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 1-16 are pending and are currently under consideration for patentability under 37 CFR 1.104.
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.
Claim 15 is 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. Claim 15 recites “the first member is a spiral tube, and the second member is a net body”. However, in [0025], the specification describes a first member composed of a cylindrical-shaped net body and a second member composed of a spiral tube. Claim 15 recites the opposite or reverse of what is described in the specification. Therefore, claim 15 fails to comply with the written description requirement.
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 1-16 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 1, the limitation “the member containing metal includes at least one of the first member or the second member” is unclear. Claim 1 previously recites “a cylindrical fist member that contains metal…a cylindrical second member that contains metal”. It is unclear 1) what feature “the member” is referring to, and 2) whether the first and/or second member contains metal. Claims 2-16 are rejected for being dependent on claim 1.
Regarding claim 13, the limitation “wherein a magnetic pattern is formed…by a magnetic detector provided outside a subject” is unclear. The features in this limitation were previously recited in claim 1. It is unclear if additional features are being recited in claim 13.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kamon (US 2020/0008653), in view of Fukatsu (US 2022/0361733) and Kubokawa (US 5,035,231).
Regarding claim 1, Kamon discloses an endoscope device (figure 1) comprising: an endoscope (12, figure 1); a processing device (16, figure 1) comprising a processor (a processor device 16 [0049]) configured to: acquire a distance from a reference position (MP, figure 6 | or reference structure [0113]) on a movement path of the endoscope to a distal end of the endoscope that is moved along the movement path (acquire an insertion length…[0079]); acquire, from a memory (position information…stored in the storage unit [0108]), target position information indicating a target position on the movement path (position information of the ROI [0100]); and perform control of giving a notification based on the distance and the target position information (position information of the ROI…displayed [0100] | warning unit 83….distal end portion 21 is close to the ROI [0093] | distance information indicating the distance from a reference structure…displayed [0113]). Kamon further discloses a graduation detection sensor (72, figure 6) that detects the measuring graduations (71, figure 6) of the insertion length to acquire the insertion length of the endoscope ([0097]), alternatively, a magnetic sensor may be provided to acquire a detection position of the distal end portion of the endoscope ([0081]). Kamon is silent regarding a magnetic detector disposed on the movement path, wherein an insertion part of the endoscope has a member containing metal, which extends in a longitudinal direction and has a magnetic pattern integrally formed along the longitudinal direction, the magnetic detector detects a magnetic field from the member, the processor is configured to derive the distance based on the magnetic field detected by the magnetic detector, the insertion part includes a soft portion of the endoscope, the soft portion has a cylindrical member having an insulating property, a cylindrical first member that contains metal and is inserted into the cylindrical member, and a cylindrical second member that contains metal and is inserted into the first member, and the member containing metal includes at least one of the first member or the second member.
Fukatsu teaches an endoscope system (1, figure 1) with an endoscope (10, figure 1), a main body apparatus (20, figure 1), and an insertion shape observing apparatus (40, figure 1). The endoscope has source coils (18, figure 2) provided in the insertion section ([0039]). The insertion shape observing apparatus (40, figure 2) detects magnetic fields emitted from the respective source coils and acquire positions of the respective plurality of source coils based on intensity of the detected magnetic fields ([0039]). Specifically, the reception antenna (410, figure 2) includes a plurality of coils for three-dimensionally detecting magnetic fields emitted from the plurality of source coils (18, figure 2 | [0083]). The insertion shape observing apparatus is configured to detect an insertion position of the insertion section inserted into the subject and acquire insertion position information and output the acquired insertion position information to the main body apparatus ([0039]).
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 synthetic resin. The endoscope has an antenna (65, figure 1) that is coated on an outer surface with an insulating material (Col. 9, lines 11-12).
It would have been obvious to modify the endoscope device to have source coils (18, figure 2) provided in the insertion section of the endoscope and an insertion shape observing apparatus (40, figure 2) as taught by Fukatsu. Doing so would provide an alternative method of determining the insertion position of the insertion section using magnetic fields ([0083]). Also, it would have been obvious to modify the endoscope device to have a flexible part (8, figure 2) with a net tube (16, figure 2) and a spiral tube (33, figure 2) formed of austenitic stainless steel and an outer coating (15, figure 2) made of insulating material as taught by Kubokawa (Col. 10, lines 15-29 | Col. 9, lines 11-12). Doing so would provide a flexible part that is paramagnetic and not obstruct operation of the endoscope device (Col. 10, lines 15-29), and insulate the endoscope device due to the magnetic field created from within the endoscope device (Col. 9, lines 11-12). The modified endoscope device would have a magnetic detector (410, figure 2; Fukatsu) disposed 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 of Fukatsu), wherein an insertion part of the endoscope (12a, figure 1; Kamon) has a member (16 or 33, figure 2 | Kubokawa) containing metal (stainless steel; Col. 10, lines 15-29 | Kubokawa), which extends in a longitudinal direction and has a magnetic pattern integrally formed along the longitudinal direction (plurality of source coils 18…provided on insides…at a predetermined interval in a longitudinal direction [0034]; Fukatsu), the magnetic detector detects (detecting magnetic fields [0083]; Fukatsu) a magnetic field from the member (generate a magnetic field [0034]; Fukatsu), the processor is configured to derive the distance based on the magnetic field detected by the magnetic detector (acquire insertion position information…[0039]; Fukatsu), the insertion part includes a soft portion of the endoscope (bending portion 22, figure 1; Kamon), the soft portion has a cylindrical member having an insulating property (15, figure 2; modified device would have the cylindrical member be made of insulating material; Col. 9, lines 11-12; Kubokawa), a cylindrical first member (16, figure 2; Kubokawa) that contains metal and is inserted into the cylindrical member (Col. 10, lines 15-29), and a cylindrical second member (33, figure 2; Kubokawa) that contains metal and is 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 2, Kamon further discloses the target position information includes information on the distance (position information of the ROI [0108]; Kamon) acquired in a state where, in a past examination performed using an endoscope (used at an endoscopic diagnosis in another facility [0108]), the endoscope images a region-of-interest in a subject under the past examination (re-search for the ROI in the other facility…[0108]).
Regarding claim 3, Kamon further discloses the reference position is a position of an ending point of the movement path (reference structure…input through the instruction input unit [0113]; Kamon | the reference structure can be an ending point of the movement path), and the target position information is acquired (position information of the ROI [0100]) in a period in which the endoscope is moved from the position of the ending point toward a starting point of the movement path in the past examination (re-searching for a ROI during a backward-direction observation [0100]).
Regarding claim 4, Kamon further discloses the processor is configured to: store the distance acquired in a first period in which the endoscope is moving from a starting point to an ending point of the movement path and in a state in which the endoscope is imaging a region-of-interest in a subject (position information of the ROI [0100]), in the memory as the target position information (position information…stored in the storage unit 85 [0108]); and perform the control in a second period in which the endoscope is moving from the ending point to the starting point of the movement path (warning unit 83….distal end portion 21 is close to the ROI [0093] | re-searching for a ROI during a backward-direction observation [0100]).
Regarding claim 5, Kamon further discloses the processor is configured to perform a control of giving a notification based on the distance acquired in the second period and a predetermined range of the movement path including the target position information (warning unit 83….distal end portion 21 is close to the ROI [0093]; Kamon | distance is smaller than or equal to a threshold value [0093]).
Regarding claim 6, Kamon further discloses the processor is configured to perform a control of giving a notification of a presence of a region to be noticed in a subject into which the endoscope is inserted, based on the distance and the target position information (warning unit 83….distal end portion 21 is close to the ROI [0093]; Kamon | distance is smaller than or equal to a threshold value [0093]).
Regarding claim 7, Kamon further discloses the processor is configured to: perform detection processing of acquiring an image captured by the endoscope and detecting a region to be noticed in the subject based on the image (see figure 8 | ROI in a lumen…[0083]; Kamon); and perform the control based on a result of the detection processing, the distance, and the target position information (warning unit…calculates the distance...threshold value [0093] | warning unit…display mode of a warning is changed…discrimination result indicating a lesion portion [0094]).
Regarding claim 8, Kamon further discloses the processor is configured to determine a movement direction of the endoscope (insertion state L [0091]; Kamon | see figure 11) and perform the control based on the distance, the target position information, and the movement direction of the endoscope (re-searching for a ROI…backward-direction [0100] | warning unit 83….distal end portion 21 is close to the ROI [0093]; Kamon | distance is smaller than or equal to a threshold value [0093]).
Regarding claim 9, Kamon further discloses the processor is configured to, in a case where the movement direction is a direction from an ending point to a starting point of the movement path (re-searching for a ROI…backward-direction [0100]; Kamon), perform a control of giving a notification based on the distance and the target position information (warning unit 83….distal end portion 21 is close to the ROI [0093]; Kamon | distance is smaller than or equal to a threshold value [0093]).
Regarding claim 10, Kamon further discloses the processor is configured to determine the movement direction based on a time change of the distance (insertion state acquisition unit 70…moved forward and backward…every time an insertion length… is measured [0080]; Kamon).
Regarding claim 11, Kamon further discloses the processor is configured to perform a control of giving a notification of information related to an end of an examination using the endoscope based on the distance and the target position information (distance….ROI…displayed [0114]; Kamon | the display of the distance can indicate the end of an examination).
Regarding claim 12, Kamon further discloses the processor is configured to: perform detection processing of acquiring an image captured by the endoscope and detecting a region to be noticed in a subject based on the image (see figure 8 | ROI in a lumen…[0083]; Kamon); and change a content of the notification of information in a case where the region is detected by the detection processing after the control is performed (warning unit…calculates the distance...threshold value [0093] | warning unit…display mode of a warning is changed…discrimination result indicating a lesion portion [0094]).
Regarding claim 13, Fukatsu further teaches a magnetic pattern is formed along a longitudinal direction on an insertion part of the endoscope (source coils 18, figure 1 | source coils 18…provided on insides…at a predetermined interval in a longitudinal direction [0034]; Fukatsu), and the processor is configured to acquire the distance based on a magnetic field from the magnetic pattern (acquire insertion position information…[0039]; Fukatsu), which is detected by a magnetic detector (410, figure 2; Fukatsu) provided outside a subject to which the endoscope is inserted (see figure 2).
Regarding claim 14, Kubokawa further teaches at least one of the first member or the second member is made from magnetizable austenitic stainless steel (austenitic stainless steel….magnetic material; Col. 10, lines 15-29 | Kubokawa).
Regarding claim 15, Kubokawa further teaches the first member is a spiral tube (see 112a rejection above | net tube 16, figure 2, where the net can be made of material that spirals around the device), and the second member is a net body (see 112a rejection above | spiral tube 33, figure 2, where the spiral tube can be made to net or woven around the device).
Regarding claim 16, Fukatsu further teaches 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]; Fukatsu | interpreted the source coils to produce magnetic fields in 3D, where the magnetic flux density can intersect in different directions), at a plurality of positions along the longitudinal direction of the member containing metal (see 18, figure 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Shelton (US 2022/0331047) detects a risk event, such as a tumor, when within a threshold distance ([0536]); Takahashi (US 2017/0367559) performs notification regarding the abnormality occurrence location when the position of the abnormality occurrence location is within the region of the visual field.
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
July 10, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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