CTFR 18/314,752 CTFR 88243 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. Detailed Action This is in response to the amendment filed 03/04/2026. Claim Rejections - 35 USC § 102 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) 1-13, 15-17, 19, 20, 21 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by U.S. Patent Publication Number 2017/0231756 (Armer et al.) Regarding claims 1-13, 15-17, 19, 20, 21 Armer et al. discloses as shown in Figure 10B, 10D, 18 an expandable frame for a docking station (docking station 10, see paragraph [0179]) configured to retain and position a transcatheter heart valve in a circulatory system, the expandable frame comprising: an enlarged first end portion (portion where end 12 extends, see paragraph [0188]) having a first outer radial portion with a first major lateral dimension, an enlarged second end portion (portion where end 14 extends, see paragraph [0188]) having a second outer radial portion with a second major lateral dimension, and a narrowed central waist portion having an inner radial portion (portion 16, see paragraph [0188]) with a third major lateral dimension smaller than the first and second major lateral dimensions; a retaining portion (cloth covering 21, see paragraph [0194]) at least partially defined by at least one of the first and second end portions; and a valve seat (valve seat 18, see paragraph [0156]) at least partially defined by the waist portion; wherein the expandable frame includes a plurality of struts extending between first apices at the first end portion to second apices (generally indicated as A) at the second end portion, wherein at least one of the first apices and the second apices are contoured radially inward, wherein the second major lateral dimension is greater than the first major lateral dimension, wherein the first major lateral dimension is greater than the second major lateral dimension, wherein the first major lateral dimension is substantially equal to the first major lateral dimension, wherein a first axial length from an axial midpoint of the waist portion to the first apices is greater than a second axial length from the axial midpoint of the waist portion to the second apices, wherein a first axial length from an axial midpoint of the waist portion to the first apices is substantially equal to a second axial length from the axial midpoint of the waist portion to the second apices, wherein the first outer radial portion has a cross-sectional shape substantially the same as a cross-sectional shape of the second outer radial portion, , wherein the first outer radial portion has a cross-sectional shape different than a cross-sectional shape of the second outer radial portion, wherein the first outer radial portion has a cross-sectional shape substantially the same as a cross-sectional shape of the inner radial portion, wherein the first outer radial portion has a cross-sectional shape different than a cross-sectional shape of the inner radial portion, wherein the first outer radial portion has a cross-sectional shape that is one of: circular, elliptical, D-shaped, and rounded D-shaped, wherein the second outer radial portion has a cross-sectional shape that is one of: circular, elliptical, D-shaped, and rounded D-shaped, wherein the inner radial portion has a cross-sectional shape that is one of: circular, elliptical, D-shaped, and rounded D-shaped, wherein an axial midpoint of the waist portion has a substantially straight axially extending profile, wherein the first end portion of the frame comprises at least one row of first end cells defined by the plurality of struts, the second end portion of the frame comprises at least one row of second end cells defined by the plurality of struts, and the waist portion of the frame comprises at least one row of central cells defined by the plurality of struts, wherein the plurality of struts include first end strut portions defining the first end portion of the frame, second end strut portions defining the second end portion of the frame, and central strut portions defining the waist portion of the frame, wherein the other of the first apices and the second apices are contoured radially inward, wherein the other of the first apices and the second apices are contoured radially outward, wherein the expandable frame is sized to be implanted at a tricuspid valve of a human heart, with the first end portion retained in a right atrium, the second end portion retained in a right ventricle, and the waist portion aligned with the tricuspid valve. See paragraph [0196] . PNG media_image1.png 420 486 media_image1.png Greyscale Claim Rejections - 35 USC § 103 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) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2017/0231756 (Armer et al.) in view of U.S. Patent Publication Number 2012/0059458 (Buchbinder et al.) Regarding claim 14, Armer et al. fails to disclose wherein an axial midpoint of the waist portion is concave. Buchbinder et al., from the same field of endeavor teaches a similar expandable frame as shown in Figure 1B and Figure 6, wherein an axial midpoint of the waist portion is concave. 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 shape of the axial midpoint disclosed by Armer et al. for the shape of the midpoint taught by Buchbinder et al. because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc. , 550 U.S. 398, 82, USPQ2d 1385 (2007) . 07-21-aia AIA Claim (s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2017/0231756 (Armer et al.) in view of U.S. Patent Publication Number 20020058989 (Chen et al.) Regarding claim 18, Armer et al. fails to disclose wherein the central strut portions have a cross-sectional area greater than a cross-sectional area of the first and second end strut portions. Chen et al., from the same field of endeavor teaches a similar expandable frame as shown in Figure 9, where the central strut portions have a cross-sectional area greater than a cross-sectional area of the first and second end strut portions for the purpose of increasing the strength of the central strut portion. See paragraph [0027]. It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the central strut portions have a cross-sectional area greater than a cross-sectional area of the first and second end strut portions in order to configure the central strut portions to be stronger . 07-21-aia AIA Claim (s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2017/0231756 (Armer et al.) in view of U.S. Patent Publication Number 2007/0043435 (Seguin et al.) Regarding claim 22, Armer et al. fails to disclose wherein the first major lateral dimension is approximately 50 mm. Seguin et al., from the same field of endeavor teaches a similar expandable frame as shown in Figure 9, wherein the first major lateral dimension is approximately 50 mm. See paragraph [0208]. It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the first major lateral dimension by substituting the size of the first major lateral dimension disclosed by Armer for the size of the first major lateral dimension taught by Seguin such that the first major lateral dimension is approximately 50 mm because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007) . 07-21-aia AIA Claim (s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2017/0231756 (Armer et al.) in view of U.S. Patent Publication Number 2013/0253642 (Brecker) Regarding claim 23, Armer et al. fails to disclose wherein the third major lateral dimension is approximately 27 mm. Brecker, from the same field of endeavor teaches a similar expandable frame as shown in Figure 9, wherein the third major lateral dimension is approximately 27 mm. See paragraph [0016]. It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the third major lateral dimension by substituting the size of the third major lateral dimension disclosed by Armer for the size of the Third major lateral dimension taught by Brecker such that the first major lateral dimension is approximately 27 mm because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007) . 07-21-aia AIA Claim (s) 24 , is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2017/0231756 (Armer et al.) in view of U.S. Patent Publication Number 2009/0222082 (Lock et al.) Regarding claim 24, Armer et al. fails to disclose at least one radiopaque marker attached to the frame. Lock et al., from the same filed of endeavor teaches a similar expandable frame as shown in Figure 1, where at least one radiopaque marker attached to the frame for the purpose of facilitating a determination of the expanded size of the frame. See paragraph [0013]. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to include at least one radiopaque marker attached to the frame in order to of facilitate a determination of the expanded size of the frame . 07-22-aia AIA Claim (s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2017/0231756 (Armer et al.) in view of U.S. Patent Publication Number 2013/0253642 (Brecker) as applied to claim 23 above, and further in view of U.S. Patent Publication Number 2009/0222082 (Lock et al.) . Regarding claim 25, Armer et al. fails to disclose wherein the at least one radiopaque marker is attached to the waist portion of the frame. Lock et al., from the same filed of endeavor teaches a similar expandable frame as shown in Figure 1, where at least one radiopaque marker attached to the frame for the purpose of facilitating a determination of the expanded size of the frame. See paragraph [0013]. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to include at least one radiopaque marker attached to the frame in order to of facilitate a determination of the expanded size of the frame. It would have been further obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the frame by attaching the marker to the waist portion of the frame because it would only require the rearrangement of parts without changing how the device operates. See In re Japikse , 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) Response to Arguments 07-38-01 AIA Applicant’s arguments, see page 6 , filed 03/04/2026 , with respect to the rejection of claim 25 under 35 USC 112, second paragraph have been fully considered and are persuasive. The rejection of claim 25 under 35 USC 112, second paragraph has been withdrawn. Applicant’s arguments, see pages 6-8, filed 03/04/2026, with respect to the rejection of claims 1-13, 15-17, 19-21 under Armer et al. have been considered but are not persuasive. The applicant argues Armer fails to disclose wherein at least one of the first apices and the second apices are contoured radially inward. In response, the Office respectfully disagrees. While it is true Armer discloses retaining portions have an outward flare, the claims do not limit the “contoured radially inward” to retaining portions. Claim 1 broadly encompasses first apices and second apices . In this case, the non-retaining apices (generally indicated as A) as clearly shown to be contoured radially inward: PNG media_image1.png 420 486 media_image1.png Greyscale 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 extension fee 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 date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is (571)270-1965. The examiner can normally be reached on Monday – Friday, 9:30 am – 6 pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho at 571-272-4696 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. If there are any inquiries that are not being addressed by first contacting the Examiner or the Supervisor, you may send an email inquiry to TC3700_Workgroup_D_Inquiries@uspto.gov . 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. /RICHARD G LOUIS/ Primary Examiner, Art Unit 3771 Application/Control Number: 18/314,752 Page 2 Art Unit: 3771 Application/Control Number: 18/314,752 Page 3 Art Unit: 3771 Application/Control Number: 18/314,752 Page 4 Art Unit: 3771 Application/Control Number: 18/314,752 Page 5 Art Unit: 3771 Application/Control Number: 18/314,752 Page 6 Art Unit: 3771 Application/Control Number: 18/314,752 Page 7 Art Unit: 3771 Application/Control Number: 18/314,752 Page 8 Art Unit: 3771
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