DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Notice of Amendment
The RCE filed on 11/20/2024 has been entered. Claims 26-34, 39-42, 44-49 are pending in the application with claims 26, 39, 44 amended, claims 1-25, 35-38, 43 cancelled, and claim 49 newly added.
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.
Claims 26-30, 34, 41 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang et al. (US Patent Application Publication No. 2012/0289858, hereinafter Ouyang) in view of Weber et al. (US Patent Application Publication No. 2021/0007591, hereinafter Weber).
In regard to claim 26, Ouyang disclose a self-contained endoscope (100, Fig. 1) comprising a single-use, disposable cannula (102,104) for imaging a patient's internal organ and a reusable handle (108) that is releasably connected to said cannula through electrical and mechanical connectors (Fig. 1), wherein:
said single-use cannula comprises:
a light source (630,632) at a distal portion of the cannula, configured to illuminate said internal organ (Fig. 6); and
an imaging structure (640) at said distal portion of the camera, configured to receive light from the internal organ and in response to produce images of the internal organ (Fig. 6);
an input gas port (114) for insufflating gas at a proximal portion of the cannula, a distal gas port (620) for said gas at the distal portion of the cannula, and a gas conduit (810) connecting the input and distal gas ports;
wherein said distal gas port is configured to direct a flow of said gas over a field of view of said imaging structure to aid in clearing debris from said field of view (Par. 121); and
said reusable handle comprises:
an integral display screen (110) configured to display images taken with said imaging structure (Fig. 1).
Ouyang does not expressly teach said single-use cannula comprises: a light source at a distal portion of the cannula, configured to illuminate said internal organ, wherein said light source is a source of white light and a source and a source of non-white light, and each of said sources of light comprises a device that converts electricity to light; and said imaging structure comprises a structure configured to generate a white light image in response to said illumination of the internal organ with said white light and a structure configured to generate a non-white light image in response to said illumination of the organ with said non-white light, wherein the imaging structure is configured to selectively vary the durations of illumination with white light and non-white light to thereby selectively enhance one or both of the white and non-white images.
Weber teaches an analogous endoscope comprising a plurality of LEDs (5, 7) and an image sensor (9) integrated into the distal tip of the endoscope. The first LED (5) is configured to emit light in a first light spectrum (19) suitable for fluorescence endoscopy and the second LED (7) is configured to emit light in a second light spectrum (21) suitable for white light endoscopy (Par. 35, 36). The image sensor (9) enables easy switching between fluorescence and white light endoscopy in a simple and rapid manner due to the possibility of fluorescence light with the first LED (5) and by way of white light with the second LED (7) filtered by way of the light filter (23, Par. 45), whereby the user can selectively switch between the fluorescence imaging mode and the white light imaging modes thereby turning on the first LED (5) for fluorescence light imaging and turning on the second LED (7) for white light imaging (i.e. changing the duration in which the first and/or second LED (5, 7) is turned on).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to substitute the LEDs and image sensor of Ouyang with the LEDs and image sensor of Weber enabling the endoscope to perform fluorescence and white light endoscopy to better navigate a body cavity and visualize structures underneath tissue, such as blood vessels.
In regard to claim 27, Weber teaches in which: said light source is configured to illuminate said internal organ with white light during first time intervals and with non-white light during second time intervals that are time-interleaved with said first time intervals (Par. 45).
In regard to claim 28, Ouyang teaches in which said distal gas port comprises an outer shell (120) that at least partly surrounds said imaging structure and directs said gas over a distal face of the imaging structure (Figs. 6,7).
In regard to claim 29, Ouyang teaches in which said gas conduit comprises space between the outer shell (120) and the imaging structure (Fig. 6).
In regard to claim 30, Ouyang teaches in which said distal gas port is further configured to direct gas flow directed distally of said distal tip of the cannula to aid in moving said distal tip of the cannula through a patient's passageway (Fig. 6, Par. 121).
In regard to claim 34, Ouyang teaches in which said imaging structure comprises an imaging sensor and a processor in a stacked arrangement (Par. 36).
In regard to claim 41, Ouyang teaches further comprising a proximal liquid port (114) at the proximal portion of the cannula and a distal liquid port (622) at the distal portion of the cannula that are in fluid flow communication with each other (Par. 123).
In regard to claim 49, Ouyang disclose a self-contained endoscope (100, Fig. 1) comprising a single-use, disposable cannula (102,104) for imaging a patient's internal organ and a reusable handle (108) that is releasably connected to said cannula through electrical and mechanical connectors (Fig. 1), wherein:
said single-use cannula comprises:
a light source (630,632) at a distal portion of the cannula, configured to illuminate said internal organ (Fig. 6); and
an imaging structure (640) at said distal portion of the camera, configured to receive light from the internal organ and in response to produce images of the internal organ (Fig. 6);
an input gas port (114) for insufflating gas at a proximal portion of the cannula, a distal gas port (620) for said gas at the distal portion of the cannula, and a gas conduit (810) connecting the input and distal gas ports;
wherein said distal gas port is configured to direct a flow of said gas over a field of view of said imaging structure to aid in clearing debris from said field of view (Par. 121); and
said reusable handle comprises:
an integral display screen (110) configured to display images taken with said imaging structure (Fig. 1).
Ouyang does not expressly teach said single-use cannula comprises: a light source at a distal portion of the cannula, configured to illuminate said internal organ, wherein said light source is a source of white light and a source and a source of non-white light, and each of said sources of light comprises a device that converts electricity to light; and said imaging structure configured to generate a white light image in response to said illumination of the internal organ with said white light and a structure configured to generate a non-white light image in response to said illumination of the organ with said non-white light, wherein the imaging structure comprises a single image sensor that receives both white light and non-white light and is configured to selectively vary the durations of illumination with white light and non-white light to thereby selectively enhance one or both of the white and non-white images.
Weber teaches an analogous endoscope comprising a plurality of LEDs (5, 7) and an image sensor (9) integrated into the distal tip of the endoscope. The first LED (5) is configured to emit light in a first light spectrum (19) suitable for fluorescence endoscopy and the second LED (7) is configured to emit light in a second light spectrum (21) suitable for white light endoscopy (Par. 35, 36). The image sensor (9) enables easy switching between fluorescence and white light endoscopy in a simple and rapid manner due to the possibility of fluorescence light with the first LED (5) and by way of white light with the second LED (7) filtered by way of the light filter (23, Par. 45), whereby the user can selectively switch between the fluorescence imaging mode and the white light imaging modes thereby turning on the first LED (5) for fluorescence light imaging and turning on the second LED (7) for white light imaging (i.e. changing the duration in which the first and/or second LED (5, 7) is turned on).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to substitute the LEDs and image sensor of Ouyang with the LEDs and image sensor of Weber enabling the endoscope to perform fluorescence and white light endoscopy to better navigate a body cavity and visualize structures underneath tissue, such as blood vessels.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Ouyang et al. (US Patent Application Publication No. 2012/0289858, hereinafter Ouyang) in view of Weber et al. (US Patent Application Publication No. 2021/0007591, hereinafter Weber), as applied to claim 26, and further in view of Igarashi et al. (US Patent Application Publication No. 2018/0220879, hereinafter Igarashi).
In regard to claim 39, Ouyang and Weber does not expressly teach in which: said light source is configured to illuminate said internal organ with white light and with non-white light in a selected wavelength range, and said imaging structure comprises a single sensor layer and a logic laver that configured to receive both white light and non-white light from the internal organ and in response produce a white light image and a non-white image of the internal organ that are spatially and temporally registered with each other.
Igarashi teaches an analogous endoscope comprising an imaging device (21) comprising a CMOS image sensor (22) and an image signal processor (ISP, 23). The image sensor is configured to receive white light via a white LED and narrow band light (NBI) from a NBI illumination light (Par. 32) and the ISP (23) includes a timing control circuit (23a) that controls the timing in which the read circuit (22b) reads an imaging signal output from the selected pixel in the light receiving unit (22a), Par. 38.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date to modify the imaging structure of Ouyang and Weber to be formed of an image sensor (22) and ISP (23) as taught by Igarashi as a matter of design choice for reading out both white light and narrow band illumination light images (Par. 38)
Claims 45-48 are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang et al. (US Patent Application Publication No. 2012/0289858, hereinafter Ouyang) in view of Weber et al. (US Patent Application Publication No. 2021/0007591, hereinafter Weber), as applied to claim 26, and further in view of Kato (US Patent application Publication No. 2019/0110686).
In regard to claims 45-48, Ouyang and Weber are silent with respect to said imaging structure comprises at least two camera modules, in which said at least two camera modules that are arranged side-by-side, in which at least one of said camera modules is configured to image white light and at least one is configured to image non-white light, in which at least one of said camera modules is configured to image white light and at least one is configured to image non-white light.
Kato teaches an endoscope device (1) comprising an endoscope (10) having an imaging unit (13) and first and second light sources configured to illuminate a body cavity with the first light source (221, 231) to emit white light to a body cavity and the second light source (222, 232) to illuminate a body cavity with non-white light (excitation-light wavelength band, Par. 6). The imaging unit (13) comprises a laminated image sensor (132) comprising a back-side illuminated visible image capturing image sensor substrate (132-1, i.e. white light sensor array) and a backside illuminated fluorescence-image capturing image sensor substrate (132-2, i.e. non-white light sensor array) laminated with a dielectric multilayer film filter layer (132-3) interposed therebetween. The visible image capturing image sensor substrate (132-1) having a photoelectric conversion layer (132-11) and wiring layer (132-12). The photoelectric conversion layer (132-11) forming a photoelectric conversion element constituting each of the R pixel (1320R), the G pixel (1320G), and the B pixel (1320B) which generates and stores signal charges according to the intensity of reflected light (visible light) incident from the microlens layer (132-5) via the on-chip color filter layer (132-4). The fluorescence-image capturing image sensor substrate (132-2) having a photoelectric conversion layer (132-21) and wiring layer (132-22), Par. 94. The photoelectric conversion layer (132-21) forming a photoelectric conversion element constituting the fluorescent pixel (1320IR) which generates and stores signal charges according to the intensity of reflected light (visible light) incident from the microlens layer (132-5) via the on-chip color filter layer (132-4), Par. 96. The imaging unit (13) further includes a reading unit (1322, i.e. readout circuit) which controls the reading of signal charges generated and stored in each pixel (1320) arranged within the pixel unit (1321), Par. 77. Kato further teaches the laminated image sensor simultaneously performs he normal photographing of the object with visible light and fluorescence photographing of the object (Par. 148).
It would’ve been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the imaging structure of Ouyang and Weber with the laminated image sensor (132) of Kato enabling simultaneous visible and fluorescent light imaging of a body cavity to identify abnormal tissue within a body cavity that can’t be as easily identified when only imaging with visible light.
Claims 31-33, 40 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang et al. (US Patent Application Publication No. 2012/0289858, hereinafter Ouyang) in view of Weber et al. (US Patent Application Publication No. 2021/0007591, hereinafter Weber), as applied to claim 26, and further in view of Williams JR. et al. (US Patent Application Publication No. 2009/0171268, hereinafter Williams).
In regard to claims 31-33 and 42, Ouyang does not expressly teach further including a gas flow controller having an input for gas and an output feeding gas to said input gas port of the cannula, in which said controller is configured to intermittently increase the pressure of gas delivered to said distal port of the cannula, further including a portable gas cartridge threaded into said flow controller, further including a source of said insufflating gas coupled with said distal gas port and configured to intermittently pulse the flow of gas from the distal gas port to aid in clearing debris adjacent the imaging structure.
Williams teaches an analogous device for insufflation/distension of the uterus (see Fig. 8). The device comprises a consumable portion (102) and reusable portion (104), wherein the consumable portion comprises an insertable member (20) and connector (46) and the resuable portion comprises a CO2 cartridge (110), pumping member (12, flow controller) and connector (47) for connection to the connector of the insertable member. The device enable CO2 to be selectively pumped, via the pumping member (12), through the insertable member and into the body cavity for insufflation or distension of the body cavity.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the reusable portion (104) of Williams with the endoscope of Ouyang thereby providing a means for delivering gas to the body cavity via a pumping member and CO2 cartridge providing cost savings since the reusable portion can be repeatedly reused (Par. 66).
In regard to claim 40, Ouyang teaches in which said cannula is a single-use, disposable cannula that is in a sterile package before use (Par. 138), and including a source of insufflating gas configured to supply said gas to said input port, wherein said source of gas is a portable cartridge that contains less than 10 grams of said gas (Williams teaches a portable cartridge, wherein the cartridge is capable of containing less than 10 grams of gas), wherein said cannula, source of gas, and handle with said image display form a self-contained, portable endoscope (each of the elements would be connected, when in use, to form a self-contained portable endoscope).
Claim 44 are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang et al. (US Patent Application Publication No. 2012/0289858, hereinafter Ouyang) in view of Weber et al. (US Patent Application Publication No. 2021/0007591, hereinafter Weber), as applied to claim 26, and further in view of Mitsui et al. (US Patent Application Publication No. 2017/0112356, hereinafter Mitsui).
In regard to claim 44, Ouyang and Weber are silent with respect to in which said imaging structure comprises a liquid crystal tunable filter configured to change between passing primarily white light and passing primarily non-white light in response to electronic control.
Ishihara teaches an analogous endoscope comprising an imaging unit (11) for white light and fluorescence imaging. A liquid crystal tunable filter (36) is provided in the imaging unit enabling fluorescence and white light imaging to be switched by electronic control (Par. 38, 83).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the imaging structure of Ouyang and Weber with the liquid crystal tunable filter of Matsui enabling both fluorescent and white light imaging to be switched by electronic control (Par. 38,83).
Response to Arguments
Applicant’s arguments with respect to claims 26-34, 39-42, 44-49 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The examiner would like to note that although Weber was not used in the previous action to teach the feature of: “wherein the imaging structure is configured to selectively vary the durations of illumination with white light and non-white light to thereby selectively enhance one or both of the white and non-white images”, upon further consideration Weber does teach the claimed feature since switching between the fluorescent imaging mode to the white light imaging mode the user can selectively vary the time in which the first LED or second LED is on (i.e. varying the duration).
Conclusion
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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 December 3, 2025