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 .
Claim Rejections - 35 USC § 102
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 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.
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) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless—
(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; or
(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sander; Fiona M. et al. (US 20170035427 A1).
Regarding claim 1, Sander discloses a system (¶ [0003], tissue anchors and methods; ¶ [0039] As shown in FIG. 1, tissue anchor 10; ¶ [0045] Referring now to FIGS. 6A and 6B, a tissue anchor 50);
comprising: a radially expanding tubular framework having a first end region, a second end region, a medial region positioned between the first end region and the second end region, and a lumen extending from the first end region to the second end region (¶ [0045], a tissue anchor 50 comprises an anchor body 52 … a lumen or central passage 58 of the body 52);
wherein the first end region comprises a first flange and the second end region comprises a second flange (¶ [0045], FIGS. 6A and 6B … double-walled flanges 54); and
an auxiliary support structure separate from and disposed about the radially expanding tubular framework and configured to support the first flange and the second flange when the radially expanding tubular framework is in an expanded state (¶ [0045], a plurality of tethers 56 which extend through a lumen or central passage 58 of the body 52 through the flange region and which then extend outwardly over the central saddle region 60 before passing back into the interior of the body … the tethers may be locked in place, typically by a locking device 64, such as crimping pledgets).
Regarding claim 2, Sander discloses that the first flange and the second flange are configured to atraumatically engage a bodily tissue (¶ [0007], alternative or improved tissue anchors and methods for their deployment and use, where the anchors can provide firm attachment of tissue while minimizing the risk of necrosis and other damage to the tissue; ¶ [0045], double-walled flanges 54, as shown in FIG. 6B).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Sander; Fiona M. et al. (US 20170035427 A1).
Regarding claim 16, Sander discloses a method (¶ [0003], tissue anchors and methods for their use in fastening adjacent tissue layers in medical procedures; ¶ [0024], methods for approximating tissue; ¶ [0025] The methods … for holding a wide variety of adjacent tissue layers together);
comprising: forming an anastomosis in tissue (¶ [0051] Referring now to FIG. 11 … This system 100 is particularly useful for connecting a wall of the gallbladder to an intestinal wall … other anastomotic connections … or any part of the gastrointestinal tract; ¶ [0056] Referring now to FIGS. 12A-12E, deployment of the stent 150 to attach gallbladder wall GBW to an intestinal wall IW will be described);
deploying a radially expanding tubular framework into the anastomosis (¶ [0056], Initially, an endoscope E will usually be trans-orally introduced so that it is within the intestines and can image the gallbladder to locate a target site for the anastomotic connection, as illustrated in FIG. 12 A; ¶ [0057], FIG. 12B … The needle 126 may then be advanced through the walls to form an initial penetration; ¶ [0060], FIG. 12E, after the penetration P has been expanded, the outer tubular member 136 will be advanced so that the stent 150 is located in the expanded penetration);
the radially expanding tubular framework comprising a first end region, a second end region, a medial region positioned between the first end region and the second end region; and a lumen extending from the first end region to the second end region (¶ [0045], a tissue anchor 50 comprises an anchor body 52 … a lumen or central passage 58 of the body 52);
wherein the first end region comprises a first flange and the second end region comprises a second flange (¶ [0045], FIGS. 6A and 6B … double-walled flanges 54); and
deploying a separate auxiliary support structure around the deployed radially expanding tubular framework (¶ [0045], a plurality of tethers 56 which extend through a lumen or central passage 58 of the body 52 through the flange region and which then extend outwardly over the central saddle region 60 before passing back into the interior of the body … the tethers may be locked in place, typically by a locking device 64, such as crimping pledgets).
Sander discloses all features of the claimed method but not in a single embodiment. This rejection modifies Sander by modifying the method of Figs. 12A-12E with the implantable tubular framework of Figs. 6A-6B. A skilled artisan would have been able to deliver the implant of Figs. 6A-6B through a tissue wall by penetrating the wall and then delivering the implant of Figs. 6A-6B into the resulting opening. One would be motivated to modify Sander’s embodiments since Sander calls for making anastomotic connections through multiple tissues (¶ [0051]). Therefore, it would have been obvious to combine Sander’s embodiments in order to use Sander’s implant in a specific surgical operation.
Claims 6-8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sander; Fiona M. et al. (US 20170035427 A1) in view of Van Dam; Jacques et al. (US 20120296257 A1).
Regarding claims 6, 8 and 20, Sander lacks a spring. Van Dam discloses implantable devices and methods for treating biliary disease comprising a stent having a tubular portion and a lumen (¶ [0024], [0027], [0060] A device 420 forming the passageway may be left in the patient for a short period of time … The device 420 may also be left in place permanently; ¶ [0073] As shown in FIG. 11, an alternate embodiment of the conduit device 1120; ¶ [0075] Turning now to FIG. 13 … The spring 1352; ¶ [0078], tubular portion 1530 of the conduit 1520 … FIG. 15A); and
an auxiliary support structure comprising a proximal flange retention member, a distal flange retention member (¶ [0078], FIG. 15B and FIG. 15c show other embodiments in which the retaining feature 1522 comprises an element 1558 in a spiral configuration that resembles a corkscrew, with a variable outer diameter); and
a spring coupled between the proximal and distal flange retention members (¶ [0075], FIG. 13 … The spring 1352 may be formed by tightly coiling a wire-shaped material, such as Nitinol, other SMA material, stainless steel, titanium, or other suitable material so that it forms a coil as shown in FIG. 13A);
wherein the spring has an unstretched length less than or equal to the foreshortened length of the stent (¶ [0075], This coil 1352 shares characteristics with an extension spring: if tension is applied at the ends of the component, the coils are caused to separate, and this results in the spring creating a compressive return force F. When no external tension is applied to the coil, the gaps between the individual winds of the coil are minimal, and these gaps may be maintained by residual compressive forces imparted to the material during manufacturing as shown in FIG. 13B).
To clarify, this rejection cites two of Van Dam’s embodiments. Figs. 15B(1) and 15B(2) describe flange retention members and Figs. 13A-13D describe a spring. A skilled artisan would have been able to combine these embodiments by attaching the retention members of 15B(1) and 15B(2) to the spring of Figs. 13A-13D, and then arrange the spring and flange retention members inside Sander’s stent.
Van Dam reinforces a gastric stent against leaks or displacement (¶ [0062], These additional retaining features serve to secure the tissue of the gallbladder wall and the connected lumen (e.g. the wall of the duodenum) and prevent leaks even as the structures undergo relative motion). One would be motivated to modify Sander with Van Dam’s spring to reinforce Sander’s implant against leaks since Sander calls for delivering the implant between the gallbladder and intestines (¶ [0051], This system 100 is particularly useful for connecting a wall of the gallbladder to an intestinal wall). Therefore, it would have been obvious to modify Sander with Van Dam’s spring in order to more securely fasten a gallbladder implant.
Regarding claim 7, Sander lacks flange retention members comprising a second diameter. Van Dam discloses proximal and distal flange retention members comprising a second diameter (¶ [0078], FIG. 15B and FIG. 15c show other embodiments in which the retaining feature 1522 comprises an element 1558 in a spiral configuration that resembles a corkscrew, with a variable outer diameter).
Sander and Van Dam are silent regarding a difference between first and second diameters. The difference between the flanges’ first diameter and the retention members’ second diameter is interpreted as a result-effective variable, subject to experimentation and testing. A result-effective variable is a parameter which achieves a recognized result. These results are obtained by the determination of optimum or workable ranges of said variable through routine experimentation. The difference in diameters determines how much the retention members will overlap the flanges, and also affects how easily they can fit inside a delivery tool.
Too low
The retention members will be at risk of falling into the tubular framework
Optimized range
The retention members will fit easily inside a delivery tool and adequately anchor the stent
Too high
The retention members will be too unwieldy both during deliver and after deployed in the patient
Therefore, it would have been obvious to adjust the difference in diameters in order to adequately anchor the stent and to avoid complicating the surgical procedure. See MPEP 2144.05(II)(A,B). Also see in re Boesch and Slaney, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Response to Arguments
The objection to claim 1 for minor informalities is withdrawn in view of the amendments filed 01 July 2026.
Applicant’s arguments filed 01 July 2026 regarding the rejection of claims 1-2, 6-8, 16 and 20 as amended, under 35 USC § 102 and 103 over Sander and Van Dam, have been fully considered but are not persuasive. Therefore, the rejections are maintained.
Applicant submits that Sander's own disclosure, however, describes the cited tethers as part of the deployment mechanism for foreshortening Sander's anchor body, not as a separate auxiliary support structure for supporting the first and second flanges of a radially expanding tubular framework (remarks p. 7). Applicant asserts that even in the locked post-deployment state, the cited tethers are not an auxiliary support structure separate from the radially expanding tubular framework (remarks p. 7).
Examiner responds that the claims and specification do not specially define the term “separate.” Applicant’s specification describes an auxiliary support structure that extends through the tubular framework’s central lumen. The embodiment of Species B combines an auxiliary support structure with a radially expanding tubular framework (¶ [0074] FIG. 11A, FIG. 11B, and FIG. 11C depict images showing a method of deploying the auxiliary compressive support structure 1000 of FIG. 10 into a deployed stent; ¶ [0076] FIG. 11C illustrates an on axis view of a stent 10 with an auxiliary compressive support structure 1000 deployed therein. FIG. 11C shows a retention end 1002 coupled to a flange 12 and the spring 1004 disposed in the lumen of the stent 10).
Deploying the auxiliary support structure through the tubular framework’s lumen brings into question the meaning of “separate” in this context. Although Sander extends the tethers 56 through a wall of the tissue anchor 50, Sander requires the tethers 56 to be secured with externally applied fasteners or knots (¶ [0045], After the flanges have been deployed, the tethers may be locked in place, typically by a locking device 64, such as crimping pledgets, use of a unidirectional slide or other ratcheting lock device, or use of a slip-knot or a sliding element that relies on friction to secure its position). Needing to apply external fasteners to the tethers 56 suggests that they extend loosely through the tissue anchor 50 and will otherwise detach or dissociate from the tissue anchor 50.
Applicant contends that because Sander's tethers are routed through the interior of the anchor body (through central passage 58 and over saddle region 60), they are neither separate from nor disposed about the radially expanding tubular framework; and because Sander's flanges are formed by operation of those same tethers, the tethers do not support flanges that the framework forms on its own, as amended claim 1 requires (remarks p. 7). Applicant reasons that Sander, by contrast, forms its flanges using the very tethers it later locks, and never deploys a separate structure about the deployed framework (remarks p. 8-9).
Examiner responds that the claims do not specify a path for the auxiliary support structure to extend through or around the tubular framework. The claims do not preclude the auxiliary support structure from passing through a wall of around the tubular framework. At most, claim 1 calls for “an auxiliary support structure separate from and disposed about the radially expanding tubular framework.” Sander's tethers 56 which extend partly through lumen 58 and also extend outwardly over the central saddle region 60 (¶ [0045]).
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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:
Tel 571-272-2590
Fax 571-273-2590
Email Adam.Marcetich@uspto.gov
The Examiner can be reached 8am-4pm Mon-Fri.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application is assigned is 571-273-8300.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
Prosecution Insights