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 .
Status of Claims
Claims 1-20 are pending, of which Claims 1-2 are amended and Claims 5-7 & 9-20 remain withdrawn for being directed to non-elected species. Claims 1-4 & 8 are examined on the merits. No new matter is found.
Response to Arguments
Applicant's arguments filed 1/2/2026 have been fully considered but they are not persuasive.
Applicant argues that since reference Abu Dayyeh’s occlusion device, which includes an occlusion member (56) and tubular member (52) with a distal tip (64), “may be occluded to prevent movement of fluid into and out of tubular member 52,” suggests that the distal tip is also not necessarily occluded. Applicant further points to [0037] of Abu Dayyeh, which discloses that the distal tip would allow passage of a wire and then sealed upon removal of the wire, as support that Abu Dayyeh fails to disclose the currently amended claim limitation “the occlusion device further adapted to block stomach contents from passing through or beyond the occlusion device.” Examiner respectfully contends that the claim does not expressly require a timeframe of the occlusion or that the blockage applies to all fluids and stomach contents. Given Abu Dayyeh does indeed disclose that the distal tip (64) prevents movement of fluid into the tubular member (which passes through the occlusion member 56), at least from the time that the occlusion device (50) is set in place in the intestine and the wire is removed (therefore distal tip 64 is sealed), one skilled in the art would reasonably expect that no fluid or stomach content can enter through the distal tip at all. Additionally, even assuming that in the situation that distal tip (64) is not sealed and that the wire aperture remains after removal of the wire, the disclosure that “the aperture to allow passage of the wire is sized such that an insignificant amount of liquid could enter through the aperture” suggests that most of the stomach liquid/content are being kept out of the occlusion device/tubular member. Examiner asserts that this would meet a broad reasonable interpretation of “adapted to block stomach contents from passing through or beyond the occlusion device” because the majority of the contents are indeed prevented from entering. Lastly, Abu Dayyeh’s disclosure, that insignificant amount of liquid would enter through the wire aperture and that the distal tip would be sealed after removing the wire, clearly implies to one skilled in the art that the device is designed to block stomach contents from passing through the occlusion device through the pylorus. As such, the amended claims are unpatentable in view of Abu Dayyeh.
Given the newly amended language is directed at a likely function of an occlusion device and the copending applications recite an occlusion device placed at the pylorus, the provisional nonstatutory double patenting rejections in view of said copending application are maintained.
Double Patenting
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/223,269 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claim 1 recites all features in the current claim 1, including an occlusion device, an anastomosis anchor, and a tether secured to the occlusion device.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/354,286 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claim 1 recites all features in the current claim 1, including an occlusion device, an anastomosis anchor, and a tether secured to the occlusion device. Said reference application claim 1 also recites the tether resists degradation from gastric juices and tethered at a second end to the anastomosis anchor.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/354,304 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claim 1 recites all features in the current claim 1, including an occlusion device, an anastomosis anchor, and a tether secured to the occlusion device. Said reference application claim 1 also recites a dynamic leash.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/354,332 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claim 1 recites all features in the current claim 1, including an occlusion device, an anastomosis anchor, and a tether secured to the occlusion device. Said reference application claim 1 also recites a delivery system comprising a guidewire, a gastric bypass device, and a delivery device that carries the gastric bypass device.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
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 –
(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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abu Dayyeh (US 2020/0390580).
Re Claim 1, Abu Dayyeh discloses an implantable medical device system, comprising:
an occlusion device (50) 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 or beyond the occlusion device ([0037] “a distal tip 64 of tubular member 52 may be occluded to prevent movement of fluid into and out of tubular member 52” and “the aperture to allow passage of the wire is sized such that an insignificant amount of liquid could enter through the aperture” implies that the distal tip 64 of tubular member 52 is intended to block liquid/content from getting past the occlusion member 56 at all times, when the placement wire is there and after the wire is retracted), through a pylorus, and into a duodenum;
an anastomosis anchor (anchor member 54) adapted to be secured in place relative to an anastomosis structure that secures an anastomosis formed between a stomach wall and a small intestine ([0038] “anchor member 54 can be configured to engage a stent that is located in anastomosis 26”); and
a tether (tube 52) adapted to extend through the duodenum (Fig. 4), the tether secured at a first end to the occlusion device (Fig. 2).
Claim Rejections - 35 USC § 103
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.
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.
Claims 2-4, 8 are rejected under 35 U.S.C. 103 as being unpatentable over Abu Dayyeh in view of Behan (US 2018/0338849).
Re Claim 2, Abu Dayyeh discloses claim 1, but does not expressly disclose wherein the anastomosis structure comprises a braided structure including:
a first annular section adapted to be disposed within the stomach;
a second annular section adapted to be disposed within the small intestine; and
an intervening portion extending between the first annular section and the second annular section.
Behan discloses a stent structure for placement in a pylorus, between a stomach and a small intestine of a patient, the stent structure have first and second annular sections disposed in the stomach and the small intestine respectively, and an intervening portion between the two annular sections (see e.g., Figs. 104, 107, 109, where funnel shaped region 801 can be considered the first annular section and bulbous region 803 is the second annular section, with softer region therebetween). It would have been obvious to one skilled in the art at the time of filing to glean from the stent shape taught by Behan as such stents are well known in the field and would be more readily available in the commercial space. It is also a self-expanding stent (e.g., [0393]) and would therefore be adaptable to anastomosis of various sizes.
Re Claim 3, Abu Dayyeh and Behan combine to disclose claim 2, and Abu Dayyeh further discloses the anastomosis anchor (54) comprises a ring anchor moveable between a collapsed configuration for delivery and an expanded configuration for anchoring to the anastomosis structure (implied by [0038] disclosing the anchor member being conical in shape and seeing Figs. 7-11 showing the structure for use at the anastomosis, 136, being an expandable structure having a ring-shaped opening, also see e.g., [0058]).
Re Claim 4, Abu Dayyeh and Behan combine to disclose claim 3, and Abu Dayyeh further discloses wherein the ring anchor comprises:
an annular structure (e.g., base 94, Fig. 10); and
a plurality of attachment members (multiple wires 108, Fig. 10) secured about a periphery of the annular structure, the plurality of attachment members adapted to secure the ring anchor to the tether (see e.g., [0060], note that tubular body 138 is equivalent to tubular body 52 and therefore may be interpreted as the tether).
Abu Dayyeh does not expressly disclose that the annular structure has an outer diameter greater than an outer diameter of any portion of the anastomosis structure. However, a person of ordinary skill has good reason to pursue the known options (the anchor having a diameter larger, equal to, or smaller than that of the anastomosis stent) within his or her technical grasp. If this leads to the anticipated success (the anchor can be engaged with or secured to the anastomosis stent), it is likely that product was not of innovation but of ordinary skill and common sense. In that instant the fact that a combination was obvious to try might show that it was obvious under § 103. See MPEP 2143 (E).
Re Claim 8, Abu Dayyeh and Behan combine to disclose claim 2, and Abu Dayyeh implies that the anastomosis anchor comprises a self-expanding braid (since tubular body 52 is formed of braided nitinol, see [0037], and anchor 54 is shows to be an integral extension of tubular body 52, Fig. 2).
Conclusion
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.
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/SUSAN S SU/ Primary Examiner, Art Unit 3781
20 January 2026