CTNF 18/588,457 CTNF 86732 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. Election/Restrictions 08-08 AIA Restriction to one of the following inventions is required under 35 U.S.C. 121: I. Claim s 1-13 , drawn to a replacement heart valve system , classified in A61F2/2427 . II. Claim s 14-20 , drawn to method of delivering a replacement heart valve implant , classified in A61F2/243 . 08-13 AIA The inventions are independent or distinct, each from the other because: 08-20 AIA Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different process of using that product, the product can be applied in an industrial setting and used for demonstration purposes . 08-21 Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: The inventions require different text search. Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention . The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention. Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention. 08-23 AIA During a telephone conversation with Glenn Seager on M on day, June 1, 2026 , a provisional election was made without traverse to prosecute the invention of group I, drawn to a replacement heart valve system , claim s 1-13 . Affirmation of this election must be made by applicant in replying to this Office action. Claim s 14-20 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. 08-23-02 AIA Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i). 08-21-04 AIA The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined. In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01. 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) 1-3 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Calomeni et al. U.S. Publication 2018/0353294 A1 . Regarding Claim 1, Calomeni et al. discloses a replacement heart valve system comprising: a replacement heart valve implant 16 comprising: an expandable framework configured to shift from a radially collapsed configuration to a radially expanded configuration; and a plurality of valve leaflets attached to the expandable framework at a plurality of commissure posts (paragraphs [0012-0013], [0029]); and an implant delivery system comprising a handle 18 and an elongate shaft assembly (see annotated Figure 1), the elongate shaft assembly comprising a tubular member fixedly attached to the handle 18 (as annotated in Figure 1), and an implant holding portion configured to constrain the expandable framework in the radially collapsed configuration; wherein the elongate shaft assembly further comprises an anti-migration element 15 configured to shift between a delivery configuration and an open configuration; wherein the anti-migration element 15 is configured to prevent proximal movement of the expandable framework relative to the tubular member in the open configuration. Regarding Claim 2, Calomeni et al. discloses wherein the anti-migration element 15 is engaged with the plurality of commissure posts 62 (as seen in Figures 2 and 6 and paragraph [0069]). Regarding Claim 3, Calomeni et al. discloses wherein the anti-migration element extends radially outward from the tubular member in the open configuration (as seen in Figure 1-2, the anti-migration element 15 is located outwardly than the tubular member forming the shaft) . 07-15-aia AIA Claim(s) 1, 3 and 9-11 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Alon et al. U.S. Publication 2010/0049313 A1 . Regarding Claim 1, Alon et al. discloses a replacement heart valve system 3100 comprising: a replacement heart valve implant 10 as seen in Figures 30-38 comprising: an expandable framework configured to shift from a radially collapsed configuration to a radially expanded configuration; and a plurality of valve leaflets attached to the expandable framework at a plurality of commissure posts (paragraphs [0012-0013], [0029]); and an implant delivery system comprising a handle 308 and an elongate shaft assembly 312 (as seen in Figures 34-35), the elongate shaft assembly comprising a tubular member 326 fixedly attached to the handle 308 (as seen in Figures 34-35), and an implant holding portion 322 configured to constrain the expandable framework in the radially collapsed configuration (paragraphs [0131-0132]); wherein the elongate shaft assembly 312 further comprises an anti-migration element configured to shift between a delivery configuration and an open configuration; wherein the anti-migration element 15 is configured to prevent proximal movement of the expandable framework relative to the tubular member in the open configuration. Regarding Claim 3, Alon et al. discloses wherein the anti-migration element extends radially outward from the tubular member in the open configuration (as seen in Figures 36-37, the anti-migration element 342, 344 is located outwardly than the tubular member 326 forming the shaft). Regarding Claim 9, Alon et al. discloses a replacement heart valve system 100 as seen in Figures 8-25 comprising: a replacement heart valve implant 10 comprising: an expandable framework 12 configured to shift from a radially collapsed configuration to a radially expanded configuration (paragraphs [0089], [0091-0092], [0101]); and a plurality of valve leaflets 14 attached to the expandable framework 12 at a plurality of commissure posts (paragraph [0098] and as seen in Figures 1-2); and an implant delivery system comprising a handle and an elongate shaft assembly (as seen in Figure 8 and paragraphs [0010-0011], [0017], [0101-0102]), the elongate shaft assembly comprising a tubular member (120, shaft) fixedly attached to the handle (as seen in Figure 8, paragraphs [0101], [0114], [0119]); and an implant holding portion 124 configured to constrain the expandable framework in the radially collapsed configuration (paragraphs [0102], [0110-0111]); wherein the elongate shaft assembly further comprises an anti-migration 114 configured to shift between a delivery configuration and an open configuration (paragraphs [0106-0107], [0110-0111]), wherein the anti-migration element 114 is configured to prevent proximal movement of the expandable framework 12 relative to the tubular member when the expandable framework is released from the implant holding portion (paragraphs [0106], [0119]). Regarding Claim 10, Alon et al. discloses wherein a portion of the anti- migration element 114 abuts the plurality of commissure posts (by portion 36 of the sutured portion, as seen in Figures 10, 14 and paragraphs [0104]). Regarding Claim 11, Alon et al. discloses wherein the anti-migration element 114 is not attached to the plurality of commissure posts (by portion 36 of the sutured portion, see Figures 1 and 10, 13-14) . 07-15-aia AIA Claim(s) 9-10 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Adamek-Bowers et al. U.S. Publication 2019/0053896 A1 . Regarding Claim 9, Adamek-Bowers discloses a replacement heart valve system 10 as seen in Figures 1-2 comprising: a replacement heart valve implant 16 comprising: an expandable framework 17 configured to shift from a radially collapsed configuration to a radially expanded configuration (paragraphs [0066-0067]); and a plurality of valve leaflets 22 attached to the expandable framework at a plurality of commissure posts 60 (paragraphs [0068-0069], [0088] and [0105-0106] and as seen in Figures 8-12); and an implant delivery system comprising a handle 18 and an elongate shaft assembly (paragraphs [0073], [0075-0076]), the elongate shaft assembly comprising a tubular member fixedly attached to the handle (paragraph [0076] and as seen in Figure 1), and an implant holding portion 12 configured to constrain the expandable framework in the radially collapsed configuration (paragraphs [0062-0063] and [0075]); wherein the elongate shaft assembly further comprises an anti-migration element 15/86 configured to shift between a delivery configuration and an open configuration (paragraphs [0064], [0071-0073]).; wherein the anti-migration element 15/86 is configured to prevent proximal movement of the expandable framework relative to the tubular member when the expandable framework is released from the implant holding portion (paragraphs [0062], [0064], [0082] and [0096]). Regarding Claim 10, Adamek-Bowers discloses wherein a portion of the anti- migration element 15/86 abuts the plurality of commissure posts 60 (as seen in Figure 2 and paragraphs [0104]) . 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) 2, 4-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alon et al. U.S. Publication 2010/0049313 A1 in view of Adamek-Bowers et al. U.S. Publication 2019/0053896 A1 . Regarding Claim 2, Alon et al. discloses wherein the anti-migration element 344 is engaged with a plurality of posts 30 (as seen in Figures 1 and paragraph [0069]). However, Alon et al. does not expressly disclose the posts are commissure posts. Adamek-Bowers et al. teaches a replacement heart valve system as seen in Figures 1-2 in the same field of endeavor comprising a replacement heart valve system 10 comprising a handle 18, an elongate shaft assembly having a tubular member and an implant holding portion 12 (sheath) and an anti-migration element 86 and an expandable framework 17 comprising a plurality of commissure post 60, wherein the anti-migration element 15/86 having a plurality of arms 82 that engages the plurality of commissure posts 60 to reversibly actuate the expandable frame 17 between a delivery and deployed configuration (paragraphs [0071-0073]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Alon’s posts that couple to an anti-migration element to be a plurality of commissure posts as taught by Adamek-Bowers for the purpose of reversibly actuate the expandable frame 17 between a delivery and deployed configuration and controlling the expansion of the replacement valve. Regarding Claim 4, Alon et al. discloses wherein the anti-migration element includes an annular ring 334 and a plurality of legs 336 extending radially outward from the annular ring 334 (as seen in Figures 36-37), the plurality of legs 336 being engaged with the plurality of posts 32. However, Alon et al. does not expressly disclose the posts are commissure posts. Adamek-Bowers et al. teaches a replacement heart valve system as seen in Figures 1-2 in the same field of endeavor comprising a replacement heart valve system 10 comprising a handle 18, an elongate shaft assembly having a tubular member and an implant holding portion 12 (sheath) and an anti-migration element 86 and an expandable framework 17 comprising a plurality of commissure post 60, wherein the anti-migration element 86 engages the plurality of commissure posts 60 to reversibly actuate the expandable frame 17 between a delivery and deployed configuration (paragraphs [0071-0073]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Alon’s posts that couple to an anti-migration element to be a plurality of commissure posts as taught by Adamek-Bowers for the purpose of reversibly actuate the expandable frame between a delivery and deployed configuration and controlling the expansion of the replacement valve. Regarding Claim 5, Alon et al. discloses wherein the annular ring 334 is fixedly attached to the tubular member 316 (as seen in Figures 32-33 and 39). Regarding Claim 6, Alon et al. discloses wherein each leg of the plurality of legs 336 extends radially outward of the plurality of the posts (as seen in Figures 36-37, the legs 336 extends radially outward of the posts 30). However, Alon et al. does not expressly disclose the posts are commissure posts. Adamek-Bowers et al. teaches a replacement heart valve system as seen in Figures 1-2 in the same field of endeavor comprising a replacement heart valve system 10 comprising a handle 18, an elongate shaft assembly having a tubular member and an implant holding portion 12 (sheath) and an anti-migration element 86 and an expandable framework 17 comprising a plurality of commissure post 60, wherein the anti-migration element 86 engages the plurality of commissure posts 60 to reversibly actuate the expandable frame 17 between a delivery and deployed configuration (paragraphs [0071-0073]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Alon’s posts that couple to an anti-migration element to be a plurality of commissure posts as taught by Adamek-Bowers for the purpose of reversibly actuate the expandable frame between a delivery and deployed configuration and controlling the expansion of the replacement valve. Regarding Claim 7, Alon et al. discloses wherein the annular ring 334 is disposed distal of a proximal most portion of the plurality of legs 336 when the anti-migration element is engaged with the plurality of posts 30 (as seen in Figures 33 and 36). However, Alon et al. does not expressly disclose the posts are commissure posts. Adamek-Bowers et al. teaches a replacement heart valve system as seen in Figures 1-2 in the same field of endeavor comprising a replacement heart valve system 10 comprising a handle 18, an elongate shaft assembly having a tubular member and an implant holding portion 12 (sheath) and an anti-migration element 86 and an expandable framework 17 comprising a plurality of commissure post 60, wherein the anti-migration element 86 engages the plurality of commissure posts 60 to reversibly actuate the expandable frame 17 between a delivery and deployed configuration (paragraphs [0071-0073]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Alon’s posts that couple to an anti-migration element to be a plurality of commissure posts as taught by Adamek-Bowers for the purpose of reversibly actuate the expandable frame between a delivery and deployed configuration and controlling the expansion of the replacement valve. Regarding Claim 8, Alon et al. discloses wherein the plurality of legs 336 extends longitudinally alongside the tubular member 316 when the expandable framework is in the radially collapsed configuration (as seen in Figures 32-33 and 39) . 07-21-aia AIA Claim (s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alon et al. U.S. Publication 2010/0049313 . Regarding Claim 12, Alon et al. discloses wherein the implant delivery system 100 includes a stent holder 122 fixedly attached to the tubular member 120 (as seen in Figure 8 and paragraphs [0101-0102], [0114]). However, in the embodiment used in the rejection above, Figure 8 does not expressly disclose the stent holder being configured to engage a distal portion of the expandable framework when the expandable framework is constrained within the implant holding portion . In an alternative embodiment as seen in Figures 52A-52B, Alon et al. teaches an implant delivery system comprising a stent holder 604 having a recessed portion 606 for receiving a distal end of a stent valve 608 (paragraph [0155]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Figure 8 of Alon to further include a nose cone at a distal end having a recessed portion as taught in Figures 52A-52B for the purpose of retaining a distal portion of the stent valve in a compressed state for delivery through a patient’s vasculature. Regarding Claim 13, Alon et al. discloses wherein the anti-migration element 114 is disposed proximal of the stent holder 122 (as seen in Figure 8 and paragraphs [0101-0102]) . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lombardi et al. WO 2015/063118 . Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /SEEMA MATHEW/ Primary Examiner, Art Unit 3774 Application/Control Number: 18/588,457 Page 2 Art Unit: 3774 Application/Control Number: 18/588,457 Page 3 Art Unit: 3774 Application/Control Number: 18/588,457 Page 4 Art Unit: 3774 Application/Control Number: 18/588,457 Page 5 Art Unit: 3774 Application/Control Number: 18/588,457 Page 6 Art Unit: 3774 Application/Control Number: 18/588,457 Page 7 Art Unit: 3774 Application/Control Number: 18/588,457 Page 8 Art Unit: 3774 Application/Control Number: 18/588,457 Page 9 Art Unit: 3774 Application/Control Number: 18/588,457 Page 10 Art Unit: 3774 Application/Control Number: 18/588,457 Page 11 Art Unit: 3774 Application/Control Number: 18/588,457 Page 12 Art Unit: 3774 Application/Control Number: 18/588,457 Page 13 Art Unit: 3774 Application/Control Number: 18/588,457 Page 14 Art Unit: 3774
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