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.
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, 7-9, 13, and 19-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by West et al. (US 2012/0271327, hereinafter “West”).
Referring to claim 1, West discloses a system (Figs. 1-6 and 24-42, Fig. 5 is reproduced below), comprising:
PNG
media_image1.png
446
595
media_image1.png
Greyscale
an elongate flexible device 12 (Fig. 5, para. [0195]: “As shown in FIG. 1 an endoscope system 10 which comprises an endoscope 12”), comprising:
a first working channel including a distal end; a second working channel including a distal end; and an imaging lumen including a distal end, the imaging lumen configured to receive an imaging device, wherein an operational space extends between a target anatomy 156 (Fig. 24) and the distal end of the first working channel, the distal end of the second working channel, and the distal end of the imaging lumen (para. [0195]: “As shown in FIG. 1 an endoscope system 10 which comprises an endoscope 12, a video display unit 14, an image processing device 16, a light source 17, a suction device 18 is used with and an endoscopic suturing device 20 as part of an endoscopic treatment system according to one embodiment of the present invention.” Based on the disclosure in paragraph [0195] and Fig. 5, West inherently discloses working channels for tissue grasper 26 as shown in Figs. 14-15, needle capture device 30 at the distal end 40 (para. [0195]: “FIG. 3 shows the distal end 40 of needle capture device 30 and the distal end helical tip 42 of tissue grasper 26 extending from instrument channels 24 and 28 respectively.”), cinch deployment system 114 as shown in Figs. 16-17 (para. [0201]), a channel for imaging device and a channel for a light source 17); and
a tool removably couplable (suturing device 20 as shown in Figs. 4-6, para. [0195]) to a distal end of the elongate flexible device, the tool comprising: a first extension member 62 (Fig. 5) configured to extend distally from the distal end of the elongate flexible device 12; and a second extension member 62 (Fig. 5) configured to extend distally from the distal end of the elongate flexible device 12, wherein when the tool 20 is coupled to the distal end of the elongate flexible device 12, the first extension member 62 and the second extension member 62 are positioned outside of the operational space such that the operational space is free from obstruction by the first extension member and the second extension member (Figs. 24-42, Fig. 24 is reproduced and annotated below. The figure shows extensions 62 is not obstructing the operational space).
PNG
media_image2.png
328
476
media_image2.png
Greyscale
Referring to claim 7, West discloses the system of claim 1, wherein a tool path (path of needle arm 48 and needle 44 as shown in Figs. 5 and 24, which are reproduced above) extends between the first extension member 62 and the second extension member 62, and wherein when the tool (suturing device 20) is coupled to the elongate flexible device 12, a longitudinal axis of the second working channel intersects the tool path (para. [0195] discloses “Positioned adjacent to needle capture device distal end 40 is needle assembly 44 which is connected to suture 46.” Figs. 4-5 shows distal end 40 is intersects the path of needle 44 and needle arm 48).
Referring to claim 8, West discloses the system of claim 7, wherein the tool is a suturing tool, the suturing tool including a needle 44, and wherein the tool path is a needle path of the needle 44 (Figs. 4-5 show needle 44 and needle arm 48 are attached to cap 38).
Referring to claim 9, West discloses the system of claim 1, wherein a tool path extends between the first extension member 62 and the second extension member 62, and wherein when the tool (needle 44 and needle arm 48 as shown in Figs. 4-5) is coupled to the elongate flexible device 12, the second working channel is misaligned with the tool path (Fig. 4 shows distal end 42 tissue grasping device is extended from a channel that is misaligned with the path of needle 44 and needle arm 48. Examiner notes that this channel can be interpreted as a second channel or a first channel).
Referring to claim 13, West discloses a system, comprising:
an elongate flexible device 12 (see rejection of claim 1 above), comprising: a first working channel (see rejection of claim 1 above) including a distal end; a second working channel (see rejection of claim 1 above) including a distal end; and an imaging lumen (see rejection of claim 1 above) including a distal end, the imaging lumen configured to receive an imaging device, wherein an operational space extends between a target anatomy 156 (Fig. 24) and the distal end of the first working channel, the distal end of the second working channel, and the distal end of the imaging lumen, wherein when a tool (suturing device 20 as shown in Figs. 4-6, para. [0195]) is coupled to a distal end of the elongate flexible device, a first extension member 62 (see rejection of claim 1 above) of the tool and a second extension member 62 (see rejection of claim 1 above) of the tool are positioned outside of the operational space such that the operational space is free from obstruction by the first extension member and the second extension member (see rejection of claim 1 above), wherein the first extension member 62 is configured to extend distally from the distal end of the elongate flexible device 12, and wherein the second extension member 62 configured to extend distally from the distal end of the elongate flexible device 12 (Fig. 5).
Referring to claim 19, West discloses the system of claim 13, wherein a tool path extends between the first extension member and the second extension member, and wherein when the tool is coupled to the elongate flexible device, a longitudinal axis of the second working channel intersects the tool path (see rejection of claim 7 above).
Referring to claim 20, West discloses the system of claim 19, wherein the tool is a suturing tool, the suturing tool including a needle, and wherein the tool path is a needle path of the needle (see rejection of claim 8 above).
Referring to claim 21, West discloses the system of claim 13, wherein a tool path extends between the first extension member and the second extension member, and wherein when the tool is coupled to the elongate flexible device, the second working channel is misaligned with the tool path (see rejection of claim 8 above).
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.
Claim(s) 4-6 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over West et al. in view of Imai (US 2013/0131453, hereinafter “Imai”).
Referring to claims 4-5, West discloses the system of claim 1, wherein the elongate flexible device 12 further comprises: an illumination lumen including a distal end, the illumination lumen configured to receive an illumination device; and a fluid lumen including a distal end (para. [0195]: “As shown in FIG. 1 an endoscope system 10 which comprises an endoscope 12, a video display unit 14, an image processing device 16, a light source 17, a suction device 18 is used with and an endoscopic suturing device 20 as part of an endoscopic treatment system according to one embodiment of the present invention.” Based on the disclosure in paragraph [0195] and Fig. 5, West inherently discloses working channels for tissue grasper 26, needle capture device 30, a channel for illumination device, and a fluid lumen for removing fluid from the surgical site). West fails to disclose an irrigation lumen including a distal end and a nozzle is positioned at the distal end of the fluid lumen, the nozzle configured to direct fluid onto the imaging device in the imaging lumen. However, in paragraph [0216] West discloses handle assembly 600 (Figs. 58-59A-59C) includes a port for receiving fluid. Examiner contends that in endoscopic procedure providing a channel for irrigating the surgical site and washing the distal end of the endoscope is well known in the art. In the same field of endeavor, which is an endoscope device (Fig. 1A), Imai discloses “[A]n air supply/water supply path (a fluid path) 28 which includes a nozzle 28a at the distal end of the insertion portion 12 and through which a cleaning liquid (e.g., a normal saline solution) or compressed air is supplied to the observation window 24a.” (Fig. 2, para. [0059). In view of Imai’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided a channel and a nozzle as suggested by Imai for irrigating the surgical site and washing the distal end of the imaging device for cleaning the imaging window and the surgical site.
Referring to claim 6, West/Imai discloses the system of claim 4, wherein the operational space further extends between the target anatomy and the distal end of the illumination lumen, the distal end of the irrigation lumen, and the distal end of the fluid lumen (Fig. 2 of Imai reference shows nozzle 28 extends a short distance from the distal surface 24a of cap 54 for the purpose of releasing irrigation fluid to the imaging window. Examiner contends that one of ordinary skill in the art will understand that Imai teaches the height of the nozzle 28 will not extend farther away from surface 24a of cap 54).
Referring to claims 16-17, West/Imai discloses wherein the elongate flexible device further comprises: an illumination lumen including a distal end, the illumination lumen configured to receive an illumination device; an irrigation lumen including a distal end; and a fluid lumen including a distal end (claim 16) and wherein a nozzle is positioned at the distal end of the fluid lumen, the nozzle configured to direct fluid onto the imaging device in the imaging lumen (claim 17)(see rejection of claims 4-5 above).
Referring to claim 18, West/Imai discloses wherein the operational space further extends between the target anatomy and the distal end of the illumination lumen, the distal end of the irrigation lumen, and the distal end of the fluid lumen (please see rejection of claim 6 above).
Claim(s) 10-12 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over West et al. as applied to claim 1 above in view of Schlesinger (US 2018/0001058, hereinafter “Schlesinger”).
Referring to claims 10-12, West discloses the system of claim 1 but fails to disclose wherein the elongate flexible device 12 further comprises a plurality of pull wire lumens, wherein each pull wire lumen is configured to receive a respective pull wire of the one or more pull wires (claims 10-11) and the pull wires are embedded in a wall of the elongate flexible device 12.
Referring again to claims 10-12, however, in the same field of endeavor, Schlesinger discloses minimally invasive medical tools include steerable catheter for insertion into natural orifices in a patient anatomy is well known in the art (paras. [0003]-[0004] and [0040]). Schlesinger discloses four pull wire imbedded in a wall of elongate flexible device 216 (Figs. 2 and 5-6, paras. [0034], [0048], [0050] and [0052]) to allow the user to steer the distal end of the flexible device through the tortuous path of the natural orifices. In view of Schlesinger’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided pull wires to the flexible body 12 of West to allow the user to steer the distal end of the flexible device through the tortuous path of the natural orifices.
Referring to claim 22, please see rejection of claim 10 above.
Allowable Subject Matter
Claims 2-3 and 14-15 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TUAN V NGUYEN/Primary Examiner, Art Unit 3771
Prosecution Insights