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 .
Status of Claims
Claims 1-20 are pending, claim 16 has been withdrawn from consideration, and claims 1-15 and 17-20 are currently under consideration for patentability under 37 CFR 1.104.
Election/Restrictions
Applicant’s election of Species 1, readable on claims 1-15 and 17-20, in the reply filed on 12/16/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claim 6 is objected to because of the following informalities: the limitation “about magnitude” should read “about a magnitude”. Appropriate correction 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.
Claims 7 and 18 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.
Regarding claim 7, the limitation “the insertion status” lacks antecedent basis. This feature has not been previously recited.
Regarding claim 7, the limitation “not indicating the situation where the patient is suffering a pain is input” is unclear. It is unclear what the situation is with respect to pain.
Regarding claim 7, the limitation “when the pain situation information indicating the situation where the patient is suffering a pain is input” is unclear. It is unclear what the pain situation information is with respect to pain.
Regarding claim 18, the limitation “acquires examination condition information…about past endoscopies” lacks antecedent basis. The features in this limitation were previously recited in claim 1 (i.e., change “examination condition information” to “the examination condition information”; apply this to each of the features listed in the limitation).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-15 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hane (WO 2019/187025 A1 has publication date of 10/03/2019; using US 2021/0048355 for English translation).
Regarding claim 1, Hane discloses an insertion support system (figures 1-2) comprising: a processor (100, figure 1 | processor [0077]), wherein the processor is configured to: acquire endoscopy status information (see 102 and 104, figure 1 | image processing device 18, figure 2) associated with an endoscopy using an endoscope (see 10, figure 1), the endoscopy status information including at least one of an endoscopic image (shape of the insertion section…camera images [0074]), insertion section shape information (see 102, figure 1), or operation recognition information (104, figure 1), the insertion section shape information being information about a shape of an endoscope insertion section (see 46 to 102, figure 1), the operation recognition information being information about a change in at least one of the shape or a position of the endoscope insertion section (104, figure 1 | change with time of the insertion section [0087]); receive input of at least one of input pain information (see 114 to 116, figure 1 | presence/absence of damage such as a pain [0217]) or the endoscopy status information (see 102 and 104 arrows to 116, figure 1), the input pain information being information about a pain of a patient acquired from the patient or a medical worker in real time (pain…[0217] | interpreted the pain information can be inputted into the processor), and acquire pain situation information upon recognition of a pain situation (concrete judgement contents…degree of the content of damage [0217]), the pain situation being a situation where the patient is suffering a pain during the endoscopy (pain caused…[0217]); acquire examination condition information including at least one of endoscope kind information (106, figure 1), patient information (a history of…estimated from insertion path based on history [0152]; 110, figure 1), and past examination information (a history of previous endoscope insertion [0152]; 110, figure 1), the endoscope kind information being information about a kind of the endoscope insertion section used for the endoscopy (stores mechanical characteristic information…of the insertion section [0085]), the patient information being information about patient attributes (a history of…estimated from insertion path based on history [0152]), and the past examination information being information about past endoscopies (a history of previous endoscope insertion [0152]); and generate insertion support information (140, figure 1) according to the pain situation information (114…pain caused [0217] | see 114 and arrows to 140, figure 1), the endoscopy status information (see 102 and 104 and arrows to 140, figure 1), and the examination condition information ([0152] and [0230]).
Regarding claim 2, Hane further discloses when both of the input pain information and the endoscopy status information are input, the processor recognizes the pain situation based on the input pain information (114…pain caused…[0217]).
Regarding claim 3, Hane further discloses when the endoscopy status information is input while the input pain information is not input, the processor recognizes the pain situation based on the endoscopy status information (shape and disposition of the insertion section…damage or pain can be judged [0223]), and generates the insertion support information according to the pain situation recognized based on the endoscopy status information (114 sends to the information output unit 116 [0224]; see 116 to 140, figure 1), and when the input pain information is input in addition to the endoscopy status information (concrete judgement…damage such as a pain [0217]), the processor recognizes the pain situation based on the input pain information (see 114, figure 1; [0217]), and generates the insertion support information according to the pain situation recognized based on the input pain information (see 114 and arrows to 140, figure 1).
Regarding claim 4, Hane further discloses the processor classifies an insertion status of the endoscope (108, figure 1 | calculates…force or stress occurring in the lumen cavity [0154]) based on at least one of the endoscopic image (shape of the insertion section…camera images [0074]), the insertion section shape information (see 102, figure 1), and the operation recognition information (104, figure 1 | [0087]), and outputs the endoscopy status information including classification results (calculates…stress [0154] | see 108 and arrow to 114 and 116, figure 1), and recognizes whether or not the insertion status indicated by the classification results corresponds to the situation where the patient is suffering a pain (damage is judged from the stress…[0219]), thereby recognizing the pain situation (sends…judgement of…damage…[0224]).
Regarding claim 5, Hane further discloses the operation recognition information includes insertion section shape displacement information being information about shape displacement of the endoscope insertion section (104, figure 1 | change with time of the insertion section [0087]), and the processor performs the classification (see arrows from 102 and 104 to 108, figure 1; [0154]) based on the insertion section shape information (see 102, figure 1) and the insertion section shape displacement information ([0087]).
Regarding claim 6, Hane further discloses the insertion section shape displacement information includes shape displacement amount information being information about magnitude of the shape displacement (change with time of the insertion section [0087] | interpreted the amount of change to be the magnitude), and the processor performs the classification (see arrows from 102 and 104 to 108, figure 1; [0154]) based on the insertion section shape information (see 102, figure 1) and the shape displacement amount information ([0087]).
Regarding claim 7, Hane further discloses when the processor generates the insertion support information corresponding to the insertion status of the endoscope based on the endoscopy status information, the processor generates first insertion support information as the insertion support information when the pain situation information not indicating the situation where the patient is suffering a pain is input (114…absence of damage/pain…[0217]; see 114 and arrow to 140, figure 1), and generates second insertion support information being different from the first insertion support information, as the insertion support information when the pain situation information indicating the situation where the patient is suffering a pain is input (114…presence of damage/pain…[0217]; see 114 and arrow to 140, figure 1).
Regarding claim 8, Hane further discloses the processor recognizes the pain situation (damage or pain can be judged…[0223]) by recognizing, based on the endoscopy status information, a situation where the pain is caused by extension of an intestinal wall of a large intestine (intestinal tract [0164] | extended…pain), a situation where a pain is caused by a mesentery (intestinal tract [0164]) being pulled (pulled [0168]), a situation where the pain is caused by the endoscope insertion section pushing the intestinal wall (see figure 11), or a situation where the pain is caused due to a relationship between a fixed colon of the large intestine and the endoscope insertion section (fixed…colon…[0179] | crushed…pain [0168]).
Regarding claim 9, Hane further discloses the processor recognizes the pain situation where the patient is suffering a pain (114…presence/absence of damage/pain…[0217]) when the processor recognizes, based on the endoscopy status information (see 102 and 104 and arrows to 114, figure 1), a situation where a push up operation to a flank side or a head side (crushed, extended, or pulled…pain [0168]) is performed near SDJ by an angle operation of the endoscope (SD-J…[0179]).
Regarding claim 10, Hane further discloses the processor recognizes the pain situation where the patient is suffering a pain (114…presence/absence of damage/pain…[0217]) when the processor recognizes, based on the endoscopy status information (see 102 and 104 and arrows to 114, figure 1), a situation where a push up operation to a head side (crushed, extended, or pulled…pain [0168]) is performed near SDJ (SD-J…[0179]) by a torque operation (rotation amount of the insertion section [0071]) and an angle operation (stress…[0171] | angle formed…[0173]) of the endoscope.
Regarding claim 11, Hane further discloses the processor recognizes the pain situation where the patient is suffering a pain (114…presence/absence of damage/pain…[0217]) when the processor recognizes, based on the endoscopy status information (see 102 and 104 and arrows to 114, figure 1), a situation where an operation is performed near SDJ (SD-J…[0179]) with the endoscope insertion section being bent (a part on which the insertion section is abutted [0165]; see 214, figure 11 | the insertion section may be bent when near the SDJ).
Regarding claim 12, Hane further discloses the processor recognizes the pain situation where the patient is suffering a pain (114…presence/absence of damage/pain…[0217]) when the processor recognizes, based on the endoscopy status information (see 102 and 104 and arrows to 114, figure 1), a situation where a pull operation is performed with looping of the endoscope (pain…a loop…[0194]).
Regarding claim 13, Hane further discloses the processor recognizes the pain situation where the patient is suffering a pain (114…presence/absence of damage/pain…[0217]) when the processor recognizes, based on the endoscopy status information (see 102 and 104 and arrows to 114, figure 1), a situation where a distal end of the endoscope insertion section is present in any of a splenic flexure, a transverse colon, and a hepatic flexure (a part on which force or stress concentrates in the intestinal tract [0166] | interpreted the splenic and hepatic flexures can be places in the intestinal tract where force/stress concentrates), and a push operation is performed when a re-loop is formed in a sigmoid colon (loop…[0194]).
Regarding claim 14, Hane further discloses the processor recognizes the pain situation where the patient is suffering a pain (114…presence/absence of damage/pain…[0217]) when the processor recognizes, based on the endoscopy status information (see 102 and 104 and arrows to 114, figure 1), a situation where a distal end of the endoscope insertion section is present in any of a splenic flexure, a transverse colon, and a hepatic flexure (a part on which force or stress concentrates in the intestinal tract [0166] | interpreted the splenic and hepatic flexures and transverse colon can be places in the intestinal tract where force/stress concentrates due to their shape and being fixed [0054]), and a pull operation is performed upon dealing with a re-loop in a sigmoid colon (loop…[0194]).
Regarding claim 15, Hane further discloses the processor recognizes the pain situation where the patient is suffering a pain (114…presence/absence of damage/pain…[0217]) when the processor recognizes, based on the endoscopy status information (see 102 and 104 and arrows to 114, figure 1), a situation where a left colon portion is pushed up (see pushing force F, figure 11 as an example) from a splenic flexure by a push operation of the endoscope (force or stress concentrates…[0166] | extended…pain [0168]).
Regarding claim 17, Hane further discloses the processor recognizes the pain situation by distinguishing situations with different pain levels (presence/absence of damage such as a pain…degree of the content of damage [0217]), different pain frequencies, or different degrees of pain avoidability from each other.
Regarding claim 18, Hane further discloses the processor acquires examination condition information including at least one of endoscope kind information (106, figure 1), patient information (a history of…estimated from insertion path based on history [0152]), and past examination information (a history of previous endoscope insertion [0152]), the endoscope kind information being information about a kind of the endoscope insertion section used for the endoscopy (stores mechanical characteristic information…of the insertion section [0085]), the patient information being information about the patient attributes (a history of…estimated from insertion path based on history [0152]; 110, figure 1), and the past examination information being information about past endoscopies (a history of previous endoscope insertion [0152]; 110, figure 1), and recognizes the pain situation based on the examination condition information (114…concrete judgement contents…degree of the content of damage [0217] | see arrows from 106 and 110 to 114, figure 1).
Regarding claim 19, Hane discloses an endoscope system (figures 1-2), comprising: an endoscope (see 10, figure 1) for use in endoscopy; and a processor (100, figure 1; processor [0077]), wherein the processor is configured to: acquire endoscopy status information (see 102 and 104, figure 1 | image processing device 18, figure 2) associated with the endoscopy using the endoscope, the endoscopy status information including at least one of an endoscopic image (shape of the insertion section…camera images [0074]), insertion section shape information (see 102, figure 1), or operation recognition information (104, figure 1), the insertion section shape information being a shape of an endoscope insertion section (see 46 to 102, figure 1), the operation recognition information being information about a change in at least one of the shape or a position of the endoscope insertion section (104, figure 1 | change with time of the insertion section [0087]); receive input of at least one of input pain information (see 114 to 116, figure 1 | presence/absence of damage such as a pain [0217]) or the endoscopy status information (see 102 and 104 arrows to 116, figure 1), the input pain information being information about a pain of a patient acquired from the patient or a medical worker in real time (pain…[0217] | interpreted the pain information can be inputted into the processor), and acquire pain situation information upon recognition of a pain situation (concrete judgement contents…degree of the content of damage [0217]), the pain situation being a situation where the patient is suffering a pain during the endoscopy (pain caused…[0217]); acquire examination condition information including at least one of endoscope kind information (106, figure 1), patient information (a history of…estimated from insertion path based on history [0152]; 110, figure 1), and past examination information (a history of previous endoscope insertion [0152]; 110, figure 1), the endoscope kind information being information about a kind of the endoscope insertion section used for the endoscopy (stores mechanical characteristic information…of the insertion section [0085]), the patient information being information about patient attributes (a history of…estimated from insertion path based on history [0152]), and the past examination information being information about past endoscopies (a history of previous endoscope insertion [0152]); and generate insertion support information (140, figure 1) according to the pain situation information (114…pain caused [0217] | see 114 and arrows to 140, figure 1), the endoscopy status information (102 and 104 and arrows to 140, figure 1), and the examination condition information ([0152] and [0230]).
Regarding claim 20, Hane discloses an insertion support method (see figure 1), comprising: acquiring endoscopy status information (see 102 and 104, figure 1 | image processing device 18, figure 2) associated with an endoscopy using an endoscope (see 10, figure 1), the endoscopy status information including at least one of an endoscopic image (shape of the insertion section…camera images [0074]), insertion section shape information (see 102, figure 1), or operation recognition information (104, figure 1), the insertion section shape information being a shape of an endoscope insertion section (see 46 to 102, figure 1), the operation recognition information being information about a change in at least one of the shape or a position of the endoscope insertion section (104, figure 1 | change with time of the insertion section [0087]); receiving input of at least one of input pain information (see 114 to 116, figure 1 | presence/absence of damage such as a pain [0217]) or the endoscopy status information (see 102 and 104 arrows to 116, figure 1), the input pain information being information about a pain of a patient acquired from the patient or a medical worker in real time (pain…[0217] | interpreted the pain information can be inputted into the processor), and acquiring pain situation information upon recognition of a pain situation (concrete judgement contents…degree of the content of damage [0217]), the pain situation being a situation where the patient is suffering a pain during the endoscopy (pain caused…[0217]); acquiring examination condition information including at least one of endoscope kind information (106, figure 1), patient information (a history of…estimated from insertion path based on history [0152]; 110, figure 1), and past examination information (a history of previous endoscope insertion [0152]; 110, figure 1), the endoscope kind information being information about a kind of the endoscope insertion section used for the endoscopy (stores mechanical characteristic information…of the insertion section [0085]), the patient information being information about patient attributes (a history of…estimated from insertion path based on history [0152]), and the past examination information being information about past endoscopies (a history of previous endoscope insertion [0152]); and generating insertion support information (140, figure 1) according to the pain situation information (114…pain caused [0217] | see 114 and arrows to 140, figure 1), the endoscopy status information (see 102 and 104 and arrows to 140, figure 1), and the examination condition information ([0152] and [0230]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Abe (US 2022/0322917).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA F WU whose telephone number is (571)272-9851. The examiner can normally be reached M-F: 8-4 PM.
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PAMELA F. WU
Examiner
Art Unit 3795
February 6, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795