DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/05/2026 has been entered.
As indicated by the amendment submitted with the request for continued examination: claims 1, 56, 63 and 96 have been amended. Claims 1-6, 8-9, 11, 16, 21, 23, 39, 41, 48-51, 53, 55, 61, 63-64, 66-67, 69, 85-89, 91-101, 103, 105-106 and 108-110 are presently pending in the application.
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.
Claim 108 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. Dependent claim 108 recites wherein the imaging detector is in the handle and is optically coupled to the distal end of the imaging tube with a plurality of optical fibers (emphasis added). Claim 108 depends from independent claim 96 which has been amended to recite, in pertinent part, an imaging detector coupled to a distal end of the imaging tube. The specification, as originally filed, does not disclose an embodiment where the imaging detector is located both at the distal end of the imaging tube, as recited in independent claim 96, and in the handle, as recited in dependent claim 108. Accordingly, the claim fails to comply with the written description requirement.
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 108 is 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. Dependent claim 108 recites wherein the imaging detector is in the handle and is optically coupled to the distal end of the imaging tube with a plurality of optical fibers (emphasis added). Claim 108 depends from independent claim 96 which has been amended to recite, in pertinent part, an imaging detector coupled to a distal end of the imaging tube. It is not clear how the imaging detector can be located both at the distal end of the imaging tube, as recited in independent claim 96, and in the handle, as recited in dependent claim 108. Accordingly, the claim is rendered indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6, 8, 9, 16, 21, 23, 39, 41, 48, 63, 64, 66-67, 69, 85-89 and 91-95 are rejected under 35 U.S.C. 103 as being unpatentable over Gill et al. (US 2009/0253967 A1) in view of Kucklick et al. (US 2005/0234298 A1) in view of Farr et al. (US 2011/0028790 A1) in view of Schutz et al. (US 2011/0009694 A1) in view of Blanquart et al. (US 2014/0160259 A1).
Regarding claim 1, Gill discloses an endoscope system comprising: an endoscope (20/400; Figs. 1 and 22A) including an imaging tube (28; par. [0056]; Figs. 1 and 22A) attached to an endoscope handle (32/402; par. [0056] and [0144]; Figs. 1 and 22A) in communication with a display device (par. [0150] – 474 integrated with 470; Fig. 22B) with a cable (par. [0150] – connection 479 can be wired; Fig. 22B) connection, the endoscope handle (32/402) being connected to a control element (par. [0144] – control panel 409 with buttons that the user employs to electrically operate the handle) to operate at least one of a light emitting diode (LED) light source (par. [0144]) and an imaging detector (404) mounted at [[in]] the end the endoscope (proximal end), the imaging detector including a pixelated imaging sensor chip including clocking and a controller for imaging sensor chip operation (par. [0145]); and an outer tubular body (34; Figs. 1 and 22A; par. [0056] and [0146]) having a diameter of 3 mm or less (par. [0005]-[0006] and claim 1) and a length for insertion into an arthroscopic joint to image a region within a joint cavity (par. [0013] and [0151]) wherein the outer tubular body surrounds the endoscope imaging tube (28); and a cannula (60; par. [0061]) to introduce the outer tubular body (34) into the [[a]] joint cavity (intended use).
Although Gill discloses the endoscope being inserted into a cannula (60; par. [0061]) for minimally invasive surgery, it does not specifically disclose the system including a surgical tool and the cannula introducing the surgical tool. Kucklick teaches an analogous endoscope system wherein an endoscope (2) and a surgical tool (par. [0048]; Figs. 11 and 14; 57/63) are inserted into an analogous cannula (3; Figs. 11 and 12) having a working channel (56) for the surgical tool and a lumen for the endoscope (2; Fig. 12). It would have been obvious to one having ordinary skill in the art to have modified the cannula of Gill with that of Kucklick, including a working channel in the cannula for a surgical tool, and to provide the surgical tool, in order reduce the number of incisions made during surgery, thereby minimizing the invasiveness of surgery, by allowing the surgeon to view the surgical site and perform a procedure through one cannula and incision.
Although Gill discloses the endoscope handle (32/400) in communication with a display device (par. [0150] – 474 integrated with 470; Fig. 22B) with a cable (par. [0150] – connection 479 can be wired; Fig. 22B) connection, it does not specifically disclose wherein an endoscope handle cable connection receives power for the endoscope; and that the display device is a tablet, wherein the tablet display camera control device includes a touchscreen display for visualizing an imaging procedure of a region of interest within a body during surgery, the touchscreen display being positioned within a tablet housing, the tablet housing including an LED power controller to control the LED light source and at least one processor configured to control operation of the imaging detector such that the tablet display camera control device sets imaging and illumination parameters using touch control operations on the touchscreen display, the at least one processor being further configured to process patient data and medical imaging data. Farr teaches an imaging system wherein the imaging apparatus (200) is in wired communication with a tablet display camera controller device (210; par. [0035], [0066]-[0069]) with a cable connection (205b; par. [0034]-[0037]) wherein an endoscope handle cable connection receives power for the endoscope (205a/205b; par. [0034]-[0037]), wherein the tablet display camera control device (210) includes a touchscreen display (touch screen; par. [0067]-[0069]) for visualizing images captured by the imaging apparatus; the touchscreen display (touch screen; par. [0067]-[0069]) being positioned within a tablet housing (of 210), the tablet housing (of 210) including an LED power controller to control the LED light source (par. [0044], [0048] and [0063] - the display and control unit 210 synchronizes the on/off timing of each LED) and at least one processor configured to control operation of the imaging detector to set imaging parameters using touch control operations (par. [0036], [0039] and [0068] - A user interface can be provided on the portable control and display unit 210 and may include hard or soft electronic keys, a mouse or joystick, a touch screen, and/or voice activated command electronics. The user interface can be employed to adjust, control, display, process, transfer, store or retrieve the image and video data.) such that the tablet display camera control device (210) sets imaging and illumination parameters using touch control operations on the touchscreen display (par. [0044], [0048], [0063] and [0066]-[0069]), the at least one processor being further configured to process patient data and medical imaging data (par. [0050]). It would have been obvious to one having ordinary skill in the art to have included the tablet display camera control device with control and power supply of Farr in the system of Gill thereby providing vision and illumination units without means of power or control electronics of their own that can be made in a compact and low cost form, as taught by Farr (par. [0035]) and making the system mobile in order to allow the operating room personnel to place the tablet in a convenient location for use and to power and control operations of the imaging device.
Although Gill teaches an imaging detector (404; par. [0009], [0097], [0145]) mounted at the proximal end of the endoscope, it does not specifically disclose it is mounted at the distal end of the endoscope, as now claimed. It is generally known in the art to mount imaging detectors at the distal end of small diameter endoscopes, as evidenced by Schultz which teaches an analogous arthroscope wherein the imaging detector (124/220; Figs. 1D-1E and 2A; par. [0057], [0060], [0120] and [0133]) is mounted at the distal end of the endoscope (Figs. 1D-1E and 2A) and includes a control element on the handle to operate the imaging detector (145; par. [0118]). Further, Blanquart teaches that endoscopes having imaging detectors at the proximal end of the endoscope, like that of Gill, transmit the incident light along its length toward the sensor via a complex set of precisely coupled optical components (par. [0002]). Blanquart also teaches that the cost of the endoscope is increased due to the expense of the optical components and that the endoscope may be mechanically delicate and relatively minor impacts can easily damage the components or upset the relative alignments thereof (par. [0002]). Blanquart teaches using a reduced area imaging detector at the distal end of the endoscope in order to greatly reduce cost among other benefits (par. [0003]). It would have been obvious to one having ordinary skill in the art to mount an imaging detector at the distal end of the endoscope in order to greatly reduce the cost of manufacturing the endoscope, as taught by Blanquart, and as generally known in the art, as evidenced by Schutlz. The Examiner notes that Applicant has disclosed the imaging detector being mounted at either the proximal end or distal end (see par. [0128] of the published application).
Regarding claim 2, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the system of claim 1 wherein the outer tubular body (34; Figs. 1 and 22A; par. [0056] and [0146]) comprises a disposable sheath having an inner tube (100; Fig. 6B; par. [0070]).
Regarding claim 3, v in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the system of claim 1, wherein the outer tubular body (34; Figs. 1 and 22A; par. [0056] and [0146]) has a diameter of 2 mm or less (par. [0005]-[0006]).
Regarding claim 4, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart the system of claim 1, wherein the surgical tool comprises an arthroscopic tool (Kucklick: par. [0048]).
Regarding claim 5, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the system of claim 4, wherein the arthroscopic tool comprises at least one of a cutting tool, abrading tool, mechanized rotary cutter, electrosurgical tool (Kucklick: par. [0048]), laser, scalpel, forceps, snare, morcellator, RF cutting element, or electrically powered tool.
Regarding claim 6, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the system of claim 2, wherein the endoscope imaging tube (28) comprises a plurality of optical fibers (26; par. [0065] and [0076]), the endoscope imaging tube being insertable within the disposable sheath having a straight or curved shape and wherein the cannula system further comprises a first cannula (Kucklick: 3) to receive the endoscope imaging tube (28) and a second cannula (Kucklick: 61/62) to receive the surgical tool (Kucklick: 63; Fig. 14).
Regarding claim 8, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the system of claim 1, wherein the cannula system comprises a single cannula body having a first cannula channel (Kucklick: 56) and a second cannula channel (Kucklick: 49; Fig. 12).
Regarding claim 9, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the system of claim 1, wherein a distal end of the surgical tool (Kucklick: 57; par. [0048]) is 4mm in size or less, or alternatively, is 3mm in size or less (par. [0041] – outer diameter of the cannula measures about 2-5mm).
Regarding claim 16, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the system of claim 1, wherein the surgical tool is configured to bend in a predetermined manner upon protrusion from a cannula (Kucklick: distal end of 57), a diameter of the surgical tool being operatively configured for insertion into a narrow access space a hip, a knee or a shoulder joint (capable of such intended use).
Regarding claim 21, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the system of claim 1 wherein the handle (32/402) comprises a power source (414; Fig. 22A; par. [0144]), a power regulation circuit (416; par. [0144]), a video transmitter (410/412; Fig. 22A; par. [0148]]) and a control transceiver (471; Fig. 22B; par. [0150]) communicating with the tablet display camera control device (470/474; Farr: 210), the touchscreen display (Farr: 210) being connected to a touch processor that is operable in response to a plurality of touch icons and touch gestures associated with a graphical user interface (GUI), a video processor and a wireless video receiver in the tablet housing (Farr: par. [0066]-[0069]).
Regarding claim 23, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the system of claim 1, wherein the outer tubular body comprises one or more light-emitting diodes (LEDs) at a distal tip (Kucklick: par. [0054]).
Regarding claim 39, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the system of claim 1, wherein the surgical tool is operatively configured to perform at least one of a biopsy, a myomectomy, a polypectomy, a hysterectomy, or a visual dilation and curettage procedure (intended use; the surgical tool may be used to suction any remaining contents during a curettage procedure).
Regarding claim 41, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the system of claim 1,wherein the LED light source further comprises at least one white LED (par. [0041]) in the endoscope handle, the at least one white LED being connected to a light emitting surface positioned around a distal end of the imaging tube (par. [0098]).
Regarding claim 48, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the system of claim 1, wherein the cannula system includes a first cannula inserted through a first entry point and a second cannula inserted through a second entry point separated from the first entry point (intended use; may be inserted into two different entry points at two different points in time).
Regarding claim 63, Gill discloses a method for arthroscopic surgery comprising: inserting a distal end of an endoscope (20/400; Figs. 1 and 22A) through a cannula channel (interior of 60; par. [0061]) into a joint cavity (par. [0013] and [0151]); the endoscope (20/400; Figs. 1 and 22A) including an imaging detector (404) mounted at an end (proximal end), a light emitting diode (LED) light source (par. [0144]) that illuminates a joint region (par. [0013] and [0151]), an endoscope handle (32/402; par. [0056] and [0144]; Figs. 1 and 22A) having a handle control element (par. [0144] – control panel 409 with buttons that the user employs to electrically operate the handle), and a tubular endoscopic device (34; Figs. 1 and 22A; par. [0056] and [0146]) having a diameter of 3 mm or less at the distal end (par. [0005]-[0006] and claim 1), the endoscope handle (32/402; par. [0056] and [0144]; Figs. 1 and 22A) being connected to a display device (par. [0150] – 474 integrated with 470; Fig. 22B) by a cable (par. [0150] – connection 479 can be wired; Fig. 22B), the display device having a display screen configured to display images generated by the imaging detector (404; par. [0145] and [0150]); the imaging detector comprising an image sensor having clocking and a controller for imaging sensor chip operation (par. [0145]); and viewing a surgical procedure performed using the endoscope (par. [0002]).
Although Gill discloses the endoscope (20/400) being inserted into a cannula channel (60; par. [0061]), it does not specifically disclose the method including inserting a surgical tool through a second cannula channel. Kucklick teaches an analogous endoscope system and method wherein an endoscope (2) and a surgical tool (par. [0048]; Figs. 11 and 14; 57/63) are inserted into an analogous cannula (3; Figs. 11 and 12) having a working channel (56) for the surgical tool and a lumen for the endoscope (2; Fig. 12). It would have been obvious to one having ordinary skill in the art to have modified the cannula of Gill with that of Kucklick, including a working channel in the cannula for a surgical tool, and to provide the surgical tool, in order reduce the number of incisions made during surgery, thereby minimizing the invasiveness of surgery, by allowing the surgeon to view the surgical site and perform a procedure through one cannula and incision.
Although Gill discloses the endoscope handle (32/402) in communication with a display device (par. [0150]) with a cable (par. [0150]), it does not specifically disclose wherein an endoscope handle cable connection receives power for the endoscope; and that the display device is a tablet, wherein the tablet display camera control device having an LED power controller and a touchscreen display configured to display images and control the endoscope in response to a plurality of touch operations using at least one of touch icons and touch gestures to set imaging and illumination parameters, the touchscreen display configured to display images received from the endoscope that are detected by the imaging detector. Farr teaches an imaging system wherein the imaging apparatus (200) is in wired communication with a tablet display camera control device (210; par. [0035], [0066]-[0069]) with a cable connection (205b; par. [0034]-[0037]) wherein an endoscope handle cable connection receives power for the endoscope (205a/205b; par. [0034]-[0037]), wherein the tablet display device (210) includes a touchscreen display (touch screen; par. [0067]-[0069]) for visualizing images captured by the imaging apparatus; the touchscreen display (touch screen; par. [0067]-[0069]) being positioned within a tablet housing (housing of 210) the tablet housing including at least one processor configured to control operation of the imaging detector to set imaging parameters using touch control operations (par. [0036], [0039] and [0068] - A user interface can be provided on the portable control and display unit 210 and may include hard or soft electronic keys, a mouse or joystick, a touch screen, and/or voice activated command electronics. The user interface can be employed to adjust, control, display, process, transfer, store or retrieve the image and video data.) and an LED power controller to control the LED light source (par. [0044], [0048] and [0063] - the display and control unit 210 synchronizes the on/off timing of each LED) to set illumination parameters using touch control operations (par. [0044], [0048], [0063] and [0066]-[0069]), the at least one processor being further configured to process patient data and medical imaging data (par. [0050]). It would have been obvious to one having ordinary skill in the art to have provided the tablet display camera control device with control and power supply of Farr for that of Gill thereby providing vision and illumination units without means of power or control electronics of their own that can be made in a compact and low cost form, as taught by Farr (par. [0035]) and making the system mobile in order to allow the operating room personnel to place the tablet in a convenient location for use and to power and control operations of the imaging device.
Although Gill teaches an imaging detector (404; par. [0009], [0097], [0145]) mounted at the proximal end of the endoscope, it does not specifically disclose it is mounted at the distal end of the endoscope, as now claimed. It is generally known in the art to mount imaging detectors at the distal end of small diameter endoscopes, as evidenced by Schultz which teaches an analogous arthroscope wherein the imaging detector (124/220; Figs. 1D-1E and 2A; par. [0057], [0060], [0120] and [0133]) is mounted at the distal end of the endoscope (Figs. 1D-1E and 2A) and includes a control element on the handle to operate the imaging detector (145; par. [0118]). Further, Blanquart teaches that endoscopes having imaging detectors at the proximal end of the endoscope, like that of Gill, transmit the incident light along its length toward the sensor via a complex set of precisely coupled optical components (par. [0002]). Blanquart also teaches that the cost of the endoscope is increased due to the expense of the optical components and that the endoscope may be mechanically delicate and relatively minor impacts can easily damage the components or upset the relative alignments thereof (par. [0002]). Blanquart teaches using a reduced area imaging detector at the distal end of the endoscope in order to greatly reduce cost among other benefits (par. [0003]). It would have been obvious to one having ordinary skill in the art to mount an imaging detector at the distal end of the endoscope in order to greatly reduce the cost of manufacturing the endoscope, as taught by Blanquart, and as generally known in the art, as evidenced by Schutlz. The Examiner notes that Applicant has disclosed the imaging detector being mounted at either the proximal end or distal end (see par. [0128] of the published application).
Regarding claim 64, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the method of claim 63, and it is generally known in the art that arthroscopic procedures are typically performed by an orthopedic surgeon and involve irrigation, distension and inspection of the joints such as at the knee, shoulder, elbow or ankle. Such arthroscopic procedures include synovectomy, meniscectomy, or repair of the anterior cruciate ligament. Additionally, Kucklick teaches treating the knee of a patient with the system (Fig. 1; par. [0031] and [0048]). Thus, it would have been obvious to one having ordinary skill in the art to have performed a meniscectomy procedure as is commonly known in the art as an arthroscopic procedure of the knee using the system of modified Gill.
Regarding claim 66, Gill in view of Kucklick in view Farr in view of Schultz in view of Blanquart disclose the method of claim 63, further comprising inserting the tubular endoscope device through a first cannula (Kucklick: 3) at a first surgical access position and inserting a surgical tool (Kucklick: 63; Fig. 14) through a second cannula (Kucklick: 61/62) that has a diameter of 2mm or less (par. [0041] – outer diameter of the cannula measures about 2-5mm).
Regarding claim 67, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the method of claim 63, further comprising inserting a single cannula body that includes the first cannula channel (Kucklick: 56) and the second cannula channel into an arthroscopic joint (Kucklick: 49; Fig. 12) and further comprising imaging with the system wherein the distal end of the endoscope system comprises a distal lens (560/562/564/566/540; Fig. 24B; par. [0152]) to view the arthroscopic joint at an off-axis angle (par. [0101] and [0155]).
Regarding claim 69, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the method of claim 63, further comprising transmitting images from the endoscope handle (32/402) using a wireless video transmission connection (par. [0150]).
Regarding claim 85, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the method of claim 63, wherein inserting the tubular endoscope device (30) comprises inserting an imaging detector at the distal end of the tubular endoscope device (Schultz: 124/220; Figs. 1D-1E and 2A; par. [0057], [0060], [0120] and [0133] and Blanquart: par. [0002]-[0003]) into the first cannula channel (par. [0041]-[0042]).
Regarding claim 86, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the method of claim 63, further comprising illuminating an arthroscopic joint wherein the tubular endoscopic device emits light at the distal end (Kucklick: par. [0054]).
Regarding claim 87, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the method of claim 63, wherein the step of operating the LED light source comprises adjusting a white balance of the light source (Farr: par. [0044] and [0048]).
Regarding claim 88, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the method of claim 63 further comprising operating the touchscreen display to adjust imaging parameters of the imaging detector (Farr: [0035]-[0036], [0039] and [0068]).
Regarding claim 89, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the method of claim 63 further comprising coupling the LED light source to a distal end of the tubular endoscopic device with a plurality of optical fibers (26; par. [0065] and [0076]).
Regarding claim 91, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the method of claim 63 further comprising actuating communication between the processor and the LED power controller (Farr: turning on power to the tablet 210; par. [0035], [0044], [0048] and [0066]-[0069]).
Regarding claim 92, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the method of claim 63 further comprising actuating the handle control element (par. [0144] – control panel 409 with buttons that the user employs to electrically operate the handle) to transmit signals to the tablet display camera control device to control an imaging operation (recording video or recording still images).
Regarding claim 93, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the method of claim 63 further comprising communicating bidirectional control signals between the tablet display camera control device and the endoscope handle using the cable (Farr: 205; par. [0034]- [0037]).
Regarding claim 94, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the method of claim 63 further comprising powering the tablet display camera control device with a battery, the tablet display camera control device being a handheld for portable use (Farr: par. [0035] and [0066]-[0069]).
Regarding claim 95, Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart disclose the method of claim 63 further comprising injecting a therapeutic agent into the body cavity through a fluid port (Kucklick: [0035] and [0058] - at proximal end of working channel 56).
Claims 96-101, 103, 105, 106 and 109-110 are rejected under 35 U.S.C. 103 as being unpatentable over Gill et al. (US 2009/0253967 A1) in view of Kucklick et al. (US 2005/0234298 A1) in view of Farr et al. (US 2011/0028790 A1) in view of Kennedy (US 2013/0201356 A1) in view of Kim (US 2016/0331213 A1) in view of Schutz et al. (US 2011/0009694 A1) in view of Blanquart et al. (US 2014/0160259 A1).
Regarding claim 96, Gill disclose an arthroscopic imaging system comprising: an arthroscope including an imaging tube (28; par. [0056]; Figs. 1 and 22A) attached to a handle (32/402) that communicates with a display device (par. [0150] – 474 integrated with 470; Fig. 22B) with a cable (par. [0150] – connection 479 can be wired; Fig. 22B) for bidirectional communication wherein the cable is connected to the handle and the display device (par. [0150]), the handle configured to operate in response to a user interface control (par. [0144] – control panel 409 with buttons that the user employs to electrically operate the handle) to operate an imaging detector coupled to an end of the imaging tube (proximal end), the imaging detector comprising an imaging sensor chip including clocking and a controller for imaging sensor chip operation (par. [0145]); and a cannula system (60; par. [0061]) to introduce at least one of a surgical tool (intended used) and the imaging tube (28) into a joint cavity, the imaging tube (28) having a diameter of 4 mm or less (par. [0005]-[0006] and claim 1).
Although Gill discloses the endoscope (20/400) being inserted into a cannula (60; par. [0061]) for minimally invasive surgery, it does not specifically disclose the system including a surgical tool and the cannula introducing the surgical tool. Kucklick teaches an analogous endoscope system wherein an endoscope (2) and a surgical tool (par. [0048]; Figs. 11 and 14; 57/63) are inserted into an analogous cannula (3; Figs. 11 and 12) having a working channel (56) for the surgical tool and a lumen for the endoscope (2; Fig. 12). It would have been obvious to one having ordinary skill in the art to have modified the cannula of Gill with that of Kucklick, including a working channel in the cannula for a surgical tool, and to provide the surgical tool, in order reduce the number of incisions made during surgery, thereby minimizing the invasiveness of surgery, by allowing the surgeon to view the surgical site and perform a procedure through one cannula and incision.
Although Gill discloses the endoscope handle (32/402) in communication with a display device (par. [0150]) with a cable (par. [0150]), it does not specifically disclose that the display device is a tablet, wherein the tablet display camera control device includes a controller, a touchscreen display for visualizing an imaging procedure of a region of interest within a body during arthroscopic surgery, the touchscreen display being positioned within the tablet display device and having a graphical user interface to operate the controller that communicates control signals to the imaging detector and a light emitting diode (LED) power controller than controls an LED light source in the arthroscope using touch control operations on the touchscreen display, the graphical user interface configured to display a plurality of touch actuated icons and an image received from the imaging detector; one or more memory devices in the tablet display device that stores patient data and images received from the imaging detector. Farr teaches an imaging system wherein the imaging apparatus (200) is in wired communication with a tablet display device (210; par. [0035], [0066]-[0069]) with a cable connection (205b; par. [0034]-[0037]) wherein an endoscope handle cable connection receives power for the endoscope (205a/205b; par. [0034]-[0037]), wherein the tablet display device (210) includes a touchscreen display (touch screen; par. [0067]-[0069]) for visualizing images captured by the imaging apparatus; the touchscreen display (touch screen; par. [0067]-[0069]) being positioned within a tablet housing (housing of 210) the tablet housing including at least one processor configured to control operation of the imaging detector to set imaging parameters using touch control operations (par. [0036], [0039] and [0068] - A user interface can be provided on the portable control and display unit 210 and may include hard or soft electronic keys, a mouse or joystick, a touch screen, and/or voice activated command electronics. The user interface can be employed to adjust, control, display, process, transfer, store or retrieve the image and video data.) and a light emitting diode (LED) power controller that controls an LED light source in a medical device (par. [0044], [0048] and [0063] - the display and control unit 210 synchronizes the on/off timing of each LED)to set illumination parameters using touch control operations (par. [0044], [0048] and [0066]-[0069]), the at least one processor being further configured to process patient data and medical imaging data (par. [0050]). It would have been obvious to one having ordinary skill in the art to have provided the tablet display device with control and power supply of Farr in the system of Gill thereby providing vision and illumination units without means of power or control electronics of their own that can be made in a compact and low cost form, as taught by Farr (par. [0035]) and making the system mobile in order to allow the operating room personnel to place the tablet in a convenient location for use and to power and control operations of the imaging device. Kennedy teaches an endoscope system wherein an endoscope handle (14) is in communication with a tablet display device (20; par. [0026]-[0027]) with at least one of a cable or a wireless connection (par. [0045]-[0046]), wherein the tablet display device(20) includes a touchscreen display (50; par. [0026]-[0027]) for visualizing an imaging procedure of a region of interest within a body during surgery (par. [0031]), the touchscreen display (50) being positioned within a tablet housing (20) and having a graphical user interface to operate the imaging detector using touch control operations (abstract, par. [0007], [0033] and [0048]); the graphical user interface configured to display a plurality of touch actuated icons and an image received from the imaging detector (par. [0024]-[0026]); one or more memory devices in the tablet display device that stores patient data (par. [0032]) and images received from the imaging detector (par. [0050]). It would have been obvious to one having ordinary skill in the art to have provided the memory devices in the tablet display device of Kennedy in that of modified Gill thereby providing more information to medical personnel.
Although modified Gill discloses the endoscope handle (32/402) in communication with tablet display camera control device and that the handle can have a power input, it does not specifically disclose the user interface control actuating operation of the tablet display camera control device. Kim teaches an analogous device having an analogous tablet display camera control device (130; Figs. 1 and 3) wherein a user interface control (24/10; Fig. 3; par. [0087]) on the handle of the medical device actuates (powers/starts) operation of the tablet display camera control device (130). It would have been obvious to one having ordinary skill in the art to actuate the operation of the tablet display camera control device of modified Gill by operating the handle control power input element thereby turning on the tablet display camera control device, as taught by Kim.
Although Gill teaches an imaging detector (404; par. [0009], [0097], [0145]) mounted at the proximal end of the endoscope, it does not specifically disclose it is mounted at the distal end of the endoscope, as now claimed. It is generally known in the art to mount imaging detectors at the distal end of small diameter endoscopes, as evidenced by Schultz which teaches an analogous arthroscope wherein the imaging detector (124/220; Figs. 1D-1E and 2A; par. [0057], [0060], [0120] and [0133]) is mounted at the distal end of the endoscope (Figs. 1D-1E and 2A) and includes a control element on the handle to operate the imaging detector (145; par. [0118]). Further, Blanquart teaches that endoscopes having imaging detectors at the proximal end of the endoscope, like that of Gill, transmit the incident light along its length toward the sensor via a complex set of precisely coupled optical components (par. [0002]). Blanquart also teaches that the cost of the endoscope is increased due to the expense of the optical components and that the endoscope may be mechanically delicate and relatively minor impacts can easily damage the components or upset the relative alignments thereof (par. [0002]). Blanquart teaches using a reduced area imaging detector at the distal end of the endoscope in order to greatly reduce cost among other benefits (par. [0003]). It would have been obvious to one having ordinary skill in the art to mount an imaging detector at the distal end of the endoscope in order to greatly reduce the cost of manufacturing the endoscope, as taught by Blanquart, and as generally known in the art, as evidenced by Schutlz. The Examiner notes that Applicant has disclosed the imaging detector being mounted at either the proximal end or distal end (see par. [0128] of the published application).
Regarding claim 97, Gill in view of Kucklick in view of Farr in view of Kennedy in view of Kim in view of Schultz in view of Blanquart disclose the system of claim 96 wherein at least one of the handle control element (par. [0144] – control panel 409 with buttons that the user employs to electrically operate the handle; Schultz: par. [0018]) and the touchscreen display controls an operation of the imaging detector that is located in the handle.
Regarding claim 98, Gill in view of Kucklick in view of Farr in view of Kennedy in view of Kim in view of Schultz in view of Blanquart disclose the system of claim 96 wherein the tablet display camera control device comprises a handheld tablet housing such that a user performs touch control operations on the touchscreen display to control the light source and the imaging detector (Farr: par. [0066]-[0069]; Kennedy: abstract, par. [0007], [0033] and [0048]) during a surgical procedure.
Regarding claim 99, Gill in view of Kucklick in view of Farr in view of Kennedy in view of Kim in view of Schultz in view of Blanquart disclose the system of claim 96 wherein the LED light source is connected to LED power controller in the tablet display camera control device that is configured to adjust a white balance of the light source (Farr: par. [0035], [0044], [0048]).
Regarding claim 100, Gill in view of Kucklick in view of Farr in view of Kennedy in view of Kim in view of Schultz in view of Blanquart disclose the system of claim 96 wherein the touchscreen display is configured to adjust imaging parameters of the imaging detector (Farr: par. [0035], [0039], [0066]- [0069]).
Regarding claim 101, Gill in view of Kucklick in view of Farr in view of Kennedy in view of Kim in view of Schultz in view of Blanquart disclose the system of claim 96 wherein the LED light source is coupled to a distal end of the tubular endoscopic device with a plurality of optical fibers (26; par. [0065] and [0076]), the LED light source comprising one or more light emitting diodes (LEDs) (Farr: par. [0043]).
Regarding claim 103, Gill in view of Kucklick in view of Farr in view of Kennedy in view of Kim in view of Schultz in view of Blanquart disclose the system of claim 96 wherein the LED power controller is connected to the LED light source that comprises one or more light emitting diodes (LEDs) (par. [0144]; Farr: par. [0035], [0043]-[0044], [0048] and [0066]-[0069] ).
Regarding claim 105, Gill in view of Kucklick in view of Farr in view of Kennedy in view of Kim in view of Schultz in view of Blanquart disclose the system of claim 96 wherein the handle control element (par. [0144] – control panel 409 with buttons that the user employs to electrically operate the handle) transmits signals to the tablet display camera control device to control an imaging operation (recording video or recording still images).
Regarding claim 106, Gill in view of Kucklick in view of Farr in view of Kennedy in view of Kim in view of Schultz in view of Blanquart disclose the system of claim 96 wherein the tablet display device and the endoscope handle communicate with bidirectional control signals using the cable (Farr: 205; par. [0034]- [0037]).
Regarding claim 109, Gill in view of Kucklick in view of Farr in view of Kennedy in view of Kim in view of Schultz in view of Blanquart disclose the system of claim 96 wherein the imaging tube (28) further comprises a disposable sheath (34; Figs. 1 and 22A; par. [0056] and [0146]) extending around an inner tube, the disposable sheath (34) being detachable from the handle (32/402) and including an annular array of optical fibers (par. [0094]) coupled to the light source.
Regarding claim 110, Gill in view of Kucklick in view of Farr in view of Kennedy in view of Kim in view of Schultz in view of Blanquart disclose the system of claim 96 wherein the cannula system comprises a first cannula (Kucklick: 61/62) at a first surgical access position for inserting a surgical tool (Kucklick: 63/14) and second cannula (Kucklick: 3) for inserting the imaging tube (36) at a viewing position.
Claims 50, 53 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Gill et al. (US 2009/0253967 A1) in view of Farr et al. (US 2011/0028790 A1) in view of Kennedy et al. (US 2013/0201356 A1) in view of Schutz et al. (US 2011/0009694 A1) in view of Blanquart et al. (US 2014/0160259 A1).
Regarding claim 50 and 53, Gill discloses an endoscope system comprising: an endoscope (20/400; Figs. 1 and 22A) including an endoscope handle (32/402; par. [0056] and [0144]; Figs. 1 and 22A) in communication with display device (par. [0150] – 474 integrated with 470; Fig. 22B), configured to display arthroscopic images, that is connected to the endoscope handle (32/402) with a cable; wherein the endoscope (20/400; Figs. 1 and 22A) further includes an (LED) light source (par. [0144]) and a tubular visualization device (34/204; Fig. 24A and 24B; par. [0151]) configured to operate in response to operation of the endoscope system control element (par. [0144] – control panel 409 with buttons that the user employs to electrically operate the handle); and wherein the tubular visualization device having a diameter of 3 mm or less (par. [0005]-[0006] and claim 1) for insertion into a joint cavity (par. [0013] and [0151]) of a patients and a distal optical assembly (560/562/564/566/540; Fig. 24B; par. [0152]) to image the field of view at an image sensor chip mounted at an end of the tubular imaging device (proximal end) and including clocking and a controller for imaging sensor chip operation (par. [0145]), the tubular visualization device (34/204) comprising an annular array of optical fibers (190/216; par. [0094] and [0152]); and wherein the distal optical assembly (560/562/564/566/540; Fig. 24B; par. [0152]) has an angle of view relative to the insertion axis of the tubular visualization device in a range of 5-45 degrees (par. [0101] and [0155]).
Although Gill discloses the endoscope handle (32/402) in communication with a display device (par. [0150]) with at least one of a cable (par. [0150]) or a wireless connection, it does not specifically disclose wherein an endoscope handle cable connection receives power for the endoscope, and that the display device is a tablet, the tablet display camera control device having a processor for processing patient data and medical image data, a light emitting diode (LED) light source power controller that sends controls signals to the LED light source, and a touchscreen display configured to operate the endoscope in response to a plurality of touch control operations including touch icons and touch gestures of a graphical user interface, the at least one processor being further configured to process patient data and medical imaging data. Farr teaches an imaging system wherein the imaging apparatus (200) is in wired communication with a tablet display device (210; par. [0035], [0066]-[0069]) with a cable connection (205b; par. [0034]-[0037]) wherein an endoscope handle cable connection receives power for the endoscope (205a/205b; par. [0034]-[0037]), wherein the tablet display device (210) includes a touchscreen display (touch screen; par. [0067]-[0069]) for visualizing images captured by the imaging apparatus; the touchscreen display (touch screen; par. [0067]-[0069]) being positioned within a tablet housing (housing of 210) the tablet housing including at least one processor configured for processing patient data and medical image data (par. [0036], [0039] and [0068] - A user interface can be provided on the portable control and display unit 210 and may include hard or soft electronic keys, a mouse or joystick, a touch screen, and/or voice activated command electronics. The user interface can be employed to adjust, control, display, process, transfer, store or retrieve the image and video data.) and an LED power controller that sends control signals to the LED light source (par. [0044], [0048] and [0063] - the display and control unit 210 synchronizes the on/off timing of each LED), the at least one processor being further configured to process patient data and medical imaging data (par. [0050]). It would have been obvious to one having ordinary skill in the art to have provided the tablet display device with control and power supply of Farr in the system of Gill thereby providing vision and illumination units without means of power or control electronics of their own that can be made in a compact and low cost form, as taught by Farr (par. [0035]) and making the system mobile in order to allow the operating room personnel to place the tablet in a convenient location for use and to power and control operations of the imaging device. Kennedy teaches an endoscope system wherein an endoscope handle (14) is in communication with a tablet display device (20; par. [0026]-[0027]) with at least one of a cable or a wireless connection (par. [0045]-[0046]), wherein the tablet display device(20) includes a touchscreen display (50; par. [0026]-[0027]) for visualizing an imaging procedure of a region of interest within a body during surgery (par. [0031]), the touchscreen display (50) being positioned within a tablet housing (20) and configured to operate the imaging detector using touch control operations including touch icons and touch gestures of a graphical user interface (abstract, par. [0007], [0033] and [0048]). It would have been obvious to one having ordinary skill in the art to have included the touch control operations of the tablet display device of Kennedy in that of modified Gill thereby making the tablet easier to control for the operator.
Although Gill teaches an imaging detector (404; par. [0009], [0097], [0145]) mounted at the proximal end of the endoscope, it does not specifically disclose it is mounted at the distal end of the endoscope, as now claimed. It is generally known in the art to mount imaging detectors at the distal end of small diameter endoscopes, as evidenced by Schultz which teaches an analogous arthroscope wherein the imaging detector (124/220; Figs. 1D-1E and 2A; par. [0057], [0060], [0120] and [0133]) is mounted at the distal end of the endoscope (Figs. 1D-1E and 2A) and includes a control element on the handle to operate the imaging detector (145; par. [0118]). Further, Blanquart teaches that endoscopes having imaging detectors at the proximal end of the endoscope, like that of Gill, transmit the incident light along its length toward the sensor via a complex set of precisely coupled optical components (par. [0002]). Blanquart also teaches that the cost of the endoscope is increased due to the expense of the optical components and that the endoscope may be mechanically delicate and relatively minor impacts can easily damage the components or upset the relative alignments thereof (par. [0002]). Blanquart teaches using a reduced area imaging detector at the distal end of the endoscope in order to greatly reduce cost among other benefits (par. [0003]). It would have been obvious to one having ordinary skill in the art to mount an imaging detector at the distal end of the endoscope in order to greatly reduce the cost of manufacturing the endoscope, as taught by Blanquart, and as generally known in the art, as evidenced by Schutlz. The Examiner notes that Applicant has disclosed the imaging detector being mounted at either the proximal end or distal end (see par. [0128] of the published application).
Regarding claim 55, Gill in view of Farr in view of Kennedy in view of Schultz in view of Blanquart disclose the system of claim 50, wherein the tubular visualization device (10/12) has a diameter of 2 mm or less (par. [0010] and [0012]) and wherein the handle (32) comprises a power source (par. [0041]-[0042]), a power regulation circuit (par. [0041]-[0042]), and a video transmitter (par. [0041]-[0042]) and a control transceiver (par. [0041]-[0042]) communicating with the tablet display camera control device (Farr: 210; Kennedy: 20) wherein the touchscreen display (Farr: 210; Kennedy: 50) is connected to a touch processor that is operable in response to the plurality of touch icons and touch gestures associated with the graphical user interface (GUI), a processor and a video receiver in the tablet housing (Kennedy: par. [0026]-[0028]).
Claims 51 and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Gill in view of Farr in view of Kennedy in view of Schultz in view of Blanquart, as applied to claim 50 above, further in view of Kucklick et al. (US 2005/0234298 A1).
Regarding claim 51, Gill in view of Farr in view of Kennedy in view of Schultz in view of Blanquart disclose the system of claim 50, and although Gill discloses the endoscope (28) and tubular sheath (34) being inserted into a cannula (60; par. [0061]) for minimally invasive surgery, it does not specifically disclose the system further comprising an arthroscopic tool operatively configured for insertion through a cannula channel, the arthroscopic tool comprising at least one of a cutting tool, abrading tool, mechanized rotary cutter, electrosurgical tool, laser, scalpel, forceps, snare, morcellator, RF cutting element, or electrically powered tool. Kucklick teaches an analogous endoscope system wherein an endoscope (2) and an arthroscopic tool (par. [0048]; Fig. 11; electrosurgical tool – ablation probe) are inserted into a cannula (3; Figs. 11 and 12) having a working channel (56) for the arthroscopic tool and a lumen for the endoscope (2; Fig. 12). Additionally, Kucklick teaches that when the cannula (3) is manufactured for use with arthroscopic instruments in smaller joints, it has an outer diameter measuring about 2-5mm (par. [0041]). It would have been obvious to one having ordinary skill in the art to have modified the cannula of Gill with that of Kucklick, including a working channel for an arthroscopic tool, and to provide the arthroscopic tool, in order reduce the number of incisions made during surgery, thereby minimizing the invasiveness of surgery, by allowing the surgeon to view the surgical site and perform a procedure through one cannula and incision.
Regarding claim 61, Gill in view of Far in view of Kennedy in view of Schultz in view of Blanquart in view of Kucklick disclose the system of claim 51, wherein the arthroscopic tool (57) is inserted through a first cannula channel (56) and the tubular visualization device is inserted through a second cannula channel (49; Fig. 12).
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Gill in view of Kucklick in view of Farr in view of Schultz in view of Blanquart, as applied to the claims above, in further view of Piskun et al. (US 2008/0255519 A1)
Regarding claim 49, Gill in view of Kucklick in view Farr in view of Schultz in view of Blanquart disclose the system of claim 1, and Gill disclose using a luer (72) to provide medication or fluids to the patient (par. [0062]). However, it does not specifically disclose, a lumen in the cannula system to deliver a therapeutic agent, a liquid, or a gas to a region of interest. Piskun teaches using a tube for supplying insufflation gas using a luer lock in order to provide a communication pathway (par. [0141] and [0149]). It would have been obvious to one having ordinary skill in the art to have provided a lumen/tube connected to the luer of Gill to supply the medication or fluids in order to provide a communication pathway, as taught by Piskun.
Response to Arguments
Applicant’s arguments, see claim amendments and remarks, filed 08/15/2024, with respect to the rejection(s) of the claim(s) under 35 USC 103 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 Schutz et al. (US 2011/0009694 A1) in view of Blanquart et al. (US 2014/0160259 A1).
Conclusion
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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
03/16/26