CTFR 19/405,284 CTFR 84989 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. Response to Arguments Applicant’s arguments/ amendments with respect to the rejection of claim(s) 9-14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, filed 5/13/2026, have been fully considered and are persuasive. The aforementioned rejection has been withdrawn. Applicant's arguments with respect to the rejection of claim(s) 1-20 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) based on Oba et al. (US 2018/0055629 A1 – as previously cited), filed 5/13/2026 (and as were discussed in the interview dated 5/5/2026) have been fully considered but they are not persuasive. In both the aforementioned interview and Applicant’s arguments Applicant argued the frame (outer frame 1640), as disclosed by Oba et al., has intermediate structures connecting the plurality of proximal struts (set of circumferentially-expansible struts 1648a) and the set of proximal undulating struts (set of circumferentially expansible struts 1648d); as such, the aforementioned structures can not be considered “directly connected” as required by the amended independent claims. Examiner agreed with this argument in part. Applicant is correct that the amended independent claims require a direction connection between the plurality of proximal struts and the set of proximal undulating struts (thus there can be no intermediate structure therebetween). However, Oba et al. discloses additional embodiments, specifically the outer frame (1800), as can be seen in fig. 37, which include a direct connection between the plurality of proximal struts and the set of proximal undulating struts (as detailed below). As such, the aforementioned rejection is being modified and maintained. 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. 07-12-aia AIA (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. 07-15-aia AIA Claim(s) 1-20 is/are rejected under 35 U.S.C. 102 (a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Oba et al. (US 2018/0055629 A1 – as previously cited) . With respect to claim 1: Oba et al. discloses a frame (outer frame 1800), as can be seen in fig. 37 (paragraph [0280]), of a replacement heart valve implant (prosthesis 1600), as can be seen in figs. 34-35, the frame (outer frame 1800) comprising: a frame body (outer frame 1800) configured to transition from a compressed configuration (collapsed configuration) to an expanded configuration (expanded configuration) (paragraphs [0244, 0257, 0281]), the frame body (outer frame 1800) comprising: a plurality of proximal struts (set of circumferentially-expansible struts 1806b) (paragraph [0285]); a plurality of strut arms (in combination structure with the eyelets 1810 and elongate struts 1806a) extending from the plurality of proximal struts (set of circumferentially-expansible struts 1806b) (paragraphs [0283, 0288]), the plurality of strut arms (eyelets 1810 and elongate struts 1806a) comprising coupling bodies (locking tabs 1812 and eyelets 1810) configured to ( capable of ) couple the frame (outer frame 1800) to a delivery device (delivery system) (paragraphs [0280, 0288]); a set of proximal undulating struts (set of circumferentially expansible struts 1806b) extending circumferentially around a central axis (longitudinal axis) (paragraph [0285]), the plurality of proximal struts (eyelets 1810 and elongate struts 1806a) directly connected to the set of proximal undulating struts (set of circumferentially expansible struts 1806b), as can be seen in fig. 37 (paragraph [0285]); and a set of distal undulating struts (set of circumferentially expansible struts 1806c) extending circumferentially around the central axis (longitudinal axis), the set of distal undulating struts (set of circumferentially expansible struts 1806c) comprising spaces (space between two adjacent struts 1806c) between individual struts (struts 1806c) (paragraph [0285]); wherein the set of proximal undulating struts (set of circumferentially expansible struts 1806b) and the set of distal undulating struts (set of circumferentially expansible struts 1806c) at least partially define openings (cells 1804b) (paragraph [0286]); and wherein the frame body (outer frame 1800) curves radially outward such that a distal end (end at lower region 1802c) of the frame body (outer frame 1800) has a larger diameter than a proximal end (end at upper region 1802a) of the frame body (outer frame 1800) when the frame body (outer frame 1800) is in the expanded configuration (expanded configuration) (paragraph [0281]); wherein the spaces (space between two adjacent struts 1806c) between individual struts (struts 1806c) are configured to (are capable of ) receive anchors (inner frame anchoring feature 1624) of an inner frame (inner frame 1620) coupled to the frame body (outer frame 1800) and reduce anchor to frame body (outer frame 1800) contact (paragraphs [0244, 0263]). (PLEASE NOTE: Applicant has not positively claimed the inner frame (inner frame 1620) with the anchors (inner frame anchoring feature 1624); as such, the spaces (space between two adjacent struts 1806c) between individual struts (struts 1806c) are capable of receiving anchors of an inner frame where the anchors of an inner frame are sized to reduce anchor to frame body (outer frame 1640) contact.) With respect to claim 2: Wherein the spaces (space between two adjacent struts 1806c) between individual struts (struts 1806c) are configured to allow (are capable of allowing) anchors to pass radially inward through the spaces (space between two adjacent struts 1648a) of the frame body (outer frame 1800). (PLEASE NOTE: Applicant has not positively claimed the anchors (inner frame anchoring feature 1624); as such, the spaces (space between two adjacent struts 1806c) between individual struts (struts 1806c) are capable of allowing anchors to pass radially inward through the spaces (space between two adjacent struts 1806c) should the anchors be sized in such a manner.) With respect to claim 3: Wherein the set of proximal undulating struts (set of circumferentially expansible struts 1806b) and the set of distal undulating struts (set of circumferentially expansible struts 1806c) are connected to each other at junctures, as can be seen in fig. 37. With respect to claim 4: Wherein the distal end (end at lower region 1802c) of the frame body (outer frame 1800/ sealing frame) is configured to (is capable of ) deflect radially inwards (conforming to seal) (paragraphs [abstract, 0110, 0284]). With respect to claim 5: Wherein the frame body (outer frame 1800) is configured to (is capable of ) inhibit the frame body (outer frame 1640) from migrating into a ventricle (paragraphs [0237, 0284]). With respect to claim 6: Wherein the coupling bodies (locking tabs 1812 and eyelets 1810) comprise at least one of tabs (locking tabs 1812) and eyelets (eyelets 1810) (paragraphs [0280, 0288]). With respect to claim 7: Wherein the coupling bodies (locking tabs 1812 and eyelets 1810) comprise two apertures (openings within both eyelets 1810 and locking tabs 1812) (paragraphs [0280, 0288]). With respect to claim 8: Wherein the set of proximal undulating struts (set of circumferentially expansible struts 1806b) and the set of distal undulating struts (set of circumferentially expansible struts 1806c) at least partially define cells (cells 1804b) having a length extending between a proximal end of an intermediate portion (where struts 1806b join struts 1806c) and a distal end of a distal portion (end of the outer frame 1800 where two adjacent struts 1806d meet), as can be seen in fig. 37. With respect to claim 9: Oba et al. discloses a frame (outer frame 1800), as can be seen in fig. 37 (paragraph [0280]), of a replacement heart valve implant (prosthesis 1600), as can be seen in figs. 34-35, the frame (outer frame 1800) comprising: a frame body (outer frame 1800) configured to transition from a compressed configuration (collapsed configuration) to an expanded configuration (expanded configuration) (paragraphs [0244, 0257, 0281]), the frame body (outer frame 1800) comprising: a proximal portion comprising a plurality of proximal struts (set of circumferentially-expansible struts 1806b) (paragraph [0285]), wherein at least some of the proximal struts (set of circumferentially-expansible struts 1806b) join into elongate strut arms (in combination structure with the eyelets 1810, locking tabs 1812, and elongate struts 1806a) having coupling bodies (eyelets 1810 and/or locking tabs 1812) configured to couple the frame (outer frame 1800) to a delivery device (delivery system) (paragraph [0280, 0288]); an intermediate portion comprising a first set of undulating struts (set of circumferentially expansible struts 1806c) circumferentially extending around a central axis (longitudinal axis), the first set of undulating struts (set of circumferentially expansible struts 1806c) directly connected to the plurality of proximal struts (set of circumferentially expansible struts 1806b) (paragraph [0285]); and a distal portion comprising a second set of undulating struts (set of circumferentially expansible struts 1806d) circumferentially extending around the central axis (longitudinal axis) (paragraph [0286]); wherein the first set of undulating struts (set of circumferentially expansible struts 1806c) and the second set of undulating struts (set of circumferentially expansible struts 1806d) at least partially define cells (cells 1804b) having a length extending between a proximal end of the intermediate portion (where struts 1806b join 1806c) and a distal end of the distal portion (end of the outer frame 1800 where two adjacent struts 1806d meet), as can be seen in fig. 37 (paragraphs [0283-0286]); and wherein the frame body (outer frame 1800) curves radially outward such that the distal end (end at lower region 1802c) of the frame body (outer frame 1800) has a larger diameter than a proximal end (end at upper region 1802a) of the proximal portion when the frame body (outer frame 1800) is in the expanded configuration (expanded configuration) (paragraph [0283]). With respect to claim 10: Wherein the spaces (space between two adjacent struts 1806c) between individual struts (struts 1806c) are configured to (are capable of ) receive anchors (inner frame anchoring feature 1624) of an inner frame (inner frame 1620) coupled to the frame body (outer frame 1800) and reduce anchor to frame body (outer frame 1640) contact (paragraphs [0244, 0263]). (PLEASE NOTE: Applicant has not positively claimed the inner frame (inner frame 1620) with the anchors (inner frame anchoring feature 1624); as such, the spaces (space between two adjacent struts 1806d) between individual struts (struts 1806d) are capable of receiving anchors of an inner frame where the anchors of an inner frame are sized to reduce anchor to frame body (outer frame 1800) contact.) With respect to claim 11: Wherein the spaces (space between two adjacent struts 1806c) between individual struts (struts 1806d) are configured to allow (are capable of allowing) anchors to pass radially inward through the spaces (space between two adjacent struts 1806d) of the frame body (outer frame 1800). (PLEASE NOTE: Applicant has not positively claimed the anchors (inner frame anchoring feature 1624); as such, the spaces (space between two adjacent struts 1806d) between individual struts (struts 1806d) are capable of allowing anchors to pass radially inward through the spaces (space between two adjacent struts 1806d) should the anchors be sized in such a manner.) With respect to claim 12: Wherein the distal end (end at lower region 1802c) of the frame body (outer frame 1800/ sealing frame) is configured to (is capable of ) deflect radially inwards (conforming to seal) (paragraphs [abstract, 0110, 0284]). With respect to claim 13: Wherein the frame body (outer frame 1800) is configured to (is capable of ) inhibit the frame body (outer frame 1640) from migrating into a ventricle (paragraphs [0237, 0284]). With respect to claim 14: Wherein the coupling bodies (locking tabs 1812 and eyelets 1810) comprise at least one of tabs (locking tabs 1812) and eyelets (eyelets 1810) (paragraphs [0280, 0288]). With respect to claim 15: Oba et al. discloses a frame (outer frame 1800), as can be seen in fig. 37 (paragraph [0280]), of a replacement heart valve implant (prosthesis 1600), as can be seen in figs. 34-35, the frame (outer frame 1800) comprising: a frame body (outer frame 1800) configured to transition from a compressed configuration (collapsed configuration) to an expanded configuration (expanded configuration) (paragraphs [0244, 0257, 0281]), the frame body (outer frame 1800) comprising: a plurality of substantially X-shaped struts (each X-shaped strut made up of two expansible struts 1806d and two expansible struts 1806c) circumferentially extending around a central axis (longitudinal axis) (paragraphs [0285-0286]); a plurality of proximal struts (set of circumferentially-expansible struts 1806b) directly connected to the plurality of substantially X-shaped struts (each X-shaped strut made up of two expansible struts 1806d and two expansible struts 1806c) (paragraph [0285]); and a plurality of strut arms (in combination structure with the eyelets 1810, locking tabs 1812, and elongated struts 106a) extending from the plurality of proximal struts (set of circumferentially-expansible struts 1806b), the plurality of strut arms (in combination structure with the eyelets 1810, locking tabs 1812, and elongated struts 106a) comprising coupling bodies (eyelets 1810 and/or locking tabs 1812) configured to ( capable of ) couple the frame (outer frame 1640) to a delivery device (delivery system) (paragraphs [0280, 0283, 0288]); wherein the plurality of substantially X-shaped struts (each X-shaped strut made up of two expansible struts 1806d and two expansible struts 1806c) at least partially define cells (cells 1804a) having a length extending between a proximal end of the intermediate portion (where struts 1806b join struts 1806c) and a distal end of the distal portion (end of the outer frame 1800 where two adjacent struts 1806d meet), as can be seen in fig. 37 (paragraph [0285]); wherein the frame body (outer frame 1800) curves radially outward such that the distal end (end at lower region 1802c) has a larger diameter than a proximal end (end at upper region 1802a) when the frame body (outer frame 1800) is in the expanded configuration (expanded configuration) (paragraphs [0283-0284]); wherein the spaces (space between two adjacent struts 1806d) between individual struts (struts 1806d) are configured to (are capable of ) receive anchors (inner frame anchoring feature 1624) and reduce anchor to frame body (outer frame 1640) contact. (PLEASE NOTE: Applicant has not positively claimed the inner frame (inner frame 1620) with the anchors (inner frame anchoring feature 1624); as such, the spaces (space between two adjacent struts 1806d) between individual struts (struts 1806d) are capable of receiving anchors of an inner frame where the anchors of an inner frame are sized to reduce anchor to frame body (outer frame 1800) contact.) With respect to claim 16: Wherein the spaces (space between two adjacent struts 1806d) between individual struts (struts 1806d) are configured to allow (are capable of allowing) anchors to pass radially inward through the spaces (space between two adjacent struts 1806d) of the frame body (outer frame 1800). (PLEASE NOTE: Applicant has not positively claimed the anchors (inner frame anchoring feature 1624); as such, the spaces (space between two adjacent struts 1806d) between individual struts (struts 1806d) are capable of allowing anchors to pass radially inward through the spaces (space between two adjacent struts 1806d) should the anchors be sized in such a manner.) With respect to claim 17: Wherein the distal end (end at lower region 1802c) of the frame body (outer frame 1800/ sealing frame) is configured to (is capable of ) deflect radially inwards (conforming to seal) (paragraphs [abstract, 0110, 0284]). With respect to claim 18: Wherein the frame body (outer frame 1800) is configured to (is capable of ) inhibit the frame body (outer frame 1640) from migrating into a ventricle (paragraphs [0237, 0284]). With respect to claim 19: Wherein the coupling bodies (locking tabs 1812 and eyelets 1810) comprise at least one of tabs (locking tabs 1812) and eyelets (eyelets 1810) (paragraphs [0280, 0288]). With respect to claim 20: Wherein the coupling bodies (locking tabs 1812 and eyelets 1810) comprise two apertures (openings within both eyelets 1810 and locking tabs 1812) (paragraphs [0280, 0288]). Conclusion 07-40 AIA Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL . See MPEP § 706.07(a). 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 REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1. 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, Jerrah Edwards can be reached at (408)918-7557. 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. /REBECCA S PRESTON/Primary Examiner, Art Unit 3774 Application/Control Number: 19/405,284 Page 2 Art Unit: 3774 Application/Control Number: 19/405,284 Page 3 Art Unit: 3774 Application/Control Number: 19/405,284 Page 4 Art Unit: 3774 Application/Control Number: 19/405,284 Page 5 Art Unit: 3774 Application/Control Number: 19/405,284 Page 6 Art Unit: 3774 Application/Control Number: 19/405,284 Page 7 Art Unit: 3774
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