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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/18/2026 has been entered.
Status of Claims
Claims 1-2, 5-17 & 21-25 are pending, of which Claim 1 is amended and Claims 21-25 are new. Claims 5-7 & 9-17 remain withdrawn and Claims 1-2, 8, & 21-25 are examined. No new matter is found.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the amendments necessitate a new ground of rejection.
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 1 & 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Abu Dayyeh (US 2020/0390580) in view of Babkes et al. (US 2013/0281911).
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).
Abu Dayyeh does not disclose wherein the anastomosis anchor comprises a metal ring defining a periphery of the anastomosis anchor and a plurality of attachment members each having a distal end attached to the metal ring and a proximal end attached to the tether. Instead Abu Dayyeh discloses a funnel-shaped anchor (occlusion member 136 from the embodiment shown in Fig. 10, configured to be placed within the anastomosis, see [0058]) formed from a webbing (106) and a plurality of attachment members (wires 108, [0060]) that allows the anchor to expand in a way similar to an umbrella ([0060], Fig. 10).
Babkes discloses a gastrointestinal implant having an anchor (stomach anchoring member 222, Fig. 13) that secures a tube/sleeve (duodenal sleeve 228) in the small intestine, wherein the anchor comprises a metal ring (outer ring 232, [0071] “Nitinol ring embedded within a silicone outer covering”) that is movable between a collapsed configuration for delivery and an expanded configuration for anchoring (e.g., [0010]), and a plurality of attachment members (flexible cords 226) each having a distal end attached to the metal ring (Figs. 13-14) and a proximal end attached to an elongated tubular sleeve (the cords 226 are attached to an entire length of the sleeve and thus the ends of the cords will be where the sleeve ends), thereby securing the metal ring to the tubular sleeve, and wherein the metal ring defines a periphery of the anastomosis anchor in the expanded configuration (see Fig. 13).
It would have been obvious to one skilled in the art at the time of filing to modify Abu Dayyeh with Babkes since the simple substitution of one known element for another (i.e., replacing a funnel-shaped stomach anchor with a similarly-shaped stomach anchor) to obtain predictable results (securing a sleeve within a small intestine) establishes a prima facie case of obviousness (MPEP 2143).
Re Claim 21, in the combination discussed in claim 1, Babkes also discloses wherein the plurality of attachment members are the only structure securing the anastomosis anchor to the tether (Fig. 13).
Re Claim 22, in the combination discussed in claim 1, Babkes also discloses wherein the metal ring comprises a planar open ring when in the expanded configuration (Figs. 13 & 14).
Re Claim 23, 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).
Abu Dayyeh does not disclose wherein the anastomosis anchor comprises a metal ring having a planar open profile defining a periphery of the anastomosis anchor and a plurality of attachment members each having a distal end attached to the metal ring and a proximal end attached to the tether. Instead Abu Dayyeh discloses a funnel-shaped anchor (occlusion member 136, configured to be placed within the anastomosis, see [0058] & Fig. 10) formed from a webbing (106) and a plurality of attachment members (wires 108, [0060]) that allows the anchor to expand in a way similar to an umbrella ([0060], Fig. 10).
Babkes discloses a gastrointestinal implant having an anchor (stomach anchoring member 222, Fig. 13) that secures a tube/sleeve (duodenal sleeve 228) in the small intestine, wherein the anchor comprises a metal ring (outer ring 232, [0071] “Nitinol ring embedded within a silicone outer covering”) that is movable between a collapsed configuration for delivery and an expanded configuration (e.g., [0010]) in which the metal ring has a planar open profile defining a periphery of the anastomosis anchor (Figs. 13-14), and a plurality of attachment members (flexible cords 226) each having a distal end attached to the metal ring (Figs. 13-14) and a proximal end attached to an elongated tubular sleeve (the cords 226 are attached to an entire length of the sleeve and thus the ends of the cords will be where the sleeve ends), thereby securing the metal ring to the tubular sleeve.
It would have been obvious to one skilled in the art at the time of filing to modify Abu Dayyeh with Babkes since the simple substitution of one known element for another (i.e., replacing a funnel-shaped stomach anchor with a similarly-shaped stomach anchor) to obtain predictable results (securing a sleeve within a small intestine) establishes a prima facie case of obviousness (MPEP 2143).
Re Claim 24, in the combination discussed in claim 23, Babkes also discloses wherein the metal ring comprises nitinol ([0071]).
Re Claim 25, in the combination discussed in claim 23, Babkes also discloses wherein each of the plurality of attachment members are flexible (e.g., [0068] “flexible cords 226”).
Claims 2 & 8 are rejected under 35 U.S.C. 103 as being unpatentable over Abu Dayyeh and Babkes as applied to claim 1 above, and further in view of Behan (US 2018/0338849).
Re Claim 2, Abu Dayyeh and Babkes combine to disclose claim 1, but they do 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 braided 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 modify with 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 8, Abu Dayyeh, Babkes 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
CN 118203744, US 2011/0004146, US 2008/0208356, and US 2013/0310727 each discloses a gastrointestinal anchor that can be formed of a ring and a plurality of struts extending therefrom.
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/SUSAN S SU/ Primary Examiner, Art Unit 3781
26 June 2026
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