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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 26 January 2026 has been entered.
Response to Arguments
Applicant’s arguments, filed 29 December 2025, with respect to the rejections of the claims over Phan and Makower have been fully considered and are partially persuasive.
Applicant argues that the method suggested by Phan and Makower fail to teach the establishment of a unidirectional flow. However, Applicant is setting forth the resulting effect of the claimed procedure. One of ordinary skill in the art would understand that once a stent is implanted, the direction of flow therethrough depends on physical characteristics on each end of the stent such as fluid pressure and viscosity. As such, the stenting procedure suggested by Phan and Makower will result in a unidirectional flow in the situations in which there is a pressure differential between the body lumens, suggesting the method claimed by Applicant.
Applicant further argues that Phan does not disclose percutaneous implantation. However, Phan references US 6,231,587 to Makower, which discloses percutaneous stent delivery to connect two lumens. Accordingly, and Makower, when taken together, teach the limitations of the claims.
Applicant argues that the techniques to deploy a stent between body lumens and body organs are materially different, but does not specify any differences. The Examiner notes that Phan discloses a method of creating a passage between body lumens, organs, or other structures (see column 1, lines 46-50). The instant Specification at ¶0015 discloses organs and lumens as interchangeable (“…body organs, lumens, and spaces…”; “…facilitate access to organs or lumens for other purposes…”’ “…manipulation of the tissue within the organ or lumen…”). Furthermore, the Specification recites “organ” only 3 times, while it recites “lumen” more than 100 times. The Specification provides no special definition of “organ,” which given a broad reasonable interpretation, includes vasculature1. As such, the prior art teaches the steps of creating a passageway between organs.
Specification
The Specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the Specification does not recite “proximal body organ” or “distal body organ.” The Specification needs to provide antecedent basis for the amended claims.
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.
Claims 1-6, 8, 9, and 11-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 8,357,193 to Phan et al in view of US 6,231,587 to Makower.
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In the specification and figures, Phan teaches the method substantially as claimed by Applicant. With regard to claims 1-9, Phan discloses a method of creating a passage between body lumens, organs, or other structures comprising the steps of inserting a distal/first end of a stent into a proximal/second lumen L1 with a needle 112 (FIG 6A), extending a distal/first end of the stent into a distal/first lumen L2 (FIG 6D), deploying/expanding the distal/first end 124 of the stent into distal/first lumen L2 (FIG 6E), after deploying the distal/first end of the stent,
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deploying/expanding a proximal/second end 122 of the stent in proximal/second lumen L1 by withdrawing a delivery system 120 (FIGS 6F, 6G), wherein the stent defines a passage between the lumina (see FIG 6, column 1, lines 46-50, column 3, lines 27-40).
Phan does not disclose percutaneous stent delivery per se, but discloses the use of a catheter and an endoscope to deploy the disclosed stent, and cites US 6,231,587 to Makower (see column 2, lines 17-45). Makower discloses percutaneous stent delivery primarily for revascularization of an organ, but also teaches that the method may be used to connect two lumens, such as shown in FIGS 22A-E (see at least column 12, lines 43-63). Since Phan cited the Makower reference as part of its disclosure, Phan clearly contemplated percutaneous stent deployment, teaching the instantly claimed method.
With regard to the direction of drainage, Applicant is setting forth the result of a known procedure. Once a passageway is created between two lumens, the direction of flow is dependent on physical characteristics of the fluid in the connected lumina, such as fluid pressure and viscosity. Phan discloses that the stent comprises a central opening to “allow the exchange of fluid between the first body lumen and the second body lumen,” (see column 3, lines 34-36).
With regard to claims 10 and 20, Phan discloses that one body lumen may comprise a stomach, and a second body lumen may comprise a gallbladder (see column 2, lines 48-67).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over US 8,357,193 to Phan et al in view of US 6,231,587 to Makower, further in view of US 9,381,041 to Brown et al.
In the specification and figures, the cited prior art discloses the method substantially as claimed by Applicant (see rejections above).
With regard to claim 19, the cited prior art does not disclose removal of the stent through a scope inserted in a natural body orifice. However, Brown discloses the endoscopic deployment of a stent between lumens that may comprise a stomach and a gallbladder using a trans oral entry, as well as removal when no longer needed (see column 7, lines 43-48, column 15, lines 10-29, column 9, line 35, column 18 lines 35-40). Where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d 1509, 1518-19 (BPAI, 2007) (citing KSR v. Teleflex, 127 S.Ct. 1727, 1740, 82 USPQ2d 1385, 1396 (2007)). It flows naturally that the combination of known steps in a method is a mere application of a second known technique to a first known technique ready for improvement. Applicant claims a combination that only unites old techniques with no change in the respective functions of those old elements, and the combination of those elements yields predictable results; absent evidence that the modifications necessary to effect the combination of elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d at 1518-19 (BPAI, 2007) (citing KSR, 127 S.Ct. at 1740, 82 USPQ2d at1396. Accordingly, since the applicant[s] have submitted no persuasive evidence that the combination of the above elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a) because it is no more than the predictable use of prior art elements according to their established functions resulting in the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement. It would have been obvious to a person having ordinary skill in the art at the time of filing to deploy a stent in the manner disclosed by the cited art, and later remove the stent, as taught by Brown, since both procedures are known in the art.
Allowable Subject Matter
Claims 7, 10, and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art fails to disclose or suggest the limitations of the claims as presented by Applicant. In particular, the prior art discloses forming an anastomosis between a gallbladder and a stomach, but does not teach that the anastomosis is formed by first deploying a first end of a stent in a gallbladder, followed by deploying a second end of a stent in a stomach.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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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.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 26 February 2026
1 See definition of “organ” from Stedman’s Medical Dictionary, 1995: (“any part of the body exercising a specific function…)