DETAILED ACTION
A complete action on the merits of pending claims 1, 6, 7, 11, 17, 18, 24, 26, 27, 29, and 49-54 appears below.
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 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.
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.
(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 1, 6, 7, 11, 17, 18, 24, 26, 27, 29, and 49-54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gifford US 20200275974.
Regarding claims 1 and 24, Gifford teaches piercing tissue along a perimeter of a heart valve with at least one electrode (Fig. 4D); applying mechanical force to the at least one electrode to deform the pierced tissue and reduce the perimeter of the heart valve annulus (par. [0077] pushing tissue together or par. [0081] walked method of turning one electrode in place to place the second); delivering tissue-ablating energy through the electrode, thereby inducing plastic deformation of the deformed tissue (par. [0078]); and releasing the mechanical force, leaving the heart valve annulus with a reduced perimeter (par. [0071]); wherein the applying mechanical force comprises placing torsion on the pierced tissue (par. [0077] pushing tissue together or par. [0081] walked method of turning one electrode in place to place the second).
Regarding claim 6, Gifford teaches wherein the at least one sharpened element also comprises an element is used to deliver the structurally disruptive energy to the tissue (par. [0078]).
Regarding claim 7, Gifford teaches wherein the at least one sharpened element delivers the structurally disruptive energy to the tissue by operating as an electrode (par. [0078]).
Regarding claim 11, Gifford teaches wherein the mechanical deforming comprises compression including pinching the tissue between a plurality of the at least one sharpened element (par. [0077] pushing tissue together).
Regarding claim 17, Gifford teaches wherein the tissue-ablating energy is provided by at least one of the group consisting of: radiofrequency energy; focused ultrasound energy; cryogenic cooling (par. [0078]).
Regarding claim 18, Gifford teaches wherein the tissue ablated comprises at least one of the group consisting of: fibrous tissue of the valve annulus; and tissue of the heart wall adjacent to the fibrous tissue of the valve annulus (par. [0070]).
Regarding claim 26, Gifford teaches wherein the applying mechanical force comprises compressing the pierced tissue (par. [0077] pushing tissue together).
Regarding claim 27, Gifford teaches wherein the tissue-ablating energy is radiofrequency energy (par. [0078]).
Regarding claim 29, Gifford teaches wherein the reduced perimeter draws leaflets of the heart valve into positions that reduce regurgitation of the valve (par. [0069]).
Regarding claim 49, Gifford teaches wherein the at least one sharpened element comprises a plurality of sharpened elements (Fig. 4D), and the tissue is compressed by the torsion without change in distance between any of the plurality of sharpened elements (par. [0081] walked method of turning one electrode in place to place the second).
Regarding claim 50, Gifford teaches comprising measuring impedance using the at least one sharpened element, and adjusting one or more of the delivery energy and operations to perform the piercing, using the measured impedance (par. [0075]).
Regarding claim 51, Gifford teaches wherein the piercing the tissue comprises: placing a casing containing the at least one sharpened element in contact with the tissue (Fig. 1 108a/108b); and extending the at least one sharpened element out of the casing and into the tissue (par. [0073]).
Regarding claim 52, Gifford teaches wherein the at least one sharpened element comprises a plurality of sharpened elements extending from the casing parallel to each other (Figs. 2 and 3).
Regarding claim 53, Gifford teaches wherein a depth of the piercing of the tissue is limited by a distal surface of the casing (Fig. 4C 108 distal end against tissue).
Regarding claim 54, Gifford teaches wherein the energy delivered comprises at least 112 Joules delivered over a period of at least 12 seconds (Watts=Joules/second and par. [0078] the heating can be done for about 15 seconds, the wattage can be between 10 and 100 Watts).
Response to Arguments
Applicant's arguments filed 3/27/26 have been fully considered but they are not persuasive. The applicant argues pars. [0077] and [0081] do not teach a torsion force on the pierced tissue. The examiner will address the arguments to par. [0081] since that is the section pertains to the torsion while par. [0077] was cited to demonstrate other forces used. The applicant argues that the pivot of the electrode is not a mode of applying force on tissue and there is no rotational force, angular displacement, or shear deformation about an axis. The examiner disagrees with this assertion. A torsion mode does not need to be an express mode of Gifford as long as it occurs in some way. To this end, par. [0081] states that the electrode is pivoted while inside of the tissue. Twisting within something else creates a torsion force. This is commonly seen in a screw turning in wood. Thus, as a screw creates a torsion force on the wood because it is turning so does the turning of the electrode in tissue. Therefore, the arguments presented by the applicant are not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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 RYAN T. CLARK whose telephone number is (408)918-7606. The examiner can normally be reached on Monday-Friday 7AM-3PM MT.
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/R.T.C./Examiner, Art Unit 3794
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