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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 5, 2024, March 26, 2025, July 16, 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
Claims 14-16, 18, 20 objected to because of the following informalities:
Claim 14: “The diagnosis support device according to The diagnosis support device according to wherein the acquisition unit acquires…” should read “The diagnosis support device according to claim 12, wherein the acquisition unit acquires…”
Claim 15: “The diagnosis support device according to The diagnosis support device according to wherein the image feature amount…” should read “The diagnosis support device according to claim 14, wherein the image feature amount…”
Claim 16: “The diagnosis support device according to The diagnosis support device according to wherein the acquisition unit acquires…” should read “The diagnosis support device according to claim 12, wherein the acquisition unit acquires…”
Claim 18: “The diagnosis support device according to The diagnosis support device according to wherein the output unit…” should read “The diagnosis support device according to claim 12, wherein the output unit…”
Claim 20: “The diagnosis support device according to The diagnosis support device according to wherein the output unit…” should read “The diagnosis support device according to claim 12, wherein the output unit…”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: "unit" in claims 12-14, 16-19, 21.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 12-25 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a
judicial exception without significantly more.
Claim 12 is directed to a method for tracking movement. Under Step 2A Prong One, the claim
recites abstract ideas including:
(1) Mental processes: "acquiring subject data including a medical image related to a brain of a subject and subject information including neuropsychological test information of the subject" (observation), "predicting a brain disease of the subject on the basis of the subject data" (evaluation and comparison that can be performed in the human mind), and "predicting a diagnosis based on the specified data and prior knowledge related to the brain disease”
(mental process of observation and logical reasoning);
(2) Certain methods of organizing human activity: "a mental process that a neurologist should follow when testing a patient for nervous system malfunctions"
(managing information about human behavior and movement).
Under Step 2A Prong Two, the claim does not integrate the judicial exception into a practical
application. The additional elements amount to: a diagnosis support device (claim 12), a computer program and non-transitory recording medium to carry out the diagnosis support device instructions (claim 22), and a diagnosis support method (claim 24). These elements do not improve the functioning of a computer or other technology, do not effect a particular transformation, and do not apply the abstract idea with a particular machine in a meaningful way.
Under Step 2B, the additional elements do not provide an inventive concept. The elements
represent well-understood, routine, conventional activity in the art, including: using conventional
medical image acquisition techniques, performing routine diagnostic decisions, using standard evaluation and prediction methods, and applying known image processing for medical diagnosis. The specification acknowledges using prior knowledge that a physician implements in practice to determine a patient prognosis in neurodegenerative disease.
Claims 13-21 depend on Claim 12 and add limitations that are also well-understood, routine,
conventional activities that do not amount to significantly more than the judicial exception.
Claim 22 recites the same abstract ideas as Claim 12 in system format. The recitation of generic
computer components ("hardware processor," "memory") does not integrate the judicial
exception into a practical application or provide significantly more.
Claim 23 depend on Claim 22 and are ineligible for the same reasons as Claims 13-21.
Claim 24 recites the method for diagnosis support, with the same abstract ideas as Claim 12.
Claim 25 dependent on Claim 24 and are ineligible for the same reasons as Claims 13-21.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 12, 14-16, 22, 24 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shiino (United States Patent Application Publication US 2023/0162351 A1).
Regarding claim 12, Shiino discloses a diagnosis support device comprising: an acquisition unit acquiring subject data including both a feature amount of a medical image related to a brain of a subject and subject information including neuropsychological test information of the subject; a prediction unit predicting a brain disease of the subject on the basis of the subject data (Shiino Figure 1, 2, brain image acquisition unit, prediction algorithm); a specification unit specifying a data item corresponding to subject data, which contributes to a prediction result of the prediction unit, in the subject data (Shiino Figure 2, teacher data generation unit); and an output unit outputting the data item specified by the specification unit and prior knowledge related to the brain disease in association with each other (Shiino Figure 19, diagnosis assistance device with display).
Regarding claim 14, Shiino discloses the diagnosis support device according to the diagnosis support device according to wherein the acquisition unit acquires, as the subject data, an image feature amount calculated on the basis of the medical image related to the brain of the subject (Shiino Figure 19, Diagnosis assistance device has MRI device image as input into the brain image acquisition unit).
Regarding claim 15, Shiino discloses the diagnosis support device according to claim 14 wherein the image feature amount includes a degree of atrophy of a part of the brain (Shiino [0126]-[0131], Figures 10-11).
Regarding claim 16, Shiino discloses the diagnosis support device according to claim 12, wherein the acquisition unit acquires, as the subject data, subject information including at least one of test information and clinical information related to the brain of the subject (Shiino Figure 15, Machine learning device includes inputs from brain image and diagnosis result, with results then inputted to the diagnosis assistance device after prediction algorithm is applied).
Regarding claim 22, the rejection rationale of claim 12 is fully incorporated herein. Shiino discloses a computer readable non-transitory recording medium recording a computer program causing a computer to execute a process comprising: acquiring subject data including both a feature amount of a medical image related to a brain of a subject and subject information including neuropsychological test information of the subject; predicting a brain disease of the subject on the basis of the subject data (Shiino Figure 1, 2, brain image acquisition unit, prediction algorithm); specifying a data item corresponding to subject data, which contributes to a prediction result of the brain disease, in the subject data (Shiino Figure 2, teacher data generation unit); and outputting the specified data item and prior knowledge related to the brain disease in association with each other (Shiino Figure 19, diagnosis assistance device with display).
Regarding claim 24, the rejection rationale of claim 12 is fully incorporated herein. Shiino discloses a diagnosis support method comprising: acquiring subject data including both a feature amount of a medical image related to a brain of a subject and subject information including neuropsychological test information of the subject; predicting a brain disease of the subject on the basis of the subject data (Shiino Figure 1, 2, brain image acquisition unit, prediction algorithm); specifying a data item corresponding to subject data, which contributes to a prediction result of the brain disease, in the subject data (Shiino Figure 2, teacher data generation unit); and outputting the specified data item and prior knowledge related to the brain disease in association with each other (Shiino Figure 19, diagnosis assistance device with display).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 13, 17-21, 23, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shiino (United States Patent Application Publication US 2023/0162351 A1) in view of Li (United States Patent Application Publication US 2023/0260630 A1).
Regarding claim 13, Shiino discloses a diagnosis support device according to claim 12. However, Shiino fails to disclose further comprising: a scaling unit scaling the subject data; wherein the prediction unit predicting a brain disease of the subject on the basis of the scaled subject data.
Li teaches further comprising: a scaling unit scaling the subject data; wherein the prediction unit predicting a brain disease of the subject on the basis of the scaled subject data (Li Figure 4, normalization unit performs normalizing processing of matching the head MRI image with the reference head MRI image). This step is important so that there is consistency between the image sizes for additional analysis. Thus, it would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have combined the teachings of Shiino and Li so that the device of Shiino has a scaling unit.
Regarding claim 17, Shiino discloses the diagnosis support device according to claim 12. However, Shiino fails to disclose further comprising: a storage unit storing the prior knowledge as known evidence related to the brain disease in association with a data item related to the brain; and a contribution degree calculation unit calculating a degree of contribution of the subject data, which contributes to the prediction result, wherein the specification unit specifies the data item corresponding to the subject data on the basis of the degree of contribution and a predetermined contribution degree threshold value, and the output unit reads prior knowledge corresponding to the specified data item from the storage unit and outputs the prior knowledge.
Li teaches further comprising: a storage unit storing the prior knowledge as known evidence related to the brain disease in association with a data item related to the brain; and a contribution degree calculation unit calculating a degree of contribution of the subject data, which contributes to the prediction result, wherein the specification unit specifies the data item corresponding to the subject data on the basis of the degree of contribution and a predetermined contribution degree threshold value, and the output unit reads prior knowledge corresponding to the specified data item from the storage unit and outputs the prior knowledge (Li, Figure 8, 20 contribution information, Figure 3 diagnosis support device with contribution derivation unit, [0008], [0110] Figure 7, the dementia opinion derivation unit). This is essential to the claimed invention because that degree of contribution gives insight into the progression of the disease at a specific time point. Thus, it would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have combined the teachings of Shiino and Li so that the contribution degree calculation unit is included in the device of Shiino.
Regarding claim 18, Shiino discloses the diagnosis support device according to claim 12. However, Shiino fails to disclose wherein the output unit outputs a degree of association between the data item and the prior knowledge.
Li teaches wherein the output unit outputs a degree of association between the data item and the prior knowledge (Li, [0119] Figure 12, derivation results in descending order of the first contribution are displayed at the display control unit). This is important to the claimed invention because the association between various images during the disease state progression and prior knowledge of the disease provides critical insight into the characteristic of the patient specific diagnosis and prognosis. Thus, it would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have combined the teachings of Shiino and Li so that the degree of association is noted in the device of Shiino.
Regarding claim 19, Li discloses the diagnosis support device according to claim 18, further comprising: an association degree calculation unit calculating the degree of association on the basis of at least one of the degree of contribution of the subject data corresponding to the data item and a reliability of the prior knowledge as evidence (Li, [0116]-[0119], Figure 12).
Regarding claim 20, Shiino discloses the diagnosis support device according to claim 12. However, Shiino fails to disclose wherein the output unit outputs the subject data corresponding to the data item.
Li teaches wherein the output unit outputs the subject data corresponding to the data item (Li, Figure 29, output unit outputs first class data which is whether dementia is developed and second-class data which is the age of patient). This is important to the claimed invention because the output allows the physician to gather the data appropriately. Thus, it would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have combined the teachings of Shiino with the teachings of Li so that the output is reflected with the subject data.
Regarding claim 21, Shiino discloses the diagnosis support device according to claim 12. However, Shiino fails to disclose further comprising: a display unit displaying the data item, the subject data, and the prior knowledge corresponding to the data item in association with one another in an order of the degree of contribution of the subject data corresponding to the data item to the prediction result.
Li teaches further comprising: a display unit displaying the data item, the subject data, and the prior knowledge corresponding to the data item in association with one another in an order of the degree of contribution of the subject data corresponding to the data item to the prediction result (Li, Figure 26 diagnosis support application displays information related to the patient and contribution results). This is important to the claimed invention because the association between various images during the disease state progression and prior knowledge of the disease provides critical insight into the characteristic of the patient specific diagnosis and prognosis. Thus, it would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have combined the teachings of Shiino and Li so that the degree of association is noted in the device of Shiino.
Regarding claim 23, Shiino discloses a computer readable non-transitory recording medium according to claim 22. However, Shiino fails to disclose recording a computer program causing a computer to execute a process comprising: scaling the subject data; predicting a brain disease of the subject on the basis of the scaled subject data.
Li teaches recording a computer program causing a computer to execute a process comprising: scaling the subject data; predicting a brain disease of the subject on the basis of the scaled subject data (Li Figure 4, normalization unit performs normalizing processing of matching the head MRI image with the reference head MRI image). This step is important so that there is consistency between the image sizes for additional analysis. Thus, it would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have combined the teachings of Shiino and Li so that the device of Shiino has a scaling unit.
Regarding claim 25, Shiino discloses a diagnosis support method according to claim 24. However, Shiino fails to disclose further comprising: scaling the subject data; predicting a brain disease of the subject on the basis of the scaled subject data.
Li teaches further comprising: scaling the subject data; predicting a brain disease of the subject on the basis of the scaled subject data (Li Figure 4, normalization unit performs normalizing processing of matching the head MRI image with the reference head MRI image). This step is important so that there is consistency between the image sizes for additional analysis. Thus, it would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have combined the teachings of Shiino and Li so that the device of Shiino has a scaling unit.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA YIFANG LIN whose telephone number is (571)272-6435. The examiner can normally be reached M-F 7:00am-6:15pm, with optional day off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vu Le can be reached at 571-272-7332. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSICA YIFANG LIN/Examiner, Art Unit 2668 March 12, 2026
/VU LE/Supervisory Patent Examiner, Art Unit 2668