CTNF 18/649,749 CTNF 75798 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement The information disclosure statement (IDS) submitted on 02/12/2025 is being considered by the examiner. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim (s) 1-6, 8-10, 12-17, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge at al. (US 20140296962 A1) Regarding claim 1, Cartledge et al. disclose an implantable prosthetic device (see Figs. 1-19) comprising a radially expandable and compressible frame (110) having an inflow end portion and an outflow end portion. Cartledge et al. further disclose an actuator mechanism including a first frame member (710) having a first inner bore, a second frame member (720) having a second inner bore, the first and second frame members being axially spaced apart from one another, and an actuator (740) extending through the first and second inner bores, wherein rotation of the actuator in a first direction causes the first and second frame members to move axially toward one another to expand the frame. Cartledge et al. do not expressly disclose a compressible cover member disposed over a portion of the actuator extending between the first and second frame members. However, Cartledge et al. expressly contemplate that the drive screws may be covered by a sleeve or cover, including a cover that is “corrugated or bellows-like or smooth or any other variation” ([0437]). In view of this express suggestion, it would have been obvious to one of ordinary skill in the art at the time the invention was made to provide a compressible cover member disposed over the portion of the actuator extending between the first and second frame members, including a corrugated or bellows-like cover, in order to protect the drive screws and adjacent implant components from exposure, wear, or interference during expansion and compression of the prosthetic device. Accordingly, claim 1 would have been obvious over Cartledge et al. under 35 U.S.C. 103. Regarding claim 2, Cartledge et al. disclose the prosthetic device of claim 1, wherein the actuator comprises an external threaded surface (see [0323] and Figs. 1-19). Cartledge’s actuator/drive screw arrangement necessarily includes threaded surfaces configured to cooperate with the surrounding drive components to produce axial movement upon rotation. Therefore, claim 2 is rendered obvious by Cartledge et al. Regarding claim 3, Cartledge et al. disclose the prosthetic device of claim 2, further including a nut (730) disposed at an outflow end portion of the second frame member, the nut including an internal threaded surface configured to engage the external threaded surface of the actuator. Cartledge’s threaded drive assembly expressly teaches the use of cooperating threaded components to convert rotational movement into axial movement. Thus, claim 3 would have been obvious over Cartledge et al. Regarding claim 4, Cartledge et al. disclose the prosthetic device of claim 1, wherein rotation of the actuator in a second direction causes the first and second frame members to move axially away from one another to radially compress the prosthetic device (see Figs. 1-19). Reverse rotation of the threaded actuator inherently produces reverse axial movement of the frame members, thereby compressing the prosthetic device. Accordingly, claim 4 is obvious over Cartledge et al Regarding claim 5, when Cartledge et al. is modified as set forth in the rejection of claim 1 above to include a compressible cover member disposed over the drive screws, Cartledge et al. further disclose a stopper (746) disposed on the actuator axially between the first and second frame members, the stopper configured to selectively abut an inflow end portion of the first frame member. The stopper 746 is expressly shown and described as a structural feature for limiting or controlling axial movement of the actuator assembly. Therefore, claim 5 would have been obvious over Cartledge et al. Regarding claim 6, the modified device of Cartledge et al. as set forth above would necessarily result in a prosthetic device wherein the compressible cover member is movable between an axially expanded configuration having a first length and an axially compressed configuration having a second, shorter length. This is the expected and inherent behavior of a compressible sleeve or bellows-like cover when positioned between axially moving frame members and subjected to alternating expansion and compression forces. Accordingly, claim 6 would have been obvious over Cartledge et al. Regarding claim 8, it would have been obvious to one of ordinary skill in the art to modify the device of Cartledge et al. such that a first end portion of the compressible cover is coupled to the first frame member and a second end portion of the compressible cover is coupled to the second frame member. Anchoring the cover to the frame members is a predictable and conventional arrangement that ensures the cover remains properly positioned over the actuator and moves in coordination with the frame members during expansion and compression. Accordingly, claim 8 would have been obvious over Cartledge et al. Regarding claims 9 and 10, Cartledge et al. do not expressly disclose that the compressible cover member is formed of a polymeric material, including polyethylene or Nylon. However, Cartledge et al. expressly teach a cover or sleeve positioned about the drive screws (740) to protect the drive screws from surrounding tissue and other components. In view of this teaching, it would have been obvious to one of ordinary skill in the art at the time the invention was made to form the cover member from a polymeric material, such as polyethylene or Nylon, because such materials are well-known, conventional materials for protective medical device covers and sleeves. The selection of a polymeric material for the cover member would have amounted to the mere use of a known material in a known structure to obtain the expected result of providing a flexible, biocompatible, and protective covering around the drive screws. The particular recited materials are routine material choices that would have been within the level of ordinary skill in the art and would not have required more than predictable design optimization. Accordingly, claims 9 and 10 would have been obvious over Cartledge et al. under 35 U.S.C. 103. Regarding claims 12 and 13, Cartledge et al. do not explicitly disclose a cover member having the specific claimed shape. However, Cartledge et al. expressly teach a cover or sleeve disposed about the drive screws (740) for the purpose of protecting the drive screws from surrounding tissue and other components. In view of that teaching, it would have been obvious to one of ordinary skill in the art at the time the invention was made to configure the cover member in a cylindrical shape having an inner bore, or in another shape such as a conical, barrel, or hourglass configuration, as recited in claims 12 and 13, because such shapes are merely predictable geometric variations adapted to surround and accommodate the cylindrical drive screws (740) disclosed by Cartledge et al. The selection of a particular cover geometry would have been a matter of routine engineering design choice, motivated by the desire to conform the cover to the underlying actuator, facilitate axial movement, and maintain protection of the drive screws during expansion and compression of the prosthetic device. Accordingly, the claimed cover shapes would have been obvious over Cartledge et al. under 35 U.S.C. 103. Regarding claim 14, Cartledge et al. do not expressly disclose that the cover member has a flexural modulus higher than a flexural modulus of the actuator. However, Cartledge et al. expressly teach a cover or sleeve positioned about the drive screws to protect the drive screws from surrounding tissue and other device components. In view of this teaching, it would have been obvious to one of ordinary skill in the art at the time the invention was made to select the cover member to have a flexural modulus greater than that of the actuator so that the cover would maintain sufficient rigidity to provide protection while avoiding collapse, buckling, or interference with movement of the actuator during expansion and compression of the prosthetic device. The selection of a cover material having a higher flexural modulus than the actuator would have been a matter of routine optimization of known materials and known mechanical properties to achieve the predictable result of a protective cover that does not impede actuator operation. Accordingly, claim 14 would have been obvious over Cartledge et al. under 35 U.S.C. 103. Regarding claim 15, Cartledge et al. expressly suggest that the cover member may comprise a bellows-like structure, stating that the cover may be “corrugated or bellows-like or smooth or any other variation” ([0437]). Therefore, Cartledge et al. teach or at least clearly suggest a bellows member as the claimed cover. Accordingly, claim 15 would have been obvious over Cartledge et al. under 35 U.S.C. 103. Regarding claim 16, Cartledge et al. do not expressly disclose that the bellows member comprises a plurality of folds each having an apex. However, a bellows having a plurality of folds with apexes is the conventional and well-understood structural configuration of a bellows. The claimed fold-and-apex arrangement is an inherent characteristic of a bellows member designed to provide axial compressibility and flexibility. It would have been obvious to one of ordinary skill in the art to provide the bellows-like cover of Cartledge et al. with the conventional fold structure recited in claim 16 in order to obtain the expected compressible and expandable movement of the cover member. Accordingly, claim 16 would have been obvious over Cartledge et al. under 35 U.S.C. 103. Regarding claim 17, Cartledge et al. do not expressly disclose that the bellows member comprises at least one of a polymeric material, a flexible metal, and an elastomer. However, such materials are well known, conventional materials used for bellows and protective surgical device covers because of their flexibility, durability, and suitability for use in implantable or medical device environments. In view of Cartledge et al.’s teaching of a bellows-like cover, it would have been obvious to one of ordinary skill in the art to form the bellows member from a polymeric material, flexible metal, or elastomer, or combinations thereof, as a matter of routine material selection to achieve predictable mechanical performance. Accordingly, claim 17 would have been obvious over Cartledge et al. under 35 U.S.C. 103. Regarding claim 19, Cartledge et al. disclose that the cover member comprises a latticed member, and that the latticed member comprises a plurality of struts defining a plurality of cells, as shown in Figs. 1-19 and described in the specification. Cartledge’s disclosed lattice structure inherently includes struts and openings or cells, and thus teaches the claimed latticed cover configuration. Accordingly, claim 19 would have been obvious over Cartledge et al. under 35 U.S.C. 103. Regarding claim 20, it would have been obvious to one of ordinary skill in the art to employ the modified prosthetic device of Cartledge et al. as set forth above in the claimed delivery method. Cartledge et al. disclose an implantable prosthetic device configured for delivery to a selected implantation site and actuated by rotation of actuator assemblies to cause axial movement of frame members and radial expansion of the prosthetic device. Modifying the Cartledge device to include a compressible cover member disposed over a portion of the actuator, as suggested by Cartledge, would not alter the fundamental manner in which the device is delivered or deployed. Accordingly, the claimed method steps of inserting a distal end of a delivery apparatus into a vasculature of a patient, advancing the prosthetic valve to a selected implantation site, and actuating the plurality of actuator assemblies to cause expansion of the prosthetic valve and compression of the cover member would have been an obvious use of the Cartledge device as modified in view of the teachings discussed above. The limitation that the compressible cover member is coupled to the first and second frame members such that the cover member does not rotate relative thereto is likewise an obvious and predictable implementation to maintain proper alignment and function of the protective cover during actuation. Therefore, claim 20 would have been obvious over Cartledge et al. under 35 U.S.C. 103 . 07-22-aia AIA Claim (s) 7, 11 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge at al. (US 20140296962 A1) as applied to claim 1 above, and further in view of Yamada et al. US 20150028245 A1 . Cartledge et al., as applied to claim 1 above, disclose the prosthetic device and the compressible cover member disposed over the actuator extending between the first and second frame members, but do not expressly disclose the following limitations: Claim 7: the cover member is biased into the expanded position; Claim 11, the modified device of Cartledge et al. disclose the cover member further comprises one or more anti-rotation features configured to engage corresponding anti-rotation features on the frame thus prevent rotation of the cover member about its longitudinal axis. Claim 18: the cover member comprises a spring. Yamada et al. disclose an external seal structure for a vacuum valve including a bellows member and a compression spring arranged to bias a component of the valve assembly and to accommodate movement while maintaining protection of the drive mechanism. Yamada thus teaches the use of bellows- like and spring-based structures in a mechanical device for biasing, accommodating motion, and protecting an internal drive component. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the compressible cover member of Cartledge et al. in view of Yamada et al. to include a spring or spring-biased configuration, thereby biasing the cover member toward the expanded position as recited in claim 7 and/or providing the cover member with spring characteristics as recited in claim 18. The combination would merely involve the predictable use of a known resilient structure to achieve the expected result of urging the cover member outward while permitting compressive axial movement during actuation of the prosthetic device. It would further have been obvious to provide the cover member with anti-rotation features as recited in claim 11, because preventing unwanted rotation of a sleeve, bellows, or cover member relative to an underlying actuator is a conventional design consideration in mechanical assemblies. Providing interengaging anti-rotation structure between the cover and the frame would have been an obvious and predictable modification to ensure proper alignment and stable operation of the cover during repeated axial movement. Such features would have functioned to maintain the cover in the desired orientation without affecting the underlying screw-driven actuation mechanism of Cartledge et al. Accordingly, claims 7, 11, and 18 would have been obvious over Cartledge et al. in view of Yamada et al. under 35 U.S.C. 103 . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tilson et al. US 20100099949 A1 disclose driver with a bellows cover. Grewe US 20070293934 A1 discloses driver with a bellows cover. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAN-UYEN THI HO whose telephone number is (571)272-4696. The examiner can normally be reached Normal Schedule M-F Between 7:00 am and 4:00 pm. 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, TAN-UYEN T HO can be reached at 7034745263. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /TAN-UYEN T HO/ Supervisory Patent Examiner, Art Unit 3771 Application/Control Number: 18/649,749 Page 2 Art Unit: 3771 Application/Control Number: 18/649,749 Page 3 Art Unit: 3771 Application/Control Number: 18/649,749 Page 4 Art Unit: 3771 Application/Control Number: 18/649,749 Page 5 Art Unit: 3771 Application/Control Number: 18/649,749 Page 6 Art Unit: 3771 Application/Control Number: 18/649,749 Page 7 Art Unit: 3771 Application/Control Number: 18/649,749 Page 8 Art Unit: 3771 Application/Control Number: 18/649,749 Page 9 Art Unit: 3771 Application/Control Number: 18/649,749 Page 10 Art Unit: 3771
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