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 .
Election/Restrictions
Applicant’s election without traverse of group I claim 1 in the reply filed on 11/13/2025 is acknowledged.
Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/13/2025.
Claim 1 is hereby the present claim under consideration.
Specification
The disclosure is objected to because of the following informalities:
Paragraph 0181 makes reference to the “ideal heatmaps … are shown in Fig. 3D” but there is no such Fig. 3D. It appears the paragraph is meant to refer to Fig. 11D.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 1 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “the EEG data including responses of the subject to an activation procedure of an electroencephalography technique” but it is unclear what “responses of the subject to an activation procedure of an electroencephalography technique” entails. It is unclear what the “activation procedure” is and how it induces an EEG response. For the purposes of this examination, the limitation will be interpreted as including response of the subject to some form of stimulation.
Claim 1 recites “identify first/second/third peaks” in line 6 but then recites “determining values of a parameter in the plurality of epochs, the parameter being a characteristic of the first/second/third peak” it is unclear whether the method identifies a single or multiple first peak, second peak, and/or third peak and if multiple peaks are identified for each one then it is unclear which peak is used for the parameter determination. For the purposes of this examination, the limitation will be interpreted as a single peak being identified for each of the first, second, and third peaks respectively.
Claim 1 recites “a graphical representation of the parameter that is presented as evidence of whether the subject is cognitively impaired” but it is unclear if the “graphical representation” of the parameter is the same as, related to, or different from the “illustration” of the peaks or heatmap of the epochs. It is unclear if both of these visual elements may be the same visual (i.e. a heatmap of display of a peak may be “graphical representation” of the parameter) or if they are separate visuals. It is further unclear what the meets and bounds of a “graphical representation of the parameter” entail. For the purposes of this examination, the limitations are interpreted as referring to the same display element.
Claim 1 recites “a graphical representation of the parameter that is presented as evidence of whether the subject is cognitively impaired” but it is unclear what “evidence of whether the subject is cognitively impaired” entails. It is unclear if the displayed parameter must be discriminatory between cognitive impairment (CI) and no CI or if any parameter may be presented as “evidence” regardless of whether it is capable of discriminating between CI or no CI in a patient. It is unclear what contribution the displayed parameter must make towards indicating CI. For the purposes of this examination, the limitation will be interpreted as the display of any parameter. Examiner’s Note: the specification describes a plurality of different parameters that may be calculated and displayed but does not provide sufficient support to indicate that every one of the described parameters are capable of discriminating between CI and no CI in a patient. Indeed Fig. 10 appears to illustrate that only a subset of the possible parameters are capable of discriminating between patients with CI and no CI. It is unclear if this recitation of “evidence” is intended to limit the displayed parameters to those capable of discriminating between CI and no CI or not and if so, what level of discrimination qualifies as sufficient to be considered “evidence”.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “the EEG data including responses of the subject to an activation procedure of an electroencephalography technique” but the specification does not appear to describe such an “activation procedure” and the responses thereto. Paragraphs 0069-0070 and 0081 indicate that the responses recorded in the EEG data are responses to auditory stimulation.
Claim 1 recites “analyzing the EEG data including a plurality of epochs corresponding to the responses to identify first peaks, second peaks, and third peaks in one or more epochs” but the specification does not fully support the claimed scope of identifying any first/second/third peaks in the epochs. Paragraphs 0091-0094 indicate that the “peaks” identified are specific peaks in specific timeframes. The claimed scope of identifying any three peaks and the subsequent parameter determination therefrom is thus not fully supported.
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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim 1 is directed to a method of processing EEG signals using a computational algorithm, which is an abstract idea. Claim 1 does not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019) and the 2024 Update on Subject Matter Eligibility (Federal Register, Vol 89, No. 137, page 58128, July 17, 2024).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a process.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] accessing electroencephalography (EEG) data of a subject, the EEG data including responses of the subject to an activation procedure of an electroencephalography technique
[B1] analyzing the EEG data including a plurality of epochs corresponding to the responses to identify first peaks, second peaks, and third peaks in one or more epochs
[C1] determining values of a parameter in the plurality of epochs, the parameter being a characteristic of the first peak, the second peak, and/or the third peak
[D1] generating a visual representation of the EEG data of the subject, the visual representation including an illustration of the first peak, the second peak and/or the third peak of a representative epoch or a heatmap compiled from the plurality of epochs, and the visual representation further including a graphical representation of the parameter that is presented as evidence of whether the subject is cognitively impaired
These elements [A1]-[D1] of claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites no additional limitations that are beyond the judicial exception. In particular, the limitation of generating the visual representation of the EEG data is recited at a high level of generality and does not constitute the generation of a particular display. Rather the recited display step is considered a mere output of results and does not qualify as significantly more than the abstract idea itself.
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome.
Claim Rejections - 35 USC § 103
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 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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Ford US Patent Application Publication Number US 2017/0281071 A1 hereinafter Ford in view of Kruglikov US Patent Application Publication Number US 2009/0062676 A1 hereinafter Kruglikov
Regarding claim 1, Ford discloses a computer-implemented method (Abstract; Paragraph 0063 ), comprising:
accessing magnetoencephalography (MEG) data of a subject, the MEG data including responses of the subject to an activation procedure of a magnetoencephalography technique (Paragraphs 0059 and 0175: the sensors detect signals from the user’s brain in response to auditory stimuli);
analyzing the MEG data including a plurality of epochs corresponding to the responses to identify first peaks, second peaks, and third peaks in one or more epochs (Paragraphs 0073-0075; Fig. 2B: the identified three peak pattern);
determining values of a parameter in the plurality of epochs, the parameter being a characteristic of the first peak, the second peak, and/or the third peak (Paragraph 0084: the plurality of candidate parameters for the three peaks are calculated for each epoch); and
generating a visual representation of the MEG data of the subject, the visual representation including an illustration of the first peak, the second peak and/or the third peak of a representative epoch or a heatmap compiled from the plurality of epochs, and the visual representation further including a graphical representation of the parameter that is presented as evidence of whether the subject is cognitively impaired (Paragraph 0078; Figs. 3A-D: the visual representation may be a heat map; Paragraphs 0132-0133; Figs 4B-C: the visual representation may be an illustration of the peaks for a representative epoch; Paragraph 0159; Fig. 5: both types of displays may be presented to a doctor to help them determine if the patient is cognitively impaired, or has Alzheimer’s Disease. The parameters are also displayed).
Ford fails to disclose the method utilizing electroencephalography (EEG) data.
Kruglikov teaches methods and devices for performing electroencephalographic (EEG) phase dependent brain imaging using evoked and event related potentials (EP, ERP) or other forms of brain imaging including functional magnetic resonance imaging (fMRI) and magnetic encephalography (MEG). The methods and devices can be used for a variety of purposes, including for the study of normal and pathological cognitive function (Abstract). Thus, Kruglikov falls within the same field of endeavor as Applicant’s invention.
Kruglikov teaches that EEG recordings may be used to identify peaks such as the P30 and P50 peaks. Kruglikov further teaches that EEG signals may be filtered to remove artifacts (Paragraphs 0064-0065).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to alter the method of Ford to use EEG signals such as is described in Kruglikov because EEG and MEG signals both measure electrical activity in the brain and thus such a change would be a simple substitution of one known element (MEG measurement) for another known element (EEG measurement) with no surprising technical effect. Furthermore, Ford recites that EEG is sensitive to event within the required time period (Ford: Paragraph 0007). While Ford does state that EEG measurement suffer from “unpredictable signal attenuation by the tissues that surround the brain [which] cause both near and far signals to be comingled” Ford does not elaborate on how or why such comingling would affect the recited method. Ford does not elaborate on how such signal attenuation would make the method non-functional. Thus, Ford is not considered to teach away from the use of EEG. One of ordinary skill in the art would have a reasonable expectation of success when using the method of Ford on EEG signals because both measurement modalities record the same type of information and are frequently used interchangeably as evidenced by Kruglikov (Paragraphs 0008, 0021 and 0042) and further evidenced by at least:
Musha US Patent Application Publication Number US 2004/0171960 A1 hereinafter Musha: paragraphs 0070 and 0083 EEG or MEG sensor may be used.
Chen US Patent Application Publication Number US 2017/0224241 A1 hereinafter Chen: paragraphs 0013 EEG or MEG sensors may be used.
D’arcy US Patent Application Publication Number US 2013/0245422 A1 hereinafter D’arcy: paragraphs 0075 EEG or MEG sensors may be used; paragraph 0130 both EEG and MEG sensor may detect evoked responses.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. US 12303285 B2 in view of Kruglikov US Patent Application Publication Number US 2009/0062676 A1 hereinafter Kruglikov. Claims 1 and 7 of US 12303285 B2 teach all the limitations of claim 1 with the exception of the analysis being performed using EEG data. Kruglikov teaches that EEG data may be used to detect responses to stimuli (Paragraphs 0064-0065).
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. US 11850058 B2 in view of Kruglikov US Patent Application Publication Number US 2009/0062676 A1 hereinafter Kruglikov. Claims 1 and 7 of US 11850058 B2 teach all the limitations of claim 1 with the exception of the analysis being performed using EEG data. Kruglikov teaches that EEG data may be used to detect responses to stimuli (Paragraphs 0064-0065).
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 10736557 B2 in view of Kruglikov US Patent Application Publication Number US 2009/0062676 A1 hereinafter Kruglikov. Claim 1 of US 10736557 B2 teaches all the limitations of claim 1 with the exception of the analysis being performed using EEG data and the display of a representative epoch or a heat map. Kruglikov teaches that EEG data may be used to detect responses to stimuli (Paragraphs 0064-0065) and that an averaged, or representative, epoch may be displayed (Paragraphs 0015 and 0030).
Conclusion
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791