CTFR 17/961,489 CTFR 82615 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 In view of the amendments filed on 2/2/2026, the claim objection, cited in the office action of 10/1/2025, is moot. In view of the amendments filed on 2/2/2026, the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph rejections, cited in the office action of 10/1/2025, are moot. Applicant’s arguments with respect to claim(s) 1-2, 4-9, 31, and 32 have been considered but are moot in view of the new grounds of rejection. Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claim 1 and its dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “dimensions and characteristics,” and the claim also recites the “dimensions include a pre-determined set diameter,” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Appropriate correction is required. 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) 1-2, 4-8, 31 and 32 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Orion et al. (WO 2010/058406 A1; hereinafter “Orion”) . Orion discloses the following regarding claim 1: an external support for a graft assembly, the external support comprising: an external support tube (e.g., 500) configured to extend along an outside of a graft allowing passage of blood therethrough (pgs. 14-17), wherein the external support is a lattice design (e.g., Figs. 1A-5B, 7A-10C, 12A-14C, 18C-18F) having a plurality of openings (e.g., 506) therein; and a lumen (e.g., central opening of element 500) extending through the external support that is sized to facilitate placement of the external support tube over the graft (e.g., Figs. 5A-5B; pgs. 14-17), wherein the external support body has dimensions and characteristics that are selected or designed to match or correspond to the graft or a specific vasculature to which the external support is mounted so as to mechanically reinforce the graft for at least a period of time after the surgical procedure (pgs. 12-18, 30-33), wherein the designed or selected dimensions include a pre-determined set diameter (pgs. 12-18, 30). Orion discloses the following regarding claim 2: the external support of claim 1 wherein the external support comprises a single layer (single strut or fiber) of a 3D printed design (pgs. 29-30). Please note that method limitations in article claims are considered to the extent that they further define the final structure of the claimed apparatus. As presently worded, the scope of the subject matter fails to structurally distinguish the claims from the prior art. Orion discloses the following regarding claim 4: the external support of claim 1 wherein the external support is of sufficient strength to be handled during a surgical procedure without an internal tubular support disposed within (pgs. 30-31, 39-40). Orion discloses the following regarding claim 5: the external support of claim 1 wherein the external support is formed of a biodegradable material that maintains structural integrity for a set period of time after the surgical procedure (pgs. 19-20). Orion discloses the following regarding claim 6: the external support of claim 5 wherein the set period of time after the surgical procedure is between 1-6 weeks (pgs. 32-33, 40-41). In addition, it has been held that the optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal degradation time needed to achieve the desired results for the implantation site. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of degradation times, would have been obvious at the time of applicant's invention in view of the teachings of Orion. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. Orion discloses the following regarding claim 7: the external support of claim 1 wherein the external support comprises one or more layers of differing properties, wherein the differing properties include any of biodegradability, bioresorption, biointegration, porosity, stiffness or any combination thereof (pgs. 14-18). Orion discloses the following regarding claim 8: the external support of claim 1 wherein the external support comprises braided pieces of biodegradable material (pgs. 14-18). Orion discloses the following regarding claim 31: the external support of claim 1 wherein the pre-determined set diameter is variable along a length of the external support (e.g., Figs. 8C, 9A-10A, 10C, 12A, 13A-13B, 16A-16B). Orion discloses the following regarding claim 32: the external support of claim 1, wherein the external support is configured to be attached to the graft and then implanted in a patient (pgs. 6-7, 35-37). Please note that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim . 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. 07-21-aia AIA Claim (s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orion in view of Stump et al. (WO 9632077 A1; hereinafter “Stump”) . Orion discloses the limitations of the claimed invention, as described above. However, it does not explicitly disclose that the external support is designed with a structural stiffness that matches or exceeds the specific vasculature to which the graft is mounted. Stump teaches that it is well known in the art that a graft device has a stiffness that matches its associated vasculature (pg. 6, lines 23-35), in order to provide the graft with the desired mechanical properties needed to best support its implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the graft of Orion to have a stiffness matching or exceeding that of the vasculature, as taught by Stump, for the purpose of optimizing the structure of the graft for its implantation site and to provide the graft with the desired mechanical properties needed to best support its implantation site. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that the optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal stiffness needed to achieve the desired results for the implantation site. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the stiffness, would have been obvious at the time of applicant's invention in view of the teachings of Orion and Stump. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. 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 Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST). If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, 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 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. /ANN HU/Primary Examiner, Art Unit 3774 Application/Control Number: 17/961,489 Page 2 Art Unit: 3774 Application/Control Number: 17/961,489 Page 3 Art Unit: 3774 Application/Control Number: 17/961,489 Page 4 Art Unit: 3774 Application/Control Number: 17/961,489 Page 5 Art Unit: 3774 Application/Control Number: 17/961,489 Page 6 Art Unit: 3774 Application/Control Number: 17/961,489 Page 7 Art Unit: 3774 Application/Control Number: 17/961,489 Page 8 Art Unit: 3774
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