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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/13/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Restriction
In view of amendment made by the applicant, the previous restriction requirement dated 12/1/2025 has been withdrawn. Thus, claims 1-18 are examined.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
an acquisition unit, a diagnosis unit, a display unit, a reception unit, and a control unit, in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 8-11, 13, 15, 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 8 recites the limitation "a proportion of performance of the diagnosis" in line 2. This phrase is unclear. Appropriate correction is required.
Claim 9 recites, “wherein the diagnosis unit determines whether the captured image acquired by the acquisition unit is that obtained by capturing a diagnosis part that is set in advance.” This phrase is unclear. Appropriate correction is required.
Claim 11, recites “wherein the diagnosis part is set based on character information that is included in an image region other than the captured image acquired by the acquisition unit from the endoscope system.”
It is unclear which image region the claim is referring to by the phrase “an image region other than the captured image”. There is one reference to the image in the claim which is “image acquired by the acquisition unit.” Thus, it is unclear where the character information is provided which makes the claim unclear.
Appropriate correction is required.
Claim 13, recites “wherein the control unit causes only the diagnosis result where an estimated probability of estimating that there is a lesion is equal to or greater than a threshold to be displayed on the display unit.” How the control unit causes only the diagnosis result. This is unclear. Appropriate correction is required.
Claim 15, recites “wherein the reception unit receives selection of the complete off mode in a deeper layer than the background mode.” The deeper layer and background mode are undefined. Thus, the claim is unclear. Appropriate correction is required.
Claims 10-11 are rejected for being dependent on a rejected base claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-5, 8-15, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaire (US 20190287240) in view of Ito (US 20190117055).
Regarding claim 1, Gaire discloses an examination support device (FIGS. 1-2) that is used by being connected to an endoscope system including a camera unit for being inserted into an inside of a body of a subject (This is not positively recited.), the examination support device comprising:
an acquisition unit (storage medium 108, processors 104; Para [0143]) for sequentially acquiring a captured image that is captured by the camera unit;
a diagnosis unit (module 114 for classifying the identified tumor; Para [0156]; image analysis system 100; FIG. 1; Para [0143]) for performing diagnosis of the inside of the body based on the captured image;
a display unit (display 102) for displaying a diagnosis result that is output by the diagnosis unit (Storing/displaying classification result; FIG.2); and
a control unit (image analysis system 100 including processor 104; FIG. 1) for causing the diagnosis result to be displayed on the display unit in real time (Storing the classification result on a storage medium; abstract; para [0157] ), and causing the diagnosis result to be stored in a storage unit without being displayed on the display unit at least while examination of the inside of the body by the camera unit is being performed (Processor displays the classification result on the display device 102 based on classification of the tumor and proximity measurement by the processor. Abstract; para [0143], [0157]).
Gaire does not expressly disclose a reception unit for receiving, from a user, selection of an on mode in which the diagnosis result is displayed on the display unit in a case where selection of the on mode is received by the reception unit or an off mode in which display is not performed in a case where selection of the off mode is received.
Ito is directed to an endoscope apparatus (FIG. 1; abstract ) and teaches a reception unit (body 110; FIG. 1) for receiving, from a user, selection of an on mode (Display mode selector 164; FIG. 1) in which the diagnosis result is displayed on the display unit in a case where selection of the on mode is received by the reception unit or an off mode in which display is not performed in a case where selection of the off mode is received (Display and observation mode are selected by an operator; The input device 160 is used for selecting and switching observation modes and/or display modes; Para [0079]; In observation mode, different lights are emitted/selected for data collection which includes data saving, memory 137. FIG.1; Claim 10; para [0056], [0315]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gaire to have a user ability to select modes in accordance with the teaching of Ito so that memory could be saved by not requiring to have displaying data all the time. Further, a user could display or not display the diagnosis result based on his desire.
Regarding claim 2, Gaire as modified, teaches wherein, in a case where selection of the off mode is received (Ito: observation mode with light and image saving without display; [0079]), the control unit causes the diagnosis result to be stored in the storage unit in a case where a storage criterion that is set in advance in relation to at least one of the captured image and the diagnosis result is satisfied (Gaire: Storing classification result by the image analysis on a storage medium based on identified image of the tumor cell; Step 212, FIG. 2).
Regarding claim 3, Gaire discloses wherein the storage criterion includes an estimated probability of estimating that there is a lesion included in the diagnosis result being equal to or greater than a threshold (Tumor cell is detected which means a threshold is used to identify and classify the cell with a threshold; Step 210, FIG. 2).
Regarding claim 4, Gaire discloses wherein the storage criterion includes a resolution of the captured image being equal to or greater than a threshold (Tumor cell is detected which means a threshold is used to identify and classify the cell with a threshold; FIG. 2).
Regarding claim 5, Gaire discloses wherein the reception unit receives setting of the storage criterion from the user (Display and observation mode are selected by an operator; The input device 160 is used for selecting and switching observation modes and/or display modes; Para [0079]; In observation mode, different lights are emitted/selected for data collection which includes data saving, memory 0137. Claim 10; para [0056], [0315]).
Regarding claim 8, Gaire as modified, teaches discloses wherein the diagnosis unit causes a proportion of performance of the diagnosis on the captured image acquired by the acquisition unit to be different between a case where selection of the on mode is received by the reception unit and a case where selection of the off mode is received (Gaire: This is an intended use because a processor can adjust the proportion of performance based on data use. If storing causes less memory consumption, the proportion of performance is adjusted accordingly.).
Regarding claim 9, Gaire as modified, teaches wherein the diagnosis unit determines whether the captured image acquired by the acquisition unit is that obtained by capturing a diagnosis part that is set in advance (Gaire: The diagnosis step such as steps 206, 210, FIG. 2, is set in advance before classifying the tumor. ), and in a case where selection of the off mode is received (Ito: Observation mode is selected by the user; Para [0056], [0315]), the control unit causes the diagnosis result to be stored in the storage unit (Storing the classification result; Step 212; FIG. 2) when capturing of the diagnosis part is determined by the diagnosis unit.
Regarding claim 10, Gaire discloses the diagnosis part is set based on a learning model that is used by the diagnosis unit (Machine learning is used for diagnosis. Para [0030]).
Regarding claim 11, Gaire discloses wherein the diagnosis part is set based on character information that is included in an image region (Received image has cell information; FIG.2) other than the captured image acquired by the acquisition unit from the endoscope system.
Regarding claim 12, Gaire discloses comprising a detection unit for detecting end of examination of the inside of the body by the camera unit (Gaire: The classification result is stored and displayed. this may be considered as end of examination. FIG. 2), wherein in a case where selection of the off mode is received, the control unit reads out the diagnosis result stored in the storage unit (Gaire: Reading images from the storage; Para [0150]) and causes the diagnosis result to be displayed on the display unit after the end of the examination is detected by the detection unit (Displaying the classification result; FIG. 2).
Regarding claim 13, Gaire discloses wherein the control unit causes only the diagnosis result (Step 210, FIG.2) where an estimated probability of estimating that there is a lesion is equal to or greater than a threshold (Displaying the classification result. Proximity measure; FIG. 2) to be displayed on the display unit.
Regarding claim 14, Gaire as modified, discloses wherein the reception unit performs reception regarding the off mode (Ito: Display and observation mode are selected by an operator; The input device 160 is used for selecting and switching observation modes and/or display modes; Para [0079]; In observation mode, different lights are emitted/selected for data collection which includes data saving; memory 0137. Claim 10; para [0056], [0315]; For this reception of the Off mode, an observation mode, is required.) while distinguishing between a background mode (Background mode is not defined. ) and a complete off mode, and the control unit causes the diagnosis result to be stored in the storage unit (Gaire: Storing classification result; FIG. 2) without being displayed on the display unit in a case where selection of the background mode is received by the reception unit, and does not cause the diagnosis unit to perform the diagnosis in a case where selection of the complete off mode is received (Ito: In observation mode, different lights are emitted/selected for data collection which includes data saving, memory 0137. Claim 10; para [0056], [0315]).
Regarding claim 15, Gaire as modified, discloses wherein the reception unit receives selection of the complete off mode (Ito: In observation mode, different lights are emitted/selected for data collection which includes data saving, memory 0137. Claim 10; para [0056], [0315]) in a deeper layer than the background mode (Deeper layer or background mode are not defined.).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaire (US 20190287240) in view of Ito (US 20190117055) and further in view of Hirakawa (US 20080039692).
Regarding claim 6, Gaire discloses wherein when selection of the on mode is received by the reception unit (Ito: Display and observation mode are selected by an operator; Para [0056], [0315]), in a case where a display criterion set in advance for at least one of the captured image (Classification display; FIG. 2) and the diagnosis result is satisfied, the control unit causes the diagnosis result to be displayed on the display together with the captured image used by the diagnosis unit for the diagnosis (Based on proximity, the tumor cell is identified; Display the classification result; FIG. 2).
Gaire does not expressly disclose wherein the control unit causes the diagnosis result to be displayed on the display unit for a predetermined period of time together with the captured image used by the diagnosis unit for the diagnosis.
Hirakawa teaches wherein the control unit causes the diagnosis result to be displayed on the display unit for a predetermined period of time (Time bar indicates the time position of the image displayed in the display. slider 111 for adjusting time; Para [0071], [0116]) together with the captured image used by the diagnosis unit for the diagnosis (Main display 12; FIG. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Gaire’s control unit to cause the diagnosis result to be displayed on the display unit for a predetermined period of time so that a user can see the result for the desired amount of time in the screen.
Regarding claim 7, Gaire as modified, discloses wherein the storage criterion and the display criterion are different from each other (In the claim, the storage criterion and display criterion are not defined. Therefore, as shown in FIG. 2, anything associated with the display and storage may be considered as criteria. Saving and displaying based on users’ choice may be considered as these criteria.).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaire (US 20190287240) in view of Ito (US 20190117055) and further in view of Kato (US 20200113541).
Regarding claim 16, Gaire does not expressly disclose wherein the control unit displays a notice indicating the off mode on the display unit so that the background mode and the complete off mode are visually distinguishable from each other.
Kato is directed to an information processing apparatuses that display images (abstract) and teaches wherein the control unit displays a notice (Image Off/on mode notice 83; FIG. 8B) indicating a mode on the display unit so that the background mode (Background mode is not define. ) and the complete off mode are visually distinguishable from each other (The computer 150 can switch the display mode between display on and off modes of the post-treatment tomographic image 21b based on a command of the user. FIG. 8A; Para [0125]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Gaire to include a status indicator of the off mode in the display in accordance with the teaching of Kato so that a status of the display could be provided to a user.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO – 892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANKAR R GHIMIRE whose telephone number is (571)272-0515. The examiner can normally be reached 8 AM - 5 PM.
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 on 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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/SHANKAR RAJ GHIMIRE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
03/13/26