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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/21/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
(a)(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.
Claim(s) 1-5, 7, 10-16 and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roth (US 2003/0181938 A1).
Regarding claim 1, Roth discloses:
A catheter for endovascular treatment of a blood vessel (see Figs. 1 and 4), comprising:
a catheter body (sheath 12, see Fig. 1) including a distal end (see Fig. 3C showing the distal tip of the sheath 12); and
a distal tip assembly (enlarging system 10, see Fig. 4,5a/b; see also Para. [0070 and [0074]) movably connected to the catheter body at the distal end of the catheter body (see Para. [0070], [0074] and [0078]);
the distal tip assembly including a plurality of tips that nest together (see Figs. 4 showing a plurality of tips) and of which each comprises a fistula forming element (cutting member 42 and engaging member 62; see Figs. 4); and a support shaft (shaft 60 and guidewire GW; see Fig. 4);
wherein at least one of the plurality of tips is independently movable relative to an adjacent one of the plurality of tips between a retracted position and an extended position to provide a treatment region therebetween (see Para. [0078]-[0079]; shaft 60 is slidable within a lumen of debulker 14; movement of the shaft 60 causes movement of engagement member 62 due to the connection between the two components per Para. [0074]).
Regarding claim 2, Roth discloses the invention of claim 1, Roth further discloses wherein an outer diameter of the adjacent one of the plurality of tips is larger than an outer diameter of the at least one of the plurality of tips (see Fig. 4 showing wherein the radial dimension of the cutting member 42 is smaller than that of the tip of the distal portion 36).
Regarding claim 3, Roth discloses the invention of claim 1, Roth further discloses wherein the support shaft of the at least one of the plurality of tips extends through the support shaft of the another of the plurality of tips (guidewire GW extends through lumen of shaft 60; see Fig. 4C showing a cross-sectional diagram).
Regarding claim 4, Roth discloses the invention of claim 1, Roth further discloses wherein the at least one of the plurality of tips is located distal of the adjacent one of the plurality of tips (see Fig. 4; tip of engaging member 62 is located distally of the cutting member tip 42), the treatment region located between a proximally-facing surface of the at least one of the plurality of tips and a distally-facing surface of the adjacent one of the plurality of tips with the at least one of the plurality of tips in the extended position (see Fig. 4 showing a “treatment region” between the proximal end of engaging member 62 and the distal end of cutting member 42).
Regarding claim 5, Roth discloses the invention of claim 4, Roth further discloses wherein the plurality of tips define at least two treatment regions therebetween (“treatment region” between engaging member 62 and cutting member 42; additional “treatment region” between cutting member 42 and distal portion 36; see Fig. 4).
Regarding claim 7, Roth discloses the invention of claim 4, Roth further discloses wherein the at least one of the plurality of tips is a distal tip (engaging member 62, see Fig. 4) and the adjacent one of the plurality of tips is a middle tip (cutting member 42, see Fig. 4), the plurality of tips further comprising a proximal tip that is adjacent the middle tip (tip of distal portion 36, see Fig. 4).
Regarding claim 10, Roth discloses:
A method of using a catheter (see Figs. 1 and 4), the method comprising:
holding a handle of the catheter for using the catheter (handle 22, see Fig. 1), the catheter comprising:
a catheter body (sheath 12, see Fig. 1) extending distally from the handle (see Fig. 1); and
a distal tip assembly (enlarging system 10, see Fig. 4; see also Para. [0070 and [0074]) movably connected to the catheter body at a distal end of the catheter body (see Para. [0070], [0074] and [0078]);
the distal tip assembly including a plurality of tips that nest together (see Figs. 4 showing a plurality of tips) each comprising a fistula forming element (cutting member 42 and engaging member 62; see Figs. 4) and a support shaft (shaft 60 and guidewire GW; see Fig. 4);
wherein at least one of the plurality of tips is independently movable relative to an adjacent one of the plurality of tips between a retracted position and an extended position to provide a treatment region therebetween (see Para. [0078]-[0079]; shaft 60 is slidable within a lumen of debulker 14; movement of the shaft 60 causes movement of engagement member 62 due to the connection between the two components per Para. [0074]);
moving the at least one of the plurality of tips to the extended position (see Para. [0078]-[0079]; see also Figs. 5A-5B); and
moving the at least one of the plurality of tips toward the retracted position (see Para. [0078]-[0079]; see also Figs. 5A-5B).
Regarding claim 11, Roth discloses the method of claim 10, Roth further discloses activating the fistula forming element of the adjacent one of the plurality of tips (see Para. [0079]).
Regarding claim 12, Roth discloses the method of claim 10, Roth further discloses wherein an outer diameter of the adjacent one of the plurality of tips is larger than an outer diameter of the at least one of the plurality of tips (see Fig. 4 showing wherein the radial dimension of the cutting member 42 is smaller than that of the tip of the distal portion 36).
Regarding claim 13, Roth discloses the method of claim 10, Roth further discloses wherein the support shaft of the at least one of the plurality of tips extends through the support shaft of the another of the plurality of tips (guidewire GW extends through lumen of shaft 60; see Fig. 4C showing a cross-sectional diagram).
Regarding claim 14, Roth discloses the method of claim 10, Roth further discloses wherein the at least one of the plurality of tips is located distal of the adjacent one of the plurality of tips (see Fig. 4; tip of engaging member 62 is located distally of the cutting member tip 42), the treatment region located between a proximally-facing surface of the at least one of the plurality of tips and a distally-facing surface of the adjacent one of the plurality of tips with the at least one of the plurality of tips in the extended position (see Fig. 4 showing a “treatment region” between the proximal end of engaging member 62 and the distal end of cutting member 42).
Regarding claim 15, Roth discloses the method of claim 14, Roth further discloses wherein the at least one of the plurality of tips is a distal tip (engaging member 62, see Fig. 4) and the adjacent one of the plurality of tips is a middle tip (cutting member 42, see Fig. 4), the plurality of tips further comprising a proximal tip that is adjacent the middle tip (tip of distal portion 36, see Fig. 4).
Regarding claim 16, Roth discloses the method of claim 14, Roth further discloses wherein the plurality of tips define at least two treatment regions therebetween (“treatment region” between engaging member 62 and cutting member 42; additional “treatment region” between cutting member 42 and distal portion 36; see Fig. 4).
Regarding claim 18, Roth discloses:
A surgical device (see Figs. 1 and 4), comprising:
a catheter for endovascular treatment of a blood vessel (sheath 12, see Fig. 1), the catheter comprising:
a catheter body (body of sheath 12, see Fig. 1); and
a distal tip assembly (enlarging system 10, see Fig. 4,5; see also Para. [0070 and [0074]) movably connected to the catheter body at a distal end of the catheter body (see Para. [0070], [0074] and [0078]);
the distal tip assembly including a first tip (engaging member 62, see Fig. 4) and a second tip adjacent the first tip (cutting member 42, see Fig. 4), the first tip being connected to a support shaft (guidewire GW, see Fig. 4) and comprising a fistula forming element (body 68, see Fig. 4);
wherein the first tip is movable between extended and retracted positions relative to the second tip to move the fistula forming element toward and away from the second tip (see Para. [0078]-[0079]; haft 60 is slidable within a lumen of debulker 14; movement of the shaft 60 causes movement of engagement member 62 due to the connection between the two components per Para. [0074]; see also Figs. 5A-5B).
Regarding claim 19, Roth discloses the invention of claim 18, Roth further discloses wherein the first tip is located distal of the second tip (see Fig. 4), wherein the fistula forming element is located at a distally-facing surface of the first tip (see Fig. 4; tapered surface of body 68 is capable of forming fistulas upon rotation).
Regarding claim 20, Roth discloses the invention of claim 18, Roth further discloses wherein an outer diameter of the second tip is larger than an outer diameter of the first tip (radial diameter of cutting member 42 is larger than the distal end of the tapered engaging portion 62, see Fig. 4).
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.
Claim(s) 6, 8-9 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roth (US 2003/0181938 A1) in view of Bayer (US 2004/0133228 A1).
Regarding claim 6, Roth discloses all of the limitations of the invention of claim 4.
However, Roth does not expressly disclose wherein the distally-facing surface and the proximally-facing surface have non-planar contours.
In the same field of endeavor, namely elongate endoscope devices having a selectively detachable/slidable distal tip, Bayer teaches a catheter for treatment within a blood vessel (instrument 10, see Fig. 1A) comprising a distal tip assembly (see Fig. 15 showing the distal tip assembly of the instrument 10) including a plurality of tips nested together (see Fig. 15; tip of shaft 12 and cradle section 714); wherein at least one of the plurality of tips is independently movable relative to an adjacent one of the plurality of tips between a retracted position and an extended position (see Para. [0099]); wherein the proximally-facing surface of one of the plurality of tips comprises an interlocking portion that interlocks with an interlocking portion of the distally-facing surface of the other one of the plurality of tips facing the proximally-facing surface (tabs 755a/755b of the shaft 12 align with and insert into corresponding cut-out portions within the cradle section; see Fig. 15 and Para. [0099]) to facilitate alignment of the two tips when in the retracted position and to help keep tissue and debris from falling into the working cavity between the two tip portions (see Para. [0099]); the corresponding tabs and recesses resulting in a non-planar contour along the surfaces of the distal end of the shaft and proximal end of the cradle section.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the distal end of the cutting member 42 and proximal end of engaging member 62 to comprise corresponding interlocking tabs and recesses as taught and suggested by Bayer to, in this case, facilitate axial and rotational alignment when the two components are abutting against one-another in the retracted configuration in addition to helping keep tissue and debris from falling into the working cavity between the two tip portions (see Bayer Para. [0099]); the corresponding tabs and recesses resulting in a non-planar contour along the surfaces of the distal end of the cutting member and proximal end of the engaging member.
Regarding claim 8, Roth discloses all of the limitations of the invention of claim 4.
However, Roth does not expressly disclose wherein the proximally-facing surface comprises an interlocking portion that interlocks with an interlocking portion of the distally-facing surface facing the proximally-facing surface.
In the same field of endeavor, namely elongate endoscope devices having a selectively detachable/slidable distal tip, Bayer teaches a catheter for treatment within a blood vessel (instrument 10, see Fig. 1A) comprising a distal tip assembly (see Fig. 15 showing the distal tip assembly of the instrument 10) including a plurality of tips nested together (see Fig. 15; tip of shaft 12 and cradle section 714); wherein at least one of the plurality of tips is independently movable relative to an adjacent one of the plurality of tips between a retracted position and an extended position (see Para. [0099]); wherein the proximally-facing surface of one of the plurality of tips comprises an interlocking portion that interlocks with an interlocking portion of the distally-facing surface of the other one of the plurality of tips facing the proximally-facing surface (tabs 755a/755b of the shaft 12 align with and insert into corresponding cut-out portions within the cradle section; see Fig. 15 and Para. [0099]) to facilitate alignment of the two tips when in the retracted position and to help keep tissue and debris from falling into the working cavity between the two tip portions (see Para. [0099]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the distal end of the cutting member 42 and proximal end of engaging member 62 to comprise corresponding interlocking tabs and recesses as taught and suggested by Bayer to, in this case, facilitate axial and rotational alignment when the two components are abutting against one-another in the retracted configuration in addition to helping keep tissue and debris from falling into the working cavity between the two tip portions (see Bayer Para. [0099]).
Regarding claim 9, the combination of Roth and Bayer makes obvious the invention of claim 8, Roth, as modified by Bayer, further teaches wherein one of the interlocking portions is a protrusion and the other one of the interlocking portions is a recess (protruding tabs along the distal end of cutting member 42 and corresponding recesses align the proximal end of engaging member 62, as incorporated from the teachings of Bayer; see Bayer Fig. 15 and Para. [0099]).
Regarding claim 17, Roth discloses all of the limitations of the method of claim 14.
However, Roth does not expressly disclose wherein the proximally-facing surface comprises an interlocking portion that interlocks with an interlocking portion of the distally-facing surface facing the proximally-facing surface.
In the same field of endeavor, namely elongate endoscope devices having a selectively detachable/slidable distal tip, Bayer teaches a catheter for treatment within a blood vessel (instrument 10, see Fig. 1A) comprising a distal tip assembly (see Fig. 15 showing the distal tip assembly of the instrument 10) including a plurality of tips nested together (see Fig. 15; tip of shaft 12 and cradle section 714); wherein at least one of the plurality of tips is independently movable relative to an adjacent one of the plurality of tips between a retracted position and an extended position (see Para. [0099]); wherein the proximally-facing surface of one of the plurality of tips comprises an interlocking portion that interlocks with an interlocking portion of the distally-facing surface of the other one of the plurality of tips facing the proximally-facing surface (tabs 755a/755b of the shaft 12 align with and insert into corresponding cut-out portions within the cradle section; see Fig. 15 and Para. [0099]) to facilitate alignment of the two tips when in the retracted position and to help keep tissue and debris from falling into the working cavity between the two tip portions (see Para. [0099]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the distal end of the cutting member 42 and proximal end of engaging member 62 to comprise corresponding interlocking tabs and recesses as taught and suggested by Bayer to, in this case, facilitate axial and rotational alignment when the two components are abutting against one-another in the retracted configuration in addition to helping keep tissue and debris from falling into the working cavity between the two tip portions (see Bayer Para. [0099]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2013/0289696 A1 to Maggard, US 2015/0367508 A1 to Hatakeyama, US 2009/0105729 A1 to Zentgraf, US 2022/0008071 A1 to Rose and US 2017/0007311 A1 to Hull all disclose devices used to form fistulas comprising a detachable distal end tip.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/Andrew Restaino/Primary Examiner, Art Unit 3771
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