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 21-39 are pending, claims 1-20 have been cancelled, claims 21-39 have been added, and claims 21-39 are currently under consideration for patentability under 37 CFR 1.104. Previous claim objections and 35 USC 112 Rejections have been withdrawn in light of Applicant’s amendments.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-15 and 17-20 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.
Claim Objections
Claims 21-26 and 39 are objected to because of the following informalities:
Regarding claim 21, on line 4, change “an endoscope” to “the endoscope” (i.e., previously recited).
Regarding claim 22, on line 2, change “determine absence” to “determine the absence” (i.e., previously recited).
Regarding claims 23-26, on line 2, change “determines presence” to “determines the presence” (i.e., previously recited).
Regarding claim 39, on line 3, change “an endoscope” to “the endoscope” (i.e., previously recited).
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 22 and 27 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 22, the limitation “acquires a pain situation that occurred in a past, outputs another operation different from the operation for reducing the pain of the subject as the insertion support information” is unclear. It is unclear if the pain situation that occurred in the past is just prior to the current determination of the absence of the pain situation or from a past examination, especially with respect to outputting another operation.
Regarding claim 27, the limitation “another insertion support information different from the insertion support information is operating a shaft retention and a shortening operation” is unclear. It is unclear if the “another insertion support information” is an additional input/information or what the insertion support information is changed to.
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) 21-24, 27-28, and 30-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hane (US WO 2019/187025 A1 with pub. 10/06/2019; using US 2021/0048355 for Eng. Translation).
Regarding claim 21, Hane discloses an insertion support system (figures 1-2) comprising: a processor (100, figure 1 | processor [0077]) comprising hardware (see 100, figure 2 | interpreted the structure of 100 to be “hardware”), the processor being configured to: acquire latest status information indicating a current status of an endoscope (see 102, figures 1 or 21), and time-series status information indicating a past status of an endoscope relative to the current status of the endoscope (history of previous endoscope insertion…[0152]); determine presence or absence of a pain situation of a subject based on the latest status information and the time-series status information (presence/absence of damage such as a pain [0217] | 114, figures 1 or 21); and when the processor determines presence of the pain situation, output an operation for reducing a pain of the subject as insertion support information (feedback circuit 120…operates the driving mechanism [0238] | set the force and stress at a certain value or less…[0255]).
Regarding claim 22, Hane further discloses when the processor is further configured to determine absence of the pain situation (presence/absence of damage such as a pain [0217] | 114, figures 1 or 21), the processor acquires a pain situation that occurred in a past (relations between inputs and judgement results, based on experience [0220] | interpreted experience includes prior history of judged pain in the patient based on second sense-of-force information relating to the force or stress; [0168]-[0169]), and outputs another operation different from the operation for reducing the pain of the subject as the insertion support information (feedback circuit 120…operates the driving mechanism [0238] | set the force and stress at a certain value or less…[0255]).
Regarding claim 23, Hane further discloses when the processor determines presence of the pain situation (presence/absence of damage such as a pain [0217] | 114, figures 1 or 21), the processor is further configured to determine a kind of the pain (tear, breakage, or perforation [0217]) and changes the insertion support information based on the kind of the pain (feedback circuit 120…operates the driving mechanism [0238] | set the force and stress at a certain value or less…[0255]).
Regarding claim 24, Hane further discloses when the processor determines presence of the pain situation (presence/absence of damage such as a pain [0217] | 114, figures 1 or 21), the processor is further configured to determine a level of the pain (pressure equation [0159]; pressure…cause of…pain [0160]) and changes the insertion support information based on the level of the pain (feedback circuit 120…operates the driving mechanism [0238] | set the force and stress at a certain value or less…[0255] | the higher the level of pain, the more the force/stress would be changed to set the force/stress to a certain value or less).
Regarding claim 27, Hane further discloses the insertion support information (feedback circuit 120…operates the driving mechanism [0238]) is manual compression, repositioning of a body position of the subject, or a pull operation of the endoscope (motor-driven…automatic…[0236]), and another insertion support information (feedback circuit 120…operates the driving mechanism [0238] ) different from the insertion support information is operating a shaft retention and a shortening operation (changing…bend shape [0236]; Hane).
Regarding claim 28, Hane further discloses the processor is configured to: acquire the current status of the endoscope from an endoscopic image or shape information about an insertion section (see 102, figures 1 and 21); and acquire the time-series status information from past examination information (history of previous endoscope insertion…[0152]).
Regarding claim 30, Hane further discloses the processor determines the level of the pain based on a displacement amount of an endoscope insertion section (presence/absence of damage such as a pain…degree of the content of damage [0217] | shape and disposition information…sense-of-force information [0089] | sense-of-force information…magnitude of force [0090]; Hane).
Regarding claim 31, Hane further discloses the processor is configured to: acquire an endoscopic image (images…[0057]; Hane) and shape information about an insertion section (102, figures 1 and 21); determine a site at which an endoscope insertion section is located (occurrence location in the insertion section [0240]); when the processor determines that the endoscope insertion section is located at a predetermined site (history of previous endoscope insertion…fixed position…[0152]), determine a shape of the endoscope insertion section (shape and disposition information [0152]); when the shape is a predetermined shape (predetermined or patterned contact state…shape of the insertion section [0215]), determine a displacement amount of the endoscope insertion section (contact state…calculate the stress…second sense-of-force information [0214]); and classify the pain situation to output insertion support information based on a result of the classification (114, figures 1 and 21 | examined body influenced judgement unit 114…presence/absence of damage such as a pain [0217]).
Regarding claim 32, Hane further discloses the site is a sigmoid colon (sigmoid…[0054]; Hane).
Regarding claim 33, Hane further discloses the processor is configured to: determine whether the shape is an extended shape (mechanical characteristics…extension/contraction [0085]; Hane); and determine based on the displacement amount whether an extension has occurred (mechanical characteristics…first sense-of-force information [0089] | contact state…calculate the stress…second sense-of-force information [0154] and [0214]).
Regarding claim 34, Hane further discloses the processor is further configured to acquire at least one of endoscope kind information (106, figure 1; Hane), patient information (a history of…estimated from insertion path based on history [0152]), or past examination information (a history of previous endoscope insertion [0152]).
Regarding claim 35, Hane further discloses the processor is further configured to recognize the pain situation where a patient is suffering a pain (114…presence/absence of damage/pain…[0217]; Hane) when the processor recognizes a situation where a push up operation to a head side (crushed, extended, or pulled…pain [0168]) is performed near Sigmoid Descending colon Junction (SDJ) (SD-J…[0179]) by a torque operation (rotational direction [0064]) and an angle operation of the endoscope (bend direction [0064]).
Regarding claim 36, Hane further discloses the processor is further configured to recognize the pain situation where a patient is suffering a pain (114…presence/absence of damage/pain…[0217]) when the processor recognizes, based on endoscopy status information (see 102 and 104 and arrows to 114, figures 1 and 21), a situation where an operation is performed near SDJ with an 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 37, Hane further discloses the processor is further configured to recognize the pain situation where a patient is suffering a pain (114…presence/absence of damage/pain…[0217]) when the processor recognizes a situation where a distal end of an 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 38, Hane discloses an endoscope system, comprising: the insertion support system as defined in claim 21 (see claim 21 rejection above); and the endoscope (12, 14, figures 1 and 21).
Regarding claim 39, Hane discloses a method comprising: acquiring, by a processor (100, figure 1 | processor [0077]), latest status information indicating a current status of an endoscope (see 102, figures 1 or 21), and time-series status information indicating a past status of an endoscope relative to the current status of the endoscope (history of previous endoscope insertion…[0152]); determining, by the processor, presence or absence of a pain situation of a subject based on the latest status information and the time-series status information (presence/absence of damage such as a pain [0217] | 114, figures 1 or 21); and when a presence of the pain situation is determined, outputting, by the processor, an operation for reducing a pain of the subject as insertion support information (feedback circuit 120…operates the driving mechanism [0238] | set the force and stress at a certain value or less…[0255]).
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) 25 is rejected under 35 U.S.C. 103 as being unpatentable over Hane (US WO 2019/187025) as applied in claim 21 above, and further in view of Tezuka (US 2020/0093353) and Cohen (US 2019/0231259).
Regarding claim 25, Hane further discloses the processor determines presence of the pain situation (presence/absence of damage such as a pain [0217] | 114, figures 1 or 21), and the processor is further configured to acquire a pain situation that occurred in a past (relations between inputs and judgement results, based on experience [0220] | interpreted experience includes prior history of judged pain in the patient based on second sense-of-force information relating to the force or stress; [0168]-[0169]). Hane is silent regarding the processor is further configured to determine a frequency of the pain, when the frequency of the pain is high, based on the frequency of the pain and the pain situation that occurred in the past, outputs discontinuation of an examination as the insertion support information.
Tezuka teaches an insertion apparatus (10, figure 1) with an endoscope (20, figure 1) and a control device (80, figure 1). A state calculator (81, figure 2) calculates shape information of the flexible tube (35, figure 2) including the bendable section (33, figure 1). The shape information includes position information of the external force detector (60, figure 2 | [0060]), and the external force detector detects the force quantity of the external force in the clockwise and counterclockwise direction ([0062]). Force quantities include a force quantity against which a patient has made some pain complaints and has not been able to stand the pain and a force quantity against which the patient has made few pain complaints and has been able to stand the pain ([0084]). The force quantity against which a patient has made some pain complaints and has not been able to stand the pain is set as the reference value ([0084] | figure 6c).
Cohen teaches stopping the movement of an actuator when pain occurs during a treatment session ([0162]). A control circuitry (602, figure 6) is connected to a pain indicator (664, figure 6), which indicates the pain level ([0235]). If the pain level is higher than a pre-determined value, the control circuity stops the operation of the actuators ([0235]).
It would have been obvious to modify the system of Hane with the control device (80, figures 2 and 5b) as taught by Tezuka. Doing so would set the force quantity where the patient cannot stand the pain as the reference value ([0084]). Further, it would have been obvious to modify the system with the control circuity (602, figure 6) to use the pain level ([0235]) and compare it to a pre-determined value ([0235]) as taught by Cohen. Doing so would stop the actuator if the pain level is higher than a predetermined level ([0235]). The modified system would have the processor is further configured to determine a frequency of the pain (see force quantity where patient has not been able to stand the pain in figure 6c; Tezuka), when the frequency of the pain is high (pain level is higher [0235]; Cohen), based on the frequency of the pain and the pain situation that occurred in the past (see figure 6c; Tezuka | relations between inputs and judgement results, based on experience [0220]; Hane | interpreted experience includes prior history of judged pain in the patient based on second sense-of-force information relating to the force or stress; [0168]-[0169]), outputs discontinuation of an examination as the insertion support information (stop the operation of the actuators [0235]; Cohen).
Claim(s) 26 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Hane (US WO 2019/187025) as applied to claim 21 above, and further in view of Shelton (US 2019/0104919)
Regarding claim 26, Hane further discloses when the processor determines presence of the pain situation (presence/absence of damage such as a pain [0217] | 114, figures 1 or 21). Hane is silent regarding the processor is further configured to determine time when the pain occurred, and the processor is further configured to acquire a pain situation that occurred in a past and changes the insertion support information based on the time when the pain occurred and the pain situation that occurred in the past.
Shelton teaches a computer system for a surgical device (abstract) that utilizes data from different times (i.e., preoperatively, intraoperatively, postoperatively) to determine relationships and/or correlations ([0337]). The context of the data can be informed by situation awareness of a surgical hub during a surgical procedure, which can indicate actionable items, such as step-specific or timed adjustments for the clinician ([0337]).
It would have been obvious to modify the system of Hane with the computer system of Shelton to utilize data from different times (i.e., preoperatively; [0337]) for pain occurrence. Doing so would allow timed adjustments for the clinician ([0337]). The modified system would have the processor is further configured to determine time when the pain occurred (data from…different times; preoperatively [0337]; Shelton), and the processor is further configured to acquire a pain situation that occurred in a past (modified system can use data of a pain situation from prior to the operation) and changes the insertion support information based on the time when the pain occurred and the pain situation that occurred in the past (timed adjustments…[0337]; Shelton | feedback circuit 120…operates the driving mechanism [0238]; Hane | set the force and stress at a certain value or less…[0255]; Hane).
Regarding claim 29, Hane discloses all of the features in the current invention as shown above in claim 21. Hane is silent regarding the processor determines the pain situation by using a machine learning model.
Shelton further teaches a situational awareness system from a surgical hub can be configured to derive the contextual information from the data received from the data sources ([0307]). For example, the situational awareness system can have a machine learning system that has been trained on training data to correlate various inputs to corresponding contextual information regarding a surgical procedure ([0307]). The contextual information pertains to the surgical procedure and can include the type of surgical procedure being performed, the particular step of the surgical procedure that the surgeon is performing, the type of tissue being operated on, or the body cavity that is the subject of the procedure ([0306]). The machine learning system can further generate or retrieve one or more control adjustments for one or more modular devices when provided the contextual information as input ([0307]).
It would have been obvious to modify the system of Hane and Shelton to include the machine learning system in the situational awareness system as taught by Shelton ([0307]) for determining the pain situation. Doing so would derive the contextual information/pain situation and generate one or more control adjustments ([0307]). The modified system would have the processor determines the pain situation (presence/absence of damage such as a pain [0217]; Hane | the contextual information [0307]; Shelton) by using a machine learning model (machine learning system [0307]; Shelton).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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
August 22, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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