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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the optical fiber of claim 2, the optical component of claims 5 and 18, the observation device of claim 11, the light detector of claim 14 and the locking device of claim 19 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
Claims 5, 6, and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 5 and 6 are dependent on claim 3, which was canceled. For the purpose of examination, the examiner is interpreting claims 5 as being dependent on claim 2 and claim 6 being dependent on claim 5. Claim 5 recites the limitation “the optical component” in lines 1-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 is dependent on claim 9, which was cancelled. For the purpose of examination, the examiner is interpreting claim 10 as being dependent on claim 1. Claim 10 recites the limitation "cross-sectional surface" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 5, 6, 10-15, 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. (US2022/0369919) in view of Altshuler et al. (US2023/0248434) and Banik et al. (US2005/0154262).
Regarding claim 1, Chu discloses an endoscope, comprising: an outer cladding tube (Figs. 3 & 4: pinch valve bridge 130A);
a working channel which runs in the outer cladding tube and extends in a longitudinal direction from a rear opening to a front opening (medical device, including ureteroscope 160, may be disposed within first lumen 132 [0077]; Fig. 3: first lumen 132 within pinch valve bridge 130A appears to have a proximal opening and a distal opening); and
a working tube with a front end and a rear end which is insertable into the rear opening of the working channel (Fig. 16: elongate shaft 164 of ureteroscope 160 is insertable through the proximal end 202 of element 200 through open slot 220 [0107]). Chu discloses the flexible ureteroscope comprising the working tube (Fig. 16: elongate shaft 164 of ureteroscope 160 [0085]), also briefly mentioning an illumination means, imaging means (optics and illumination means disposed within distal tip 166 [0084, 0094, 0111]), irrigation and aspiration means (handle 162 of ureteroscope 160 may comprise buttons 172 to activate irrigation and/or aspiration [0073, 0085]), however fails to disclose the specific structure of these means within the working tube. In the same field of endeavor, Altshuler teaches a substantially similar flexible ureteroscope, the ureteroscope forming a working tube with a front end and a rear end (Fig. 1: catheter shaft 33 comprises a distal portion 35 and a proximal portion 36 [0074]), wherein the working tube comprises
at least one light guide channel for guiding laser radiation (illumination fiber optics 132 may extend through catheter 32 and be coupled to illumination system 52 at the handle 38 [0078]; the lumen channel through which illumination fiber optics 132 extends through is at least one light guide channel),
at least one flushing channel configured for guiding a flushing gas and/or flushing liquid (working port 122 and working channel 124 for irrigation [0086]), and
at least one suction channel (working channel 102, may be coupled to aspiration system 44 at handle 38 [0080]).
Since Chu fails to explicitly disclose the details of its endoscope, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any endoscope known in the art, including the one taught by Altshuler, which teaches the various channels also well-known in the endoscope art, as an equivalent alternative to the endoscope of Chu.
Chu and Altshuler fails to disclose wherein the working tube of an endoscope comprises multiple flushing channels. In the same field of endeavor, Banik teaches a substantially similar endoscope device comprising at least one light guide channel for guiding laser radiation (if external light sourced used, fiber optic illumination guide withing the imaging endoscope [0075, 0139]), at least one suction channel (vacuum lumen within imaging endoscope 20 [0077]), and multiple flushing channels, wherein each of said multiple flushing channels being configured for guiding a flushing gas and/or flushing liquid, wherein each of said multiple flushing channels comprises a valve through which the through-flow of the flushing gas and/or the flushing gas is controllably allowed or prevented, wherein each of the valves in the multiple flushing channels is independently controllable (insufflation gas/air and irrigation liquid may be provided by the same lumen, or alternatively, be provided in separate lumens if desired [0070]; valves 70 control the insufflation and irrigation can be separate or together and may be located inside or outside the cabinet or along the endoscope [0077]). In view of Banik, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included an additional flushing channel, as taught by Banik, as it is known in the endoscope art that irrigation and insufflation may be alternatively in a combined lumen or separate lumens, if desired, and the separate lumens allow for delivery of additional fluids, or therapeutic or contrasts substances to the patient [0076].
Regarding claim 2, Chu, modified by Altshuler and Banik, discloses the endoscope according to claim 1. Altshuler further teaches wherein the light guide channel is designed as an optical fiber and/or as a waveguide and/or a free beam (illumination fiber optics 132 [0078]).
Regarding claim 5, Chu, modified by Altshuler and Banik, discloses the endoscope according to claim 2. Altshuler further teaches wherein the optical component is designed such that light that is guided through the light guide channel and passes through the optical component exits the optical component along an exit direction which is at an angle of at least 10° to the longitudinal direction of the working channel (although the degree/angle is not explicitly stated, the transparent cap 100 of Altshuler appears to disperse light at an angle at least 45 degrees to the longitudinal direction of the working channel, see dotted lines of Fig. 10; further, each illumination fiber optic 132 may be configured to diffuse, refract, scatter or redirect visible light 222 radially into the transparent cap 100, the transparent cap also is configured to diffuse and scatter the light 222 [0109]).
Regarding claim 6, Chu, modified by Altshuler and Banik, discloses the endoscope according to claim 5. Altshuler teaches wherein the angle is at least 30° to the longitudinal direction of the working channel (although the degree/angle is not explicitly stated, the transparent cap 100 of Altshuler appears to disperse light at an angle at least 45 degrees to the longitudinal direction of the working channel, see dotted lines of Fig. 10; further, each illumination fiber optic 132 may be configured to diffuse, refract, scatter or redirect visible light 222 radially into the transparent cap 100, the transparent cap also is configured to diffuse and scatter the light 222 [0109]).
Regarding claim 10, Chu, modified by Altshuler and Banik, discloses the endoscope of claim 1. Chu further teaches wherein a surface area of the cross-sectional surface is constant (a surface area of the cross-sectional surface at one cross-sectional of the ureteroscope of Chu would be constant, as one cross-sectional surface would not change in area or shape).
Regarding claim 11, Chu, modified by Altshuler and Banik, discloses the endoscope according to claim 1. Altshuler further teaches the endoscope comprising an observation device provided in at least one of the outer cladding tube and the working tube, wherein the observation device is configured to detect light entering the observation device from a predetermined solid angle range relative to the longitudinal direction of the working channel (imaging device 144 within the distal head portion 34 of catheter shaft 32 [0084], imaging receiver 142 may be an imaging device 144 such as a CMOS, CCD that has a field of view 148 within a range of 90 to 120 degrees, 45-60 degrees inclusive from the viewing axis of the imaging receiver [0084]).
Regarding claim 12, Chu, modified by Altshuler and Banik, discloses the endoscope according to claim 11. Altshuler further teaches wherein an exit direction lies within the predetermined solid angle range (viewing axis of the imaging device 144 is the center point of the field of view 148 of the imaging device [0084]).
Regarding claim 13, Chu, modified by Altshuler and Banik, discloses the endoscope according to claim 12. Altshuler further teaches wherein the predetermined solid angle range is symmetrical about the exit direction (field of view 148 is within a range of 90-120 degrees, viewing axis is the center line of the field of view, 45-60 degrees including from the viewing axis of the imaging receiver [0084]).
Regarding claim 14, Chu, modified by Altshuler and Banik, discloses the endoscope according to claim 11. Altshuler further teahces wherein the observation device comprises a light detector (imaging device 144 may be a CMOS or CCD that detects light [0084]).
Regarding claim 15, Chu, modified by Altshuler and Banik, discloses the endoscope according to claim 1. Chu further teaches wherein the working channel is designed as a tube (Fig. 3: first lumen 132 are tubular in shape). Altshuler further teaches wherein the flushing channel and/or the suction channel are designed as tubes (Fig. 3A-3C: separate working channels 102 and 124 enables irrigation and aspiration to occur simultaneously and continuously [0086], channel 102 and 124 are tubes and tubular in shape). Banik also teaches wherein the multiple flushing channels and/or the suction channel are designed as tubes (Fig. 6A: tubes extend proximally from distal tip 400, strongly suggesting that the multiple flushing channels/and or the vacuum lumen are designed as tubes [0143]).
Regarding claim 17, Chu, modified by Altshuler and Banik, discloses the endoscope according to claim 1. Altshuler further teaches wherein the front end of the working tube is closed by an end cap (transparent cap 100), and wherein the at least one guide channel, the flushing channel, and the at least one suction channel are guided through the end cap (illumination fiber optic 132 passes through an illumination fiber optic port 134 formed in the distal tip portion 96 and may extend into transparent cap 100 [0078]; Fig. 3 & 3A: working ports 122 connected to the working channel 124 passes through transparent cap 100, working port 103 connected to working channel 102 passes through transparent cap 100). Banik teaches wherein the endoscope comprises multiple flushing channels (insufflation gas/air and irrigation liquid may be provided by the same lumen, or alternatively, be provided in separate lumens if desired [0070]; valves 70 control the insufflation and irrigation can be separate or together and may be located inside or outside the cabinet or along the endoscope [0077]).
Regarding claim 18, Chu, modified by Altshuler and Banik, discloses the endoscope according to claim 17. Alshuler further teaches the endoscope comprising an optical component located toward the front end of the working tube, and wherein the end cap protrudes in the longitudinal direction of the working channel beyond the optical component (imaging device 144, which includes imaging optics [0084], is an optical component toward the front of catheter shaft 33 [0084-0085]; Fig. 3A: transparent cap 100 extends distally in the longitudinal direction beyond the imaging device 144).
Regarding claim 19, Chu, modified by Altshuler and Banik, discloses the endoscope according to claim 1. Chu further discloses the endoscope comprising locking device associated with the working tube, wherein the locking device is configured to lock the working tube to the working channel in one or more predetermined orientations (first delectable 140 may be deflected radially inward while a medical device is disposed in the first lumen 132 to lock an orientation of the medical device relative to the access sheath 100 [0077]).
Regarding claim 20, Chu, modified by Altshuler and Banik, discloses a working tube for an endoscope according to claim 1 (Chu: Fig. 16: elongate shaft 164 of ureteroscope 160 is insertable through the proximal end 202 of element 200 through open slot 220 [0107]; Altshuler: Fig. 1: catheter shaft 33 comprises a distal portion 35 and a proximal portion 36).
Claims 1 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Chu in view of Ikuma.
Regarding claim 1, Chu discloses an endoscope, comprising: an outer cladding tube (Figs. 3 & 4: pinch valve bridge 130A);
a working channel which runs in the outer cladding tube and extends in a longitudinal direction from a rear opening to a front opening (medical device, including ureteroscope 160, may be disposed within first lumen 132 [0077]; Fig. 3: first lumen 132 within pinch valve bridge 130A appears to have a proximal opening and a distal opening); and
a working tube with a front end and a rear end which is insertable into the rear opening of the working channel (Fig. 16: elongate shaft 164 of ureteroscope 160 is insertable through the proximal end 202 of element 200 through open slot 220 [0107]). Chu discloses the flexible ureteroscope comprising the working tube (Fig. 16: elongate shaft 164 of ureteroscope 160 [0085]), also briefly mentioning an illumination means, imaging means (optics and illumination means disposed within distal tip 166 [0084, 0094, 0111]), irrigation and aspiration means (handle 162 of ureteroscope 160 may comprise buttons 172 to activate irrigation and/or aspiration [0073, 0085]), however fails to disclose the specific structure of these means within the working tube. In the same field of endeavor, Ikuma teaches a substantially similar flexible ureteroscope, wherein the ureteroscope comprising a working tube (Fig. 1 & 3: multi-lumen tube 17 formed of multiple lumens [0086]), further comprising:
at least one light guide channel for guiding laser radiation (Fig. 2 & 3: channel tube 12 [0062]),
multiple flushing channels (Fig. 4: conduits 33 and 31), wherein each of said multiple flushing channels being configured for guiding a flushing gas and/or flushing liquid (three-way stock cock, in its second state, allows saline from conduit 31 to flow to conduit 33 [0100], thus both conduits 33 and 31 are configured to guide flushing liquid), wherein each of saif multiple flushing channels comprises a valve through which the through-flow of the flushing gas and/or the flushing liquid is controllably allowed or prevented, wherein each of the valves in the multiple flushing channels is independently controllable (Fig. 4: conduit 31 comprises valve 24, conduit 33 comprises stopcock 26; valve 24 and stopcock 26 are independently controlled by control unit 21 [0092], stopcock 26 toggles between pattern A and pattern B while valve 24 remains open [0100]), and at least one suction channel (Fig. 2 & 3: suction tube 14 [0064]).
Since Chu fails to explicitly disclose the details of its endoscope, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any endoscope known in the art, including the one taught by Ikuma, which teaches the various channels also well-known in the endoscope art, as an equivalent alternative to the endoscope of Chu.
Regarding claim 21, Chu, modified by Ikuma, discloses a method for operating an endoscope according to claim 1. Ikuma further teaches the method comprising: guiding laser radiation through the light guide channel (surgeon inserts laser probe 3a into channel tube 12 [0062]); guiding a flushing gas and/or flushing liquid through the multiple flushing channels (Fig. 4: conduits 33 and 31; three-way stock cock, in its second state, allows saline from conduit 31 to flow to conduit 33 [0100], thus both conduits 33 and 31 are configured to guide flushing liquid); and extracting material or fluid through the suction channel (suction is applied through suction tube 14 using suction pump 23 to extract fluid [0076, abstract]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Chu in view of Ikuma and Altshuler.
Regarding claim 22, Chu, modified by Ikuma, discloses the method according to claim 21, however Ikuma fails to disclose the details of the laser radiation. In the same field of endeavor, Altshuler teaches a substantially similar ureteroscope, further teaching wherein the laser radiation has a wavelength of 2013 + 100 nm and/or an output of 5 W to 150 W and/or is pulsed laser radiation with a pulse length of 200 us to 1 s (max average power of laser lithotripsy for ureteral application can be between 30-50 watts; for kidney applicants, 60-120 watts; for bladder applications, up to 200 watts [0138]). Since Ikuma fails to disclose the details to the laser radiation power, wavelength, or pulse, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied any laser radiation power, wavelength or pulse known in the art, particularly that used for ureteroscopy, including the one taught by Altshuler, to ablate body calculi or stone [0135].
Response to Arguments
Applicant’s arguments filed March 30, 2026, with respect to the rejection(s) of claim 1 under Chu in view of Altshuler have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Banik.
Applicant’s arguments filed March 30, 2026, with respect to the rejection(s) of claim 1 under Chu in view of Ikuma have been fully considered and are persuasive, however the prior art reference Ikuma was reinterpreted to distinguish multiple flushing channels for the rejection of claim 1.
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 LI-TING SONG whose telephone number is (571)272-5771. The examiner can normally be reached 8-5.
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/LI-TING SONG/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
06/25/26
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