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 .
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.
Claims 7-9 are 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. Regarding claims 7-9, the originally filed specification fails to provide support for an electroencephalogram (EEG) data analysis system wherein one of glasses, sunglasses, a headphone, or a hearing aid are provided with the claimed processor of claim 1. As shown in Figure 27 and discussed in its description, the processor of claim 1 (element 2702) is not part of the glasses, sunglasses, headphones, or hearing aid (element 2703). Instead, as shown in Figures 21B, 21C, and 21D, the processor of the electronic device of claim 1 is a device (e.g., smartphone, tablet PC, TV set) separate from the measurement device (the glasses, sunglasses, headphone, or hearing aid).
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 3 and 7-9 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 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 claims provides to the claimed invention. Claim 3 describes calculating a P300 peak latency, which is already recited in claim 1.
Regarding claims 7-9, it is unclear what is meant by “provided with the processor”. It is unclear if the claim intends for the processor to be part of/within/attached to the glasses, sunglasses, headphone, and hearing aid, or if “provided” is being used as a verb to indicate that the glasses, sunglasses, headphone, and hearing aid are given to (“provided to”) a subject along with the separate electronic device (which houses the processor). For the purpose of examination, and because the originally filed disclosure does not support glasses, sunglasses, a headphone, or a heading aid comprising the claimed processor, the claims are being interpreted such that the electronic device, which houses the processor, is provided to the subject along with the measurement device, wherein the measurement device is separate from the electronic device, and is one of glasses, sunglasses, a headphone, or a hearing aid.
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 1-9 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 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 acquiring and wirelessly transmitting EEG data. The structural elements configured to acquire and transmit EEG data are each recited at a high level of generality (e.g., an EEG detection sensor and a wireless transmitter) 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 1-6 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).
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), the processor being configured to present, to a subject, examination data that is used for examining a cognitive function of the subject at a time the subject is executing an operation that has 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 executing an operation having a purpose different from that of the EEG measurement);
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.
Regarding claim 2, the examination data (the stimuli) 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 4, as noted above with respect to claim 1, the EEG data analysis system is capable of presenting the subject examination data at any time, including at a time of when the subject is receiving an incoming call.
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).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Coleman et al.’686 in view of Anwar et al.’187, as applied to claim 1, further in view of Connor’947 (US Pub No. 2017/0188947 – previously cited).
Coleman et al.’686 in view of Anwar et al.’187 discloses all of the elements of the current invention, as discussed in paragraph 9 above, except for the measurement device being glasses or sunglasses provided with the processor. 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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Coleman et al.’686 in view of Anwar et al.’187, as applied to claim 1, further in view of Kim’484 (US Pub No. 2017/0339484 – previously cited).
Coleman et al.’686 in view of Anwar et al.’187 discloses all of the elements of the current invention, as discussed in paragraph 9 above, except for the measurement section being a headphone provided with the EEG data acquisition system. Kim’484 teaches an EEG data analysis system wherein an EEG data acquisition section is provided on headphones (Figures 1-9, and sections [0017], [0030], and [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 EEG data analysis system of Coleman et al.’686 in view of Anwar et al.’187 to include a headphone provided with the EEG data acquisition section, as taught by Kim’484, 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 an EEG data acquisition section that measures EEG data generated in response to a user receiving an audio stimulus, and that the measurement device of Kim’484 is an EEG data acquisition section that not only provides an audio stimulus, but also measures EEG signals that result from a user being presented the audio stimulus.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Coleman et al.’686 in view of Anwar et al.’187, as applied to claim 1, further in view of Kidmose et al.’731 (US Pub No. 2013/0296731 – previously cited).
Coleman et al.’686 in view of Anwar et al.’187 discloses all of the elements of the current invention, as discussed in paragraph 9 above, except for the measurement section being a hearing aid provided with the EEG data acquisition system. Kidmose et al.’731 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]). 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 a hearing aid provided with the EEG data acquisition section, as taught by Kidmose et al.’731, 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 an EEG data acquisition section that measures EEG data generated in response to a user receiving an audio stimulus, and that the measurement device of Kidmose et al.’731 is an EEG data acquisition section that not only provides an audio stimulus, but also measures EEG signals that result from a user being presented the audio stimulus.
Response to Arguments
Applicant's arguments filed 18 November 2025 have been fully considered.
Regarding the rejection of the claims under 35 U.S.C. 101, Applicant’s arguments are not persuasive. The claimed analysis system is a system comprising generically claimed components: an electronic device comprising a processor, and a measurement device comprising an EEG detection sensor and a wireless transmitter.
The processor is configured to perform steps that are capable of being performed in the human mind –
receiving EEG data (looking at a screen displaying acquired EEG data),
detecting an index of a cognitive function of a subject by calculating a P300 peak latency from EEG data and comparing the calculated P300 peak latency with a reference value (the human mind is capable of mentally determining the time difference between a P300 peak and a time at which a stimulus was provided; the human mind is also capable of comparing a calculated P300 peak latency value to a reference value), and
outputting or indicating 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 (this is an observation/evaluation that can be made mentally based on the calculated P300 peak latency differing from the reference value).
The other two claimed components, the EEG detection sensor and wireless transmitter, are generic components configured to perform routine data gathering and transmitting activity.
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 performs another unrelated operation, it is noted that the current invention is drawn to a system, not a method. As long as an EEG data analysis system is capable of being used while a subject performs another unrelated operation, its processor is configured to present examination data while the subject performs another unrelated operation. For “the processor presents examination data while the subject performs another unrelated operation” to be given any patentable weight, the claims would need to be drawn to a method, not a system. Because when the processor is configured to present the examination data provides no patentable weight to the claimed invention, Applicant’s argument that an improvement is provided because of the timing is not persuasive.
Regarding the previous rejections of the claims under 35 U.S.C. 112(b), while the amendments have overcome the previous rejections, as discussed in paragraph 5 above, the amendments have created new indefiniteness issues within some of the claims.
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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Farwell’217 (US Pub No. 2002/0188217) 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) 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) teaches that latency of the P300 peak may help distinguish Alzheimer’s disease from other forms of dementia (section [0254]). Each of 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791