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 (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.
(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 1, 5, 6, and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Musbach et al. (U.S. Patent Pub. No. 20070135763) hereinafter Musbach.
Regarding claim 1, Musbach discloses a catheter (catheter 116; see FIG. 6, the Examiner notes that all reference characters cited below refer to FIG. 6 unless otherwise stated) comprising:
a shaft (shaft 132; “elongate shaft 132 may be a micromachined hypotube such as those described with respect to FIGS. 1-5”, [0083]) comprising a proximal end (end of shaft near region 118), a distal end (end near region 122), an actuating portion (portion proximally adjacent to port 130) proximal to the distal end, and a first lumen (lumen of shaft 150, see FIG. 10) extending along a length of the shaft between the proximal and distal ends; and
a plurality of slots (slots 22; see FIG. 1) disposed and spaced-apart from each other along the actuating portion, the plurality of slots extending radially into the first lumen (see FIG. 1).
Regarding claim 5, Musbach discloses the claimed invention as discussed above concerning the rejection of claim 1, and Musbach further discloses wherein each of the plurality of slots extends radially through the first lumen (the Examiner notes [0062] of Musbach details that individual slots can have varying wall thickness ranging from a depth less than the wall thickness of the tube to a depth extending completely through the tube).
Regarding claim 6, Musbach discloses the claimed invention as discussed above concerning the rejection of claim 1, and Musbach further discloses comprising a second lumen (see FIG. 10) extending through the shaft, wherein the plurality of slots is external to the second lumen (the Examiner notes [0062] of Musbach details that individual slots can have varying wall thickness ranging from a depth less than the wall thickness of the tube to a depth extending completely through the tube).
Regarding claim 8, Musbach discloses the claimed invention as discussed above concerning the rejection of claim 1, and Musbach further discloses wherein a cross-sectional profile of the plurality of slots transverse to a longitudinal axis along the length of the shaft comprises a U-shape, a V-shape (see FIG. 3), a box-shape (see FIGS. 1, 2, 4, and 5), or a combination thereof.
Regarding claim 9, Musbach discloses the claimed invention as discussed above concerning the rejection of claim 1, and Musbach further discloses wherein an axial spacing between each of the plurality of slots along the length of the shaft is longer than an axial length of each of the plurality of slots (see FIG. 1; “hypotube 10 may be formed having any desired length, width, material thickness, and slot size as required to satisfy the requirements of any particular application.”, [0066]).
Regarding claim 10, Musbach discloses the claimed invention as discussed above concerning the rejection of claim 1, and Musbach further discloses wherein the plurality of slots is uniformly distributed along a length of the actuating portion (“each of the slots 22 disposed within micromachined hypotube 10 are evenly axially spaced.”, [0067]).
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.
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.
Claims 2-4 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Musbach et al. (U.S. Patent Pub. 20070135763) hereinafter Musbach, in further view of Adams et al. (U.S. Patent Pub. 20120053607), hereinafter Adams.
Regarding claim 2, Musbach discloses the claimed invention as discussed above concerning the rejection of claim 1, however, Musbach does not expressly state comprising a wire coupled to the distal end of the shaft and extending externally along the actuating portion of the shaft.
Adams teaches a sphincterotome comprising a catheter shaft (see Claim 1) comprising a wire (element 40; “cutting element 40 may be a stranded or braided wire.”, [0027]) coupled to the distal end (end 22) of the shaft and extending externally along the actuating portion of the shaft (portion of the shaft with tube 56; see FIG. 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Musbach to comprise a wire coupled to the distal end of the shaft and extending externally along the actuating portion of the shaft. Doing so would provide a cutting element to be actuated, as taught by Adams (see [0042-0044]).
Regarding claim 3, Musbach in view of Adams teaches the claimed invention as discussed above concerning the rejection of claim 2, and Adams further teaches wherein the wire (element 40) is disposed within the first lumen proximal to the actuating portion (the Examiner notes FIG. 6 depicts element 40 being disposed within lumen of shaft 18).
Regarding claim 4, Musbach in view of Adams teaches the claimed invention as discussed above concerning the rejection of claim 2, and Adams further teaches wherein the wire (element 40) is disposed substantially at a midpoint (See FIG. 6) across the plurality of slots (slots 70 and 72).
Regarding claim 11, Musbach in view of Adams teaches the claimed invention as discussed above concerning the rejection of claim 2, and Adams further teaches comprising a handle (handle 16) coupled to a proximal end (see FIG. 1) of the wire (element 40), the handle configured to proximally and distally translate the wire through the first lumen (see claims 17 and 18).
Regarding claim 12, Musbach discloses Musbach discloses a catheter (catheter 116; see FIG. 6, the Examiner notes that all reference characters cited below refer to FIG. 6 unless otherwise stated) comprising:
a shaft (shaft 132; “elongate shaft 132 may be a micromachined hypotube such as those described with respect to FIGS. 1-5”, [0083]) comprising a proximal end (end of shaft near region 118), a distal end (end near region 122), a central longitudinal axis (axis 20) therethrough, an actuating portion (portion proximally adjacent to port 130) proximal to the distal end, and a first lumen (lumen of shaft 150, see FIG. 10) extending along a length of the shaft between the proximal and distal ends; and
and at least one slot (slots 22; see FIG. 1) disposed along the actuating portion, the slot extending radially into the first lumen (see FIG. 1). However, Musbach does not expressly state a wire coupled to the distal end, extending external to the shaft along the actuating portion, and within the first lumen proximal of the actuating portion, and wherein the slot is disposed between the central longitudinal axis and the wire.
Adams teaches a sphincterotome comprising a catheter shaft (see Claim 1) comprising a wire (element 40; “cutting element 40 may be a stranded or braided wire.”, [0027]) coupled to the distal end (end 22), extending external to the shaft along the actuating portion (portion of the shaft with tube 56; see FIG. 6), and within the first lumen proximal of the actuating portion (the Examiner notes FIG. 6 depicts element 40 being disposed within lumen of shaft 18), and wherein the slot is disposed between the central longitudinal axis and the wire (see FIG. 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Musbach to comprise a wire coupled to the distal end, extending external to the shaft along the actuating portion, and within the first lumen proximal of the actuating portion, and wherein the slot is disposed between the central longitudinal axis and the wire. Doing so would provide a cutting element to be actuated, as taught by Adams (see [0042-0044]).
Regarding claim 13, Musbach in view of Adams teaches the claimed invention as discussed above concerning the rejection of claim 12, and Musbach further teaches wherein the slot extends radially through the first lumen (the Examiner notes [0062] of Musbach details that individual slots can have varying wall thickness ranging from a depth less than the wall thickness of the tube to a depth extending completely through the tube).
Regarding claim 14, Musbach in view of Adams teaches the claimed invention as discussed above concerning the rejection of claim 12, and Musbach further teaches comprising a second lumen (see FIG. 10) extending along the length of the shaft, wherein the slot is external to the second lumen (the Examiner notes [0062] of Musbach details that individual slots can have varying wall thickness ranging from a depth less than the wall thickness of the tube to a depth extending completely through the tube).
Regarding claim 15, Musbach in view of Adams teaches the claimed invention as discussed above concerning the rejection of claim 14, however, Musbach in view of Adams does not expressly state wherein a wall thickness of the second lumen ranges from about 0.05 mm to about 0.10 mm.
The Examiner notes [0062] of Musbach details that individual slots can have varying wall thickness ranging from a depth less than the wall thickness of the tube to a depth extending completely through the tube.
Further, it would have been obvious to one having ordinary skill in the art at the effective filing date the invention to modify the wall of Musbach in view of Adams to have a thickness of the second lumen ranging from about 0.05 mm to about 0.10 mm because where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Musbach et al. (U.S. Patent Pub. 20070135763) hereinafter Musbach.
Regarding claim 7, Musbach discloses the claimed invention as discussed above concerning the rejection of claim 6, however, Musbach does not expressly state wherein a wall thickness of the second lumen ranges from about 0.05 mm to about 0.10 mm.
The Examiner notes [0062] of Musbach details that individual slots can have varying wall thickness ranging from a depth less than the wall thickness of the tube to a depth extending completely through the tube.
Further, it would have been obvious to one having ordinary skill in the art at the effective filing date the invention to modify the wall of Musbach to have a thickness of the second lumen ranging from about 0.05 mm to about 0.10 mm because where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Agro et al. (U.S. Patent Pub. 20110196344), hereinafter Agro, in further view of Adams et al. (U.S. Patent Pub. 20120053607), hereinafter Adams, in further view of Musbach et al. (U.S. Patent Pub. 20070135763) hereinafter Musbach.
Regarding claim 16, Agro discloses a method of cannulating an opening in a body lumen (see [0105]), comprising:
inserting a catheter into the body lumen of a patient (see [0105]); and
proximally translating a wire (guidewire 34);
wherein the wire extends through at least a portion of a first lumen (lumen 58) of the catheter (see FIG. 1). However, Agro does not expressly state proximally translating a wire coupled to a distal end of a catheter to curve an actuating portion of the catheter towards the opening in the body lumen; wherein the catheter comprises a plurality of slots along the actuating portion of the catheter, the plurality of slots extending radially into the first lumen.
Adams teaches a sphincterotome comprising a catheter shaft (see Claim 1) proximally translating a wire coupled to a distal end of a catheter to curve an actuating portion (curved configuration, see [0017]) of the catheter towards the opening in the body lumen (see FIG. 6); wherein the catheter comprises a plurality of slots (slots 70 and 72) along the actuating portion of the catheter (see FIG. 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Agro to comprise proximally translating a wire coupled to a distal end of a catheter to curve an actuating portion of the catheter towards the opening in the body lumen; wherein the catheter comprises a plurality of slots along the actuating portion of the catheter. Doing so would provide a cutting element to be actuated, as taught by Adams (see [0042-0044]).
However, Agro in view of Adams does not expressly state the plurality of slots extending radially into the first lumen.
Musbach teaches catheters that include micromachine hypotubes (Abstract) wherein the plurality of slots extend radially into the first lumen (the Examiner notes [0062] of Musbach details that individual slots can have varying wall thickness ranging from a depth less than the wall thickness of the tube to a depth extending completely through the tube).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the slots of Agro in view of Adams to extend radially into the first lumen. Doing so would provide varying depths and thickness for satisfying requirements of various applications and enhanced flexibility and strength, as taught by Musbach (see [0062-0069]).
Regarding claim 17, Agro in view of Adams in view of Musbach teaches the claimed invention as discussed above concerning the rejection of claim 16, and Adams further teaches wherein curving the actuating portion (portion of the shaft with tube 56) of the catheter comprises reducing an axial width of each of the plurality of slots (slots 70 and 72, see FIG. 6).
Regarding claim 18, Agro in view of Adams in view of Musbach teaches the claimed invention as discussed above concerning the rejection of claim 16, and Agro further teaches supplying a fluid through a second lumen of the catheter into the body lumen (“ Extending longitudinally between the shaft proximal end 38 and distal end 40 is an ancillary lumen 54 and an ancillary lumen 56. Ancillary lumen 54 and ancillary lumen 56 may be injection lumens, allowing for high contrast media flow”, [0061]).
Regarding claim 19, Agro in view of Adams in view of Musbach teaches the claimed invention as discussed above concerning the rejection of claim 16, and Adams further teaches wherein proximally translating (see claims 16-18) the wire (element 40) comprises pulling the wire toward a handle (handle 16) of the catheter external to the plurality of slots along the actuating portion (see FIG. 1).
Regarding claim 20, Agro in view of Adams in view of Musbach teaches the claimed invention as discussed above concerning the rejection of claim 16, and Adams further teaches cutting a portion of the body lumen by electrically activating the wire (element 40; “In some cases, activating the cutting wire may include application of an electrical current”, [0006]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
05/11/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights