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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 22 April 2026 has been entered.
Claim Rejections - 35 USC § 112
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 2 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. The originally filed disclosure fails to provide support for providing examination data as part of a notification of an incoming call, wherein the examination data has first data related to the subject and second data different from the first data. Paragraph [0093] of the specification as filed makes clear that the examination data has first data related to the subject (visual picture data) or second data different from the first data (auditory voice data).
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 3 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.
Regarding claim 3, it is unclear what further limitation the claim provides to the claimed invention. Claim 3 describes calculating a P300 peak latency (“a time period from the presentation time of the event to a time at which a positive peak of a P300 event-related potential appears” is a P300 peak latency), which is already recited in claim 1. Is the determined P300 peak latency in claim 3 different than the calculated P300 peak latency of claim 1? For this examination, the determined P300 peak latency of claim 3 is being considered the calculated P300 peak latency of claim 1.
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 1-3, 5, and 6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites an electroencephalogram data analysis system comprising an electronic device and a measurement device. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The functions of detecting an index of cognitive function by calculating a P300 peak latency from EEG data, comparing the calculated P300 peak latency with a reference value, and outputting or indicating the possibility that a subject’s cognitive function is declining or that dementia is present based on determining that the calculated P300 peak latency deviates from the reference value set forth a judicial exception. These functions describe concepts performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea. While a processor is configured to perform these functions, according to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an Abstract Idea does not integrate the Abstract Idea into a practical application.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites outputting or indicating the possibility that the subject’s cognitive function is declining or that dementia is present, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The function of outputting or indicating the possibility that the subject’s cognitive function is declining or that dementia is present does not provide an improvement to the technological field, the analysis system does not effect a particular treatment or effect a particular change based on the output or indication, nor is a particular machine used to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional elements drawn to presenting examination data, and acquiring and wirelessly transmitting EEG data. The structural elements configured to present the examination data (a processor) and acquire and transmit EEG data (an EEG detection sensor located on glasses/sunglasses, and a wireless transmitter) are each recited at a high level of generality such that they amount to generic components configured to perform insignificant presolution activity, e.g., mere data gathering steps necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional element that distinguishes the claimed elements from well-understood, routine, and conventional data gathering and transmitting elements used by medical professionals prior to Applicant's invention.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The dependent claims also fail to add something more to the abstract independent claim as they generally recite functions pertaining to broad and routinely performed data gathering and display of data. The functional limitations recited in the independent claim maintain a high level of generality even when considered in combination with the dependent claims.
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 1-3, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Coleman et al.’686 (US Pub No. 2015/0305686 – previously cited) in view of Anwar et al.’187 (US Pub No. 2018/0078187 – previously cited) further in view of Connor’947 (US Pub No. 2017/0188947 – previously cited).
Regarding claims 1 and 3, Figure 1A of Coleman et al.’686 discloses an electroencephalogram (EEG) data analysis system (sections [0005] and [0009]), the system comprising:
an electronic device 101,103,115,120 including a processor (section [0059] discloses that all of elements 101, 103, 115, and 120 can be embodied in a single electronic device, including a smartphone), the processor being configured to: receive an incoming call (Official notice is being taken that a smartphone is capable of receiving an incoming call); present, to a subject at a time of receiving the incoming call, examination data as part of a notification of the incoming call, wherein the examination data comprises information associated with a caller of the incoming call (Official notice is being taken that it is well known that smartphones provide visual information to a receiver of the call, the visual information being associated with the caller – e.g., a picture and name associated with the caller, or a phone number and/or name of the caller) and that can be used for examining a cognitive function of the subject, wherein receiving the incoming call is an operation having a purpose different from a purpose of measuring an EEG of the subject (sections [0049-0050] -- the examination data is capable of being presented at any time, including at a time of receiving a call; the caller identification information (picture and name, or phone number and/or name) can also be used as the examination data);
and a measurement device 110,111 including: an EEG detection sensor configured to acquire EEG data from the subject while the examination data is presented to the subject (sections [0051-0052]); and a communication section that transmits, to the electronic device, the EEG data acquired by the EEG detection sensor (in order for the electronic device to receive, process, and analyze the acquired physiological signals as discussed in sections [0053-0058], measurement device 110,111 would need a communication section to transmit the signals to the electronic device; also, see section [0066], which discusses the transmission of EEG signals from electrodes of the measurement section to a remote computer system);
wherein the processor is configured to: receive the EEG data from the measurement device (sections [0053-0058]); detect an index of the cognitive function of the subject by calculating a P300 peak latency from the EEG data (sections [0077], [0085], [0100-0104]); and output or indicate the possibility that the subject’s cognitive function is declining or that dementia is present based on determining that the calculated P300 peak latency deviates from the reference value (sections [0074], [0116]).
Coleman et al.’686 discloses all of the elements of the current invention, as discussed above, except for explicitly disclosing that the processor is configured to compare the calculated P300 peak latency with a reference value. Coleman et al.’686 does, however, teach that increased P300 peak latencies, as compared to those of healthy subjects, is present in subject’s with Alzheimer’s disease (section [0077]). With this teaching by Coleman et al.’686, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have configured the processor of Coleman et al.’686 to compare the calculated P300 peak latency with a reference value (a calculated P300 peak latency determined to be representative of healthy subjects), as this would provide an indication as to whether the subject is affected by Alzheimer’s disease.
Coleman et al.’686 discloses all of the elements of the current invention, as discussed above, except for explicitly reciting that the communication section wirelessly transmits the EEG data acquired by the EEG detection sensor to the electronic device. Anwar et al.’187 discloses an EEG data analysis system comprising a measurement device and an electronic device, wherein EEG data acquired by the measurement device is transmitted wirelessly to the electronic device via a wireless transmitter (sections [0035-0036]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the measurement device of Coleman et al.’686 to include a wireless transmitter that wirelessly transmits the EEG data acquired by the EEG detection sensor to the electronic device, since this would provide a means by which to transmit the EEG data from the EEG detection sensor to the electronic device. The modification to Coleman et al.’686 would merely be combining prior art elements according to known methods to yield predictable results. Furthermore, Coleman et al.’686 already discloses that the EEG data is transmitted from the EEG detection sensor to a remote computing system. One of ordinary skill in the art would have found it obvious to use a wireless transmitter to transmit the data to a remote computing system (the electronic device) as it is well known in the art to transmit data to a remote location using a wireless transmitter.
Coleman et al.’686 in view of Anwar et al.’187 discloses all of the elements of the current invention, as discussed above, except for the measurement device being glasses or sunglasses. Connor’947 teaches an EEG data analysis system wherein a measurement device is provided on glasses (Figures 41 and 42, and section [0204]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the EEG data analysis system of Coleman et al.’686 in view of Anwar et al.’187 to include glasses provided with the measurement device, as taught by Connor’947, as it would merely be the simple substitution of one known measurement device arrangement for another to obtain predictable results. It is noted that Coleman et al.’686 requires a measurement device that comes into contact with a subject’s forehead, and that the measurement device of Connor’947 is a measurement device that comes into contact with a subject’s forehead.
Regarding claim 2, the examination data (the stimuli and the caller identification information) has first data related to the subject, and is capable of having second data different from the first data (section [0049] of Coleman et al.’686 teaches using multiple types of stimuli), and a frequency of presentation of the first data is capable of being different from that of the second data (sections [0049] and [0071] of Coleman et al.’686 – section [0049] discloses the use of frequency parameters associated with a type of stimulus, and section [0071] teaches that the frequency of a particular stimulus can be set individually by a user).
Regarding claim 5, a frequency of presentation of the examination data can be set at any frequency (section [0071]), and the processor is configured to set the frequency of presentation (section [0071]).
Regarding claim 6, the processor is configured to notify at least a person other than the subject of the output or indication of the possibility made by the processor (sections [0104] and [0116] of Coleman et al.’686– the provided reports are capable of being seen by a person other than the subject; section [0115] also indicates that a physician may use the data analysis system).
Response to Arguments
Applicant's arguments filed 22 April 2026 have been fully considered.
Regarding the rejection of the claims under 35 U.S.C. 101, Applicant’s arguments are not persuasive. A human mind, reading a screen showing processed EEG signals, could mentally determine the amount of time between the presentation of a stimulus and the occurrence of a P300 peak. The signal processing required to output a processed EEG signal falls under routine, presolutional data gathering activity. Applicant’s arguments regarding the processor of the claimed invention being configured to receive an incoming call, access information associated with a caller of an incoming call and present that caller-associated information as examination data is not persuasive as these are routine, conventional, and well-understood functions of a processor of a smartphone. In the context of the claimed invention, these functions are also drawn to presolutional data gathering activities. The step of wirelessly transmitting data from a data acquisition unit to a data processing unit is routine, conventional, and well-understood. As noted above, calculating a P300 peak latency is capable of being performed in the human mind, as if the function of comparing the calculated P300 peak latency to a reference value. As noted in paragraph 8 above, outputting or indicating the possibility that the subject’s cognitive function is declining or that dementia is present is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). Contrary to Applicant’s assertion that the claim as a whole integrates the abstract idea into a practical application of a particular machine, no particular machine is used (the claimed system comprises a generic electronic device comprising a processor, and a measurement device that includes a sensor and a wireless transmitter), and no practical application that defines something significantly more than merely outputting a possibility of a subject’s cognitive function is recited. In response to Applicant’s argument on page 15 of the Remarks that the claim recites a specific technical integration in which a real-world event of receiving an incoming call serves both as a trigger for the examination and as the source of the examination stimulus content, it is noted that the claimed invention does not recite using an incoming call as a trigger for conducting an examination. Applicant’s argument that without the wearable glasses or sunglasses measurement device, the subject could not be wearing an EEG sensor during the ordinary activity of receiving a phone call is not persuasive as portable EEG measurement devices that are wirelessly linked to separate processing devices (e.g., smartphones, tables, laptops) are well known in the art.
It is noted that the claims are not necessarily drawn to an EEG system that integrates cognitive function examination into a call-notification user interface triggered by an incoming call, as argued by the Applicant. Instead, the claims merely require examination data to be presented when a call is received. Any visual provided to a receiver of a call identifying the caller could be considered examination data as recited in the claims. As noted in paragraph 10 above, it is well known that caller identification data is provided to a receiver of a call when receiving an incoming call.
Regarding Applicant’s assertion that the claimed system embodies a technical improvement and non-conventional use of EEG data because the processor presents examination data while the subject is receiving a call, it is noted that the current invention is drawn to a system, not a method. Coleman makes clear that its electronic device can be a smartphone. Smartphones are known to present to a subject, at a time of receiving a call, visual information associated with a caller of the incoming call. This visual information is capable of being used as the examination data of Coleman in view of Anwar further in view of Connor.
Regarding the “well-understood, routine, and conventional data gathering and transmitting elements” of the claimed invention, the Examiner has provided references in the Conclusion section below that show that EEG detection sensors and wireless transmitters are known to be used in the EEG signal acquisition, transmission, and processing art.
Regarding the previous rejections of the claims under 35 U.S.C. 112(b), while the amendments have overcome the previous rejections of claims 7-9, as discussed in paragraph 6 above, claim 3 remains indefinite.
Regarding the previous rejections of the claims in view of prior art, Applicant’s arguments are moot as the amendments to the claims have warranted new grounds of rejections under 35 U.S.C. 103. Applicant is reminded that because the claimed invention is drawn to a system, the prior art need only teach structural elements that are capable of performing the recited functions in the claims. As the electronic device of Coleman can be a smartphone, and because smartphones provide some type of visual information to a receiver of a call regarding the identity of the caller, Coleman teaches an electronic device (the smartphone) that is configured to receive an incoming call and present to a subject at a time of receiving the call examination data as part of a notification of the incoming call, the examination data comprising the information associated with the identity of the caller. The measurement device of Coleman is capable of acquiring EEG data from the subject while the subject is looking at the caller identification information being provided when receiving a call. The subject of Coleman is capable of receiving an incoming call while in the controlled environment described by Applicant. It is noted that the subject would not need to answer the phone, reach for the phone, or converse in order for the measurement device to acquire EEG data while the subject looks at who is calling.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Each of Perini, II’089 (US Pub No. 2014/0020089) and Parra et al.’615 (US Pub No. 2015/0248615) teach an EEG data analysis system comprising a smart phone as an electronic device that comprises a processor, the processor being configured to receive EEG data from a measurement device and process the EEG data to identify P300 latencies.
Each of Kraft et al.’178 (US Pub No. 2012/0330178), LeBoeuf et al.’100 (US Pub No. 2010/0217100 – previously cited), Chiu et al.’578 (US Pub No. 2013/0035578), Denison et al.’230 (US Pub No. 2014/0316230 – previously cited) teach a portable, wireless EEG apparatus comprising EEG detection sensors and a wireless transmitter, the wireless transmitter configured to transmit acquired EEG data to a smartphone for EEG signal analysis.
Farwell’217 (US Pub No. 2002/0188217 – previously cited) teaches that research has shown substantial increase in the latency of P300 in demented subjects (section [0026]), that research has established that the latency of the P300 component provides an index of the speed of cognitive stimulus evaluation (section [0116]), and that the latency of the P300 component provides a measure of the cognitive deficits affecting memory (section [0137]).
Fadem’727 (US Pub No. 2007/0191727 – previously cited) teaches that P300 latency is reported to be related to cognitive abilities with shorter latencies associated with better cognitive performance (section [0045]).
Fadem et al.’072 (US Pub No. 2008/0208072 – previously cited) teaches that latency of the P300 peak may help distinguish Alzheimer’s disease from other forms of dementia (section [0254]).
Each of Kim’484 (US Pub No. 2017/0339484 – previously cited), Denison et al.’230 (US Pub No. 2014/0316230 – previously cited), LeBoeuf et al.’100 (US Pub No. 2010/0217100 – previously cited), and Chuang et al.’509 (US Pub No. 2013/0039509 – previously cited) teach implementing an EEG measuring section in a headphone.
Kidmose et al.’731 (US Pub No. 2013/0296731 – previously cited) teaches an EEG data analysis system wherein an EEG data acquisition section is provided on a hearing aid (Figures 3 and 4, and section [0009]).
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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