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 April 17th, 2026 has been entered. Claims 1 and 9 have been
amended. Claims 8 and 14-17 are cancelled. Claims 1-7, 9-13 are now pending in the application. The previous 35 U.S.C. 112(b) rejection of claim 9 is withdrawn in light of Applicant's amendment.
Response to Arguments
Applicant's arguments filed 04/17/2026 have been fully considered but they are not persuasive.
In response to arguments that Piskun (US 20180185018 A1) does not disclose “an endoscope body extending between a proximal end and a distal end and having a distal tip,” examiner respectfully disagrees. As detailed below, the catheter system (11) is interpreted as an endoscope, and an endoscope can be reasonably interpreted as any medical instrument consisting of some sort of tubular body with an imaging means; the catheter (11) is a tubular body having an imaging means (30) present at its distal end for viewing inside the body [FIG. 4A, 0067]. Moreover, the imaging means (30) provided at the distal tip (38) of endoscope (11) can reasonably considered an optical sensor since imaging means (30) is described as a distal viewing endoscope with a wide distal viewing area and a viewing lens and appropriately reads on the meets and bounds of the invention as claimed [0067].
Furthermore, the applicant argues that Piskun does not disclose “working channel extending along the endoscope body to a channel opening located at the distal tip,” examiner respectfully disagrees. The expanded working space (41) is reasonably interpreted as a working channel, to one of ordinary skill in the art, as it is a hollow space through which working instruments may advance [FIG. 5].
Therefore, the examiner maintains the rejection under 35 U.S.C. 102(a)(1) with Piskun (US 20180185018 A1), however, the examiner has updated the rejection below.
Examiner’s Comments
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
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, 9-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Piskun (US 20180185018 A1).
Regarding Claim 1, Piskun discloses
An endoscope (endoscopic system 10, FIG. 1) configured for insertion into a urethra of a patient (par. 7 discloses endoscopic system, i.e. catheter, used within body lumen of a patient), the endoscope comprising:
an endoscope body (flexible catheter 11, FIG. 1) extending between a proximal end and a distal end (depicted in FIG. 1) and having a distal tip (distal cap 38, FIG. 2A),
the endoscope body defining an instrument socket (window 48, FIG. 2A) having a socket wall (FIG. 20B, par. 77 disclose window can be closed, i.e. wall of window);
an optical sensor (endoscope 30, FIG. 4A) located at the distal tip and configured to provide a distal field of view from the distal tip (FIG. 4A, par. 67 disclose endoscope is a distal viewing scope with a wide distal viewing area); and
an expandable and collapsible working channel (expanded working space 41, FIG. 6) configured for reception of an instrument (FIG. 5, par. 62 disclose working instruments inserted in working space),
the working channel extending along the endoscope body to a channel opening (seal 39, FIG. 4A) located at the distal tip (depicted in FIG. 4A),
the working channel being defined within the endoscope body between a socket wall and a channel wall (expandable member 40; depicted in FIGS. 2B, 20B),
wherein the working channel has a collapsed configuration (depicted in FIG. 2A) and an expanded configuration (depicted in FIG. 2B), and wherein:
in the collapsed configuration, the working channel is collapsed and a channel wall (expandable member 40, FIG. 2B) is in a first position relative to the socket wall (depicted in FIG. 2A, 20B), and
the working channel has a first cross-sectional area (depicted in FIG. 2A); and
in the expanded configuration, the working channel is expanded and the channel wall is displaced away from the socket wall relative to the first position (depicted in FIG. 2B) and
the working channel has a second cross-sectional area larger than the first cross-sectional area (depicted in FIG. 2B).
Regarding Claim 2, Piskun discloses
The endoscope of claim 1, wherein the channel wall is elastically deformed in the expanded configuration (depicted in FIGS. 2A-2B).
Regarding Claim 3, Piskun discloses
The endoscope of claim 2, wherein the channel wall is unfurled in the expanded configuration (depicted in FIGS. 2A-2B).
Regarding Claim 4, Piskun discloses
The endoscope of claim 1, wherein the channel wall is unfurled in the expanded configuration (depicted in FIGS. 2A-2B).
Regarding Claim 5, Piskun discloses
The endoscope of claim 1, wherein the channel wall is configured to conformally expand in response to insertion of the instrument received in the working channel (par. 59 discloses working channel is expanded as tools advance therethrough, i.e. conformally).
Regarding Claim 9, Piskun discloses
The endoscope of claim 1, wherein the channel wall is more proximate the socket wall, in the collapsed configuration, than the channel wall is from the socket wall in the expanded configuration (depicted in FIGS. 2A-2B).
Regarding Claim 10, Piskun discloses
The endoscope of claim 1,
further comprising the instrument received in the working channel (FIGS. 4A-5 depict several instruments extending through expanding working space such as endoscopic instruments), and
the instrument projects from the distal tip at the channel opening (depicted in FIG. 4A).
Regarding Claim 11, Piskun discloses
The endoscope of claim 1, wherein the instrument includes one or more of a scalpel, scissors, forceps, guidewire, or laser fiber (par. 48 discloses working channels allows any type of endoscopic tool such as forceps, scissors and/or a laser fiber).
Regarding Claim 12, Piskun discloses
The endoscope of claim 1, further comprising a fluid supply line (fluid channel 42, FIGS. 2A-2B).
Regarding Claim 13, Piskun discloses
The endoscope of claim 1, further comprising one or more inflatable balloons configured to transition the working channel between the collapsed configuration and the expanded configuration (par. 12 discloses expandable region is formed by inflatable balloon, par. 68 discloses expansion, and inherently collapsing, is achieved via inflating of balloon).
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) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piskun (US 20180185018 A1) as applied to claim 1 above, and further in view of Piskun (US 20180264239 A1, hereinafter Piskun B to provide clarity).
Regarding Claim 6, Piskun discloses all of the elements of the current invention disclosed in claim 1, however, Piskun does not disclose further comprising one or more working channel members including the channel wall, and the working channel features are configured to unfurl with the working channel in the expanded configuration.
Piskun B teaches an analogous endoscope (endoscopic system 10, FIG. 1) having an endoscope body (flexible catheter 11, FIG. 1) comprising an expandable and collapsible working channel (expanded working space 41, FIG. 3). The working channel (41) includes a window (45, i.e. working channel member) which expands/ unfurls with the expansion of the working channel [FIGS. 2A-2B].
It would have been obvious to one of ordinary skill in the art at the effective filing date of
the invention to provide the endoscope of Piskun with the working channel members of Piskun B in order to provide additional pathways for instruments to access and use in surgical operation within the body when target legions are located at a position adjacent to the expandable working channel [Piskun B - FIG. 4C, 0024, 0049]
Regarding Claim 7, Piskun, as previously modified by Piskun B, discloses all of the elements of the current invention disclosed in claim 1, and Piskun B further teaches
The endoscope of claim 6, wherein the one or more working channel members include at least one door (window 45, FIG. 2B), and
the at least one door is configured to open with the working channel in the expanded configuration (par. 57 discloses upon collapse of expandable member, window is closed, i.e. it is inherent that window is opened upon expansion, as depicted in FIG. 2B).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABDUL HADI ABBASI whose telephone number is (571)272-4076. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 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, Anhtuan Nguyen can be reached at (571) 272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABDUL HADI ABBASI/Examiner, Art Unit 3795
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795