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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/30/2025 has been entered.
Status of Claims
Applicant’s amendments filed 05/30/2025 have been entered. Claim 1-29 are pending, claims 12, 14-20, and 22-28 are withdrawn from consideration, and claims 1-11, 13, 21, and 29 are currently under consideration for patentability under 37 CFR 1.104. Previous rejections under 35 USC 112(a) for enablement have been withdrawn in light of Applicant’s amendments.
Foreign Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copies have been received.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 24, 2008 has been considered by the examiner.
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 1, 29, and all dependent claims thereof 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. MPEP 2161.01I. 6TH PARA states:
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed.
The pending claims recite several computer function limitations that are not explained in sufficient detail in the specification so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. These limitations are:
“acquire, based on at least one of the insertion shape information and an endoscopic image obtained by picking up an image of an inside of the subject with the endoscope, examination situation information indicating an examination situation in the endoscopic examination performed on the subject using the endoscope,” in claim 1. Paragraphs [0051]-[0055] discuss how examination situation information is determined from a single endoscope image. This portion broadly points to a multilayer neural network without any discussion of what specific image analysis is being performed. Paragraph [0062] discusses how examination situation information is determined from insertion shape information and again does not provide any specific steps and only discusses functions in terms of desired outcomes.
“determine a first recognition result of an examination situation corresponding to one of the endoscopic image among a plurality of endoscope images,” in claim 4. This corresponds to the disclosure of paragraphs [0051]-[0055]. This portion broadly points to a multilayer neural network without any discussion of what specific image analysis is being performed.
“determine a second recognition result of an examination situation corresponding to a subset of endoscopic images among the plurality of endoscopic images, wherein the subset of endoscopic images are in plurality and are temporally consecutive” in claim 4. This corresponds to the disclosure of paragraphs [0056]-[0059]. This portion broadly points to a multilayer neural network without any discussion of what specific image analysis is being performed.
“acquire the examination situation information using at least one of: (i) the first recognition result; (ii) the second recognition result; (iii) insertion position information included in the insertion shape information wherein the insertion position information is information indicating an insertion position of the insertion section inserted into the subject; or (iv) an insertion shape image included in the insertion shape information, wherein the insertion shape image is information obtained by visualizing an insertion shape of the insertion section inserted into the subject,” in claim 4. There is no disclosure in the specification as to how the processor determines examination situation information using the above variables.
“wherein the at least one processor is configured to: estimate whether operation corresponding to guide information included in the operation support information is completed,” in claim 6. There is no disclosure in the specification for any specific steps or algorithms that function to estimate (not calculate) guide information is completed.
“wherein the at least one processor is configured to: determine, based on information indicating the estimation result recorded by the recording unit, an operation completion ratio corresponding to each piece of guide information presented during the endoscopic examination being completed, wherein the operation completion ratio is one of the the one or more evaluation indicators of the procedure; and present the operation completion ratio in the first display image as part of the procedure evaluation information,” in claim 7. Paragraphs [0155]-[0156] discuss displaying the operation completion ratio. However, there is no disclosure in the specification as to the specific steps or algorithm to calculate an operation completion ratio.
“the at least one processor is configured to determine, based on the endoscopic examination information recorded by the recording unit, an examination evaluation value used to evaluate a quality of the endoscopic examination,” in claim 9. Paragraph [0164] of the published specification discusses “an examination evaluation value” but is completely silent as to how it is calculated.
“wherein the at least one processor is configured to determine, as the examination evaluation value, at least one of an ileocecum reaching ratio, an intestinal tract cleaning degree, or an adenoma detection rate,” in claim 10. Paragraph [0164] of the published specification discusses an ileocecum reaching ratio, an intestinal tract cleaning degree, or an adenoma detection rate but is completely silent as to how each is calculated.
“acquire the examination situation information by using at lest one of: (i) the first set of evaluation indicators; (ii) the second set of evaluation indicators; (iii) the insertion position information; (iv) the insertion shape image; or (v) they physical condition information,” in claim 21. There is no disclosure in the specification as to how the processor determines examination situation information using the above variables.
“acquiring, based on at least one of the insertion shape information and an endoscopic image obtained by picking up an image of an inside of the subject with the endoscope, examination situation information indicating an examination situation in the endoscopic examination performed on the subject using the endoscope,” in claim 29. Paragraphs [0051]-[0055] discuss how examination situation information is determined from a single endoscope image. This portion broadly points to a multilayer neural network without any discussion of what specific image analysis is being performed. Paragraph [0062] discusses how examination situation information is determined from insertion shape information and again does not provide any specific steps and only discusses functions in terms of desired outcomes.
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.
Claim(s) 1-4 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al. (WO 2018/211674) in view of Tanaka (U.S. 2009/0149703).
U.S. 2020/0090548 will be relied upon as the English translation of Kimura et al.
With respect to claim 1, Kimura et al. teaches an endoscopic examination supporting apparatus comprising:
at least one processor comprising hardware (FIG. 23), wherein the at least one processor is configured to:
acquire insertion shape information indicating an insertion shape of an insertion section of an endoscope and insertion position information indicating an insertion position of the insertion section inserted into the subject (para [0051]);
acquire, based on at least on of the insertion shape information and an endoscopic image obtained by picking up an image of the inside of the subject with the endoscope, examination situation information indicating an examination situation in an endoscopic examination performed on the subject using the endoscope (FIG. 25, para [0156]); and
determine, based on the insertion shape information and the insertion position information, one or more evaluation indicators of a procedure (para [0157] for example),
However, Kimura et al. does no teach the one or more evaluation indicators comprises a first evaluation indicator that is an insertion length of the insertion section inserted into the subject and a second evaluation indicator that is a rotation amount of the insertion section included in the acquired examination situation information and generating a first display image to present the one or more evaluation indicators
With respect to claim 1, Tanaka teaches at least one processor comprising hardware (FIG. 23), wherein the at least one processor is configured to:
determine one or more evaluation indicators of a procedure, wherein the procedure includes an inserting operation for the insertion section performed by a user who operates the endoscope examination, the one or more evaluation indicators comprises a first evaluation indicator that is an insertion length of the insertion section inserted into the subject and a second evaluation indicator that is a rotation amount of the insertion section included in the acquired examination situation information (para [0088] for example); and
generate a first display image to present the one or more evaluation indicators as procedure evaluation information in a display, wherein the procedure evaluation information comprises a temporal change of a third evaluation indicator indicating a specific type of operation, among one or more evaluation indicators, according to the insertion length (FIG. 4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Kimura et al. to utilize the display as taught by Tanaka so that an integrated shape determination processing system based on a plurality of determination conditions can be easily constructed, thereby improving the accuracy of the aid information presented for the operator (para [0125] of Tanaka).
With respect to claim 2, Tanaka teaches the processor is configured to determine, based on the examination situation information including the rotation amount of the insertion section, operation support information for supporting the inserting operation performed by the user (para [0123] for example); and
generate a second display image to present the determined operation support information in the display (52, FIG. 4).
cy of the aid information presented for the operator (para [0125] of Tanaka).
With respect to claim 3, Kimura et al. in view of Tanaka teaches a recording unit (10 of Kimura et al., 41f of Tanaka) configured to record in correlation with one another, as endoscopic examination information:
an endoscopic image group including the endoscopic image in plurality obtained during the endoscopic examination (para [0062], [0072] of Kimura et al., para [0102] of Tanaka);
an insertion shape information group including the insertion shape information in plurality (para [0051] of Kimura et al., para [0101] of Tanaka); and
an operation support time information group including the operation support information in plurality in correlation with one another (para [0118] of Tanaka),
wherein the at least one processor is configured to present the endoscopic examination information recorded by the recording unit in the first display image as part of the procedure evaluation information (FIG. 16-17 of Kimura et al.).
With respect to claim 4, Kimura et al. teaches the at least one processor is configured to:
determine a first recognition result an examination situation corresponding to one of the endoscopic image among a plurality of endoscopic images ( in a case where the insertion target is the lower digestive tract, the insertion target determination unit 121 determines a section obtained by appropriately combining any one or more of the rectum, the sigmoid colon, the descending colon, the transverse colon, and the ascending colon, as the specific section, based on the image acquired by the acquisition unit 2, in a case where the insertion target is the lower digestive tract, the insertion target determination unit 121 determines a section obtained by appropriately combining any one or more of the rectum, the sigmoid colon, the descending colon, the transverse colon, and the ascending colon, as the specific section, based on the image acquired by the acquisition unit 2—para [0129]);
determine a second recognition result of an examination situation corresponding to a subset of endoscopic images among the endoscopic image group, wherein the subset of endoscopic are in plurality and are temporally consecutive (the time calculation unit 13 calculates the transit time in the specific section by a difference in imaging time point between an image determined to be a start of the specific section by the specific section determination unit 12 and an image determined to be an end—para [0134]).
With respect to claim 4, Tanaka teaches the at least one processor is configured to:
acquire the examination situation information by using at least one of: (i) the first recognition result; (ii) the second recognition result; (iii) insertion position information included in the insertion shape information, wherein the insertion position informatoin is information indicating an insertion position of the insertion section inserted into the subject; or (iv) an insertion shape image included in the insertion shape information wherein the insertion shape image is information obtained by visualizing an insertion shape of the insertion section inserted into the subject (FIG. 6, 8).
With respect to claim 29, Kimura et al. teaches a non-transitory recording medium recording a program for casing a computer to execute processing for:
acquiring insertion shape information indicating an insertion shape of an insertion section of an endoscope and insertion position information indicating an insertion position of the insertion section inserted into the subject (para [0051]);
acquiring, based on at least on of the insertion shape information and an endoscopic image obtained by picking up an image of the inside of the subject with the endoscope, examination situation information indicating an examination situation in an endoscopic examination performed on the subject using the endoscope (FIG. 25, para [0156]); and
determining, based on the insertion shape information and the insertion position information, one or more evaluation indicators of a procedure (para [0157] for example),
However, Kimura et al. does no teach the one or more evaluation indicators comprises a first evaluation indicator that is an insertion length of the insertion section inserted into the subject and a second evaluation indicator that is a rotation amount of the insertion section included in the acquired examination situation information and generating a first display image to present the one or more evaluation indicators
With respect to claim 29, Tanaka teaches a non-transitory recording medium recording a program for casing a computer to execute processing for:
determining one or more evaluation indicators of a procedure, wherein the procedure includes an inserting operation for the insertion section performed by a user who operates the endoscope examination, the one or more evaluation indicators comprises a first evaluation indicator that is an insertion length of the insertion section inserted into the subject and a second evaluation indicator that is a rotation amount of the insertion section included in the acquired examination situation information (para [0088] for example); and
generating a first display image to present the one or more evaluation indicators as procedure evaluation information in a display, wherein the procedure evaluation information comprises a temporal change of a third evaluation indicator indicating a specific type of operation, among one or more evaluation indicators, according to the insertion length (FIG. 4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Kimura et al. to utilize the display as taught by Tanaka so that an integrated shape determination processing system based on a plurality of determination conditions can be easily constructed, thereby improving the accuracy of the aid information presented for the operator (para [0125] of Tanaka).
Response to Arguments
Applicant's arguments filed 10/30/2025 have been fully considered but they are not persuasive.
It is noted that on page 13, section b of the Final Rejection mailed 08/01/2025, claim 2 was rejected for failing to comply with the written description requirement. On page 25 of the Remarks, Applicant states “the limitation identified by Examiner is now removed from claim 2.” However it is noted that this rejected language was added to independent claim 1. As Applicant did not provide any specific support for where to find the written description of this claim language, claim 1 is rejected under the same rationale previously applied to claim 2.
Applicants arguments with respect to the written description rejection of claims 4, 6, 7, 9, 10, 21, and 29 are not persuasive. As set forth above, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. Applicant has not provided support for sufficient detail of the steps/procedures to be taken.
On page 39, Applicant argues that Tanaka does not cure the deficiencies of Kimura et al. without any specific arguments to support this assertion. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexandra Newton Surgan whose telephone number is (571)270-1618. The examiner can normally be reached Monday-Friday 8am-4pm EST.
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/ALEXANDRA L NEWTON/Primary Examiner, Art Unit 3799
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