secondary guidewire;
attaching a leaflet anchor of the secondary guidewire to the calcified leaflet of a valve;
retracting the secondary guidewire attached to the calcified leaflet to open the valve; and
advancing the primary guidewire through the open valve.
Specifically, regarding independent claims 29 and 33, as well as dependent claims 16, 17, 26, and 27, the prior art to Hartman and Cohen, either alone or in combination, fails to disclose or render obvious the specific method, structural, and/or functional features as claimed;
wherein the method further includes:
detaching the secondary guidewire from the calcified leaflet; and
utilizing the primary guidewire to perform a medical procedure; or
wherein the leaflet anchor comprises a cone shape or pyramid shape having: a pointed end; and a base surface opposite the pointed end; wherein the pointed end is configured to pierce a proximal surface of the leaflet and the base surface is configured to abut against a distal surface of the leaflet; or
wherein the leaflet anchor comprises a first prong actuatable to a first configuration and a second configuration; and a second prong; wherein in the first configuration, the first prong is substantially parallel to the second prong, and in the second configuration the first prong is substantially perpendicular to the second prong.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 10/05/2026
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