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 .
Response to Amendment
The amendment filed November 26th, 2025 has been entered. Claims 1-20 remain pending; claims 1-13 are withdrawn from consideration.
Response to Arguments
Applicant's arguments filed November 26th, 2025 have been fully considered but they are not persuasive. Applicant argues that instead of being directed to a method of accessing an opening of a body lumen, as claimed, Vakharia is directed toward a method of creating a new opening in tissue, and in contrast to claim 14, Vakharia does not disclose or suggest articulating a distal end of an elongated tube toward any target via at least one of a plurality of conductive wires much less toward an opening of a body lumen. The examiner respectfully disagrees, Vakharia explicitly discloses that the elongated medical device is inserted into a body lumen, wherein the distal end of the elongated tube is articulated within the lumen of the body by selectively tensioning at least of the wires to cut tissue within the lumen of the body ([Col. 3, lines 1-12]), as the distal end is articulated/bent within the body lumen the examiner is considering the distal end to be articulated towards the opening of the body lumen as the distal end is being articulated within a body lumen in order to cut tissue within the body lumen.
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.
Claims 14-16 & 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vakharia et al. (previously presented-US 7833223 B2), hereinafter “Vakharia”.
Regarding claim 14, Vakharia discloses a method of accessing an opening of a body lumen, comprising: inserting a flexible elongate tube of a medical device having a distal end into a patient to the opening of the body lumen ([Col. 4, lines 49-55] & [Col. 5, lines 5-13]; Figure 1A—element 112 & 112b; the flexible elongated tube 112 of the medical device 110 is delivered to a tissue site in a delivery configuration); articulating the distal end of the elongate tube toward the opening of the body lumen via at least one of a plurality of conductive wires extending within respective lumens through the flexible elongate tube ([Col. 3, lines 1-34], [Col. 4, line 50 – Col. 5, line 4], & [Col. 5, lines 12-25]; Figures 1A-2C—elements 122/123/124; following the delivery of the medical device to the tissue site; the wires 122/123/124 can be selectively and individually tensioned to bend the distal end of the elongate tube 112), at least a portion of each of the respective lumens in the form of a longitudinally extending channel that is open to an exterior of the tube ([Col. 4, line 49 – Col. 5, line 4] & [Col. 5, lines 25-43]; Figure 1C & 1D—elements 130/132/134 & 136/137/138), the plurality of wires connected at the distal end of the tube ([Col. 4, lines 49-58]) and each having a distal portion extendable radially outward from the respective longitudinally extending channel external to an outer surface of the elongate tube ([Col. 5, lines 5-24]; Figures 1B & 1C—elements 122/123/124 & 136/137/138); extending a first wire of the plurality of wires radially outward to a first radial distance from the elongate tube into contact with the body lumen; and energizing at least one of the plurality of wires ([Col. 3, lines 1-34] & [Col. 9, lines 1-50]; the method can include extending a first of the wires to a tissue-cutting orientation and delivering energy to the first of the wires when it is in the tissue-cutting orientation).
Regarding claim 15, Vakharia discloses all of the limitations of claim 14, as described above.
Vakharia further discloses wherein articulating the distal end of the elongate tube further comprises sliding one or more of the plurality of wires proximally relative to the tube ([Col. 6, lines 9-31]).
Regarding claim 16, Vakharia discloses all of the limitations of claim 14, as described above.
Vakharia further discloses cannulating the opening of the body lumen with the distal end of the elongate tube ([Col. 5, lines 45-51]; Figure 1—element 112b; the distal end 112b of the elongated tube 112 facilitates insertion into tissue by being tapered); and extending a second wire of the plurality of wires radially outward to a second radial distance from the elongate tube into contact with the body lumen ([Col. 3, lines 1-34], [Col. 5, lines 5-24], & [Col. 9, lines 25-50]; the method can include extending a second of the wires to a tissue-cutting orientation).
Regarding claim 18, Vakharia discloses all of the limitations of claim 14, as described above.
Vakharia further discloses extending multiple wires of the plurality of wires radially outward to the first radial distance from the elongate tube into contact with the body lumen, energizing at least one of the plurality of wires ([Col. 3, lines 35-44], [Col. 6, lines 9-53], [Col. 9, lines 1-24], [Col. 9, lines 52-67]; multiple wires of the plurality of wires can simultaneously extend to a tissue cutting orientation; and RF energy can be delivered to the wires; the actuators an selectively apply tension to the wires to extend the wires to the tissue cutting orientation; a locking mechanism can hold the actuators in place to hold the wires in the desired position; the examiner is considering the first radial distance to be a distance where the wires are partially tensioned/extended), and extending multiple wires of the plurality of wires radially outward to a second radial distance from the elongate tube into contact with the body lumen ([Col. 3, lines 35-44], [Col. 6, lines 9-53], [Col. 9, lines 1-24], [Col. 9, lines 52-67]; multiple wires of the plurality of wires can simultaneously extend to a tissue cutting orientation; and RF energy can be delivered to the wires; the actuators an selectively apply tension to the wires to extend the wires to the tissue cutting orientation; a locking mechanism can hold the actuators in place to hold the wires in the desired position; the examiner is considering the second radial distal to be a distance where the wires are fully tensioned/extended).
Regarding claim 19, Vakharia discloses all of the limitations of claim 14, as described above.
Vakharia further discloses wherein the extending a first wire of the plurality of wires radially outward further comprises sequentially extending a second wire of the plurality of wires radially outward and selectively energizing at least one of the first and second wires ([Col. 3, lines 1-34] & [Col. 9, lines 25-67]; the first wire 122 can be extended to the tissue-cutting orientation to form a cut in tissue, then a second wire 123 can be extended to the tissue-cutting orientation and energy can be delivered to the second wire).
Regarding claim 20, Vakharia discloses all of the limitations of claim 14, as described above.
Vakharia further discloses wherein the distal end of the tube is articulated using at least one of the plurality of wires that is a different wire than the at least one wire of the plurality of wires that is energized ([Col. 9, lines 1-24] & [Col. 9, lines 52-67]; as energy is applied to one wire (e.g. 122), tension can be selectively applied to another wire (e.g. 123)).
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.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Vakharia in view of Burbank et al. (previously presented-US 6331166 B1), hereinafter “Burbank”.
Regarding claim 17, Vakharia discloses all of the limitations of claim 14, as described above.
Vakharia does not disclose retracting a sheath from about the flexible elongate tube after cannulating the opening of the body lumen.
Burbank teaches a method of accessing an opening of a body lumen comprising and elongated tube and an energize-able wire ([Col. 4, line 44 – Col. 5, line 16]; Figure 1—elements 18 & 20), the method comprising retracting a sheath from about the flexible elongate tube after cannulating the opening of the body lumen ([Col. 6, lines 9-58]; Figure 1—element 30; after the tip 14 pierces through tissue the sheath 30 can be retracted so as to uncover the cutting wire).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the cannulating of the opening of the body lumen, as disclosed by Vakharia, to include retracting a sheath from about the flexible elongate tube, as taught by Burbank, as both references and the claimed invention are directed toward methods of accessing a body lumen. As disclosed by Burbank, after the tip of the elongated tube pierces through tissue to access the target tissue site, the sheath can be retracted so as to uncover the cutting wire ([Col. 6, lines 9-58]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cannulating of the opening of the body lumen, as disclosed by Vakharia, to include retracting a sheath from about the flexible elongate tube, as taught by Burbank, as such a modification would prevent the cutting wires from contacting tissue while the device is being advanced to the target location.
Conclusion
Accordingly, claims 14-20 are rejected.
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 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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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794