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 Arguments
Applicant's arguments filed 12/3/2025 have been fully considered. The rejection of claims 1-8, 10-12, and 16 under 35 U.S.C. 102(a)(2) as being anticipated by Menon is overcome in light of applicant’s statement pursuant to the exception of 35 U.S.C. 102(b)(2)(C). Since this was the only rejection of claim 8, claims 8 and 9 are allowable. New claims 20 and 21 are also allowable for the same reason since they could only be rejected in view of Menon which is disqualified as prior art.
Regarding the rejection of claims 1-3, 5-7, and 10-16 under 35 U.S.C. 102(a)(1) as being anticipated by Scheinblum, applicant argues Scheinblum does not disclose a device in which all guide fingers of the leaflet folding accessory include a leaflet contact portion which is configured to be disposed radially within the frame and contact an inner surface of a leaflet of the at least one leaflet and configured to not directly contact an outer surface of the leaflet. Applicant argues that “configured to” is not the same as “capable of” and argues “configured to” means that the device “is designed or constructed to be used in a specific manner and therefore must be accorded significant weight”. This is not persuasive because “configured to” is a functional limitation and MPEP 2173.05g par.2 says that a functional limitation is often used in association with an element, ingredient, or step of a process to define a particular capability or purpose that is served by the recited element, ingredient or step. According to MPEP 2114, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim (Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)). Since Scheinblum discloses all the structural limitations as claimed by applicant it would follow that it would be capable of performing the recited functions. Furthermore, one of ordinary skill in the art at the time of the invention could have used the structure of Scheinblum in order to achieve this function should they have desired. For instance, par.51 of Scheinblum states “the fingers 306 can be made from a sufficiently resilient material such that the fingers can be bent radially inwardly or outwardly to facilitate positioning the fingers against the inner or outer surfaces of the leaflets”. This shows that all fingers, including what are called outer fingers, are configured to be/capable of being positioned against only the inner surfaces of the leaflets.
Applicant further argues that fingers 314, 410, 508, 610 are configured for placement between the outer surface of the leaflets and the inner surface of the frame and thus are not configured to contact the inner surface of the leaflets. This is not persuasive because, as discussed above, par.51 of Scheinblum states “the fingers 306 can be made from a sufficiently resilient material such that the fingers can be bent radially inwardly or outwardly to facilitate positioning the fingers against the inner or outer surfaces of the leaflets”. It is clear that even when all of the fingers of Scheinblum are considered part of the plurality of guide fingers, all of the fingers are flexible and therefore capable of contacting the inner surface of the leaflets.
In another interpretation of the claims and Scheinblum, only the inner fingers can be considered the plurality of guide fingers wherein all guide fingers of the leaflet folding accessory include a leaflet contact portion which is configured to be disposed radially within the frame and contact an inner surface of a leaflet of the at least one leaflet and configured to not directly contact an outer surface of the leaflet. The embodiments of figs. 3A-4 and figs. 5-6 each show two sets/pluralities of fingers, namely, inner fingers 316 and 412, and outer fingers 314 and 410. The examiner considers the inner fingers 316, 412 “a plurality of guide fingers” wherein all the guide fingers 316, 412 include a leaflet contact portion which is configured to be disposed radially within the frame and contact only an inner surface of a leaflet. The claims do not preclude a second plurality of fingers for engaging the outer surface of the leaflets. Accordingly, the examiner maintains that Scheinbaum anticipates claims 1-3, 5-7, and 10-16.
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.
Claims 1-3, 5-7, and 10-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scheinblum et al. US 2018/0133000 (hereafter referred to as Scheinblum).
Regarding claim 1, Scheinblum discloses an assembly comprising: a transcatheter valve prosthesis 100 including a frame 112 and a prosthetic valve component 114 including at least one leaflet 122 disposed within and secured to the frame, the transcatheter valve prosthesis having an expanded configuration and a crimped configuration for delivery within a vasculature (par.24); a leaflet folding accessory 300, 400, 500 configured for use when compressing the transcatheter valve prosthesis into the crimped configuration, the leaflet folding accessory including a plurality of guide fingers 316, 412, 508, (for the embodiments of figs.3-4 and figs. 5-6 the plurality of guide fingers are considered the inner fingers only; the outer fingers of Scheinblum can be considered other types of fingers and the claims do not limit the leaflet folding accessory to only having guide fingers) wherein all guide fingers 316, 412, 508 of the leaflet folding accessory include a leaflet contact portion which is capable of being disposed radially within the frame and contacting an inner surface of a leaflet of the at least one leaflet and configured to not directly contact an outer surface of the leaflet (figs. 4, 6, and 9; all of the inner fingers 316 and 412, which are considered a plurality of guide fingers, are shown in figs. 4 and 6 to be contacting the inner surface of the leaflets only; in the embodiment of fig.9 the fingers 508 are capable of only contacting the inner surface of the leaflets if the practitioner choosing to use the accessory in this way), wherein, during crimping of the transcatheter valve prosthesis, the plurality of guide fingers are capable of remaining disposed radially within the frame such that the at least one leaflet preferentially folds around the plurality of guide fingers (figs.4 and 6 specifically show the inner fingers within the frame and contacting only an inner surface of a leaflet; par.66 discloses in the embodiment of figs.8-9 the fingers can abut the inner leaflet surface). Additionally, par.51 states “the fingers 306 can be made from a sufficiently resilient material such that the fingers can be bent radially inwardly or outwardly to facilitate positioning the fingers against the inner or outer surfaces of the leaflets”. This shows that all fingers, including what are called outer fingers, are configured to be/capable of being positioned against only the inner surfaces of the leaflets. Therefore, both an interpretation where only the inner fingers are considered the plurality of guide fingers and an interpretation where both inner and outer fingers are considered a plurality of guide fingers anticipate the claim.
Regarding claims 2 and 3, inner fingers 316 and 412 are considered a plurality of guide fingers including exactly three guide fingers for contacting exactly three leaflets (figs. 4 and 6). The claims do not preclude a second plurality of fingers for engaging the outer surface of the leaflets.
Regarding claim 5, see par.52 for “soft, flexible, resilient, lubricious and/or compressible material” including polymers.
Regarding claim 6, see figs. 3B, 5, and 8 for circumferentially spaced apart fingers.
Regarding claim 7, see at least handle 318 in figs. 3A and par.53.
Regarding claims 10-12, see figs. 3A and 3B for fingers having curved end portions which are substantially circular in cross-section. At least the tips of the fingers are tapered.
Regarding claim 13, see fig.5 and par.58 for fingers having flattened ribbon-like cross-sections.
Regarding claim 14, see par.47 for the finger sets being separate. In which case the base of the set is considered a nut which is removably attached to the end of the handle (fig.3A).
Regarding claim 15, see valve seat locator 514 in figs. 8-9 and par.67.
Regarding claim 16, see hubs 304, 404, and 504 in figs. 3A, 5, and 8.
Allowable Subject Matter
Claims 8 and 9 are allowed.
Claims 20 and 21 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
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 MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774