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 Species I in the reply filed on 4/22/26 is acknowledged.
Claims 12-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/22/26.
The Examiner is also withdrawing claims 12-20, since, independent claim 12 is directed to a different embodiment. For example, claim 12 discloses that the actuation connector is pulled by the actuation element to pull the paddle frame. In the elected embodiment the actuation is performed by a rotational movement. Therefore, claims 12-20 are withdrawn.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “3090 in Fig. 189” has been used to designate both the proximal end and the distal end of the inner portion. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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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 1-11 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.
Claim 1 recites the limitation "the coaptation element" in line 3. The coaptation element in line 2 was deleted. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the coaptation element" in line 3. The coaptation element in line 2 was deleted. There is insufficient antecedent basis for this limitation in the claim.
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.
(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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Delgado et al US patent Pub. 2022/0233312A1.
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
NOTE: see figure below showing the Examiner’s interpretation of the paddle frame, the paddle frame has been interpreted as two separate parts.
Delgado et al discloses an implantable device (300, see Fig. 55) comprising a distal portion having a cap (307) that is movable relative to the coaptation element (not shown in the figure); an anchor portion (306) comprising one or more anchors (308) coupled to the coaptation element and the cap (307). The one or more anchors (308) being configured to attach to one or more leaflets of a native heart valve. Wherein each of the one or more anchors comprise an inner paddle (322, see figure below), an outer paddle (320, see figure below), and a paddle frame (see figure below). The paddle frame includes a rigid inner portion (see figure below) having a first width (see figure below or Fig. 55) and a flexible outer portion (see figure below) having a second width (see figure below or Fig. 55). The second width is greater than the first width (See Fig. 55) and wherein the one or more anchors (308) are configured to move between an open position and a closed position by movement of the cap relative to the coaptation element.
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Regarding claim 2, as disclosed in paragraph 216, the gap created in the natural occurring leaflets can have a width between 2.5mm to about 17.5mm, therefore, in order to fix the heart valve regurgitation, the narrowed width of the paddle frame can fall withing the claimed range from about 3mm to about 8mm.
Regarding claim 3, as shown in Fig. above, the ratio of the second width to the first width is about 6/5.
Regarding claim 4, the outer portion flexes when the structure goes from the closed (delivery configuration) to the expanded configuration (see Figs. 8-21).
Claims 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Delgado et al US Patent Pub. 2019/0000613A1.
Delgado et al discloses an implantable device (500, see Fig. 121) comprising a distal portion comprising a cap (See figure 125) that is movable relative to the coaptation element (510). An anchor portion (504) comprising one or more anchors (506) coupled to the coaptation element and the cap (See Fig. 121). Wherein the one or more anchors (506) are configured to attach to one or more leaflets of a native heart valve. Wherein each of the one or more anchors (506) comprise an inner paddle (see figure below), an outer paddle (see figure below) and a paddle frame (1524). One or more actuation elements (112, see Fig. 10) connected to the paddle frame such that a user can move the paddle frame (1524) from an expanded position having an expanded width to a narrowed position having a narrowed width, wherein the expanded width is greater than the narrowed width (See Figs. 122 and 124). Wherein the one or more anchors are configured to move between an open position and a closed position by movement of the cap relative to the coaptation element (see Figs. 121 and 123).
Regarding claim 8, as disclosed in paragraph 188, the gap created in the natural occurring leaflets can have a width between 2.5mm to about 17.5mm, therefore, in order to fix the heart valve regurgitation, the narrowed width of the paddle frame can fall withing the claimed range from about 3mm to about 8mm.
Regarding claim 9, as shown in Fig. above, the ratio of the second width to the first width is about 6/5.
Allowable Subject Matter
Claims 5, 6, 10 and 11 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 5/25/26
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