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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 11/11/2025. As directed by the amendment: Claims 1 and 6 have been amended, no claims have been cancelled, and claims 14-15 have been added. Claims 11-13 were previously withdrawn due to a Restriction Requirement. Thus, claims 1-10 and 14-15 are presently under consideration in this application.
Response to Arguments
Applicant's arguments, see pages 5-11, filed 11/11/2025, regarding 35 U.S.C. 101 have been fully considered but they are not persuasive.
Applicant argues on pages 6-7 that “Applicant respectfully submits that the plain language of claim 1 shows that the asserted limitation is not merely a mental process at least because the recited result "to inhibit intermixture of a heart-rate evoked potential (HEP) of the subject with the ERP signal" is not caused by signal analysis and processing… Instead, the result "to inhibit intermixture of a heart-rate evoked potential (HEP) of the subject with the ERP signal" is caused by the claimed step of "inducing an evoked potential to the subject by presenting an ERP stimulus to the subject on the basis of the continuous R-peak signal" together with the restriction that "during a certain period of time from when any R-peak of the continuous R-peak signal occurs, the ERP stimulus is not presented to the subject"”
However, Applicant has failed to address how the R peak determination cannot be done in the human mind. Furthermore, Applicant is asserting the abstract idea itself as the improvement. However, the abstract idea cannot be an “additional element” that shows integration into a practical application.
Applicant then argues on pages 8-9 that “Applicant respectfully submits that the claims integrate such steps into a practical application. In particular, the R-peak determination is practically applied to control presentation of the ERP stimulus to the subject during a specified period of time following the R-peak. As described throughout Applicant's specification disclosure, this practical application yields an ERP signal that suffers from less distortion from a reoccurring heart-rate evoked potential. In the absence of such regulation of the ERP stimulus, the measured ERP signal remains contaminated by the noise generated from activity of the heart (specification [0004]-[0009], Figs. 4A, 4B, 8A, 8B, 8C, 8D, 8E). Similarly, in claim 6, the recited ERP stimulus controller is configured to control the ERP stimulus presented to the subject during a certain period after occurrence of the R-peak in a practical application to yield an ERP signal that suffers from less distortion from a reoccurring heart-rate evoked potential. In the absence of such regulation of the ERP stimulus, the measured ERP signal remains contaminated by the noise generated from activity of the heart (specification [0004]-[0009], Figs. 4A, 4B, 8A, 8B, 8C, 8D, 8E)… the R-peak determination is practically applied to control the presentation of the ERP stimulus to the subject during a specified period of time following the R-peak. As described in the specification disclosure, conventional noise removal algorithms for an EEG
signal that are effective to control for a subject's muscular movement or blinking are not effective against contamination from an HEP signal that generates continuously occurring noise”
Applicant is asserting the abstract idea itself as the improvement. However, the abstract idea cannot be an “additional element” that shows integration into a practical application. The order of calculations and the particular calculations claimed do not make the abstract idea any less abstract. The claims are currently structured as simply using a generic computer to implement the abstract idea (mental process), which is not enough to show a practical application. Further, Examiner disagrees since the processing of data on a microcontroller unit is merely performing this process on a generic computer structure. The transmitting of signals is simply a generic computer function performed by a generic computer structure, wherein implementing the abstract idea with a generic computer is not enough to show integration into a practical application or significantly more than the abstract idea itself. The transmission of data to and from the sensor systems is merely data gathering, which is insignificant extra-solution activity.
Lastly, Applicant argues on page 11 that “Applicant does not concede the assertion that "controlling presentation of ERP stimulus. [is] not found in the claim."… Instead, these limitations meaningfully integrate the alleged mental steps into a practical application in which heart-related noise is prevented from contaminating the measured ERP signal.”
Presenting a stimulus is insufficient to integrate the judicial exception into practical application. An ERP signal is gathered following the ERP stimulus, which is the gathering of data following the stimulus, which does not integrate the judicial exception into practical application. The prevention of contaminated ERP is not claimed, and would further be considered applying the abstract idea into a processor. Therefore, the rejection is maintained.
Applicant’s arguments, see pages 11-22, filed 11/11/2025, with respect to 35 U.S.C. 103 have been fully considered and are not persuasive.
Applicant asserts on pages 11 and 13 that “a person having ordinary skill in the art would recognize that the above excerpt of Park does not teach or suggest "on the basis of the continuous R-peak signal" as alleged by the rejection.” Applicant then argues on page 13 “the presentation of the ERP stimulus in Park is entirely separate from the discussion of R-peak. As excerpted above and illustrated in Fig. 5, Park teaches ERP stimulus of presented alphanumeric characters. To this end, Park excludes visual fatigue caused by background flicker, in order to minimize contamination of the desired signal. There is no evidence or technical reasoning of record that indicates that the ERP stimulus is in any way related to the R-peak signal. In particular, there is no teaching or suggestion in Park that the ERP stimulus ("presentations of alphanumeric characters randomly drawn from the set A-K + 5 or P") (Park p. 123, col. 1) are presented on the basis of the continuous R-peak signal.”
Examiner disagrees. Fig. 1 of Park explains the heart-brain synchronization where EEG and HEP signals are established. Furthermore, under the heading “Data acquisition and signal processing”, the EEG and ECG signals were acquired before and after each recorded stimulation/viewing [ERP stimulus], in which EEG signals were extracted from R peaks at specific intervals. HEP (heart rate evoked potential) is induced on the basis on R peaks, as noted in the steps of HEP extraction of Park, before and following the stimulus.
Applicant then argues on pages 14-15 that “an essential inquiry under obviousness analysis is what a person having ordinary skill in the art reading Park and Whang would have recognized as the scope and content of the respective references… First, the rejection offers no specific evidence to support its assertion that 2D/3D videos fall within the scope of ERP stimulus. As best understood by Applicant, the list of the representative number of species identified by the rejection rationale arises from uncited extrinsic sources. Applicant respectfully requests that the record be made complete with respect to the factual inquiry of what is understood to constitute the claim term "ERP stimulus."”
Examiner notes that although a stimulus may be recited broadly, the Park and Whang reference are visual stimulus, in which a MWL is administered to a user, similar to the instant specification’s stimulus of [0048], which is consistent in why the art is the same field of endeavor.
Applicant then argues on page 15 that “Second, the claim interpretation appears to broaden the term "ERP stimulus" to simply the term "stimulus." As best understood by Applicant, the rejection interprets the claim term "[event-related potential] stimulus" as any kind of stimulus, such as a 2D/3D video because such video can "stimulate" cognitive fatigue. Applicant submits, however, that the claimed "ERP stimulus" elicits an "event-related potential" as expressly recited in the claims. In the present case, while a 2D/3D video may "stimulate" cognitive fatigue, cognitive fatigue is not an event-related potential, nor is cognitive fatigue treated as an event-related potential in the cited references. Rather, Park follows established protocol to display ERP stimulus ("presentations of alphanumeric characters randomly drawn from the set A-K + 5 or P") (Park p. 123, col. 1) to elicit a measurable ERP, which is a well-recognized term of art.”
Examiner notes that although the phrase ERP stimulus is broad, Examiner has used the instant specifications definition and used Park and Whang for that reason, as the term of art is referring to the MWL stimulus, which is in line with the Park definition.
Applicant then argues on page 16 that “Fourth, the rejection has not articulated any reason that a person having ordinary skill in the art reading the cited references would have extended the meaning of "ERP stimulus" beyond the expressly disclosed usage. That is, the cited references treat "ERP stimulus" to mean "presentations of alphanumeric characters randomly drawn from the set A-K + 5 or P") (Park p. 123, col. 1) in order to elicit ERPs-that is, event-related potentials. If a person having ordinary skill in the art would have substituted "2D/3D videos" in place of the presentations of alphanumeric characters within the experimental protocol of the cited references-that is, according to the scope of "ERP stimulus" proffered by the rejections-the technical disclosure and experimental results would be muddled, if not incomprehensible. In other words, while the claims terms may have the broadest reasonable interpretation in light of the specification disclosure, a person having ordinary skill in the art reading the term "EPR stimulus" in the technical disclosures of Park and reading Whang would have no reason to understand the term "ERP stimulus" to refer to 2D/3D videos. Doing so would yield a non- sensical disclosure to the person having ordinary skill in the art reading the cited references.”
Examiner disagrees. Examiner is not asserting the substitution of the "presentations of alphanumeric characters randomly drawn from the set A-K + 5 or P") (Park p. 123, col. 1), with the videos. Both Park and Whang are directed to analyzing cognitive fatigue before and after view videos, using stimuli.
Applicant then asserts on page 17 that “In Park, the video-viewing cognitive task does not employ the ERP stimulus recognized in the art such as employed in the pre-cognitive task or the post-cognitive task.” Applicant then argues on page 18 that “The Office has not established why a person having ordinary skill in the art reading Park would have considered the 3D video to constitute an "ERP stimulus", especially when Park expressly identifies particular stimuli in the ERP task and does not describe or regard the 2D or 3D video as an "ERP stimulus."”
Examiner disagrees. Applicant is misconstruing Examiner’s argument of the ERP stimulus to be a video. Pg. 123 left column line 5 of Park recites a stimulator for measuring cognitive fatigue and Fig. 2 of Whang shows the experimental stimulus provided to the user ([0052]), similar to the stimulator of Park. Coles and Rugg, 1996, cited by Park and in Applicant’s arguments, uses an auditory stimulus for ERP (See page 6 lines 15-18). Everything that Examiner has clarified is clearly provided under the 35 U.S.C. 103 heading of the Office Action filed 08/15/2025, as Examiner shows that the stimulator is used for inducing ERP. Coles and Riggs definition of ERP is found on page 8 where “an ERP component is defined more in terms of the information processing operation with which it is correlated. Thus, components are defined in terms of the cognitive function thought to be performed by the brain systems whose activity is recorded at the scalp. The ‘cognitive function’ is specified by the nature of independent variables whose manipulation effects the component, and by the relationships observed between the component and other measures (e.g. overt behavioral measures like response speed and accuracy).” As noted by Coles and Rugg, ERP analyzes cognitive function of the user. The stimulator, before and after viewing of the movie, is used to characterize cognitive function. Applicant is mischaracterizing the Examiner’s position. Examiner’s position is that the stimulator, and not the 3D video for fatigue, is used for MWL where the ERP is analyzed. Applicant has failed to address what is wrong with Examiner’s interpretation of the stimuli of both Park and Whang.
Applicant then argues on page 19 that “Applicant respectfully traverses the rejection's reliance on Whang as curing Park with respect to teaching the ERP stimulus presented after a certain time. As best understood by Applicant, the rejection relies on Whang to cure deficiencies in Park by Whang's teaching that video content was presented for 70 minutes where ERP, HEP, and TEPR analysis was conducted before and after viewing the video content. Applicant submits that a person having ordinary skill in the art reading the cited references would have recognized that a video eliciting cognitive fatigue (e.g., mental workload) is not an ERP stimulus. For example, Park employs 3D video to induce cognitive fatigue (Park Abstract; p. 120, col. 1), while an ERP stimulus is regarded by Park, and known in the art, as a single stimulus or event of interest (Park, p. 121, col. 1 referencing Coles and Rugg, 1996).” Applicant further asserts on page 20 that “Both Park and Whang positively disclose an ERP stimulus as known in the art to be a single stimulus or event of interest employed to evoke a discrete neurophysiological signal for measurement in a subject. In addition, Park and Whang both teach a separate protocol to induce cognitive fatigue that does not include such an ERP stimulus. Namely, in both Park and Whang, evaluation of the neurophysiological response occurs prior to the mental workload (MWL) challenge and after the MWL challenge. In both Park and Whang, the video-viewing cognitive task does not employ the ERP stimulus recognized in the art such as employed in the pre-cognitive task or the post-cognitive task.” Applicant further argues on page 22 that “The Office has not established why a person having ordinary skill in the art reading Park and Whang would have considered the 3D video of Whang to constitute an "ERP stimulus", especially when Whang expressly identifies particular stimuli in the ERP task and does not describe or regard the 2D or 3D video as an "ERP stimulus."”
Examiner disagrees. Applicant is misconstruing Examiner’s argument of the ERP stimulus to be a video. Pg. 123 left column line 5 of Park recites a stimulator for measuring cognitive fatigue and Fig. 2 of Whang shows the experimental stimulus provided to the user ([0052]), similar to the stimulator of Park. Coles and Rugg, 1996, cited by Park and in Applicant’s arguments, uses an auditory stimulus for ERP (See page 6 lines 15-18). Everything that Examiner has clarified is clearly provided under the 35 U.S.C. 103 heading of the Office Action filed 08/15/2025, as Examiner shows that the stimulator is used for inducing ERP. Coles and Riggs definition of ERP is found on page 8 where “an ERP component is defined more in terms of the information processing operation with which it is correlated. Thus, components are defined in terms of the cognitive function thought to be performed by the brain systems whose activity is recorded at the scalp. The ‘cognitive function’ is specified by the nature of independent variables whose manipulation effects the component, and by the relationships observed between the component and other measures (e.g. overt behavioral measures like response speed and accuracy).” As noted by Coles and Rugg, ERP analyzes cognitive function of the user. The stimulator, before and after viewing of the movie, is used to characterize cognitive function. Applicant is mischaracterizing the Examiner’s position. Examiner’s position is that the stimulator, and not the 3D video for fatigue, is used for MWL where the ERP is analyzed. Applicant has failed to address what is wrong with Examiner’s interpretation of the stimuli of both Park and Whang.
Applicant argues on page 22 that “Previously, the rejection appeared to regard specification [0041] as an admission by Applicant that the recited ERP stimulus induces cognitive fatigue such that the cited 3D video, which induces cognitive fatigue, therefore falls within the scope of an ERP stimulus.
(i) Applicant does not admit the characterization asserted.
(ii) The rejection relies on a false equivalency. The rejection logic asserts that a common
result necessitates that the causative factors are identical.
The same rejection logic may erroneously assert that, because reading the present Response to the Office Action causes cognitive fatigue, therefore, it is a 3D video, which causes cognitive fatigue. Just as a person having ordinary skill in the art would not have understood reading the present Response to the Office Action to fall within the scope of the recited ERP stimulus, so a person having ordinary skill in the art would not have understood the 3D video of Whang to fall within the scope of the recited ERP stimulus.
(iii) Specification paragraph [0048] elaborates on the experimental stimulus briefly mentioned in paragraph [0041]. In particular, a person having ordinary skill in the art reading the entire specification disclosure would readily appreciate that "a mental arithmetic task is performed to observe an ERP response according to a mental workload (MWL)." A skilled artisan reading the entire specification disclosure would not have considered the mental arithmetic task, which may be used to induce cognitive fatigue, to constitute or employ an ERP stimulus as described by Applicant.”
Examiner disagrees. Examiner would like to clarify on the record that the 3D or 2D video is not the ERP stimulus, as noted on page 10 of the Office Action filed 08/15/2025 where “the stimulator” of Park from Pg. 123 left col. line 5-9 is the ERP stimulus. Cognitive fatigue is evaluated before and after the view of a 2D or 3D video, via the ERP stimulus. The MWL of Park is not used to induce cognitive fatigue, but rather, measure ERP that is associated with cognitive fatigue. Everything that Examiner has clarified is clearly provided under the 35 U.S.C. 103 heading of the Office Action filed 08/15/2025, as Examiner shows that the stimulator is used for inducing ERP. The rejection of the claims has been maintained.
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 1-5 and 14 are rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 has been amended to include the limitation, " the basis of the continuous R-peak signal for presenting the ERP stimulus is that, during a certain period of time from when any R-peak of the continuous R-peak signal occurs, the ERP stimulus is not presented to the subject to inhibit intermixture of a heart-rate evoked potential (HEP) of the subject with the ERP signal ". The limitation does not have support in the instant specification nor in the parent application.
The specification provides support for “an evoked potential to the subject by presenting an ERP stimulus to the subject for a certain period on the basis of the R-peak signal” ([0014]). The “basis” is interpreted to mean, alongside, and not the controlling of when stimulus occurs. However, the specification does not provide support for the basis of the R peak for presenting ERP stimulus, the ERP is not presented. In other words, the R-peaks do not control when not to present ERP stimulus, as insinuated by the claim . Applicant has not indicated where the disclosure provides adequate written description support for the instant claim limitation, "the basis of the continuous R-peak signal for presenting the ERP stimulus is that, during a certain period of time from when any R-peak of the continuous R-peak signal occurs, the ERP stimulus is not presented to the subject to inhibit intermixture of a heart-rate evoked potential (HEP) of the subject with the ERP signal”. Therefore, the new claim limitations introduce new matter.
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 1-5 and 14-15 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 limitation "the basis" in lines 6 and 9. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-5 and 14 are rejected due to their dependency of claim 1.
Regarding claims 14 and 15, it is unclear what the metes and bounds of the claim are. Specifically, how is it possible to look at “any” R peaks from claim 1, when we are looking at a period after “any” R peak and before the “any” R peak. It appears that the claim is looking at many R peak at the same time. This also fails to define the metes and bounds of a “certain period” of time.
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 1-10, and 14-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Each of independent claim 1 recites a step extract a heart-rate evoked potential (HEP) signal by detecting an R-peak from the ECG signal…wherein, during a latency from a point in time when the R-peak occurs, the ERP stimulus is prohibited from being presented to the subject to inhibit intermixture of a heart-rate evoked potential (HEP) of the subject with the ERP signal, which is a mental process. Each of independent claim 6 recites a step extract a heart-rate evoked potential (HEP) signal by detecting an R-peak from the ECG signal… an ERP stimulus controller configured to inhibit intermixture of an HEP of the subject with the ERP signal by restricting the ERP stimulus presented to the subject during a certain period after occurrence of the R-peak detected from the ECG signal, which is a mental process. This judicial exception is not integrated into a practical application because the generically recited computer elements (ie. a controller and processing unit), detect ECG and EEG, and extracting R peaks do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are to receiving data, processing data, and extracting R peaks and inhibiting intermixture, which are all well-understood, routine, and conventional computer functions. See MPEP § 2106.05(d).
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject
matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claim 6 is directed to a system (i.e. machine) and thus meets the step 1 requirements.
Claim 1 is directed to a method and thus meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claims 1 and 6, the following step is an abstract idea:
“extract a heart-rate evoked potential (HEP) signal by detecting an R-peak from the ECG signal…wherein, during a latency from a point in time when the R-peak occurs, the ERP stimulus is prohibited from being presented to the subject to inhibit intermixture of a heart-rate evoked potential (HEP) of the subject with the ERP signal” and “extract a heart-rate evoked potential (HEP) signal by detecting an R-peak from the ECG signal… an ERP stimulus controller configured to inhibit intermixture of an HEP of the subject with the ERP signal by restricting the ERP stimulus presented to the subject during a certain period after occurrence of the R-peak detected from the ECG signal”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could extract HEP by analyzing R peaks and following a stimulation, inhibiting the intermixing of HEP and ERP by excluding HEP from ERP.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claims 1 and 6, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “signal processing unit”, “stimulator”, and “an ERP stimulus controller” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “ECG measurer”, “EEG measurer” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “ERP”, “R peak”, “ECG”, “EEG” and “HEP” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
Examiner suggest looking into MPEP 2106.04(d)(2)(c) for guidance regarding the meaningful limitations on the judicial exception of gathering and processing data (extra-solution activity) following the end of stimulation or treatment.
Step 2B – significantly more/inventive concept
The following claim elements do not add any meaningful limitation to the abstract idea:
- “signal processing unit”, “stimulator”, and “an ERP stimulus controller” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “ECG measurer”, “EEG measurer” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “ERP”, “R peak”, “ECG”, “EEG” and “HEP” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
The additional elements of claims 1 and 6, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, processing unit and controller, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The ECG sensor and EEG sensor are claimed very generically and are used only to gather the data they are designed for. These are well-understood, routine and conventional structure since the diagnostic art in Zhao et al (US 20170258356) teaches the use of ECG/EKG sensors to collect ECG signals.
Dependent claims 2-5, 7-10, and 14-15 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 1 and 6. The dependent claim limitations are directed to the processing of data (claims 2-5, 7-10, and 14-15) which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional.
In summary, claims 1-10, and 14-15 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
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.
Claim(s) 1-10 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (“Evaluation of 3D cognitive fatigue using heart–brain synchronization” International Journal of Psychophysiology Volume 97, Issue 2 , August 2015, Pages 120-130) (Hereinafter Park) in view of Whang et al. (US 20180220885)(Hereinafter Whang).
Regarding claim 1, Park teaches A method of detecting an event-related potential (ERP) signal (Fig. 3), the method comprising:
detecting a continuous R-peak signal from an electrocardiogram (ECG) signal of a subject by an ECG sensor (Pg. 124 right col. lines 1-2 “The HEP extraction steps were as follows. (1) The R-peak was detected in the ECG signal based on the QRS detection algorithm”); and
inducing an evoked potential to the subject by presenting an ERP stimulus to the subject on the basis of the continuous R-peak signal (Pg. 123 left col. lines 5-9 and right col. lines 7-9 “A stimulator was designed to measure cognitive fatigue. The design incorporated a technique validated in a previous study (Mun et al., 2012, Park et al., 2014), in which the visual fatigue caused by background flicker during measurement of the steady-state visual evoked potential was excluded to minimize contamination of the desired signal…. The EEG and electrooculography (EOG) data collected during target presentation following the bar press constituted the input to the ERP analysis.”);
detecting an electroencephalogram (EEG) signal of the subject exposed to the ERP stimulus by using an EEG sensor and extracting an ERP signal from the EEG signal (Pg. 123 right col. lines 11-13 “EEG signals were recorded from eight channels on the scalp at positions F3, F4, C3, C4, P3, P4, O1, and O2 based on the international “10–20” system.”).
However, Park does not explicitly teach a certain period of time from when any R-peak of the continuous R-peak signal occurs, the ERP stimulus is not presented to the subject. Whang, in the same field of endeavor, teaches analyzing ERP, via an experimental stimulus, before and after watching a 2D and 3D visual for analyzing cognitive fatigue ([0006], [0052]), similar to the device of Park, and further teaches wherein, the basis of the continuous R-peak signal for presenting the ERP stimulus is that, during a certain period of time from when any R-peak of the continuous R-peak signal occurs, the ERP stimulus is not presented to the subject to inhibit intermixture of a heart-rate evoked potential (HEP) of the subject with the ERP signal ([0087] “FIG. 11 shows average values for the HEP first (alpha power in 50-250 ms period after the R-peak) and second (alpha power in 250-600 ms period after the R-peak) components in eight brain regions for 2D and 3D conditions. This values were calculated with the difference value between before and after each viewing condition” Examiner notes that the HEP is collected before and after the viewing condition, which means that ERP signal is not presented during a certain period of an occurrence of R peak. For example, before presentation, R peak is viewed, and following that detection is the viewing condition. Examiner notes the phrase falls on the basis of continuous R peak for presenting ERP stimulus does not affect the interpretation because even if the ERP stimulus was controlled by the R peak, ERP stimulus is not presented during viewing following the latest R peak of the prior to viewing experimental stimulus timeframe.) to compare conditions before and after viewing of stimuli ([0088]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Park, with the certain period of time from when any R-peak of the continuous R-peak signal occurs, the ERP stimulus is not presented to the subject of Whang, because such a modification would allow to increase HEP components indicating the time interval required to process the data acquired.
Regarding claim 2, Park teaches wherein the certain period includes a time range corresponding to at least one of a first component and a second component of the HEP (Fig. 2 where HEP components are in two separate time ranges).
Regarding claim 3, claim 1 is obvious over Park and Whang. However, Park does not teach the ERP stimulus presented after a certain time. Whang, in the same field of endeavor, teaches analyzing ERP from watching a 2D and 3D visual ([0006]), similar to the device of Park, and further teaches wherein the ERP stimulus is presented to the subject after about 50 ms to about 600 ms from the time point of the occurrence of the R- peak ([0105] “The alpha power of first and second components in HEP were increased after watching a 3D video than 2D video. The alpha power of first (50-250 ms after the R-peak) and second (250-600 ms after the R-peak) components in HEP showed the time interval required to transmit the cardiac information and the hydraulic blood pressure wave in the heart to travel to the brain through afferent pathways in the vagus nerve.” It is noted that since HEP was increased after watching the video, a comparison between HEP before and after the visual presentation must occur to show such an increase. Therefore, there must be at least 1 R peak that occurred prior to the visual stimulation occurring in which the user did not see the visual and therefore the ERP stimulus presenting after 50-600 ms of the occurrence of the R peak.) to increase HEP components indicating the time interval required to transmit information from the heart to the brain ([0105]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Park, with the ERP stimulus presented after a certain time of Whang, because such a modification would allow to increase HEP components indicating the time interval required to transmit information from the heart to the brain.
Regarding claim 4, claim 1 is obvious over Park and Whang. However, Park does not teach the ERP stimulus presented after a certain time. Whang, in the same field of endeavor, teaches analyzing ERP from watching a 2D and 3D visual ([0006]), similar to the device of Park, and further teaches wherein the HEP includes a first component and a second component, and the ERP stimulus is presented to the subject from a time point beyond a point in time when the first component of the HEP occurs ([0105] “The alpha power of first and second components in HEP were increased after watching a 3D video than 2D video. The alpha power of first (50-250 ms after the R-peak) and second (250-600 ms after the R-peak) components in HEP showed the time interval required to transmit the cardiac information and the hydraulic blood pressure wave in the heart to travel to the brain through afferent pathways in the vagus nerve.” It is noted that since HEP was increased after watching the video, a comparison between HEP before and after the visual presentation must occur to show such an increase. Therefore, there must be at least 1 R peak that occurred prior to the visual stimulation occurring in which the user did not see the visual and therefore the ERP stimulus presenting after 50-600 ms of the occurrence of the R peak.) to increase HEP components indicating the time interval required to transmit information from the heart to the brain ([0105]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Park, with the ERP stimulus presented after a certain time of Whang, because such a modification would allow to increase HEP components indicating the time interval required to transmit information from the heart to the brain.
Regarding claim 5, claim 1 is obvious over Park and Whang. However, Park does not teach the ERP stimulus presented after a certain time. Whang, in the same field of endeavor, teaches analyzing ERP from watching a 2D and 3D visual ([0006]), similar to the device of Park, and further teaches wherein the HEP is detected from the subject, and the certain period for which the ERP stimulus is not presented is calculated from the HEP obtained from the subject ([0105] “The alpha power of first and second components in HEP were increased after watching a 3D video than 2D video. The alpha power of first (50-250 ms after the R-peak) and second (250-600 ms after the R-peak) components in HEP showed the time interval required to transmit the cardiac information and the hydraulic blood pressure wave in the heart to travel to the brain through afferent pathways in the vagus nerve.” It is noted that since HEP was increased after watching the video, a comparison between HEP before and after the visual presentation must occur to show such an increase. Therefore, there must be at least 1 R peak that occurred prior to the visual stimulation occurring in which the user did not see the visual and therefore the ERP stimulus presenting after 50-600 ms of the occurrence of the R peak.) to increase HEP components indicating the time interval required to transmit information from the heart to the brain ([0105]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Park, with the ERP stimulus presented after a certain time of Whang, because such a modification would allow to increase HEP components indicating the time interval required to transmit information from the heart to the brain.
Regarding claim 6, Park teaches An apparatus and method for detecting an event-related potential (ERP) (Fig. 3), the apparatus comprising:
a simulator configured to induce an evoked potential to a subject by presenting an ERP stimulus to the subject (Pg. 123 left col. lines 5-9 and right col. lines 7-9 “A stimulator was designed to measure cognitive fatigue. The design incorporated a technique validated in a previous study (Mun et al., 2012, Park et al., 2014), in which the visual fatigue caused by background flicker during measurement of the steady-state visual evoked potential was excluded to minimize contamination of the desired signal…. The EEG and electrooculography (EOG) data collected during target presentation following the bar press constituted the input to the ERP analysis.”);
an electrocardiogram (ECG) measurer having an ECG sensor configured to detect an ECG signal from the subject exposed to the ERP stimulus (Pg. 124 left col. lines 1-2 “ECG signals were recorded through one channel with the lead-I method.”);
an electroencephalogram (EEG) measurer having an EEG sensor configured to detect an EEG signal from the subject (Pg. 123 right col. lines 11-13 “EEG signals were recorded from eight channels on the scalp at positions F3, F4, C3, C4, P3, P4, O1, and O2 based on the international “10–20” system.”);
a signal processing unit configured to extract a heart-rate evoked potential (HEP) signal by detecting a continuous R-peak signal from the ECG signal, and detect an ERP signal from the EEG signal (Pg. 124 right col. lines 1-2 “The HEP extraction steps were as follows. (1) The R-peak was detected in the ECG signal based on the QRS detection algorithm” Pg. 129 right col. lines 11-13 “In addition, because the HEP can be used to measure real-time 3D visual fatigue, the method has an advantage over offline methods.”).
However, Park does not explicitly teach a processing unit, a stimulus controller, and the ERP signal by not presenting the ERP stimulus to the subject during a certain period after occurrence of any R-peak of the continuous R-peak signal. Whang, in the same field of endeavor, teaches analyzing ERP from watching a 2D and 3D visual ([0006]), similar to the device of Park, and further teaches a processing unit ([0015]) and an ERP stimulus controller ([0056] “A blu-ray player (BD-ES6000, Samsung) was used to play the 2D and 3D contents on an LED-3DTV (UN4OES6800F, Samsung)”) an ERP stimulus controller configured to inhibit intermixture of an HEP of the subject with the ERP signal by not presenting the ERP stimulus to the subject during a certain period after occurrence of any R-peak of the continuous R-peak signal detected from the ECG signal by the signal processing unit ([0087] “FIG. 11 shows average values for the HEP first (alpha power in 50-250 ms period after the R-peak) and second (alpha power in 250-600 ms period after the R-peak) components in eight brain regions for 2D and 3D conditions. This values were calculated with the difference value between before and after each viewing condition” Examiner notes that the HEP is collected after the viewing condition, which means that ERP signal is not presented during a certain period after occurrence of R peak, because before presentation, R peak is viewed, and following that detection is the viewing condition.) to compare conditions before and after viewing of stimuli ([0088]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Park, with the processing unit, a stimulus controller, and the ERP signal by not presenting the ERP stimulus to the subject during a certain period after occurrence of any R-peak of the continuous R-peak signal of Whang, because such a modification would allow to increase HEP components indicating the time interval required to process the data acquired.
Regarding claims 7, Park teaches wherein the certain period includes a time range corresponding to at least one of a first component and a second component of the HEP (Fig. 2 where HEP components are in two separate time ranges).
Regarding claim 8, claim 6 is obvious over Park and Whang. However, Park does not teach the ERP stimulus presented after a certain time. Whang, in the same field of endeavor, teaches analyzing ERP from watching a 2D and 3D visual ([0006]), similar to the device of Park, and further teaches wherein the ERP stimulus is presented to the subject after the certain period of about 50 ms to about 600 ms from the time point of the occurrence of the R- peak ([0105] “The alpha power of first and second components in HEP were increased after watching a 3D video than 2D video. The alpha power of first (50-250 ms after the R-peak) and second (250-600 ms after the R-peak) components in HEP showed the time interval required to transmit the cardiac information and the hydraulic blood pressure wave in the heart to travel to the brain through afferent pathways in the vagus nerve.” It is noted that since HEP was increased after watching the video, a comparison between HEP before and after the visual presentation must occur to show such an increase. Therefore, there must be at least 1 R peak that occurred prior to the visual stimulation occurring in which the user did not see the visual and therefore the ERP stimulus presenting after 50-600 ms of the occurrence of the R peak.) to increase HEP components indicating the time interval required to transmit information from the heart to the brain ([0105]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Park, with the ERP stimulus presented after a certain time of Whang, because such a modification would allow to increase HEP components indicating the time interval required to transmit information from the heart to the brain.
Regarding claim 9, claim 6 is obvious over Park and Whang. However, Park does not teach the ERP stimulus presented after a certain time. Whang, in the same field of endeavor, teaches analyzing ERP from watching a 2D and 3D visual ([0006]), similar to the device of Park, and further teaches wherein the HEP includes a first component and a second component, and the ERP stimulus is presented to the subject after the first component of the HEP occurs ([0105] “The alpha power of first and second components in HEP were increased after watching a 3D video than 2D video. The alpha power of first (50-250 ms after the R-peak) and second (250-600 ms after the R-peak) components in HEP showed the time interval required to transmit the cardiac information and the hydraulic blood pressure wave in the heart to travel to the brain through afferent pathways in the vagus nerve.” It is noted that since HEP was increased after watching the video, a comparison between HEP before and after the visual presentation must occur to show such an increase. Therefore, there must be at least 1 R peak that occurred prior to the visual stimulation occurring in which the user did not see the visual and therefore the ERP stimulus presenting after 50-600 ms of the occurrence of the R peak.) to increase HEP components indicating the time interval required to transmit information from the heart to the brain ([0105]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Park, with the ERP stimulus presented after a certain time of Whang, because such a modification would allow to increase HEP components indicating the time interval required to transmit information from the heart to the brain.
Regarding claim 10, claim 6 is obvious over Park and Whang. However, Park does not teach the ERP stimulus presented after a certain time. Whang, in the same field of endeavor, teaches analyzing ERP from watching a 2D and 3D visual ([0006]), similar to the device of Park, and further teaches wherein the HEP is detected from the subject, and the certain period for which the ERP stimulus is not presented is calculated from the HEP obtained from the subject ([0105] “The alpha power of first and second components in HEP were increased after watching a 3D video than 2D video. The alpha power of first (50-250 ms after the R-peak) and second (250-600 ms after the R-peak) components in HEP showed the time interval required to transmit the cardiac information and the hydraulic blood pressure wave in the heart to travel to the brain through afferent pathways in the vagus nerve.” It is noted that since HEP was increased after watching the video, a comparison between HEP before and after the visual presentation must occur to show such an increase. Therefore, there must be at least 1 R peak that occurred prior to the visual stimulation occurring in which the user did not see the visual and therefore the ERP stimulus presenting after 50-600 ms of the occurrence of the R peak.) to increase HEP components indicating the time interval required to transmit information from the heart to the brain ([0105]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Park, with the ERP stimulus presented after a certain time of Whang, because such a modification would allow to increase HEP components indicating the time interval required to transmit information from the heart to the brain.
Regarding claims 14 and 15, claim 6 is obvious over Park and Whang. However, Park does not teach the certain period occurs after the any R- peak of the continuous R-peak signal and before the next R-peak following the any R-peak of the continuous R-peak signal. Whang, in the same field of endeavor, teaches analyzing ERP from watching a 2D and 3D visual ([0006]), similar to the device of Park, and further teaches wherein the certain period occurs after the any R- peak of the continuous R-peak signal and before the next R-peak following the any R-peak of the continuous R-peak signal ([0087] “FIG. 11 shows average values for the HEP first (alpha power in 50-250 ms period after the R-peak) and second (alpha power in 250-600 ms period after the R-peak) components in eight brain regions for 2D and 3D conditions. This values were calculated with the difference value between before and after each viewing condition” Examiner notes that the HEP is collected before and after the viewing condition, which means that ERP signal is not presented during a certain period of an occurrence of R peak. For example, before presentation, R peak is viewed, and following that detection is the viewing condition. Examiner selects the final R peak before the start of viewing, the first R peak after the viewing of the video.) to increase HEP components indicating the time interval required to transmit information from the heart to the brain ([0105]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention, to modify the invention of Park, with the certain period occurs after the any R- peak of the continuous R-peak signal and before the next R-peak following the any R-peak of the continuous R-peak signal of Whang, because such a modification would allow to increase HEP components indicating the time interval required to transmit information from the heart to the brain.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Whang (US 20180235498)
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796