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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
The certified copy/copies of JP2024-112631 has/have been received on 07/28/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/03/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
A series of singular dependent claims is permissible in which a dependent claim refers to a preceding claim which, in turn, refers to another preceding claim.
A claim which depends from a dependent claim should not be separated by any claim which does not also depend from said dependent claim. It should be kept in mind that a dependent claim may refer to any preceding independent claim. In general, applicant's sequence will not be changed. See MPEP § 608.01(n). Claims 5-7 depend on Claim 2, and are improper because it is separated by Claims 3 and 4, claims that do not depend on Claim 2.
Claims 1 and 8-10 are objected to because of the following informalities:
In Claim 1, “comprising one or more processors acquiring a … and displaying a” is suggested to read “comprising one or more processors configured to acquire a … and display a”.
In Claim 1, “relating to a diagnosis region, based on a plurality” is suggested to read “relating to a diagnosis region based on a plurality”.
In Claim 8, “select the chronological change value to be further assigned to a third axis from the plurality of feature amounts” is suggested to read “select a chronological change value to be further assigned to a third axis from the plurality of feature amounts”.
In Claim 9, “comprising one or more processors: acquiring a … and displaying a” is suggested to read “comprising one or more processors configured to: acquire a … and display a”.
In Claim 10, “medium recording a program to cause one or more processors to execute processing comprising: …” is suggested to read “medium storing a program that causes one or more processors to execute a process comprising: …”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites “display a scatter plot” it is unclear whether this is referring to the scatterplot displayed in Claim 1, or a new/different/second one. For the sake of further prosecution, Examiner will interpret this limitation as displaying an updated a scatter plot (now having a third axis).
Claim Rejections - 35 USC § 101
Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim 1 is directed to an abstract idea. The claim does not include additional elements that are sufficient to amount to the judicial exception.
For Claim 1:
Step 1: The claim(s) as a whole fall within one or more statutory categories
Claim 1 is directed to a machine (a classification assisting device).
Step 2A, Prong 1: Is/Are the claim(s) directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea)?
Claim 1 is directed to an abstract idea, see rationale below.
Claim 1:
acquiring a chronological change value of each of a plurality of feature amounts relating to a diagnosis region, based on a plurality of diagnosis images imaged at times different from each other → mental process because a human can practically acquire changes in diagnosis images imaged at different times and assign values to them
Step 2A, Prong 2: Do they claim(s) recite additional elements that integrate the exception into a practical application of the exception?
one or more processors → generic computer components
displaying a scatter diagram in which the chronological change value to be assigned to a first axis and the chronological change value to be assigned to a second axis are selected from a plurality of feature amounts → outputting
The judicial exception is not integrated into a practical application. Although Claim 1 recites “one or more processors … displaying a scatter diagram in which the chronological change value to be assigned to a first axis and the chronological change value to be assigned to a second axis are selected from a plurality of feature amounts”, the claim does not amount to significantly more than a generic device performing a mental process.
Step 2B: Does the claim as a whole amount to significantly more than the judicial exception? I.e. Are there any additional elements (features/limitations/steps) recited in the claim beyond the abstract idea?
The claims do not include additional elements that amount to significantly more than the abstract idea. The step “acquiring a chronological change value of each of a plurality of feature amounts relating to a diagnosis region, based on a plurality of diagnosis images imaged at times different from each other” is a mental process, “one or more processors” are generic computer components, and “displaying a scatter diagram in which the chronological change value to be assigned to a first axis and the chronological change value to be assigned to a second axis are selected from a plurality of feature amounts” is outputting data. As a whole, these operations are generic steps taken on a computer.
Claims 9 and 10 are similar in scope to Claim 1, and are directed to an abstract idea. Claim 9 recites a method of the operations performed by the device of Claim 1, the claim does not amount to significantly more than a generic method with a processor and outputting data to perform the abstract ideas in the claim. Claim 10 recites a non-transitory computer-readable recording medium recording a program to cause one or more processors to execute processing of the operations performed by the device of Claim 1, the claim does not amount to significantly more than a generic non-transitory computer-readable recording medium with a processor and outputting data to perform to perform the abstract ideas in the claim.
Claim 2 is supplemental to the device of Claim 1 and recites “acquire a value of change in feature amounts of the diagnosis region images from the reference time to the diagnosis time as the chronological change value”. This step is part of a mental process that could be performed practically by the human mind, similar to the acquiring operation in Claim 1. The claim further recites additional limitations that fail to amount to anything more than the abstract idea. Therefore, the claim as a while does not include additional elements that are sufficient to amount to significantly more than the judicial exception of an abstract idea
Claim 5 is directed to further limit Claim 2 and does not include additional elements that are sufficient to amount to significantly more than the judicial exception of an abstract idea.
Claim 6 is directed to further limit Claim 2 and does not include additional elements that are sufficient to amount to significantly more than the judicial exception of an abstract idea.
Claim 7 is directed to further limit Claim 6 and does not include additional elements that are sufficient to amount to significantly more than the judicial exception of an abstract idea.
Claim 3 is directed to further limit Claim 1 and does not include additional elements that are sufficient to amount to significantly more than the judicial exception of an abstract idea.
Claim 4 is directed to further limit Claim 1 and does not include additional elements that are sufficient to amount to significantly more than the judicial exception of an abstract idea.
Claim 8 is directed to further limit Claim 1 and does not include additional elements that are sufficient to amount to significantly more than the judicial exception of an abstract idea.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hojo (JP 2019069178 A), hereinafter referenced as Hojo in view of Suzuki et al. (“Effect of Tumor Burden and Growth Rate on Treatment Outcomes of Nivolumab in Head and Neck Cancer”, 2020), hereinafter referenced as Suzuki.
Regarding Claim 1, Hojo discloses
A classification assisting device (Hojo: [0005-0008], discloses a classification assisting device to assist doctors in making accurate diagnosis <classification> by providing ease of viewing/understanding of images),
comprising one or more processors (Hojo: [0020], discloses a CPU <a processor>; see [Fig. 4] below)
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Hojo fails to explicitly disclose
acquiring a chronological change value of each of a plurality of feature amounts relating to a diagnosis region, based on a plurality of diagnosis region images imaged at times different from each other
and displaying a scatter diagram in which the chronological change value to be assigned to a first axis and the chronological change value to be assigned to a second axis are selected from the plurality of feature amounts
However, Suzuki discloses
acquiring a chronological change value of each of a plurality of feature amounts relating to a diagnosis region, based on a plurality of diagnosis region images imaged at times different from each other (Suzuki: [Abs, pg. 1], discloses calculating a growth rate and the sum of the diameters of target regions <chronological change values, sum> of a D0 and Dpre <a plurality of feature amounts> relating to target lesions calculated using RECIST ver.1.1. <a method using CT/MRI scans, which are images>; [Discussion, pg. 7], specifies Gr is taken from images across two times),
and displaying a scatter diagram in which the chronological change value to be assigned to a first axis and the chronological change value to be assigned to a second axis are selected from the plurality of feature amounts (Suzuki: [Fig. 3a], displays a scatter diagram in which growth rate, Gr, and sum of diameters of the target lesions, SumTL, are selected from the plurality of features which comprise at least both Gr and SumTL <two features create a plurality>).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply and/or modify the device disclosed by Hojo by graphing change in features chronologically as taught by Suzuki. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to make this modification to convey medical data in a visually easily understandable manner.
Regarding Claim 9, it recites limitations similar to Claim 1 but as a method. As shown in the rejection, the combination of Hojo and Suzuki disclose the device of Claim 1. The combination of Hojo and Suzuki further disclose
A classification assisting method, comprising one or more processors (Hojo: [0001, 0005-0008], disclose a method performed by the classification assisting device; [0019-0020, Fig. 4], disclose the device comprising a CPU <processor>): …
Regarding Claim 10, it recites limitations similar to Claims 1 and 9 but as a non-transitory computer-readable recording medium. As shown in the rejection, the combination of Hojo and Suzuki disclose the device and method of Claims 1 and 9 respectively. The combination of Hojo and Suzuki further disclose
A non-transitory computer-readable recording medium recording a program to cause one or more processors to execute processing (Hojo: [0074], discloses a DVD <non-transitory computer readable recording medium> storing a program to cause a computer to implement the medical imaging operations) comprising: …
Regarding Claim 2, the combination of Hojo and Suzuki disclose the device of Claim 1. The combination of Hojo and Suzuki further disclose(s) wherein the one or more processors
accept input of two times from among times at which the diagnosis region images are imaged (Suzuki: [Discussion, pg. 7], discloses evaluating tumors <diagnosis regions calculated by input images> from two different times; [Abs, pg. 1], discloses two variables D0 and Dpre representing diameters at baseline <first time> and pre-baseline <a second time>),
set, of the accepted two times, an earlier time as a reference time and a time closer to a current time as a diagnosis time (Suzuki: [Abs, pg. 1; Evaluation of tumor parameters, pg. 2], discloses baseline <diagnosis time> and pre-baseline <reference time> times where pre-baseline, the earlier time, had images done before the baseline and baseline imaging was performed just before the start of nivolumab),
and acquire a value of change in feature amounts of the diagnosis region images from the reference time to the diagnosis time as the chronological change value (Suzuki: [Abs, pg. 1], discloses acquiring a grow rate and diameter sum <values of chronological change> in feature amounts of the diagnosis region between baseline and pre-baseline times).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply and/or modify the device disclosed by the combination of Hojo and Suzuki by acquiring chronological change values of sum and rate by two different imaging times as further taught by Suzuki. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to make this modification to support early detection of malignancy with proactive monitoring by tracking changes in growths.
Regarding Claim 8, the combination of Hojo and Suzuki disclose the device of Claim 1. The combination of Hojo and Suzuki further disclose disclose(s) wherein the one or more processors
select the chronological change value to be further assigned to a third axis from the plurality of feature amounts (Suzuki: [Fig. 3b], illustrates a third selected feature, PFS to be assigned to a third axis in the scatter plot from the data in the paper <plurality of feature amounts>; [Abs, pg. 1; Statistical analyses, pg. 2; Efficacy, pg. 3], discloses PFS is the rate of progression free survival over time <a chronological change value>),
and display a scatter diagram based on the chronological change value to be assigned to a first axis, the chronological change value to be assigned to a second axis, and the chronological change value to be assigned to a third axis (Suzuki: [Fig. 3b], illustrates a scatter diagram based on tumor growth rate <chronological change value to be assigned to a first axis>, sum of diameters of the target regions <the chronological change value to be assigned to a second axis>, and PFS < the chronological change value to be assigned to a third axis>).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply and/or modify the device disclosed by the combination of Hojo and Suzuki by creating a 3-dimensional scatterplot as further taught by Suzuki. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to make this modification to enhance the visualization of skin lesion data.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Hojo and Suzuki in view of “How to add images instead of dots in a plotly scatter plot (python) [duplicate]”, 2021, Stack Overflow, hereinafter referenced as StackOverflow.
Regarding Claim 5, the combination of Hojo and Suzuki disclose the device of Claim 2. The combination of Hojo and Suzuki further disclose wherein the one or more processors
arrange a pair of images including the diagnosis region image at the reference time and the diagnosis region image at the diagnosis time (Hojo: [0070], discloses superimposing <arranging> a pair of images including a skin area in first and second diagnosis times <where the skin image at the first diagnosis time is interpreted as the diagnosis region image at the reference time and the skin image at the second diagnosis time is interpreted as the diagnosis region at the diagnosis time, see [Fig. 21] below)
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The combination of Hojo and Suzuki fail to explicitly disclose
arrange an image in the scatter diagram as a plot point
However, StackOverflow discloses
arrange an image in the scatter diagram as a plot point (StackOverflow: [Images 1-3], discloses arranging an image in the scatter diagram as a plot point).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply and/or modify the device disclosed by the combination of Hojo and Suzuki by using images as plot points as taught by StackOverflow. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to make this modification to visualize data/change in tumor progression a visually easily understandable manner.
Regarding Claim 6, the combination of Hojo and Suzuki disclose the device of Claim 2. The combination of Hojo and Suzuki disclose(s) wherein the one or more processors
an image obtained by superimposing the diagnosis region image at the reference time on the diagnosis region image at the diagnosis time (Hojo: [0070], discloses superimposing a first and second diagnosis of skin images, therefore obtaining a superimposed image)
The combination of Hojo and Suzuki fail to disclose
arrange an image
However, StackOverflow discloses
arrange an image (StackOverflow: [Images 1-3], discloses arranging an image in the scatter diagram as a plot point).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply and/or modify the device disclosed by the combination of Hojo and Suzuki by using images as plot points as taught by StackOverflow. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to make this modification to visualize data/change in tumor progression a visually easily understandable manner.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Hojo, Suzuki, and StackOverflow in view of Orimoto et al. (US 20050044500 A1), hereinafter referenced as Orimoto.
Regarding Claim 7, the combination of Hojo, Suzuki, and StackOverflow disclose the device of Claim 6. The combination of Hojo, Suzuki, and StackOverflow further disclose wherein the one or more processors
the diagnosis region image at the reference time (Hojo: [0070], discloses superimposing different skin diagnosis images captured at different times, a first, earlier, time interpreted as the reference time)
superimposing the diagnosis region image at the reference time on the diagnosis region image at the diagnosis time (Hojo: [0070], discloses superimposing different skin diagnosis images captured at different times, a first time interpreted as the reference time and the second time interpreted as the diagnostic time)
elapsed time from the reference time to the diagnosis time (Hojo: [0070], discloses skin diagnosis images captured at two different times <therefore having an elapsed period of time)
The combination of Hojo, Suzuki, and StackOverflow fail to explicitly disclose
change transparency
However, Orimoto discloses
change transparency ofan agent at a time of superimposing the agent over a background according to length of an elapsed time (Orimoto: [0008-0009, 0014], discloses changing the transparency level of a superimposition when <at the time> of superimposing an agent on the background based on the elapsed time after a detection).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply and/or modify the device disclosed by the combination of Hojo, Suzuki, and StackOverflow by changing the transparency level based on elapsed time as taught by Orimoto. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to make this modification to prevent clutter and direct attention by fading out older overlays.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Hojo and Suzuki in view of Schettler (“ISIC – Detect Skin Cancer – Let’s Learn Together”, July 7, 2024), hereinafter referenced as Schettler.
Regarding Claim 3, the combination of Hojo and Suzuki disclose the device of Claim 1. The combination of Hojo and Suzuki fail to explicitly disclose the limitations of Claim 3, however, Schettler discloses wherein the one or more processors
accept input of two feature amounts from among color, size, and a degree of malignancy (Schettler: [Images 4-5, 8-9], discloses parameters of two feature amounts: clin_size_long_diam_mm, representing maximum diameter of the lesion <size> and tbp_lv_area_perim_ratio, representing jaggedness, the ratio between lesions perimeter and area. Circular lesions will have low values; irregular shaped lesions will have higher values. <interpreted as degree of malignancy because a higher area-perimeter ratio indicates a higher probability of malignancy> from among features that also include tbp_lv_H, which represents hue inside the lesion; calculated as the angle of A* and B* in LAB* color space. Typical values range from 25 (red) to 75 (brown)),
and assign one of the accepted two feature amounts to the first axis and the other to the second axis (Schettler: [Images 8-9], see below, where the input features are assigned to the axes of a scatter plot).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply and/or modify the device claimed by the combination of Hojo and Suzuki by selecting features and displaying them on axes as taught by ISIC. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to make this modification to visualize data in a visually easily understandable manner.
Regarding Claim 4, the combination of Hojo and Suzuki disclose the device of Claim 1. The combination of Hojo and Suzuki further disclose(s) wherein the one or more processors
diagnosis region images (Hojo: [0070], discloses diagnosis region images)
The combination of Hojo and Suzuki fail to explicitly disclose
arrange the
However, StackOverflow discloses
arrange the (StackOverflow: [Images 1-3], disclose arranging the images in the scatter diagram as plot points).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply and/or modify the device disclosed by the combination of Hojo and Suzuki by using images as plot points as taught by StackOverflow. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to make this modification to visualize data/change in tumor progression a visually easily understandable manner.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Eisenhauer et al. (“New response evaluation criteria in solid tumors: Revised RECIST guideline (version 1.1)”, 2008) discloses RECIST guidelines.
Ames (US 20080294671 A1) discloses a scatter plot with a chronological change value of a feature represented on the z-axis.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISABELLA OCHSNER whose telephone number is (571)272-9322. The examiner can normally be reached 9:30 - 6:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devona Faulk can be reached at (571) 272-7515. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.O./Examiner, Art Unit 2618
/DEVONA E FAULK/Supervisory Patent Examiner, Art Unit 2618
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