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 .
Claims 11, 13-17, 20-32, 34-35, and 37-40 are pending.
Prosecution Reopened
In view of the Appeal Brief filed on December 18, 2025, PROSECUTION IS HEREBY REOPENED. New grounds for rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
Claim Objections
Claim 11 is objected to because of the following informalities: line 22 includes the feature “the handle”, which has no antecedent basis. Examiner believes that this is a typographical error, and should read “the handpiece”. Appropriate correction by Applicant is required.
Claim Rejections - 35 USC § 112
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 11 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. Lines 29-31 claim “the working channel port, the cable port, the one or more controls, and the steering controller are positioned generally in line with the longitudinal central plane of the handpiece”. It is unclear and indefinite how close to the longitudinal central plane the working channel port, the cable port, the one or more controls, and the steering controller are to be positioned. Are they required to within 1° offset from the longitudinal central plane; or 10° offset from the longitudinal central plane; or 25° offset from the longitudinal central plane; etc.? The specification provides no guidance for this matter, only describing the positioning of such features as enabling “the handpiece 110 to be used with either a left or a right hand, or switched between hands during use” (e.g., see paragraph [0040] of the present specification). (See also the definition in Dictionary.com for “generally”, which is defined as “without reference to or disregarding particular persons, things, situations, etc.”; https://web.archive.org/web/20170702031829/https://www.dictionary.com/browse/generally).
Appropriate correction by Applicant is required.
For purposes of Examination, Examiner interprets “positioned generally in line with the longitudinal central plane of the handpiece” as having no patentable significance.
Claim 20 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. Lines 7-9 claim “a moving member that has a portion that is generally opposite to the one or more controls”. It is unclear and indefinite what “generally opposite” means.
Appropriate correction by Applicant is required.
For purposes of examination, Examiner interprets “a moving member that has a portion that is generally opposite to the one or more controls” as “a moving member that is distal to the one or more controls”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 11, 13-17, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Oskin et al. (US PGPUB 2013/0190561 – “Oskin”) in view of McGrail et al. (US PGPUB 2011/0130632 – “McGrail”) and Zwolinski (US PGPUB 2010/0191050 – “Zwolinski”).
Regarding Claim 11, Oskin discloses:
An endoscope system (Examiner-annotated Oskin FIG. 1 shown below, medical device 1), comprising:
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a handpiece (Oskin FIG. 1, handle assembly 2) including:
a catheter end (Oskin FIG. 1, distal end 18);
a control end (Oskin FIG. 1, proximal end 19) disposed proximally from and opposite to the catheter end;
one or more controls (Oskin FIG. 4, control module 24; Oskin paragraph [0056], “One or more actuators or buttons may be disposed on control module 24 to control illumination source 25 and camera system 20. Alternatively, the one or more actuators or buttons may be disposed on handle assembly 2.”) positioned at least proximate to the control end (Oskin FIG. 1, proximal end 19 of handle assembly 2);
a central portion (Oskin FIG. 1, central portion of handle assembly 2) positioned between the catheter end and the control end, the central portion having a rounded first surface (Oskin FIG. 1, rounded first surface on handle assembly 2), a rounded second surface opposite to the rounded first surface (Oskin FIG. 1, rounded second surface on handle assembly 2), a longitudinal central plane of the handpiece (Oskin FIG. 1, longitudinal central plane within center of handle assembly 2);
a working channel port (Oskin FIG. 1, port 12; Oskin paragraph [0049], “port 12 may provide access for one or more medical tools to a working channel extending through elongate member 3 and out tip 9”) disposed on the rounded first surface (Oskin FIG. 1, rounded first surface on handle assembly 2) along the longitudinal central plane proximate to the catheter end and distal to the control end;
a steering controller (Oskin FIG. 2, steering mechanism 11); and
a cable port (Oskin FIG. 1, connector hub 32) disposed on the rounded second surface (Oskin FIG. 1, connector hub 32 disposed on rounded second surface of handle assembly 2) along the longitudinal central plane proximate to the catheter end and distal to the control end, the cable port being oriented for a cable (Oskin FIG. 1, connector 17) connected thereto to extend distally from the cable port;
a catheter (Oskin FIG. 1, elongate member 3) extending from the catheter end of the handpiece, the catheter including a working channel in fluid communication with the working channel port (Oskin paragraph [0049], “port 12 may provide access for one or more medical tools to a working channel extending through elongate member 3 and out tip 9”), an active bend portion (Oskin FIG. 1, distal portion 5 of elongate member 3) operably coupled to the steering controller on the handle (Oskin paragraph [0050], “Steering mechanism 11 may be configured to control the steering and deflection of distal portion 5 of elongate member 3.”), a proximal end disposed at the catheter end of the handpiece (Oskin FIG. 1, proximal end of elongate member 3 disposed at the catheter end of handle assembly 2), a distal end (Oskin FIG. 1, tip 9), an image sensor (Oskin FIG. 1, image sensor 7) positioned at the distal end of the catheter,
wherein the cable port on the rounded second surface is spaced proximally from the catheter end and protrudes from the second rounded surface (Oskin FIG. 1, connector hub 32 proximal from the catheter end of handle assembly 2 and protruding from the rounded second surface) at an orientation for the cable connected thereto to extend away from the proximal end of the catheter,
wherein at least one of the one or more controls is configured to control the image sensor (Oskin FIG. 4, control module 24; Oskin paragraph [0056], “One or more actuators or buttons may be disposed on control module 24 to control illumination source 25 and camera system 20. Alternatively, the one or more actuators or buttons may be disposed on handle assembly 2.”), and
wherein the working channel port (Oskin FIG. 1, port 12), the cable port (Oskin FIG. 1, connector hub 32), the one or more controls (Oskin FIG. 6, showing second actuator 15 positioned in line with the longitudinal central plane shown in Oskin FIG. 1), and the steering controller (Oskin FIG. 5, steering mechanism 11) are positioned generally in line with the longitudinal central plane of the handpiece such that the handpiece is configured for use with either a right hand of an operator and/or a left hand of the operator, the cable port and the working channel port being positioned less than one-third of a distance from the catheter end to the control end (Oskin FIG. 1, showing connector hub 32 and port 12 in the distal third portion of handle assembly 2).
Note that although Oskin FIG. 1 is not drawn to scale, it nonetheless clearly shows connector hub 32 and port 12 in the distal third portion of handle assembly 2. It would be obvious to a person having ordinary skill in the art of endoscopes to position these hub/port in a location that would not interfere with a user’s hand when holding handle assembly 2. Furthermore, as stated in MPEP 2144.04(IV)(A), “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”). See also Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Oskin does not explicitly disclose a central portion of the handle having two opposing substantially flat sides between the rounded first surface and the rounded second surface.
McGrail teaches a central portion of the handle (Examiner-annotated McGrail FIG. 35 shown below, handle 1030) having two opposing substantially flat sides (McGrail FIG. 35, opposing substantially flat sides) between the rounded first surface and the rounded second surface (McGrail FIG. 35, first and second rounded surface).
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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 McGrail’s flat and rounded sides on substitute McGrail’s handle having curved/flat sides for the central portion disclosed by Oskin. 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 an endoscope system that has a handle that facilitates alignment feature using tactile engagement without requiring a user to visually align two components (see McGrail paragraph [0129]).
Oskin in view of McGrail does not explicitly teach a working channel connector secured to the working channel port, the working channel port retaining at least a portion of the working channel connector extending proximally from the working channel port.
Zwolinski teaches a working channel connector (Zwolinski FIG. 1, connector 120) secured to the working channel port (Zwolinski FIG. 13, working channel port 62), the working channel port retaining at least a portion of the working channel connector extending proximally from the working channel port (Zwolinski paragraph [0060], “second connector 120 can be mounted to a flange, or another suitable retaining member, extending from endoscope 30 such that the aperture extending through manipulation accessory 100 can be aligned, or at least substantially aligned, with a working channel port 62 in endoscope 30.”).
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 Zwolinski’s working channel connector with Oskin’s working channel port, in the endoscope system taught by Oskin in view of McGrail. 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 working channel having a connector capable of being aligned with an entrance port for a working channel, in order to avoid kinking, etc. of the accessory 100.
Regarding Claim 13, Oskin in view of McGrail and Zwolinski teach the features of Claim 11, as described above.
Oskin further discloses at least one light source (Oskin FIG. 1, illumination unit 8) at the distal end of the catheter, wherein at least one of the one or more controls is configured to activate and deactivate the at least one light source (Oskin paragraph [0056], “One or more actuators or buttons may be disposed on control module 24 to control illumination source 25 and camera system 20. Alternatively, the one or more actuators or buttons may be disposed on handle assembly 2.”).
Regarding Claim 14, Oskin in view of McGrail and Zwolinski teach the features of Claim 11, as described above.
Oskin further discloses wherein the handpiece includes a communication interface (Oskin FIG. 2, camera system 20) configured to communicate with one or more electronic devices (Oskin FIG. 4, control module 24; Oskin paragraph [0056], “control module 24 may include imaging electronics configured to process and/or transfer signals received from camera system 20, signals controlling camera system 20”), the communication interface being housed within the central portion of the handpiece and electrically coupled to the one or more controls and the image sensor (Oskin paragraph [0056], “One or more actuators or buttons may be disposed on control module 24 to control illumination source 25 and camera system 20. Alternatively, the one or more actuators or buttons may be disposed on handle assembly 2.”).
Regarding Claim 15, Oskin in view of McGrail and Zwolinski teach the features of Claim 14, as described above.
Oskin further discloses wherein the one or more electronic devices include at least a display operable to display one or more images collected by the image sensor (Oskin FIG. 4, control module 24 and image sensor 7; Oskin paragraph [0054], “Camera system 20 may include image sensor 7”; Oskin paragraph [0056], “control module 24 may include imaging electronics configured to process and/or transfer signals received from camera system 20, signals controlling camera system 20, and patient image data to a display”).
Regarding Claim 16, Oskin in view of McGrail and Zwolinski teach the features of Claim 15, as described above.
Oskin further discloses wherein at least one of the one or more controls is configured to adjust at least one of a brightness (Oskin paragraph [0056], “One or more actuators or buttons may be disposed on control module 24 to control illumination source 25…Alternatively, the one or more actuators or buttons may be disposed on handle assembly 2.”), a zoom, a focus, or a contrast of the one or more images displayed on the display.
Regarding Claim 17, Oskin in view of McGrail and Zwolinski teach the features of Claim 15, as described above.
Oskin further discloses wherein at least one of the one or more controls is configured to activate or deactivate the image sensor (Oskin paragraph [0056], “One or more actuators or buttons may be disposed on control module 24 to control…camera system 20. Alternatively, the one or more actuators or buttons may be disposed on handle assembly 2.”), change an image collection mode of the image sensor from a still image mode to a video stream mode, or activate a frame grab to record a still image during the video stream mode.
Regarding Claim 37, Oskin in view of McGrail and Zwolinski teach the features of Claim 11, as described above.
Oskin further teaches wherein the endoscope system includes a ureteroscope system (Oskin FIG. 1, ureteroscope 1).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Oskin et al. (US PGPUB 2013/0190561 – “Oskin”) in view of McGrail et al. (US PGPUB 2011/0130632 – “McGrail”), Zwolinski (US PGPUB 2010/0191050 – “Zwolinski”), and Takahashi et al. (US Patent 3,610,231 – “Takahashi”).
Regarding Claim 20, Oskin in view of McGrail and Zwolinski teach the features of Claim 15, as described above.
Oskin further discloses wherein the handpiece includes a longitudinal axis (Oskin FIG. 1, longitudinal axis along handle assembly 2) extending longitudinally from the catheter end towards the control end and the cable (Oskin FIG. 1, connector 17) connected or connectable to the handpiece at the cable port (Oskin FIG. 1, connector hub 32) and communicate with one or more electronic devices and the communication interface (Oskin paragraph [0056], “control module 24 may include imaging electronics configured to process and/or transfer signals received from camera system 20, signals controlling camera system 20, and patient image data to a display”), the cable port being oriented such that the cable extending distally from the cable port at an acute angle relative to the longitudinal axis.
Oskin in view of McGrail and Zwolinski does not explicitly teach wherein the handle is configured to provide power to the image sensor, and wherein the steering controller is secured at least proximate to the control end and includes a moving member that has a portion that is generally opposite to the one or more controls disposed at least proximate to the control end.
Takahashi teaches wherein the handle is configured to provide power to the image sensor (Takahashi col. 7, lines 61-65, “The illuminating optical systems 35 can be replaced by lamp means located in the forward end section I to which the electric power is supplied through lead wire means extending from the control housing.”), and wherein the steering controller is secured at least proximate to the control end and includes a moving member that has a portion that is generally opposite to the one or more controls disposed at least proximate to the control end (Takahashi FIG. 1, showing projection 20a for bending controller disc 20, and knob 12a for manually actuating the shutter blade 12 shown in Takahashi FIG. 3, as being on opposite sides of control housing 1).
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 Takahashi’s power supply for the image sensor and the moving member with the endoscope system taught by Oskin in view of McGrail and Zwolinski. 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 an endoscope having a powered image sensor and a manual moving member for controlling movement of an insertion portion of the endoscope.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Oskin et al. (US PGPUB 2013/0190561 – “Oskin”) in view of McGrail et al. (US PGPUB 2011/0130632 – “McGrail”), Zwolinski (US PGPUB 2010/0191050 – “Zwolinski”), Takahashi et al. (US Patent 3,610,231 – “Takahashi”), and Reever et al. (US PGPUB 2018/0132703 – “Reever”).
Regarding Claim 21, Oskin in view of McGrail, Zwolinski, and Takahashi teaches the features of Claim 20, as described above.
Oskin further discloses one or more electronic devices including at least a host machine (Oskin FIG. 4, control module 24) and the display (Oskin paragraph [0056], “control module 24 may include imaging electronics configured to process and/or transfer signals received from camera system 20, signals controlling camera system 20, and patient image data to a display (not shown) for viewing by a user.”).
Oskin in view of McGrail, Zwolinski, and Takahashi does not explicitly teach wherein the host machine is configured to display one or more view settings on the display responsive to actuation of at least one of the one or more controls, the one or more view settings including at least one of the brightness, the zoom, the focus, or the contrast of the one or more images displayed on the display.
Reever teaches wherein the host machine is configured to display one or more view settings on the display (Reever FIG. 1, display 42) responsive to actuation of at least one of the one or more controls, the one or more view settings including at least one of the brightness, the zoom, the focus, or the contrast of the one or more images displayed on the display (Reever paragraph [0033], “Display 42 may include a touch screen for displaying image data, and for receiving inputs or commands from a user. User interaction may be directed toward aspects of image capture, video capture, brightness control, mode controls, narrow band imaging toggle, and/or any other controls that may be part of a typical ureteroscopy procedure.”).
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 Reever’s touch screen image controller with the endoscope system taught by Oskin in view of McGrail, Zwolinski, and Takahashi. 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 an endoscope having image capturing that is readily controlled by a user.
Claims 22-24, 26-27, 29-32, 35, and 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Oskin et al. (US PGPUB 2013/0190561 – “Oskin”) in view of Birnkrant (US PGPUB 2014/0107416 – “Birnkrant”), and Zwolinski (US PGPUB 2010/0191050 – “Zwolinski”).
Regarding Claim 22, Oskin discloses:
An endoscope system (Oskin FIG. 1, medical device 1), comprising:
a catheter (Oskin FIG. 1, elongate member 3) including a distal end (Oskin FIG. 1, distal end portion 5) and an image sensor (Oskin FIG. 1, image sensor 7) positioned at the distal end of the catheter; and
a handpiece (Oskin FIG. 1 handle assembly 2) having a catheter end (Oskin FIG. 1 distal end 18) with the catheter extending therefrom, a control end (Oskin FIG. 1 proximal end 19) disposed proximally from and opposite to the catheter end, a communication interface (Oskin FIG. 2, camera system 20) configured to communicate with at least one of one or more electronic devices (Oskin FIG. 4, control module 24; Oskin paragraph [0056], “control module 24 may include imaging electronics configured to process and/or transfer signals received from camera system 20, signals controlling camera system 20”), one or more controls positioned on the handpiece (Oskin FIG. 4, control module 24; Oskin paragraph [0056], “One or more actuators or buttons may be disposed on control module 24 to control illumination source 25 and camera system 20. Alternatively, the one or more actuators or buttons may be disposed on handle assembly 2.”) positioned at least proximate to the control end (Oskin FIG. 1, proximal end 19 of handle assembly 2) proximate to the control end, a working channel port (Oskin FIG. 1, port 12; Oskin paragraph [0049], “port 12 may provide access for one or more medical tools to a working channel extending through elongate member 3 and out tip 9”) disposed proximate to the catheter end and distal to the control end, a cable port (Oskin FIG. 1, connector hub 32) disposed proximate to the catheter end and distal to the control end, the cable port being spaced proximally from the catheter end and protruding from a side of the handpiece at an orientation for a cable connected thereto to extend distally from the cable port away from the catheter, the cable port and the working channel port being positioned less than one-third of a distance from the catheter end to the control end (Oskin FIG. 1, showing connector hub 32 and port 12 in the distal third portion of handle assembly 2).
Note that although Oskin FIG. 1 is not drawn to scale, it nonetheless clearly shows connector hub 32 and port 12 in the distal third portion of handle assembly 2. It would be obvious to a person having ordinary skill in the art of endoscopes to position these hub/port in a location that would not interfere with a user’s hand when holding handle assembly 2. Furthermore, as stated in MPEP 2144.04(IV)(A), “ where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”). See also Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Oskin further discloses:
wherein the one or more electronic devices include at least a display operable to display one or more images collected by the image sensor (Oskin FIG. 4, control module 24 and image sensor 7; Oskin paragraph [0054], “Camera system 20 may include image sensor 7”; Oskin paragraph [0056], “control module 24 may include imaging electronics configured to process and/or transfer signals received from camera system 20, signals controlling camera system 20, and patient image data to a display”).
Oskin does not explicitly disclose wherein at least one of the one or more controls is configured to adjust at least one of a focus or a contrast of the one or more images displayed on the display.
Birnkrant teaches wherein at least one of the one or more controls (Birnkrant FIG. 5, control pad 404) is configured to adjust at least one of a focus or a contrast of the one or more images displayed on the display (Birnkrant paragraph [0062], “Using a control pad 404 mounted on the exterior of the handle 102 and connected to the imaging controller 402, a user can adjust the image quality of the image data, such as increasing or decreasing the resolution (e.g., pixel resolution, spatial resolution, spectral resolution, temporal resolution).”).
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 Birnkrant’s image focus controller with the endoscope taught by Oskin. 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 an endoscope that enables a user to “adjust the focus of the image sensor and improve the clarity of the image data received by the controller” (see paragraph [0062] of Birnkrant).
Oskin in view of Birnkrant does not explicitly teach a working channel connector secured to the working channel port with the working channel port retaining at least a portion working channel connector extending proximally from the working channel port.
Zwolinski teaches a working channel connector (Zwolinski FIG. 1, connector 120) secured to the working channel port (Zwolinski FIG. 13, working channel port 62) with the working channel port retaining at least a portion working channel connector extending proximally from the working channel port (Zwolinski paragraph [0060], “second connector 120 can be mounted to a flange, or another suitable retaining member, extending from endoscope 30 such that the aperture extending through manipulation accessory 100 can be aligned, or at least substantially aligned, with a working channel port 62 in endoscope 30.”).
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 Zwolinski’s working channel connector with Oskin’s working channel port, in the endoscope system taught by Oskin in view of Birnkrant. 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 working channel having a connector capable of being aligned with an entrance port for a working channel, in order to avoid kinking, etc. of the accessory 100.
Regarding Claim 23, Oskin in view of Birnkrant and Zwolinski teach the features of Claim 22, as described above.
Oskin further discloses at least one light source (Oskin FIG. 1, illumination unit 8) at the distal end of the catheter, wherein at least one of the one or more controls is configured to activate and deactivate the at least one light source (Oskin paragraph [0056], “One or more actuators or buttons may be disposed on control module 24 to control illumination source 25 and camera system 20. Alternatively, the one or more actuators or buttons may be disposed on handle assembly 2.”).
Regarding Claim 24, Oskin in view of Birnkrant and Zwolinski teach the features of Claim 22, as described above.
Oskin further discloses wherein at least one of the one or more controls is configured to activate or deactivate the image sensor (Oskin paragraph [0056], “One or more actuators or buttons may be disposed on control module 24 to control…camera system 20. Alternatively, the one or more actuators or buttons may be disposed on handle assembly 2.”), change an image collection mode of the image sensor from a still image mode to a video stream mode, or activate a frame grab to record a still image during the video stream mode.
Birnkrant further teaches wherein at least one of the one or more controls is configured to adjust at least a contrast of the one or more images displayed on the display (Birnkrant paragraph [0062], “Using a control pad 404 mounted on the exterior of the handle 102 and connected to the imaging controller 402, a user can adjust the image quality of the image data, such as increasing or decreasing the resolution (e.g., pixel resolution, spatial resolution, spectral resolution, temporal resolution).”).
Regarding Claim 26, Oskin in view of Birnkrant and Zwolinski teach the features of Claim 22, as described above.
Oskin further discloses:
the catheter (Oskin FIG. 1, elongate member 3) includes a working channel in fluid communication with the working channel port (Oskin paragraph [0049], “port 12 may provide access for one or more medical tools to a working channel extending through elongate member 3 and out tip 9”); and
the endoscope system includes the cable (Oskin FIG. 1, connector 17) connected or connectable to the handpiece at the cable port and configured to communicate with the one or more electronic devices and the communication interface (Oskin FIG. 4, showing connector 17 connecting camera system 20 to control module 24), the cable extending distally from the cable port.
Birnkrant further teaches a cable configured to provide power to the image sensor (Birnkrant FIG. 3A, power cable 210; Birnkrant paragraph [0042], “image sensor 214 receives power from the power cable 210”).
Regarding Claim 27, Oskin in view of Birnkrant and Zwolinski teach the features of Claim 26, as described above.
Oskin further discloses wherein the working channel port (Oskin FIG. 1, port 12) and the cable port (Oskin FIG. 1, showing cable port/connector hub 32 on opposite sides of handle assembly 2) are each positioned opposite one another on a longitudinal central plane of the handpiece.
Regarding Claim 29, Oskin discloses:
A method of operating an endoscope system, comprising:
operably coupling an endoscope (Oskin FIG. 1, medical device 1) to one or more electronic devices (Oskin FIG. 4, control module 24), the one or more electronic devices including at least a display (Oskin paragraph [0056], “control module 24 may include imaging electronics configured to process and/or transfer signals received from camera system 20, signals controlling camera system 20, and patient image data to a display”) and the endoscope including handpiece (Oskin FIG. 1, handle assembly 2) and a catheter (Oskin FIG. 1, elongate member 3) connected to a catheter end of the handpiece, the handpiece including a control end disposed proximally from and opposite to the catheter end, a working channel port (Oskin FIG. 1k port 12) disposed proximate to the catheter end and distal to the control end, a cable port (Oskin FIG. 1, hub 32) disposed proximate to the catheter end and distal to the control end, the cable port being spaced proximally from the catheter end and protruding from a side of the handpiece at an orientation for a cable connected thereto to extend distally from the cable port away from the catheter, the cable port and the working channel port being positioned less than one-third of a distance from the catheter end to the control end (Oskin FIG. 1, showing connector hub 32 and port 12 in the distal third portion of handle assembly 2).
Note that although Oskin FIG. 1 is not drawn to scale, it nonetheless clearly shows connector hub 32 and port 12 in the distal third portion of handle assembly 2. It would be obvious to a person having ordinary skill in the art of endoscopes to position these hub/port in a location that would not interfere with a user’s hand when holding handle assembly 2. Furthermore, as stated in MPEP 2144.04(IV)(A), “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”). See also Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
inserting at least a distal end of the catheter of the endoscope into a patient (Oskin paragraph [0044], “Medical device 1 may be inserted into a variety of body lumens and/or cavities, such as, for example, any portion of a urinary tract including a ureter, a gastrointestinal lumen including an esophagus, a vascular lumen, an airway, and the like.”), the distal end including an image sensor (Oskin FIG. 1, image sensor 7);
displaying one or more images collected by the image sensor on the display (Oskin FIG. 4, control module 24 and image sensor 7; Oskin paragraph [0054], “Camera system 20 may include image sensor 7”; Oskin paragraph [0056], “control module 24 may include imaging electronics configured to process and/or transfer signals received from camera system 20, signals controlling camera system 20, and patient image data to a display”).
Oskin does not explicitly disclose a working channel connector secured to the working channel port with the working channel port retaining at least a portion of the working channel connector extending proximally from the working channel port.
Zwolinski teaches a working channel connector (Zwolinski FIG. 2, coupling portion 28) secured to the working channel port (Zwolinski FIG. 2, access port 20; Zwolinski paragraph [0054], “access port 20 of handpiece 12, which provides access to working channel 16 of endoscope 10, is illustrated. Access port 20, which may extend from the side of endoscope 10 or at another location, may include a coupling portion 28 for coupling a cap 30 to access port 2”) with the working channel port retaining at least a portion working channel connector extending proximally from the working channel port (Zwolinski FIG. 2, showing access port 20 retaining coupling portion 28).
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 Zwolinski’s working channel connector with Oskin’s working channel port. 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 working channel having a connector capable of attaching an instrument or even a cap (see paragraph [0054] of Zwolinski).
Oskin in view of Zwolinski does not explicitly teach adjusting at least one of a focus or a contrast of the one or more images displayed on the display using at least one of one or more controls positioned on the control end of the handpiece distal to the catheter end.
Birnkrant teaches adjusting at least one of a focus or a contrast of the one or more images displayed on the display (Birnkrant paragraph [0062], “Using a control pad 404 mounted on the exterior of the handle 102 and connected to the imaging controller 402, a user can adjust the image quality of the image data, such as increasing or decreasing the resolution (e.g., pixel resolution, spatial resolution, spectral resolution, temporal resolution”) using at least one of one or more controls positioned on the control end of the handpiece distal to the catheter end (Birnkrant FIG. 5, control pad 404).
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 Birnkrant’s image focus/contrast controller with the endoscope taught by Oskin in view of Zwolinski. 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 an endoscope that enables a user to “adjust the focus of the image sensor and improve the clarity of the image data received by the controller” (see paragraph [0062] of Birnkrant).
Regarding Claim 30, Oskin in view of Zwolinski and Birnkrant teach the features of Claim 29, as described above.
Oskin further discloses activating at least one light source (Oskin FIG. 1, illumination unit 8) at the distal end of the catheter using at least one of the one or more controls (Oskin paragraph [0056], “One or more actuators or buttons may be disposed on control module 24 to control illumination source 25 and camera system 20. Alternatively, the one or more actuators or buttons may be disposed on handle assembly 2.”).
Regarding Claim 31, Oskin in view of Zwolinski and Birnkrant teach the features of Claim 29, as described above.
Oskin further teaches activating or deactivating the image sensor using at least one of the one or more controls (Oskin paragraph [0056], “One or more actuators or buttons may be disposed on control module 24 to control…camera system 20. Alternatively, the one or more actuators or buttons may be disposed on handle assembly 2.”).
Regarding Claim 32, Oskin in view of Zwolinski and Birnkrant teach the features of Claim 29, as described above.
Oskin further discloses changing an image collection mode of the image sensor from a still image mode to a video stream mode using the one or more controls (Oskin paragraph [0047], “Image sensor 7 may be configured to capture images and/or full-motion video images.”; Oskin paragraph [0056], “One or more actuators or buttons may be disposed on control module 24 to control…camera system 20. Alternatively, the one or more actuators or buttons may be disposed on handle assembly 2.”).
Regarding Claim 35, Oskin in view of Zwolinski and Birnkrant teach the features of Claim 29, as described above.
Oskin further discloses inserting at least one of a surgical instrument or an irrigation device in the working channel port (Oskin paragraph [0044], “Medical device 1 may be any device configured to allow an operator to access and view internal body anatomies of a patient, as well as to deliver medical instruments, such as, for example, biopsy forceps, graspers, baskets, snares, probes, scissors, retrieval devices, lasers, and other tools, into the patient's body.”), wherein operably coupling an endoscope to one or more electronic devices includes connecting the cable of the endoscope to at least one of the one or more electronic devices, the cable being connected to the cable port and extending distally from the handpiece (Oskin FIG. 4, showing ureteroscope 1 connected to control module 24).
Regarding Claim 38, Oskin in view of Birnkrant and Zwolinski teach the features of Claim 22, as described above.
Oskin further teaches wherein the endoscope system includes a ureteroscope system (Oskin FIG. 1, ureteroscope 1).
Regarding Claim 39, Oskin in view of Birnkrant and Zwolinski teach the features of Claim 22, as described above.
Birnkrant further teaches wherein the one or more controls (Birnkrant FIG. 5, control pad 404) is configured to adjust a focus of the one or more images displayed on the display (Birnkrant paragraph [0062], “Using a control pad 404 mounted on the exterior of the handle 102 and connected to the imaging controller 402, a user can adjust the image quality of the image data, such as increasing or decreasing the resolution (e.g., pixel resolution, spatial resolution, spectral resolution, temporal resolution).”).
Regarding Claim 40, Oskin in view of Zwolinski and Birnkrant teach the features of Claim 29, as described above.
Oskin further teaches wherein the endoscope includes a ureteroscope (Oskin FIG. 1, ureteroscope 1).
Claims 25 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Oskin et al. (US PGPUB 2013/0190561 – “Oskin”) in view of Birnkrant (US PGPUB 2014/0107416 – “Birnkrant”), Zwolinski (US PGPUB 2010/0191050 – “Zwolinski”), and Reever et al. (US PGPUB 2018/0132703 – “Reever”).
Regarding Claim 25, Oskin in view of Birnkrant and Zwolinski teach the features of Claim 22, as described above.
Oskin further discloses the one or more electronic devices including at least the display and a host machine (Oskin paragraph [0056], “control module 24 may include imaging electronics configured to process and/or transfer signals received from camera system 20, signals controlling camera system 20, and patient image data to a display”).
Oskin in view of Birnkrant and Zwolinski does not explicitly teach wherein the host machine is configured to display one or more view settings on the display responsive to actuation of at least one of the one or more controls, the one or more view settings including at least one of the brightness, the zoom, the focus, or the contrast of the one or more images displayed on the display.
Reever teaches wherein the host machine is configured to display one or more view settings on the display (Reever FIG. 1, display 42) responsive to actuation of at least one of the one or more controls, the one or more view settings including at least one of the brightness, the zoom, the focus, or the contrast of the one or more images displayed on the display (Reever paragraph [0033], “Display 42 may include a touch screen for displaying image data, and for receiving inputs or commands from a user. User interaction may be directed toward aspects of image capture, video capture, brightness control, mode controls, narrow band imaging toggle, and/or any other controls that may be part of a typical ureteroscopy procedure.”).
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 Reever’s touch screen image controller with the endoscope system taught by Oskin in view of Birnkrant and Zwolinski. 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 an endoscope having image capturing that is readily controlled by a user.
Regarding Claim 34, Oskin in view of Zwolinski and Birnkrant teach the features of Claim 29, as described above.
Oskin in view of Zwolinski and Birnkrant does not explicitly teach displaying one or more view settings on the display using at least one of the one or more controls, the one or more view settings including at least one of the brightness, the focus, or the contrast of the one or more images displayed on the display.
Reever teaches displaying one or more view settings on the display using at least one of the one or more controls, the one or more view settings including at least one of the brightness, the focus, or the contrast of the one or more images displayed on the display (Reever paragraph [0033], “Display 42 may include a touch screen for displaying image data, and for receiving inputs or commands from a user. User interaction may be directed toward aspects of image capture, video capture, brightness control, mode controls, narrow band imaging toggle, and/or any other controls that may be part of a typical ureteroscopy procedure.”).
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 Reever’s touch screen image controller with the endoscope system taught by Oskin in view of Zwolinski and Birnkrant. 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 an endoscope having image capturing that is readily controlled by a user.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Oskin et al. (US PGPUB 2013/0190561 – “Oskin”) in view of Birnkrant (US PGPUB 2014/0107416 – “Birnkrant”), Zwolinski (US PGPUB 2010/0191050 – “Zwolinski”), and McGrail et al. (US PGPUB 2011/0130632 – “McGrail”).
Regarding Claim 28, Oskin in view of Birnkrant and Zwolinski teach the features of Claim 27, as described above.
Oskin further discloses:
the handpiece includes a central portion (Oskin FIG. 1, central portion of handle assembly 2) positioned between the catheter end and the control end, the central portion including a rounded first surface (Oskin FIG. 1, rounded first surface on handle assembly 2), a rounded second surface opposite to the rounded first surface (Oskin FIG. 1, rounded second surface on handle assembly 2);
the longitudinal central plane (Oskin FIG. 1, longitudinal central plane within center of handle assembly 2) extends between the rounded first surface and the rounded second surface;
the working channel port (Oskin FIG. 1, port 12) is positioned on the rounded first surface along the longitudinal central axis (Oskin FIG. 1); and
the cable port (Oskin FIG. 1, connector hub 32) is positioned on the rounded second surface (Oskin FIG. 1, connector hub 32 disposed on rounded second surface of handle assembly 2) along the longitudinal central axis (Oskin FIG. 1, showing port 12 and hub 32 positioned along the same longitudinal central plane).
Oskin in view of Birnkrant and Zwolinski does not explicitly teach a central portion of the handle having two opposing substantially flat sides between the rounded first surface and the rounded second surface.
McGrail teaches a central portion of the handle (Examiner-annotated McGrail FIG. 35 shown below, handle 1030) having two opposing substantially flat sides (McGrail FIG. 35, opposing substantially flat sides) between the rounded first surface and the rounded second surface (McGrail FIG. 35, first and second rounded surface).
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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 McGrail’s flat and rounded sides with the handle taught by Oskin in the endoscope system taught by Oskin in view of Birnkrant and Zwolinski. 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 an endoscope system that has a handle that facilitates alignment feature using tactile engagement without requiring a user to visually align two components (see McGrail paragraph [0129]).
Response to Arguments
Applicant’s arguments, see pages 10-19, filed in the December 18, 2025 Appeal Brief, with respect to the rejection(s) of Claim 11 under 35 U.S.C. 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 McGrail et al. (US PGPUB 2011/0130632 – “McGrail”).
On page 10 and pages 13-14, Applicant argues that previously-cited Takahashi et al. (US Patent 3,610,231 – “Takahashi”) fails to teach “a central portion positioned between the catheter end and the control end, the central portion having a rounded first surface, a rounded second surface opposite to the rounded first surface, and two opposing substantially flat sides between the rounded first surface and the rounded second surface”. McGrail is now cited as teaching these features, as described in the rejection of Claim 11 above.
While Claim 11 is rejected under newly-cited art, Examiner maintains the further rejection of Claim 11 based on the teachings of Oskin et al. (US PGPUB 2013/0190561 – “Oskin”) in view of McGrail et al. (US PGPUB 2011/0130632 – “McGrail”) and Zwolinski (US PGPUB 2010/0191050 – “Zwolinski”), as described above.
On pages 11-13, Applicant argues that Oskin does not teach “the working channel port, the cable port, the one or more controls, and the steering controller are positioned generally in line with the longitudinal central plane of the handpiece”. Examiner respectfully disagrees.
First, Examiner notes that the phrase “generally in line with the longitudinal central plane of the handpiece” is indefinite under 35 U.S.C. 112(b), as rejected above. That is, it is unclear how close to the longitudinal central plane the working channel port, the cable port, the one or more controls, and the steering controller are to be positioned. Are they required to within 1° offset from the longitudinal central plane; or 10° offset from the longitudinal central plane; or 25° offset from the longitudinal central plane; etc.” The specification provides no guidance for this matter, only describing the positioning of such features as enabling “the handpiece 110 to be used with either a left or a right hand, or switched between hands during use” (e.g., see paragraph [0040] of the present specification). (See also the definition in Dictionary.com for “generally”, which is defined as “without reference to or disregarding particular persons, things, situations, etc.”; https://web.archive.org/web/20170702031829/https://www.dictionary.com/browse/generally).
Second, It is unclear what specific positioning enables one to operate the handle with either hand. Simple rotation of the handle enables use thereof, regardless of where the working channel port, the cable port, the one or more controls, and the steering controller are positioned.
On pages 14-17, Applicant argues that Oskin fails to teach or suggest “one or more controls is configured to control the image sensor”. Examiner respectfully disagrees. Oskin paragraph [0056] explicitly states “One or more actuators or buttons may be disposed on control module 24 to control illumination source 25 and camera system 20. Alternatively, the one or more actuators or buttons may be disposed on handle assembly 2.” On page 15, Applicant notes that the previous rejection of Claim 11 referred to Oskin’s first actuator 14 and second actuator 15 as controllers that are configured to control the image sensor. While Examiner believes that Oskin’s first actuator 14 and second actuator 15 moving image sensor 7 in the distal end of elongate member 3 constitute controlling the image sensor 7, the present rejection refers to Oskin paragraph [0056] for teaching image controllers. Thus, the wording of the rejection of Claim 11 regarding this feature overcomes Applicant’s arguments on pages 14-17.
On pages 17-18, Applicant argues that Oskin does not teach the cable port and the working channel port being positioned less than one-third of the distance from the catheter end to the control end. Oskin FIG. 2 was cited for the general teaching of port 12 (working channel port) and port/hub 32 (cable port) being positioned on handle assembly 2. However, as stated in the rejection of Claim 11, the exact positioning of the working channel port and the cable port have no patentable significance. In paragraph [0043] of the present specification, Applicant states “both the cable port 120 and the working channel port 118 may be positioned less than one-half of a distance from the catheter end 114 to the control end 112, less than one-third of the distance from the catheter end 114 to the control end 112, less than one-quarter of the distance from the catheter end 114 to the control end 112, or less than one-fifth of the distance from the catheter end 114 to control end 112.” In other words, Applicant states that it doesn’t matter where the cable port and the working channel port are positioned on the handpiece, and thus this feature has no patentable significance.
On pages 19-20, Applicant argues that the feature of “cable port and the working channel port being positioned less than one-third of a distance from the catheter end to the control end” in Claim 22 is not cited in the prior art. Examiner refers Applicant to the response above regarding the rejection of this feature in Claim 11.
On pages 20-23, Applicant argues the Oskin does not teach or suggest the feature controls on a handpiece that controls a sensor. This is addressed above in the argument against the rejection of Claim 11. Applicant then argues on pages 22-23 that Birnkrant would change the intended purpose of Oskin, since “In Birnkrant…the steering control and control pad have a handle positioned therebetween to allow the user to ‘readily access the steering control 122 with his or her index or middle finger’ to move the controller…without interfering with the control pad”. Applicant mis-cites MPEP 2143.01(VI) by omitting the requirement that modifying prior art not only can be performed without “a substantial reconstruction and redesign of the elements shown in [the primary reference]”, but also must “change in the basic principle under which the [primary reference] construction was designed to operate." Examiner does not believe that having controllers in different positions would change the basic principle of controlling an endoscope system.
On pages 23-27, regarding Claim 29, Applicant reiterates the arguments described above in the rejections of Claims 11 and 22, without any further arguments.
On pages 28-29, Applicant argues that Claim 27 should not be rejected for the same reasons presented above in the rejection of Claim 11, without any further arguments.
On pages 29-30, Applicant argues that Claim 28 should not be rejected for the same reasons presented above in the rejection of Claim 11, without any further arguments.
Thus, the rejections of Claims 11, 13-17, 20-32, 34-35, and 37-40 under 35 U.S.C. 103 are maintained.
Conclusion
As stated above, this non-final Office Action is the result of reopening prosecution after Applicant’s December 18, 2025 filing of an Appeal Brief. A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
02/24/2026