DETAILED ACTION
Status of Claims
This is a Final Office Action in response to the arguments and/or amendments filed on 26 November 2025.
Claim(s) 1, 7, 11, and 12 is/are amended.
Claim(s) 1-15 is/are currently pending and have been examined.
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 .
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1, which is representative of claim 7, recites a method for predicting the accumulation of Alzheimer’s disease-related biomarkers using medical imaging, the method comprising:
acquiring,
calculating
outputting the predicted values of biomarker accumulation for each brain region as results of the prediction.
Similarly, claims 11 recites in part: a method for providing information for companion diagnostics related to Alzheimer's disease treatments using medical imaging, the method comprising:
acquiring,
calculation,
a first calculation operation
a second calculation operation
a first comparison operation
a second comparison operation
The preceding recitations of the claims have had strikethroughs applied to the additional elements beyond the abstract idea to more clearly demonstrate the limitations setting forth the abstract idea. The remaining limitations describe concepts of collecting data cortical thickness data, analyzing it, and providing results.
This concept describes a mental process that a health care provider should follow to determine and evaluate a patient’s accumulation of Alzheimer’s related biomarkers similar to the “mental process that a neurologist should follow when testing a patient for nervous system malfunctions” given in MPEP 2106.04(a)(2)(II)(C) as an example of managing personal behavior in the methods of organizing human activity sub-grouping. As such, these limitations set forth a method of organizing human activity. Alternatively, this concept is analogous to the examples of “observation”, “evaluation”, and “judgement” given in MPEP 2106.04(a)(2)(III). Further, this concept as claimed does not require a scale of data beyond the mental faculties of a human being and the operations of the abstract idea can be practically performed in the human mind. As such, these limitations are determined to recite a mental process. Still further alternatively, the “calculating” limitations expressly describe a mathematical calculation, and as such the claims recites a mathematical concept. While the above limitations set forth concepts that fall within different groupings of abstract ideas, they all set forth abstract ideas. As such, per MPEP 2106.04(II)(B), these concepts are considered together as a single abstract idea for further analysis. Therefore the claims are determined to recite an abstract idea.
MPEP 2106, reflecting the 2019 PEG, directs examiners at Step 2A Prong Two to consider whether the additional elements of the claims integrate a recited abstract idea into a practical application.
Claims 1 and 7 recites a data acquisition processor and a prediction processor. These additional elements are recited at an extremely high level of generality, and are interpreted as generic computing devices. Per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not integrate an abstract idea into a practical application in Step 2A Prong Two, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, these additional elements do not integrate the abstract idea into a practical application.
The claims further recite the additional element of a trained neural network model. At the level of generality claimed, this additional element amounts to instructions to implement the abstract idea with a computing device. As such, this additional element does not integrate the abstract idea into a practical application.
Examiner notes that while the acquiring and outputting limitations are considered part of the abstract idea, that if these features were considered as additional elements they would not integrate the abstract idea into a practical application. Specifically, as these limitations are necessary data gathering and outputting for the abstract idea, these limitations would be insignificant extra-solution activity, and thus would not integrate the abstract idea into a practical application.
There are no further additional elements. When considered as a combination, the additional elements amount to instructions to implement the abstract idea with a generic computing device. As such, the combination does not integrate the abstract idea into a practical application. Therefore the claims are determined to be directed to an abstract idea.
At Step 2B of the Mayo/Alice analysis, examiners are to consider whether the additional elements amount to significantly more than the abstract idea.
As previously noted, the claims recite additional elements which may be interpreted as generic computing devices used to implement the abstract idea or instructions to implement the abstract idea with a computing device. However, per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, these additional elements do not amount to significantly more. There are no further additional elements. When considered as a combination, the additional elements amount to instructions to implement the abstract idea with a generic computing device. As such, the combination does not amount to significantly more than the abstract idea. Therefore, when considered individually and as a combination, the additional elements of the independent claims do not amount to significantly more than the abstract idea. Thus the independent claims are not patent eligible.
Dependent claims 3, 6, 8, 10, and 12-14 further limit the abstract idea, but the claims continue to recite an abstract idea, albeit a narrowed one. Dependent claims 3, 6, 8, 10, and 12-14 do not recite any further additional elements. The previously identified additional elements, individually and in combination, do not integrate the narrowed abstract ideas into a practical application for reasons equivalent to those identified above. As such these claims continue to be directed to an abstract idea. The previously identified additional elements, individually and in combination, do not amount to significantly more than the narrowed abstract ideas for reasons equivalent to those identified above. Dependent claim 2 recites the additional element of data measured from T1-weighted magnetic resonance imaging. When considered individually and in combination with the prior additional element, this additional element does not impose a meaningful limit on the implementation of the abstract idea, and instead amounts to necessary data gathering. As such this additional element, individually and in combination with the previously identified additional element, does not integrate the abstract idea into a practical application. Additionally, Alexander et al. (US 2002/0087274 A1) demonstrates (“Conventional T1 and T2-weighted MRI” [0083]) that measuring data from T1 MRI was conventional long before the priority date of the claimed invention. The conventionality of the data gathering technique further supports the conclusion that this additional element is insignificant extra-solution activity. As such, the additional elements, individually and as a combination, do not amount to significantly more than the abstract idea. Dependent claims 4, 9, and 15 recite the additional element of machine learning. At the level of generality recited, this additional element amounts to instructions to implement the abstract idea with a computing device. As previously noted, implementing an abstract idea on a generic computing device does not integrate an abstract idea into a practical application in Step 2A Prong Two. As such, this additional element, individually and in combination with the previously identified additional elements, does not integrate the abstract idea into a practical application or amount to significantly more than the abstract idea. Dependent claim 5 recites the additional element of data obtained from positron emission tomography (PET). When considered individually and in combination with the prior additional element, this additional element does not impose a meaningful limit on the implementation of the abstract idea, and instead amounts to necessary data gathering. As such this additional element, individually and in combination with the previously identified additional element, does not integrate the abstract idea into a practical application. Additionally, Song (US 2003/0031380 A1) demonstrates (“conventional medical scanners, such as positron emission tomography (PET)” [0110]) that obtaining data from PET was conventional long before the priority date of the claimed invention. The conventionality of the data gathering technique further supports the conclusion that this additional element is insignificant extra-solution activity. As such, the additional elements, individually and as a combination, do not amount to significantly more than the abstract idea. Thus as the dependent claims remain directed to a judicial exception, and as the additional elements of the claims do not amount to significantly more, the dependent claims are not patent eligible.
Response to Arguments
Applicant’s Argument Regarding 101 Rejections of claims 7-10 and 12: Claim 7 has been amended to replace the term “unit” with “processor” while maintaining the original technical meaning and structure of the claim.
Examiner’s Response: Applicant's amendments 26 November 2025 have been fully considered and they resolve the identified issues. The rejections under 112(b) are withdrawn.
Applicant’s Argument Regarding 101 Rejections of claims 1-15:
Amended claim 1 explicitly recites concrete technological operations implemented by defined hardware components.
“acquiring, by a data acquisition processor, first cerebral cortical thickness data for each region in the brain of a subject from MRI data of the brain processed to obtain cortical thickness data” (a physical operation performed on MRI signals, not an abstract idea)
“calculating, by a prediction processor executing a trained neural network model” (a specific computing algorithm operating on acquired cortical thickness data to generate a predicted value of biomarker accumulation)
The claim cannot be performed as a mental process or by pen and paper, and thus is not directed to an abstract idea.
The claimed method processes MRI image data to compute predicted biomarker accumulation values for respective brain regions. This provides a specific improvement to a technological process, namely, non-invasive prediction of Alzheimer’s disease-related biomarker accumulation without the need for PET scanning.
The additional claim elements, including (i) the data acquisition processor that processes MRI signals, and (ii) the prediction processor executing a trained neural network model, represent “significantly more” than a generic computer implementation.
Examiner’s Response: Applicant's arguments filed 26 November 2025 have been fully considered but they are not persuasive.
Applicant’s argument that the claims are eligible because they recite “concrete technological operations implemented by defined hardware components” does appear to address any of the eligibility considerations of the Mayo/Alice analysis. Examiner notes that numerous claims involving ostensibly technical operations performing by general computing devices have been found by the courts to be ineligible.
Examiner notes that the claim does not require any operations on MRI signals. As written the claim requires acquiring cerebral cortical thickness data from processed MRI data. The claim does not require the processing or the use of the MRI signals directly, and instead encompasses reading results off a sheet of paper.
Examiner notes that the generic invocation of “a trained neural network model” does not constitute “a specific computing algorithm.”
Examiner notes that MPEP 2106.04(a)(2)(III) does not require the entirety of a claim to be performable in the human mind for the claim to set forth a mental process. Thus the presence of generic processors and a trained neural network does not per se exclude the claim from reciting a mental process. Further, that consideration exclusively applies to the mental processes subgrouping, and a claim may still recite an abstract idea by setting forth methods of organizing human activity or mathematical concepts that are not practically performable in the human mind.
Per MPEP 2106.05(a), “It is important to note, the judicial exception alone cannot provide the improvement.” Here, the asserted improvement appears to be entirely of the abstract idea. As such, it does not render the claim eligible.
Examiner notes (1) that the claims do not recite a processor that “processes MRI signals”, and (2) the presence of a neural network does not per se constitute significantly more, as illustrated in Example 47, Claim 2: “The additional element of ‘using the trained ANN’ in limitations (d) and (e) are at best mere instructions to ‘apply’ the abstract ideas, which cannot provide an inventive concept. See MPEP 2106.05(f).”
Applicant’s Argument Regarding 102 Rejections of Claims 1-10 and 103 Rejections of claims 11-15: Seo fails to disclose outputting region-level predicted values of biomarker accumulation as results of the prediction. Seo provides only binary classification results, indicating whether tau accumulation is positive or negative, without producing continuous, region-specific prediction data. The present invention, by contrast, outputs predicted values of biomarker accumulation for each brain region.
Examiner’s Response: Applicant's arguments filed 26 November 2025 have been fully considered and they are persuasive. The rejections under 102 and 103 are withdrawn.
Additional Considerations
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found in the PTO-892 of the prior office action dated 27 August 2025.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bion A Shelden whose telephone number is (571)270-0515. The examiner can normally be reached M-F, 12pm-10pm EST.
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/Bion A Shelden/ Primary Examiner, Art Unit 3685 2026-02-04