CTNF 18/770,297 CTNF 82775 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. Double Patenting 08-33 AIA The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. 08-34 AIA Claim s 1-2, 7-9, 11-13, 16, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 10 and 11 of U.S. Patent No. 12,059,348. Regarding claims 1, 11-13, 16, and 20 although the claims at issue are not identical, they are not patentably distinct from each other because the patent and the instant application are claiming common subject matter including a method comprising inserting a delivery apparatus comprising a delivery sheath containing a prosthetic valve in a radially compressed state (claim 1 of patent), wherein the prosthetic valve is releasably secured to the delivery apparatus via a plurality of suture loops (claim 8 of patent) and a suture retention member (claim 8 of patent); at least one release member forming a releasable connection between the valve and delivery apparatus (claim 11); retracting the delivery sheath relative to the prosthetic valve to fully deploy the prosthetic valve from the delivery sheath, allowing the prosthetic valve to radially expand while still secured to the delivery apparatus via the suture loops (claim 9 of patent); and after fully deploying the prosthetic valve from the delivery sheath, recapturing the prosthetic valve by advancing the delivery sheath distally back over the prosthetic valve (claim 10 of patent). The difference between claims of the instant application and the claims of the patent lies in the fact that the patent claims include many more elements and are thus much more specific. Thus, the invention of the patent claims are in effect a “species” of the “generic” invention of the instant application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman , 29 USPQ2d 2010 (Fed. Cir. 1993). Regarding claim 2 of the instant application, see patent claim 1. Regarding claims 7-9, see patent claims 8-10 . Claim Rejections - 35 USC § 102 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 1, 4-13, 15-18, and 20 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Alon et al. (US 2010/0049313, hereinafter “Alon”) . Regarding claim 1, Alon discloses a method, comprising: inserting a delivery apparatus (Figs 40-48; para [0141]) into a vasculature of a patient (para [0100,0113]), the delivery apparatus comprising a delivery sheath (406) containing a prosthetic valve (10/12) in a radially compressed state (Fig 40; para [0141, 0152]), wherein the prosthetic valve is releasably secured to the delivery apparatus via a plurality of suture loops (500/504) (Figs 47-49; para [0151]); retracting the delivery sheath relative to the prosthetic valve to fully deploy the prosthetic valve from the delivery sheath, allowing the prosthetic valve to radially expand while still secured to the delivery apparatus via the suture loops (Figs 49-51; para [0152]); and after fully deploying the prosthetic valve from the delivery sheath, recapturing the prosthetic valve by advancing the delivery sheath distally back over the prosthetic valve (para [0152]). Regarding claim 4, wherein the delivery apparatus further comprises a first shaft and a second shaft extending through the first shaft, wherein retracting the delivery sheath comprises rotating the second shaft relative to the first shaft in a first direction (para [0102-0105; 0152]). Regarding claim 5, wherein the delivery apparatus further comprises a screw connected to a distal end of the second shaft and a nut mounted on the screw and connected to the delivery sheath, wherein rotating the second shaft relative to the first shaft is configured to move the nut axially along the screw (para [0102-0105; 0152]). Regarding claim 6, wherein advancing the delivery sheath comprises rotating the second shaft relative to the first shaft in a second direction opposite to the first direction (para [0102-0105; 0152]). Regarding claim 7, wherein the plurality of suture loops (500/504) is releasably connected to a plurality of apices (502) of the prosthetic valve (12), wherein advancing the delivery sheath distally is configured to tension the plurality of suture loops so as to cause the plurality of apices to collapse radially inward (Fig 48; para [0151-0152]). Regarding claim 8, wherein the delivery apparatus further comprises a suture retention member (510) and a suture release member (506), wherein the plurality of suture loops (500/504) extends from the suture retention member and the suture release member extends through the plurality of suture loops when the prosthetic valve is contained within the delivery sheath, the method further comprising sliding the suture release member proximally relative to the suture retention member so that the plurality of suture loops can slide off the suture release member (Figs 47-49; para [0151-0152]). Regarding claim 9, further comprising moving the suture retention member (510) in a proximal direction relative to the prosthetic valve so as to disconnect the plurality of suture loops from the plurality of apices of the prosthetic valve (para [0151-0152]). Regarding claim 10, further comprising loading the prosthetic valve (12) into the delivery sheath (406) before inserting the delivery apparatus, wherein the loading comprises advancing the delivery sheath distally over the prosthetic valve until the plurality of apices of the prosthetic valve bears against a distal surface of the suture retention member (para [0110-0113]). Regarding claim 11, Alon discloses a method, comprising: inserting a delivery apparatus (Figs 40-48; para [0141]) into a vasculature of a patient (para [0100,0113]), the delivery apparatus comprising a delivery sheath (406) containing a prosthetic valve (10/12) in a radially compressed state (Fig 40; para [0141, 0152]), wherein the delivery apparatus further comprises a shaft (412), a suture retention member (510) coupled to a distal end portion of the shaft, a plurality of suture loops (500/504) extending through openings in a frame of the prosthetic valve (502), and at least one release member (506) extending through the suture loops to form a releasable connection between the prosthetic valve and the delivery apparatus (Fig 48; para [0151-0152]), wherein each suture loop defines a loop portion extending from a location on the suture retention member (510) and through a respective opening of the frame (502) (Fig 48); and deploying the prosthetic valve from the delivery sheath (406), allowing the prosthetic valve to radially expand while still secured to the delivery apparatus via the suture loops (Fig 49; para [0152]). Regarding claim 12, wherein deploying the prosthetic valve from the delivery sheath comprises fully deploying the prosthetic valve from the delivery sheath and the method further comprises, after fully deploying the prosthetic valve from the delivery sheath, recapturing the prosthetic valve back inside of the delivery sheath (para [0152]). Regarding claim 13, wherein further comprising, after deploying the prosthetic valve from the delivery sheath, removing the at least one release member (506) from the suture loops to disconnect the prosthetic valve from the delivery apparatus (para [0152]). Regarding claim 15, Alon teaches in an alternative embodiment the at least one release member comprises a plurality of release members (522), each of which extends through one or more of the suture loops (521) of a respective suture (Fig 51; para [0154]). Regarding claim 16, Alon discloses a method, comprising: attaching a prosthetic valve (10/12) to a suture retention member (510) of a delivery apparatus when the prosthetic valve is in a radially expanded state, wherein a plurality of suture loops (500/504) are connected to and extend from the suture retention member, wherein the attaching comprises inserting the suture loops through openings (502) of a frame of the prosthetic valve and then sliding at least one release member (506) through the suture loops (Figs 47-49); and loading the prosthetic valve into a delivery sheath (406) of the delivery apparatus, wherein the loading comprises advancing the delivery sheath distally over the prosthetic valve, which causes the prosthetic valve to radially collapse from the radially expanded state to a radially collapsed state inside of the delivery sheath (para [0152, 0110-0113]). Regarding claim 17, wherein advancing the delivery sheath distally over the prosthetic valve comprises advancing the delivery sheath (406) over the suture loops (500/504), which tensions the suture loops and causes an end of the frame to collapse radially (Fig 48; para [0151-0152]). Regarding claim 18, wherein each suture loop comprises a double-stranded loop portion extending from a location on the suture retention member (Fig 48; para [0151-0152]). Regarding claim 20, further comprising advancing the delivery apparatus through a vasculature of a patient until the prosthetic valve retained within the delivery sheath is positioned within a native heart valve annulus of the patient, and deploying the prosthetic valve from the delivery sheath, which allows the prosthetic valve to self-expand from the radially collapsed state to the radially expanded state (para [0100, 0151-0152]) . 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) 3, 14 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alon (US 2010/0049313), as applied to claims 11 and 16 above, further in view of Dwork et al. (US 2011/0264203, hereinafter “Dwork”) . Regarding claim 3, Alon discloses the invention substantially as claimed, including a delivery sheath (406) including a distal end portion and a proximal end portion (proximal end portion may be proximal end of 406 or proximal end of attached main catheter 404), wherein the distal end portion extends over and retains the prosthetic valve in the radially compressed state (Figs 40, 48) when inserting and advancing the delivery apparatus, wherein the proximal end portion extends through the ascending aorta, the aortic arch and into the descending aorta when the prosthetic valve is positioned within the aortic annulus (para [0141, 0151-0152]). However, Alon fails to disclose the proximal end portion is more flexible than the distal end portion. Dwork discloses a similar method of delivering a prosthetic heart valve and teaches the sheath should be sufficiently flexible to pass through the patient's vasculature, but the portion of the sheath (50) retaining the prosthetic valve (30) has a more stiffened construction exhibiting radial or circumferential rigidity to overtly resist the expected expansive forces of the stented heart valve when compressed within the sheath (para [0039]). Therefore, 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 of Alon such that the distal portion of the sheath was stiffened to resist the expected expansive forces of the stented heart valve (10) and the proximal portion of the sheath was more flexible for passage through the patient's vasculature, as taught by Dwork. Regarding claims 14 and 19, Alon discloses the invention substantially as claimed, as shown above, but fails to teach the shaft comprises a slotted metal tube. Dwork discloses a similar method of delivering a prosthetic heart valve and teaches the shaft of the sheath may be formed of a combination of polymeric and laser cut or slotted metal tubes to achieve the desired flexibility/stiffness of the shaft portions (para [0039]). Therefore, 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 of Alon such that the shaft comprised a slotted metal tube to achieve the desired flexibility, as taught by Dwork . Allowable Subject Matter Claim 2 would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and if rewritten or amended to overcome the rejection(s) on the ground of nonstatutory double patenting or if a terminal disclaimer is filed. 13-03-01 AIA The following is a statement of reasons for the indication of allowable subject matter: The prior art fails to teach or disclose a method for delivering a prosthetic valve, as claimed, particularly wherein when the prosthetic valve is positioned within the aortic annulus and contained within the delivery sheath , the delivery sheath extends through an ascending aorta and an aortic arch and a proximal-most end of the delivery sheath is within a descending aorta of the patient . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Burriesci et al. (US 2013/0296999) and Bloom et al. (US 2009/0192585) additionally teach a method for delivery and recapture of a prosthetic valve or stent . Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5. 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, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KATHERINE M RODJOM/Primary Examiner, Art Unit 3771 Application/Control Number: 18/770,297 Page 2 Art Unit: 3771 Application/Control Number: 18/770,297 Page 3 Art Unit: 3771 Application/Control Number: 18/770,297 Page 4 Art Unit: 3771 Application/Control Number: 18/770,297 Page 5 Art Unit: 3771 Application/Control Number: 18/770,297 Page 6 Art Unit: 3771 Application/Control Number: 18/770,297 Page 7 Art Unit: 3771 Application/Control Number: 18/770,297 Page 8 Art Unit: 3771 Application/Control Number: 18/770,297 Page 9 Art Unit: 3771 Application/Control Number: 18/770,297 Page 10 Art Unit: 3771 Application/Control Number: 18/770,297 Page 11 Art Unit: 3771
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