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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites wherein “a catheter is non-removably integrated with the insertion end section” and claim 9 recites wherein “the suction channel is non-removably integrated with a suction catheter”. The specification does not support the non-removably integrated feature of the catheter and the insertion end section, nor the same feature between the suction channel and the suction catheter. There is no mention of explicit nor implicit (for example, welding of the structures together would highly suggest non-removability) non-removability between the two tubular structures in the specification. The examiner is interpreting “non-removably integrated” in claims 1 and 9 as the two structures integrated with one another in such a way that would require disassembly to be separated from one another.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-8 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.
Claim 1 recites the limitation "the insertion end" twice in lines 15-16 and line 17. There is insufficient antecedent basis for this limitation in the claim. It appears the applicant intended to write “the insertion end section” in both those instances. For the purpose of examination, the examiner is interpreting “the insertion end” in lines 15-17 of claim 1 as “the insertion end section”.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Wood et al.
(US2017/0238903) in view of Boulais et al. (US2006/0173244) and Popovic (US2011/0251455).
Regarding claim 1, Wood discloses a multi-channel endoscope system having an endoscope device with a control section (Fig. 1: handle 104 [0020]) and an insertion end section (Fig. 1: distal portion of shaft 102, articulation section 106 [0022]), the multi-channel endoscope system comprising: the endoscope device (endoscope 100), including:
an actuator coupled with the control section (Fig. 1: proximal end of handle 104 comprises knobs 122 and 124);
a lumen disposed within an insertion section (shaft 102 is generally cylindrical [0020] and the interior of the shaft 102, as a whole, forms a lumen) connecting the control section and insertion end section (shaft 102 connects the handle 104 to the distal end of shaft 102, the articulation section 106), the lumen extending from the control section and terminating at the insertion end section (shaft 102 and its interior lumen extends from the handle 104 to the distal end of the shaft 102, the articulation section 106):
wherein a proximal portion of the insertion end section is located at a distal end portion of the lumen (Fig. 1: proximal portion of articulation section 106 is located at the distal end portion of shaft 102 and its interior lumen):
at least one working channel extending within the insertion section and the insertion end section (Fig. 1: working lumen 108 extends to working opening 150 [0034]); and
a fluidic channel disposed within the insertion end section (fluid channel 110 with opening 146 may be used for suction [0021]).
Wood fails to disclose the fluidic channel including a catheter non-removably integrated with the insertion end section, the catheter configured to extend arcuately from an originating position within the insertion end of the multi-channel endoscope system toward a target site and to retract within the insertion end;
wherein in a retracted state, the insertion end section houses the catheter;
wherein the actuator is operationally coupled with the catheter and the actuator is configured to control a position of the catheter.
In the same field of endeavor, Boulais teaches a fluidic channel of an endoscope (endoscope 110 including distal shaft 112 and articulating distal tip [0025], Fig. 6A: fluidic channel of endoscope indicated by dotted lines within tube 510) including a catheter non-removably integrated within an insertion end section of the endoscope (trapping device 520 comprising insertion tube 524 and flexible portion 522 [0044]; trapping device 520 may be disposed within the outer wall of the distal tip 500, or, alternatively, may be disposed within a lumen position within the distal tip 500 [0044]; insertion tube 524 may be attached to a user input device, such as the handheld controller 114 via one or more control wires [0045], highly suggesting that removing the insertion tube 524 would require some level of disassembly, thus being non-removably integrated within the distal tip), the catheter configured to extend linearly from an originating position within the insertion end of the endoscope toward a target site and to retract within the insertion end (trapping device 520 may be disposed within a lumen positioned within a distal tip such as an aspiration lumen or a working channel lumen [0044]; trapping device 520 comprises an open-ended insertion tube 524 which extends linearly to the proximal region of endoscope 110 and is attached to the vacuum lines in the fluid/suction assembly 120); wherein in a retracted state, the insertion end section houses the catheter (outer flexible portion 522 is attached to an insertion tube 524 that is capable of extending and retracting the outer flexible portion 522 into and out of the distal tip 500 [0044]); wherein the actuator is operationally coupled to the catheter and the actuator is configured to control a position of the catheter (insertion tube 524 is attached to a user input device, such as the handheld controller 114 via one or more control wire [0045]; handheld controller 114 accepts user input via standard activation devices [0029])).
In view of Boulais, 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 the telescoping suction catheter of Boulais to the suction channel of Wood, as the retracting and extending feature of the suction catheter allows the operator to target the distal end of the suction catheter towards debris or an obstruction within hard-to-reach area of the body lumen.
Boulais teaches wherein the catheter extends linearly from the originating position, therefore
fails to teach wherein the catheter extends arcuately from the originating position. In the same field of
endeavor, Popovic teaches a substantially similar endoscope comprising a catheter that extends linearly
or arcuately from an originating position within an insertion end of endoscope toward a target site and
to retract within the insertion end (bronchoscope 10 comprises nested cannula 20, which comprises
telescoping tube 21-24; Fig. 6: telescoping tubes 21-24 extend arcuately from the distal end of bronchoscope 10; tubes 22-24 of nested cannula 20 may have arc tubes and/or straight tubes [0031]). In view of Popovic, 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 the arcuately extending telescoping tubes, as taught in Popovic, to the catheter of Boulais, as it is known in the endoscope art that curved tubular structures can predictably navigate through narrow bending sections of a body lumen to advance towards hard-to reach lesions while preventing trauma to the tissue [0007-0011].
Regarding claim 2, Wood, modified by Boulais and Popovic, discloses the multi-channel endoscope system of claim 1. Wood further discloses the system including at least one guidewire sized and shaped for being received in the at least one working channel (working lumen 108 allows for the passage of various instrument including a guidewire [0021]).
Regarding claim 3, Wood, modified by Boulais and Popovic, discloses the multi-channel endoscope system of claim 1. Wood further discloses the system including a laser fiber (working lumen 108 allows for the passage of various instruments including laser emitters [0021]).
Regarding claim 4, Wood, modified by Boulais and Popovic, discloses the multi-channel endoscope system of claim 1. Wood further discloses the system including: a user control mechanism the positions the insertion section that extends from the distal end portion of the control section to the proximal end portion of the insertion end (Fig. 1: proximal portion of shaft 102 extends from the distal end of handle 104 [0020] to the proximal end of the insertion end, which is a distal section of the shaft 102); wherein the lumen houses the at least one working channel and the fluidic channel (shaft 102 forms a lumen which houses several lumens extending therethrough including working lumen 108 and fluid lumen 110 [0021]; Fig. 1: proximal end of handle comprises knobs 122 and 124 for steering [0023]).
Regarding claim 5, Wood, modified by Boulais and Popovic, discloses the multi-channel endoscope system of claim 1. Boulais further teaches wherein the catheter is a suction catheter including a telescoping portion with a plurality of shaft elements (Fig. 6A: trapping device 520 comprises two telescoping shaft elements including outer flexible portion 522 and insertion tube 524).
Regarding claim 6, Wood, modified by Boulais and Popovic, discloses the multi-channel endoscope system of claim 5. Boulais further teaches wherein the actuator is configured to extend and retract the telescoping portion (outer flexible portion 522 is attached to an insertion tube 524 that is capable of extending and retracting the outer flexible portion 522 into and out of the distal tip 500 [0044]; insertion tube 524 is attached to a user input device such as a handheld controller via one or more control wires [0045]; handheld controller 114 accepts user input via standard activation devices [0029]).
Regarding claim 7, Wood, modified by Boulais and Popovic, discloses the multi-channel endoscope system of claim 1. Boulais further teaches wherein the actuator includes at least one of a button, a lever, a joystick, a knob, a dial, or a touch sensor (push buttons, switches, rotary knobs, joysticks, keyboard, touch screen, other activation devices [0029]).
Regarding claim 8, Wood, modified by Boulais and Popovic, discloses the multi-channel endoscope system of claim 1. Boulais further teaches wherein the catheter of the fluidic channel is at least one of a suction catheter or an irrigation catheter (trapping device 520 comprises an open-ended insertion tube 524 which extends to the proximal region of the endoscope 110 and is attached to the vacuum lines in the fluid/suction assembly 120 [0044]).
Regarding claim 9, Wood discloses the multi-channel ureteroscope having a control section with a handle (Fig. 1: endoscope system 100 with handle 104), a lumen with a distal insertion end section and a proximal controlling end portion (Fig. 1: shaft 102 has a proximal section and a distal articulation section 106 at the distal region of shaft 102), the multi-channel ureteroscope comprising :a user control mechanism coupled to the handle (articulation control assembly 120 comprises knobs 122 and 124 [0023]); at least one working channel traversing an internal portion of the handle and extending to the distal insertion end section for receiving at least one medical instrument (working lumen 108 extends through shaft 102 and allows for passage of various treatment instruments [0021] to the distal articulation section 106; working lumen 108 is in communication with port 128, extending through the handle 104 [0023]); and a suction channel traversing the internal portion of the handle and extending to the distal insertion end section (fluid lumen 110, which may be used as a suction lumen, extends to the distal face to fluid opening 146 [0024]; handle 104 may include one or more ports for providing access to one or more of the lumens of the shaft 102 from a position exterior of the handle 104 [0023]).
Wood fails to disclose wherein the suction channel is non-removably integrated with a suction catheter that extends through the suction channel. In the same field of endeavor, Boulais teaches a catheter (trapping device 520 comprising insertion tube 524 and flexible portion 522 [0044]) including an extendible portion that is configured to extend through an aspiration lumen to a treatment end in a linear direction (trapping device 520 may be disposed within a lumen positioned within a distal tip such as an aspiration lumen or a working channel lumen [0044]; trapping device 520 comprises an open-ended insertion tube 524 which extends linearly to the proximal region of endoscope 110 and is attached to the vacuum lines in the fluid/suction assembly 120; insertion tube 524 may be attached to a user input device, such as the handheld controller 114 via one or more control wires [0045], highly suggesting that removing the insertion tube 524 would require some level of disassembly, thus being non-removably integrated within the distal tip); wherein the extendible portion is housed within a distal insertion end section when the extendible portion is in a retracted configuration (outer flexible portion 522 is attached to an insertion tube 524 that is capable of extending and retracting the outer flexible portion 522 into and out of the distal tip 500 [0044]). In view of Boulais, 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 the telescoping suction catheter of Boulais to the suction channel of Wood, as the retracting and extending feature of the suction catheter allows the operator to target the distal end of the suction catheter towards debris or an obstruction within hard-to-reach area of the body lumen.
Boulais teaches wherein the catheter extends linearly from the suction channel, therefore fails
to teach wherein the catheter extends arcuately from the suction channel. In the same field of
endeavor, Popovic teaches a substantially similar endoscope comprising a catheter that extends arcuately from an instrument channel within an insertion end of endoscope toward a target site and to
retract within the instrument channel (bronchoscope 10 comprises nested cannula 20, which comprises telescoping tube 21-24; Fig. 6: telescoping tubes 21-24 extend arcuately from the distal end of bronchoscope 10 in instrument channel 12; tubes 22-24 of nested cannula 20 may have arc tubes
and/or straight tubes [0031]). In view of Popovic, 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 the arcuately extending
telescoping tubes, as taught in Popovic, to the catheter of Boulais, as it is known in the endoscope art
that curved tubular structures can predictably navigate through bending sections of a body lumen to
advance towards hard-to reach lesions while preventing trauma to the tissue [0007-0011].
Regarding claim 10, Wood, modified by Boulais and Popovic, discloses the multi-channel ureteroscope of claim 9. Boulais further teaches wherein the user control mechanism is configured to manipulate at least one of the at least one medical instrument or the suction catheter (the insertion tube 524 is attached to the user input device such as the handheld controller 114 via one or more control wires [0045]; handheld controller 144 accepts user input via standard activation devices [0029]).
Regarding claim 11, Wood, modified by Boulais and Popovic, discloses the multi-channel ureteroscope of claim 9. Boulais further teaches wherein the suction catheter includes the extendible portion formed from a shape memory extendible tube (the outer flexible portion 522 is attached to an insertion tube 524 that is capable of extending and retracting the outer flexible portion 522 into and of the distal tip 500 [0044]; expandable outer flexible portion 530 may be made from material such as Nitinol, which is a shape memory material). Popovic also teaches wherein the catheter includes the extendible portion formed from a shape memory extendable tube (tubes are fabricated from a material exhibiting desirable levels of flexibility/elasticity, which as Nitinol which has super elastic properties that allow the Nitinol to bend when a force is applied and to return to its original shape once the force is removed [0008]).
Regarding claim 12, Wood, modified by Boulais and Popovic, discloses the multi-channel ureteroscope of claim 11. Boulais further teaches wherein the extendible portion includes a telescoping
portion with a plurality of shaft elements (the outer flexible portion 522 and the insertion tube 524 are telescoping). Popovic also teaches wherein the extendible portion includes a telescoping
portion with a plurality of shaft elements (Fig. 6: telescoping tubes 21-24 extend arcuately from the distal end of bronchoscope 10 in instrument channel 12).
Regarding claim 13, Wood, modified by Boulais and Popovic, discloses the multi-channel ureteroscope of claim 9, however Wood fails to disclose wherein the handle includes a first actuator couplable to the at least one medical instrument. In the same field of endeavor, Boulais teaches a
medical instrument (tools pass through a working channel lumen 422 of an endoscope 110, the working channel lumen 422 accessible through a biopsy port in the handheld controller 144 [0042]) within an endoscope shaft, the medical instrument coupled to a first actuator on the handle (excising device 424 may be extended beyond the distal tip 410 of the endoscope 110 or retracted into the distal tip 410 via controls on a user input device located on the handheld controller 114 [0043]). Since Wood fails to disclose the details of the medical instrument, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any manipulation/actuation feature known in the art, including the one taught by Boulais, as it is well-known in the endoscope art that medical instruments are manipulated by an actuation feature.
Regarding claim 14, Wood, modified by Boulais and Popovic, discloses the multi-channel ureteroscope of claim 13. Boulais further teaches wherein the handle includes a second actuator couplable to the suction catheter for extending and retracting the suction catheter (the insertion tube 524 is attached to the user input device such as the handheld controller 114 via one or more control wires [0045]; handheld controller 144 accepts user input via standard activation devices [0029]).
Regarding claim 15, Wood, modified by Boulais and Popovic, discloses the multi-channel ureteroscope of claim 9. Wood further discloses wherein the multi-channel ureteroscope is configured
to be coupled to one or more external components including at least one of a light source, a video
system, a photo interface, a fluid supply or a suction system (illumination source, fluid or suction source [0043], system controller may include a suitable computing or processing devices [0042]; image data and control signals transmitted using wire and cables for processing and/or displaying to user, suggesting a monitor or photo interface [0039]).
Claims 16-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Boulais et al.
(US2006/0173244) in view of Popovic (US2011/0251455).
Regarding claim 16, Boulais discloses a method of removing a target object from a body using an endoscope (endoscope 110 [0025]) including an insertion section (Fig. 2: distal shaft 112 and proximal shaft 116 [0025]) including a lumen having a working channel (working channel 422 [0042]) and a fluidic channel (aspiration lumen 430 [0042]), the method comprising: fracturing the target object into fragments (obstructions that interfere with the colonoscopy are detected, irrigation and/or mechanical maceration is initiated using excising device 424 [0051]); wherein the working channel is configured to accommodate a medical instrument to fracture the target object (working channel lumen 422 running through the length of endoscope 110 is used for passing tools, such as excising device 424 [0042]); extending a fluidic catheter integrated with an insertion end section in a linear direction from an original retracted configuration in the insertion end section towards the fragments (trapping device 520, which extends and retracts, is deployed to aid in the entrapment and aspiration of obstructing material [0051]; trapping device 520 extends from the distal tip 500 of endoscope 110 [0044], similar to the endoscope 110 including a distal shaft 112 with an articulating distal tip [0025]); wherein in the original retracted configuration the fluidic catheter is housed within the insertion end section (the outer flexible portion 522 is attached to an insertion tube 524 that is capable of extending and retracting the outer flexible position 522 into and out of the distal tip 500 [0044]); wherein the insertion end section is located at a distal end portion of the insertion section (endoscope 110 including a distal shaft 112 with an articulating distal tip [0025], distal tip 500 [0044]); and applying at least one of suction or irrigation through the fluidic catheter toward at least a portion of the target object (trapping device 520 comprises an open-ended insertion tube 524 that extends to the proximal region of endoscope 110 and is attached to the vacuum line in the fluid/suction assembly [0044 & 0047-0057]).
Boulais fails to disclose wherein the fluidic catheter extends arcuately from an original retracted configuration, however, Popovic, in the same field of endeavor, teaches a substantially similar endoscope comprising a catheter that extends linearly and arcuately from an instrument channel within an insertion end of the endoscope toward a target site and to retract within the instrument channel (bronchoscope 10 comprises nested cannula 20, which comprises telescoping tube 21-24; Fig. 6: telescoping tubes 21-24 extend arcuately from the distal end of bronchoscope 10 in instrument channel 12; tubes 22-24 of nested cannula 20 may have arc tubes and/or straight tubes [0031]). In view of Popovic, 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 the arcuately extending telescoping tubes, as taught in Popovic, to the catheter of Boulais, as it is known in the endoscope art that curved tubular structures can predictably navigate through bending sections of a body lumen to advance towards hard-
to reach lesions while preventing trauma to the tissue [0007-0011].
Regarding claim 17, Boulais, modified by Popovic, discloses the method of claim 16, wherein the fluidic catheter includes a suction catheter and the method includes: extending a telescoping portion of the suction catheter to the target object (trapping device is attached to the vacuum line in the fluid/suction assembly [0044]; insertion tube 524 and flexible portion 522 of the trapping device 520 is a telescoping portion [0044]).
Regarding claim 18, Boulais, modified by Popovic, discloses the method of claim 17. Boulais further disclose the method comprising: articulating more than one of the telescoping portion to the target object (trapping device 520 moves, draws in, secures and aspirates material [0044]; trapping device 520 is deployed to trap obstructing material and aspirating trapped material [0054]; insertion tube 524 and flexible portion 522 of trapping device 520 is the telescoping portion [0044]).
Regarding claim 20, Boulais, modified by Popovic, discloses the method of claim 16. Boulais further discloses wherein fracturing the target object with the medical instrument and applying at least one of suction or irrigation are independently actuatable via a first actuator and a second actuator (excising device 424 may be operated via controls on the user input device located on the handheld controller [0043]; insertion tube 524 is attached to a user input device, such as the handheld controller 114 via one of more control wires [0045]; handheld controller 114 accepts user input via standard activation devices [0029]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Boulais in view of Popovic
and Ikuma (US2023/0031136).
Regarding claim 19, Boulais, modified by Popovic, discloses the method of claim 16, further comprising: inserting the insertion end section of the endoscope in a patient towards the target object (distal shaft 112 is introduced to patient’s colon, excising device 424 used for obstructions that interfere with colonoscopy [0051]); and passing the medical instrument through the working channel to the target object (working channel lumen 422 running through the length of endoscope 110 is used for passing tools, such as excising device 424 [0042]), but fails to disclose wherein the medical instrument includes a laser fiber. In the same field of endeavor, Ikuma teaches wherein a laser fiber is pass through a working channel of an endoscope to fracture a target object into fragments (laser device 5 including laser fiber 41 can be intubated into the instrument insertion channel 14a of endoscope 11 [0036]; kidney stone is easily broken by laser fiber 41 [0065]). In view of Ikuma, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized that laser fibers, like the one taught by Ikuma, are an obvious alternative to the excising device, and a common instrument in the endoscope art for breaking apart obstructions.
Response to Arguments
Applicant's arguments filed October 28, 2025 have been fully considered but they are not persuasive.
The applicant argues that Boulais fails to teach of suggest a fluidic channel including a catheter non-removably integrated with the insertion end section, the catheter configured to extend arcuately from an originating position within the insertion end section of the multi-channel endoscope system toward a target site and to retract within the insertion end. Applicant submits the endoscope of Boulais includes a trapping device 520 (alleged catheter), disposed within a lumen positioned within the distal tip 500, and the Boulais fails to teach that the trapping device 520 is integrated with the distal tip (alleged insertion end section). Further, applicant points to paragraph [0044] of Boulais to evidence “the trapping device 520 may be disposed within a lumen positioned within the distal tip 500”, arguing that the Boulais fails to disclose the trapping device is non-removably integrated, and instead, Boulais states that the trapping device “may be disposed” and that the trapping device is “positioned within the distal tip”. The examiner respectfully disagrees.
To begin, the term “non-removably integrated” was not explicitly or implicitly described in the specification, therefore the examiner was unsure as to what structure in applicant’s endoscope system would contribute to the non-removable feature between a catheter and the insertion end section. For the purpose of examination, the examiner has interpreted “non-removably integrated” as meaning two structures integrated with one another in such a way that would require disassembly of the device to be separated from one another. Under this interpretation, Boulais does read on the limitation reciting wherein a catheter is non-removably integrated with the insertion end section. Boulais states that the insertion tube 524 may be attached to a user input device, such as the handheld controller 114 via one or more control wires [0045], highly suggesting that removing the insertion tube 524 would require some level of disassembly.
Applicant has submitted that Boulais teaches a trapping device 520 disposed within a lumen positioned within the distal tip 500 – this statement itself teaches the trapping device 520 integrated within a lumen within the distal tip 500. The statement that trapping device “may be disposed” per se appears to mean that the trapping device is single-use, removable or disposable, but the entire statement is “the trapping device disposed within a lumen” meaning that the trapping device is located within a lumen.
Applicant also submits that the one of ordinary skill in the art would not have included the arcuately extending telescoping tubs, as taught by Popovic, to the catheter of Boulais, because the cannula of Popovic is designed to be removable and customizable, whereas the device of Boulais is not customizable. The examiner is unsure where in the prior art Popovic the “removable” assertion is supported. Regardless, the argument that the cannula of Popovic is designed to be removable is moot, as the non-removable feature in claim 1 and 9 have been rejected in view of Boulais. Applicant also argues that the cannula of Popovic is designed to be customizable, and that since the device of Boulais is not customizable, there would be hindsight to include the telescoping tubes to Popovic to the catheter of Boulais. The examiner respectfully disagrees. Popovic teaches the cannula to be extendible linearly and arcuately, and states that an endoscope is used to explore conventional reachable areas, whereas the nested cannula performs the final expansion to arrive at the desired target location, toward hard-to-reach areas within the body [0025]. The nested cannula can precisely navigate through small orifices [0025]. These advantages support the inclusion of the arcuately extending nested cannula, as the arcuately extending nested cannula can reach difficult and further locations, and body lumens are not usually linear.
Applicant points to paragraph [0013] of present application specification as support for the suction catheter 255 to be integrated with the suction channel 250, however, the examiner does not find this to be sufficient support for the non-removable aspect. Applicant also points to paragraph 0017 to evidence support of the concept of a non-removable integrated catheter because it states that a challenge of the present technology is non-integrated components of endoscopes. Examiner respectfully disagrees. Applicant has italicized a portion of paragraph 0017 which reads “which can be a challenge of using an endoscope without integrated or suction capabilities”. The examiner believes that there is support for the suction catheter to be integrated with the suction channel, however paragraph [0017] of applicant’s specification does not mention the non-removable concept. Regardless, the examiner has interpreted “non-removably integrated” as meaning two structures integrated with one another in such a way that would require disassembly of the device to be separated from one another. Under this interpretation, Boulais does read on the limitation reciting wherein the suction channel is non-removably integrated with a suction catheter. Boulais states that the insertion tube 524 may be attached to a user input device, such as the handheld controller 114 via one or more control wires [0045], highly suggesting that removing the insertion tube 524 would require some level of disassembly, thus being non-removably integrated.
Regarding claim 16, Applicant submits that Boulais teaches a trapping device 520 (alleged catheter) disposed within a lumen positioned within the distal tip 500, and submits that Boulais fails to teach that the trapping device (alleged catheter) is integrated with the distal tip (alleged insertion end section). Applicant further argues that Boulais, instead, states that the trapping device “may be disposed” and that the trapping device is “positioned within the distal tip”, further asserting that neither of these two statements teach or suggest that the trapping device is non-removably integrated with the insertion end. The examiner respectfully disagrees.
Applicant’s claim 16 only recites that “a fluidic catheter integrated with an insertion end section”, thus the non-removable concept was not introduced to the claim. The Merriam-Webster Dictionary defines the term “integrate” as “to form, coordinate or blend into a functioning or united whole” or “to incorporate into a larger unit”. The examiner believes these two definitions best describe what the applicant is attempting to define in the claim. Applicant has submitted that Boulais teaches a trapping device 520 disposed within a lumen positioned within the distal tip 500 – this statement itself teaches the trapping device 520 integrated within a lumen within the distal tip 500. The statement that trapping device “may be disposed” per se appears to mean that the trapping device is single-use, removable or disposable, but the entire statement is “the trapping device disposed within a lumen” meaning that the trapping device is located within a lumen.
For the reasons stated above, the applicant’s arguments were found not persuasive.
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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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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/LI-TING SONG/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
2/13/26