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
Claims 14-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 11/14/2025.
Claim Objections
Claims 8 and 9 objected to because of the following informalities:
Claim 8 recites “arms is configured” but should recite “arms are configured”
Claim 9 recites “leaflets is wound” but should recite “leaflets are wound”
Claim 9 recites “a second direction being similar” but the term similar is unclear and the limitation should recite something like “a second direction being the same”
Appropriate correction is required.
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.
Claim 11 is 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 11 recites “the stent frame” without proper antecedent basis.
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)(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.
Claim(s) 1-2, and 6 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Corona (WO 2022159427 A1).
Regarding claim 1, Corona teaches a prosthetic heart valve system (valve 150, fig 1a), comprising: a prosthetic heart valve including a stent (stent 152, fig 1a), a cuff (connecting skirt, for example [095-096]) and a plurality of leaflets (leaflets 160, fig 1a), the cuff and the plurality of leaflets forming a valve assembly (see vascular structure 154, fig 1a); and an expandable balloon having a deflated state and an inflated state ([0082]), the expandable balloon being configured and arranged to transition the prosthetic heart valve from a collapsed condition to an expanded condition ([053]) and protect portions of the valve assembly during crimping and delivery ([006], preventing direct contact is protecting valve).
Regarding claim 2, Corona teaches wherein the expandable balloon includes a plurality of pleats ([086]).
Regarding claim 6, Corona teaches wherein the plurality of pleats define a number of interior pockets configured and arranged to receive portions of the plurality of leaflets (structure is capable of this, see interior pockets between balloon pleats, fig 26).
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.
Claim(s) 3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corona (WO 2022159427 A1) in view of Steese-Bradley (US 6544224 B1).
Regarding claim 3, Corona does not exactly teach the number of pleats. Steese-Bradley teaches a balloon with pleats wherein the plurality of pleats includes three pleats (fig 7/ fig 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Corona by including number of pleats, as taught by Steese-Bradley, because it would be obvious to try choosing from a finite number of identified pleats with a reasonable expectation of success of a functional and optimized balloon to solve a design need (MPEP 2143).
Regarding claim 5, Corona does not exactly teach the number of pleats. Steese-Bradley teaches a balloon with pleats wherein the plurality of pleats corresponds to the plurality of leaflets (fig 7/ fig 8, see three pleats and device has three leaflets).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Corona by including number of pleats, as taught by Steese-Bradley, because it would be obvious to try choosing from a finite number of identified pleats with a reasonable expectation of success of a functional and optimized balloon to solve a design need (MPEP 2143).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corona (WO 2022159427 A1) in view of Butaric (EP 0935973 A2).
Regarding claim 4, Corona does not exactly teach the number of pleats. Butaric teaches a balloon with pleats wherein the plurality of pleats includes six pleats (fig 6a/ fig 6b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Corona by including number of pleats, as taught by Butaric, because it would be obvious to try choosing from a finite number of identified pleats with a reasonable expectation of success of a functional and optimized balloon to solve a design need (MPEP 2143).
Claim(s) 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corona (WO 2022159427 A1) in view of Schwager (US 9295570 B2).
Regarding claim 7, Corona teaches wherein the expandable balloon includes a plurality of arms in the deflated state (see folded arms in fig 6/ fig 26). Corona does not specifically teach wherein the balloon is star shaped. Schwager describes and expandable balloon with pleats wherein the expandable balloon is star-shaped (fig 1b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Corona by including star shape, as taught by Schwager in order to allow the balloon to have increases stability, flexibility, or predictability (col 3, lines 10-36).
Regarding claim 8, Corona teaches wherein the plurality of arms is configured and arranged to gather and wind portions of the plurality of leaflets (structure is capable of this, see fig 6/fig 26 portions of leaflets and skirt wound in balloon).
Regarding claim 9, Corona teaches wherein the star-shaped balloon is wound in a first direction, and the plurality of leaflets is wound in a second direction, the first direction and the second direction being similar (structure is capable of being used in this way, fig 26).
Regarding claim 10, Corona teaches wherein the star-shaped balloon is wound in a first direction, and the plurality of leaflets is wound in a second direction, the first direction and the second direction being different (structure is capable of being used in this way, fig 26).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corona (WO 2022159427 A1) in view of Stevens (US 5584803 A) and Gurovich (WO 2021207123 A1).
Regarding claim 11, Corona fails to teach the details of a removable protective sleeve. Stevens teaches using a removable protective sleeve used in a medical device to protect the device against wear (col 27, lines 18-24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Corona by applying the teachings of a removable sleeve, as taught by Stevens in order to protect the device against wear (col 27, lines 18-24).
Corona in view of Stevens fails to teach the placement of a protective sleeve between the valve assembly and the stent frame during delivery. Gurovich teaches wherein there is a need for prosthetic heart valves to have protection between the leaflets and frame to protect them from abrasion and wear from the frame ([075]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Corona in view of stevens by applying the teachings of a protection location, as taught by Gurovich in order to protect leaflets from abrasion and wear from the frame ([075]).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corona (WO 2022159427 A1) in view of Board (AU 2013385566 A1).
Regarding claim 12, Corona teaches a collapsed state however fails to teach the details of a non-circular state. Board teaches a prosthetic valve wherein the prosthetic heart valve has a non-circular state (Fig 7c).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Corona by applying the teachings of a triangular cross section, as taught by Board in order to complete a simple substitution of one known valve cross section design for another to obtain predictable results of a desired shape within the patient’s anatomy (MPEP 2143).
Regarding claim 13, Corona teaches a collapsed state however fails to teach the details of a non-circular state. Board teaches a prosthetic valve wherein the prosthetic heart valve has a substantially triangular state (fig 7c).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Corona by applying the teachings of a triangular cross section, as taught by Board in order to complete a simple substitution of one known valve cross section design for another to obtain predictable results of a desired shape within the patient’s anatomy (MPEP 2143).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA LOUISE PASQUALINI whose telephone number is (703)756-1984. The examiner can normally be reached Telework 8:30PM-4:30PM EST M-F (occasionally off Fridays).
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/H.L.P./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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