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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/19/2026 has been entered.
Response to Arguments
Applicant's arguments, see Remarks pages 2-10, filed 08/19/2026, with respect to the 35 USC 101 rejection of claims 17-18, 20, 24, 25, 28-29, and 31-34 have been fully considered but they are not persuasive.
In response to the applicant’s arguments that the claims do not recite mental processes, the examiner respectfully disagrees. The examiner maintains the contention from the previous office action that the step(s) within the claims that are being interpreted as part of the abstract idea are indeed mental processes capable of being performed in the human mind and/or mathematical concepts.
In response to the applicant’s arguments that the claims do not recite mathematical concepts, the examiner respectfully disagrees. The examiner maintains the contention from the previous office action that the step(s) within the claims that are being interpreted as part of the abstract idea are indeed mental processes capable of being performed in the human mind and/or mathematical concepts.
In response to the applicant’s argument that the judicial exception is drawn into a practical application, the examiner respectfully disagrees. The applicant lists five features that they allege disclose technical benefits. The examiner contends that the four-channel frontal-and-parietal acquisition is adding structure to data acquisition step, which is being interpreted as insignificant extra-solution activity that amounts to mere data gathering and is assessed at step 2B of the Alice/Mayo test. The remaining four features (the automated signal processing pipeline, extracting the recited EEG metric, the symbolic transformation, and predefining a threshold) appear to be merely “applying” the judicial exception that are implemented on a computer or using a computer as a tool to perform the abstract idea (see MPEP 2106.05(f)). Thus, simply disclosing that a “processor” performs the abstract idea does not draw the claims into eligible subject matter at Step 2A Prong 2.
In response to the applicant’s argument that the ordered combination amounts to significantly more, the examiner respectfully disagrees. As mentioned in the previous office action, the electrode placement disclosed in the applicant’s claimed invention is taught by the examiner’s reference, Morley, which teaches the standard 10/20 International EEG Placement, which includes frontal and parietal locations.
Therefore, the examiner maintains the contention that the 35 USC 101 rejection of claims 17-18, 20, 24, 25, 28-29, and 31-34.
Examiner’s Note
The examiner finds that new claims 35 and 36 are merely adding steps to the calculation/mental process being performed and thus would not draw the claims into eligible subject matter.
In the interest of compact prosecution, the examiner believes that if the “extracting” wSMI step cannot reasonably be performed in the human mind, then this is potentially the best avenue to overcome the 35 USC 101 rejection. However, the examiner notes the “extracting” step, as claimed, is currently being interpreted as capable of being performed in the human mind.
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 17-18, 20-21, 24-29, and 31-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent Claim 17 recites:
A system for measuring and monitoring neurodegeneration of a subject suffering from preclinical Alzheimer's disease, thereby identifying an early preclinical Alzheimer's disease stage from a late preclinical Alzheimer's disease stage, said system comprising an electroencephalography (EEG) apparatus having electrodes positioned on predetermined areas of a scalp of said subject, the predetermined areas configured for identifying an early preclinical Alzheimer’s disease stage from a late preclinical Alsheimer’s disease stage, said subject being perceptually isolated; at least one processor; and amplifier unit, the amplifier unit configured for magnifying and converting analog signals from the EEG apparatus to a digital format to be processed by the at least one processor, the at least one processor configured to:
transmit an instruction to the EEG apparatus to control acquisition of electroencephalographic signals with multiple EEG channels, and to receive said electroencephalographic signals from the EEG apparatus in real time in response to the transmission of said instruction, wherein the multiple EEG channels comprises at least four EEG channels including two EEG channels on a frontal area and two EEG channels on a parietal area, the frontal and parietal areas corresponding to the predetermined areas configured for identifying an early preclinical Alzheimer's disease stage from a late preclinical Alzheimer's disease stage;
pre-process the received electroencephalographic signals by an automated signal processing pipeline configured with automated artefact removal;
extract, from said pre-processed electroencephalographic signals with multiple EEG channels, at least one EEG metric representative of said neurodegeneration in its preclinical stage, said at least one EEG metric comprising a weighted symbolic mutual information, and wherein to extract said weighted symbolic mutual information, the at least one processor is configured to perform a symbolic transformation of the electroencephalographic signals into a series of discrete symbols and to calculate the weighted symbolic mutual information using said series of discrete symbols;
evaluate said at least one EEG metric and extract a preclinical Alzheimer's disease neurodegeneration index based on the evaluation of the at least one EEG metric, wherein the evaluation is a comparison of the at least one EEG metric with at least one predefined threshold, the at least one predefined threshold based on a variation of the at least one EEG metric between preclinical Alzheimer’s disease subjects and non-preclinical Alzheimer’s disease subjects; said preclinical Alzheimer's disease neurodegeneration index being representative of the neurodegeneration affecting said subject suffering from the preclinical Alzheimer's disease;
wherein the preclinical Alzheimer's disease neurodegeneration index is either associated with the early preclinical Alzheimer's disease stage or the late preclinical Alzheimer's disease stage; and
a user interface module configured to provide the preclinical Alzheimer's disease neurodegeneration index as output indicating an early diagnosis of preclinical Alzheimer’s disease, independent of any other neuroimaging.
Independent Claim 28 recites:
A computer-implemented method for measuring and monitoring neurodegeneration of the subject suffering from preclinical Alzheimer's disease, comprising the steps of:
transmitting, to an electroencephalography (EEG) apparatus having electrodes positioned on predetermined areas of a scalp of a subject, the predetermined areas configured for identifying an early preclinical Alzheimer’s disease stage from a late preclinical Alzheimer’s disease stage, said subject being perceptually isolated, an instruction to control acquisition of electroencephalographic signals with multiple EEG channels from the subject, and receiving said electroencephalographic signals from the EEG apparatus in real time in response to the transmission of said instruction, wherein the multiple EEG channels comprises at least four EEG channels including two EEG channels on a frontal area and two EEG channels on a parietal area, the frontal and parietal areas corresponding to the predetermined areas configured for identifying an early preclinical Alzheimer's disease stage from a late preclinical Alzheimer's disease stage;
magnifying and converting, by an amplifyier unit, analog signals from the EEG apparatus to a digital format to be processed by at least one processor;
pre-processing the received electroencephalographic signals by an automated signal processing pipeline configured with automated artefact removal;
extracting, from said pre-processed electroencephalographic signals, at least one EEG metric representative of said neurodegeneration in its preclinical stage,, said at least one EEG metric comprising a weighted symbolic mutual information, and said extracting of said weighted symbolic mutual information comprising:
performing a symbolic transformation of the electroencephalographic signals into a series of discrete symbols; and
calculating the weighted symbolic mutual information using said series of discrete symbols so as to extract the weighted symbolic mutual information; evaluating said at least one EEG metric and extracting a preclinical Alzheimer's disease neurodegeneration index based on the evaluation of the at least one EEG metric, wherein the evaluation is a comparison of the at least one EEG metric with at least one predefined threshold, the at least one predefined threshold based on a variation of the at least one EEG metric between preclinical Alzheimer’s disease subjects and non-preclinical Alzheimer’s disease subjects; wherein the preclinical Alzheimer's disease neurodegeneration index is either associated with the early preclinical Alzheimer's disease stage or the late preclinical Alzheimer's disease stage; and
outputting, by a user interface module, the preclinical Alzheimer's disease neurodegeneration index as output indicating an early diagnosis of preclinical Alzheimer’s disease, independent of any other neuroimaging.
Step 1:
The examiner finds independent claim 17 drawn to a machine and independent claim 28 drawn to a method.
Step 2A Prong 1:
The above claim limitations constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
“A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018).
The claimed steps of extracting, calculating, evaluating, and comparing recite mathematical concepts (i.e., mathematical relationships, mathematical formulas or equations, and mathematical calculations).
The steps of “…acquire electroencephalographic signals…”, “…receiving electroencephalographic signals…”, “transmitting” data, and “magnifying and converting” signals in independent Claims 17 and 28 are insignificant extra-solution activities that amount to mere data gathering/output steps that utilizes a computational device. The step of “…extracting at least one EEG metric…” in independent Claims 17 and 28 is a mathematical calculation to isolate relevant data from a larger data set so that an inference may be performed from the extracted value. The step of “…calculating the weighted symbolic mutual information…” in claim 28 is a mathematical calculation using discrete symbols to extract said wSMI. The step of “…evaluating said at least one EEG metric…” in claims 17 and 28 can reasonably be interpreted as both a mental process and/or mathematical calculation. As a mental process, the human mind is capable of evaluating data and making an inference. As a mathematical concept, evaluating comprises finding a numerical expression for said metric(s). The step “comparison of the at least one EEG metric with at least one predefined threshold” in independent claim 17 is an example of a mental process capable of being performed in the human mind. For example, the human mind is capable of taking two values and comparing similarities and differences between their characterstics. The step of “pre-processing” data with artefact removal is a mental process capable of being performed in the human mind. For example, the human mind is capable of filtering a dataset and removing outliers prior to evaluating said dataset.
The claimed steps of extracting, calculating, evaluating, comparing, and pre-processing can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
“[T]he ‘mental processes’ abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.” MPEP 2106.04(a)(2) III. The pending claims merely recite steps for estimation that include observations, evaluations, and judgments.
Examples of ineligible claims that recite mental processes include:
• a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind,
Electric Power Group, LLC v. Alstom, S.A.;
• claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind,
University of Utah Research Foundation v. Ambry Genetics Corp.
• a claim to collecting and comparing known information, which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Regarding the dependent claims 18, 20-21, 23-27, 29, and 31-36, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
Step 2A Prong 2:
This judicial exception (abstract idea) in Claims 17-18, 20-21, 23-29, and 31-36 is not integrated into a practical application because:
• The abstract idea amounts to simply implementing the abstract idea on a computing device. For example, the recitations regarding the generic computing components for acquiring, receiving, extracting, calculating, evaluating, and comparing merely invoke a computer as a tool.
• The data-gathering step (acquiring and receiving) and the data-output step (transmitting, outputting) do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
• There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computing device that is used as a tool for extracting, calculating, evaluating, comparing, and pre-processing.
• The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to estimate bio-information.
• The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computing device for extracting, calculating, evaluating, comparing, and pre-processing. The claims do not apply the obtained prediction to a particular machine. Rather, the data is merely output in a post-solution step.
Step 2B:
The additional elements are identified as follows: a processor, a non-transitory computer-readable storage medium, and an EEG system comprising two electrodes, at least four EEG channels including at least two EEG channels on a frontal area and two EEG channels on a parietal area.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
• Applicant’s specification (e.g. page 17 lns. 15-25) which discloses that the computer-readable storage medium comprise generic computer components that are configured to perform the generic functions (e.g. storing instructions for a processor to carry out) that are well-understood, routine, and conventional activities previously known to the pertinent industry;
• Farwell (US 5363858 A) col. 20 lns. 51-57 recite the use of a two-electrode system on the scalp of a patient as conventional;
• Morley (Morley, Andrew, Lizzie Hill, and A. Kaditis. "10-20 system EEG Placement." European Respiratory Society, European Respiratory Society (2016) [online], [retrieved on 05/14/2026]. Retrieved from the Internet <URL: https://web.archive.org/web/20200604122447id_/https://www.ers-education.org/lrmedia/2016/pdf/298830.pdf> which discloses which disclose at least two channels on a frontal position and two channels on a parietal position as is routine in the 10/20 International EEG Placement [see Examiner Figure 1 below from Morley, positions with “F” as frontal and “P” as parietal].
• Applicant’s specification [see page 19 lns. 21-22] which recites the use of a user interface to provide general user interface functions (i.e., output data to a user);
• Applicant’s specification [see page 19 lns. 7-9] which generally recite the use of an amplifier unit to perform generic amplifier functions;
• The non-patent literature of record in the application.
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional generic computer components as those claimed. See option III. A. 2. In the Berkheimer memorandum.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the units associated with the steps do not add meaningful limitation to the abstract idea. A computer, processor, memory, or equivalent hardware is merely used as a tool for executing the abstract idea(s). The process claimed does not reflect an improvement in the functioning of the computer.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Examiner Figure 1
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HANEY whose telephone number is (571)272-0985. The examiner can normally be reached Monday through Friday, 0730-1630 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571)272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HANEY/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights