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 and 3-24 are pending, claim 2 has been cancelled, and claims 1 and 3-24 are currently under consideration for patentability under 37 CFR 1.104. Previous 35 USC 112 Rejections have been withdrawn in light of Applicant’s amendments.
Response to Arguments
Applicant's arguments filed 12/05/2025 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that “Applicant respectfully disagrees…Fukatsu does not specify, for these time periods, which part of the endoscope passages through a splenic flexure in the intestinal tract or a hepatic flexure in the intestinal tract…as a result, Fukatsu fails to disclose the feature “wherein the event includes that the distal end of the endoscope reaches a specific site in a subject” recited in currently amended claim 1” (pg. 13 of Remarks), the Examiner respectfully disagrees. Fukatsu discloses the time-period-of-attention information ADB includes a time period when operation related to passage through a splenic flexure in the intestinal track was performed ([0143]). Fukatsu further discloses that the insertion operation for the insertion section at a passage time for a site ([0116]), like a sigmoid colon, includes whether the distal end portion has completed passage through the site ([0132]). Therefore, Fukatsu does disclose the event includes that the distal end of the endoscope reaches a specific site in a subject ([0132] and [0143]).
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 21-22 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 claims 21-22, the limitation “the member….includes at least one of the first member or the second member” is unclear. It is unclear if the first or the second members are considered a separate feature or a part of the member. Further, it is unclear if the member is made from metal, or if it is the first and second members that are made from metal and included in the member. The Examiner suggests amending these claims to use a first member (for the member), a second member (for the first member), and a third member (for the second member) to clarify each of these as separate features.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 8-13, 15-17, and 24 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fukatsu (US 2022/0361733).
Regarding claim 1, Fukatsu discloses a processing device (20, figures 1-2) comprising: a processor (270, figure 2) configured to acquire a distance (312…obtain an analysis result…an insertion length of the insertion section [0078]) from a reference position (410, figure 2) on a movement path of an endoscope to a distal end of the endoscope that is moved along the movement path (insertion length…inserted into the intestinal tract [0078] | interpreted the length is determined relative to a proximal portion of an endoscope not in the intestinal tract), acquire an elapsed time from a start of an examination using the endoscope (time series information…[0141]), acquire event information (ADB, figure 12) that is information on an event related to the examination in a case where the event has occurred (ADB…dangerous operation or special operation [0142]), and perform control to store the distance, the elapsed time, and the event information in association with each other (outputted from the procedure evaluating unit 274…[0140] | recording unit 273…an endoscopic examination information…and the like during the examination [0070]), the event includes that the distal end of the endoscope reaches a specific site in a subject (distal end portion…passage through [0132]; time period when operation related to passage through…splenic flexure…hepatic flexure [0143]).
Regarding claim 8, Fukatsu further discloses the event includes that an operator of the endoscope performs a specific operation (special operation [0142] | operation for…[0143]).
Regarding claim 9, Fukatsu further discloses the specific operation of the operator includes manual compression (operation…shaft shortening [0143] | interpreted shaft shortening as compression performed by the operator).
Regarding claim 10, Fukatsu further discloses the processor is configured to receive correction of at least one of the stored elapsed time or the stored event information (S4, figure 6; input apparatus 50…processing of the loop [0114]).
Regarding claim 11, Fukatsu further discloses the processor is configured to acquire, from a memory (recording unit 273…an endoscopic examination information…and the like during the examination [0070]), reference data indicating at least a relationship between the elapsed time and the distance stored in the memory before a start of the examination (time series information [0142]; figure 12 | see start of graph in figure 12), display the reference data on a display device (60, figure 12), and display the elapsed time and the distance acquired after the start of the examination in association with the reference data on the display device (figure 12 | temporal change of one evaluation indicator…[0142]; evaluation indicator…insertion length [0078]).
Regarding claim 12, Fukatsu further discloses the reference data is data indicating a relationship among the distance, the elapsed time, and the event information (see graph DGB in figure 12).
Regarding claim 13, Fukatsu further discloses the processor is configured to, in a case where a specific event (ADB, figure 12) related to the examination occurs in the examination, start to display the distance with an occurrence timing (see shading for ADB, figure 12) of the event in the reference data (see figure 12) as a starting point (broadly interpreted as a visual marker for ADB, figure 12).
Regarding claim 15, Fukatsu further discloses a magnetic pattern is formed on an insertion part of the endoscope along a longitudinal direction of the insertion part (see 18 along 11, figure 1), and the processor is configured to acquire the distance (insertion length [0078]) based on a magnetic field (magnetic field…[0034]) from the magnetic pattern, which is detected by a magnetic detector (410, figure 2; 40, figure 1) provided outside a subject to which the endoscope is inserted (see 40, figures 1-2).
Regarding claim 16, Fukatsu further discloses the reference position is a position of the magnetic detector (see 410, figure 2).
Regarding claim 17, Fukatsu discloses an endoscope device comprising: the processing device according to claim 1 (see rejection for claim 1 above); and the endoscope (10, figure 1).
Regarding claim 24, Fukatsu discloses a processing method comprising: acquiring a distance (312…obtain an analysis result…an insertion length of the insertion section [0078]) from a reference position (410, figure 2) on a movement path of an endoscope (10, figure 1) to a distal end of the endoscope that is moved along the movement path (insertion length…inserted into the intestinal tract [0078] | interpreted the length is determined relative to a proximal portion of an endoscope not in the intestinal tract); acquiring an elapsed time of an examination using the endoscope (time series information…[0141]); acquiring event information (ADB, figure 12) that is information on an event related to the examination in a case where the event has occurred (ADB…dangerous operation or special operation [0142]); and storing the distance, the elapsed time, and the event information in association with each other (outputted from the procedure evaluating unit 274…[0140] | recording unit 273…an endoscopic examination information…and the like during the examination [0070]), wherein the event includes that the distal end of the endoscope reaches a specific site in a subject (distal end portion…passage through [0132]; time period when operation related to passage through…splenic flexure…hepatic flexure [0143]).
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) 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over Fukatsu (US 2022/0361733) as applied to claims 1 above, in view of Makrinich (US 2021/0313052).
Regarding claim 3, Fukatsu discloses all of the features in the current invention as shown above in claim 1. Fukatsu is silent regarding the event includes that a specific operation of the endoscope is performed.
Makrinich teaches an interface (1800, figure 18) having a timeline (1815, figure 18) with one or more markers (1811, 1813, and 1817, figure 18). The markers may correspond to surgical events, decision points, or other points of interest ([0281]). The surgical events may be identified using received video frames, such as through image recognition algorithms ([0052]). Further a surgical event may be related to surgical action ([0090]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the device to acquire/detect surgical events, decision points, or other points of interest as taught by Makrinich ([0281]). Doing so would identify features of one or more frames of the video footage ([0052]). The modified device would have the event includes that a specific operation of the endoscope is performed (surgical action [0090]; Makrinich).
Regarding claim 4, Makrinich further teaches the specific operation includes an operation of a treatment tool of the endoscope (surgical action…incision procedure [0090]; Makrinich).
Regarding claim 5, Makrinish further teaches the specific operation includes a rotation operation of the endoscope (surgical action [0090]; endoscope [0298]; Makrinich | rotation of the endoscope can be a specific operation).
Regarding claim 6, Fukatsu discloses all of the features in the current invention as shown above in claim 1. Fukatsu is silent regarding the event includes that a lesion region is detected.
Makrinich teaches an interface (1800, figure 18) having a timeline (1815, figure 18) with one or more markers (1811, 1813, and 1817, figure 18). The markers may correspond to surgical events, decision points, or other points of interest ([0281]). The surgical events may be identified using received video frames, such as through image recognition algorithms ([0052]). Further a surgical event may be related to surgical action ([0090]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the device to acquire/detect surgical events, decision points, or other points of interest as taught by Makrinich ([0281]). Doing so would identify features of one or more frames of the video footage ([0052]). The modified device would have the event includes that a lesion region is detected (image recognition algorithm [0052]; Makrinich | a lesion can be recognized).
Regarding claim 7, Fukatsu discloses all of the features in the current invention as shown above in claim 1. Fukatsu is silent regarding the processor is configured to acquire a captured image captured by the endoscope, and detect occurrence of the event based on the captured image.
Makrinich teaches an interface (1800, figure 18) having a timeline (1815, figure 18) with one or more markers (1811, 1813, and 1817, figure 18). The markers may correspond to surgical events, decision points, or other points of interest ([0281]). The surgical events may be identified using received video frames, such as through image recognition algorithms ([0052]). Further a surgical event may be related to surgical action ([0090]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the device to acquire/detect surgical events, decision points, or other points of interest as taught by Makrinich ([0281]). Doing so would identify features of one or more frames of the video footage ([0052]). The modified device would have the processor is configured to acquire a captured image captured by the endoscope (received video frames [0052]; Makrinich), and detect occurrence of the event based on the captured image (identify surgical events…image recognition algorithm [0052]; Makrinich).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Fukatsu (US 2022/0361733) as applied to claim 1 above, and further in view of Shelton (US 2019/0200844).
Fukatsu discloses all of the features in the current invention as shown above in claim 1. Fukatsu is silent regarding the processor is configured to generate information indicating statistical correspondence between the event information and the distance based on data of the distance and the event information for each elapsed time from a start of the examination using the endoscope acquired in each of a plurality of times of the examination.
Shelton teaches a control circuit that can aggregate data in comparison groups of types of data, where a first type of data can be stored in association with a second type (or third) of data ([0963]). This allows the data aggregated into comparison groups to be utilized for studies, stored into lookup tables/arrays ([0963]).
It would have been obvious to modify the processor to be able to aggregate data in comparisons groups of types of data as taught by Shelton ([0963]). Doing so would provide data that can be queried and used for studies ([0963]). The modified device would have the processor is configured to generate information indicating statistical correspondence between the event information and the distance based on data of the distance and the event information for each elapsed time (first type of data….more than two different types of data can be aggregated [0963]; Shelton) from a start of the examination using the endoscope acquired in each of a plurality of times of the examination (automatically aggregating and storing the data…[0963]).
Claim(s) 18-21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Fukatsu (US 2022/0361733) as applied to claim 17 above, and further in view of Kubokawa (US 5,035,231).
Regarding claim 18, Fukatsu further discloses a magnetic detector (410, figure 2) arranged on the movement path (the magnetic detector is interpreted to be on the movement path as it detects the magnetic fields from the source coils 18, which move; see figure 1), wherein an insertion part (11, figure 1) of the endoscope, which extends in a longitudinal direction of the insertion part and has a magnetic pattern integrally formed along the longitudinal direction (see 18 extends along 11, figure 1), the magnetic detector detects a magnetic field (magnetic field…[0034]), and the processor is configured to derive the distance based on the magnetic field detected by the magnetic detector (insertion length [0078]). Fukatsu is silent regarding the insertion part has a member containing metal, the magnetic detector detects the magnetic field from the member.
Kubokawa teaches an endoscope (1, figure 1) with a flexible part (8, figure 2). The flexible part has a net tube (16, figure 2) with a spiral tube (33, figure 2) formed of austenitic stainless steel to be paramagnetic to have operation unobstructed (Col. 10, lines 15-29). The flexible part is coated with an outer coating (15, figure 2), such as a synthetic resin. The endoscope has an antenna (65, figure 1) that is coated on the outer surface with an insulating material (Col. 9, lines 11-12).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the endoscope device of Fukatsu to have a flexible part (8, figure 2) with a net tube (16, figure 2) and spiral tube (33, figure 2) formed of austenitic stainless steel and an outer coating (15, figure 2) as taught by Kubokawa (Col. 10, lines 15-29). Doing so would provide a flexible part that is paramagnetic and not obstruct operation of the endoscope device (Col. 10, lines 15-29). Further, it would have been obvious to modify the outer coating (15, figure 2) to be made of insulating material (Col. 9, lines 11-12) as taught by Kubokawa. Doing so would insulate the endoscope device due to the magnetic field created from within the endoscope device (Col. 9, lines 11-12). The modified device would have the insertion part has a member (16 or 33, figure 2; Kubokawa) containing metal (stainless steel; Col. 10, lines 15-29), the magnetic detector detects the magnetic field (magnetic field…[0034]; Fukatsu) from the member (the modified device would have either 16 or 33, figure 2 of Kubokawa have the source coils 18, figure 1 of Fukatsu).
Regarding claim 19, Fukatsu and Kubokawa further disclose the insertion part includes a soft portion of the endoscope (see 14, figure 1; Fukatsu | 8, figure 2; Kubokawa).
Regarding claim 20, Kubokawa further teaches the soft portion has a member (15, figure 2; Kubokawa), which is cylindrical, having an insulating property (modified device would have the member be made of insulating material; Col. 9, lines 11-12; Kubokawa), a first member (16, figure 2; Kubokawa), which is cylindrical, containing metal and being inserted into the member (Col. 10, lines 15-29), and a second member (33, figure 2; Kubokawa), which is cylindrical, containing metal and being inserted into the first member (Col. 10, lines 15-29), and the member containing metal includes at least one of the first member or the second member (see 112b rejection above | Col. 10, lines 15-29).
Regarding claim 21, Fukatsu further discloses a magnetic detector (410, figure 2; Fukatsu) arranged on the movement path (the magnetic detector is interpreted to be on the movement path as it detects the magnetic fields from the source coils 18, which move; see figure 1), wherein an insertion part of the endoscope (11, figure 1), which extends in a longitudinal direction of the insertion part and has a magnetic pattern formed along the longitudinal direction (see 18 extends along 11, figure 1), the magnetic detector detects a magnetic field (magnetic field…[0034]), the processor is configured to derive the distance based on the magnetic field detected by the magnetic detector (insertion length [0078]). Fukatsu is silent regarding the insertion part of the endoscope has a member containing metal, the magnetic detector detects the magnetic field from the member, the insertion part has a member, which is cylindrical, having an insulating property, a first member, which is cylindrical, containing metal and being inserted into the member, and a second member, which is cylindrical, containing metal and being inserted into the first member, the member containing metal includes at least one of the first member or the second member, the first member is a net body, and the second member is a spiral tube.
Kubokawa teaches an endoscope (1, figure 1) with a flexible part (8, figure 2). The flexible part has a net tube (16, figure 2) with a spiral tube (33, figure 2) formed of austenitic stainless steel to be paramagnetic to have operation unobstructed (Col. 10, lines 15-29). The flexible part is coated with an outer coating (15, figure 2), such as a synthetic resin. The endoscope has an antenna (65, figure 1) that is coated on the outer surface with an insulating material (Col. 9, lines 11-12).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the endoscope device of Fukatsu to have a flexible part (8, figure 2) with a net tube (16, figure 2) and spiral tube (33, figure 2) formed of austenitic stainless steel and an outer coating (15, figure 2) as taught by Kubokawa (Col. 10, lines 15-29). Doing so would provide a flexible part that is paramagnetic and not obstruct operation of the endoscope device (Col. 10, lines 15-29). Further, it would have been obvious to modify the outer coating (15, figure 2) to be made of insulating material (Col. 9, lines 11-12) as taught by Kubokawa. Doing so would insulate the endoscope device due to the magnetic field created from within the endoscope device (Col. 9, lines 11-12). The modified device would have the insertion part of the endoscope has a member (16 or 33, figure 2; Kubokawa) containing metal (stainless steel; Col. 10, lines 15-29), the magnetic detector detects the magnetic field (magnetic field…[0034]; Fukatsu) from the member (the modified device would have either 16 or 33, figure 2 of Kubokawa have the source coils 18, figure 1 of Fukatsu), the insertion part has a member (15, figure 2; Kubokawa), which is cylindrical, having an insulating property (modified device would have the cylindrical member be made of insulating material; Col. 9, lines 11-12; Kubokawa), a first member (16, figure 2; Kubokawa), which is cylindrical, containing metal (stainless steel; Col. 10, lines 15-29) and being inserted into the member (see figure 2), and a second member (33, figure 2; Kubokawa), which is cylindrical, containing metal (stainless steel; Col. 10, lines 15-29) and being inserted into the first member (see figure 2), the member containing metal (see 112b rejection above | stainless steel; Col. 10, lines 15-29) includes at least one of the first member or the second member (16 or 33, figure 2; Kubokawa), the first member is a net body (net tube 16, figure 2), and the second member is a spiral tube (spiral tube 33, figure 2).
Regarding claim 23, Fukatsu further discloses the magnetic detector detects a first magnetic flux density in a first direction and a second magnetic flux density in a second direction intersecting the first direction (three-dimensionally detecting magnetic fields emitting from the respective plurality of source coils [0083] | interpreted the source coils to produce magnetic fields in three dimensions, where there magnetic flux density can intersect in different directions), at a plurality of positions along the longitudinal direction of the member containing metal (the source coils 18, see figure 1; Fukatsu).
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Fukatsu (US 2022/0361733) and Kubokawa (US 5,035,231) as applied to claim 20 above, and further in view of Isaacson (US 2017/0347913).
Regarding claim 22, Kubokawa further teaches at least one of the first member or the second member is made from austenitic stainless steel (austenitic stainless steel; Col. 10, lines 15-29). Fukatsu and Kubokawa are silent regarding at least one of the first member or the second member is made from magnetizable austenitic stainless steel.
Isaacson teaches a medical device with a plurality of spaced magnetic regions (abstract). Austenitic stainless steel is a common material that is used to make invasive medical devices ([0054]). Austenitic stainless steel can be made to be magnetic by modifying a portion of its microstructure through martensitic stress induced transformation ([0055]). This can improve magnetic location sensing ([0061]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the device to use magnetizable austenitic stainless steel for the first or second member as taught by Isaacson ([0055]). Doing so would improve magnetic location sensing ([0061]).
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 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
March 18, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795