STENT

DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/30/26 has been entered. Response to Arguments Applicant’s arguments with respect to claim(s) 1,14,20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument, particularly referring to the new feature in the amendment. The teachings of Camrud address Applicant’s arguments pertaining to annular sections and self-expanding stent material. Claim Objections Applicant is advised that should claim 1 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim Rejections - 35 USC § 103 The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Claim(s) 1,3,4,6-8,10,14,15,20 are rejected under 35 U.S.C. 103 as being unpatentable over Haindl (DE 10223399) in view of Camrud et al. (6258117). Haindl shows (Fig. 3) a stent for transluminal implantation into hollow organs, the stent comprising an at least substantially tubular body that extends along a longitudinal direction and that can be converted from a compressed state having a first cross-sectional diameter into an expanded state having an enlarged second cross-sectional diameter, with the tubular body defined by an inner body (10) and an outer body (12) such that the outer body surrounds the inner body at least regionally, with the outer body (12) completely running around at least one section of the inner body (10). Haindl discloses (page 3 of translation) the outer body being formed from a bioresorbable material or comprises a bioresorbable material. It is noted that Haindl discloses (page 3 of translation) the stent device is balloon expandable and thus the outer body is balloon-expandable. However, Haindl does not disclose the inner body is self-expanding and the inner body comprises a plurality of annular sections being formed separate from one another and each annular section comprises a plurality of cells that are arranged in a row following one another in the peripheral direction of the stent and that are defined by bordering elements formed by the inner body. Camrud et al. teach (col. 7, lines 17-19) that a stent can be provided with an inner body being self-expandable. Camrud et al. also teach (Figs. 6A-C) that a stent a plurality of annular sections 12,14,16,18 being formed separate from one another and each annular section comprises a plurality of cells 26 that are arranged in a row following one another in the peripheral direction of the stent and that are defined by bordering elements formed by the inner body. Please note claims are interpreted in light of the applicant’s disclosure, which the final resulting product are annular inner bodies separate after degradation of the outer body. Haindl discloses the same concept, the inner body of annular rings are separate after the outer body degrades and further Camrud teaches the same of separable inner annular body stent ring sections of cells that are established after degradation of the connectors. Therefore, it would have been obvious to one of ordinary skill in the art to utilize the self-expanding material for the inner body and form as a plurality of annular sections being formed separate from one another and each annular section comprises a plurality of cells that are arranged in a row following one another in the peripheral direction of the stent and that are defined by bordering elements formed by the inner body as taught by Camrud et al. for the stent of Haindl such that it provides a greater coverage or support to the vessel wall in which it is placed by using larger sections or cell defined annular rings as opposed to the single wire rings as seen in Fig. 3 of Haindl. It is also noted that Camrud teaches that the use of self-expanding stent structures are combined with balloon expandable structure, col. 7, lines 20-24. Regarding claim 3, it can be seen (Fig. 3) Haindl shows the annular sections (per modification with Camrud) are held by the outer body. Regarding claim 4, it can be construed that Haindl shows (Fig. 3) that the outer body 12 is an independent stent, since it is one structure and each of the individual rings 10 per the modification with annular cell bodies taught by Camrud define independent stents. Regarding claim 6, it is noted Haindl shows, Figs. 3,4 that an outer body can completely surround the inner body at least regionally with it completely running around at least one section of the inner body, it just did not show the outer body with the plurality of cells of bordering elements about an inner body with the bordering elements. However, Camrud et al. teach (Fig. 7A) a plurality of cells 108 that are defined by bordering elements 110,112. It would have been obvious to one of ordinary skill in the art to alternatively provide the outer body with a plurality of cells that are defined by bordering elements formed by the outer body as taught by Camrud et al. with the stent of Haindl such that they maintain the stent during delivery until degradation occurs within the time frame of body response to the material. Regarding claim 7, per the modification of Camrud with Haindl it can be seen (Fig. 7A) of Camrud teach that cells of an outer body can be provided with a convex polygon, particularly a diamond shape 108. Regarding claim 8, it can be seen (Figs. 6A,7A) that Camrud teaches per modifying with Haindl resulting cells of the inner body and of the outer body have the same shape or a similar shape, wherein the cells of the inner body and the outer body are arranged offset from one another. With respect to claim 10, Haindl discloses (page 3 of translation) the inner body is to press against the outer body in the expanded state since it encloses the inner body sections. Regarding claim 15, Camrud teaches (col. 5, lines 34-39) the stent can be used in blood vessels and the modification with Haindl results in a stent fully capable of use in a vessel as recited in the claim. Claim(s) 11,12,18 are rejected under 35 U.S.C. 103 as being unpatentable over Haindl (DE 10223399) in view of Camrud et al. (6258117) as applied to claim 1 above, and further in view of Neuss (WO 2019/175330). Haindl in view of Camrud et al. is explained supra. Regarding claim 11, Haindl as modified by Camrud et al. did not explicitly disclose fastening means on one of the inner body and the outer body to fasten each other respectively. Neuss teaches (page 4 of translation) the inner body and/or the outer body has fastening means to fasten the respective bodies together. It would have been obvious to one of ordinary skill in the art to utilize known fastening means with a stent as taught by Neuss and incorporate with the stent of Haindl as modified with Camrud et al. such that it assures the inner and outer bodies remain assembled together during deployment and do not separate until desired or when the body degrades the outer body to cause separation. Regarding claim 12, Haindl as modified by Camrud et al. did not explicitly disclose one of the inner body and the outer body is surrounded by a stent graft. Neuss teaches (Fig. 1) both the inner and outer stent bodies are surrounded by stent graft 4,5 respectively. Neuss further teaches (page 4 of translation) a known material for the stent graft, ePTFE. It would have been obvious to one of ordinary skill in the art to use a stent graft for one of the inner and outer bodies of a stent as taught by Neuss with the stent of Haindl as modified by Camrud et al. such that it provides a suitable lining for biocompatibility and tissue engagement, known in the art. With respect to claim 18, Neuss teaches (page 4 of translation) fastening means such as bonding means or adhesive means can be used to join inner and outer body members together. Claim(s) 9,17 are rejected under 35 U.S.C. 103 as being unpatentable over Haindl (DE 10223399) in view of Camrud et al. (6258117) as applied to claim 1 above, and further in view of Berglung et al. (2011/0264186). Haindl in view of Camrud et al. is explained supra. However, Haindl in view of Camrud et al. did not explicitly disclose the outer body with rails that extend along the longitudinal direction. Berglung et al. teach (Fig. 11) a stent 1100 for transluminal implantation with a tubular body comprising an inner body (110) and an outer body (106A,B), with the outer body (106A,B) including rails 1150 that extend along the longitudinal direction. Berglung et al. further disclose (paragraph 46) the rails can be bioresorbable. It would have been obvious to one of ordinary skill in the art to alternatively incorporate rails with the outer body as taught by Berglung et al. in the stent of Haindl as modified with Camrud et al. such that it can provide a less constrictive central section in the circumferential radius of the stent to allow for more outward expansion against the vessel. Regarding claim 17, it can be seen (Fig. 11) Berglung teaches the rails on the outer surface of the outer body Claim(s) 13,19 are rejected under 35 U.S.C. 103 as being unpatentable over Haindl (DE 10223399) in view of Camrud et al. (6258117) as applied to claim 1 above, and further in view of Hoffman et al. (WO 2008/092435). Haindl in view of Camrud et al. is explained supra. It is noted that Haindl disclose the outer body can be a metal material that degrades, see claim 19 of document which is referring to body 12. However, Haindl in view of Camrud et al. did not explicitly disclose the bioresorbable metal comprises zinc with a mass between 90 to 99.5% and silver with a mass between 0.05 to 10%. Hoffmann et al. teach (page 9 of translation) that a stent material that degrades can be formed from zinc with a mass between 90 to 99.5% and (page 10 of translation) silver with a mass between 0.05 to 10%. It would have been obvious to one of ordinary skill in the art to provide a stent layer that degrades with a bioresorbable material comprising zinc with a mass between 90 to 99.5% and silver with a mass between 0.05 to 10% as taught by Hoffmann et al. in the stent of Haindl as modified by Camrud et al. such that the appropriate degradation rate or time of presence is provided for the structural device as optimization of the materials only involves routine skill in the art. Regarding claim 19, Hoffmann et al. teach that the combination of materials of zinc and silver is an option only based on the scope of the disclosure of Hoffman, see pages 9,10 of translation. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Letac et al. (EP 850607) teach an outer body stent which form a concave polygon and in particular have a diamond shape. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F. 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, Thomas Barrett can be reached at 571-272-4746. 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. /BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799