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 amendment filed on 6/8/2026 has been entered. Claims 26-34, 39-42, 44, 47-49 are pending in the application with claims 26, 49 amended, claims 1-25, 35-38, 43, 45, 46, cancelled.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 39 and 44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 39 recites “said imaging structure comprises a single sensor layer and a logic layer that contains readout circuits to read electronic circuits from the sensor layer, 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” in Lines 4-8, wherein this limitation appears to contradict newly recited Claim 26 which recites there are two cameras with one of the cameras configured to generate a white light image the other camera configured to generate a non-white light image. Additionally, Claim 39 is directed towards subject matter relating to non-elected Species A and Claim 26 from which it depends is directed towards subject matter in Species B due to the first and second image sensors. Appropriate correction is required.
Claim 44 recites “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” in Lines 1-3, wherein Claim 26, from which Claim 44 depends, is directed towards first and second image sensors which are configured side-by-side as shown in Fig. 8, Species B, however the liquid crystal tunable filter is only used in non-elected Species A, Figs. 1-7 due to the stacked arrangement of the image sensors. Therefore, the combination of Claim 44 and 26 would result in new matter since features of Species B are being combined with Species A. Appropriate correction is required.
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.
Claims 47 and 48 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 47 and 48 both depend from cancelled claims and therefore it’s unclear the scope of the claims. Additionally, assuming Claims 47 and 48 were meant to depend from Claim 26, they do not appear to further limit Claim 26. Appropriate correction is required.
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 Ishihara (US Patent Application Publication No. 2012/0302893).
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 tip 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 the imaging structure including at least two camera modules in a side-by-side arrangement, said single-use cannula comprises: a light source at a distal tip portion of the cannula, configured to illuminate said internal organ, wherein said light source comprises a source of white light and a source of non-white light, and each of said sources of light comprises a device that converts electricity to light; and an imaging structure at said distal tip portion of the cannula, the imaging structure including at least two camera modules in a side-by-side arrangement configured to receive light from the internal organ and in response to produce images of the internal organ, wherein a first of said at least two camera modules is configured to generate a white light image in response to said illumination of the internal organ with said white light and a second of said at least two camera modules is 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.
Ishihara teaches an analogous endoscope comprising first and second image sensors (38, 39) with the first image sensor (39) being a white-light image capturing portion configured to image white light produce by light source (10) and generate a white-light image and the second image sensor (38) being a fluorescence-image-capturing portion (39) configured to image fluorescence light produce by light source (10) and generate a fluorescence image. Image processing is then performed by dividing the fluorescence image by the white-light image at a same target location within the body and then corrects the fluorescence image to remove false-positive readings when determined a diseased region.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the endoscope of Ouyang with the light source and image sensors of Ishihara 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 as well as identifying diseased tissue while limiting the false-positive readings.
In regard to claim 27, Ishihara 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. 50).
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 tip portion of the cannula, configured to illuminate said internal organ, wherein said light source comprises a source of white light and a source of non-white light, and each of said sources of light comprises a device that converts electricity to light; and an imaging structure at said distal tip portion of the cannula, the imaging structure including at least two camera modules in a side-by-side arrangement configured to receive light from the internal organ and in response to produce images of the internal organ, wherein a first of said at least two camera modules is configured to generate a white light image in response to said illumination of the internal organ with said white light and a structure second of said at least two camera modules is configured to generate a non-white light image in response to said illumination of the organ with said non-white light; wherein the imaging comprises a single image sensor that receives both white light and non-white light and is configured to selectively vary the respective durations of illumination with white light and non-white light and thus to selectively enhance one or both of the white and non-white images.
Ishihara teaches an analogous endoscope comprising first and second image sensors (38, 39) with the first image sensor (39) being a white-light image capturing portion configured to image white light produce by light source (10) and generate a white-light image and the second image sensor (38) being a fluorescence-image-capturing portion (39) configured to image fluorescence light produce by light source (10) and generate a fluorescence image. Image processing is then performed by dividing the fluorescence image by the white-light image at a same target location within the body and then corrects the fluorescence image to remove false-positive readings when determined a diseased region.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the endoscope of Ouyang with the light source and image sensors of Ishihara 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 as well as identifying diseased tissue while limiting the false-positive readings.
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 Ishihara (US Patent Application Publication No. 2012/0302893), 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).
Response to Arguments
Applicant’s arguments with respect to claims 26-34, 39-42, 44, 47-49 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.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 July 9, 2026
Prosecution Insights