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 .
DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group II (claims 9-22) in the reply filed on 13 July 2026 is acknowledged. The traversal is on the ground(s) that the claimed inventions of Groups I, II, and III are functionally interrelated, as they collectively encompass a pipeline for evaluating brain tissue: determining optimal discriminants from arrays of data (Group I), determining candidate optical discriminants from optical spectra (Group II), and designating a subject as normal or non-normal using PCA transformation applied to optical spectrum data (Group III); and that the mere existence of different search classifications, standing alone, does not demonstrate a serious search or examination burden. This is not found persuasive because each group has different claimed subject matter; and hence, they are distinct inventions which lead to a serious search and/or examination burden. The newly added claims 26-36 will be under examination along with the elected Group II readable on claims 9-22.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-8 and 23-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 13 July 2026.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 9-22 and 26-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 9 (Original) – Computer-implemented method includes:Receiving first and second optical spectra; determining a diagnostic cut-off value based on an average of median values of spectral intensity; determining first and second quantities based on the cut-off; determining a discriminant statistic based on the quantities; and selecting a threshold (based on discriminant statistic values) that selects index elements as candidate optical discriminants that separate the two groups of subjects.
• Step 1: Statutory (process).
• Step 2A Prong 1: Yes – abstract idea (mathematical concepts / mental processes: averaging medians, deriving a cut-off, counting quantities relative to the cut-off, computing a discriminant statistic, and applying a threshold).
• Step 2A Prong 2: No practical application. Generic “computing device” + conventional data reception. Medical utility and optical-spectra field-of-use limitations do not integrate the abstract idea.
• Step 2B: No inventive concept. Routine mathematical data processing on a generic computer.
Conclusion: ineligible.
Claim 21 (Original) – Apparatus includes: One or more processors + memory storing instructions that cause the apparatus to perform essentially the same steps as claim 9.
• Same abstract idea as claim 9.
• Generic processors + memory do not supply a practical application or inventive concept.
Conclusion: ineligible (same reasoning as claim 9).
Claim 26 (New) – One or more non-transitory computer-readable media includes: Instructions that, when executed, cause a processor to perform essentially the same steps as claim 9.
• Same abstract idea as claim 9.
• Non-transitory CRM + generic processor is conventional and does not integrate the idea or add significantly more.
Conclusion: ineligible (same reasoning as claim 9).
Dependent Claims – Method (claims 10–20)
Claim 10 – Further comprising determining a subset of the candidate optical discriminants; determining a PCA transformation that reduces dimensionality; and reducing the dimensionality of the subject of the candidate optical discriminants.
Adds conventional PCA (well-known mathematical technique). Does not integrate the abstract idea or supply an inventive concept.
Conclusion: ineligible.
Claim 11 – Further comprising receiving an optical spectrum corresponding to a subject and designating the subject as normal or non-normal by applying the PCA transformation (based on the reduced subset) to the spectrum.
Adds classification of a new spectrum using the prior mathematical results. Still abstract data analysis + generic computer.
Conclusion: ineligible
Claim 12 – Wherein the first optical spectra are associated with specimens having a medical condition and the second with specimens not having the condition.
Field-of-use / data-source limitation. Does not integrate or add significantly more.
Conclusion: ineligible.
Claim 13 – Medical condition comprises Alzheimer’s disease.
Further narrows the field of use.
Conclusion: ineligible.
Claim 14 – Medical condition comprises one or more Lewy bodies in brain tissue.
Same as claim 13.
Conclusion: ineligible.
Claim 15 – Medical condition comprises Gulf War Illness.
Same as claim 13.
Conclusion: ineligible.
Claim 16 – Further comprising determining wavelengths present in the spectra and determining the median value of spectral intensity for each spectrum based on those wavelengths.
Explicitly recites the median calculation already implicit in claim 9. Purely mathematical.
Conclusion: ineligible.
Claim 17 – Wherein the first quantity comprises median values ≤ the diagnostic cut-off.
Defines the quantity mathematically.
Conclusion: ineligible.
Claim 18 – Wherein the second quantity comprises median values ≤ the diagnostic cut-off.
Same as claim 17.
Conclusion: ineligible.
Claim 19 – Wherein the threshold value comprises a product of the first quantity and the second quantity.
Specific mathematical formula for the threshold. Still an abstract idea.
Conclusion: ineligible.
Claim 20 – Wherein the threshold value is 0.45.
Specific numerical value for the product threshold. Conventional parameter selection; does not create eligibility.
Conclusion: ineligible.
Dependent Claims – Apparatus (claim 22)
Claim 22 –wherein the spectra are associated with specimens having / not having a medical condition.
Same field-of-use limitation as claim 12.
Conclusion: ineligible.
Dependent Claims – CRM (claims 27–36)
Claim 27 – Further instructions to determine a subset of candidate discriminants, determine a PCA transformation reducing dimensionality, and reduce dimensionality.
Same as claim 10.
Conclusion: ineligible.
Claim 28 – Further instructions to receive a subject spectrum and designate normal/non-normal by applying the PCA transformation to it.
Same as claim 11.
Conclusion: ineligible.
Claim 29 – Spectra associated with specimens having / not having a medical condition.
Same as claim 12.
Conclusion: ineligible.
Claim 30 – Medical condition comprises Alzheimer’s disease.
Same as claim 13.
Conclusion: ineligible.
Claim 31 – Medical condition comprises Lewy bodies.
Same as claim 14.
Conclusion: ineligible.
Claim 32 – Medical condition comprises Gulf War Illness.
Same as claim 15.
Conclusion: ineligible.
Claim 33 – Further instructions to determine wavelengths and median spectral intensities.
Same as claim 16.
Conclusion: ineligible.
Claim 34 – First quantity comprises medians ≤ cut-off.
Same as claim 17.
Conclusion: ineligible.
Claim 35 – Second quantity comprises medians ≤ cut-off.
Same as claim 18.
Conclusion: ineligible.
Claim 36 – Threshold comprises a product of the first and second quantities.
Same as claim 19.
Conclusion: ineligible.
Since there are no limitations in these claims that transform the exception into a patent eligible application such that these claims amount to significantly more than the exception itself, claims 9-22 and 26-36 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Etkin et al (US 12,383,196) disclose a method of identifying antidepressant-responsive depression phenotypes in subjects undergoing treatment of depression with an antidepressant using a machine learning model. Samadani et al (US 11,304,601) disclose methods and kits for detecting, screening, quantifying or localizing the etiology for reduced or impaired cranial nerve function or conduction or associated cranial nucleus or supranuclear input, useful for detecting, diagnosing or screening for increased intracranial pressure, or useful for detecting, diagnosing, monitoring progression of or screening for a disease or condition featuring increased intracranial pressure by tracking eye movement of the subject. Hanlon et al (US 10,405,751) disclose spectroscopic devices and methods of detecting brain damage from disease, such as Alzheimer's disease, or brain injury, such as traumatic brain injury.
Contact Information
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/AN H DO/Primary Examiner, Art Unit 2853
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