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 .
Election/Restrictions
Claims 11-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 17, 2026.
Claim Objections
Claim 10 is objected to because of the following informalities: please change “incudes” to “includes” in line 1. Appropriate correction is required.
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 (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.
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(s) 1 and 4-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gilmartin et al. (US 2020/0214858), disclosed by the December 9, 2022 filed IDS.
Regarding claim 1, Gilmartin discloses a stent 10 configured to connect two spaced apart anatomical locations (see Fig. 11; par.62, 66, 75), the stent comprising: an elongated tubular member 12 (see Fig. 6, par.63) having a longitudinal axis X-X (see Fig. 7), the elongated tubular member comprising at least one knitted filament 24 forming a plurality of twisted knit stitches 22 with rungs 26 (see Fig. 7) extending circumferentially between radially adjacent twisted knit stitches (see Fig. 7), wherein each twisted knit stitch is interconnected with a longitudinally adjacent twisted knit stitch forming a series of linked stitches (see Fig. 7), the elongated tubular member configured to move between a relaxed configuration and an elongated configuration (see par.6, elongated configuration is relaxed configuration and relaxed configuration is expanded configuration); wherein each of the plurality of twisted knit stitches is formed by a single filament defining a loop portion and a crossed base region (see Fig. 9, par.22); and wherein the elongated tubular member has a first longitudinal length in the relaxed configuration and a second longitudinal length in the elongated configuration (elongated tubular member will inherently have lengths in both configurations), wherein the first longitudinal length is less than the second longitudinal length (see par.19).
Regarding claim 4, Gilmartin discloses the loop portion of at least some of the twisted knit stitches is wrapped around the crossed base region of the longitudinally adjacent twisted knit stitch (see Figs. 8-9).
Regarding claim 5, Gilmartin discloses when in the relaxed configuration the rungs define an outer surface 40 of the elongated tubular member and the crossed base region of each twisted knit stitch extends radially outward from the outer surface (see Fig. 10).
Regarding claim 6, Gilmartin discloses wherein the crossed base regions form a raised ridge 34 extending helically around the elongated tubular member in the relaxed configuration (see Fig. 10).
Regarding claim 7, Gilmartin discloses wherein the at least one knitted filament is only a single knitted filament (see par.22).
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gilmartin as applied to claim 1 above, and further in view of Zheng et al. (US 2013/0331927).
Regarding claim 2, Gilmartin discloses the elongated tubular member has a first outer diameter in the relaxed configuration and a second diameter in the elongated configuration (see Figs. 7, 8; par.69-70, each configuration has diameter). Gilmartin does not disclose the first and second outer diameters are substantially the same.
Zheng discloses having a stent at an initial diameter and then having a stent at a deployed diameter, wherein the initial diameter is 1-1.5 times the stent deployed diameter, depending on patterning of the stent. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the initial diameter of Gilmartin be 1-1.5 times the deployed diameter in order to provide a stent with such diameters for deployment within a body, which would predictably result with a deployed stent having a diameter with a relaxed configuration and elongated configuration. As 1 times would be substantially equal, such a range discloses diameters that are substantially the same.
Regarding claim 3, Gilmartin and Zheng disclose the limitations of claim 2 and Gilmartin discloses the first and second outer diameters are defined by the rungs 26 (see Figs. 7, 8).
Claim(s) 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Gilmartin in view of Binmoeller et al. (US 2016/0135941).
Regarding claim 8, Gilmartin discloses a method, the method including inserting an implantable and expandable stent 10 within a patient (see Fig. 11), wherein the stent comprises: an elongated tubular member 12 (see Fig. 6. Par. 63) having a longitudinal axis X-X (see Fig. 7), the elongated tubular member comprising at least one knitted filament 24 forming a plurality of twisted knit stitches 22 with rungs 26 extending circumferentially between circumferentially adjacent twisted knit stitches (see Fig. 7), wherein each twisted knit stitch is interconnected with a longitudinally adjacent twisted knit stitch forming a series of linked stitches (see Fig. 7), the elongated tubular member configured to move between a relaxed configuration and an elongated configuration (see par.6, elongated configuration is relaxed configuration and relaxed configuration is expanded configuration); wherein each of the plurality of twisted knit stitches is formed by a single filament defining a loop portion and a crossed base region (see Fig. 9, par.22); and wherein the elongated tubular member has a first longitudinal length in the relaxed configuration and a second longitudinal length in the elongated configuration (elongated tubular member will inherently have lengths in both configurations), wherein the first longitudinal length is less than the second longitudinal length (see par.19).
Gilmartin does not disclose the method for providing an artificial bridge between a first organ and a second organ of a patient comprising a first end of the expandable stent to the first organ and securing a second end of the stent to the second organ such that an interior of the first organ is in fluid communication with an interior of the second organ through the stent, wherein the first and second organs are spaced apart and at least one of the first and second organs moves relative to the other of the first and second organ during normal function of the first and second organs. Gilmartin discloses the stents described may be used and sized for use in other locations such as, but not limited to: bodily tissue, bodily organs, vascular lumens, non-vascular lumens and combinations thereof, such as, but not limited to, in the coronary or peripheral vasculature, trachea, bronchi, colon, small intestine, biliary tract, urinary tract, prostate, brain, stomach and the like (see par.62).
Binmoeller discloses a method used with stent to connect lumens such as a hepatic duct with the stomach (see par. 34) to drain fluid from the ducts if blocked (see par. 34). Binmoeller further discloses one end of the stent is secured within the stomach and the other end is secured within the bile duct, such that an interior of the bile duct is in fluid communication with an interior of the stomach through the stent allowing for drainage (see par. 91). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the method further include a method used with a stent to connect lumens such as a hepatic duct with the stomach, as disclosed by Binmoeller, in order to drain fluid from ducts if blocked. Consequently, the method would be for providing an artificial bridge between a first organ, hepatic duct, to a second organ, stomach, within a patient’s digestive tract and the first and second organs would be spaced apart from one another and move relative one another during digestion, as this is what a hepatic duct would do with respect to a stomach.
Regarding claim 9, Gilmartin and Binmoeller disclose the limitations of claim 8 and as explained above, the first organ is described as a hepatic duct and the second organ is the patient’s stomach (see rejection of claim 8).
Regarding claim 10, Gilmartin and Binmoeller disclose the limitations of claim 10, but do not disclose the stent includes an uncoated portion and a coated portion, wherein the coated portion includes at least 70% of a length of the stent and the coated portion includes a fluid impervious coating, wherein the uncoated portion extends into the hepatic duct.
Binmoeller discloses the stent connecting the hepatic duct to the stomach can have an uncovered portion on the end that is released inside the hepatic duct (see par. 91) to facilitate flow of bile and the stent deployed in the stomach can be covered to reduce contact between the bile and the wall of the stomach, with coatings disclosed which would be fluid impervious (see par. 41, covering/membrane interpreted as coating and ptfe and silicone materials). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include an uncoated portion and coated portion, with the uncoated portion extending into the hepatic duct as disclosed by Binmoeller in order to facilitate flow and reduce contact between wall of the stomach. While Binmoeller does not disclose the percent of uncoated vs coated, Binmoeller discloses such a variable affecting both facilitated flow and contact between wall of the stomach such that it is a result effective variable. Further, it appears that one of ordinary skill in the art would have had da reasonable expectation of success in modifying the stent to within the claimed coated range of at least 70% as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to a person having ordinary skill before the effective filing date of the claimed invention to have the coated portion include at least 70% of the length of the stent as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gilmartin in view of Zheng and further in view of Binmoeller.
Regarding claim 19, Gilmartin discloses a method, the method including inserting an implantable stent 10 within the patient (see Fig. 11), wherein the implantable stent 10 includes a tubular member 12 formed from at least one knitted wire filament 24, forming a plurality of twisted knit stitches 22 with rungs 26 extending circumferentially between circumferentially adjacent twisted knit stitches (see Figs. 6-8), wherein each twisted knit stitch includes a loop portion and a crossed base region (see Fig. 9, par.22) and is interconnected with a longitudinally adjacent twisted knit stitch forming a series of linked stitches (see Figs. 6-8), the tubular member configured to move between a relaxed configuration with a first longitudinal length and a first diameter, and an elongated configuration with a second longitudinal length and a second diameter (see par.6, elongated configuration is relaxed configuration and relaxed configuration is expanded configuration; elongated tubular member will inherently have lengths and diameters in both configurations), wherein the first longitudinal length is less than the second longitudinal length (see par.19).
Gilmartin does not disclose the first and second outer diameters are substantially the same.
Zheng discloses having a stent at an initial diameter and then having a stent at a deployed diameter, wherein the initial diameter is 1-1.5 times the stent deployed diameter, depending on patterning of the stent. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the initial diameter of Gilmartin be 1-1.5 times the deployed diameter in order to provide a stent with diameters before and after deployment within a body, which would predictably result with a deployed stent having a diameter with a relaxed configuration and elongated configuration, and could be done in such a range depending on patterning. As 1 times would be substantially equal, such a range discloses diameters that are substantially the same.
Gilmartin and Zheng do not disclose the method for draining of fluids from a first organ to a second organ within a patient’s digestive tract or the positioning a first end of the tubular member within the first organ of the patient and a second end of the tubular member within the second organ of the patient, wherein the first and second organs are spaced apart from one another and move relative one another during digestion. Gilmartin discloses the stents described may be used and sized for use in other locations such as, but not limited to: bodily tissue, bodily organs, vascular lumens, non-vascular lumens and combinations thereof, such as, but not limited to, in the coronary or peripheral vasculature, trachea, bronchi, colon, small intestine, biliary tract, urinary tract, prostate, brain, stomach and the like (see par.62).
Binmoeller discloses a method used with stent to connect lumens such as a hepatic duct with the stomach (see par. 34) to drain fluid from the ducts if blocked (see par. 34). Binmoeller further discloses one end of the stent is within the stomach and the other end is within the bile duct (see par. 91). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the method further include a method used with a stent to connect lumens such as a hepatic duct with the stomach, as disclosed by Binmoeller, in order to drain fluid from ducts if blocked. Consequently, the method would be for draining fluids from a first organ, hepatic duct, to a second organ, stomach, within a patient’s digestive tract and the first and second organs would be spaced apart from one another and move relative one another during digestion, as this is what a hepatic duct would do with respect to a stomach.
Regarding claim 20, teachings of Gilmartin and Binmoeller are described above and Gilmartin further discloses in the relaxed configuration the rungs define an outer surface 40 of the tubular member and the crossed base region of each twisted knit stitch extends radially outward from the outer surface (see Fig. 11).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fox (US 2015/0045882) discloses a delivery diameter equal to implantation diameter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA E EISENBERG can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARIANA ZIMBOUSKI/ Primary Examiner, Art Unit 3781
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