CTFR 18/223,269 CTFR 95446 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. Status of the Claims The amendment filed 02/17/2026 has been entered. Claims 1-7, 11 and 14-22 are pending and under consideration. Response to Arguments In response to the applicant’s arguments with respect to 35 USC 102 and 103 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation. Double Patenting 08-33 AIA The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. 08-35 Claim s 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/354304 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claim 1 recites all feature in the current claim 1, including an occlusion device, an anastomosis anchor and a tether . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 08-35 Claim 1 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/354286 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claim 1 recites all feature in the claim 1, including an occlusion device, an anastomosis anchor and a tether This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 08-35 Claim 1 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/354155 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claim 1 recites all feature in the claim 1, including an occlusion device, an anastomosis anchor and a tether This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 08-35 Claim 1 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/354332 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claim 1 recites all feature in the claim 1, including an occlusion device, an anastomosis anchor and a tether This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 08-35 Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1, 5 and 6 of copending Application No. 18/354346 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims 1, 5 and 6 recites all feature in the claim 1, including an occlusion device, an anchor is adapted to be secured in place relative to the patient’s small intestine or stomach wall and adapted to pierce tissue of the patient’s small intestine or stomach wall and a tether This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 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 Claim s 1-3, 5, 6 and 11 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Abu Dayyeh (US 20200390580 A1) . Regarding claim 1, Abu Dayyeh teaches an implantable medical device system, comprising: an occlusion device (figure 9 and [0058], small intestinal occlusion device 134) adapted to be secured in place within a stomach relative to a pyloric sphincter, the occlusion device further adapted to block stomach contents from passing through a pylorus and into a duodenum (figures 4 and 9 [0040 and 0058] the occlusion device 134, specifically occlusion member 136, is configured to secured to and occlude pyloric sphincter 20 ); wherein the occlusion device comprises an expandable frame (figures 9 and 10, [0058 and 0060] Occlusion member 136 is an expandable cone with multiple wires 108 interconnected at neck 96) with a plurality of interconnected struts (figure 10, wires 108) and a polymeric covering (figure 10, webbing 10 extending over wires) extending over at least a portion of the expandable frame; an anastomosis anchor (figures 2, 4 and 9, anchor member 140 is configured to be anastomosis 26 formed between the stomach wall 14 and jejunum 24) adapted to be secured in place relative to an anastomosis formed between the stomach wall and a small intestine; and a tether (figures 4 and 9, tubular body 138 extend through the duodenum 18 secured between the anchor member 140 and occlusion member 136) adapted to extend through the duodenum, the tether secured at a first end to the occlusion device and at a second end to the anastomosis anchor. Examiners note , although the embodiment relied upon in the rejection (figures 9-10 and [0058]) describes the anchor member 140 as being secured at the pyloric sphincter and pylorus between the stomach and the duodenum with the occlusion member 136 placed within the anastomosis, all other embodiments consistently teach the opposite configuration (figures 4, 5 and [0007-0015 and 0040] and claims). Specifically, the occlusion member is positioned at the pyloric sphincter or pylorus and the anchor member configured to be secured at the anastomosis. Examiner believes that [0058] contains a typographical error and was intended to disclose the same arrangement as the other embodiments. Therefore, for consistency with the remainder of the specification, the anchor member and occlusion member in figures 9 and 10 are interpreted in the same manner as in the other embodiments. Regarding claim 2 , Abu Dayyeh teaches the implantable medical device system of claim 1. Abu Dayyeh further teaches wherein the occlusion device is adapted to be secured within the pyloric sphincter (Figure 4 and 0040) the occlusion device 134, specifically occlusion member 136, is configured to be secured within pyloric sphincter 20) Regarding claim 3, Abu Dayyeh teaches the implantable medical device system of claim 1. Abu Dayyeh further teaches wherein the occlusion device has a maximum outer diameter (OD), where the maximum OD determines an implantation distance from the pyloric sphincter ([0047] the occlusion member can have variable diameter, and its maximum outer diameter is selected and configured to be positioned to pyloric channel). Regarding claim 5 , Abu Dayyeh teaches the implantable medical device system of claim 1. Abu Dayyeh further teaches wherein the expandable frame tapers from the maximum OD to a minimal OD proximate to where the occlusion device is secured to the first end of the tether (figures 9 and 19 and [0060] the occlusion member 136 comprising webbing 106 made of silicone has a conical shape that have maximum outer diameter at base 94 and minimum diameter at neck 96 where the occlusion member being secured to tubular body 138). Regarding claim 6, Abu Dayyeh teaches the implantable medical device system of claim 1. Abu Dayyeh further teaches wherein the expandable frame comprises a plurality of cells defined by the plurality of interconnected struts (figure 10, plurality of cells defined between interconnected wires 108). Regarding claim 11 , Abu Dayyeh teaches the implantable medical device system of claim 1. Abu Dayyeh further teaches wherein the expandable frame comprises an expandable nitinol frame ([0060] wires 108 are expandable nitinol wires) 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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Abu Dayyeh (US 20200390580 A1) . Regarding claim 4, Abu Dayyeh teaches the implantable medical device system of claim 3. Abu Dayyeh further teaches wherein: a maximum OD of 2 to 8 centimeters for the occlusion device corresponds to the occlusion device being adapted for deployment within the patient's pylorus; and a maximum OD of 4 to 12 centimeters for the occlusion device corresponds to the occlusion device being adapted for deployment within the patient's antrum ([0047] occlusion member having variable diameter, for example about 4-6 centimeters, can be positioned within the patient’s pylorus and antrum as claimed). Abu Dayyeh does not teach wherein a maximum OD of 1 to 3 centimeters for the occlusion device corresponds the occlusion device to being adapted for deployment within the patient's pyloric sphincter; However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Abu Dayyeh such that a maximum OD of 1 to 3 centimeters for the occlusion device corresponds the occlusion device to being adapted for deployment within the patient's pyloric sphincter as such a modification would have been an obvious matter of design choice involving a change in Size /Proportion. A Change in size/proportion generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04 IV.A). One of skill in the art motivated to do so for the purpose of providing the occlusion member at desired location that effectively occlude the content pass through from the stomach . 07-21-aia AIA Claim s 7, 15-17 and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Abu Dayyeh (US 20200390580 A1) in view of Birk (US 20130013084 A1) . Regarding claim 7, Abu Dayyeh teaches the implantable medical device system of claim 1. Abu Dayyeh does not teach wherein the polymeric covering comprises polytetrafluoroethylene; In the same field of endeavor, namely a bariatric device, Birk teaches wherein the polymeric covering comprises polytetrafluoroethylene (figure 2 and [0127] nitinol mesh covered by PTFE). Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Abu Dayyeh to incorporate the teachings of Birk and provides the polymeric covering as claimed for the purpose of enhancing acid resistant as taught by Birk ([0022]). Regarding claim 15, Abu Dayyeh teaches the implantable medical device system of claim 11. Abu Dayyeh does not teach wherein the expandable frame comprises a braided or woven structure. In the same field of endeavor, namely a bariatric device, Birk teaches an occlusion device (figure 2 and [0127-0128] expandable stomach element 26) comprises an expandable frame ([0020]), the expandable frame comprises a braided or woven structure ([0018]). Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Abu Dayyeh, to incorporate the teachings of Birk and provides the expandable frame as claimed for the purpose of effectively anchor the device at the desired location while withstanding he continuous pressure and mechanical forces exerted by the stomach as taught by Birk (0019)) . Regarding claim 16 , Abu Dayyeh teaches an occlusion device (figure 9 and [0058] small intestinal occlusion device 134) adapted for use in a biliary gastric bypass system including a tether (figures 4 and 0 [0058] tubular body 138 extend through the duodenum 18 to an anastomosis 26) that extends through a duodenum to an anastomosis formed between a stomach wall and a small intestine, the tether secured relative to the anastomosis (figure 4, the tubular body 138 secured at anchor member 140), the occlusion device comprising: an expandable occlusion member frame (figures 9 and 10 [0058 and 0060] expandable occlusion member 136) comprising a plurality of interconnected nitinol struts (figure 10 and [0060], nitinol wires 108 connected at neck 96); and a polymeric occlusion membrane (figures 9 and 10, webbing 106) supported by the expandable occlusion member frame, Abu Dayyeh does not teach the polymeric occlusion membrane comprising polytetrafluoroethylene; In the same field of endeavor, namely a bariatric device, Birk teaches wherein the polymeric covering comprises polytetrafluoroethylene (figure 2 and [0127] nitinol mesh covered by PTFE). Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Abu Dayyeh to incorporate the teachings of Birk and provides the polymeric covering as claimed for the purpose of providing acid resistant as taught by Birk ([0022]). Regarding claim 17, Abu Dayyeh, as modified by Birk, teaches the occlusion device of claim 16. The combination further teaches wherein the expandable frame comprises a plurality of cells defined by the plurality of interconnected struts (figure 10, plurality of cells defined between wires 108). Regarding claim 19 , Abu Dayyeh teaches an occlusion device (figure 9 and [0058] occlusion device 134) adapted to be secured to a tether (figure 4 and 9, the occlusion device 134 is configured to be secure to a tubular body 138 extends through the duodenum 18 to an anastomosis 26) that extends through a duodenum to an anastomosis formed between a stomach wall and a small intestine, the occlusion device comprising: a tapered occlusion member (figure 10, occlusion member 136 being tapered when expanded) having a maximum OD at a proximal end (figure 10 and [0053], maximum outer diameter at base) thereof and a minimum OD at a distal end (figure 10 and [0053] minimum outer diameter at neck 96) thereof, the distal end adapted to be secured to the tether ([0060]); wherein the tapered occlusion member comprises an expandable nitinol frame ([0060] the occlusion member 136 comprises expandable nitinol wires) and a covering (figure 10, webbing 106) extending over the expandable nitinol frame; and wherein the tapered occlusion member is adapted to limit flow of stomach contents past the tapered occlusion member (figure 4 and [0037] the occlusion member configured to occlude and limit flow of stomach contents through the occlusion member 136 ). Abu Dayyeh does not teach the covering is polytetrafluoroethylene. In the same field of endeavor, namely a bariatric device, Birk teaches wherein the polymeric covering comprises polytetrafluoroethylene (figure 2 and [0127] nitinol mesh covered by PTFE). Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Abu Dayyeh to incorporate the teachings of Birk and provides the polymeric covering as claimed for the purpose of providing acid resistant as taught by Birk ([0022]). Regarding claim 20, Abu Dayyeh, as modified by Birk, teaches the occlusion device of claim 19. The combination further teaches wherein the maximum OD of the tapered occlusion member is selected to define an implantation distance from the pyloric sphincter (Abu Dayyeh; [0047] the occlusion member can have variable diameter, and its maximum outer diameter is selected and configured to be positioned to pyloric channel) Regarding claim 21 , Abu Dayyeh, as modified by Birk, teaches the occlusion device of claim 19. The combination further teaches wherein the tapered occlusion member comprises a plurality of cells defined by the plurality of interconnected struts (Abu Dayyeh; figure 10, plurality of cells defined between wires 108). Regarding claim 22 , Abu Dayyeh, as modified by Birk, teaches the occlusion device of claim 21. The combination further teaches wherein the expandable nitinol frame comprises a plurality of cells defined by the plurality of interconnected struts (Abu Dayyeh; [0060] expandable nitinol wires 108 comprises plurality of cells defined between interconnected wires 106) . 07-21-aia AIA Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Abu Dayyeh (US 20200390580 A1) in view of Thompson et al (US 20120184893 A1) . Regarding claim 14, Abu Dayyeh teaches the implantable medical device system of claim 11. Abu Dayyeh does not expressly teach wherein the expandable frame comprises a laser cut expandable frame. In the same field of endeavor, namely anchors for intestinal bypass sleeves, Thompson teaches wherein the expandable frame (figure 7 [0016-0018, 0147 and 0149] anchor 110 can be laser cut) comprises a laser cut expandable frame. Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Abu Dayyeh to incorporate the teachings of Thompson and provides the expandable frame as claimed, and one of skill in the art motivated to do so, for the purpose of providing precises structure and allows the entire structure to be carved from a single piece of material, such as nitinol tubing or flat sheet ([0016]). This monolithic construction eliminates need for welds and joints, thereby improving overall structural integrity . 07-21-aia AIA Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Abu Dayyeh (US 20200390580 A1) in view of Birk (US 20130013084 A1), and in further view of Thompson et al (US 20120184893 A1) . Regarding claim 18 , Abu Dayyeh, as modified by Birk, teaches the occlusion device of claim 16. The combination does not teach wherein the expandable frame comprises a laser cut expandable frame. In the same field of endeavor, namely anchors for intestinal bypass sleeves, Thompson teaches wherein the expandable frame (figure 7 [0016-0018, 0147 and 0149] anchor 110 can be laser cut) comprises a laser cut expandable frame. Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Abu Dayyeh, as modified by Birk, to incorporate the teachings of Thompson and provides the expandable frame as claimed, and one of skill in the art motivated to do so, for the purpose of providing precises structure and allows the entire structure to be carved from a single piece of material, such as nitinol tubing or flat sheet ([0016]). This monolithic construction eliminates needs for welds and joints, thereby improving overall structural integrity. 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 SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700. 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, Sarah Al-Hashimi can be reached at (571) 272-7159. 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. /S.H./Examiner, Art Unit 3781 /PHILIP R WIEST/Primary Examiner, Art Unit 3781 Application/Control Number: 18/223,269 Page 2 Art Unit: 3781 Application/Control Number: 18/223,269 Page 3 Art Unit: 3781 Application/Control Number: 18/223,269 Page 4 Art Unit: 3781 Application/Control Number: 18/223,269 Page 5 Art Unit: 3781 Application/Control Number: 18/223,269 Page 6 Art Unit: 3781 Application/Control Number: 18/223,269 Page 7 Art Unit: 3781 Application/Control Number: 18/223,269 Page 8 Art Unit: 3781 Application/Control Number: 18/223,269 Page 9 Art Unit: 3781 Application/Control Number: 18/223,269 Page 10 Art Unit: 3781 Application/Control Number: 18/223,269 Page 11 Art Unit: 3781 Application/Control Number: 18/223,269 Page 12 Art Unit: 3781 Application/Control Number: 18/223,269 Page 13 Art Unit: 3781 Application/Control Number: 18/223,269 Page 14 Art Unit: 3781
Prosecution Insights