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 . 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 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.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-7) in the reply filed on 05/17/2026 is acknowledged.
Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected inventions, there being no allowable generic or linking claim. Accordingly, claims 1-7 are currently under consideration.
Information Disclosure Statement
Applicant is reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this application.
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 Objections
Claims 1 and 4 are objected to because of the following informalities:
Regarding claim 1, the recitation of “the method comprises” should instead read –wherein the method comprises--. The recitation of “and one of” should instead read –wherein one of--.
Regarding claim 4, the recitation of “which uses” should instead read –which use--.
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.
Claims 1-7 are 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 pre-AIA the applicant regards as the invention.
Regarding claims 1-7, the acronyms “iNPH” and “LTT” are unclear because they have not been defined.
Regarding claim 1, because there is no “and” before the last “training” step, it is unclear whether this is actually the last element of the claim.
Further regarding claim 1, the recitation of “performing the same visual Oddball paradigm experiment” is unclear because the previous recitation refers to experiments, not one experiment. Which of the experiments is performed?
Regarding claim 2, there is insufficient antecedent basis for the recitation of “said experimenting.”
The term “standard” in claim 4 is a relative term which renders the claim indefinite. The term “standard” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear what makes an electrode “standard,” or what makes an Ag/AgCl electrode “standard.”
Regarding claim 4, it is unclear how a channel number can include “leads.”
Regarding claim 5, antecedent basis for the second recitation of “filtering” is unclear, since the claim already recites “filtering out invalid data.” This also applies to “the filtering comprises…” since it is unclear which filtering is being referred to.
The term “bad” in claim 5 is a relative term which renders the claim indefinite. The term “bad” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear what makes a lead “bad.”
Further regarding claim 5, there is insufficient antecedent basis for the recitation of “the second predetermined time window.”
Regarding claim 6, antecedent basis for the recitation of “the calculation” is unclear. Which calculation? Also, what does “each trial” refer to? What is averaged and what is overlayed?
Regarding claim 7, there is insufficient antecedent basis for the recitation of “the presentation.”
Further regarding claim 7, the recitation of “training said iNPH prediction model to obtain the iNPH prediction model” is unclear because it is circular.
Claims 2-7 are rejected because they depend on rejected claims.
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 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1-7 are directed to a “method,” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 1 recites (“sets forth” or “describes”) the abstract idea of a mathematical concept, substantially as follows:
preprocessing on the before LTT standard stimulation EEG signal data, the before LTT target stimulation EEG signal data, the after LTT standard stimulation EEG signal data and the after LTT target stimulation EEG signal data, to obtain the before LTT standard stimulation event-related potential features, the before LTT target stimulation event-related potential features, the after LTT standard stimulation event-related potential features and the after LTT target stimulation event-related potential features, wherein event-related potential features are P300 amplitude features; training the iNPH prediction model based on the before LTT standard stimulation event-related potential characteristics, before LTT target stimulation event-related potential characteristics, after LTT standard stimulation event-related potential characteristics, and after LTT target stimulation event-related potential characteristics.
The preprocessing and training steps involve the mathematical concepts of signal processing and model training. These steps correspond to “[w]ords used in a claim operating on data to solve a problem [that] can serve the same purpose as a formula.” See MPEP 2106.04(a)(2)(I).
Prong Two: Claim 1 does not include additional elements that integrate the mathematical concept into a practical application. Therefore, the claim is “directed to” the mathematical concept. The additional elements merely:
add insignificant extra-solution activity (the pre-solution activity of: performing visual Oddball paradigm experiments before and after LTT), and
describe field-of-use (one of the target populations being iNPH patients).
As a whole, the additional elements merely serve to gather and feed information to the abstract idea. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and nothing is done with the trained model. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 1 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above.
Dependent Claims
The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
further describe the abstract idea (e.g. pre-processing and averaging (claims 5 and 6), etc.),
further describe the pre-solution activity (or the structure used for such activity) (e.g. presenting images (claims 2 and 3), using configured EEG caps (claims 2 and 4), etc.), and
introduce post-solution activity (e.g. generic presentation of data (claim 7), etc.).
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way (e.g. the trained model is not used for anything). They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves another technology or technical field, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
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 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Applicant Admitted Prior Art (“AAPA”) in view of non-patent publication de la Calzada, M. D., et al. "Cognitive event-related brain potentials (P300) in patients with normal pressure hydrocephalus. Results of a prospective study." Neurología (English Edition) 25.1 (2010): 32-39 (“de la Calzada”) and US Patent Application Publication 2020/0237247 (“Glik”).
Regarding claim 1, AAPA teaches [a] method for [diagnosing iNPH] (¶ 0002 of the specification as filed), the method comprises: performing … experiments on a target population prior to LTT to obtain before LTT … data for the target population (¶ 0003 of the specification as filed, describing MMSE and MoCA assessments); performing the same … experiment on the target population after LTT to obtain after LTT … data for the target population (¶ 0003 of the specification as filed); … and one of the target populations is iNPH patients (¶¶s 0002 and 0003).
AAPA does not appear to explicitly teach the method being for constructing an iNPH prediction model based on the visual Oddball paradigm, which includes performing visual Oddball paradigm experiments pre- and post-LTT, the experiments including standard stimulation and target stimulation EEG signal data.
de la Calzada teaches performing a visual Oddball paradigm experiment that includes standard (distracting) and target (target/oddball) stimulation EEG signal data, specifically based on the P300 wave as observed via EEG (page 34, first paragraph of the “Neurophysiologic evaluation” section – also see page 33, the “Introduction” section).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an Oddball paradigm experiment in AAPA as in de la Calzada, as the simple substitution of one known neurophysiologic evaluation method (e.g. MMSE or MoCA as in AAPA) for another (that of de la Calzada) with predictable results (de la Calzada: Abstract, evaluating effects of surgery on cognitive function, as also contemplated by AAPA).
AAPA-de la Calzada does not appear to explicitly teach preprocessing on the before LTT standard stimulation EEG signal data, the before LTT target stimulation EEG signal data, the after LTT standard stimulation EEG signal data and the after LTT target stimulation EEG signal data, to obtain the before LTT standard stimulation event-related potential features, the before LTT target stimulation event-related potential features, the after LTT standard stimulation event-related potential features and the after LTT target stimulation event-related potential features, wherein event-related potential features are P300 amplitude features (although de la Calzada does specifically mention P300); training the iNPH prediction model based on the before LTT standard stimulation event-related potential characteristics, before LTT target stimulation event-related potential characteristics, after LTT standard stimulation event-related potential characteristics, and after LTT target stimulation event-related potential characteristics.
Glik teaches preprocessing EEG data before running it through a classifier (¶ 0399, filtering). Glik teaches training a classification/prediction model to make decisions on EEG microstates (¶ 0263).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to preprocess the EEG data of the combination as in Glik, thereby obtaining the event-related P300 features, for the purpose of making classification easier by e.g. reducing noise and otherwise unnecessary data (Glik: ¶¶s 0399, 0400, 0403, 0407, etc.). It would have been obvious to train an iNPH prediction model based on the P300 features observed from the Oddball paradigm experiments of the combination, as in Glik, for the purpose of being able to make automatic classification decisions (Glik: ¶ 0263) and track changes over time (as already contemplated – Glik: ¶ 0263; AAPA: ¶ 0002).
Regarding claim 7, AAPA-de la Calzada-Glik teaches all the features with respect to claim 1, as outlined above. AAPA-de la Calzada-Glik further teaches wherein: the presentation of the event-related potential characteristics of the target group comprises: a standard stimulus event-related potential characteristic before LTT; a target stimulus event-related potential characteristic before LTT; a standard stimulus event-related potential characteristic after LTT; and a target stimulus event-related potential features after LTT, wherein the presentation of the event-related potential characteristics of the target group is configured to reflect improvement in the cognitive function of iNPH patients without reaching the minimum cognitive function level of a healthy population (de la Calzada: Fig. 2. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to present the characteristics, as in de la Calzada, for the purpose of showing change over time and being able to graphically evalaute efficacy of treatment); and training said iNPH prediction model to obtain the iNPH prediction model based on the before LTT standard stimulus event-related potential feature, the before LTT target stimulus event-related potential feature, the after LTT standard stimulus event-related potential feature, and the after LTT target stimulus event-related potential feature, comprises training the iNPH prediction model to obtain the iNPH prediction model based on a change in characteristics of the standard stimulus event-related potential feature before LTT, the target stimulus event-related potential feature before LTT, the standard stimulus event-related potential feature after LTT, and the target stimulus event-related potential feature after LTT (as noted above with respect to e.g. Glik and AAPA).
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over AAPA-de la Calzada-Glik in view of US Patent Application Publication 2018/0228419 (“Farzan”).
Regarding claim 2, AAPA-de la Calzada-Glik teaches all the features with respect to claim 1, as outlined above. AAPA-de la Calzada-Glik further teaches wherein said experimenting with the visual Oddball paradigm on a target population comprises: configuring EEG [sensors] for the target population (de la Calzada: “Introduction” section, describing EEG); presenting a number of images to the target population at predetermined time intervals, wherein stimuli with a high probability of image occurrence are defined as standard stimuli and stimuli with a low probability of image occurrence are defined as target stimuli in the visual Oddball paradigm experiment, and asking the target population to silently memorize the number of times that the target stimuli appeared; and presenting the images to the target population, wherein the EEG signal data of the target population is obtained through the EEG [sensors] (de la Calzada: “Neurophysiologic evaluation” section), but does not appear to explicitly teach the use of an EEG cap.
Farzan teaches the use of an EEG cap to obtain EEG data (¶ 0079).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a cap for the EEG measurements of the combination, as in Farzan, for the purpose of making it easier to locate and wear the electrodes (Farzan: ¶ 0079).
Regarding claim 3, AAPA-de la Calzada-Glik-Farzan teaches all the features with respect to claim 2, as outlined above. AAPA-de la Calzada-Glik-Farzan further teaches wherein said presenting the number of images to the target population at the predetermined time interval comprises: presenting a plurality of rounds of image stimuli to the target population, each round of image stimuli comprising a first patterned image stimulus and a second patterned image stimulus, wherein the probability of the first patterned image appearing is 80% and the first patterned image stimulus is a standard stimulus, the probability of the second patterned image appearing is 20% and the second patterned image stimulus is a target stimulus, and wherein there is a predetermined resting time between each round of image stimuli; and presenting the first pattern image or the second pattern image to the target population each time in accordance with a predetermined maintenance duration, wherein there is a predetermined time interval between each pattern image stimulation (de la Calzada: “Neurophysiologic evaluation” section). Although de la Calzada does not explicitly teach an 80/20 split, the split is a known results-effective variable because it can be changed as desired based on different stimuli and desired responses. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an 80/20 split instead of an 82/18 split, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over AAPA-de la Calzada-Glik-Farzan in view of US Patent Application Publication 2022/0040148 (“Fillit”).
Regarding claim 4, AAPA-de la Calzada-Glik-Farzan teaches all the features with respect to claim 3, as outlined above. AAPA-de la Calzada-Glik-Farzan further teaches wherein said configuring the EEG cap for the target population comprises: equipping the target population with EEG caps, … with electrodes placed with reference to the international 10-20 system (Farzan: ¶ 0072), wherein the number of channels is [64] leads (Farzan: ¶ 0073); and setting the parameters of the EEG caps to a sampling rate of [10 kHz] and a band-pass filtering of [0.05 to 1 kHz] (Farzan: ¶ 0073), wherein the acquisition process is performed with the top of the head of the target population as a reference, with the forehead grounded (Farzan: ¶ 0073) and the impedance between the scalp and the electrodes are maintained at less than 10 KΩ (Farzan: ¶ 0073), but does not appear to explicitly teach the caps using Ag/AgCl electrodes to form 32 channels, and setting parameters including a sampling rate of 1,000 Hz and filtering of 0.1 to 200 Hz.
Fillit teaches an EEG cap that uses 32 channels/leads with Ag/AgCl electrodes, a sampling rate of 5 kHz, filtering at 0.1-1000 Hz, etc. (¶ 0035).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Ag/AgCl electrodes in the combination as in Fillit, since they are known for the purpose (Fillit: ¶ 0035). Further, the number of electrodes and other details such as the sampling rate and filtering range are known results-effective variables because they can be changed as desired based on the depth of processing desired. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use e.g. 32 channels/leads instead of 64, a sampling rate of 1000 Hz, filtering of 0.1 to 200 Hz, etc. for the purpose of conserving resources where possible (i.e., no need to use the full capabilities of the cap of Farzan), and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over AAPA-de la Calzada-Glik-Farzan-Fillit in view of US Patent Application Publication 2022/0273907 (“Poltorak”).
Regarding claim 5, AAPA-de la Calzada-Glik-Farzan-Fillit teaches all the features with respect to claim 4, as outlined above. AAPA-de la Calzada-Glik-Farzan-Fillit further teaches wherein said preprocessing comprises filtering out invalid data (Glik: ¶ 0287; Farzan: ¶¶s 0073, 0076, etc.), filtering (Glik: ¶ 0399), downsampling (Farzan: ¶ 0076), data segmentation (Farzan: ¶ 0076), …, wherein: the filtering out invalid data comprises checking for bad lead data in the EEG signal data and filtering it out (Farzan: ¶ 0076, removing 60 Hz noise or noise due to muscle movements, etc.); the filtering comprises filtering the EEG signal data using a filter with a filter range of 0.5 to 30 Hz (Glik: ¶ 0399, obvious to modify to the claimed range based on the routine optimization explained above), the downsampling comprises downsampling the EEG signal data to 200 Hz (Farzan: ¶ 0076, obvious to modify to the claimed range for the purpose of conserving resources, and based on another routine optimization (the sampling rate is still a results-effective variable, as explained above)); the data segmentation comprises: defining the start moment of each image stimulation as the zero moment; and segmenting and intercepting the EEG signal data in accordance with a first predetermined time window (Farzan: ¶ 0076), but does not appear to explicitly teach baseline correction, wherein: the baseline correction comprises baseline correcting the EEG signal data obtained from each image stimulation by using the EEG signal data segment of the second predetermined time window as a baseline.
Poltorak teaches baseline-correcting EEG data based on different time windows (¶ 0508).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to baseline-correct the data of the combination, as in Poltorak, for the purpose of taking pre-event baseline activity into consideration (Poltorak: ¶ 0508).
Regarding claim 6, AAPA-de la Calzada-Glik-Farzan-Fillit-Poltorak teaches all the features with respect to claim 5, as outlined above. AAPA-de la Calzada-Glik-Farzan-Fillit-Poltorak further teaches
wherein said pre-processing of the before LTT standard stimulation EEG signal data, the before LTT target stimulation EEG signal data, the after LTT standard stimulation EEG signal data, and the after LTT target stimulation EEG signal data, to obtain the before LTT standard stimulus stimulation event-related potential feature, the before LTT target stimulation event-related potential features, the after LTT standard stimulation event-related potential features and the after LTT target stimulation event-related potential features, includes obtaining the event-related potential characteristics based on the preprocessed EEG signal data, by averaging the EEG signal data of each trial separately at each electrode by overlaying the calculation (de la Calzada: first paragraph on page 35; Glik: ¶ 0405; Farzan: ¶ 0076; Poltorak: ¶¶s 0112).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson, can be reached at telephone number (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791
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