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 .
Acknowledgement of Amendment
The following office action is in response to the applicant’s amendment filed on 07/24/2026. Claims 1-28 and 30-32 are pending. Claims 1-28 and 30-31 are amended. Claim 29 is canceled. Claim 32 is newly added. Claims 1-24, 27-28 and 30-32 are rejected under 35 U.S.C. 103 for the reasons stated in the Response to Arguments and 35 U.S.C. 103 sections below. Claims 25-26 are objected to as being dependent from a rejected claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments, see Remarks page 14, filed 07/24/2026, with respect to the objections to the specification have been fully considered and are persuasive. The objections to the specification in the non-final rejection of 04/30/2026 have been withdrawn.
Applicant’s arguments, see Remarks page 14-18, filed 07/24/2026, with respect to the rejection of the claims under 35 U.S.C. 102 have been fully considered and are mostly persuasive.
Regarding claim 1, as amended, it is directed to an ultrasound endoscope that includes a medical assistance apparatus comprising a processor together with an ultrasound probe, and further recites that the target site of observation is a lesion and that the processor displays a range corresponding to the lesion and a range corresponding to a pancreas. Claims 30 and 31 have been amended correspondingly, each within its own statutory class.
Claim 1, as amended, recites inter alia: ...an ultrasound probe that, when inserted into a body, emits an ultrasonic wave inside the body and receives a reflected wave of the ultrasonic wave...the target site of observation is a lesion, ... the processor is configured to display, on the screen, a range corresponding to the lesion and a range corresponding to a pancreas...
The Applicant argues that Imai does not describe an ultrasound probe that is inserted into a body. Imai describes an ultrasound diagnostic apparatus 1 whose ultrasound probe 21 "is operated by the user to be brought into contact with a body surface of the subject" (Imai at [0059]). A probe brought into contact with a body surface is applied from outside the body, and is not a probe that, when inserted into a body, emits an ultrasonic wave inside the body. The Office Action recognizes this in relying on Endo, rather than on Imai, for the ultrasound endoscope of original claim 29 and for the endoscopic ultrasound image of claim 28.
The examiner acknowledges that Imai describes an ultrasound diagnostic apparatus 1 whose ultrasound probe 21 is “operated by the user to be brought into contact with a body surface of the subject” (See [0059]). This is different than a probe which is inserted into the body prior to emitting ultrasonic waves. The examiner recognizes that Endo teaches an ultrasound endoscope.
Furthermore, the Applicant argues that Imai also does not describe displaying a range corresponding to a pancreas. Imai names as measurement targets a gallbladder Al, A2, a portal vein A3, and a kidney (Imai at [0049], [0062], and [0075], and FIGS. 4 and 5). A pancreas appears nowhere in Imai, and Imai accordingly does not describe a processor configured to display, on a screen, a range corresponding to a pancreas in addition to a range corresponding to the lesion whose size is measured. The pancreas is an anatomical structure separate from the lesion, and amended claim 1 requires the processor to identify and display a range corresponding to it. Both what is displayed and the information conveyed to the user therefore differ from what Imai describes.
The examiner respectfully recognizes that Imai does not describe displaying a range corresponding to a pancreas because a pancreas is not mentioned in Imai at all. Accordingly, Imai does not describe that a processor is configured to display a range corresponding to a pancreas in addition to a range corresponding to the lesion whose size is measured.
Separately, and independently of the amendments, Imai does not describe the
predetermined condition recited in claim 1. Claim 1 requires that the predetermined condition "includes a condition stipulating that a length of the target site of observation is equal to or greater than a reference value." The Office Action reasons that, in order for the measurement result panel PR to show the major axis and minor axis measurements of the gallbladder, the target site of observation must satisfy such a condition, "i.e. corresponding to the length of the measurement lines between the calipers CIA, CIB and C2A, C2B." That reasoning takes the measured length itself to be the reference value, so that the recited condition would be met by every ultrasound image in which any measurement is displayed. A condition satisfied in every case is not a condition, and reading the limitation in that way reads it out of the claim. Imai measures and displays whatever length its measurement algorithm returns for the recognized measurement target (Imai at 1 [0062] and [0065]); it does not compare a length of a measurement target to a reference value, and it does not use any such comparison to determine which of the ultrasound images in a time series are displayed. For this additional reason, Imai does not anticipate claim 1.
For at least the foregoing reasons, Imai does not describe each and every element of amended claim 1 arranged as in the claim, and the rejection of claim 1 under 35 U.S.C. § 102(a)(1) is respectfully traversed. Independent claims 30 and 31 recite corresponding limitations and are patentable over Imai for the same reasons.
The examiner acknowledges that Imai does not describe the predetermined condition recited in claim 1, which includes a condition stipulating that a length of the target site of observation is equal to or greater than a reference value. The examiner agrees that Imai measures and displays whatever length its measurement algorithm returns for the recognized measurement target (see [0062] and [0065]), therefore it does not compare a length of a measurement target to a reference value. Additionally, it does not use any such comparison to determine which of the ultrasound images in a time series is displayed.
Thus, the examiner agrees that Imai does not describe each and every element of amended claim 1. Additionally, since amended claims 30 and 31 recite similar features to that of claim 1, they are subject to the same reasoning.
Thus, the rejection of claims 1, 30 and 31 under 35 U.S.C. 102 in the non-final rejection of 04/30/2026 have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Endo et al. US 2021/0007709 A1 “Endo” and Uchihara et al. US 2021/0369238 A1 “Uchihara” as discussed in the 35 U.S.C. 103 section below.
Regarding claims 2-6, 8-9, 11-22, and 27, the examiner acknowledges that each depend from claim 1 and include all of its limitations, thus, they are subject to the reasoning provided therein. Therefore, these claims are subject to the new ground(s) of rejection made in view of Endo et al. US 2021/0007709 A1 “Endo” and Uchihara et al. US 2021/0369238 A1 “Uchihara” as discussed in the 35 U.S.C. 103 section below.
Regarding claims 13-16, the Applicant argues that these claims are patentable over Imai for a further reason. Claim 13 requires that "the second size is a size of the target site of observation shown in a second ultrasound image different from the first ultrasound image among the plurality of ultrasound images." The Office Action identifies the second size as "either the major axis or the minor axis" shown in the measurement result panel PR of FIG. 4. The major axis of 5.6 cm and the minor axis of 3.1 cm are both measured in the same ultrasound image U1 of FIG. 4 (Imai at [0062] and [0065]). Two measurements taken in a single image cannot be both a first size shown in a first ultrasound image and a second size shown in a second ultrasound image different from the first. Claims 14 to 16 depend from claim 13 and are patentable for at least the same reason.
The examiner acknowledges that claim 13 requires the second size to be a size of the target site of observation shown in a second ultrasound image different from the first ultrasound image among the plurality of ultrasound images. The examiner recognizes that two measurements taken in a single image cannot be both a first size shown in a first ultrasound image and a second size shown in a second ultrasound image different from the first.
Therefore, claims 13-16 are subject to the new ground(s) of rejection made in view of Endo et al. US 2021/0007709 A1 “Endo” and Uchihara et al. US 2021/0369238 A1 “Uchihara” as discussed in the 35 U.S.C. 103 section below.
Regarding claims 9, 11, and 12, are patentable over Imai for a further reason. Claim 9 requires a timespan "defined with respect to a selected ultrasound image that is selected from the plurality of ultrasound images according to a given first instruction." Imai saves the ultrasound images of all frames captured in a determined time from the present frame (Imai at [0112]), so the set of frames made available is defined with respect to the present frame rather than with respect to any image a user has selected. The flag mark F1 marks the position of the optimum image on the display bar B (Imai at [0116]); it does not define the extent of that set. Claim 12 further requires that "the length of the timespan is defined according to a given second instruction." The Office Action supports this limitation by observing that the display bar B "extends right and left along a lateral direction D." The physical extent of a bar on a display is not an instruction, and Imai does not describe any instruction by which a user sets the length of the timespan.
The examiner acknowledges that claim 9 requires a timespan “defining with respect to a selected ultrasound image that is selected from the plurality of ultrasound images according to a given first instruction”. The examiner agrees that Imai saves the ultrasound images of all frames captured in a determined time from the present frame, so the set of frames made available is defined with respect to the present frame rather than with respect to any image a user has selected. The examiner recognizes that the flag mark F1 marks the position of the optimum image on the display bar B (Imai at [0116]); it wherein moving the flag mark F1 along the display bar B selects images within the set of ultrasound images. Additionally, the examiner agrees that claim 12 further requires that "the length of the timespan is defined according to a given second instruction." The examiner respectfully maintains that the physical extent of a bar on a display represents an instruction (i.e. set by a user), and Imai therefore describes an instruction by which a user sets the length of the timespan (i.e. through selecting a location on the display bar B).
That being said, claims 9, and 11-12 are subject to the new ground(s) of rejection made in view of Endo et al. US 2021/0007709 A1 “Endo” and Uchihara et al. US 2021/0369238 A1 “Uchihara” as discussed in the 35 U.S.C. 103 section below.
Regarding claim 6, the Applicant argues that this claim is patentable over Imai for a further reason. Claim 6 requires that the predetermined condition includes "a condition stipulating that a length of the target site of observation is a maximum value or a mode." The predetermined condition of claim 1 governs which of the plurality of ultrasound images in a time series is displayed as the first ultrasound image. The Office Action supports claim 6 by pointing to the placement of the calipers CIA, C1B, C2A, and C2B such that the distance between two points on the inner wall of the gallbladder Al is a maximum (Imai at [0062]). That passage describes where Imai places its calipers within a single image. It does not describe any condition applied across the plurality of ultrasound images to determine which image is displayed. The same conflation underlies the treatment of the reference value in claim 1 discussed above.
The examiner recognizes that claim 6 requires that the predetermined condition include “a condition stipulating that a length of the target site of observation is a maximum value or a mode”. The examiner maintains that the placement of the calipers CIA, C1B, C2A, and C2B such that the distance between two points on the inner wall of the gallbladder Al is a maximum (Imai at [0062]) reads on the predetermined condition including a condition stipulating that a length of the target sire of observation is a maximum value. This claim as written does not require that multiple images be analyzed in order to determine the maximum value of the target site of observation.
That being said, claim 6 is subject to the new ground(s) of rejection made in view of Endo et al. US 2021/0007709 A1 “Endo” and Uchihara et al. US 2021/0369238 A1 “Uchihara” as discussed in the 35 U.S.C. 103 section below.
Regarding claim 27, the Applicant argues that this claim is patentable over Imai for a further reason. Claim 27 requires that the first size information and/or related information "are saved in an external apparatus and/or medical record." The Office Action identifies a "medical record stored in the image memory 24." Imai describes the image memory 24 as saving the ultrasound images and the measurement results (Imai at [0085]) and describes the saving controller 23 as storing the ultrasound image of the present frame and the measurement result there (Imai at [0096]). Imai does not describe a medical record, and stored images and measurement values do not become a medical record merely by being stored.
The examiner acknowledges that claim 27 requires that the first size information and/or related information “are saved in an external apparatus and/or medical record”. In Imai, “a medical record stored in image memory 24”, this image memory 24 saving the ultrasound images and the measurement results (see [0085]). Furthermore, Imai describes the saving controller 23 as storing the ultrasound image of the present frame and the measurement result there (see [0096]). The examiner respectfully maintains that the inclusion of the phrase “and/or” makes it such that a reference need only satisfy one of the saving to an external apparatus or a medical record. Therefore, the examiner respectfully maintains that Imai teaches that the first size information and/or related information to the first size information are saved to an external apparatus (i.e. image memory 24).
That being said, claim 27 is subject to the new ground(s) of rejection made in view of Endo et al. US 2021/0007709 A1 “Endo” and Uchihara et al. US 2021/0369238 A1 “Uchihara” due to its dependence on claim 1.
Applicant’s arguments, see Remarks page 18-21, filed 07/24/2026, with respect to the rejection of the claims under 35 U.S.C. 103 have been fully considered and are persuasive.
Regarding claim 7, the Office Action also rejects claim 7 under 35 U.S.C. § 103 over Imai in view of Ryan. Because amended claim 1 recites that the target site of observation is a lesion, claim 7 has been amended to recite that, in a case in which the lesion is an annular lesion, the length is a length of a range from one end to another end of a line segment traversing an outline of a cross section of the annular lesion. Support is found at least at paragraphs [0184] to [0186] and Fig. 18 of the specification as filed. Ryan is cited for calculating a radial distance or a diameter of a blood vessel from signals produced by transducers 18 aimed circumferentially around a medical device 10 (Ryan at [0050] and [0052], FIG. 6). Ryan describes measuring across a vessel or a cavity; it does not describe an annular lesion, and it does not describe a length of a range from one end to another end of a line segment traversing an outline of a cross section of an annular lesion. Neither does Imai. Withdrawal of the rejection of claim 7 is respectfully requested.
The examiner acknowledges that claim 7 has been amended to recite that, in a case in which the lesion is an annular lesion, the length is a length of a range from one end to another end of a line segment traversing an outline of a cross section of the annular lesion. The examiner recognizes that support is found in at least paragraphs [0184] to [0186] and FIG. 18 of the Applicant’s disclosure. The examiner recognizes that Ryan is cited for calculating a radial distance or a diameter of a blood vessel from signals produced by transducers 18 aimed circumferentially around a medical device 10 (Ryan at [0050] and [0052], FIG. 6). Furthermore, Ryan describes measuring across a vessel or a cavity; it does not describe an annular lesion, and it does not describe a length of a range from one end to another end of a line segment traversing an outline of a cross section of an annular lesion. Imai does not cure this deficiency.
Thus, the rejection has been withdrawn and claim 7 is subject to the new ground(s) of rejection made in view of Endo et al. US 2021/0007709 A1 “Endo” and Uchihara et al. US 2021/0369238 A1 “Uchihara” as discussed in the 35 U.S.C. 103 section below.
Regarding claim 23-26, these claims are rejected under 35 U.S.C. § 103 over Imai in view of Sarojam. Claims 23-26 depend, through amended claims 21 and 22, from amended claim 1, and Sarojam is not relied on for any of the limitations discussed above. Sarojam is cited for repositioning a caliper 1104 or 1106 in response to a user input and updating a first dimensional length 1116 (Saroiam at [0106]), and for determining a third dimensional length 1216 from a second boundary 1220 (Sarojam at [0111]). Neither passage describes an ultrasound probe that is inserted into a body, a range corresponding to a pancreas, or the predetermined condition of claim 1, and Sarojam therefore does not cure the deficiencies of Imai.
The examiner acknowledges that claims 23-26 are dependent from claims 21 and 22, which depend from amended claim 1 and that Sarojam is not relied on for any limitations discussed with respect to claim 1. The examiner agrees that Sarojam is cited for repositioning a caliper 1104 or 1106 in response to a user input and updating a first dimensional length 1116 (Saroiam at [0106]), and for determining a third dimensional length 1216 from a second boundary 1220 (Sarojam at [0111]). The examiner recognizes that neither reference describes an ultrasound that is inserted into a body, a range corresponding to a pancreas, or the predetermined condition of claim 1, and Sarojam therefore does not cure the deficiencies of Imai.
Thus, the rejection has been withdrawn and claims 23-24 are subject to the new ground(s) of rejection made in view of Endo et al. US 2021/0007709 A1 “Endo” and Uchihara et al. US 2021/0369238 A1 “Uchihara” as discussed in the 35 U.S.C. 103 section below.
With respect to claim 25, the Office Action states that the major axis and the minor axis of the gallbladder Al of Imai "have different priorities (i.e. importance)." Claim 25 requires that "the ranges are assigned a priority, and calipers indicating the ranges are displayed in a state allowing for identification of the priority." Imai assigns no priority to its measurement lines ML1 and ML2 or to the ranges those lines define, and it does not display the calipers CIA, C1B, C2A, and C2B in a state that allows a user to identify any such priority. The measurement result panel PR of Imai reports a major axis of 5.6 cm and a minor axis of 3.1 cm (Imai at [0065], FIG. 4); it reports two measured values, not a priority assigned to two ranges. Sarojam is not relied on for the priority and does not describe one. The priority relied on in the rejection is supplied by the Office Action rather than by Imai. Withdrawal of the rejection of claims 23-26 is respectfully requested.
The examiner acknowledges that claim 25 requires that "the ranges are assigned a priority, and calipers indicating the ranges are displayed in a state allowing for identification of the priority." The examiner recognizes that Imai assigns no priority to its measurement lines ML1 and ML2 or to the ranges those lines define, and it does not display the calipers CIA, C1B, C2A, and C2B in a state that allows a user to identify any such priority. The measurement result panel PR of Imai reports a major axis of 5.6 cm and a minor axis of 3.1 cm (Imai at [0065], FIG. 4); thus it reports two measured values, not a priority assigned to two ranges. Additionally, the examiner recognizes that Sarojam is not relied on for the priority and does not describe one.
Thus, the rejection has been withdrawn and claim 25. The examiner respectfully refers the Applicant to the Allowable subject matter section below with respect to claims 25-26.
Regarding claims 10 and 28-29, the Applicant notes that these claims are rejected under 35 U.S.C. § 103 over Imai in view of Endo.
Claim 29 has been canceled, and its limitations have been incorporated into amended claim 1, so the rejection of claim 29 is moot. Claims 10 and 28 depend from amended claim 1. Because the ultrasound endoscope and the ultrasound probe of canceled claim 29 now appear in claim 1, Applicant addresses Endo with respect to amended claim 1 as well.
The Applicant argues that Endo does not supply what Imai lacks. Endo describes an ultrasonic endoscope apparatus 10 in which an operator specifies a first measurement point A and a second measurement point B on an ultrasound image G displayed on the monitor 20, and in which correction support information is generated to assist the operator in correcting the positions of those operator- specified points (Endo at [0085] and [0086], FIG. 5). The first range Al and the second range B1 of Endo are search ranges used to detect measurement candidate points in the vicinity of the points the operator has specified (Endo at [0118] to [0120]); they are not ranges corresponding to detected anatomical sites that are displayed on a screen. The references in Endo to a pancreas are of a different character still: Endo identifies the pancreas as an example of an observation target site that is difficult to test from the body surface side of the patient (Endo at [0036]), and as one of several conditions according to which the size of the search ranges Al and B1 may be varied (Endo at [0120]). Endo does not describe detecting a lesion and a pancreas as separate sites in an ultrasound image and displaying a range corresponding to each, and it does not describe the predetermined condition of claim 1. Endo also performs no image recognition. The measurement points are specified by the operator, and the correction support information generation unit 158A detects candidate points from brightness profiles in the vicinity of those operator-specified points (Endo at [0096] and [0097]). Substituting the automatic recognition and measurement of Imai for that operation would remove the correction support for operator-specified measurement points that Endo is directed to providing. The combination of Imai and Endo therefore does not teach or suggest amended claim 1 and claims 10 and 28 are patentable over that combination for at least that reason. Withdrawal of the rejection of claims 10 and 28-29 is respectfully requested.
The examiner respectfully acknowledges that Endo does not supply what Imai lacks at least with respect to displaying a range of the pancreas. The examiner agrees that Endo describes an ultrasonic endoscope apparatus 10 in which an operator specifies a first measurement point A and a second measurement point B on an ultrasound image G displayed on the monitor 20, and in which correction support information is generated to assist the operator in correcting the positions of those operator-specified points (Endo at [0085] and [0086], FIG. 5). The first range Al and the second range B1 of Endo are search ranges used to detect measurement candidate points in the vicinity of the points the operator has specified (Endo at [0118] to [0120]); however, the examiner agrees that they are not ranges corresponding to detected anatomical sites that are displayed on a screen.
Furthermore, the examiner recognizes that Endo identifies the pancreas as an example of an observation target site that is difficult to test from the body surface side of the patient (Endo at [0036]), and as one of several conditions according to which the size of the search ranges Al and B1 may be varied (Endo at [0120]). The examiner agrees that Endo does not describe detecting a lesion and a pancreas as separate sites in an ultrasound image and displaying a range corresponding to each, and it does not describe the predetermined condition of claim 1. The examiner acknowledges that Endo also performs no image recognition. In Endo, the measurement points are specified by the operator, and the correction support information generation unit 158A detects candidate points from brightness profiles in the vicinity of those operator-specified points (Endo at [0096] and [0097]). Substituting the automatic recognition and measurement of Imai for that operation would remove the correction support for operator-specified measurement points that Endo is directed to providing. The combination of Imai and Endo therefore does not teach or suggest amended claim 1.
Therefore, the rejection of claims 10 and 28 have been withdrawn and claims 10 and 28 are subject to the new ground(s) of rejection made in view of Endo et al. US 2021/0007709 A1 “Endo” and Uchihara et al. US 2021/0369238 A1 “Uchihara” as discussed in the 35 U.S.C. 103 section below. The rejection of claim 29 is withdrawn due to its cancellation.
Regarding newly added claim 32, this claim depends from claim 1 and recites that the reference value is a statistical value of lengths of the target site of observation shown in the plurality of ultrasound images. Support is found at least at paragraphs [0101] and [0134] of the specification as filed. None of Imai, Ryan, Sarojam, or Endo describes a reference value that is a statistical value of lengths measured across a plurality of ultrasound images. Imai determines an optimum image by identifying a frame in which a measurement value is a maximum (Imai: [0093]), which is a different determination.
The examiner acknowledges that none of Imai, Ryan, Sarojam, or Endo describes a reference value that is a statistical value of lengths measured across a plurality of ultrasound images. The examiner respectfully refers the Applicant to the 35 U.S.C. 103 section below with respect to the rejection of claim 32.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-22, 27-28, and 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable by Endo et al. US 2021/0007709 A1 “Endo” and further in view of Imai US 2021/0077066 A1 “Imai” and Uchihara et al. US 2021/0369238 A1 “Uchihara”.
Regarding claims 1, 30 and 31, Endo teaches “An ultrasound endoscope comprising: a medical assistance apparatus comprising a processor; and an ultrasound probe that, when inserted into a body, emits an ultrasonic wave inside the body and receives a reflected wave of the ultrasonic wave” (Claim 1) (“An outline of an ultrasonic endoscope apparatus 10 which is an embodiment of an ultrasound diagnostic apparatus according to the embodiment of the present invention will be described with reference to FIGS. 1 and 2. FIG. 1 is a diagram illustrating a schematic configuration of an ultrasonic endoscope apparatus 10. FIG. 2 is a block diagram illustrating a configuration of an ultrasonic endoscope 12 and an ultrasonic processor apparatus 14” [0035]; “As illustrated in FIG. 1, the ultrasonic endoscope 12 has an insertion part 22 inserted into the body cavity of a patient and an operation unit 24 operated by an operator (user) such as a doctor or a technician. In addition, an ultrasound transducer unit 46 comprising a plurality of ultrasound transducers is attached to a distal end part 40 of the insertion part 22.” [0038]; “The operator can acquire an endoscopic image of an inner wall of the body cavity of the patient and an ultrasound image of an observation target site by the function of the ultrasonic endoscope 12 […] The ultrasound image is an image obtained by receiving reflected waves (echo) of ultrasound waves transmitted from the body cavity of the patient toward an observation target site and imaging the received signal” [0039]; “The monitor 20 is connected to the ultrasonic processor apparatus 14 and the endoscopic processor apparatus 16, and displays an ultrasound image generated by the ultrasonic processor apparatus 14, an endoscopic image generated by the endoscopic processor apparatus 16, and the like” [0044].
Therefore, Endo describes an ultrasound endoscope (i.e. ultrasonic endoscope apparatus 10) comprising a medical assistance apparatus (i.e. combination of ultrasonic processor apparatus 14, endoscopic processor apparatus 16 and monitor 20) comprising a processor (i.e. 14 or 16), and an ultrasound probe (i.e. ultrasonic endoscope 12) that, when inserted into a body, emits an ultrasonic wave inside the body and receives a reflected wave of the ultrasonic wave (see [0044]).);
“A medical assistance method for an ultrasound endoscope including a medical assistance apparatus comprising a processor and an ultrasound probe that when inserted into a body emits an ultrasonic wave inside the body and receives a reflected wave of the ultrasonic wave, the medical assistance method comprising:” (Claim 30) (See [0035], [[038], [0039], and [0044] above and “The present invention has been accomplished in consideration of the above-described situation, and an object of the invention is to provide a measurement apparatus, an ultrasound diagnostic apparatus, a measurement method, and a measurement program that can set an intended measurement target range with high accuracy for an ultrasound image” [0008]. Therefore, Endo describes a medical assistance method (i.e. measurement method) for an ultrasound endoscope (i.e. ultrasonic endoscope apparatus 10).);
“A non-transitory computer-readable storage medium storing a program executable by a computer to execute a process for an ultrasound endoscope including a medical assistance apparatus comprising a processor and an ultrasound probe that, when inserted into a body, emits an ultrasonic wave inside the body and receives a reflected wave of the ultrasonic wave, the process comprising:” (Claim 31) (See [0035], [[038], [0039], and [0044] above and “A non-transitory computer readable recording medium storing a measurement program that causes a computer to perform a correction support information generation […]” [0197].);
“display(ing), on a screen, a first ultrasound image among a plurality of ultrasound images in a time series, the ultrasound image showing a target site of observation and […]” (Claims 1, 30 and 31) (“FIG. 5 illustrates a state where two measurement points (a first measurement point A and a second measurement point B) are specified for an ultrasound image G being displayed on the monitor 20 by the operation of the operator. In FIG. 5, a pointer P(A) indicating the first measurement point A and a pointer P(B) indicating the second measurement point B are displayed on the ultrasound image G in an overlapping manner. The ultrasound image G has a region T suspected of being a lesion” [0085]; “Here, the “live mode” is a mode in which ultrasound images (motion pictures) obtained at a predetermined frame rate are sequentially displayed (real-time display). The “freeze mode” is a mode in which an ultrasound image (still pictures) for one frame acquired in the past is read out from a cine memory (not illustrated) and displayed.” [0048]. Therefore, the method carried out by the ultrasound endoscope includes displaying, on a screen, a first ultrasound image among a plurality of ultrasound images (i.e. obtained during the “live mode”) in a time series, the ultrasound image showing a target site (i.e. region T suspected of being a lesion).);
“output(ting) first size information indicating a first size” (Claims 1, 30 and 31) (“As illustrated in FIG. 5, in a case where the first measurement point A and the second measurement point B are specified by the operator, the measurement unit 158B displays a straight line L1a connecting the first measurement point A and the second measurement point B on the ultrasound image G in an overlapping manner, further measures the length (distance between first measurement point A and second measurement point B) of the straight line L1a, and displays the measurement result on the ultrasound image G as a provisional measurement result (the result is “Distance 8.0 mm” in the example of FIG. 5) in an overlapping manner” [0086]. Therefore, the method carried out by the ultrasound endoscope includes outputting first size information indicating a first size (i.e. measurement result corresponding to length between first measurement point A and second measurement point B).); […]
“measure(ing) the target site of observation according to a measurement method appropriate for the detected target site of observation, wherein” (Claims 1, 30 and 31) (See [0086] as discussed above. Therefore, the method carried out by the ultrasound endoscope includes measuring the target site of observation according to a measurement method appropriate for the detected target site of observation.);
“the ultrasound image is generated on a basis of the reflected wave” (Claims 1, 30, and 31) (See [0039] and [0044] as discussed above. Therefore, the ultrasound image is generated on a basis of the reflected wave.);
“the target site of observation is a lesion” (Claims 1, 30, and 31) (See [0085] above. Therefore, the target site of observation is a lesion.);
“the first size is a size of the target site of observation shown in the first ultrasound image” (See [0086] as discussed above and “In a case where the screen as illustrated in FIG. 7 or 8 is displayed, the operator performs an operation of determining two measurement points on the ultrasound image G. In a case where the set button 104 is pressed by the operator while the pointer P(A), the pointer P(B), and the pointer P (Bx) are displayed as illustrated in FIG. 7, the measurement unit 158B sets the first measurement point A as a first final measurement point, and sets the second measurement candidate point Bx as a second final measurement point” [0110]. As shown in FIG. 7, the distance between points P(A) and P(B) (i.e. 8mm) and between points P(A) and P(Bx) (i.e. 9.5 mm) are displayed. Therefore, since the measurement result is displayed on the ultrasound image G, the first size is a size of the target site of observation shown in the first ultrasound image.); […]
“the processor is configured to display, on the screen, a range corresponding to the lesion […]” (Claim 1); “the medical assistance method further comprising displaying, on the screen, a range corresponding to the lesion […]” (Claim 30); “the process further comprises displaying, on the screen, a range corresponding to the lesion” (Claim 31) (See FIGS. 5 and 7 and paragraphs [0086], and [0110] above. The straight ling L1a shown in FIGS. 5 and 7, represents a range of the lesion (i.e. region T suspected of being a lesion.);
“the measurement method includes a first measurement method and/or a second measurement method” (Claims 1, 30 and 31) (See [0086], [0110] above and “In a case of being specified, as illustrated in FIG. 16, the measurement unit 158B displays a straight line L1a connecting the first measurement point A and the second measurement point B, and a straight line L2a having a predetermined length that is orthogonal to the straight line L1a and passes through a midpoint of the straight line L1a on the ultrasound image G in an overlapping manner. Then, at one end of the straight line L2a, a pointer P (C) indicating a temporary third measurement point C is displayed, and at the other end of the straight line L2a, a pointer P (D) indicating a temporary fourth measurement point D is displayed. In addition, the measurement unit 158B also displays an ellipse CR1 having the straight line L1a as a short axis and the straight line L2a as a long axis. Further, the measurement unit 158B measures an area of the ellipse CR1, and displays the result (in the example of FIG. 16, “Area 0.8 cm.sup.2”)” [0160]. FIGS. 5 and 7 show one measurement line, while FIG. 16 shows two measurement lines, thus these lines represent two different measurement methods. Therefore, the measurement method includes a first measurement method and/or a second measurement method.);
“the first measurement method is a method for measuring the target site of observation in one direction” (Claims 1, 30 and 31) (See FIG. 5 and FIG. 7. As shown in these figures, the straight line L1a (i.e. measurement line) is within one direction. Therefore, the first measurement method is a method for measuring the target site of observation in one direction.), and
“the second measurement method is a method for measuring the target site of observation in multiple directions” (Claims 1, 30 and 31) (See FIG. 16 and [0160] above. As shown in FIG. 16, there are two lines for performing the measurement of the area displayed on the ultrasound image G. Therefore, the second measurement method is a method for measuring the target site (i.e. T) of observation in multiple directions.).
However, Endo does not teach that the first ultrasound image is “satisfying a predetermined condition” (Claims 1, 30 and 31); that “the predetermined condition includes a condition stipulating that a length of the target site of observation is equal to or greater than a reference value” (Claims 1, 30 and 31); “detect(ing) the target site of observation by performing image recognition processing on the ultrasound image” (Claims 1, 30 and 31); that the processor displays “a range corresponding to a pancreas” (Claim 1); that the medical assistance method involves displaying “a range corresponding to a pancreas” (Claim 30); or that the process further comprises displaying “a range corresponding to a pancreas” (Claim 31).
Imai is within a related field of endeavor to the claimed invention because it involves a measurement target recognition unit 9 that automatically recognizes a measurement target included in an ultrasound image of a present frame (see [Abstract]).
Imai teaches that the first ultrasound image is “satisfying a predetermined condition” (Claims 1, 30 and 31); that “the predetermined condition includes a condition stipulating that a length of the target site of observation is equal to or greater than a reference value” (Claims 1, 30 and 31); “detect(ing) the target site of observation by performing image recognition processing on the ultrasound image” (Claims 1, 30 and 31) (“An ultrasound diagnostic apparatus 1 sequentially displays ultrasound images of a plurality of continuous frames during imaging on a display unit 8, and includes a measurement target recognition unit 9 that automatically recognizes a measurement target included in an ultrasound image of a present frame displayed on the display unit 8, a measurement algorithm setting unit 12 that sets a measurement algorithm for the measurement target recognized by the measurement target recognition unit 9, and a measurement unit 10 that measures the measurement target based on the measurement algorithm set by the measurement algorithm setting nit 12 and displays a measurement result on the display unit 8 to be superimposed on the ultrasound image of the present frame” [Abstract]; “The measurement target recognition unit 9 of the processor 22 recognizes a measurement target included in the ultrasound image by performing image recognition on the ultrasound image generated by the image generation unit 6. Here, the measurement target can include a part to be a target of measurement, such as an organ, or a lesion part, such as a tumor, a cyst, or bleeding. For example, the measurement target recognition unit 9 can distinguish the measurement target in the ultrasound image using machine learning, such as deep learning. In this case, for example, a neural network can be constructed by making the measurement target recognition unit 9 learn a large amount of typical pattern data for the measurement target as positive data in advance and learn a large amount of pattern data other than the typical pattern data for the measurement target as negative data in advance. The measurement target recognition unit 9 can distinguish a measurement target by calculating a length or the like of a characteristic portion for patterns included in the ultrasound image and classifying the patterns into learned pattern data using a calculation result and the constructed neural network” [0044]; “In this case, the measurement target recognition unit 9 can recognize the measurement target by providing likelihood for the learned pattern data to the patterns included in the ultrasound image and performing threshold value determination for the likelihood” [0045].
Therefore, since the measurement target recognition unit 9 can measure a lesion part (i.e. measurement target using machine learning and can distinguish it by calculating a length or the like of a characteristic portion (see [0044]) and performing threshold value determination (see [0045]), the first ultrasound image is satisfying a predetermined condition (i.e. length of characteristic portion, see [0044]) and the predetermined condition includes a condition stipulating that a length of the target site of observation (i.e. lesion part) is equal to or greater than a reference value” (i.e. threshold value determination, see [0045]). Additionally, since the measurement target recognition unit automatically recognizes a measurement target by performing image recognition on the ultrasound image, the method carried out by the apparatus involves detecting the target site of observation by performing image recognition processing on the ultrasound image.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound endoscope, medical assistance method and non-transitory computer-readable storage medium of Endo such that first ultrasound image is “satisfying a predetermined condition” wherein the “predetermined condition includes a condition stipulating that a length of the target site of observation is equal to or greater than a reference value” and the processor is configured to detect the target site of observation by performing image recognition processing on the processing image as disclosed in Imai in order to automate the process of identifying the lesion part within the ultrasound image. Performing image recognition with a neural network, wherein image recognition involves calculating a length of a characteristic portion and classifying it by performing threshold value determination is one of a finite number of techniques which can be used to distinguish features within an ultrasound image with a reasonable expectation of success. Thus, modifying the ultrasound endoscope, medical assistance method and non-transitory computer-readable storage medium of Endo such that first ultrasound image is “satisfying a predetermined condition” wherein the “predetermined condition includes a condition stipulating that a length of the target site of observation is equal to or greater than a reference value” and the processor is configured to detect the target site of observation by performing image recognition processing on the processing image as disclosed in Imai would yield the predictable result of automating the process of identifying the lesion part within the ultrasound image.
The combination of Endo and Imai does not teach that the processor is configured to display “a range corresponding to the pancreas” (Claim 1); that the medical assistance method further comprises displaying a “a range corresponding to a pancreas” (Claim 30); or that the process further comprises displaying, “a range corresponding to a pancreas” (Claim 31).
Uchihara is within the same field of endeavor as the claimed invention because it involves an ultrasound endoscope system and method of operating an ultrasound endoscope system (see [Abstract]).
Uchihara teaches that the processor is configured to display “a range corresponding to the pancreas” (Claim 1); that the medical assistance method further comprises displaying a “a range corresponding to a pancreas” (Claim 30); and that the process further comprises displaying, “a range corresponding to a pancreas” (Claim 31) (“In a case where designation is made to display the range of the organ in response to an instruction from the operator, as shown in FIG. 22B, the display controller 172B colors, for example, the internal region of the range of the organ recognized by the ultrasound image recognition unit 168B in a given color, and the range of the organ with the internal region colored is displayed on the monitor 20” [0320], “For example, in a case where designation is made to display only the name of the organ in response to an instruction from the operator, as shown in FIG. 22A, the display controller 172B displays only the name of the organ without coloring the range of the organ. In a case where designation is made to perform only coloring of the range of the organ, as shown in FIG. 22B, the display controller 172B colors only the range of the organ without displaying the name of the organ” [0344]. As shown in FIG. 22A, the organ that is represented in the pancreas. Likewise, the organ shown in FIG. 22B is also the pancreas, in which the range is colored and displayed on the monitor.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound endoscope, medical assistance method and non-transitory computer-readable storage medium of Endo in view of Imai such that the processor is configured to carry out the step of displaying a range corresponding to the pancreas as disclosed in Uchihara in order to allow a user to easily identify the location and shape of the pancreas within the ultrasound image. Displaying a range of an organ is one of a finite number of techniques which can be used to aid a user in identifying an organ with a reasonable expectation of success. Thus, modifying the ultrasound endoscope, medical assistance method and non-transitory computer-readable storage medium of Endo in view of Imai such that the processor is configured to carry out the step of displaying a range corresponding to the pancreas as disclosed in Uchihara would yield the predictable result of allowing a user to easily identify the location and shape of the pancreas within the ultrasound image.
Regarding claim 2, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 1 above, and Imai further teaches “wherein the outputting of the first size information includes displaying the first size on the screen” (See Distance measurements in FIGS. 5 and 7. As shown in FIG. 5, the distance between the points P(A) and P(B) is 8mm and FIG. 7 shows the distance between P(A) and P(B) is 8mm, while the distance between P(A) and P(Bx) is 9.5 mm Therefore, outputting the first size information includes displaying the first size on the screen.).
Regarding claim 3, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 1 above, and Imai further teaches “wherein the predetermined condition includes a condition stipulating an image which is among the plurality of ultrasound images and in which the target site of observation is detected and the size of the detected target site of observation is measured” (“In a case where the ultrasound image of the present frame is displayed on the display unit 8 in this manner, in Step S3, the measurement target recognition unit 9 automatically recognizes a measurement target included in the ultrasound image of the present frame”. [0061] and “In subsequent Step S4, the measurement algorithm setting unit 12 sets a measurement algorithm for the measurement target recognized in Step S3. For example, as shown in FIG. 4, in a case where the measurement target is the gallbladder A1, the measurement algorithm setting unit 12 sets a measurement algorithm that a line segment having a maximum distance with two points disposed on an inner wall of a region representing the gallbladder A1 in the ultrasound image U1 as end points is decided as a measurement line, and a length of the measurement line is measured. In the example shown in FIG. 4, a measurement line ML1 having calipers C1A and C1B as end points and a measurement line ML2, which is perpendicular to the measurement line ML1 and has calipers C2A and C2B as end points, are set in two directions perpendicular to each other such that a distance between two points on the inner wall of the gallbladder A1 is a maximum” [0062].
Therefore, since FIG. 4 shows an image of the gallbladder in which measurements of the major axis and the minor axis are displayed, this image satisfies the predetermined condition which includes a condition stipulating an image which is among the plurality of ultrasound images and in which the target site of observation (i.e. gallbladder) is detected (i.e. by the measurement target recognition unit 9 automatically, see [0061]) and the size of the detected target site of observation is measured (i.e. by the measurement algorithm set by the measurement algorithm setting unit 12).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound endoscope of Endo such that the predetermined condition includes a condition stipulating an image which is among the plurality of ultrasound images and in which the target site of observation is detected and the size of the detected target site of observation is measured as disclosed in Imai in order to allow a user to select a desired image for analysis.
Regarding claim 4, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 1 above, and Imai further teaches “wherein the predetermined condition includes a condition stipulating an image which is among the plurality of ultrasound images and in which a specific target site of observation is detected among a plurality of target sites of observation and the size of the specific target site of observation is measured” (See FIG. 4, and [0061], [0062] as discussed in claim 1 above. Therefore, since the gallbladder is detected (see FIG. 4) and measurements (i.e. major axis and minor axis) are performed based on the measurement target recognized (i.e. by the measurement algorithm), the predetermined condition includes a condition stipulating an image which is among the plurality of ultrasound images and in which a specific target site of observation is detected among a plurality of target sites of observation and the size of the specific target site of observation is measured.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound endoscope of Endo such that stipulating an image which is among the plurality of ultrasound images and in which a specific target site of observation is detected among a plurality of target sites of observation and the size of the specific target site of observation is measured as disclosed in Imai in order to allow a user to select a desired image for analysis.
Regarding claim 5, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 1 above, and Imai further teaches “wherein the processor is configured to output a plurality of ultrasound images which are among the plurality of ultrasound images and in which the target site of observation is detected and the size of the target site of observation is measured” (“For example, as shown in FIG. 10, the saving controller 23 can display the ultrasound images of a plurality of frames and the measurement results saved in the image memory 24 on the display unit 8. Here, the saving controller 23 can execute a display aspect shown in FIG. 10, for example, with issuance of an instruction from the user through the operating unit 15 as a trigger. In the example shown in FIG. 10, an ultrasound image U1 that is determined to be an optimum image by the optimum image determination unit 25 and includes a gallbladder A1 as a measurement target, calipers C1A, C1B, C2A, and C2B that are measurement results in the ultrasound image U1, measurement lines ML1 and ML2, a measurement result panel PR, a display bar B extending along one direction, and a flag mark F1 disposed in the vicinity of the display bar B are displayed on the display unit 8” [0113]. Therefore, since the saving controller 23 can display the ultrasound images of a plurality of frames as a user drags their finger along the display bar B (i.e. corresponding to flag mark F1), the processor is configured to output a plurality of ultrasound imaged which are among the plurality of ultrasound images and in which the target site of observation (i.e. gallbladder) is detected and the size of the target site of observation is measured (i.e. measurement results panel PR).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound endoscope of Endo such that the processor is configured to output a plurality of ultrasound images which are among the plurality of ultrasound images and in which the target site of observation is detected and the size of the target site of observation is measured as disclosed in Imai in order to allow a user to select a desired image for analysis.
Regarding claim 6, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 1 above, and Imai further teaches “wherein the predetermined condition includes a condition stipulating that a length of the target site of observation is a maximum value or a mode” (“In the example shown in FIG. 4, a measurement line ML1 having calipers C1A and C1B as end points and a measurement line ML2, which is perpendicular to the measurement line [ML2] and has calipers C2A and C2B as end points, are set in two directions perpendicular to each other such that a distance between two points on the inner wall of the gallbladder A1 is a maximum” [0062]. Therefore, since the calipers are placed such that the distance between the two points on the inner wall of the gallbladder A1 is a maximum, the predetermined condition includes a condition stipulating that a length of the target site of observation is a maximum value or a mode (i.e. a maximum value).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound endoscope of Endo such that the predetermined condition includes a condition stipulating that a length of the target site of observation is a maximum value or a mode as disclosed in Imai in order to allow a user to select a desired image/target site for analysis.
Regarding claim 7, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 1 above. Endo further teaches “wherein in a case in which the lesion is an annular lesion, the length is a length of a range from one end to another of a line segment transversing an outline of a cross section of the annular lesion” (See FIG. 16. As shown in FIG. 16, the region T (i.e. suspected of being a lesion) is an annular shape and includes lines which traverse it in two directions in order to calculate the area. Therefore, in a case in which the lesion is an annular lesion, the length is a length of a range from one end to another of a line segment transversing an outline of a cross section of the annular lesion.).
Regarding claim 8, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 1 above, and Imai further teaches “wherein size information indicating the size of the target site of observation is applied to each of the ultrasound images, and the processor is configured to output the size information applied to the first ultrasound image as the first size information” (“For example, as shown in FIG. 10, the saving controller 23 can display the ultrasound images of a plurality of frames and the measurement results saved in the image memory 24 on the display unit 8. Here, the saving controller 23 can execute a display aspect shown in FIG. 10, for example, with issuance of an instruction from the user through the operating unit 15 as a trigger. In the example shown in FIG. 10, an ultrasound image U1 that is determined to be an optimum image by the optimum image determination unit 25 and includes a gallbladder A1 as a measurement target, calipers C1A, C1B, C2A, and C2B that are measurement results in the ultrasound image U1, measurement lines ML1 and ML2, a measurement result panel PR, a display bar B extending along one direction, and a flag mark F1 disposed in the vicinity of the display bar B are displayed on the display unit 8” [0113]. Therefore, since the saving controller 23 displays the ultrasound images of a plurality of frames and the measurement results (i.e. in the measurement result panel PR), the size information indicating the size of the target site of observation is applied to each of the ultrasound images, and the processor is configured to output the size information applied to the first ultrasound image as the first size information (i.e. see FIG. 4, for example).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound endoscope of Endo such that size information indicating the size of the target site of observation is applied to each of the ultrasound images, and the processor is configured to output the size information applied to the first ultrasound image as the first size information as disclosed in Imai in order to allow a user to view size information for each of the images of the target site of observation when performing an analysis thereof.
Regarding claim 9, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 1 above, and Imai further teaches “wherein the first ultrasound image is an ultrasound image that satisfies the predetermined condition from among the ultrasound images in a timespan defined with respect to a selected ultrasound image that is selected from the plurality of ultrasound images according to a given first instruction” (See [0113] as discussed in claim 8 above and FIG. 10. As shown in FIG. 10, the display unit 8 includes a display bar B and the image shown at the position F1 (i.e. flag mark) corresponds to the optimum image (i.e. same as image shown in FIG. 4). Therefore the first ultrasound image is an ultrasound image that satisfies the predetermined condition from among the ultrasound images in a timespan (i.e. time line corresponding to display bar B) defined with respect to a selected ultrasound image (i.e. optimum image, see FIG. 4) that is selected from the plurality of ultrasound images according to a given first instruction (i.e. corresponding to the positioning of the flag mark F1 with a user’s finger FU).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound endoscope of Endo such that the first ultrasound image is an ultrasound image that satisfies the predetermined condition from among the ultrasound images in a timespan defined with respect to a selected ultrasound image that is selected from the plurality of ultrasound images according to a given first instruction as disclosed in Imai in order to allow a user to make a selection of an ultrasound image on which analysis is performed.
Regarding claim 10, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 9 above and Endo further teaches “wherein the selected ultrasound image is a freeze image, and the freeze image is the ultrasound image displayed on the screen in a frozen state according to the first instruction in a situation in which the plurality of ultrasound images are being displayed as a dynamic image on the screen” (“Further, the operator can set various control parameters on the console 100 in a case of performing the ultrasound diagnosis. The control parameters include, for example, a selection result of a live mode and a freeze mode, a set value of a display depth (depth), and a selection result of an ultrasound image generation mode” [0047]; “Here, the “live mode” is a mode in which ultrasound images (motion pictures) obtained at a predetermined frame rate are sequentially displayed (real-time display). The “freeze mode” is a mode in which an ultrasound image (still pictures) for one frame acquired in the past is read out from a cine memory (not illustrated) and displayed” [0048]. Therefore, the selected ultrasound image is a freeze image, and the freeze image is the ultrasound image displayed on the screen in a frozen (i.e. still picture) state according to the first instruction in a situation in which the plurality of ultrasound images are being displayed as a dynamic image (i.e. real-time display) on the screen.).
Regarding claim 11, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 9 above, and Imai further teaches “wherein the timespan is a timespan going back from the point in time when the selected ultrasound image is obtained” (See FIG. 10. As shown in FIG. 10, the display bar B (i.e. timeline) extends back from the point in time (i.e. flag mark F1) when the selected ultrasound image is obtained. Therefore, the timespan is a timespan going back from the point in time when the selected ultrasound image is obtained.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound endoscope of Endo such that the timespan is a timespan going back from the point in time when the selected ultrasound image is obtained as disclosed in Imai in order to allow a user to make a selection of an ultrasound image on which analysis is performed, said image corresponding to the timespan in which images are obtained for analysis.
Regarding claim 12, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 10 above, and Imai further teaches “wherein the length of the timespan is defined according to a given second instruction” (“Furthermore, as shown in FIG. 10, it is assumed that the display bar B extends right and left along a lateral direction D” [0114]. Therefore, since the display bar B extends right and left along a lateral direction D and its length corresponds the plurality of frames of ultrasound images which are displayed on the display unit 8, the length of the timespan is defined according to a given second instruction.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound endoscope of Endo such that the length of the timespan is defined according to a given second instruction as disclosed in Imai in order to allow a user to make a selection of only images that are included within a specific time frame when performing analysis thereof.
Regarding claim 13, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 1 above, and Endo further teaches “wherein the processor is configured to output second size information indicating a second size, and the second size is a size of the target site of observation shown in a second ultrasound image different from the first ultrasound image among the plurality of ultrasound images” (See FIG. 16 and [0160] as discussed in claim 1 above. As shown in FIG. 16, the shape of the region T (i.e. suspected lesion) is different than that of the region T shown in FIGS. 5 and 7 (i.e. which show the first size). Furthermore, the display in FIG. 16 shows the area of the region T located therein. Thus, the processor is configured to output second size information indicating a second size (i.e. area), and the second size is a size of the target site of observation shown in a second ultrasound image different (i.e. differently shaped region T is shown in FIG. 16 verses FIGS. 5 and 7, thus indicating a different ultrasound image) from the first ultrasound image among the plurality of ultrasound images.).
Regarding claim 14, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 13 above, and Imai further teaches “wherein size information indicating the size of the target site of observation is applied to each of the ultrasound images, and the processor is configured to output the size information applied to the second ultrasound image as the second size information” (See FIG. 4 and [0062] as discussed in claim 3 above and [0113] as discussed in claim 8 above. Therefore, since the saving controller displays a plurality of frames along with their measurement results (i.e. major axis and minor axis in measurement result panel PR), the size information indicating the size of the target site of observation is applied to each of the ultrasound images, and the processor is configured to output the size information applied to the second ultrasound image as the second size information.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound endoscope of Endo such that the size information indicating the size of the target site of observation is applied to each of the ultrasound images, and the processor is configured to output the size information applied to the second ultrasound image as the second size information as disclosed in Imai in order to allow a user to better assess the size of the target site of observation (i.e. lesion) in each of the ultrasound images obtained.
Regarding claim 15, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 13 above, and Endo further teaches “wherein the outputting of the second size information includes displaying the second size on the screen” (See FIG. 16. As shown in FIG. 16, the area of the region T (i.e. suspected lesion) is displayed on the screen. Therefore, the outputting of the second size information (i.e. area, for example) includes displaying the second size on the screen.).
Regarding claim 16, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 13 above, and Endo further teaches “wherein the processor is configured to output the first size information and the second size information in a distinguishable manner” (See FIGS. 5 and 7 and FIG. 16. In this case, the display shown in FIGS. 5 and 7 represents first size information (i.e. distance), while the display shown in FIG. 16 represents second size information (i.e. area). Therefore, the processor is configured to output the first size information and the second size information in a distinguishable manner (i.e. through labeling what the measurement corresponds to).).
Regarding claim 17, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 1 above, and Imai further teaches “wherein the predetermined condition includes a condition stipulating an image which is among the plurality of ultrasound images and in which the target site of observation is detected and the size of the target site of observation is measured according to a measurement method appropriate for the detected target site of observation” (See [0062] as discussed in claim 3 above and [0113] as discussed in claim 8 above and “The transmitting circuit 144 is a circuit that supplies a driving voltage for transmitting ultrasound waves to the ultrasound transducer selected by the multiplexer 140 in order to transmit the ultrasound waves from the ultrasound transducer unit 46” [0065]. As shown in FIG. 4 and FIG. 10, the ultrasound image includes the gallbladder and the measurement result panel PR showing the major and minor axis measurements. Therefore, the predetermined condition includes a condition stipulating an image which is among the plurality of ultrasound images (i.e. plurality of frames, see [0113]) and in which the target site of observation is detected (i.e. gallbladder is detected by the measurement target recognition unit 9, see [0061]) and the size of the target site of observation is measured according to a measurement method appropriate for the detected target site of observation (i.e. measurement algorithm setting unit 12).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound endoscope of Endo such that the predetermined condition includes a condition stipulating an image which is among the plurality of ultrasound images and in which the target site of observation is detected and the size of the target site of observation is measured according to a measurement method appropriate for the detected target site of observation as discussed in Imai in order to allow a user to effectively select an image which can be used to perform analysis.
Regarding claim 18, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 1 above, and Imai further teaches “wherein the predetermined condition includes a condition stipulating an image which is among the plurality of ultrasound images and in which a specific target site of observation is detected among a plurality of target sites of observation and the size of the specific target site of observation is measured according to a measurement method appropriate for the specific target site of observation” (See [0062] as discussed in claim 3 above and [0113] as discussed in claim 8 above, and [0065] as discussed in claim 17 above. As shown in FIG. 4 and FIG. 10, the ultrasound image includes the gallbladder and the measurement result panel PR showing the major and minor axis measurements. Therefore, the predetermined condition includes a condition stipulating an image which is among the plurality of ultrasound images (i.e. plurality of frames, see [0113]) and in which a specific target site of observation is detected (i.e. gallbladder is detected by the measurement target recognition unit 9, see [0061]) among a plurality of target sites of observation and the size of the specific target site of observation is measured according to a measurement method appropriate for the specific target site of observation (i.e. selected by the measurement algorithm setting unit 12, [0062]).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound endoscope of Endo such that the predetermined condition includes a condition stipulating an image which is among the plurality of ultrasound images and in which a specific target site of observation is detected among a plurality of target sites of observation and the size of the specific target site of observation is measured according to a measurement method appropriate for the specific target site of observation as discussed in Imai in order to allow a user to effectively select an image which can be used to perform analysis.
Regarding claim 19, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 1 above, and Imai further teaches “wherein the processor is configured to output a plurality of ultrasound images which are among the plurality of ultrasound images and in which the target site of observation is detected and the size of the target site of observation is measured according to a measurement method appropriate for the target site of observation” (See [0113] as discussed in claim 8 above. Therefore, since the saving controller 23 displays a plurality of frames of ultrasound images along with their measurement results (i.e. major axis, minor axis of the gallbladder), the processor is configured to output a plurality of ultrasound images which are among the plurality of ultrasound images and in which the target site of observation (i.e. gallbladder) is detected and the size of the target site of observation is measured according to a measurement method appropriate for the target site of observation.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound endoscope of Endo such that the processor is configured to output a plurality of ultrasound images which are among the plurality of ultrasound images and in which the target site of observation is detected and the size of the target site of observation is measured according to a measurement method appropriate for the target site of observation as discussed in Imai in order to allow a user to effectively select and view multiple image when performing an analysis.
Regarding claim 20, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 19 above, and Endo further teaches “wherein the measurement method includes a first measurement method and/or a second measurement method” (See [0086], [0110] and [0160] as discussed in claim 1 above. FIGS. 5 and 7 show one measurement line, while FIG. 16 shows two measurement lines, thus these lines represent two different measurement methods. Therefore, the measurement method includes a first measurement method and/or a second measurement method.);
“the first measurement method is a method for measuring the target site of observation in one direction” (See FIG. 5 and FIG. 7. As shown in these figures, the straight line L1a (i.e. measurement line) is within one direction. Therefore, the first measurement method is a method for measuring the target site of observation in one direction.), and
“the second measurement method is a method for measuring the target site of observation in multiple directions” (See FIG. 16 and [0160] above. As shown in FIG. 16, there are two lines for performing the measurement of the area displayed on the ultrasound image G. Therefore, the second measurement method is a method for measuring the target site (i.e. T) of observation in multiple directions.).
Regarding claim 21, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 1 above, and Endo further teaches “wherein the first size is a size of the range corresponding to the lesion” (See FIG. 7. A shown in FIG. 7, the ultrasound image includes a box with a distance measurement between point P(A) and P(B) and point P(A) and P(Bx). These distances represent the first size which is a range (i.e. length) corresponding to the target site of observation (i.e. region T, suspected of being a lesion).).
Regarding claim 22, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 21 above, and Endo further teaches “wherein calipers defining the range corresponding to the lesion are displayed on the screen” (See FIG. 7. As shown in FIG. 7, there are two cross symbols (i.e. calipers) located on the border of region T (i.e. suspected lesion). Therefore, calipers defining the range corresponding to the lesion are displayed on the screen).
Regarding claim 27, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 1 above, and Imai further teaches “wherein the first size information and/or related information that is related to the first size information are saved in an external apparatus and/or medical record” (See FIG. 8 and “In Step S9, the saving controller 23 saves the ultrasound image of the present frame and the measurement result in the image memory 24. In this manner, the optimum image is saved in the image memory 24, whereby the user can confirm the optimum image and the measurement result saved in the image memory 24 after ultrasound diagnosis ends” [0096]; “In subsequent Step S10, the notification unit 26 notifies the user that the optimum image is saved. In this case, for example, as shown in FIG. 8, the notification unit 26 can display a notification panel PA representing saving of the optimum image on the display unit 8 through the display controller 7 [0097]. As shown in FIG. 8, the measurement results panel PR is shown along with the ultrasound image and a notification is provided in panel PA indicating that the saving controller 23 has saved the ultrasound image and the measurement result (i.e. major and/or minor axes of the gallbladder). Therefore, the first size information and/or related information that is related to the first size information are saved to an external apparatus and/or medical record (i.e. medical record stored in the image memory 24).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound endoscope of Endo such that the first size information and/or related information that is related to the first size information are saved in an external apparatus and/or medical record as disclosed in Imai in order to allow first size information and/or related information to be saved and thus accessed at a later time when performing analysis.
Regarding claim 28, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 1 above, and Endo teaches “wherein the ultrasound image is an endoscopic ultrasound image” (“The operator can acquire an endoscopic image of an inner wall of the body cavity of the patient and an ultrasound image of an observation target site by the function of the ultrasonic endoscope 12” [0039]; “FIG. 5 illustrates a state where two measurement points (a first measurement point A and a second measurement point B) are specified for an ultrasound image G being displayed on the monitor 20 by the operation of the operator” [0085]. Therefore, the ultrasound image is an endoscopic ultrasound image and calipers are displayed thereon, see FIG. 5.).
Claim(s) 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Endo et al. US 2021/0007709 A1 “Endo”, Imai US 2021/0077066 A1 “Imai” and Uchihara et al. US 2021/0369238 A1 “Uchihara” as applied to claims 21 and 22 above, and further in view of Sarojam et al. US 2017/0124700 A1 “Sarojam”.
Regarding claim 23, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 22 above. However, the combination does not teach “wherein a geometric property of the calipers is changed according to a given third instruction, and the range is changed in association with the change in the geometric property”.
Sarojam is within a related field of endeavor to the claimed invention because it involves methods and systems for measuring a volume of an organ of interest in an ultrasound image (See [Abstract]).
Sarojam teaches “wherein a geometric property of the calipers is changed according to a given third instruction, and the range is changed in association with the change in the geometric property” (“For example, a user via the touchscreen display 120 may select and reposition one of the calipers 1104 or 1106. The controller 202 may reposition the selected caliper 1104 or 1106 displayed on the GUI 1100 in response to the change in position of the selected caliper 1104 or 1106 by the user. The controller 202 updates and/or adjusts the first dimensional length 1116 based on the repositioned opposing caliper 1104 or 1106. Additionally, or alternatively, the controller 202 may update the measurement window 1114 based on the adjusted first dimensional length 1116” [0106]. The calipers 1104 and 1106 are shown in FIG. 11. Therefore, when a user changes the position of the caliper 1104 or 1106, the first dimensional length 1116 changes to reflect the new length. Therefore, a geometric property of the calipers is changed according to a given third instruction (i.e. user input), and the range (i.e. first dimensional length 1116) is changed in association with the change in the geometric property.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound endoscope of Endo in view of Imai and Uchihara such that a geometric property of the calipers is changed according to a given third instruction, and the range is changed in association with the change in the geometric property as disclosed in Sarojam in order to allow a user to have better control in adjusting the positioning of calipers such that measurements can be accurately performed on a target site of observation. Receiving a user input to adjust the position of a caliper is one of a finite number of techniques which can be used to perform a measurement of a target site within an ultrasound image with a reasonable expectation of success. Thus, modifying the medical assistance apparatus of Imai such that a geometric property of the calipers is changed according to a given third instruction, and the range is changed in association with the change in the geometric property as disclosed in Sarojam would yield the predictable result of allowing a user to have better control in adjusting the positioning of calipers such that measurements can be accurately performed on a target site of observation.
Regarding claim 24, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 21 above. However, the combination does not teach “wherein while the first ultrasound image is being displayed on the screen, the processor is configured to output third size information indicating a third size of the range selected according to a given fourth instruction among a plurality of ranges”.
Sarojam teaches “wherein while the first ultrasound image is being displayed on the screen, the processor is configured to output third size information indicating a third size of the range selected according to a given fourth instruction among a plurality of ranges” (“The methods and systems further determine a first boundary of the OOI within the first ultrasound image and a second boundary of the OOI within the second ultrasound image by executing a contour model stored in the memory, determine a first second dimensional length of the OOI from the first boundary and a third dimensional length of the OOI from the second boundary, and calculate a volume of the OOI derived from the first, second, and third dimensional links” [Abstract]; “The method may also include determining first and second dimensional lengths of the OOI from the first boundary and a third dimensional length of the OOI from the second boundary, and calculating a volume of the OI tried the first, second, and third dimensional lengths” [0004]; “At 718, the controller 202 determines a third dimensional length 1216 of the OOI from the second boundary 1220. The third dimensional length 1216 may be formed from two opposing points along the second boundary 1220. The third dimensional length 1216 may correspond to dimensions of the OOI, such as a height. The GUI 1200 may further include opposing calipers 1204 and 1206 that define the third dimensional length 1216. For example, the third dimensional length 1116 is formed from opposing points shown by the calipers 1204 and 1206. The calipers 1204 and 1206 are positioned at a widest point or distance along the second boundary 1220 to form the third dimensional length 1216” [0111]. Therefore, first, second and third dimensional lengths are calculated and used to determine the volume of the OOI (i.e. organ of interest). Thus, while the first ultrasound image is being displayed on the screen, the processor is configured to output third size information (i.e. third length) indicating a third size of the range selected according to a given fourth instruction among a plurality of ranges (i.e. third dimension length 1216).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound endoscope of Endo in view of Imai and Uchihara such that while the first ultrasound image is displayed on the screen, a processor is configured to output third size information indicating a third size of the range selected according to a given fourth instruction among a plurality of ranges as disclosed in Sarojam in order to allow for the calculation of a volume of an organ of interest. Measuring three lengths is one of a finite number of techniques which can be used to measure a characteristic of an organ such as its volume with a reasonable expectation of success. Thus, modifying the medical assistance apparatus of Imai such that while the first ultrasound image is displayed on the screen, a processor is configured to output third size information indicating a third size of the range selected according to a given fourth instruction among a plurality of ranges as disclosed in Sarojam would yield the predictable result of allowing for the calculation of a volume of an organ of interest.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Endo et al. US 2021/0007709 A1 “Endo”, Imai US 2021/0077066 A1 “Imai” and Uchihara et al. US 2021/0369238 A1 “Uchihara” as applied to claims 21 and 22 above, and further in view of Wang et al. CN 104657984 A1 “Wang”.
Regarding claim 32, Endo in view of Imai and Uchihara discloses all features of the claimed invention as discussed with respect to claim 1 above, however the combination does not teach “wherein the reference value is a statistical value of lengths of the target site of observation shown in the plurality of ultrasound images”.
Wang is within a related field of endeavor to the claimed invention because it involves performing image processing to extract a tumor (i.e. lesion) region (see [Abstract]).
Wang teaches “wherein the reference value is a statistical value of lengths of the target site of observation shown in the plurality of ultrasound images” (“Thus, for one suspected tumor image group contains 7 images, we can obtain 7-1 overlapping rate. To the 7-1 characteristic by induction, respectively calculating the average, standard deviation, and the product gradient average value, as the feature of the classification” [0032]. Therefore, based on the 7 images contained in the tumor image group, the tumor being representative of a type of lesion, a 7-1 characteristic (i.e. reference) is calculated through an average, standard deviation and product gradient average value. Therefore, the method carried out by Wang involves calculating a reference value (i.e. 7-1 characteristic), wherein the reference value is a statistical value of lengths of the target site of observation (i.e. tumor/lesion) shown in the plurality of ultrasound images.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ultrasound endoscope of Endo in view of Imai and Uchihara such that the reference value is a statistical value of lengths of the target site of observation shown in the plurality of ultrasound images as disclosed in Wang in order to better characterize the lesion/tumor present within the ultrasound images. Calculating a statistical value, such as an average or standard deviation, based on a plurality of ultrasound images is one of a finite number of techniques which can be used to assess whether additional images contain features that are indicative of the presence of a lesion/tumor with a reasonable expectation of success. Thus, modifying the ultrasound endoscope of Endo in view of Imai and Uchihara such that the reference value is a statistical value of lengths of the target site of observation shown in the plurality of ultrasound images as disclosed in Wang would yield the predictable result of characterizing whether an ultrasound image contains a lesion/tumor based on comparing characteristics to the calculated statistical value.
Allowable Subject Matter
Claims 25 and 26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 25, Endo in view of Imai and Uchihara and Sarojam discloses all features of the claimed invention as discussed with respect to claim 24 above, however the combination does not teach “wherein the ranges are assigned a priority, and calipers indicating the ranges are displayed in a state allowing for identification of the priority”.
Furthermore, during the examiner’s updated search no prior art references were found to teach the above limitations both alone or in combination with the other limitations of claims 1, 21, 24 on which this claim depends.
Thus, claim 25 would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 26, Endo in view of Imai and Uchihara and Sarojam discloses all features of the claimed invention as discussed with respect to claim 25 above, however, the combination does not teach “wherein the calipers are displayed on the screen in an order corresponding to the priority”.
Furthermore, during the examiner’s updated search no prior art references were found to teach the above limitations both alone or in combination with the other limitations of claims 1, 21, 24 and 25 on which this claim depends.
Thus, claim 26 would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
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/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797
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