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.
(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 50 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mazhar et al. (US PGPUB 2022/0110516 – “Mazhar”).
Regarding Claim 50, Shelton discloses:
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An optical cannula system (Examiner-annotated Shelton FIG. 3B shown above, endoscope system 300B) comprising:
a handle (Shelton FIG. 3B, handle of endoscope 310B) comprising:
a body (Shelton FIG. 3B, hub 312);
a first port (Shelton FIG. 3B, irrigation port 313B) extending at least partially through the body, the first port configured to connect to a first hose (Shelton FIG. 3B, irrigation line 336); and
a second port (Shelton FIG. 3B, suction port 313A) extending at least partially through the body, the second port configured to connect to a second hose (Shelton FIG. 3B, suction line 326); and
a cannula (Shelton FIG. 3B, tube 311) comprising:
an outer cannula wall (Shelton FIG. 3B, outer wall of tube 311) having a proximal portion and a distal end, the proximal portion configured to be disposed within the body (Shelton paragraph [0049], “endoscope comprises a tubular portion insertable into an interior of an organ or a cavity of the body to assist in diagnosis or treatment”);
a first channel (Shelton FIG. 1, suction channel 112 within medical device 110; Shelton paragraph [0060], “Another example of the medical device 110 can include an endoscope”) within the outer cannula wall, the first channel configured to be in fluid communication with the first port in a first configuration (Shelton FIG. 5, showing suction channel 112 in fluid communication with suction source 120) and the second port in a second configuration (Shelton FIG. 6A, showing suction channel 112 in fluid communication with irrigation source 130); and
a second channel (Shelton FIG. 1, irrigation channel 114 within medical device 110) within the outer cannula wall, the second channel configured to be in fluid communication with the second port in the first configuration (Shelton FIG. 5, showing irrigation channel 114 in fluid communication with irrigation source 130) and the first port in the second configuration (Shelton FIG. 6A, showing irrigation channel 114 in fluid communication with suction source 120).
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.
Claims 31, 40-42, 44, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Mazhar et al. (US PGPUB 2022/0110516 – “Mazhar”) in view of Shelton et al. (US PGPUB 2020/0187768 – “Shelton”).
Regarding Claim 31, Mazhar discloses:
An optical cannula system (Mazhar FIG. 1, system 10; Mazhar FIG. 5, waveguide 154; Mazhar paragraph [0138], “waveguide 154 may be an optical fiber including a core and a surrounding cladding and may be configured to provide total internal reflection”) comprising:
a cannula (Mazhar FIG. 1, probe 130), comprising:
a proximal portion (Mazhar FIG. 1, proximal end of shaft 132 of probe 130);
a distal end (Mazhar FIG. 1, distal end of shaft 132 of probe 130);
an axis extending between the proximal portion and the distal end (Mazhar FIG. 1, longitudinal probe axis P-P of probe 130);
an outer cannula wall (Mazhar FIG. 5, outer wall of shaft 132) defining an interior space extending along the axis; and
one or more inner cannula walls within the outer cannula wall extending along the axis (Mazhar FIG. 6, inner walls defined by shaft 132), the one or more inner cannula walls dividing the interior space into a first channel (Mazhar FIG. 6, lumen 142) and a second channel (Mazhar FIG. 6, lumen 144).
Mazhar does not explicitly disclose:
a handle configured to receive the proximal portion of the cannula, the handle configured to connect to a first tube and to a second tube; and
a valve assembly connected to the handle, the valve assembly having a first configuration in which the first tube is in fluid communication with the first channel and the second tube is in fluid communication with the second channel simultaneously, the valve assembly having a second configuration in which the first tube is in fluid communication with the second channel and the second tube is in fluid communication with the first channel simultaneously.
Shelton teaches:
a handle (Shelton FIG. 2A, hand piece 210) configured to receive the proximal portion of the cannula (Shelton FIG. 2A, proximal portion 226 of tubular assembly 222), the handle configured to connect to a first tube (Shelton FIG. 6A, suction channel 112) and to a second tube (Shelton FIG. 6A, irrigation channel 114; Shelton paragraph [0065], “the suction channel 112 and the irrigation channel 114 can be disposed in a parallel orientation along a length of a tubular portion of the hand piece of the medical device 110”); and
a valve assembly (Shelton FIG. 6A, pressure regulation system 600) connected to the handle (Shelton FIG. 6A, controller module 160 connected to flow monitor 650, which is connected to flow sensor 652 within suction channel 112; Examiner interprets Shelton elements 160, 650, 652, and 112 to be components of a valve assembly used to selectively swap irrigation and suction between channels 112 and 114, as shown in Shelton FIG. 5 compared to Shelton FIG. 6A.), the valve assembly having a first configuration (Shelton FIG. 5) in which the first tube (Shelton FIG. 3B, suction line 326) is in fluid communication with the first channel (Shelton FIG. 5, suction channel 112 connected to suction source 120 via the suction line 326 shown in Shelton FIG. 3B) and the second tube (Shelton FIG. 3B, irrigation line 336) is in fluid communication with the second channel (Shelton FIG. 5, irrigation channel 114 connected to irrigation source 130 via the irrigation line 336 shown in Shelton FIG. 3B) simultaneously, the valve assembly having a second configuration (Shelton FIG. 6A) in which the first tube (Shelton FIG. 3B, suction line 326) is in fluid communication with the second channel (Shelton FIG. 6A, irrigation channel 114 connected to suction source 120 via the suction line 326 shown in Shelton FIG. 3B) and the second tube (Shelton FIG. 3B, irrigation line 336) is in fluid communication with the first channel (Shelton FIG. 6A, suction channel 112 connected to irrigation source 130 via the irrigation line 336 shown in Shelton FIG. 3B) simultaneously.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Shelton’s valve assembly with the optical annual system disclosed by Mazhar. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield predictable result of an endoscopic system having switchable irrigation/suction channels within an insertion portion for selectively applying suction to the irrigation channel in order to clear a blockage in the irrigation channel (see Shelton paragraph [0105]). As (1) the combination of the prior art includes each element claimed, although not necessarily in a single prior art reference, as described above; (2) the record shows no evidence of each element taught by the cited prior art performing differently in combination as it does separately (i.e., either alone or in combination the system for focusing performs in a same manner); and (3) a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable (i.e., nothing in the record supports anything other than the predicable result of an insertion portion of an endoscope having the ability to self-clear an obstructed irrigation channel by using Shelton’s feedback-controlled pressure regulation system 600). As such, no additional findings based on the Graham (Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966) factual inquiries are necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Regarding Claim 40, Mazhar in view of Shelton teaches the features of Claim 31, as described above.
Shelton further teaches wherein the first tube (Shelton FIG. 3B, irrigation port 313b) forms a distal end of an irrigation hose (Shelton FIG. 3B, irrigation line 336) and the second tube (Shelton FIG. 3B, suction port 313A) forms a distal end of a suction hose (Shelton FIG. 3B, suction line 326), the irrigation hose and the suction hose configured to be removably connected to the handle (Shelton FIG. 3B, showing irrigation line 336 and suction line 326 coupled to endoscope handle hub 312).
Regarding Claim 41, Mazhar discloses:
An optical cannula system (Mazhar FIG. 1, system 10; Mazhar FIG. 5, waveguide 154; Mazhar paragraph [0138], “waveguide 154 may be an optical fiber including a core and a surrounding cladding and may be configured to provide total internal reflection”) comprising:
a cannula (Mazhar FIG. 1, probe 130), comprising:
an outer cannula wall (Mazhar FIG. 1, outer wall of shaft 132) having a proximal portion (Mazhar FIG. 1, proximal end of shaft 132 of probe 130) and a distal end (Mazhar FIG. 1, distal end of shaft 132 of probe 130);
a first channel (Mazhar FIG. 6, lumen 144) within the outer cannula wall;
a second channel (Mazhar FIG. 6, lumen 142) within the outer cannula wall; and
one or more internal walls (Mazhar FIG. 6, walls of lumen that are within the outer wall of shaft 132) within the outer cannula wall, the one or more internal walls extending at least partially along a length of the outer cannula wall between the proximal portion and the distal end, the one or more internal walls at least partially defining the first channel (Mazhar FIG. 6, lumen 144) and a second channel (Mazhar FIG. 6, lumen 142).
Mazhar does not explicitly disclose:
the first channel configured for suction in a first configuration of the optical cannula system and configured for irrigation in a second configuration of the optical cannula system;
the second channel configured for irrigation in the first configuration and suction in the second configuration; and
a handle configured to receive the proximal portion of the cannula,
wherein the optical cannula system is configured to provide both suction and irrigation in the first configuration and the second configuration.
Shelton teaches:
the first channel (Shelton FIG. 5, channel 112) configured for suction in a first configuration (Shelton FIG. 5) of the optical cannula system (Shelton FIG. 5, showing channel 112 configured for suction) and configured for irrigation in a second configuration (Shelton FIG. 6A) of the optical cannula system (Shelton FIG. 6A, showing channel 112 configured for irrigation);
the second channel (Shelton FIG. 5, channel 114) configured for irrigation in the first configuration (Shelton FIG. 5, showing channel 114 configured for irrigation) and suction in the second configuration (Shelton FIG. 6A, showing channel 114 configured for suction); and
a handle (Shelton FIG. 2A, hand piece 210) configured to receive the proximal portion of the cannula (Shelton FIG. 2A, proximal portion 226 of tubular assembly 222),
wherein the optical cannula system is configured to provide both suction and irrigation in the first configuration and the second configuration (Shelton FIG. 5 and Shelton FIG. 6, both showing suction and irrigation being provided simultaneously).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Shelton’s valve assembly with the optical annual system disclosed by Mazhar. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield predictable result of an endoscopic system having switchable irrigation/suction channels within an insertion portion for selectively applying suction to the irrigation channel in order to clear a blockage in the irrigation channel (see Shelton paragraph [0105]). As (1) the combination of the prior art includes each element claimed, although not necessarily in a single prior art reference, as described above; (2) the record shows no evidence of each element taught by the cited prior art performing differently in combination as it does separately (i.e., either alone or in combination the system for focusing performs in a same manner); and (3) a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable (i.e., nothing in the record supports anything other than the predicable result of an insertion portion of an endoscope having the ability to self-clear an obstructed irrigation channel by using Shelton’s feedback-controlled pressure regulation system 600). As such, no additional findings based on the Graham (Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966) factual inquiries are necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Regarding Claim 42, Mazhar in view of Shelton teaches the features of Claim 41, as described above.
Shelton further teaches a valve assembly (Shelton FIG. 6A, pressure regulation system 600) connected to the handle (Shelton FIG. 6A, controller module 160 connected to flow monitor 650, which is connected to flow sensor 652 within suction channel 112; Examiner interprets Shelton elements 160, 650, 652, and 112 to be components of a valve assembly used to selectively swap irrigation and suction between channels 112 and 114, as shown in Shelton FIG. 5 compared to Shelton FIG. 6A.), the valve assembly configured to transition the optical cannula system between the first configuration (Shelton FIG. 5) and the second configuration v.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Shelton’s valve assembly with the optical annual system disclosed by Mazhar. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield predictable result of an endoscopic system having switchable irrigation/suction channels within an insertion portion for selectively applying suction to the irrigation channel in order to clear a blockage in the irrigation channel (see Shelton paragraph [0105]). As (1) the combination of the prior art includes each element claimed, although not necessarily in a single prior art reference, as described above; (2) the record shows no evidence of each element taught by the cited prior art performing differently in combination as it does separately (i.e., either alone or in combination the system for focusing performs in a same manner); and (3) a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable (i.e., nothing in the record supports anything other than the predicable result of an insertion portion of an endoscope having the ability to self-clear an obstructed irrigation channel by using Shelton’s feedback-controlled pressure regulation system 600). As such, no additional findings based on the Graham (Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966) factual inquiries are necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Regarding Claim 44, Mazhar in view of Shelton teaches the features of Claim 41, as described above.
Mazhar further discloses:
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the cannula further comprises a channel port (Examiner-annotated Mazhar FIG. 1 shown above, cannula channel connection for conduit 165T), the channel port extending through the outer cannula wall near the distal end and into the second channel (Mazhar FIG. 1, delivery controller 168; Mazhar paragraph [0147], “delivery controller 168 is operable to control actuation of the delivery source 112 and/or to selectively allow and prevent fluid flow through the conduits 166, 165T to the delivery lumen 144”), the second channel port configured to allow fluid communication between an environment external to the cannula and the second channel (Mazhar FIG. 1, delivery controller 168 for irrigation fluid).
Regarding Claim 49, Mazhar in view of Shelton teaches the features of Claim 41, as described above.
A second embodiment of Mazhar further discloses wherein the cannula (Mazhar FIG. 22, probe 430) further comprises a curved region (Mazhar Fig. 22, flexible shaft 484) between the distal end (Mazhar FIG. 22, tip section 438) and the proximal portion (Mazhar FIG. 22, intermediate section 437) such that a central axis of the distal end is at a non-zero angle relative to a central axis of the proximal portion (Mazhar paragraph [0337], “flexible shaft 484 allows for the distal end portion of the probe 430 to be bent”; Examiner interprets flexible shaft 484 as bending probe 430 such that the proximal intermediate section 437 an distal tip section 438 have non-aligned axes).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Mazhar’s flexible shaft 484 with the system taught by the first embodiment of Mazhar in view of Shelton. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield predictable result of a system that is able to maneuver through narrow passages (see Mazhar paragraph [0337]). As (1) the combination of the prior art includes each element claimed, although not necessarily in a single prior art reference, as described above; (2) the record shows no evidence of each element taught by the cited prior art performing differently in combination as it does separately (i.e., either alone or in combination the system for focusing performs in a same manner); and (3) a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable (i.e., nothing in the record supports anything other than it would be obvious to bend the insertion portion taught by the first embodiment of Mazhar in view of Shelton). As such, no additional findings based on the Graham (Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966) factual inquiries are necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Claims 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Mazhar et al. (US PGPUB 2022/0110516 – “Mazhar”) in view of Shelton et al. (US PGPUB 2020/0187768 – “Shelton”) and Edwardsen et al. (US PGPUB 2002/0133077 – “Edwardsen”).
Regarding Claim 37, Mazhar in view of Shelton teaches the features of Claim 31, as described above.
Mazhar in view of Shelton does not explicitly teach a rotation handle connected to the cannula, the rotation handle configured to rotate the cannula relative to the handle.
Edwardsen teaches a rotation handle (Edwardsen FIG. 2, rotation control wheel 226) connected to the cannula (Edwardsen FIG. 2, rotating shaft 220), the rotation handle configured to rotate the cannula relative to the handle (Edwardsen FIG. 2, handle 210; Edwardsen FIG. 2, arrow showing rotation of rotating shaft 220 relative to handle 220; see also Edwardsen paragraph [0021]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Edwardsen’s rotating insertion shaft with the optical annual system taught by Mazhar in view of Shelton. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield predictable result of an endoscopic system having a rotatable insertion shaft that provides orientation control over a scanhead at the distal end of the rotatable insertion shaft (see Edwardsen FIG. 2, scanhead 222 including an imaging element 224, and Edwardsen paragraph [0021], describing movement control of scanhead 222). As (1) the combination of the prior art includes each element claimed, although not necessarily in a single prior art reference, as described above; (2) the record shows no evidence of each element taught by the cited prior art performing differently in combination as it does separately (i.e., either alone or in combination the system for focusing performs in a same manner); and (3) a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable (i.e., nothing in the record supports anything other than the predicable result of an insertion portion of an endoscope having the ability to aim a camera at the distal end of the insertion portion using Edwardsen’s rotation control wheel 226). As such, no additional findings based on the Graham (Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966) factual inquiries are necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Regarding Claim 38, Mazhar in view of Shelton and Edwardsen teaches the features of Claim 37, as described above.
Shelton teaches wherein the first channel and the second channel are in fluid communication with their respective tubes, as described above in the rejection of Claim 31 (Shelton FIG. 3B, suction line 326 in fluid communication with suction channel 112; Shelton FIG. 3B, irrigation line 336 in fluid communication with irrigation channel 114 shown in Shelton FIG. 5).
Edwardsen teaches rotation of the cannula relative to the handle (Edwardsen FIG. 2, rotation control wheel 226 rotating shaft 220; Edwardsen FIG. 2, arrow showing rotation of rotating shaft 220 relative to handle 220). Examiner notes that Edwardsen is cited solely for teaching a rotatable shaft. As such, the combination of Shelton and Edwardsen teaches wherein the first channel and the second channel are in fluid communication with their respective tubes during rotation of the cannula relative to the handle.
Regarding Claim 39, Mazhar in view of Shelton and Edwardsen teaches the features of Claim 37, as described above.
Edwardsen further teaches a rotation assembly comprising the rotation handle (Edwardsen FIG. 2, rotation control wheel 226) and an insertion portion (Edwardsen FIG. 2, ultrasound probe 200 including a rotating shaft 220) connected to the rotation handle, the insertion portion extending at least partially into the handle (Edwardsen FIG. 3, rotating tube 325; Edwardsen paragraph [0022], “rotating tube 325 extends throughout the body of the rotating shaft 220 and into the control handle 210”), wherein the insertion portion is positioned between the outer cannula wall and a plurality of circumferential seals (Edwardsen FIG. 3, O-rings 334; Edwardsen paragraph [0022], “O-rings 334 provide a sealing connection between the control handle 210 and the rotating tube 325”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Edwardsen’s O-rings with the optical cannula system taught by Mazhar in view of Shelton and Edwardsen. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield predictable results of an insertion portion having a proximal end that is located with an endoscope handle in order to prevent fluids within the insertion portion from leaking out through the handle (see Edwardsen paragraph [0024], “the O-rings 334 form a fluid-tight seal between the control handle 210 and the rotating endoscope shaft 220.”).
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Mazhar et al. (US PGPUB 2022/0110516 – “Mazhar”) in view of Shelton et al. (US PGPUB 2020/0187768 – “Shelton”) and Kamrava (US PGPUB 2004/012286 – “Kamrava”).
Regarding Claim 43, Mazhar in view of Shelton teaches the features of Claim 41, as described above.
Mazhar further discloses:
wherein the first channel (Mazhar FIG. 6, lumen 144) comprises a main channel portion and a side channel portion extending from the main channel portion (Examiner interprets the side channel as being a side portion of the main channel, as described in Applicant’s FIG. 35B as first channel 623’ and side portion 605’), the one or more internal walls at least partially defining the main channel portion and the side channel portion (Mazhar FIG. 6, showing lumen 144 defined by internal wall of elongated shaft 132).
Mazhar in view of Shelton does not explicitly teach the main channel portion configured to receive a shaft of a tool, the side channel portion configured to allow fluid communication around the main channel portion and the shaft of the tool.
Kamrava teaches the main channel portion (Kamrava FIG.7, operational channel 220) configured to receive a shaft of a tool, the side channel portion configured to allow fluid communication around the main channel portion and the shaft of the tool (Kamrava FIG. 7, valve 226; Kamrava paragraph [0047], “valve 226 may…provide individual access ports for an instrument and for gas or fluid (e.g., allowing introduction of a gas or fluid through operational channel 220 at the same time an instrument is inserted through operational channel 220)”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Kamrava’s valve system with the system taught by Mazhar in view of Shelton. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield predictable result of a system that permits simultaneous usage of a single lumen for both entrance of a tool and or introduction of a gas of liquid, in order to enable the system to insufflate or lavage a target area while the tool is in use (see paragraph [0047] of Kamrava). As (1) the combination of the prior art includes each element claimed, although not necessarily in a single prior art reference, as described above; (2) the record shows no evidence of each element taught by the cited prior art performing differently in combination as it does separately (i.e., either alone or in combination the system for focusing performs in a same manner); and (3) a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable (i.e., nothing in the record supports anything other than the ability to utilize Kamrava’s valve 226 with the system taught by Mazhar in view of Shelton). As such, no additional findings based on the Graham (Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966) factual inquiries are necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Claims 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Mazhar et al. (US PGPUB 2022/0110516 – “Mazhar”) in view of Shelton et al. (US PGPUB 2020/0187768 – “Shelton”) and Wood et al. (US PGPUB 2017/0238903 – “Wood”).
Regarding Claim 45, Mazhar in view of Shelton teaches the features of Claim 41, as described above.
Mazhar in view of Shelton does not explicitly teach an optical cap housing a camera chip, the optical cap configured to be connected to the distal end of the cannula.
Wood teaches an optical cap (Wood FIG. 1, end cap 130) housing a camera chip (Wood FIG. 1, CCD within optical visualization assembly 136), the optical cap configured to be connected to the distal end of the cannula (Wood FIG. 1, distal end of shaft 102 of endoscope system 100).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Wood’s CCD/optical cap with the cannula system taught by Mazhar in view of Shelton. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a cannula system having visualization capabilities for visualizing instruments and pathological areas of interest during endoscopic surgery.
As (1) the combination of the prior art includes each element claimed, although not necessarily in a single prior art reference, as described above; (2) the record shows no evidence of each element taught by the cited prior art performing differently in combination as it does separately (i.e., either alone or in combination the system for focusing performs in a same manner); and (3) a finding that one of ordinary skill in the art would have recognized that the results of the combination were predictable (i.e., nothing in the record supports anything other than the ability to utilize Wood’s camera chip and cap with the system taught by Mazhar in view of Shelton). As such, no additional findings based on the Graham (Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966) factual inquiries are necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Regarding Claim 46, Mazhar in view of Shelton and Wood teaches the features of Claim 45, as described above.
Wood further teaches the optical cap further comprises a central opening (Wood FIG. 1, fluid opening 146 on distal face 132 of end cap 130) configured to be at least partially aligned with the first channel (Wood FIG. 1, fluid lumen 110), the central opening allowing fluid communication between the first channel and an external environment through the optical cap (Wood paragraph [0024], “Distal face 132 may have one or more fluid openings 146, 148 in communication with one or more fluid lumens 110, 112 for irrigation, insufflation, aspiration, and/or suction.”).
Claims 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over Mazhar et al. (US PGPUB 2022/0110516 – “Mazhar”) in view of Shelton et al. (US PGPUB 2020/0187768 – “Shelton”), Wood et al. (US PGPUB 2017/0238903 – “Wood”), and Wales et al. (US PGPUB 2018/0000321 – “Wales”).
Regarding Claim 47, Mazhar in view of Shelton and Wood teaches the features of Claim 45, as described above.
Mazhar in view of Shelton and Wood does not explicitly teach wherein the optical cap further comprises a side port extending through a side wall thereof, the side port configured to allow fluid communication between the second channel and an external environment through the optical cap.
Wales teaches the optical cap further comprises a side port (Wales, FIG. 1, drain hole 40) extending through a side wall thereof, the side port configured to allow fluid communication between the second channel and an external environment through the optical cap (Wales drain hole provides fluid communication between an interior/channel of shaft 12 and the external environment around cap 24).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Wales’ tapered optical cap for Wood’s end cap in the cannula system taught by Mazhar in view of Shelton and Wood. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain the predictable result of a cannula system capable of removing blood or other visual obstructions from a central lumen of an endoscope (see paragraph [0034] of Wales).
Regarding Claim 48, Mazhar in view of Shelton, Wood, and Wales teaches the features of Claim 47, as described above.
Wales further teaches the optical cap further comprising a second side port (Wales FIG. 1, cap channel 42) extending through a side wall thereof, the second side port configured to allow fluid communication between the first channel and an external environment through the optical cap (Wales drain hole provides fluid communication between an interior/channel of shaft 12 and the external environment around cap 24).
Allowable Subject Matter
Claim 32 is 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.
The following is a statement of reasons for the indication of allowable subject matter: the claimed invention is allowable over the prior art of record for not disclosing or fairly suggesting a valve shaft connected to the valve handle, in the first configuration, the valve shaft configured to allow fluid communication between the first tube and the first channel and between the second tube and the second channel, and in the second configuration, the valve shaft configured to allow fluid communication between the first tube and the second channel and between the second tube and the first channel. The closest identified prior art is Salman et al. (US PGPUB 2015/0182105 – “Salman”), which teaches in Salman FIG. 3A a valve shaft 310 connected to a switcher handle 305 that directs suction through suction module 130 shown in Salman FIG. 1A through one or both suction valves 131 and/or 132. However, Salman’s suction module 130 would not be a reasonable or obvious modification of the pressure regulation system 600 shown in Shelton FIG. 6A, since the two valve assemblies are unrelated in structural features (Shelton is electronic while Salman is mechanical). Furthermore, there is no reason or suggestion provided in the prior art to modify the above prior art to teach the limitations as claimed above, and the only reason to modify the references would be based on Applicant's disclosure, which is impermissible hindsight reasoning.
Claims 33-36 are deemed allowable, subject to fulfilment of conditions required for allowing Claim 32, for depending on Claim 32.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
Prosecution Insights