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
The amendments filed 21 NOVEMBER 2025 have been entered. Claims 1 – 9 and 11 -23 are pending. Applicant’s amendments to the claims have overcome each and every objection to the claims previously applied in the office action dated 01 JULY 2025. Applicant’s amendments to the claims have not overcome each and every rejection to the claims under 35 U.S.C. 112 previously applied in the office action dated 01 JULY 2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 – 8 and 13 – 20 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.
As previously applied, Claim 6 (line 8), Claim 7 (line 7), Claim 8 (lines 10 – 11), Claim 17 (line 7), Claim 18 (line 7), Claim 19 (lines 13 – 14), and Claim 20 (lines 9 – 10) each recites the limitation "the level of connectivity of a healthy control group of users" in line 8. There is insufficient antecedent basis for this limitation in the claims. It is unclear if this “level of connectivity” is the same for the collecting group of users as the “level of connectivity between two regions of the brain” as previously recited for a user in Claim 1. For the purposes of examination, "the level of connectivity of a healthy control group of users" is deemed to claim “a level of connectivity of a healthy control group of users.”
Claim 13 recites the term “wherein displaying second information with the first condition that causes a first reaction”. Per the amendment of Claim 13 and not 12, adding “first” to reaction, it is unclear if the “first reaction” of Claim 13 is intended to be the same or different than the “reaction” of Claim 12, from which this claim depends. For the purposes of examination, the term “a reaction” in Claim 12 is deemed to claim “a first reaction”, and the term “a first reaction” in Claim 13 is deemed to claim “the first reaction”. Claims 14 – 20 are similarly rejected due to their dependence on Claim 13.
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 and 11 -23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claims 1, 22, and 23, the claims each recite an apparatus, which is one of the statutory categories of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Regarding Claim 21, the claim recites "an act or step, or series of acts or steps" for performing operations for the detection of attention deficit hyperactivity disorder (ADHD), and is therefore a process, which is a statutory category of invention (Step 1). The claims are then analyzed to determine whether they are directed to any judicial exception (Step 2A, Prong 1).
Each of Claims 1 – 23 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1 – 9 and 11 -23 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, each of Claims 1 – 9 and 11 -23 recites an abstract idea.
Specifically, Independent Claims 1, 21, 22, and 23 recite (underlined are observations, judgements, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
For Claim 1:
A non-transitory computer-readable medium including instructions that, when executed by at least one processor, cause the at least one processor to perform operations for automated detection of attention deficit hyperactivity disorder (ADHD), the operations comprising:
For Claim 21:
A computer-implemented method for automated detection of attention deficit hyperactivity disorder (ADHD), the method comprising:
For Claim 22:
An attention deficit detection system, comprising:
one or more memory devices storing processor-executable instructions; and one or more processors configured to execute instructions to cause the attention deficit detection system to perform operations comprising:
For Claims 1, 21, and 22:
providing one or more stimuli to a user to activate a plurality of brain regions of the user representing an attention network, wherein the one or more stimuli include displaying information with a first condition that causes a reaction based on a displayed category of text or graphic and a second condition as an exception to the first condition based on a feature of the text or graphic;
retrieving a plurality of signals from the plurality of brain regions for each of the one or more stimuli, wherein each signal of the plurality of signals is accessed over a period of time from a sensor, wherein the period of time starts when the information is displayed and ends when the reactions of the user are captured; and
evaluating the plurality of signals to detect ADHD for the user based on a level of connectivity within the attention network when each signal of the plurality of signals corresponds to the one or more stimuli, wherein the level of connectivity is based on a dependency measurement between the plurality of brain regions or a generated metric of information transfer within the attention network.
Claim 23
An attention deficit detection system, comprising:
one or more memory devices storing processor-executable instructions; and
one or more processors configured to execute instructions to cause the attention deficit detection system to perform operations comprising:
monitoring electrical activity form one or more brain regions of a user using a plurality of sensors;
determining first signal data from the user based on a sensor of the plurality of sensors, the first signal data being in response to a stimuli corresponding to a first task and a second task;
determining a first plurality of time series based on the first signal data, wherein each of the first plurality of time series corresponds to a respective source position located inside a cranial cavity of the user;
determining, based on the first plurality of time series, whether each of a first condition of the second task, a second condition of the second task, and a third condition of the second task are met;
calculating a first correlation value for a first pair of time series, the first pair of time series being included in the determined first plurality of time series;
generating a score based on the first correlation value and the determination that each of the first, second, and third conditions are met, the score being indicative of the user having a cognitive impairment, such as an attention deficiency or ADHD; and
outputting the generated score.
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mathematical calculation and/or a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a human with the aid of a pen and paper, or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Independent Claims 1, 21, 22, and 23, these limitations include:
Observation and judgment to retrieve a plurality of signals from the plurality of brain regions for each of the one or more stimuli, wherein each signal of the plurality of signals is observed and judged over a period of time from a sensor, wherein the period of time starts when the information is displayed and ends when the reactions of the user are captured;
Observation and judgment to evaluate the plurality of signals to detect ADHD for the user based on a level of connectivity within an attention network when each signal of the plurality of signals corresponds to the one or more stimuli.
Observation and judgment of first signal data from the user based on a sensor of the plurality of sensors, the first signal data being in response to a stimuli corresponding to a first task and a second task;
Observation and judgment to evaluate a first plurality of time series based on the first signal data, wherein each of the first plurality of time series corresponds to a respective source position located inside a cranial cavity of the user;
Observation and judgment, based on the first plurality of time series, whether each of a first condition of the second task, a second condition of the second task, and a third condition of the second task are met;
evaluating a first correlation value for a first pair of time series, the first pair of time series being included in the determined first plurality of time series;
Observation and judgment to evaluate a score based on the first correlation value and the determination that each of the first, second, and third conditions are met, the score being indicative of a patient having a cognitive impairment, such as an attention deficiency or ADHD;
Observation and judgment to communicate the generated score.
all of which are grouped as mental processes under the 2019 PEG.
Similarly, the dependent claims include the following abstract limitations, in addition the aforementioned limitations in Independent Claims 1, 21, 22, and 23 (underlined observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG):
filtering alpha band oscillation signals…or beta band oscillation signals…of two or more regions of the plurality of brain regions of the user upon receiving the first reaction…or the second reaction from the user
evaluation to mathematically filter alpha band oscillation signals…or beta band oscillation signals…of two or more regions of the plurality of brain regions of the user upon receiving the first reaction…or the second reaction from the user
determining connectivity between two regions of the brain using the alpha…or beta…band oscillation signals;
observation and judgment of connectivity between two regions of the brain using the alpha…or beta… band oscillation signals;
comparing the level of connectivity between the two regions of the brain of the user to a level of connectivity of a healthy control group of users when the first condition of the first task satisfies…the active state…(or the silent state)…and the second condition is negative (is positive for the silent state), wherein if the level of connectivity of the user is less than the level of connectivity of the healthy control group of users, then the user is indicative of having ADHD.
observation and judgment of to compare a level of connectivity between the two regions of the brain of the user to the level of connectivity of a healthy control group of users when the first condition of the first task satisfies the active state, and the second condition is negative, wherein if the level of connectivity of the user is less than (or greater than for beta signals) the level of connectivity of the healthy control group of users, then the user is indicative of having ADHD.
determining the level of connectivity between the two regions of the brain of the user when the first condition of the first task satisfies the silent state and the first condition of the first task satisfies the active state;
observation and judgment the level of connectivity between the two regions of the brain of the user when the first condition of the first task satisfies the silent state and the first condition of the first task satisfies the active state;
comparing a reduction in the level of connectivity of the user between when the reaction for the first task satisfies the silent state and when the first task satisfies the active state to a reduction in the level of connectivity of a healthy control group of users between when the reaction for the first task satisfies the silent state and when the first task satisfies the active state, wherein if the reduction in the level of connectivity of the user is less than the reduction in the level of connectivity of the healthy control group of users, then the user is indicative of having ADHD.
Observation and judgment to compare a reduction in the level of connectivity of the user between when the reaction for the first task satisfies the silent state and when the reaction for the first task satisfies the active state to a reduction in the level of connectivity of a healthy control group of users between when the first task satisfies the silent state and when the first task satisfies the active state, wherein if the reduction in the level of connectivity of the user is less than the reduction in the level of connectivity of the healthy control group of users, then the user is indicative of having ADHD.
combining signal data of each of the plurality of signals,
Observation and judgment to combine signal data of each of the plurality of signals,
determining an increase in the level of connectivity compared to an existing level of connectivity between regions from the plurality of regions or a reduction in the level of connectivity from the existing level of connectivity of the region of the plurality of regions.
Observation and judgment of an increase in the level of connectivity compared to an existing level of connectivity between regions from the plurality of regions or a reduction in the level of connectivity from the existing level of connectivity of the region of the plurality of regions.
waiting for a threshold period for any input shared by the user.
Observation and judgment to wait for a threshold period for any input shared by the user.
selecting a sub-category of a category of text or graphic meeting the first condition;
Observation and judgment to select a sub-category of a category of text or graphic meeting the first condition;
displaying the sub-category of the text or graphic.
Observation and judgment to communicate the sub-category of the text or graphic.
comparing the level of connectivity between the two regions of the brain of the user to the level of connectivity of a healthy control group of users when the first condition of the second task satisfies the active state, the second condition is negative and the third condition is negative, or when the first condition of the second task satisfies the active state, the second condition is positive and the third condition is positive, wherein if the level of connectivity of the user is greater than (or less than for the theta wave claim 18) the level of connectivity of the healthy control group of users, then the user is indicative of having ADHD.
Observation and judgment to compare the level of connectivity between the two regions of the brain of the user to the level of connectivity of a healthy control group of users when the first condition of the second task satisfies the active state, the second condition is negative and the third condition is negative, or when the first condition of the second task satisfies the active state, the second condition is positive and the third condition is positive, wherein if the level of connectivity of the user is greater than (or less than for the theta wave claim 18) the level of connectivity of the healthy control group of users, then the user is indicative of having ADHD.
determining connectivity between two regions of the brain using the theta band oscillation signals;
observation and judgment of connectivity between two regions of the brain using the theta band oscillation signals;
determining a variation in the level of connectivity between the two regions of the brain of the user when presenting the instance of data for the second task where the first condition of the second task satisfies the active state, the second condition of the second task is positive and the third condition of the second task is positive to the level of connectivity between the two regions of the brain of the user when presenting the instance of data for the first task where the first condition of the first task satisfies the active state, and the second condition of the first task is positive;
observation and judgment of a variation in the level of connectivity between the two regions of the brain of the user when presenting the instance of data for the second task where the first condition of the second task satisfies the active state, the second condition of the second task is positive and the third condition of the second task is positive to the level of connectivity between the two regions of the brain of the user when presenting the instance of data for the first task where the first condition of the first task satisfies the active state, and the second condition of the first task is positive;
comparing the variation in the level of connectivity of the user to the variation in the level of connectivity of a healthy control group of users, wherein if the variation in the level of connectivity of the user is different than the variation in the level of connectivity of the healthy control group of users, then the user is indicative of ADHD.
observation and judgment to compare the variation in the level of connectivity of the user to the variation in the level of connectivity of a healthy control group of users, wherein if the variation in the level of connectivity of the user is different than the variation in the level of connectivity of the healthy control group of users, then the user is indicative of ADHD.
all of which are grouped as mental processes under the 2019 PEG.
Accordingly, as indicated above, each of the above-identified claims recite an abstract idea.
Step 2A, Prong 2
The above-identified abstract ideas in each of Independent Claims 1, 21, 22, and 23 (and their respective Dependent Claims) are not integrated into a practical application under 2019 PEG because the additional elements (identified above in Independent Claims 1, 12, and 23), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, the additional elements of:
“one or more memory devices”
a plurality of sensors; “sensor”
non-transitory computer readable medium
processor; one or more processors
screen
pointing device
button
Additional elements recited include “one or more memory devices”, “non-transitory computer medium” to “include instructions”, “one or more processors”, a “plurality of sensors”, “sensor”, a “screen”, “pointing device”, and “button”, in the Independent Claims 1, 21, 22, and 23 and their dependent claims. These components are recited at a high level of generality, , i.e., as a memory performing a generic function of storing data “include instructions”). These generic hardware component limitations for “one or more memory devices”, “non-transitory computer medium”, “one or more processors”, a “plurality of sensors”, “sensor”, a “screen”, “pointing device”, and “button”, are no more than mere instructions to apply the exception using generic computer and hardware components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Further additional elements from Independent Claims 1, 21, 22, and 23 include pre-solution activity limitations, such as:
A non-transitory computer-readable medium including instructions that, when executed by at least one processor, cause the at least one processor to perform operations for automated detection of attention deficit hyperactivity disorder (ADHD)
providing one or more stimuli to a user to activate a plurality of brain regions of the user representing an attention network, wherein the one or more stimuli include displaying information with a first condition that causes a reaction based on a displayed category of text or graphic and a second condition as an exception to the first condition based on a feature of the text of graphic;
one or more memory devices storing processor-executable instructions; and one or more processors configured to execute instructions to cause the attention deficit detection system to perform operations comprising:
In addition the aforementioned extra-solution activity limitations in Independent Claims 1, 21, 22, and 23, additional extra-solution activity limitations recited in the Dependent Claims include:
presenting an instance of data matching a first task, wherein the first task includes the first condition for expectation of an active state and a silent state of a first reaction, the second condition restricting the expectation of the active state of the first reaction.
wherein the first reaction is at least one of clicking a pointing device, pressing a button, or taking no action for a time threshold.
presenting an instance of data matching a second task, wherein the second task includes the first condition for expectation of an active state and a silent state of a second reaction, the second condition restricting expectation of the active state of the second reaction, and the third condition that is an exception to the second condition for expectation of silent state of the second reaction.
displaying information on a screen meeting the first condition for expectation of the active state and the silent state of the second reaction
wherein the second reaction is at least one of clicking a pointing device, pressing a button, or taking no action for a threshold time.
These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps.
The “one or more memory devices”, “non-transitory computer medium”, “one or more processors”, a “plurality of sensors”, “sensor”, a “screen”, “pointing device”, and “button” as recited in Independent Claims 1, 21, 22, and 23 and their dependent claims are generically recited computer and hardware elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract ideas identified above in Independent Claims 1, 21, 22, and 23 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in Independent Claims 1, 21, 22, and 23 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, Independent Claims 1, 21, 22, and 23 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B –
None of Claims 1 – 9 and 11 - 23 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “one or more memory devices”, “non-transitory computer medium”, “one or more processors”, a “plurality of sensors”, “sensor”, a “screen”, “pointing device”, and “button” as recited in Independent Claims 1, 21, 22, and 23 and their dependent claims.
The additional elements of the “one or more memory devices”, “non-transitory computer medium”, “one or more processors”, a “plurality of sensors”, “sensor”, a “screen”, “pointing device”, and “button” in Claims 1 – 9 and 11 - 23, as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the “one or more memory devices” is described generically in [00164] as “any mechanism that stores information in a form accessible by a machine” with a listing of generic hardware examples “and the like”. The one or more memory devices is likely represented as generic box element “Memory 461” in Figure 4.
Per Applicant’s specification, the “plurality of sensors” and “sensor” is described generically in [00122] as “Sensors can be probes from an…EEG or…MEG device…fMRI…fNIRS.” The “plurality of sensors” and “sensor” are shown in Fig 3. The specific sensor(s) are not shown in a Figure.
Per Applicant’s specification, the “non-transitory computer medium” is included in the specification as “computer-readable storage medium” and “medium” in [00164] with a listing of generic hardware examples. The non-transitory computer medium is likely represented as generic box element “Storage Devices 414” in Figure 4.
Per Applicant’s specification, the “one or more processors” is described generically [0038] “User device 150 may be a processor or a complete computing device, such as a laptop, desktop computer, mobile device, smart home appliance, IoT device, etc.” The processor is represented as generic box element “main processors 417” in Figure 4.
Per Applicant’s specification, the ”screen” is described generically in [00115] with “displays (e.g., cathode ray tube (CRT), liquid crystal display (LCD), touch screen, etc.)” The screen is potentially part of “peripheral device 440” in Figure 4, per [00115]
Per Applicant’s specification, the hardware associated with “pointing device” is described generically in [00115] with “and input devices (e.g., keyboard, mouse, soft keypad, etc.).” The pointing device is potentially part of “peripheral device 440” in Figure 4, per [00115].
Per Applicant’s specification, the hardware associated with “button” is described generically in [00115] with “and input devices (e.g., keyboard, mouse, soft keypad, etc.).” The button is potentially part of “peripheral device 440” in Figure 4, per [00115].
Accordingly, in light of Applicant’s specification, the claimed terms “one or more memory devices”, “non-transitory computer medium”, “one or more processors”, a “plurality of sensors”, “sensor”, a “screen”, “pointing device”, and “button” are reasonably construed as a generic computing and hardware devices. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “one or more memory devices”, “non-transitory computer medium”, “one or more processors”, a “plurality of sensors”, “sensor”, a “screen”, “pointing device”, and “button”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1 – 9 and 12 - 23 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatuses and method of Claims 1 – 9 and 11 - 23 are directed to applying an abstract idea as identified above on a general-purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1 – 9 and 11 - 23 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements for Step 2A Prong 2 in Independent Claims 1, 21, 22, and 23 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1 – 9 and 11 - 23 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1 – 9 and 11 - 23 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1 – 9 and 11 - 23 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 – 4, 9 - 10, 21, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Machida et. al., “Electrophysiological Correlates of Response Time Variability During a Sustained Attention Task”, hereinafter Machida.
Regarding Claims 1, 21 and 22, Machida discloses
For Claim 1:
A non-transitory computer-readable medium including instructions that, when executed by at least one processor, cause the at least one processor to perform operations ([Page 4, “Analysis” and “EEG Analysis” Section”, Paragraph 1] “The recorded EEG with 64 electrodes was imported and pre-processed in MATLAB and Fieldtrip”)(Examiner notes that the data is “imported” for analysis on MATLAB software that is used on a computer, and that executes data analysis instructions via processing power. It is software requires one of more processors to run it.) for automated detection of attention deficit hyperactivity disorder (ADHD) ([Abstract]; [Page 3, Right Column Paragraph 3] “This study aims to investigate the relationship between brain connectivity, RTV, and levels of ADHD symptoms...”; [Page 4, “Materials” Section] “The experimental paradigm was created using MATLAB (MathWorks Inc.) and Psychtoolbox”), the operations comprising:
For Claim 21:
A computer-implemented method ([Abstract]; [Page 4, “Materials Section”, Paragraph 1] “Participants were presented a series of digits (1–9) on a computer screen.”) for automated detection of attention deficit hyperactivity disorder (ADHD) ([Abstract]), the method, comprising:
For Claim 22:
An attention deficit detection system (([Abstract]), comprising:
one or more memory devices storing processor-executable instructions ([Page 4, “Analysis” and “EEG Analysis” Section”, Paragraph 1] “The recorded EEG with 64 electrodes was imported and pre-processed in MATLAB and Fieldtrip”)(Examiner notes that MATLAB software is used on a computer, to which the data is “imported”, and has capabilities to execute instructions saved on memory for analysis.); and one or more processors configured to execute instructions to cause the attention deficit detection system to perform operations ([Page 4, “Analysis” and “EEG Analysis” Section”, Paragraph 1] “The recorded EEG with 64 electrodes was imported and pre-processed in MATLAB and Fieldtrip”)(Examiner notes that MATLAB the data is “imported” for analysis on MATLAB software by executing data analysis instructions. It is software requires one of more processors to run it.) comprising:
For the remainder of Claims 1, 21, and 22, Machida discloses:
providing one or more stimuli to a user ([Page 4, “Materials Section”, All of Paragraph 1] including “The Sustained Attention to Response Task (SART)”, description of “participants” being presented “a series of digits (1–9)”, “a single digit”, “a mask”, “a response cue”, and a “fixation cross” with an “interstimulus interval”) to activate a plurality of brain regions of the user representing an attention network ([Page 5, Paragraph 2] “Using connectivity matrices treated as weighted networks, global efficiency and modularity were computed…”)(Examiner notes that “global efficiency” is a metric of connectivity across a plurality of brain regions.), wherein the one or more stimuli ([Page 4, “Materials Section”, Paragraph 1], including “a series of digits (1–9)”, “a single digit”, “a mask”, “a response cue”, and a “fixation cross”) include displaying information with a first condition that causes a reaction ([Page 4, “Materials Section”, All of Paragraph 1], including “The participants were asked to respond when the response cue appeared on screen”)(Examiner notes that the participants were not supposed to respond when the response cue was not on the screen, “to limit impulsive response styles shown by children and some people with high ADHD symptoms”) based on a displayed category of text or graphic ([Page 4, “Materials Section”, Paragraph 1], including “a series of digits (1–9)”)(Examiner notes that the category of text or graphic is a numeric digit that is present/shown, as opposed to no number present.), and a second condition as an exception to the first condition based on a feature of the text or graphic ([Page 4, “Materials Section”, All of Paragraph 1], “Participants were asked to respond to every digit except “3.”)(Examiner notes that not responding to 3 is the exception to responding during the “response cue” time after a number has been shown, where the feature of the text of graphic is that it looks like a 3.);
retrieving a plurality of signals ([Page 4, “EEG Analysis” Section, Paragraph 2] “EEG data”; [Page 5, Left Column, Paragraph 2] “These two measures were averaged to three frequency ranges, theta (4–8 Hz), alpha (8–13 Hz), and beta (13–30 Hz) bands”) from the plurality of brain regions for each of the one or more stimuli ([Page 4, “Procedure” Section, Paragraph 1] “Participants were asked to complete the SARTs while the EEG was recorded using a 64 electrode Biosemi system.”)(Examiner notes that the 64 electrodes are measuring multiple brain regions.) wherein each signal of the plurality of signals is accessed over a period of time ([Pages 4 - 5, “Procedure” Section, Paragraph 1] “The data were…segmented into trials from -200 to 1200 ms, where 0 was set at the presentation of the target digit of the SART.”) from a sensor ([Page 4, “Procedure” Section, Paragraph 1] “…EEG was recorded using a 64 electrode Biosemi system.”) wherein the period of time starts when the information is displayed and ends when the reactions of the user are captured ([Pages 4 - 5, “Procedure” Section, Paragraph 1] “…where 0 was set at the presentation of the target digit of the SART.”)(Examiner notes that, per the timing described in [Page 4, “Materials Section”, All of Paragraph 1], the response cue was presented at 313 ms + 125 ms + 63 ms = 501 ms, which is within the 1200 ms collection window to capture the user reaction); and
evaluating the plurality of signals to detect ADHD for the user ([Abstract], [Page 3, Right Column, Paragraph 3] “This study aims to investigate the relationship between brain connectivity, RTV, and levels of ADHD symptoms in children and adolescents on two measures of sustained attention.”) based on a level of connectivity within the attention network ([Page 5, Left Column, All of Paragraph 2], including “…the event related networks approach”, “Functional connectivity was computed using Phase Lag Index (PLI) and connectivity matrices were produced”) when each signal of the plurality of signals corresponds to the one or more stimuli ([Page 4, “EEG Analysis” Section, Paragraph 2] “EEG data”; [Page 5, Left Column, All of Paragraph 2] including “The time frequency analysis was applied from 1 to 40 Hz in steps of 1 Hz and from -200 to 1200 ms in steps of 10 ms using the Complex Morlet Wavelet”)(Examiner notes that the -200 to 1200 ms window is the collection window for each stimuli-related task’s signal.) wherein the level of connectivity is based on a dependency measurement between the plurality of brain regions ([Page 5, Left Column, 1st Full Paragraph] “Functional connectivity was computed using Phase Lag Index (PLI) and connectivity matrices were produced”; [Page 4, “Procedure” Section, Paragraph 1] “…EEG was recorded using a 64 electrode Biosemi system.”; [Page 13, Left Column, 2nd Full Paragraph] “…overall connectivity patterns of the surface of the whole brain.”)(Examiner notes that a plurality of brain regions can broadly include the whole brain. Looking to [00126], Applicant describes “dependency measures” to include Phase-Lag Index or Phase-Locking Value, or measures based on connectivity between brain regions between different frequency bands.) or a generated metric of information transfer within the attention network.
Regarding Claim 2, Machida discloses The non-transitory computer-readable medium of claim 1, wherein displaying information with a first condition that causes a reaction and a second condition as an exception to the first condition (See citation in Claim 1). For the remainder of Claim 2, Machida discloses further comprises:
presenting an instance of data matching a first task ([Page 4, “Materials Section”, All of Paragraph 1] including “The Sustained Attention to Response Task (SART)”, description of “participants” being presented “a series of digits (1–9)”, “a single digit”, “a mask”, “a response cue”, and a “fixation cross” with an “interstimulus interval”),
wherein the first task ([Page 4, “Materials Section”, Paragraph 1] = “The Sustained Attention to Response Task (SART)”) includes the first condition ([Page 4, “Materials Section”, Paragraph 1], including “The participants were asked to respond when the response cue appeared on screen”)(Examiner notes that the condition is such that that the participants respond after a number has been shown on the screen during the time when the response cue is on the screen”) for expectation of an active state ([Page 4, “Materials Section”, Paragraph 1], “Participants were asked to respond”) and a silent state of a first reaction ([Page 4, “Materials Section”, Paragraph 1], participant does not respond when the number has not been shown and the response cue is not active) the second condition restricting the expectation of the active state of the first reaction ([Page 4, “Materials Section”, Paragraph 1], “Participants were asked to respond to every digit except “3.”)(Examiner notes that not responding to 3 is the exception to responding during the “response cue” time after a number has been shown.).
Regarding Claim 3, Machida discloses The non-transitory computer-readable medium of claim 2, wherein the first reaction. For the remainder of Claim 3, Machida discloses further comprises:
displaying the information on a screen ([Page 4, “Materials Section”, Paragraph 1], “Participants were presented a series of digits (1–9) on a computer screen.”) meeting the first condition ([Page 4, “Materials Section”, Paragraph 1], including “Participants were presented a series of digits (1–9) on a computer screen…Participants were asked to respond to every digit except “3.”…The participants were asked to respond when the response cue appeared on screen”)(Examiner notes that the condition is such that that the participants respond after a number has been shown on the screen during the time when the response cue is on the screen”) for expectation of the active state ([Page 4, “Materials Section”, Paragraph 1], “Participants were asked to respond to every digit…”) and the silent state of the first reaction ([Page 4, “Materials Section”, Paragraph 1], participant does not respond when the number has not been shown and the response cue is not active, thereby Not Responding to the state: No digit shown); and
waiting for a threshold period for any reaction shared by the user ([Page 4, “Materials Section”, Paragraph 1],” Each trial was set-up with this timing: a single digit was presented for 313 ms, followed by a mask for 125 ms. A response cue was presented for 63 ms”)(Examiner notes that the reaction is communicated by the user during the “response cue”).
Regarding Claim 4, Machida discloses, as described above, The non-transitory computer-readable medium of claim 2. For the remainder of Claim 4, Machida discloses, wherein the first reaction is at least one of clicking a pointing device, pressing a button, or taking no action ([Page 4, “Materials Section”, Paragraph 1],” Participants were asked to respond to every digit except “3.”) for a time threshold ([Page 4, “Materials Section”, Paragraph 1], “Each trial was set-up with this timing: a single digit was presented for 313 ms, followed by a mask for 125 ms. A response cue was presented for 63 ms.”)
Regarding Claim 9, Machida discloses as described above, The non-transitory computer-readable medium of claim 1, evaluating the plurality of signals to detect ADHD based on the level of connectivity within the attention network (See citation in Claim 1). For the remainder of Claim 9, Machida discloses further comprises:
combining signal data of each of the plurality of signals ([Page 7, “Network Measures—ADHD Index, Age, and SART Task” Section] “In the third type of model, network measures were inserted as outcome variables for the three frequency bands (theta, alpha, beta) and two time periods (baseline, task).”)(Examiner notes that the combining is having both “task” and “baseline” time period data.) wherein combining signal data includes determining an increase in the level of connectivity ([Page 7, “Network Measures—ADHD Index, Age, and SART Task” Section] “task”) compared to an existing level ([Page 7, “Network Measures—ADHD Index, Age, and SART Task” Section] “baseline”) of connectivity between regions from the plurality of regions ([End of Page 7 – Page 9, Left column, Paragraph 1] “In adolescents, lower ADHD Index was associated with a greater increase in global efficiency from the baseline to the task in the theta band.”) or a reduction in the level of connectivity from the existing level of connectivity of the region of the plurality of regions.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the Various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Zeman et. al. (US Patent Application Publication US 2013/0060125 A1), hereinafter Zeman, in view of Vaurio et. al., “Increased intra-individual reaction time variability in attention-deficit/hyperactivity disorder across response inhibition tasks with different cognitive demands”, hereinafter Vaurio.
Regarding Claim 23, Zeman discloses An attention deficit detection system (Fig 1 and 2), comprising:
one or more memory devices storing processor-executable instructions ([0552] “neurological feedback device may implement the methods as described herein by executing software instructions in a program memory accessible to the processors”); and
one or more processors ([0225] “a processor”) configured to execute instructions to cause the attention deficit detection system to perform operations ([0225] “a processor for running software that provides the task in which the participant will participate and for synchronizing data.”) comprising:
monitoring electrical activity from one or more brain regions of a user using a plurality of sensors (Fig 1, “EEG Cap”; [0081] “EEG…dataset…identifying components of the EEG…distinct modular areas of the brain”; [0096] “EEG electrodes”)
determining first signal data from the user ([0077] “…acquiring MEG data and EEG data”, “collecting and storing EEG data and collecting and storing behavioural data…”; [0423]) based on a sensor of the plurality of sensors ([0077] “…EEG data”; Fig 1, “EEG Cap”; [0423] “EEG components…”), the first signal data being in response to a stimuli ([0077] “displaying stimuli”; [0200] “stimulus locked power fluctuation of multiple visual areas of the brain in relation to the start of the trial.”; [0423] “…topographies and waveforms of EEG components (1) through (5)…construct the stimulation data”; Fig 20) corresponding to a first task and a second task ([0080] “the individual may perform a different set of one or more tasks or the same set of one or more tasks.”; Figure 53 “Task software events”; [0079] “one or more tasks”; Fig 54 procedure…; [0174] “Complex Task”, “Simple Task”);
determining a first plurality of time series based on the first signal data ([0091] – [0097] Step 5: Data Mining to Identify Physically Distinct Brain Sources”, Eq (2) and (3), of {0096] “the observed mixture x contains K rows of spatially distributed, time-domain sensor measurements (Equation 2), while the source matrix s contains J rows of unknown time-domain sources activities (Equation 3).”) , wherein each of the first plurality of time series corresponds to a respective source position located inside a cranial cavity of the user ([0096] “There should be at least as many EEG electrodes or MEG sensors as there are unknown sources, such that K ≥ J”; [All of 117] including, “….single source location qp where H(qp) is the Kx3…transfer matrix from locations inside the head to the surface of the scalp x…”);
calculating a first correlation value for a first pair of time series ([0189] - [0196] including “2. Calculated the value of correlations between the pair of segments” and “…mapping the distribution of correlation value to a Gaussian distribution”), the first pair of time series being included in the determined first plurality of time series (Fig 39 and 41, [0201] “FIG. 41 shows two examples of the time-varying pair-wise zero-lag correlations in the frequency band 34 to 36 Hz relating to a subset of the brain volumes illustrated in FIG. 39”; “[0197] “Repeat steps 1 to 2 for all other pairs of components that have been validated”; [0188] “the interval of analysis of one component will differ by a selected lag (time shift) with respect to the other component's interval of analysis.”)
generating a score based on the first correlation value ([0189] - [0196]) and the response per a behavioral condition to the task are met (([“Data Analysis” section for [0316] – [0317], including “2. Use the numeric output (for intervals of data related to key moments in the behavioural task; [“Data Analysis” section for [0316] – [0318], including “2. Use the numeric output (for intervals of data related to key moments in the behavioural task) calculated and stored for each participant to generate a set of values for each participant…”; [0489] “Information describing which areas of the brain are active, when they are active during the task, and under what behavioural conditions they are active…time-varying power levels that correspond to each of the resolved brain volumes”; Fig 40; [0490])(Examiner notes that Zemon discloses that “one or more tasks” can be performed, and analysis occurs for each of the tasks. Therefore, the conditions of the second task being met are broadly included.), the score being indicative of the user having a cognitive impairment ([0318] “In this example, this statistical distribution characterizes the group of participants with Parkinson's Dementia and this statistical distribution provides a reference point to relate data collected from ostensibly healthy persons”; [0089] “data from an individual participant may be mined in isolation”)(Examiner notes that the user could broadly be one of a group of participants.), such as an attention deficiency or ADHD ([0248] “The disclosed technology can be used in the participant screening process in investigations of drug therapies and treatments for a variety of brain diseases brain dysfunctions, and brain injuries that include…attention deficit hyperactivity disorder”); and
outputting the generated score ([“Data Analysis” section for [0316] – [0317], including “2. Use the numeric output (for intervals of data related to key moments in the behavioural task) calculated and stored for each participant to generate a set of values for each participant and add them to the ‘map’)(Examiner notes that an example of a ‘map’ is shown in Figure 4)
Zemon does not particularly disclose determining, based on the first plurality of time series, whether each of a first condition of the second task, a second condition of the second task, and a third condition of the second task are met; and generating a score based on the first correlation value and the determination that each of the first, second, and third conditions are met. However, Zemon is open to combine with a particular task-set with events, such as the Complex Go/No-Go Task of Vaurio, because [0176] “Given an interval for analysis identified according to an event in the task software (for example, the start of a trial or the presentation of a reward to the participant) or a participant response event (for example, a button press), the EEG or MEG data can be analyzed with respect to the event…” and [0259] “Use the disclosed technology to process the recorded MEG or EEG data for all participants with respect to the recorded events in the task software and the data containing participant responses.” Zemon discloses that “one or more tasks” can be performed, and analysis occurs for each of the tasks. Therefore, the conditions of the second task being met are broadly included in the overall analysis steps.
Vaurio teaches a particular set of inhibition tasks with different cognitive demands that are used to test for ADHD, such as a “simple” Go/No-Go task and a “complex” Go/No-Go task. Specifically for Claim 23, Vaurio teaches determining, based on the first plurality of time series ([Page 7, Last Paragraph] “..reaction time series”; [Page 8, 1st Full Paragraph] “…preprocessing steps were undertaken…Spectral density of a time series of equally spaced observations…discrete Fourier transform…”) whether each of a first condition of the second task ([Page 7, “2.4. Complex Go/No-Go Task” Section”] “Children were instructed to push the button as quickly as possible in response to a green spaceship…”)(Examiner notes that the first condition such that the child must “push the button” when a green spaceship is shown. The “no action” portion of that first condition is not to press the button when a spaceship is not shown.), a second condition of the second task ([Page 7, “2.4. Complex Go/No-Go Task” Section”] “Children were instructed to push the button as quickly as possible…and in response to a red spaceship preceded by an even number of green spaceships.)(Examiner notes that the second condition is an exception to only pressing the button when a green spaceship appears, since a red one can also be pressed if there has been an even number of green spaceships before it.), and a third condition of the second task ([Page 7, “2.4. Complex Go/No-Go Task” Section”] “They were to refrain from responding to red spaceships preceded by an odd number of green spaceships.”)(Examiner notes that the third condition is a condition that provides another situation in which a red spaceship is not pressed, an exception to pressing red spaceships); are met ([Page 9, “3.2. Comparison of speed and accuracy” section] “reaction time”, “commission errors on the complex task…percentage…complex M = 0.41, SD = 0.19)(Examiner notes that detecting whether the conditions are met, or that correct answer is receiving would be the situation that a “commission error” is not made, which would be the remaining percentage of 100% relative to the commission error percent.),
the determination that each of the first, second, and third conditions are met ([Page 7, Last Paragraph] “reaction time series…”; [Page 7, “2.4. Complex Go/No-Go Task” Section”]; [Page 9, “3.2. Comparison of speed and accuracy” section], described in more detail above);
Zemon calculates a score based on the correlation calculation and determining effects that result from behavioral results that are reactions to stimuli in the presented tasks, and is open to include Go/No-Go tasks at [0238] of “one or more neuropsychological tests or more generally, any set of activities from which psychometric data can be obtained” and computer-based games. Vaurio teaches a motivation to substitute its “complex” Go/No-Task to use as a neuropsychological test with [Abstract] “…and a more “complex” Go/No-go task with increased working memory load.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that increasing the working memory load in a test could increase the magnitude of the visible results in the EEG data studying ADHD, a mental-load-associated brain condition. It would be predictable to use the spaceship-based “Complex Go/No-Go”-type inhibition test as one of the “one or more tasks” disclosed Zemon’s system, as it would continue to function as a diagnostic stimulus-response test for diagnosing ADHD.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the apparatus for EEG processing that calculates a score based on EEG data and the results of user-performed task sets to detect ADHD disclosed by Zemon with the with the colored spaceship-based “Complex Go/No-Go”-type inhibition test (task trial) with results for the response conditions taught by Vaurio, creating a single EEG processing system that uses a spaceship-based “Complex Go/No-Go”-type inhibition test that induces higher working memory load on test subjects and increases the magnitude of visible results in the EEG data studying ADHD.
Claims 5 – 6 are rejected under 35 U.S.C. 103 as being unpatentable over Machida in view of Coelli et. al., “Sustained attention task-related changes of functional connectivity in children with ADHD”, hereinafter Coelli.
Regarding Claims 5 and 6, Machida discloses as described above, The non-transitory computer-readable medium of claim 2, evaluating the plurality of signals to detect ADHD based on the level of connectivity within the attention network (See citation in Claim 2 above). For the remainder of Claims 5 and 6, Machida discloses further comprises:
For both Claims 5 and 6, Machida discloses:
filtering alpha band oscillation signals ([Page 4, “EEG Analysis” Section, Paragraph 2] “The data were band pass filtered from 0.5 to 40 Hz”; [Page 5, Left Column, Paragraph 2, continuation of “EEG Analysis Section”] “These two measures were averaged to three frequency ranges… alpha (8–13 Hz)…Examiner notes that the alpha band oscillation signals are part of the “EEG data”, and all of the EEG data were initially filtered, regardless of band.) of two or more regions of the plurality of brain regions of the user upon receiving the first reaction ([Page 4, “Procedure” Section, Paragraph 1] “Participants were asked to complete the SARTs while the EEG was recorded using a 64 electrode Biosemi system.”)(Examiner notes that the 64 electrodes are measuring multiple brain regions, and the first reaction comes from the first SART.) and determining connectivity between two regions of the brain ([Page 13, “Limitations Section”, Paragraph 2”] “Our analysis was performed using surface level EEG recording with 64 electrodes. This allowed us to infer overall connectivity patterns of the surface of the whole brain”)(Examiner notes that the “whole brain” contains at least two regions of the brain.) using the alpha band oscillation signals ([Page 5, Right Column, Paragraph 1] “This analysis resulted in measures of global efficiency and modularity at the three frequencies (theta, alpha, beta) during the task period for the Fixed and Random SARTs separately.”)(Examiner notes that “global efficiency” is a measure of connectivity between all of the regions of the brain, which includes at least two regions.); and
For Claim 5:
when the first condition of the first task satisfies the active state, and the second condition is negative (Table 1, “Commission Errors, ADHD”)(Examiner notes that “commission” errors occur when a response is made on a “No-Go” trial, or a response is erroneously made making the second condition negative.)
For Claim 6:
when the first condition of the first task satisfies the silent state, the second condition is positive ([Table 1, “Mean RT, ADHD”)(Examiner notes that since this is a “correct” reaction to not react when a reaction is not warranted, it would be within the “Mean Reaction Time” data.)
For both Claims 5 and 6, Machida does not disclose
comparing the level of connectivity between the two regions of the brain of the user to a level of connectivity of a healthy control group of users when the first condition of the first task satisfies the active state (For Claim 5) or the silent state (For Claim 6), and the second condition is negative (For Claim 5) or positive (For Claim 6), wherein if the level of connectivity of the user is less than the level of connectivity of the healthy control group of users, then the user is indicative of having ADHD.
For Claim 5:
Coelli teaches comparing the level of connectivity between the two regions of the brain of the user to a level of connectivity of a healthy control group of users (Fig 3, ΔGlobal Efficiency, of ImCoh(theta)) (Examiner notes that Global Efficiency is a measurement of connectivity across the entire brain, including all regions.) when the first condition of the first task satisfies the active state, and the second condition is negative ([Page 587, “D. Graph analysis” Section”, Paragraph 3] “To simplify the evaluation of the indexes while keeping as much as possible both the temporal and spatial information, we averaged their values within each minute of recordings”; [Page 587, “A. Behavioral results” Section] “ADHD participants showed on average a higher rate of omission and commission errors…”)(Examiner notes that each minute of recordings would likely include at least one commission error in the dataset due to that “higher rate of omission and commission errors.”)
For Claim 6:
Coelli teaches comparing the level of connectivity between the two regions of the brain of the user to the level of connectivity of a healthy control group of users (Fig 3, ΔGlobal Efficiency, of ImCoh(theta)) (Examiner notes that Global Efficiency is a measurement of connectivity across the entire brain, including all regions.) when the first condition of the first task satisfies the silent state, the second condition is positive ([Page 587, “D. Graph analysis” Section”, Paragraph 3] “To simplify the evaluation of the indexes while keeping as much as possible both the temporal and spatial information, we averaged their values within each minute of recordings”; [Page 587, “A. Behavioral results” Section] “ADHD participants showed on average… higher performances variability and higher mean response time (HRT)…”)(Examiner notes that each minute of recordings would likely include at least “response time” associated with a proper silent state response),
For both Claim 5 and 6, Coelli teaches:
wherein if the level of connectivity of the user is less than (Fig 3, ΔGlobal Efficiency, of ImCoh(theta), ADHD group on the left box and whisker, with a median lower than the median of the healthy “Control” group on the right) the level of connectivity of the healthy control group of users (Fig 3, ΔGlobal Efficiency, of ImCoh(theta), healthy “Control” group on the right box and whisker, with a median higher than the median of the ADHD group on the left; [Page 588, “IV. DISCUSSION AND CONCLUSION” Section, Paragraph 1] “we studied changes in functional connectivity pattern during a sustained attention task as variations of graph measures with respect to a baseline, in a group of ADHD and healthy children.”)(Examiner notes, as recited, the level of connectivity metric is broad and not limited to a specific band), then the user is indicative of having ADHD (Page 588, “IV. DISCUSSION AND CONCLUSION” Section, Paragraph 1] “…in a group of ADHD and healthy children.”; Fig 3, “ADHD” on the left)
Coelli teaches a prior art brain connectivity EEG test device for ADHD studies upon which the claimed invention (comparing connectivity data between users with ADHD and a control population of “healthy” users) can be seen as an “improvement.” Coelli’s prior art comparable device (brain connectivity EEG test device for ADHD studies) includes a population of subjects with ADHD and a control population of children without ADHD. Coelli teaches a motivation to combine Machida’s disclosure with Coelli’s teaching with [Page 588, Right column, Paragraph 2] “functional connectivity task-related changes should get more attention and be further tested on wider and more homogenous groups of ADHD and healthy children.” A person having ordinary skill in the art before the effective filing date of the invention would recognize that comparing as much data as possible between a group of subjects with ADHD and a control group could more clearly indicate the brain connectivity features particularly associated with ADHD.
Thus, the manner of enhancing a particular device (brain connectivity EEG test device for ADHD studies) was made part of the ordinary capabilities of one skilled in the art based upon the teaching improvement in Coelli. Accordingly, one of ordinary skill in the art would have been capable of applying this known “improvement” technique in the same manner to the prior art brain connectivity EEG ADHD test device of Machida, and the results would have been predictable to one of ordinary skill in the art. Namely, one skilled in the art would have readily recognized that the sample populations (Machida’s “participants” and Coelli’s “subjects”) could include a control population of “healthy subjects” without ADHD in order to give a comparative result of which connectivity measures are associated with ADHD.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the “participants” in the brain connectivity EEG test device for ADHD studies) disclosed in Machida and the “subjects” including a control population of persons without ADHD taught by Coelli, creating a single testing system and method with capability to determine a comparative result of connectivity measures that are associated with ADHD. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Machida in view Michelini, “Atypical functional connectivity in adolescents and adults with persistent and remitted ADHD during a cognitive control task”, hereinafter Michelini.
Regarding Claim 7, Machida discloses as described above, The non-transitory computer-readable medium of claim 2. For the remainder of Claim 7, Machida discloses the operations further comprising:
filtering beta band oscillation signals ([Page 4, “EEG Analysis” Section, Paragraph 2] “The data were band pass filtered from 0.5 to 40 Hz”; [Page 5, Left Column, Paragraph 2, continuation of “EEG Analysis Section”] “These two measures were averaged to three frequency ranges, theta (4–8 Hz), alpha (8–13 Hz), and beta (13–30 Hz) bands”)(Examiner notes that the beta band oscillation signals are part of the “EEG data”, and all of the EEG data were initially filtered, regardless of band.) of two or more regions of the plurality of brain regions of the user upon receiving the first reaction ([Page 4, “Procedure” Section, Paragraph 1] “Participants were asked to complete the SARTs while the EEG was recorded using a 64 electrode Biosemi system.”)(Examiner notes that the 64 electrodes are measuring multiple brain regions, and the first reaction comes from the first SART.) and determining connectivity between two regions of the brain ([Page 13, “Limitations Section”, Paragraph 2”] “Our analysis was performed using surface level EEG recording with 64 electrodes. This allowed us to infer overall connectivity patterns of the surface of the whole brain”)(Examiner notes that the “whole brain” contains at least two regions of the brain.) using the beta band oscillation signals ([Page 5, Right Column, Paragraph 1] “This analysis resulted in measures of global efficiency and modularity at the three frequencies (theta, alpha, beta) during the task period for the Fixed and Random SARTs separately.”)(Examiner notes that “global efficiency” is a measure of connectivity between all of the regions of the brain, which includes at least two regions.); and when the first condition of the first task satisfies the silent state, the second condition is positive ([Table 1, “Mean RT, ADHD”)(Examiner notes that since this is a “correct” reaction to not react when a reaction is not warranted, it would be within the “Mean Reaction Time” data.)
Machida does not disclose comparing the level of connectivity between the two regions of the brain of the user to the level of connectivity of a healthy control group of users when the first condition of the first task satisfies the silent state, the second condition is positive, wherein if the level of connectivity of the user is greater than the level of connectivity of the beta band oscillation signals of the healthy control group of users, then the user is indicative of having ADHD.
Michelini teaches a brain-network connectivity study for adolescents and adults with persistent and remitted ADHD as compared to control participants. Specifically for Claim 7, Michelini teaches comparing the level of connectivity between the two regions of the brain ([Page 5, Left Column, Paragraph 1] “The following commonly used graph measures were calculated…global efficiency (how efficient the network is in transferring information)”) (Examiner notes that Global Efficiency is a measurement of connectivity across the entire brain, including all regions.) of the user to the level of connectivity of a healthy control group of users ([Page 3, Right Column] “including 110 adolescents and young adults who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for combined-type ADHD in childhood (10 sibling pairs and 90 singletons) and 169 control participants (76 sibling pairs and 17 singletons)”) when the first condition of the first task satisfies the silent state the second condition is positive ([Page 4, “Task” Section”] “Eriksen Flanker paradigm”; “Participants had to indicate whether this arrow pointed toward the left or right…”, “Both flankers either pointed in the same (congruent) or opposite (incongruent) direction to the target.”, Only incongruent trials were considered in the present in-depth analysis of the data included in our previous study“) Examiner notes that the Eriksen Flanker paradigm is a response inhibition test, as is the “Go/No-Go Test. The first condition for Eriksen Flanker is Press a Direction Button Corresponding to the Arrow when the Arrows are Visible vs Don’t Press a Button when the arrows are not visible. The second condition for Eriksen Flanker is Press the Direction of the Arrow that is Present, Unless that Arrow is the Outside Arrow, Then Press the Direction of the Inside Arrow. Examiner further notes that the “incongruent trials” would be when the subject needs to successfully not select the outside arrows that are pointed opposite the inside arrows, actively making a choice to press an alternate direction.), wherein if the level of connectivity of the user is greater than the level of connectivity of the beta band oscillation signals of the healthy control group of users ([Abstract] “Graph-theory measures converged in indicating that, compared to controls, ADHD persisters showed increased connectivity in pre-stimulus theta, alpha, and beta and in post-stimulus beta (all p < .01)”), then the user is indicative of having ADHD ([Abstract] “ADHD persisters…”).
Michelini teaches a prior art brain connectivity EEG test device for ADHD studies upon which the claimed invention (comparing connectivity data between users with ADHD and a control population of “healthy” users) can be seen as an “improvement.” Michelini’s prior art comparable device (brain connectivity EEG test device for ADHD studies) includes a population of adolescent and adult subjects with ADHD and a control population of participants without ADHD. Michelini teaches a motivation to combine Machida’s disclosure with Michelini’s teaching with [Page 2, Left Column, Paragraph 1] “Characterizing the atypical patterns of whole-brain functional connectivity across development may thus provide new insights into ADHD neurobiology.” and [Page 2, Right Column, Paragraph 2] “Remission of ADHD may be explained in light of…which posit that remission may underlie (1) a “normalization” of neural processes (markers of remission) that improve concurrently with clinical symptoms and impairment, whereby individuals with remitted ADHD (ADHD “remitters”) converge toward neurotypical individuals but diverge from individuals with persistent ADHD (ADHD “persisters”). A person having ordinary skill in the art before the effective filing date of the invention would recognize that comparing data for a wide subject pool of persons with and without ADHD would allow comparative insight into neurotypical and neurodivergent brain connectivity features for increased diagnostic capabilities of ADHD, whether active or remitted.
Thus, the manner of enhancing a particular device (brain connectivity EEG test device for ADHD studies) was made part of the ordinary capabilities of one skilled in the art based upon the teaching improvement in Michelini. Accordingly, one of ordinary skill in the art would have been capable of applying this known “improvement” technique in the same manner to the prior art brain connectivity EEG ADHD test device of Machida, and the results would have been predictable to one of ordinary skill in the art. Namely, one skilled in the art would have readily recognized that the sample populations (Machida’s “participants” and Michelini’s “participants”) could include a control population of “healthy subjects” without ADHD in order to give a comparative result of which connectivity measures are associated with ADHD.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the “participants” in the brain connectivity EEG test device for ADHD studies) disclosed in Machida and the “participants” including a control population of persons without ADHD taught by Michelini, creating a single testing system and method with capability to determine a comparative result of connectivity measures that are associated with ADHD. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Machida in view Kowalczyk, “Task-Based Functional Connectivity in Attention-Deficit/Hyperactivity Disorder: A Systematic Review”, hereinafter Kowalczyk.
Regarding Claim 8, Machida discloses as described above, The non-transitory computer-readable medium of claim 2. For the remainder of Claim 8, Machida discloses the operations further comprising:
filtering alpha band oscillation signals ([Page 4, “EEG Analysis” Section, Paragraph 2] “The data were band pass filtered from 0.5 to 40 Hz”; [Page 5, Left Column, Paragraph 2, continuation of “EEG Analysis Section”] “These two measures were averaged to three frequency ranges, theta (4–8 Hz), alpha (8–13 Hz), and beta (13–30 Hz) bands”)(Examiner notes that the alpha band oscillation signals are part of the “EEG data”, and all of the EEG data were initially filtered, regardless of band.) of two or more regions of the plurality of brain regions of the user upon receiving the first reaction ([Page 4, “Procedure” Section, Paragraph 1] “Participants were asked to complete the SARTs while the EEG was recorded using a 64 electrode Biosemi system.”)(Examiner notes that the 64 electrodes are measuring multiple brain regions, and the first reaction comes from the first SART.) and determining connectivity between two regions of the brain ([Page 13, “Limitations Section”, Paragraph 2”] “Our analysis was performed using surface level EEG recording with 64 electrodes. This allowed us to infer overall connectivity patterns of the surface of the whole brain”)(Examiner notes that the “whole brain” contains at least two regions of the brain.) using the alpha band oscillation signals ([Page 5, Right Column, Paragraph 1] “This analysis resulted in measures of global efficiency and modularity at the three frequencies (theta, alpha, beta) during the task period for the Fixed and Random SARTs separately.”)(Examiner notes that “global efficiency” is a measure of connectivity between all of the regions of the brain, which includes at least two regions.);
Machida does not disclose comparing a reduction in the level of connectivity of the user between when the first task satisfies the silent state and when the first task satisfies the active state to a reduction in the level of connectivity of a healthy control group of users between when the first task satisfies the silent state and when the first task satisfies the active state, wherein if the reduction in the level of connectivity of the user is less than the reduction in the level of connectivity of the healthy control group of users, then the user is indicative of having ADHD.
Kowalczyk teaches comparing a reduction in the level of connectivity of the user between when the reaction for the first task satisfies the silent state ([Page 352, Left Column, Paragraph 2] “ADHD was related to predominantly decreased functional connectivity compared with neurotypical control subjects during response inhibition”)(Examiner notes that correctly choosing the silent state reaction is “response inhibition”) and when the reaction for the first task satisfies the active state ([End of Page 351 – Page 352, Left Column, Paragraph 1] “There was an overall decrease of connectivity in ADHD compared with neurotypical control subjects during attention tasks”)(Examiner notes that satisfying the active state requires “attention”, therefore an “attention task”. Further, “between” is defined in definition 5 on dictionary.com as “among”. Among the two types of tasks, there is a reduction in the level of connectivity for both of these types of tasks, silent state and active state for persons with ADHD.) to a reduction in the level of connectivity of a healthy control group of users between when the first task satisfies the silent state ([Page 352, Left Column, Paragraph 2] “…compared with neurotypical control subjects during response inhibition”)(Examiner notes that correctly choosing the silent state reaction is “response inhibition”) and when the first task satisfies the active state ([End of Page 351 – Page 352, Left Column, Paragraph 1] “… compared with neurotypical control subjects during attention tasks”) (Examiner notes that the comparison is made among the results for ADHD and a control group of users.) wherein if the reduction in the level of connectivity of the user is less than the reduction in the level of connectivity of the healthy control group of users ([Page 352, Left Column, Paragraph 2] “There was an overall decrease of connectivity in ADHD compared with neurotypical control subjects during attention tasks” and “ADHD was related to predominantly decreased functional connectivity compared with neurotypical control subjects during response inhibition”)(Examiner notes that there was a reduction in connectivity among each of the task response types relative to the control group) , then the user is indicative of having ADHD ([Page 352, Left Column, Paragraph 2] “ADHD was related…”)
Kowalczyk teaches a systematic review prior art concerning brain connectivity EEG test devices and protocols for ADHD studies upon which the claimed invention (comparing the brain connectivity results based on the type of responses on specific tasks, either active state or silent state) can be seen as an “improvement.” Kowalczyk’s prior art comparable devices (brain connectivity EEG test devices and protocols for ADHD studies) teaches brain conductivity analysis results for particular types of test response, including the “attention tasks” (active state) and the “inhibition tasks” (silent state). Kowalczyk teaches a motivation to combine Machida’s disclosure with Kowalczyk’s teaching with [Page 350, Right Column, Paragraph 1] “Assessments of task-based functional connectivity, however, allow these findings to be extended by investigating functional connections specific to distinct cognitive processes.” A person having ordinary skill in the art before the effective filing date of the invention would recognize that comparing data on a task-basis for “attention” and “inhibition” tasks would give useful data for understanding functional connections specific to distinct cognitive processes in persons with ADHD.
Thus, the manner of enhancing a particular device (brain connectivity EEG test devices and protocols for ADHD studies was made part of the ordinary capabilities of one skilled in the art based upon the teaching improvement in Kowalczyk. Accordingly, one of ordinary skill in the art would have been capable of applying this known “improvement” technique in the same manner to the prior art brain connectivity EEG ADHD test device of Machida, and the results would have been predictable to one of ordinary skill in the art. Namely, one skilled in the art would have readily recognized that the EEG test data (Machida’s EEG data from the “SART” testing and Kowalczyk’s “task-based” data) could be analyzed for brain connectivity characteristics on a task-basis, for “attention” and “inhibition” tasks, in order to investigate functional connections specific to distinct cognitive processes in persons with ADHD.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the EEG data from the “SART” testing in the brain connectivity EEG test device for ADHD studies disclosed in Machida and the “task-based functional connectivity” analysis taught by Kowalczyk, creating a single testing system and method with capability to determine a response-based comparative result of connectivity measures that are associated with ADHD. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious.
Claims 11 – 16 are rejected under 35 U.S.C. 103 as being unpatentable over Machida in view of Vaurio et. al., “Increased intra-individual reaction time variability in attention-deficit/hyperactivity disorder across response inhibition tasks with different cognitive demands”, hereinafter Vaurio.
Regarding Claim 11, Machida discloses as described above, The non-transitory computer-readable medium of claim 1. For the remainder of claim 11, Machida does not specifically disclose wherein the second condition includes displaying the category of text or graphic in a particular color. Machida is open to displaying a category of text or graphic in any legible color, as no specific color is disclosed for the text or number graphic.
Vaurio teaches simple and complex “Go/No-Go”-type inhibition tests for investigating reaction time variability in attention-deficit/hyperactivity disorder. Specifically for Claim 11, Vaurio teaches, wherein the second condition ([Page 7, “Simple Go/No-Go Task” Section”] “Children were seated in front of a computer screen and instructed to..refrain from pushing the button when shown a red (i.e. “no-go”) spaceship.”) includes displaying the category of text or graphic in a particular color ((Page 7, “Simple Go/No-Go Task” Section”] “…a computer screen”, “shown a red (i.e. “no-go”) spaceship.”)
Vaurio teaches a prior art comparable “Go/No-Go”-type inhibition test upon which the claimed invention (having a particular color for the text or graphic corresponding to the second condition) can be seen as an “improvement.” For the “Simple Go/No-Go Task” on page 7, Vaurio teaches a first condition such that the child must “push the button” when a spaceship is shown. The “no action” portion of that first condition is not to press the button when a spaceship is not shown. For the second condition, Vaurio teaches to not press the button when a specifically “red” color of spaceship is shown. Vaurio and Machida both include “Go/No-Go”type inhibition tests with two conditions for response. Vaurio merely chooses to set the second condition apart with a “red” color choice as opposed to a letter (shape)-change or graphic-change (which Machida does by having the second condition be “not 3”). Vaurio presents a motivation to combine with Machida at [Abstract] with “A total of 140 children (57 with ADHD and 83 typically developing controls), ages 8–13 years, completed both a “simple” Go/No-go task.” A person having ordinary skill in the art before the effective filing date of the invention would recognize that using colors instead of, or in addition to numbers, would allow for accessibility for young children who may be more familiar with their colors (or the presence of a color change) than the memorized identity of individual numbers.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the “number” shown disclosed in Machida and the “red” color of the graphic shown, creating a single “Go/No-Go”-type inhibition test in which color can differentiate the “No-Go” case from the “Go” cases for trials to be used with connectivity analysis for ADHD diagnosis in a broad-aged subject group. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious.
Regarding Claim 12, Machida discloses as described above, The non-transitory computer-readable medium of claim 1, wherein the one or more stimuli. For the remainder of Claim 12, Machida discloses further comprise:
displaying second information ([Page 4, “Materials Section”, Paragraph 1], “Participants were presented a series of digits (1–9) on a computer screen.”) (Examiner notes that the SART test is performed for multiple trials, so a subsequent trial with the next digit displayed could be second information.), with the first condition that causes a reaction ([Page 4, “Materials Section”, Paragraph 1], including “Participants were presented a series of digits (1–9) on a computer screen…Participants were asked to respond to every digit except “3.”…The participants were asked to respond when the response cue appeared on screen”)(Examiner notes that the first condition is such that that the participants respond after a number has been shown on the screen during the time when the response cue is on the screen. Participants should not click if there are not currently numbers on the screen). the second condition as the exception to the first condition ([Page 4, “Materials Section”, Paragraph 1], including “Participants were presented a series of digits (1–9) on a computer screen…Participants were asked to respond to every digit except “3.”…)
Machida does not disclose and a third condition as an exception to the second condition.
Vaurio teaches displaying second information ([Page 7, “2.4. Complex Go/No-Go Task” Section”] “Complex Go/No-Go Task”; “The same green and red spaceship stimuli, presented one at a time and at midline, were used in this task as the simple task.”) with the first condition that causes a reaction ([Page 7, “2.4. Complex Go/No-Go Task” Section”] “Children were instructed to push the button as quickly as possible in response to a green spaceship…”)(Examiner notes that the first condition such that the child must “push the button” when a green spaceship is shown. The “no action” portion of that first condition is not to press the button when a spaceship is not shown.) the second condition as the exception to the first condition ([Page 7, “2.4. Complex Go/No-Go Task” Section”] “Children were instructed to push the button as quickly as possible…and in response to a red spaceship preceded by an even number of green spaceships.)(Examiner notes that the second condition is an exception to only pressing the button when a green spaceship appears, since a red one can also be pressed if there has been an even number of green spaceships before it.) and a third condition as an exception to the second condition ([Page 7, “2.4. Complex Go/No-Go Task” Section”] “They were to refrain from responding to red spaceships preceded by an odd number of green spaceships.”)(Examiner notes that the third condition is a condition that provides another situation in which a red spaceship is not pressed, an exception to pressing red spaceships).
Vaurio teaches a “Go/No-Go”-type inhibition test for use to discern information about persons with ADHD. This is the same function as Machida’s “Sustained Attention to Response Test (SART)”. Vaurio and Machida both include “Go/No-Go”type inhibition tests with at least two conditions for response. Vaurio teaches a motivation to substitute the more “complex” Go/No-Task at [Abstract] “…and a more “complex” Go/No-go task with increased working memory load.” A person having ordinary skill in the art before the effective filing date of the invention would recognize that increasing the working memory load in a test could increase the magnitude of the visible results in the EEG data studying ADHD, a mental-load-associated brain condition. While Vaurio’s taught test uses graphics of spaceships, and Machida’s disclosed test used numbers, they are both “Go/No-Go”-type inhibition tests used for the same purpose of studying ADHD brain function. Therefore, a person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that variations of colored spaceship graphics “Go/No-Go”-type inhibition test would be useful for studying ADHD-associated brain function.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the number-based “Go/No-Go”-type inhibition test of Machida with the colored spaceship-based “Complex Go/No-Go”-type inhibition test of Vaurio. Machida discloses an EEG-based study using “Go/No-Go”-type inhibition test as input, which is the same function of the “Complex Go/No-Go”-type spaceship inhibition test for an EEG study in Vaurio. Therefore it would yield a predictable result to substitute Vaurio’s colored spaceship-based “Complex Go/No-Go”-type inhibition test for the number-based “Go/No-Go”-type inhibition test of Machida. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved.
Regarding Claim 13, Machida in view of Vaurio discloses as described above, The non-transitory computer-readable medium of claim 12, wherein displaying second information with the first condition that causes a first reaction, the second condition as the exception to the first condition, and a third condition as an exception to the second condition. For the remainder of Claim 13, Machida discloses further comprises:
presenting an instance of data matching a second task ([Page 4, “Materials Section”, All of Paragraph 1] including “The Sustained Attention to Response Task (SART)”, description of “participants” being presented “a series of digits (1–9)”, “a single digit”, “a mask”, “a response cue”, and a “fixation cross” with an “interstimulus interval”) (Examiner notes that the SART test is performed for multiple trials, so a subsequent trial with the next digit displayed could be associated with data matching a second task)
wherein the second task ([Page 4, “Materials Section”, Paragraph 1] = “The Sustained Attention to Response Task (SART)”) includes the first condition ([Page 4, “Materials Section”, Paragraph 1], including “Participants were presented a series of digits (1–9) on a computer screen…Participants were asked to respond to every digit except “3.”…The participants were asked to respond when the response cue appeared on screen”)(Examiner notes that the condition is such that that the participants respond after a number has been shown on the screen during the time when the response cue is on the screen”) for expectation of an active state ([Page 4, “Materials Section”, Paragraph 1], “Participants were asked to respond to every digit…”) and a silent state of a second reaction ([Page 4, “Materials Section”, Paragraph 1], participant does not respond when the number has not been shown and the response cue is not active, thereby Not Responding to the state: No digit shown) (Examiner notes that the SART test is performed for multiple trials, so a subsequent trial with the next digit displayed could be associated with a second reaction) the second condition restricting the expectation of the active state of the second reaction ([Page 4, “Materials Section”, Paragraph 1], “Participants were asked to respond to every digit except “3.”)(Examiner notes that not responding to 3 is the exception to responding during the “response cue” time after a number has been shown.).
Machida does not disclose and the third condition that is an exception to the second condition for expectation of silent state of the second reaction.
Vaurio teaches presenting an instance of data matching a second task ([Page 7, “2.4. Complex Go/No-Go Task” Section”] “Complex Go/No-Go Task”; “The same green and red spaceship stimuli, presented one at a time and at midline, were used in this task as the simple task.”), wherein the second task includes the first condition ([Page 7, “2.4. Complex Go/No-Go Task” Section”] “Children were instructed to push the button as quickly as possible in response to a green spaceship…”)(Examiner notes that the first condition such that the child must “push the button” when a green spaceship is shown. The “no action” portion of that first condition is not to press the button when a spaceship is not shown.) for expectation of an active state ([Page 7, “2.4. Complex Go/No-Go Task” Section”] pressing button for green spaceships) and a silent state of a second reaction ([Page 7, “2.4. Complex Go/No-Go Task” Section”], not pressing a button when a spaceship is not shown) the second condition restricting expectation of the active state of the second reaction ([Page 7, “2.4. Complex Go/No-Go Task” Section”] “Children were instructed to push the button as quickly as possible…and in response to a red spaceship preceded by an even number of green spaceships.)(Examiner notes that the second condition is an exception to the active state of only pressing the button when a green spaceship appears, since a red one can also be pressed if there has been an even number of green spaceships before it.), and the third condition that is an exception to the second condition for expectation of silent state of the second reaction ([Page 7, “2.4. Complex Go/No-Go Task” Section”] “They were to refrain from responding to red spaceships preceded by an odd number of green spaceships.”)(Examiner notes that the third condition is a condition that provides another situation in which a red spaceship is not pressed, an exception to pressing red spaceships instead of not pressing green spaceships).
The motivation for Claim 13 to combine Machida with Vaurio is the same as that described in more detail in Claim 12. In summary, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the number-based “Go/No-Go”-type inhibition test of Machida with the colored spaceship-based “Complex Go/No-Go”-type inhibition test of Vaurio. Machida discloses an EEG-based study using “Go/No-Go”-type inhibition test as input, which is the same function of the “Complex Go/No-Go”-type spaceship inhibition test for an EEG study in Vaurio. Therefore it would yield a predictable result to substitute Vaurio’s colored spaceship-based “Complex Go/No-Go”-type inhibition test for the number-based “Go/No-Go”-type inhibition test of Machida. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved.
Regarding Claim 14, Machida in view of Vaurio discloses as described above, The non-transitory computer-readable medium of claim 13, wherein the second reaction. For the remainder of Claim 14, Machida discloses further comprises:
displaying information on a screen ([Page 4, “Materials Section”, Paragraph 1], “Participants were presented a series of digits (1–9) on a computer screen.”) meeting the first condition ([Page 4, “Materials Section”, Paragraph 1], including “Participants were presented a series of digits (1–9) on a computer screen…Participants were asked to respond to every digit except “3.”…The participants were asked to respond when the response cue appeared on screen”)(Examiner notes that the condition is such that that the participants respond after a number has been shown on the screen during the time when the response cue is on the screen”) for expectation of the active state ([Page 4, “Materials Section”, Paragraph 1], “Participants were asked to respond to every digit…”) and the silent state of the second reaction ([Page 4, “Materials Section”, Paragraph 1], participant does not respond when the number has not been shown and the response cue is not active, thereby Not Responding to the state: No digit shown) (Examiner notes that the SART test is performed for multiple trials, so a subsequent trial with the next reaction could be second reaction.); and
waiting for a threshold period for any input shared by the user ([Page 4, “Materials Section”, Paragraph 1],” Each trial was set-up with this timing: a single digit was presented for 313 ms, followed by a mask for 125 ms. A response cue was presented for 63 ms”)(Examiner notes that the response input is communicated by the user during the “response cue”).
Regarding Claim 15, Machida in view of Vaurio discloses as described above, The non-transitory computer-readable medium of claim 13, wherein the third condition. For the remainder of Claim 15, Machida does not disclose includes: selecting a sub-category of a category of text or graphic meeting the first condition and displaying the sub-category of the text or graphic.
Vaurio teaches wherein the third condition includes: selecting a sub-category of a category of text or graphic meeting the first condition ([Page 7, “2.4. Complex Go/No-Go Task” Section”] “They were to refrain from responding to red spaceships preceded by an odd number of green spaceships.”)(Examiner notes that red spaceship is a sub-category of spaceship (in the first condition, Spaceship is Shown). It is selected by the device/method continuing to use spaceships as the stimulus.); and displaying the sub-category of the text or graphic ([Page 7, “2.4. Complex Go/No-Go Task” Section”] “Complex Go/No-Go Task”; “The same green and red spaceship stimuli, presented one at a time and at midline, were used in this task as the simple task.”).
Vaurio teaches a “Go/No-Go”-type inhibition test, using a single category of graphic (spaceships) for use to discern information about persons with ADHD. This is the same function as Machida’s “Sustained Attention to Response Test (SART)” that uses a single category of graphic (numbers).
The motivation for Claim 15 to combine Machida with Vaurio is essentially the same as that described in more detail in Claim 12. In summary, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the number-based “Go/No-Go”-type inhibition test of Machida with the colored spaceship-based “Complex Go/No-Go”-type inhibition test of Vaurio directed toward children. Machida discloses an EEG-based study using “Go/No-Go”-type inhibition test as input, which is the same function of the “Complex Go/No-Go”-type spaceship inhibition test for an EEG study in Vaurio. Therefore it would yield a predictable result to substitute Vaurio’s colored spaceship-based “Complex Go/No-Go”-type inhibition test for the number-based “Go/No-Go”-type inhibition test of Machida. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved.
Regarding Claim 16, Machida in view of Vaurio discloses as described above, The non-transitory computer-readable medium of claim 13. For the remainder of Claim 16, Machida discloses
wherein the second reaction is at least one of clicking a pointing device, pressing a button, or taking no action ([Page 4, “Materials Section”, Paragraph 1],” Participants were asked to respond to every digit except “3.”)(Examiner notes that the SART was performed for multiple trials, so subsequent SART is second reaction) for a threshold time ([Page 4, “Materials Section”, Paragraph 1], “Each trial was set-up with this timing: a single digit was presented for 313 ms, followed by a mask for 125 ms. A response cue was presented for 63 ms.”)
Claims 17 – 19 are rejected under 35 U.S.C. 103 as being unpatentable over Machida in view of Vaurio, further in view of Coelli.
Regarding Claims 17 and 18, Machida in view of Vaurio discloses as described above, The non-transitory computer-readable medium of claim 13, the operations further comprising. For the remainder of Claims 17 and 18, Machida discloses the operations further comprising:
For Claim 17:
filtering beta band oscillation signals ([Page 4, “EEG Analysis” Section, Paragraph 2] “The data were band pass filtered from 0.5 to 40 Hz”; [Page 5, Left Column, Paragraph 2, continuation of “EEG Analysis Section”] “These two measures were averaged to three frequency ranges, theta (4–8 Hz), alpha (8–13 Hz), and beta (13–30 Hz) bands”)(Examiner notes that the beta band oscillation signals are part of the “EEG data”, and all of the EEG data were initially filtered, regardless of band.) of two or more regions of the plurality of brain regions of the user upon receiving the second reaction ([Page 4, “Procedure” Section, Paragraph 1] “Participants were asked to complete the SARTs while the EEG was recorded using a 64 electrode Biosemi system.”)(Examiner notes that the 64 electrodes are measuring multiple brain regions, and the second reaction comes from the second SART. Examiner again notes second reaction could be part of a second SART) and determining connectivity between two regions of the brain ([Page 13, “Limitations Section”, Paragraph 2”] “Our analysis was performed using surface level EEG recording with 64 electrodes. This allowed us to infer overall connectivity patterns of the surface of the whole brain”)(Examiner notes that the “whole brain” contains at least two regions of the brain.) using the beta band oscillation signals ([Page 5, Right Column, Paragraph 1] “This analysis resulted in measures of global efficiency and modularity at the three frequencies (theta, alpha, beta) during the task period for the Fixed and Random SARTs separately.”)(Examiner notes that “global efficiency” is a measure of connectivity between all of the regions of the brain, which includes at least two regions.);
For Claim 18:
filtering theta band oscillation signals ([Page 4, “EEG Analysis” Section, Paragraph 2] “The data were band pass filtered from 0.5 to 40 Hz”; [Page 5, Left Column, Paragraph 2, continuation of “EEG Analysis Section”] “These two measures were averaged to three frequency ranges, theta (4–8 Hz), alpha (8–13 Hz), and beta (13–30 Hz) bands”)(Examiner notes that the theta band oscillation signals are part of the “EEG data”, and all of the EEG data were initially filtered, regardless of band.) of two or more regions of the plurality of brain regions of the user upon receiving the second reaction ([Page 4, “Procedure” Section, Paragraph 1] “Participants were asked to complete the SARTs while the EEG was recorded using a 64 electrode Biosemi system.”)(Examiner notes that the 64 electrodes are measuring multiple brain regions, and the second reaction comes from the second SART. Examiner again notes second reaction could be part of a second SART.) and determining connectivity between two regions of the brain ([Page 13, “Limitations Section”, Paragraph 2”] “Our analysis was performed using surface level EEG recording with 64 electrodes. This allowed us to infer overall connectivity patterns of the surface of the whole brain”)(Examiner notes that the “whole brain” contains at least two regions of the brain.) using the theta band oscillation signals ([Page 5, Right Column, Paragraph 1] “This analysis resulted in measures of global efficiency and modularity at the three frequencies (theta, alpha, beta) during the task period for the Fixed and Random SARTs separately.”)(Examiner notes that “global efficiency” is a measure of connectivity between all of the regions of the brain, which includes at least two regions.);
For both Claims 17 and 18:
Machida does not disclose comparing the level of connectivity between the two regions of the brain of the user to the level of connectivity of a healthy control group of users when the first condition of the second task satisfies the active state, the second condition is negative and the third condition is negative, or when the first condition of the second task satisfies the active state, the second condition is positive and the third condition is positive, wherein if the (signal data of the for Claim 18) level of connectivity of the user is greater than (For Claim 17) or less than (For Claim 18) the level of connectivity of the healthy control group of users, then the user is indicative of having ADHD.
Vaurio teaches an inhibition-response test with additional variables in which optional answers include the first condition of the second task ([Page 7, “2.4. Complex Go/No-Go Task” Section”] “Complex Go/No-Go Task”) satisfies the active state, the second condition is negative and the third condition is negative ([Page 9, “3.2. Comparison of speed and accuracy” Section, Paragraph 2] “Analysis of percent commission errors, indicated…children across both groups showing more commission errors on the complex task than on the simple task”) or when the first condition of the second task satisfies the active state, the second condition is positive and the third condition is positive ([Page 9, “3.2. Comparison of speed and accuracy” Section, Paragraph 1] “reaction time (i.e., mean reaction time) for either diagnostic category or task”, “children in the ADHD group performing significantly slower on the complex task”)
In order to combine Machida and Vaurio for the limitations of Claim 17, the motivation is the same as that in Claim 13 (from with this claim depends), as described in more detail in Claim 12. In summary, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the number-based “Go/No-Go”-type inhibition test of Machida with the colored spaceship-based “Complex Go/No-Go”-type inhibition test of Vaurio. Machida discloses an EEG-based study using “Go/No-Go”-type inhibition test as input, which is the same function of the “Complex Go/No-Go”-type spaceship inhibition test for an EEG study in Vaurio. Therefore it would yield a predictable result to substitute Vaurio’s colored spaceship-based “Complex Go/No-Go”-type inhibition test for the number-based “Go/No-Go”-type inhibition test of Machida. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved.
Coelli teaches comparing the level of connectivity between the two regions of the brain of the user to the level of connectivity of a healthy control group of users (Fig 3, Δ Shortest Path Length, of ImCoh(theta) for parieto-occipital to frontal regions)(Examiner notes that shorted path length is a metric of connectivity.)
For Claim 17, Coelli teaches:
wherein if the level of connectivity of the user is greater than the level of connectivity of the healthy control group of users (Fig 3, Δ Shortest Path Length, of ImCoh(theta) for parieto-occipital to frontal regions, ADHD on left median is greater than Control box on right) (Examiner notes, as recited, the level of connectivity metric is broad and not limited to a specific band), then the user is indicative of having ADHD (Fig 3, Δ Shortest Path Length, of ImCoh(theta); “ADHD”).
For Claim 18, Coelli teaches:
wherein if signal data of the level of connectivity of the user is less than the level of connectivity of the healthy control group of users (Fig 3, ΔGlobal Efficiency, of ImCoh(theta) for parieto-occipital to frontal regions, ADHD on left median is less than Control box on right) (Examiner notes, as recited, the level of connectivity metric is broad and not limited to a specific band), then the user is indicative of having ADHD (Fig 3, Δ Global Efficiency, of ImCoh(theta); “ADHD”).
Coelli teaches a comparative analysis between ADHD and control brain connectivity data with an inhibition response test for when there has been an appropriate reaction ([Page 586, Left Column, Paragraph 3] “mean hit reaction time (HRT)”) and when there has been a commission error ([Page 586, Left Column, Paragraph 3] “commission errors”). The limitations with the first condition of the second task satisfies the active state, the second condition is negative and the third condition is negative yield the same type of error: a commission-type error, merely using a test with an additional variable. The situation in which when the first condition of the second task satisfies the active state, the second condition is positive and the third condition is positive, is the same type of SUCCESS condition, merely using a test with an additional variable. This is the same as Machida’s SART test with yields results with commission errors ([Page 5, Right Column, Paragraph 2] “commission errors”) and appropriate reaction ([Page 5, Right Column, Paragraph 2] “mean RT”).
Coelli teaches a prior art brain connectivity EEG test device for ADHD studies upon which the claimed invention (comparing connectivity data between users with ADHD and a control population of “healthy” users) can be seen as an “improvement.” Coelli’s prior art comparable device (brain connectivity EEG test device for ADHD studies) includes a population of subjects with ADHD and a control population of children without ADHD. Coelli teaches a motivation to combine Machida’s disclosure with Coelli’s teaching with [Page 588, Right column, Paragraph 2] “functional connectivity task-related changes should get more attention and be further tested on wider and more homogenous groups of ADHD and healthy children.” A person having ordinary skill in the art before the effective filing date of the invention would recognize that comparing as much data as possible between a group of subjects with ADHD and a control group could more clearly indicate the brain connectivity features particularly associated with ADHD.
Thus, the manner of enhancing a particular device (brain connectivity EEG test device for ADHD studies) was made part of the ordinary capabilities of one skilled in the art based upon the teaching improvement in Coelli. Accordingly, one of ordinary skill in the art would have been capable of applying this known “improvement” technique in the same manner to the prior art brain connectivity EEG ADHD test device of Machida, and the results would have been predictable to one of ordinary skill in the art. Namely, one skilled in the art would have readily recognized that the sample populations (Machida’s “participants” and Coelli’s “subjects”) could include a control population of “healthy subjects” without ADHD in order to give a comparative result of which connectivity measures are associated with ADHD.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the “participants” in the brain connectivity EEG test device for ADHD studies) disclosed in Machida and the “subjects” including a control population of persons without ADHD taught by Coelli, creating a single testing system and method with capability to determine a comparative result of connectivity measures that are associated with ADHD. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious.
Regarding Claim 19, Machida discloses as described above, The non-transitory computer-readable medium of claim 13, the operations. For the remainder of Claim 18, Machida discloses further comprising:
filtering alpha band oscillation signals ([Page 4, “EEG Analysis” Section, Paragraph 2] “The data were band pass filtered from 0.5 to 40 Hz”; [Page 5, Left Column, Paragraph 2, continuation of “EEG Analysis Section”] “These two measures were averaged to three frequency ranges, theta (4–8 Hz), alpha (8–13 Hz), and beta (13–30 Hz) bands”)(Examiner notes that the alpha band oscillation signals are part of the “EEG data”, and all of the EEG data were initially filtered, regardless of band.) of two or more regions of the plurality of brain regions of the user upon receiving the second reaction ([Page 4, “Procedure” Section, Paragraph 1] “Participants were asked to complete the SARTs while the EEG was recorded using a 64 electrode Biosemi system.”)(Examiner notes that the 64 electrodes are measuring multiple brain regions, and the second reaction comes from the second SART.) and determining connectivity between two regions of the brain ([Page 13, “Limitations Section”, Paragraph 2”] “Our analysis was performed using surface level EEG recording with 64 electrodes. This allowed us to infer overall connectivity patterns of the surface of the whole brain”)(Examiner notes that the “whole brain” contains at least two regions of the brain.) using the alpha band oscillation signals ([Page 5, Right Column, Paragraph 1] “This analysis resulted in measures of global efficiency and modularity at the three frequencies (theta, alpha, beta) during the task period for the Fixed and Random SARTs separately.”)(Examiner notes that “global efficiency” is a measure of connectivity between all of the regions of the brain, which includes at least two regions.);
Machida does not disclose determining a variation in the level of connectivity between the two regions of the brain of the user when presenting the instance of data for the second task where the first condition of the second task satisfies the active state, the second condition of the second task is positive and the third condition of the second task is positive to the level of connectivity between the two regions of the brain of the user when presenting the instance of data for the first task where the first condition of the first task satisfies the active state, and the second condition of the first task is positive; and comparing the variation in the level of connectivity of the user to the variation in the level of connectivity of a healthy control group of users, wherein if the variation in the level of connectivity of the user is greater than or less than the variation in the level of connectivity of the healthy control group of users, then the user is indicative of ADHD.
Vaurio teaches, as described above in Claim 17, where the first condition of the second task satisfies the active state, the second condition of the second task is positive and the third condition of the second task is positive (See citation in Claim 17).
In order to combine Machida and Vaurio for the limitations of Claim 19, the motivation is the same as that in Claim 13 (from with this claim depends), as described in more detail in Claim 12. In summary, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the number-based “Go/No-Go”-type inhibition test of Machida with the colored spaceship-based “Complex Go/No-Go”-type inhibition test of Vaurio. Machida discloses an EEG-based study using “Go/No-Go”-type inhibition test as input, which is the same function of the “Complex Go/No-Go”-type spaceship inhibition test for an EEG study in Vaurio. Therefore it would yield a predictable result to substitute Vaurio’s colored spaceship-based “Complex Go/No-Go”-type inhibition test for the number-based “Go/No-Go”-type inhibition test of Machida. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved.
Coelli teaches determining a variation in the level of connectivity between the two regions of the brain of the user (Fig 3, ΔGlobal Efficiency, of ImCoh(theta), ADHD on left) (Examiner notes that Global Efficiency is a measurement of connectivity across the entire brain, including all regions.) when presenting the instance of data ([Page 587, “D. Graph analysis” Section”, Paragraph 3] “To simplify the evaluation of the indexes while keeping as much as possible both the temporal and spatial information, we averaged their values within each minute of recordings”; [Page 587, “A. Behavioral results” Section] “ADHD participants showed on average… higher performances variability and higher mean response time (HRT)…”)(Examiner notes that this is as in presented a first task of the data that would be followed by addition tasks-worth of data) when presenting the instance of data for the first task where the first condition of the first task satisfies the active state, and the second condition of the first task is positive ([Page 587, “D. Graph analysis” Section”, Paragraph 3] “To simplify the evaluation of the indexes while keeping as much as possible both the temporal and spatial information, we averaged their values within each minute of recordings”; [Page 587, “A. Behavioral results” Section] “ADHD participants showed on average… higher performances variability and higher mean response time (HRT)…”); and
comparing the variation in the level of connectivity of the user (Fig 3, Δ Global Efficiency, of ImCoh(theta) over time, ADHD group on the left box and whisker, with a median lower than the median of the healthy “Control” group on the right; [Page 587, “D. Graph analysis” Section”, Paragraph 3] “To simplify the evaluation of the indexes while keeping as much as possible both the temporal and spatial information, we averaged their values within each minute of recordings”)(Examiner notes that this is a measure of the change or variation in global efficiency for the user over a time period of each minute of recordings, which includes multiple tasks-worth of data, yielding the variation in the level of conductivity.) to the variation in the level of connectivity of a healthy control group of users (Fig 3, Δ Global Efficiency, of ImCoh(theta), healthy “Control” group on the right box and whisker, with a median higher than the median of the ADHD group on the left; [Page 588, “IV. DISCUSSION AND CONCLUSION” Section, Paragraph 1] “we studied changes in functional connectivity pattern during a sustained attention task as variations of graph measures with respect to a baseline, in a group of ADHD and healthy children.”)(Examiner notes, as recited, the level of connectivity metric is broad and not limited to a specific band, and that Δ Global Efficiency is a measure of the change or variation in global efficiency), wherein if the variation in the level of connectivity of the user is greater than or less than the variation in the level of connectivity of the healthy control group of users (Fig 3, ΔGlobal Efficiency, of ImCoh(theta), healthy “Control” group on the right box and whisker, with a median higher than the median of the ADHD group on the left) (Examiner notes, as recited, the level of connectivity metric is broad and not limited to a specific band), then the user is indicative of ADHD (Fig 3, “ADHD”)
Similarly to Claim 17, Coelli teaches data analysis for an inhibition study with appropriate reaction and commission error data. In order to combine Machida in view of Vaurio with Coelli for the limitations of Claim 19, the motivation is the same as that in Claim 17. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the “participants” in the brain connectivity EEG test device for ADHD studies) disclosed in Machida and the “subjects” including a control population of persons without ADHD taught by Coelli, creating a single testing system and method with capability to determine a comparative result of connectivity measures that are associated with ADHD. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Machida in view of Vaurio, further in view of Coelli, and further in view of McNorgan et. al., “Linking ADHD and Behavioral Assessment Through Identification of Shared Diagnostic Task-Based Functional Connections”, hereinafter McNorgan.
Regarding Claim 20, Machida in view of Vaurio, further in view of Coelli discloses as described above, The non-transitory computer-readable medium of claim 19, operations. For the remainder of Claim 20, Machida discloses further comprising:
filtering alpha, beta, and theta band oscillation signals ([Page 4, “EEG Analysis” Section, Paragraph 2] “The data were band pass filtered from 0.5 to 40 Hz”; [Page 5, Left Column, Paragraph 2, continuation of “EEG Analysis Section”] “These two measures were averaged to three frequency ranges, theta (4–8 Hz), alpha (8–13 Hz), and beta (13–30 Hz) bands”)(Examiner notes that the alpha band oscillation signals are part of the “EEG data”, and all of the EEG data were initially filtered, regardless of band.) of two or more regions of the plurality of brain regions of the user upon receiving the first reaction and the second reaction ([Page 4, “Procedure” Section, Paragraph 1] “Participants were asked to complete the SARTs while the EEG was recorded using a 64 electrode Biosemi system.”)(Examiner notes that the 64 electrodes are measuring multiple brain regions, and the first reaction comes from the first SART. Examiner again notes that multiple SARTs are recorded, so a subsequent SART could include the second reaction.) and determining connectivity between two regions of the brain ([Page 13, “Limitations Section”, Paragraph 2”] “Our analysis was performed using surface level EEG recording with 64 electrodes. This allowed us to infer overall connectivity patterns of the surface of the whole brain”)(Examiner notes that the “whole brain” contains at least two regions of the brain.) using the alpha, beta, and theta band oscillation signals ([Page 5, Right Column, Paragraph 1] “This analysis resulted in measures of global efficiency and modularity at the three frequencies (theta, alpha, beta) during the task period for the Fixed and Random SARTs separately.”)(Examiner notes that “global efficiency” is a measure of connectivity between all of the regions of the brain, which includes at least two regions.); and
Machida does not disclose evaluating the probability of the detection of ADHD based on the comparison of the level of connectivity, reduction in the level of connectivity, and the variation in the level of connectivity between the regions of the brain of the user to the level of connectivity of a healthy control group of users when varying the first condition, the second condition of the first task, and the first condition, the second condition, and the third condition of the second task.
Vaurio teaches when varying the first condition ([Page 7, “Simple Go/No-Go Task” Section”] the child must “push the button” when a spaceship is shown. The “no action” portion of that first condition is not to press the button when a spaceship is not shown.) the second condition ([Page 7, “Simple Go/No-Go Task” Section”] second condition, not press the button when a specifically “red” color of spaceship is shown.) of the first task ((Page 7, “Simple Go/No-Go Task” Section”] “…a computer screen”, “shown a red (i.e. “no-go”) spaceship.”), and the first condition reaction ([Page 7, “2.4. Complex Go/No-Go Task” Section”] “Children were instructed to push the button as quickly as possible in response to a green spaceship…”)(Examiner notes that the first condition such that the child must “push the button” when a green spaceship is shown. The “no action” portion of that first condition is not to press the button when a spaceship is not shown.), the second condition ([Page 7, “2.4. Complex Go/No-Go Task” Section”] “Children were instructed to push the button as quickly as possible…and in response to a red spaceship preceded by an even number of green spaceships.)(Examiner notes that the second condition is an exception to only pressing the button when a green spaceship appears, since a red one can also be pressed if there has been an even number of green spaceships before it.), and the third condition ([Page 7, “2.4. Complex Go/No-Go Task” Section”] “They were to refrain from responding to red spaceships preceded by an odd number of green spaceships.”)(Examiner notes that the third condition is a condition that provides another situation in which a red spaceship is not pressed, an exception to pressing red spaceships) of the second task ([Page 7, “2.4. Complex Go/No-Go Task” Section”] “Complex Go/No-Go Task”; “The same green and red spaceship stimuli, presented one at a time and at midline, were used in this task as the simple task.”).
In order to combine Machida and Vaurio for the limitations of Claim 20, the motivation is the same as that in Claim 13 (from with this claim depends), as described in more detail in Claim 12. In summary, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the number-based “Go/No-Go”-type inhibition test of Machida with the colored spaceship-based “Complex Go/No-Go”-type inhibition test of Vaurio. Machida discloses an EEG-based study using “Go/No-Go”-type inhibition test as input, which is the same function of the “Complex Go/No-Go”-type spaceship inhibition test for an EEG study in Vaurio. Therefore it would yield a predictable result to substitute Vaurio’s colored spaceship-based “Complex Go/No-Go”-type inhibition test for the number-based “Go/No-Go”-type inhibition test of Machida. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved.
Vaurio does not disclose evaluating the probability of the detection of ADHD based on the comparison of the level of connectivity, reduction in the level of connectivity, and the variation in the level of connectivity between the regions of the brain of the user to the level of connectivity of a healthy control group of users
McNorgan teaches evaluating the probability of the detection of ADHD ([Page 3, Right Column, Paragraph 3] “the machine learning classifiers can be constrained to take advantage of joint probability distributions to identify the functional connections that predict both ADHD diagnosis and IGT performance, establishing the neural bases for the diagnosticity of the IGT and a potential means of identifying ADHD subtypes on the basis of behavioral test performance. “) based on the comparison of the level of connectivity ([Page 4, “Functional Data Processing” section] “We applied here the data processing pipeline used in a recent application of a multilayer machine learning classifier to functional connectivity”), reduction in the level of connectivity ([Page 3, Left Column, Paragraph 4] “Though the DMN is a task-negative network, task-positive activity is associated with increased functional connectivity relating the dorsolateral prefrontal cortex to the DMN”, “Because DMN activity normally decreases during tasks, Konrad and Eickhoff (2010) suggest that failure to inhibit DMN activity may be a neural signature of ADHD.”), and the variation in the level of connectivity between the regions of the brain of the user (Fig 1) to the level of connectivity of a healthy control group of users ([Page 2, All of “Neural Processing Dynamics as an Indicator of ADHD”], including “Within healthy controls, GLMA studies show the network of brain regions that are recruited by the task appears to dynamically change as the task progresses, and the task history changes participant’s expectations. When comparing ADHD to healthy controls…”)
McNorgan teaches a prior art concerning brain connectivity EEG testing devices and protocols for ADHD studies upon which the claimed invention (determining a probability of ADHD diagnosis based on brain connectivity metrics from a behavioral test) can be seen as an “improvement.” McNorgan’s prior art comparable device (brain connectivity EEG test devices and protocols for ADHD studies) teaches a particular strategy for using brain conductivity analysis results from behavioral tests within a machine learning classifier to identify ADHD subtypes. McNorgan teaches a motivation to combine Machida’s disclosure with McNorgan’s teaching with [Abstract] “We hypothesized that a machine-learning classifier may use task-based functional connectivity to compute a joint probability function that identifies connectivity signatures that accurately predict ADHD diagnosis and performance on a clinically-relevant behavioral task, providing an explicit neural mechanism linking behavioral phenotype to diagnosis.” A person having ordinary skill in the art before the effective filing date of the invention would recognize that using the behavioral test EEG and brain connectivity analysis in a probability function classifier would give be useful for more accurately diagnosing ADHD.
Thus, the manner of enhancing a particular device (brain connectivity EEG test devices and protocols for ADHD studies was made part of the ordinary capabilities of one skilled in the art based upon the teaching improvement in McNorgan. Accordingly, one of ordinary skill in the art would have been capable of applying this known “improvement” technique in the same manner to the prior art brain connectivity EEG ADHD test device of Machida, and the results would have been predictable to one of ordinary skill in the art. Namely, one skilled in the art would have readily recognized that the EEG test data from the behavioral test (Machida’s EEG data from the “SART” testing and McNorgan’s brain connectivity data from “behavioral task”) could be analyzed using a machine-learning classifier with a joint probability function to diagnose ADHD.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the EEG data from the “SART” testing in the brain connectivity EEG test device for ADHD studies disclosed in Machida and the “machine-learning classifier with a joint probability function” analysis taught by McNorgan, creating a single testing system and method with capability to diagnose ADHD. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious.
Response to Arguments
Applicant's arguments filed 21 NOVEMBER 2025 have been fully considered but they are not persuasive.
Regarding the 35 U.S.C. 112 Rejections:
Applicant has amended claims 1, 5, 8, and 19 and requests withdrawal of the 35 US.C. 112 rejections as a results. However, there remains a previously-applied 35 U.S.C. Rejection regarding the limitation "the level of connectivity of a healthy control group of users" to claims 6, 7, 8, 17, 18, 19, and 20 without a corresponding amendment to overcome the rejection. The argument is not persuasive.
Regarding the 35 U.S.C. 101 Rejections:
Applicant argues at [Page 14, “A. The claims do not recite an abstract idea under Prong One” Section] – [Page 15, Paragraph 3] that the office does not identify what the abstract ideas of Claim 1 are. The abstract ideas of Claim 1 are underlined in the 35 U.S.C. 101 analysis above, including “retrieving a plurality of signals from the plurality of brain regions for each of the one or more stimuli…are captured” and ”evaluating the plurality of signals to detect ADHD for the user…within the attention network.” The retrieving abstract idea is broadly the act of a researcher obtaining a read-out of a dataset, such as downloading an electronic file or obtaining a print-out binder. The evaluating limitation could merely be observing the plurality of signals output from the sensor, that are gathered with the purpose “to detect ADHD for the user”. The argument is not persuasive.
Applicant argues at [Page 15, Paragraph 4] – [Page 17, Paragraph 6] that the claimed features, when considered as a whole, cannot be practically performed mentally or with a pen and paper, and when considered as a whole, such as “retrieving a plurality of signals from the plurality of brain regions” of a user, “monitoring electrical activity…using a plurality of sensors”, “determining first signal data from the user based on a sensor…a first task and a second task”, and “determining a first plurality of time series based on the first signal data…corresponds to a respective source position inside a cranial cavity of the user”. As described above, “retrieving a plurality of signals” is broadly the act of a researcher obtaining a read-out of a dataset, such as downloading an electronic file or obtaining a print-out binder, and “monitoring electrical activity…using a plurality of sensors” is similarly an act that a researcher performs by observing the electronic file or sensor output over time on a screen or a print out. “Determining a first signal data…” is broadly the researcher looking at the signal data output and choosing a section, such as peaks. “Determining a first plurality of time series based on a sensor” can be performed by applying a textbook mathematical equation to said electronic file or print-out, with the aid of time, equations, and paper (or a mathematical software package used in a usual way as a tool, such as MATLAB®). The argument is not persuasive.
Applicant argues at [Page 17, Paragraph 6] – [Page 18, Top] that the claimed features are analogous to Ex Parte Subham Ghosh, Appeal No 2024-001820, at 2 (P.T.A.B. 2025) in that a human mind cannot generate electrical signals from the tissue of a patient. As recited “retrieve…signals” encompasses obtaining a save file with the information in it, such as “retrieving” a thumb drive or a binder with a print-off of the signal outputs from the sensor. The measurement itself of the signals is extra-solution activity, serving as data gathering for the subsequent steps. As recited, the limitation is a literal gathering of the pre-solution electrical signal data. The claims recite a series of limitations that encompass an abstract idea of manipulating variables obtained from electronic components used in a usual way, and that variable manipulation can be accomplished with the aid of time, equations, and paper. The argument is not persuasive.
Applicant argues at [Page 18, “B. The claims integrate the alleged abstract idea into a practical application under Prong Two.” Section”] – [Page 19, Top] that the claims integrate the abstract ideas into a practical application by improving the technical field of detecting ADHD for a user by “retrieving…”, and “evaluating…” As discussed above, the “retrieving…” limitation is an abstract idea that is broadly the act of a researcher obtaining a read-out of a dataset, such as downloading an electronic file or obtaining a print-out binder. The “evaluating…” limitation could merely be observing the plurality of signals output from the sensor, that are gathered with the purpose “to detect ADHD for the user”. There is nothing particularly-recited that links the abstract ideas to a particular machine or practical application. From MPEP 2106.05(a): It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). The argument is not persuasive.
Applicant argues at [Page 19, 1st Full Paragraph] – [Page 20, Top] that the specification and claims reflects claimed improvements to the evaluation and detection of ADHD to improve the treatment or prophylaxis of ADHD, citing Ex Parte Sang Do Shin, Appeal No. 2025-00877 at 4-5 (P.T.A.B. 2025). There is no positively-recited treatment of ADHD recited in the claims. From MPEP § 2106.04(d)(2): If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the “treatment or prophylaxis” consideration. For example, a step of “prescribing a topical steroid to a patient with eczema” is not a positive limitation because it does not require that the steroid actually be used by or on the patient. The argument is not persuasive.
Applicant argues at [Page 20, “A. The claims, as a whole, recite significantly more” section] – [Page 21, 1st Full Paragraph] that the claims recite a specific, discrete way of detecting ADHD for a user via measures of connectivity, citing BASCOM Global Internet Serv., Inc. v. AT&T Mobility LLC. The claims of BASCOM Global Internet Serv., Inc. v. AT&T Mobility LLC recite filtering schemes, filtering elements, and filtering schemes, and “exclusive lists” regarding allowing network access requests that improve the functioning of a computer itself. There is nothing particularly recited in the instant claims that improves the functioning of a computer itself. The “evaluating…” limitation could merely be observing the plurality of signals output from the sensor, that are gathered with the purpose “to detect ADHD for the user”. There is nothing particularly-recited that links the abstract ideas to a particular machine or practical application. The argument is not persuasive.
Applicant summarily argues at [Page 21, 2nd Full Paragraph] that the rejection of Claims 1 – 9 and 11 - 23 should be withdrawn because the independent claims are allowable. Based on the 35 U.S.C 101 analysis herein and the discussion of arguments above, Claims 1 – 9 and 11 - 23 do not qualify as eligible subject matter under 35 U.S.C. 101. The argument is not persuasive.
Regarding the 35 U.S.C. 102 Rejections:
Applicant argues at [Page 21, bottom] – [Page 22, Paragraph 1] that Machida only teaches a single condition as displaying a response or not, but does not contemplate a first condition together with a second condition related to the information presented for the first condition. As cited in the 35 U.S.C. 102 rejection above, Machida discloses a first condition: [Page 4, “Materials Section”, All of Paragraph 1], “The participants were asked to respond when the response cue appeared on screen”, “a series of digits (1–9)” The category of text or graphic is a numeric digit that is present/shown, as opposed to no number present. The participants were not supposed to respond when the response cue was not on the screen, “to limit impulsive response styles shown by children and some people with high ADHD symptoms”. The second condition is an exception to the first condition [Page 4, “Materials Section”, All of Paragraph 1], “Participants were asked to respond to every digit except “3.”. (Examiner notes that not responding to 3 is the exception to responding during the “response cue” time after a number has been shown, where the feature of the text of graphic is that it looks like a 3. The argument is not persuasive.
Applicant summarily argues at [Page 22, Paragraph 2] that the dependent claims 1 – 4 and independent claims 21 – 22 are allowable based on their dependence on Claim 1. Based on the 35 U.S.C. 102 rejection and the discussion of arguments above, Machida discloses the elements of Claim 1. The argument is not persuasive.
Applicant argues at [Page 22, Paragraph 3] – [Page 23, top] that Zeman does not disclose the newly-amended elements of Claim 23. Based on the newly-added limitations to Claim 23, the 35 U.S.C. 102 rejection for Claim 23 is withdrawn, and Zemon is combined with Vaurio in a 35 U.S.C. 103 rejection.
Regarding the 35 U.S.C. 103 Rejections:
Applicant argues at [Page 23, “VII. Rejection Under 35 U.S.C. 103” Section] that Machida examines associations between symptom levels and behavioral measures to determine group-level correlations for the study population, but does not disclose or suggest detecting ADHD for a user, as recited in Claim 1; Applicant further argues that Coelli, Michelini, Kowalczyk, and Vaurio alone or in combination fail to cure such deficiencies in Machida. Machida teaches at [Page 4, 1st Full Paragraph] that “For each participant, for the Fixed and Random SARTs separately, each dependent variable was computed following these steps…” The resulting data of the groups of adolescents and children is made up of analysis results of the individual “users” of the device. The argument is not persuasive.
Conclusion
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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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791