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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: reactivity device in claim 1, 10, and 17.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim limitation “reactivity device” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. While the instant application provides some general description of the reactivity device in paragraphs 0052-0055 and Fig. 1B, no actual structure of the device is disclosed. Instead, the specification merely provides additional functions of the device while the drawings merely show a box diagram where the device interacts with other elements of the system Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Utilizing the two step process adopted by the Supreme Court (Alice Corp vs CLS Bank Int'l, US
Supreme Court, 110 USPQ2d 1976 (2014) and the recent 101 guideline Federal Register Vol. 84, No., Jan
2019)), determination of the subject matter eligibility under the 35 U.S.C. 101 is as follows: Specifically, the Step 1 requires claim belongs to one of the four statutory categories (process, machine, manufacture, or composition of matter). If Step 1 is satisfied, then in the first part of Step 2A (Prong One), identification of any judicial recognized exceptions in the claim is made. If any limitation in the claim is identified as judicial recognized exception, then in the second part of Step 2A (Prong Two), determination is made whether the identified judicial exception is being integrated into practical application. If the identified judicial exception is not integrated into a practical application, then in Step 2B, the claim is further evaluated to see if the additional elements, individually and in combination provide "inventive concept" that would amount to significantly more than the judicial exception. If the element and combination of elements do not amount to significantly more than the judicial recognized exception itself, then the claim is ineligible under the 35 U.S.C. 101.
Claims 1-20 are rejected under 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. The claim recite(s) "forming the reactivity profile by, via the at least one processor of the reactivity system, temporally aligning the received stimulus data with the predetermined sequence, the aligning including defining segments of the received stimulus data based on temporal positions of the plurality of reactivity outputs in the predetermined sequence". This judicial exception is not integrated into a practical application and the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 1 satisfies Step 1, namely the claim is directed to one of the four statutory classes, process. Following Step 2A Prong one, any judicial exceptions are identified in the claims. In claim 1, the limitations "forming the reactivity profile by, via the at least one processor of the reactivity system, temporally aligning the received stimulus data with the predetermined sequence, the aligning including defining segments of the received stimulus data based on temporal positions of the plurality of reactivity outputs in the predetermined sequence" are abstract ideas as they are directed to a mental process as the human mind is capable of observing received data and making mental judgments to define segments of data based on temporal positions in order to align data from different data sets. With the identification of an abstract idea, the next phase is to proceed Step 2A, Prong Two, wherewith additional elements and taken as a whole, evaluation occurs of whether the identified abstract idea is integrated into a practical application.
In Step 2A, Prong Two, the claim does not recite any additional elements or evidence that amounts to significantly more than the judicial exception. Besides the abstract idea, the claim recites the additional elements “causing, via at least one processor of a reactivity system, a reactivity device to generate a plurality of reactivity outputs according to a predetermined sequence, the plurality of reactivity outputs respectively associated with different stimulus modalities; in parallel with the predetermined sequence, receiving, via the at least one processor of the reactivity system, stimulus data that includes electroencephalogram (EEG) data captured by sensors applied to the patient”. However, these components may be seen as the use of well-understood, routine, or conventional elements to perform a non-mental process in order to gather data for the mental process step, much like the example given in MPEP 2106.04(d)(2)(c), such that these limitations are extra-solution activity and thus do not integrate the judicial exception into a practical application. The steps lead to the final limitation of “forming the reactivity profile” such that the end result of use of the system is only the generic formed profile which may include any generic output, or no output at all. As this formation is not defined as requiring any further action, such as a form of prophylaxis or treatment or an improvement to a computer or other technology, the claim limitations constitute mere generation of data, in this case the measurement of EEG data in response to reactivity outputs, such that the claim does not integrate the judicial exception into any practical application. Regarding “via the at least one processor”, the limitation amounts to nothing more than an instruction to apply the abstract idea using a generic computer, which does not render an abstract idea eligible. The step of forming the profile as performed by the processor is, as claimed, capable of being performed in the human mind similar to the examples given in MPEP 2106.04(a)(2)(III)(A)-(C), wherein it is described that “a claim to ‘collecting information, analyzing it, and displaying certain results of the collection and analysis’ where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind” recites a mental process and that claims which merely use a computer as a tool to perform a mental process are not eligible when “there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper” such as “mental processes of parsing and comparing data” when the steps are recited at a high level of generality and a computer is used merely as a tool to perform the processes. Under the broadest reasonable interpretation, the claim elements are recited with a high level of generality (as written, each claimed step of the process may be performed by a person in an undefined manner including observing a stimulus output signal and a received EEG signal and noting the times that a stimulus is provided on the EEG signal data) that there are no meaningful limitations to the abstract idea. Consequently, with the identified abstract idea not being integrated into a practical application, the next step is Step 2B, evaluating whether the additional elements provide "inventive concept" that would amount to significantly more than the abstract idea.
In Step 2B, claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The limitation of “causing, via at least one processor of a reactivity system, a reactivity device to generate a plurality of reactivity outputs according to a predetermined sequence, the plurality of reactivity outputs respectively associated with different stimulus modalities; in parallel with the predetermined sequence, receiving, via the at least one processor of the reactivity system, stimulus data that includes electroencephalogram (EEG) data captured by sensors applied to the patient” constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic memory, processor, and EEG sensors, which Viertio-Oja (US 20070179399 A1) describes as well-understood, routine, or conventional in its description of a generic computer components to be used in an EEG reactivity monitoring system (Paragraph 0068-0070, 0072, 0075) and EEG monitoring as well-stablished for assessing brain activity (Paragraph 0004-0014). See also Coleman (US 20150248470 A1) which similarly discloses the additional elements as being well-understood, routine, or conventional elements of a computer-based system for monitoring EEG. As discussed above with respect to integration of the abstract idea into a practical application, the present elements amount to no more than mere indications to apply the exception.
In Summary, claim 1 recites abstract idea without being integrated into a practical application, and does not provide additional elements that would amount to significantly more. As such, taken as a whole, the claim and is ineligible under the 35 U.S.C. 101.
Claims 10 and 17 are rejected under 35 U.S.C. 101 for similar reasons.
Claims 2-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. As each of these claims depends from claim 1, which was rejected under 35 U.S.C. 101 in paragraph 10 of this action, these claims must be evaluated on whether they sufficiently add to the practical application of claim 1, or comprise significantly more than the limitations of claim 1.
Besides the abstract idea of claim 1: claims 2-6 and 8-9 recite limitations which constitute the use of well-understood, routine, or conventional elements to perform a non-mental process in order to gather data for the mental process step or merely output the result of the mental process step, much like the example given in MPEP 2106.04(d)(2)(c), such that these limitations are extra-solution activity and thus do not integrate the judicial exception into a practical application, wherein the various limitations relating to the types of stimuli provided and the storing of a profile may be seen as, respectively, steps performed to gather data for the mental process step and steps which merely output the result of the mental process step. It is additionally noted that claims 2 and 9 recite additional elements which are well-understood, routine, or conventional for the performance of these extra-solution activities and are thus not indicative of integration into a practical application. The claim limitations constitutes adding a display and network, which Viertio-Oja (US 20070179399 A1) describes as well-understood, routine, or conventional in its description of a generic computer components to be used in an EEG reactivity monitoring system (Paragraph 0051, 0068-0070, 0072, 0075, 0077). See also Coleman (US 20150248470 A1) which similarly discloses the additional elements as being well-understood, routine, or conventional elements of a computer-based system for monitoring EEG.; claims 6-7 recite additional limitations which constitute abstract ideas as they relate to concepts which may be performed in the human mind, wherein temporally aligning data and defining segments of data may be done in the mind by making observations and judgments.
The claim element of claim 1 of a computer system is recited with a high level of generality (as written, the actions of the processing circuitry may be carried out by a person alone or with a generic computer in any undefined manner). This limitation provides no practical application, nor does it provide meaningful limitations to the abstract idea.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 7, 10-14, 16-18 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Viertio-Oja (US 20070179399 A1).
Regarding claim 1, Viertio-Oja teaches a computer-implemented method for generating a reactivity profile of a patient (Fig. 1, 4a-4b—method; Fig. 5 shows computer implementation; paragraph 0020—method for measuring the physiological signal reactivity), the method comprising:
causing, via at least one processor of a reactivity system, a reactivity device (Paragraph 0071-- The monitoring device may further be provided with one or more stimulator units 58, 58' for giving the stimuli; stimulating system 58, 58’) to generate a plurality of reactivity outputs according to a predetermined sequence (Paragraph 0036, 0071-0073-- The computer or control unit 53 controls the stimulator unit… the stimulus/stimuli is/are produced intentionally to assess the EEG reactivity…), the plurality of reactivity outputs respectively associated with different stimulus modalities (Paragraph 0071-- The system may comprise one unit 58 for generating stimuli sensed through the sensory nervous system and another unit 58' for generating electromagnetic stimulus pulses; paragraph 0036-- The stimulus signal may assume any suitable form and may thus be an electrical, a mechanical, an electromagnetic, or an auditory stimulus, for example. Moreover, the stimulus is preferably predetermined in the sense that the system knows the parameters defining the stimulus.; Paragraph 0053-0056-- the determination of the EEG reactivity is combined with another GCS-type scoring system, which the user may perform with the assistance of the monitoring device of the invention. The said another scoring system may be any other observational scoring system in which the user, such as an ICU doctor or nurse, examines the external responses of the patient. In this example, the observational scoring system utilizes the following four types of stimuli: a vocal stimulus, a noisy stimulus, a TOF stimulus, and a tetanic stimulus…);
in parallel with the predetermined sequence, receiving, via the at least one processor of the reactivity system, stimulus data (Paragraph 0036-0037, 0051, 0055-0056-- When the EEG signal is stable enough, a stimulus is given (step 14)…A time label indicating the time instant of the stimulus is attached to the EEG signal data to indicate the moment of the stimulus in the data sequence… response caused by the stimulus in the EEG signal is then detected) that includes electroencephalogram (EEG) data captured by sensors applied to the patient (Paragraph 0068-- The EEG signal data obtained from electrodes applied to the forehead of a patient 100);
forming the reactivity profile by, via the at least one processor of the reactivity system, (Paragraph 0043-0045, 0058, 0061, 0071—indicator of the reactivity…) temporally aligning the received stimulus data with the predetermined sequence, the aligning including defining segments of the received stimulus data based on temporal positions of the plurality of reactivity outputs in the predetermined sequence (Paragraph 0017-0021, 0036, 0039, 0046-0050-- EEG signal data obtained from a patient is aligned temporally with a stimulus that stimulates the patient).
Regarding claim 2, Viertio-Oja teaches the computer-implemented method of claim 1. Viertio-Oja additionally teaches causing, via the at least one processor of the reactivity system, a display of the reactivity system (Paragraph 0070; monitor 54); to output the reactivity profile on a user interface, wherein the user interface includes a plurality of interactive elements (paragraph 0056, 0072--the monitoring device… prompts the user to input the score for the observational scoring system (step 417); Paragraph 0070-- The reactivity indicator, its trend, and the above-described user notifications may be displayed on the screen of a monitor 54, which forms part of the user interface of the device; paragraph 0077-- the user may give the stimulus signal manually, using a horn, for example, and indicate the moment of the stimulus signal through the user interface of the module. The user may, for example, press a certain button simultaneously when he/she gives the stimulus signal. The EEG reactivity module may further comprise a display of its own for displaying the reactivity indicators to the user).
Regarding claim 3, Viertio-Oja teaches the computer-implemented method of claim 2. Viertio-Oja additionally teaches further comprising: causing, via the at least one processor of the reactivity system, the display of the reactivity system to output a previously formed reactivity profile in conjunction with the reactivity profile (Paragraph 0051-- it may assess the EEG reactivity repeatedly by applying at least one stimulus at regular intervals, e.g. every 30 minutes. In this way, the EEG reactivity may be monitored continually. The monitoring device may then keep track of the trend of the EEG reactivity and display it graphically; Paragraph 0070-- The reactivity indicator, its trend, and the above-described user notifications may be displayed on the screen of a monitor 54, which forms part of the user interface of the device; paragraph 0077-- The EEG reactivity module may further comprise a display of its own for displaying the reactivity indicators to the user; It is noted that the “trend” of the reactivity indicator would necessarily include previously formed reactivity indicators).
Regarding claim 4, Viertio-Oja teaches the computer-implemented method of claim 1. Viertio-Oja additionally teaches wherein the different stimulus modalities include at least two of: at least one visual modality, at least one auditory modality, and at least one somatosensory modality (Paragraph 0071-- The system may comprise one unit 58 for generating stimuli sensed through the sensory nervous system and another unit 58' for generating electromagnetic stimulus pulses; paragraph 0036-- The stimulus signal may assume any suitable form and may thus be an electrical, a mechanical, an electromagnetic, or an auditory stimulus, for example. Moreover, the stimulus is preferably predetermined in the sense that the system knows the parameters defining the stimulus.; Paragraph 0053-0056-- the determination of the EEG reactivity is combined with another GCS-type scoring system, which the user may perform with the assistance of the monitoring device of the invention. The said another scoring system may be any other observational scoring system in which the user, such as an ICU doctor or nurse, examines the external responses of the patient. In this example, the observational scoring system utilizes the following four types of stimuli: a vocal stimulus, a noisy stimulus, a TOF stimulus, and a tetanic stimulus…).
Regarding claim 5, Viertio-Oja teaches the computer-implemented method of claim 1. Viertio-Oja additionally teaches wherein each of the plurality of reactivity outputs respectively includes:
at least one washout period with a length based on a predetermined post-stimulus settling period (Paragraph 0037-0042-- M consecutive time windows after the stimulus…); and
at least one stimulus period with a stimulus length based on a predetermined physiological stimulus period, the at least one stimulus period preceding the at least one washout period (Paragraph 0018-- A time reference that indicates the position of the stimulus in time domain may thus indicate a time instant, a time interval, or several distinct time instants. The value sets determined thus have defined positions with respect to the time reference in time domain; paragraph 0036-0042-- the stimulus is preferably predetermined in the sense that the system knows the parameters defining the stimulus. A time label indicating the time instant of the stimulus is attached to the EEG signal data to indicate the moment of the stimulus in the data sequence).
Regarding claim 7, Viertio-Oja teaches the computer-implemented method of claim 1. Viertio-Oja additionally teaches wherein the defining segments of the received stimulus data includes defining start times and end times for stimuli associated with the plurality of reactivity outputs (Paragraph 0018-- A time reference that indicates the position of the stimulus in time domain may thus indicate a time instant, a time interval, or several distinct time instants. The value sets determined thus have defined positions with respect to the time reference in time domain; paragraph 0036-0042-- the stimulus is preferably predetermined in the sense that the system knows the parameters defining the stimulus. A time label indicating the time instant of the stimulus is attached to the EEG signal data to indicate the moment of the stimulus in the data sequence).
Regarding claim 10, Viertio-Oja teaches a computer system for generating a reactivity profile of a patient (Fig. 5), the computer system comprising:
a reactivity device operable to generate a reactivity output (Paragraph 0071—The monitoring device may further be provided with one or more stimulator units 58, 58' for giving the stimuli; stimulating system 58, 58’);
a plurality of sensors configured to be applied to the patient (Paragraph 0068-- The EEG signal data obtained from electrodes applied to the forehead of a patient 100);
at least one memory storing processor-readable instructions (Paragraph 0069-- The computer unit is provided with a memory or database 56 holding the digitized signal data obtained from the electrodes. The memory or database may also store one of the EEG reactivity algorithms 57 described above in FIGS. 1 to 4b); and
at least one processor (Control unit 53) operatively connected to the reactivity device, the plurality of sensors, and the at least one memory, the at least one processor configured to execute the processor-readable instructions to perform a plurality of operations (Paragraph 0069-0072-- control unit executes the stored algorithm, whereby a measure of the EEG reactivity is obtained as disclosed in connection with FIGS. 1 to 4b. Various data needed by the algorithm, such as the reactivity values that correspond to the stimuli, may be pre-stored in the memory or the algorithm may calculate such data; Fig. 5), including:
causing the reactivity device to generate a plurality of reactivity outputs according to a predetermined sequence (Paragraph 0036, 0071-0073-- The computer or control unit 53 controls the stimulator unit… the stimulus/stimuli is/are produced intentionally to assess the EEG reactivity…), the plurality of reactivity outputs respectively associated with different stimulus modalities (Paragraph 0071-- The system may comprise one unit 58 for generating stimuli sensed through the sensory nervous system and another unit 58' for generating electromagnetic stimulus pulses; paragraph 0036-- The stimulus signal may assume any suitable form and may thus be an electrical, a mechanical, an electromagnetic, or an auditory stimulus, for example. Moreover, the stimulus is preferably predetermined in the sense that the system knows the parameters defining the stimulus.; Paragraph 0053-0056-- the determination of the EEG reactivity is combined with another GCS-type scoring system, which the user may perform with the assistance of the monitoring device of the invention. The said another scoring system may be any other observational scoring system in which the user, such as an ICU doctor or nurse, examines the external responses of the patient. In this example, the observational scoring system utilizes the following four types of stimuli: a vocal stimulus, a noisy stimulus, a TOF stimulus, and a tetanic stimulus…);
in parallel with the predetermined sequence, receiving, via the reactivity device, stimulus data that includes electroencephalogram (EEG) data captured by the plurality of sensors (Paragraph 0036-0037, 0051, 0055-0056-- When the EEG signal is stable enough, a stimulus is given (step 14)…A time label indicating the time instant of the stimulus is attached to the EEG signal data to indicate the moment of the stimulus in the data sequence… response caused by the stimulus in the EEG signal is then detected); and
forming the reactivity profile (Paragraph 0043-0045, 0058, 0061, 0071—indicator of the reactivity…) by temporally aligning the received stimulus data with the predetermined sequence, the aligning including defining segments of the received stimulus data based on temporal positions of the plurality of reactivity outputs in the predetermined sequence (Paragraph 0017-0021, 0036, 0039, 0046-0050-- EEG signal data obtained from a patient is aligned temporally with a stimulus that stimulates the patient).
Regarding claim 11, Viertio-Oja teaches the computer system of claim 10. Viertio-Oja additionally teaches a display (Paragraph 0070; monitor 54); wherein the plurality of operations further include causing the display to output the reactivity profile on a user interface, wherein the user interface includes a plurality of interactive elements (paragraph 0056, 0072--the monitoring device… prompts the user to input the score for the observational scoring system (step 417); Paragraph 0070-- The reactivity indicator, its trend, and the above-described user notifications may be displayed on the screen of a monitor 54, which forms part of the user interface of the device; paragraph 0077-- the user may give the stimulus signal manually, using a horn, for example, and indicate the moment of the stimulus signal through the user interface of the module. The user may, for example, press a certain button simultaneously when he/she gives the stimulus signal. The EEG reactivity module may further comprise a display of its own for displaying the reactivity indicators to the user).
Regarding claim 12, Viertio-Oja teaches the computer system of claim 11. Viertio-Oja additionally teaches wherein the plurality of operations further include: causing, via the reactivity system, the display of the reactivity system to output a previously formed reactivity profile in conjunction with the reactivity profile (Paragraph 0051-- it may assess the EEG reactivity repeatedly by applying at least one stimulus at regular intervals, e.g. every 30 minutes. In this way, the EEG reactivity may be monitored continually. The monitoring device may then keep track of the trend of the EEG reactivity and display it graphically; Paragraph 0070-- The reactivity indicator, its trend, and the above-described user notifications may be displayed on the screen of a monitor 54, which forms part of the user interface of the device; paragraph 0077-- The EEG reactivity module may further comprise a display of its own for displaying the reactivity indicators to the user; It is noted that the “trend” of the reactivity indicator would necessarily include previously formed reactivity indicators).
Regarding claim 13, Viertio-Oja teaches the computer system of claim 10. Viertio-Oja additionally teaches wherein the different stimulus modalities include at least two of: at least one visual modality, at least one auditory modality, and at least one somatosensory modality (Paragraph 0071-- The system may comprise one unit 58 for generating stimuli sensed through the sensory nervous system and another unit 58' for generating electromagnetic stimulus pulses; paragraph 0036-- The stimulus signal may assume any suitable form and may thus be an electrical, a mechanical, an electromagnetic, or an auditory stimulus, for example. Moreover, the stimulus is preferably predetermined in the sense that the system knows the parameters defining the stimulus.; Paragraph 0053-0056-- the determination of the EEG reactivity is combined with another GCS-type scoring system, which the user may perform with the assistance of the monitoring device of the invention. The said another scoring system may be any other observational scoring system in which the user, such as an ICU doctor or nurse, examines the external responses of the patient. In this example, the observational scoring system utilizes the following four types of stimuli: a vocal stimulus, a noisy stimulus, a TOF stimulus, and a tetanic stimulus…).
Regarding claim 14, Viertio-Oja teaches the computer system of claim 10. Viertio-Oja additionally teaches wherein each of the plurality of reactivity outputs respectively includes:
at least one washout period with a length based on a predetermined post-stimulus settling period (Paragraph 0037-0042-- M consecutive time windows after the stimulus…); and
at least one stimulus period with a stimulus length based on a predetermined physiological stimulus period, the at least one stimulus period preceding the at least one washout period (Paragraph 0018-- A time reference that indicates the position of the stimulus in time domain may thus indicate a time instant, a time interval, or several distinct time instants. The value sets determined thus have defined positions with respect to the time reference in time domain; paragraph 0036-0042-- the stimulus is preferably predetermined in the sense that the system knows the parameters defining the stimulus. A time label indicating the time instant of the stimulus is attached to the EEG signal data to indicate the moment of the stimulus in the data sequence).
Regarding claim 16, Viertio-Oja teaches the computer system of claim 10. Viertio-Oja additionally teaches wherein the defining segments of the received stimulus data includes defining start times and end times for stimuli associated with the plurality of reactivity outputs (Paragraph 0018-- A time reference that indicates the position of the stimulus in time domain may thus indicate a time instant, a time interval, or several distinct time instants. The value sets determined thus have defined positions with respect to the time reference in time domain; paragraph 0036-0042-- the stimulus is preferably predetermined in the sense that the system knows the parameters defining the stimulus. A time label indicating the time instant of the stimulus is attached to the EEG signal data to indicate the moment of the stimulus in the data sequence).
Regarding claim 17, Viertio-Oja teaches a non-transitory computer-readable medium comprising instructions that are executable by a processor to perform operations for generating a reactivity profile of a patient (Fig. 1, 4a-4b—method; Fig. 5 shows computer implementation; paragraph 0020, 0023, 0069—method for measuring the physiological signal reactivity… a computer program product by means of which known patient monitoring devices may be upgraded and thus their applicability extended to include the assessment of physiological signal reactivity…memory or database may also store one of the EEG reactivity algorithms 57 described above in FIGS. 1 to 4b), the operations including:
causing, via at least one processor of a reactivity system, a reactivity device (Paragraph 0071-- The monitoring device may further be provided with one or more stimulator units 58, 58' for giving the stimuli; stimulating system 58, 58’) to generate a plurality of reactivity outputs according to a predetermined sequence (Paragraph 0036, 0071-0073-- The computer or control unit 53 controls the stimulator unit… the stimulus/stimuli is/are produced intentionally to assess the EEG reactivity…), the plurality of reactivity outputs respectively associated with different stimulus modalities (Paragraph 0071-- The system may comprise one unit 58 for generating stimuli sensed through the sensory nervous system and another unit 58' for generating electromagnetic stimulus pulses; paragraph 0036-- The stimulus signal may assume any suitable form and may thus be an electrical, a mechanical, an electromagnetic, or an auditory stimulus, for example. Moreover, the stimulus is preferably predetermined in the sense that the system knows the parameters defining the stimulus.; Paragraph 0053-0056-- the determination of the EEG reactivity is combined with another GCS-type scoring system, which the user may perform with the assistance of the monitoring device of the invention. The said another scoring system may be any other observational scoring system in which the user, such as an ICU doctor or nurse, examines the external responses of the patient. In this example, the observational scoring system utilizes the following four types of stimuli: a vocal stimulus, a noisy stimulus, a TOF stimulus, and a tetanic stimulus…);
in parallel with the predetermined sequence, receiving, via the at least one processor of the reactivity system, stimulus data (Paragraph 0036-0037, 0051, 0055-0056-- When the EEG signal is stable enough, a stimulus is given (step 14)…A time label indicating the time instant of the stimulus is attached to the EEG signal data to indicate the moment of the stimulus in the data sequence… response caused by the stimulus in the EEG signal is then detected) that includes electroencephalogram (EEG) data captured by sensors applied to the patient (Paragraph 0068-- The EEG signal data obtained from electrodes applied to the forehead of a patient 100);
forming the reactivity profile by, via the at least one processor of the reactivity system, (Paragraph 0043-0045, 0058, 0061, 0071—indicator of the reactivity…) temporally aligning the received stimulus data with the predetermined sequence, the aligning including defining segments of the received stimulus data based on temporal positions of the plurality of reactivity outputs in the predetermined sequence (Paragraph 0017-0021, 0036, 0039, 0046-0050-- EEG signal data obtained from a patient is aligned temporally with a stimulus that stimulates the patient).
Regarding claim 18, Viertio-Oja teaches the non-transitory computer-readable medium of claim 17. Viertio-Oja additionally teaches wherein the defining segments of the received stimulus data includes defining start times and end times for stimuli associated with the plurality of reactivity outputs (Paragraph 0018-- A time reference that indicates the position of the stimulus in time domain may thus indicate a time instant, a time interval, or several distinct time instants. The value sets determined thus have defined positions with respect to the time reference in time domain; paragraph 0036-0042-- the stimulus is preferably predetermined in the sense that the system knows the parameters defining the stimulus. A time label indicating the time instant of the stimulus is attached to the EEG signal data to indicate the moment of the stimulus in the data sequence).
Claim(s) 1, 4-8, 10, and 13-19 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Coleman (US 20150248470 A1).
Regarding claim 1, Coleman discloses a computer-implemented method for generating a reactivity profile of a patient (paragraph 0081-0082-- methods and systems for providing a cognitive and/or sensory assessment of a subject, e.g., including at least one of the following exemplary profile categories: cognitive performance profile, a sensory performance profile, a cognitive and sensory performance profile, and/or a state of awareness profile), the method comprising:
causing, via at least one processor of a reactivity system (System 100), a reactivity device (Stimulus presentation computer 110 and specific stimulus presentation structure 111) to generate a plurality of reactivity outputs according to a predetermined sequence (paragraph 0068-0069, 0081-- system 100 includes a stimulus presentation module 110 to configure a specific stimulus presentation structure 111 to effectuate a presentation of a stimulus or a sequence of stimuli to a subject 121. In some examples, the stimulus presentation module 110 is embodied in a computing device, e.g., including a processor and memory unit…eliciting and extracting various brain ERPs (e.g., N400 and P300) measured by EEG recordings using visual stimuli and auditory stimuli...; paragraph 0094-0097--FIG. 2 shows a diagram of an exemplary sequence of presented visual stimuli. This diagram portrays images of specific presented exemplars and the pre-programmed pseudo-randomized order of presentation), the plurality of reactivity outputs respectively associated with different stimulus modalities (paragraph 0068-0069, 0081--the stimuli can include any stimulus type, including a visual, auditory, olfactory, tactile, or gustatory stimulating medium. The specific stimulus presentation structure 111 can be configured to include, but is not limited to, a particular type or types of stimuli, the duration of presentation of the stimuli, an inter-stimuli interval, a number of repetitions (if any) of each presentation, magnitude and/or frequency parameters associated with type of stimuli (e.g., intensity of sound or brightness or contrast level of light), a digital marker associated with the presentation of each stimuli, and a label or category of the stimuli (e.g., target or non-target));
in parallel with the predetermined sequence, receiving, via the at least one processor of the reactivity system, stimulus data that includes electroencephalogram (EEG) data captured by sensors applied to the patient (paragraph 0070, 0081, 0097--The system 100 includes a physiological and/or behavioral data acquisition module 130 to acquire physiological signals and/or behavioral signals of the subject 121 before, during, and/or after the presentation of the stimuli or sequence of stimuli via the stimulus delivery module 120. For example, the physiological and/or behavioral data acquisition module 130 can include, but is not limited to, an electroencephalography (EEG) system...; EEG recording 130); and
forming the reactivity profile by, via the at least one processor of the reactivity system (analysis pre-processing module 140 which feeds into Profile generator 150; paragraph 0071-0076, 0081-- the profile generation module 150 processes the physiological and/or behavioral data to generate an information set 152 that includes one or more quantitative values that are associated with the selected profile category, e.g., such as a knowledge evaluation or state of awareness profile. For example, the information set 152 provides more than a measure of psychological and neurophysiological natural events. For example, the profile can provide an individual (or group) assessment of one's (or group's) level of knowledge of specific issues (e.g., determination of a given person knowledge about a specific topic, event, learned skill or even preference) and/or state of conscious (or unconscious) awareness) temporally aligning the received stimulus data with the predetermined sequence, the aligning including defining segments of the received stimulus data based on temporal positions of the plurality of reactivity outputs in the predetermined sequence (paragraph 0058, 0071-0076, 0095-- method 170 can include a process 171 to identify a time interval associated with the physiological signals and/or behavioral signal data based upon the presented stimuli and the selected profile category. For example, a time interval can include contiguous, discontinuous, continuous, discrete, or single time points. The method 170 can include a process 172 to group the data (e.g., physiological and/or behavioral) corresponding to the time interval into one or more grouped data sets…; Figs. 2-3 show that the stimuli timing may be aligned with the EEG signal timing).
Regarding claim 4, Coleman discloses the computer-implemented method of claim 1. Coleman additionally discloses wherein the different stimulus modalities include at least two of: at least one visual modality, at least one auditory modality, and at least one somatosensory modality (paragraph 0068-0069, 0081--the stimuli can include any stimulus type, including a visual, auditory, olfactory, tactile, or gustatory stimulating medium. The specific stimulus presentation structure 111 can be configured to include, but is not limited to, a particular type or types of stimuli, the duration of presentation of the stimuli, an inter-stimuli interval, a number of repetitions (if any) of each presentation, magnitude and/or frequency parameters associated with type of stimuli (e.g., intensity of sound or brightness or contrast level of light), a digital marker associated with the presentation of each stimuli, and a label or category of the stimuli (e.g., target or non-target); paragraph 0085--the disclosed methods can be applied to elicit and extract the N400 ERP (e.g., with auditory stimulation, visual stimulation, both, or other stimuli mediums, Including, but not limited to olfactory, tactile, or gustatory) and be used to subsequently infer cognitive relevant information.).
Regarding claim 5, Coleman discloses the computer-implemented method of claim 1. Coleman additionally discloses wherein each of the plurality of reactivity outputs respectively includes: at least one washout period with a length based on a predetermined post-stimulus settling period (paragraph 0068, 0095-- specific stimulus presentation structure 111 can be configured to include, but is not limited to, a particular type or types of stimuli, the duration of presentation of the stimuli, an inter-stimuli interval…For example, the first was sent to the EEG recording computer to mark the stimulus onset relative to the ongoing neurophysiological recording. For example, the second was sent to the ISCAN eye-tracking computer (e.g., ISCAN ETL-200) to mark the stimulus onset…short pause was used to ensure that the stimulation from the onset of the fixation dot would not interfere with the stimulation from the subsequent image exemplar…; paragraph 0181--After the presentation of each word within a string, an inter-stimulus interval (ISI) of 1000 ms was given. Between each string, an inter-trial interval (ITI) of 2500 ms was given to create an obvious break between each string presentation. For example, after every six to nine strings, a blue square was presented for 2000 ms, which indicated a "mini break" in which the subject could briefly pause, rest, scratch their nose, etc.); and at least one stimulus period with a stimulus length based on a predetermined physiological stimulus period, the at least one stimulus period preceding the at least one washout period (paragraph 0068, 0095, 0181-- specific stimulus presentation structure 111 can be configured to include, but is not limited to, a particular type or types of stimuli, the duration of presentation of the stimuli, an inter-stimuli interval…For example, the second was sent to the ISCAN eye-tracking computer (e.g., ISCAN ETL-200) to mark the stimulus onset, its entire duration, and its offset relative to the eye-tracking recording…).
Regarding claim 6, Coleman discloses the computer-implemented method of claim 1. Coleman additionally discloses comprising: in parallel with the predetermined sequence, receiving, via the at least one processor of the reactivity system, sensor data from at least one sensor configured to capture one or more of a biological property or a physiological property of the patient different than the EEG data (paragraph 0011, 0070, 0179-- the physiological and/or behavioral data acquisition module 130 can include, but is not limited to, an electroencephalography (EEG) system, an electrocardiography (ECG) system, an electromyography (EMG) system, an electrochemical sensing system, and an eye tracking system, among others; paragraph 0095--To mark each stimulus onset, two triggers were sent from the presentation computer running the exemplary stimulus presentation paradigm via parallel port. For example, the first was sent to the EEG recording computer to mark the stimulus onset relative to the ongoing neurophysiological recording. For example, the second was sent to the ISCAN eye-tracking computer (e.g., ISCAN ETL- 200) to mark the stimulus onset, its entire duration, and its offset relative to the eye-tracking recording.);
temporally aligning the received sensor data with the predetermined sequence, the aligning including defining segments of the received sensor data based on temporal positions of the plurality of reactivity outputs in the predetermined sequence (paragraph 0071-0076, 0095---- method 170 can include a process 171 to identify a time interval associated with the physiological signals and/or behavioral signal data based upon the presented stimuli and the selected profile category. For example, a time interval can include contiguous, discontinuous, continuous, discrete, or single time points. The method 170 can include a process 172 to group the data (e.g., physiological and/or behavioral) corresponding to the time interval into one or more grouped data sets…; Figs. 2-3 show that the stimuli timing may be aligned with the physiological signal timing).
Regarding claim 7, Coleman discloses the computer-implemented method of claim 1. Coleman additionally discloses wherein the defining segments of the received stimulus data includes defining start times and end times for stimuli associated with the plurality of reactivity outputs (paragraph 0058, 0071-0076, 0095---- method 170 can include a process 171 to identify a time interval associated with the physiological signals and/or behavioral signal data based upon the presented stimuli and the selected profile category. For example, a time interval can include contiguous, discontinuous, continuous, discrete, or single time points. The method 170 can include a process 172 to group the data (e.g., physiological and/or behavioral) corresponding to the time interval into one or more grouped data sets…; Figs. 2-3).
Regarding claim 8, Coleman discloses the computer-implemented method of claim 1. Coleman additionally teaches further comprising: storing the reactivity profile in a library of reactivity profiles, wherein the library of reactivity profiles includes one or more of an intra-patient library or an inter-patient library (Paragraph 0064, 0066, 0074--the system can be implemented to provide the cognitive and/or sensory profile including previously acquired physiological and/or behavioral data from the subject, or other subjects (e.g., group data); Fig. 1A—profiles generated by the profile generator continue to be used in the method as they are stored in the cloud).
Regarding claim 10, Coleman discloses a computer system for generating a reactivity profile of a patient (paragraph 0081-0082-- methods and systems for providing a cognitive and/or sensory assessment of a subject, e.g., including at least one of the following exemplary profile categories: cognitive performance profile, a sensory performance profile, a cognitive and sensory performance profile, and/or a state of awareness profile), the system comprising:
a reactivity device operable to generate a reactivity output (Stimulus presentation computer 110 and specific stimulus presentation structure 111)
a plurality of sensors configured to be applied to the patient (EEG recording 130);
at least one memory storing processor-readable instructions; and at least one processor operatively connected to the reactivity device, the plurality of sensors, and the at least one memory, the at least one processor configured to execute the processor-readable instructions to perform a plurality of operations (System 100), including:
causing the reactivity device (Stimulus presentation computer 110 and specific stimulus presentation structure 111) to generate a plurality of reactivity outputs according to a predetermined sequence (paragraph 0068-0069, 0081-- system 100 includes a stimulus presentation module 110 to configure a specific stimulus presentation structure 111 to effectuate a presentation of a stimulus or a sequence of stimuli to a subject 121. In some examples, the stimulus presentation module 110 is embodied in a computing device, e.g., including a processor and memory unit…eliciting and extracting various brain ERPs (e.g., N400 and P300) measured by EEG recordings using visual stimuli and auditory stimuli...; paragraph 0094-0097--FIG. 2 shows a diagram of an exemplary sequence of presented visual stimuli. This diagram portrays images of specific presented exemplars and the pre-programmed pseudo-randomized order of presentation), the plurality of reactivity outputs respectively associated with different stimulus modalities (paragraph 0068-0069, 0081--the stimuli can include any stimulus type, including a visual, auditory, olfactory, tactile, or gustatory stimulating medium. The specific stimulus presentation structure 111 can be configured to include, but is not limited to, a particular type or types of stimuli, the duration of presentation of the stimuli, an inter-stimuli interval, a number of repetitions (if any) of each presentation, magnitude and/or frequency parameters associated with type of stimuli (e.g., intensity of sound or brightness or contrast level of light), a digital marker associated with the presentation of each stimuli, and a label or category of the stimuli (e.g., target or non-target));
in parallel with the predetermined sequence, receiving, via the at least one processor of the reactivity system, stimulus data that includes electroencephalogram (EEG) data captured by sensors applied to the patient (paragraph 0070, 0081, 0097--The system 100 includes a physiological and/or behavioral data acquisition module 130 to acquire physiological signals and/or behavioral signals of the subject 121 before, during, and/or after the presentation of the stimuli or sequence of stimuli via the stimulus delivery module 120. For example, the physiological and/or behavioral data acquisition module 130 can include, but is not limited to, an electroencephalography (EEG) system...; EEG recording 130); and
forming the reactivity profile by, via the at least one processor of the reactivity system (analysis pre-processing module 140 which feeds into Profile generator 150; paragraph 0071-0076, 0081-- the profile generation module 150 processes the physiological and/or behavioral data to generate an information set 152 that includes one or more quantitative values that are associated with the selected profile category, e.g., such as a knowledge evaluation or state of awareness profile. For example, the information set 152 provides more than a measure of psychological and neurophysiological natural events. For example, the profile can provide an individual (or group) assessment of one's (or group's) level of knowledge of specific issues (e.g., determination of a given person knowledge about a specific topic, event, learned skill or even preference) and/or state of conscious (or unconscious) awareness) temporally aligning the received stimulus data with the predetermined sequence, the aligning including defining segments of the received stimulus data based on temporal positions of the plurality of reactivity outputs in the predetermined sequence (paragraph 0058, 0071-0076, 0095-- method 170 can include a process 171 to identify a time interval associated with the physiological signals and/or behavioral signal data based upon the presented stimuli and the selected profile category. For example, a time interval can include contiguous, discontinuous, continuous, discrete, or single time points. The method 170 can include a process 172 to group the data (e.g., physiological and/or behavioral) corresponding to the time interval into one or more grouped data sets…; Figs. 2-3 show that the stimuli timing may be aligned with the EEG signal timing).
Regarding claim 13, Coleman discloses the computer system of claim 10. Coleman additionally discloses wherein the different stimulus modalities include at least two of: at least one visual modality, at least one auditory modality, and at least one somatosensory modality (paragraph 0068-0069, 0081--the stimuli can include any stimulus type, including a visual, auditory, olfactory, tactile, or gustatory stimulating medium. The specific stimulus presentation structure 111 can be configured to include, but is not limited to, a particular type or types of stimuli, the duration of presentation of the stimuli, an inter-stimuli interval, a number of repetitions (if any) of each presentation, magnitude and/or frequency parameters associated with type of stimuli (e.g., intensity of sound or brightness or contrast level of light), a digital marker associated with the presentation of each stimuli, and a label or category of the stimuli (e.g., target or non-target); paragraph 0085--the disclosed methods can be applied to elicit and extract the N400 ERP (e.g., with auditory stimulation, visual stimulation, both, or other stimuli mediums, Including, but not limited to olfactory, tactile, or gustatory) and be used to subsequently infer cognitive relevant information.).
Regarding claim 14, Coleman discloses the computer system of claim 10. Coleman additionally discloses wherein each of the plurality of reactivity outputs respectively includes: at least one washout period with a length based on a predetermined post-stimulus settling period (paragraph 0068, 0095-- specific stimulus presentation structure 111 can be configured to include, but is not limited to, a particular type or types of stimuli, the duration of presentation of the stimuli, an inter-stimuli interval…For example, the first was sent to the EEG recording computer to mark the stimulus onset relative to the ongoing neurophysiological recording. For example, the second was sent to the ISCAN eye-tracking computer (e.g., ISCAN ETL-200) to mark the stimulus onset…short pause was used to ensure that the stimulation from the onset of the fixation dot would not interfere with the stimulation from the subsequent image exemplar…; paragraph 0181--After the presentation of each word within a string, an inter-stimulus interval (ISI) of 1000 ms was given. Between each string, an inter-trial interval (ITI) of 2500 ms was given to create an obvious break between each string presentation. For example, after every six to nine strings, a blue square was presented for 2000 ms, which indicated a "mini break" in which the subject could briefly pause, rest, scratch their nose, etc.); and at least one stimulus period with a stimulus length based on a predetermined physiological stimulus period, the at least one stimulus period preceding the at least one washout period (paragraph 0068, 0095, 0181-- specific stimulus presentation structure 111 can be configured to include, but is not limited to, a particular type or types of stimuli, the duration of presentation of the stimuli, an inter-stimuli interval…For example, the second was sent to the ISCAN eye-tracking computer (e.g., ISCAN ETL-200) to mark the stimulus onset, its entire duration, and its offset relative to the eye-tracking recording…).
Regarding claim 15, Coleman discloses the computer system of claim 10. Coleman additionally discloses comprising: in parallel with the predetermined sequence, receiving, via the at least one processor of the reactivity system, sensor data from at least one sensor configured to capture one or more of a biological property or a physiological property of the patient different than the EEG data (paragraph 0011, 0070, 0179-- the physiological and/or behavioral data acquisition module 130 can include, but is not limited to, an electroencephalography (EEG) system, an electrocardiography (ECG) system, an electromyography (EMG) system, an electrochemical sensing system, and an eye tracking system, among others; paragraph 0095--To mark each stimulus onset, two triggers were sent from the presentation computer running the exemplary stimulus presentation paradigm via parallel port. For example, the first was sent to the EEG recording computer to mark the stimulus onset relative to the ongoing neurophysiological recording. For example, the second was sent to the ISCAN eye-tracking computer (e.g., ISCAN ETL- 200) to mark the stimulus onset, its entire duration, and its offset relative to the eye-tracking recording.);
temporally aligning the received sensor data with the predetermined sequence, the aligning including defining segments of the received sensor data based on temporal positions of the plurality of reactivity outputs in the predetermined sequence (paragraph 0071-0076, 0095---- method 170 can include a process 171 to identify a time interval associated with the physiological signals and/or behavioral signal data based upon the presented stimuli and the selected profile category. For example, a time interval can include contiguous, discontinuous, continuous, discrete, or single time points. The method 170 can include a process 172 to group the data (e.g., physiological and/or behavioral) corresponding to the time interval into one or more grouped data sets…; Figs. 2-3 show that the stimuli timing may be aligned with the physiological signal timing).
Regarding claim 16, Coleman discloses the computer system of claim 10. Coleman additionally discloses wherein the defining segments of the received stimulus data includes defining start times and end times for stimuli associated with the plurality of reactivity outputs (paragraph 0058, 0071-0076, 0095---- method 170 can include a process 171 to identify a time interval associated with the physiological signals and/or behavioral signal data based upon the presented stimuli and the selected profile category. For example, a time interval can include contiguous, discontinuous, continuous, discrete, or single time points. The method 170 can include a process 172 to group the data (e.g., physiological and/or behavioral) corresponding to the time interval into one or more grouped data sets…; Figs. 2-3).
Regarding claim 17, Coleman discloses a non-transitory computer-readable medium comprising instructions that are executable by a processor to perform operations for generating a reactivity profile of a patient (paragraph 0081-0082, 0304-- methods and systems for providing a cognitive and/or sensory assessment of a subject, e.g., including at least one of the following exemplary profile categories: cognitive performance profile, a sensory performance profile, a cognitive and sensory performance profile, and/or a state of awareness profile… Implementations of the subject matter described in this specification can be implemented as one or more computer program products, i.e., one or more modules of computer program instructions encoded on a tangible and non-transitory computer readable medium for execution by, or to control the operation of, data processing apparatus), the operations including:
causing, via at least one processor of a reactivity system (System 100), a reactivity device (Stimulus presentation computer 110 and specific stimulus presentation structure 111) to generate a plurality of reactivity outputs according to a predetermined sequence (paragraph 0068-0069, 0081-- system 100 includes a stimulus presentation module 110 to configure a specific stimulus presentation structure 111 to effectuate a presentation of a stimulus or a sequence of stimuli to a subject 121. In some examples, the stimulus presentation module 110 is embodied in a computing device, e.g., including a processor and memory unit…eliciting and extracting various brain ERPs (e.g., N400 and P300) measured by EEG recordings using visual stimuli and auditory stimuli...; paragraph 0094-0097--FIG. 2 shows a diagram of an exemplary sequence of presented visual stimuli. This diagram portrays images of specific presented exemplars and the pre-programmed pseudo-randomized order of presentation), the plurality of reactivity outputs respectively associated with different stimulus modalities (paragraph 0068-0069, 0081--the stimuli can include any stimulus type, including a visual, auditory, olfactory, tactile, or gustatory stimulating medium. The specific stimulus presentation structure 111 can be configured to include, but is not limited to, a particular type or types of stimuli, the duration of presentation of the stimuli, an inter-stimuli interval, a number of repetitions (if any) of each presentation, magnitude and/or frequency parameters associated with type of stimuli (e.g., intensity of sound or brightness or contrast level of light), a digital marker associated with the presentation of each stimuli, and a label or category of the stimuli (e.g., target or non-target));
in parallel with the predetermined sequence, receiving, via the at least one processor of the reactivity system, stimulus data that includes electroencephalogram (EEG) data captured by sensors applied to the patient (paragraph 0070, 0081, 0097--The system 100 includes a physiological and/or behavioral data acquisition module 130 to acquire physiological signals and/or behavioral signals of the subject 121 before, during, and/or after the presentation of the stimuli or sequence of stimuli via the stimulus delivery module 120. For example, the physiological and/or behavioral data acquisition module 130 can include, but is not limited to, an electroencephalography (EEG) system...; EEG recording 130); and
forming the reactivity profile by, via the at least one processor of the reactivity system (analysis pre-processing module 140 which feeds into Profile generator 150; paragraph 0071-0076, 0081-- the profile generation module 150 processes the physiological and/or behavioral data to generate an information set 152 that includes one or more quantitative values that are associated with the selected profile category, e.g., such as a knowledge evaluation or state of awareness profile. For example, the information set 152 provides more than a measure of psychological and neurophysiological natural events. For example, the profile can provide an individual (or group) assessment of one's (or group's) level of knowledge of specific issues (e.g., determination of a given person knowledge about a specific topic, event, learned skill or even preference) and/or state of conscious (or unconscious) awareness) temporally aligning the received stimulus data with the predetermined sequence, the aligning including defining segments of the received stimulus data based on temporal positions of the plurality of reactivity outputs in the predetermined sequence (paragraph 0058, 0071-0076, 0095-- method 170 can include a process 171 to identify a time interval associated with the physiological signals and/or behavioral signal data based upon the presented stimuli and the selected profile category. For example, a time interval can include contiguous, discontinuous, continuous, discrete, or single time points. The method 170 can include a process 172 to group the data (e.g., physiological and/or behavioral) corresponding to the time interval into one or more grouped data sets…; Figs. 2-3 show that the stimuli timing may be aligned with the EEG signal timing).
Regarding claim 18, Coleman discloses the non-transitory computer-readable medium of claim 17. Coleman additionally discloses wherein the defining segments of the received stimulus data includes defining start times and end times for stimuli associated with the plurality of reactivity outputs (paragraph 0058, 0071-0076, 0095---- method 170 can include a process 171 to identify a time interval associated with the physiological signals and/or behavioral signal data based upon the presented stimuli and the selected profile category. For example, a time interval can include contiguous, discontinuous, continuous, discrete, or single time points. The method 170 can include a process 172 to group the data (e.g., physiological and/or behavioral) corresponding to the time interval into one or more grouped data sets…; Figs. 2-3).
Regarding claim 19, Coleman discloses the non-transitory computer-readable medium of claim 17. Coleman additionally teaches further comprising: storing the reactivity profile in a library of reactivity profiles, wherein the library of reactivity profiles includes one or more of an intra-patient library or an inter-patient library (Paragraph 0064, 0066, 0074--the system can be implemented to provide the cognitive and/or sensory profile including previously acquired physiological and/or behavioral data from the subject, or other subjects (e.g., group data); Fig. 1A—profiles generated by the profile generator continue to be used in the method as they are stored in the cloud).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2-3 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coleman in view of Dennison (US 20140316230 A1).
Regarding claim 2, Coleman discloses the computer-implemented method of claim 1. Coleman generally discloses transmitting and providing the profile to a remote computer device (Paragraph 0014) and demonstrates that graphical representations based on the reactivity outputs and stimulus data may be created and displayed to allow for monitoring of a user’s profile (See Figs. 3-14, 22; paragraph 0108-0109, 0195-0196, 0219). However, Coleman does not explicitly disclose further comprising: causing, via the at least one processor of the reactivity system, a display of the reactivity system to output the reactivity profile on a user interface, wherein the user interface includes a plurality of interactive elements.
Dennison, in the same field of endeavor of EEG-based brain activity monitoring devices, discloses causing, via the at least one processor of the reactivity system, a display of the reactivity system to output the reactivity profile on a user interface, wherein the user interface includes a plurality of interactive elements (paragraph 0069--These EEG waveform-dependent results will be reported to users in the form of visual elements such as graphs that show progress in specific areas over time, which will be displayed on a dashboard-type User Interface (UI). Areas of interest can be selected by users for inclusion on the dashboard, to avoid displaying unnecessary information (e.g. only epileptics would be interested in seizure data); fig. 13).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method, as disclosed by Coleman, to include the interactive display as disclosed by Dennison in order to predictably improve the method by allowing a healthcare provider to easily observe the profile of a user to be used in making healthcare decisions (See Dennison paragraph 0069, fig. 13 and Coleman, paragraph 0219).
Regarding claim 3, the combination of Coleman and Dennison discloses the computer-implemented method of claim 2. Coleman generally discloses transmitting and providing the profile to a remote computer device (Paragraph 0014) and demonstrates that graphical representations based on the reactivity outputs and stimulus data may be created and displayed to allow for monitoring of a user’s profile (See Figs. 3-14, 22; paragraph 0108-0109, 0195-0196, 0219). However, Coleman does not explicitly disclose further comprising: causing, via the at least one processor of the reactivity system, the display of the reactivity system to output a previously formed reactivity profile in conjunction with the reactivity profile.
Dennison additionally discloses comprising: causing, via the at least one processor of the reactivity system, the display of the reactivity system to output a previously formed reactivity profile in conjunction with the reactivity profile (paragraph 0066--the system can be implemented to provide the cognitive and/or sensory profile including previously acquired physiological and/or behavioral data from the subject, or other subjects (e.g., group data); paragraph 0167-0171--first screenshot 1310 depicts a user menu screen allowing them to begin meditating, view their progress via historical data, view their achievements fourth screenshot 1340 depicts a meditation screen for a user during a meditation session wherein the time remaining and their mental state progress are depicted; fifth screenshot 1350 depicts a meditation screen for a user showing their meditation history indicating time meditating, total time, progress in last meditation session, and their maximum sustained meditation period, see fig. 13).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method, as disclosed by Coleman, to include the multiple profiles obtained at different times as disclosed by Dennison in order to predictably improve the method by allowing a healthcare provider to easily observe changes in the profile of a user over time to be used in making healthcare decisions (See Dennison paragraph 0069, fig. 13 and Coleman, paragraph 0219).
Regarding claim 11, Coleman discloses the computer system of claim 10. Coleman generally discloses transmitting and providing the profile to a remote computer device (Paragraph 0014) and demonstrates that graphical representations based on the reactivity outputs and stimulus data may be created and displayed to allow for monitoring of a user’s profile (See Figs. 3-14, 22; paragraph 0108-0109, 0195-0196, 0219). However, Coleman does not explicitly disclose a display; wherein the plurality of operations further include causing the display to output the reactivity profile on a user interface, wherein the user interface includes a plurality of interactive elements.
Dennison, in the same field of endeavor of EEG-based brain activity monitoring devices, discloses a display; wherein the plurality of operations further include causing the display to output the reactivity profile on a user interface, wherein the user interface includes a plurality of interactive elements (paragraph 0069--These EEG waveform-dependent results will be reported to users in the form of visual elements such as graphs that show progress in specific areas over time, which will be displayed on a dashboard-type User Interface (UI). Areas of interest can be selected by users for inclusion on the dashboard, to avoid displaying unnecessary information (e.g. only epileptics would be interested in seizure data); fig. 13).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system, as disclosed by Coleman, to include the interactive display as disclosed by Dennison in order to predictably improve the method by allowing a healthcare provider to easily observe the profile of a user to be used in making healthcare decisions (See Dennison paragraph 0069, fig. 13 and Coleman, paragraph 0219).
Regarding claim 12, the combination of Coleman and Dennison discloses the computer system of claim 11. Coleman generally discloses transmitting and providing the profile to a remote computer device (Paragraph 0014) and demonstrates that graphical representations based on the reactivity outputs and stimulus data may be created and displayed to allow for monitoring of a user’s profile (See Figs. 3-14, 22; paragraph 0108-0109, 0195-0196, 0219). However, Coleman does not explicitly disclose wherein the plurality of operations further include: causing, via the reactivity system, the display of the reactivity system to output a previously formed reactivity profile in conjunction with the reactivity profile.
Dennison additionally discloses wherein the plurality of operations further include: causing, via the reactivity system, the display of the reactivity system to output a previously formed reactivity profile in conjunction with the reactivity profile (paragraph 0066--the system can be implemented to provide the cognitive and/or sensory profile including previously acquired physiological and/or behavioral data from the subject, or other subjects (e.g., group data); paragraph 0167-0171--first screenshot 1310 depicts a user menu screen allowing them to begin meditating, view their progress via historical data, view their achievements fourth screenshot 1340 depicts a meditation screen for a user during a meditation session wherein the time remaining and their mental state progress are depicted; fifth screenshot 1350 depicts a meditation screen for a user showing their meditation history indicating time meditating, total time, progress in last meditation session, and their maximum sustained meditation period, see fig. 13).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system, as disclosed by Coleman, to include the multiple profiles obtained at different times as disclosed by Dennison in order to predictably improve the method by allowing a healthcare provider to easily observe changes in the profile of a user over time to be used in making healthcare decisions (See Dennison paragraph 0069, fig. 13 and Coleman, paragraph 0219).
Claim(s) 6, 8, 15, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Viertio-Oja in view of Coleman.
Regarding claim 6, Viertio-Oja teaches the computer-implemented method of claim 1, including generally receiving sensor data in parallel with the predetermined sequence via the reactivity system and temporally aligning the received sensor data with the predetermined sequence, the aligning including defining segments to the received sensor data based on temporal positions of the plurality of reactivity outputs in the predetermined sequence. However, Viertio-Oja fails to teach in parallel with the predetermined sequence, receiving, via the reactivity system, sensor data from at least one sensor configured to capture one or more of a biological property or a physiological property of the patient different than the EEG data; and temporally aligning the received sensor data with the predetermined sequence, the aligning including defining segments to the received sensor data based on temporal positions of the plurality of reactivity outputs in the predetermined sequence.
Coleman, in the same field of endeavor of a system for monitoring EEG reactivity of a user in response to stimuli, discloses the system may include in parallel with the predetermined sequence, receiving, via the reactivity system, sensor data from at least one sensor configured to capture one or more of a biological property or a physiological property of the patient different than the EEG data (paragraph 0011, 0070, 0179-- the physiological and/or behavioral data acquisition module 130 can include, but is not limited to, an electroencephalography (EEG) system, an electrocardiography (ECG) system, an electromyography (EMG) system, an electrochemical sensing system, and an eye tracking system, among others; paragraph 0095--To mark each stimulus onset, two triggers were sent from the presentation computer running the exemplary stimulus presentation paradigm via parallel port. For example, the first was sent to the EEG recording computer to mark the stimulus onset relative to the ongoing neurophysiological recording. For example, the second was sent to the ISCAN eye-tracking computer (e.g., ISCAN ETL- 200) to mark the stimulus onset, its entire duration, and its offset relative to the eye-tracking recording).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the method of Viertio-Oja including the temporal alignment of sensor data and stimuli to include additional sensor data as described by Coleman in order to predictably improve the ability of the system to monitor a user by providing additional indicators of the user status during the monitoring which may additionally provide indications of reactivity (or lack thereof) such as an amount of body or eye movement.
Regarding claim 8, Viertio-Oja teaches the computer-implemented method of claim 1. Viertio-Oja generally teaches a database for storing data (database 56, paragraph 0069) and generally teaches that multiple reactivity profiles may be available to a user (Paragraph 0070-- The reactivity indicator, its trend, and the above-described user notifications may be displayed on the screen of a monitor 54).
However, Viertio-Oja does not explicitly disclose storing the reactivity profile in a library of reactivity profiles, wherein the library of reactivity profiles includes one or more of an intra-patient library or an inter-patient library.
Coleman, in the same field of endeavor of a system for monitoring EEG reactivity of a user in response to stimuli, discloses further comprising: storing the reactivity profile in a library of reactivity profiles, wherein the library of reactivity profiles includes one or more of an intra-patient library or an inter-patient library (Paragraph 0064, 0066, 0074--the system can be implemented to provide the cognitive and/or sensory profile including previously acquired physiological and/or behavioral data from the subject, or other subjects (e.g., group data); Fig. 1A—profiles generated by the profile generator continue to be used in the method as they are stored in the cloud).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the method of Viertio-Oja to include a library of reactivity profiles as described by Coleman in order to predictably improve the system by enabling a healthcare provider to access and compare reactivity profiles over time of a single patient or across a population of patients in order to make healthcare determinations such as monitoring progress or decline of a single patient over time or comparing performance of a patient to other patients having known diagnoses.
Regarding claim 15, Viertio-Oja teaches the computer system of claim 10, including generally receiving sensor data in parallel with the predetermined sequence via the reactivity system and temporally aligning the received sensor data with the predetermined sequence, the aligning including defining segments to the received sensor data based on temporal positions of the plurality of reactivity outputs in the predetermined sequence. However, Viertio-Oja fails to teach in parallel with the predetermined sequence, receiving, via the reactivity system, sensor data from at least one sensor configured to capture one or more of a biological property or a physiological property of the patient different than the EEG data; and temporally aligning the received sensor data with the predetermined sequence, the aligning including defining segments to the received sensor data based on temporal positions of the plurality of reactivity outputs in the predetermined sequence.
Coleman, in the same field of endeavor of a system for monitoring EEG reactivity of a user in response to stimuli, discloses the system may include in parallel with the predetermined sequence, receiving, via the reactivity system, sensor data from at least one sensor configured to capture one or more of a biological property or a physiological property of the patient different than the EEG data (paragraph 0011, 0070, 0179-- the physiological and/or behavioral data acquisition module 130 can include, but is not limited to, an electroencephalography (EEG) system, an electrocardiography (ECG) system, an electromyography (EMG) system, an electrochemical sensing system, and an eye tracking system, among others; paragraph 0095--To mark each stimulus onset, two triggers were sent from the presentation computer running the exemplary stimulus presentation paradigm via parallel port. For example, the first was sent to the EEG recording computer to mark the stimulus onset relative to the ongoing neurophysiological recording. For example, the second was sent to the ISCAN eye-tracking computer (e.g., ISCAN ETL- 200) to mark the stimulus onset, its entire duration, and its offset relative to the eye-tracking recording).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Viertio-Oja including the temporal alignment of sensor data and stimuli to include additional sensor data as described by Coleman in order to predictably improve the ability of the system to monitor a user by providing additional indicators of the user status during the monitoring which may additionally provide indications of reactivity (or lack thereof) such as an amount of body or eye movement.
Regarding claim 19, Viertio-Oja teaches the non-transitory computer-readable medium of claim 17. Viertio-Oja generally teaches a database for storing data (database 56, paragraph 0069) and generally teaches that multiple reactivity profiles may be available to a user (Paragraph 0070-- The reactivity indicator, its trend, and the above-described user notifications may be displayed on the screen of a monitor 54).
However, Viertio-Oja does not explicitly disclose storing the reactivity profile in a library of reactivity profiles, wherein the library of reactivity profiles includes one or more of an intra-patient library or an inter-patient library.
Coleman, in the same field of endeavor of a system for monitoring EEG reactivity of a user in response to stimuli, discloses further comprising: storing the reactivity profile in a library of reactivity profiles, wherein the library of reactivity profiles includes one or more of an intra-patient library or an inter-patient library (Paragraph 0064, 0066, 0074--the system can be implemented to provide the cognitive and/or sensory profile including previously acquired physiological and/or behavioral data from the subject, or other subjects (e.g., group data); Fig. 1A—profiles generated by the profile generator continue to be used in the method as they are stored in the cloud).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the method of Viertio-Oja to include a library of reactivity profiles as described by Coleman in order to predictably improve the system by enabling a healthcare provider to access and compare reactivity profiles over time of a single patient or across a population of patients in order to make healthcare determinations such as monitoring progress or decline of a single patient over time or comparing performance of a patient to other patients having known diagnoses.
Claim(s) 9 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Viertio-Oja in view of Ludving (US 20080082019 A1).
Regarding claim 9, Viertio-Oja teaches the computer-implemented method of claim 8. Viertio-Oja generally teaches a database for storing data (database 56, paragraph 0069) and generally teaches that multiple reactivity profiles may be available to a user and that the system may utilize a network through which the data is distributed (Paragraph 0070-- The reactivity indicator, its trend, and the above-described user notifications may be displayed on the screen of a monitor 54… the processing of the data may also be distributed among different units/processors (servers) within a network).
However, Viertio-Oja fails to explicitly disclose generating, by the reactivity system, a portal configured to provide access to the library of reactivity profiles, wherein the library of reactivity profiles is accessible via at least one network.
Ludving, in analogous art of a system for obtaining EEG data of a user to create a user profile (Paragraph 0017), additionally discloses the computer-implemented method of claim 8, further comprising: generating, by the reactivity system, a portal configured to provide access to the library of reactivity profiles, wherein the library of reactivity profiles is accessible via at least one network (paragraph 0034-0036-- a memory (not shown) storing reference data corresponding to EEG data… The reference data may include previous EEG data recorded from the subject or from a group of subjects… the computing device 15 may store or have access to the reference data… EEG data may be downloaded (e.g., batch, streamed) to the computing device 15 when the processing unit 30 detects the epileptic event or onset thereof. Thus, a nurse, physician or other caregiver may monitor the EEG data to determine the severity of epileptic events, a proper treatment).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method, as disclosed by Viertio-Oja, to include a portal, as disclosed by Ludving in order to predictably improve the method by allowing a provider easily access the reference data to enable comparison and monitoring over time and between a user and other users to determine severity of a condition or progress in treatment (See Ludving- paragraph 0034; paragraph 0036).
Regarding claim 20, Viertio-Oja teaches the non-transitory computer-readable medium of claim 19. Viertio-Oja generally teaches a database for storing data (database 56, paragraph 0069) and generally teaches that multiple reactivity profiles may be available to a user and that the system may utilize a network through which the data is distributed (Paragraph 0070-- The reactivity indicator, its trend, and the above-described user notifications may be displayed on the screen of a monitor 54… the processing of the data may also be distributed among different units/processors (servers) within a network).
However, Viertio-Oja fails to explicitly disclose generating, by the reactivity system, a portal configured to provide access to the library of reactivity profiles, wherein the library of reactivity profiles is accessible via at least one network.
Ludving, in analogous art of a system for obtaining EEG data of a user to create a user profile (Paragraph 0017), additionally discloses the computer-implemented method of claim 8, further comprising: generating, by the reactivity system, a portal configured to provide access to the library of reactivity profiles, wherein the library of reactivity profiles is accessible via at least one network (paragraph 0034-0036-- a memory (not shown) storing reference data corresponding to EEG data… The reference data may include previous EEG data recorded from the subject or from a group of subjects… the computing device 15 may store or have access to the reference data… EEG data may be downloaded (e.g., batch, streamed) to the computing device 15 when the processing unit 30 detects the epileptic event or onset thereof. Thus, a nurse, physician or other caregiver may monitor the EEG data to determine the severity of epileptic events, a proper treatment).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method, as disclosed by Viertio-Oja, to include a portal, as disclosed by Ludving in order to predictably improve the method by allowing a provider easily access the reference data to enable comparison and monitoring over time and between a user and other users to determine severity of a condition or progress in treatment (See Ludving- paragraph 0034; paragraph 0036).
Claim(s) 9 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coleman in view of Ludving (US 20080082019 A1).
Regarding claim 9, Coleman discloses the computer-implemented method of claim 8. However, Coleman fails to explicitly disclose generating, by the reactivity system, a portal configured to provide access to the library of reactivity profiles, wherein the library of reactivity profiles is accessible via at least one network.
Ludving, in analogous art of a system for obtaining EEG data of a user to create a user profile (Paragraph 0017), additionally discloses the computer-implemented method of claim 8, further comprising: generating, by the reactivity system, a portal configured to provide access to the library of reactivity profiles, wherein the library of reactivity profiles is accessible via at least one network (paragraph 0034-0036-- a memory (not shown) storing reference data corresponding to EEG data… The reference data may include previous EEG data recorded from the subject or from a group of subjects… the computing device 15 may store or have access to the reference data… EEG data may be downloaded (e.g., batch, streamed) to the computing device 15 when the processing unit 30 detects the epileptic event or onset thereof. Thus, a nurse, physician or other caregiver may monitor the EEG data to determine the severity of epileptic events, a proper treatment).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method, as disclosed by Coleman, to include the portal, as disclosed by Ludving in order to predictably improve the method by allowing a provider easily access the reference data to enable comparison and monitoring over time and between a user and other users to determine severity of a condition or progress in treatment (See Ludving- paragraph 0034; paragraph 0036).
Regarding claim 20, Coleman discloses the non-transitory computer-readable medium of claim 19. However, Coleman fails to explicitly disclose generating, by the reactivity system, a portal configured to provide access to the library of reactivity profiles, wherein the library of reactivity profiles is accessible via at least one network.
Ludving, in analogous art of a system for obtaining EEG data of a user to create a user profile (Paragraph 0017), additionally discloses the computer-implemented method of claim 8, further comprising: generating, by the reactivity system, a portal configured to provide access to the library of reactivity profiles, wherein the library of reactivity profiles is accessible via at least one network (paragraph 0034-0036-- a memory (not shown) storing reference data corresponding to EEG data… The reference data may include previous EEG data recorded from the subject or from a group of subjects… the computing device 15 may store or have access to the reference data… EEG data may be downloaded (e.g., batch, streamed) to the computing device 15 when the processing unit 30 detects the epileptic event or onset thereof. Thus, a nurse, physician or other caregiver may monitor the EEG data to determine the severity of epileptic events, a proper treatment).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method, as disclosed by Coleman, to include the portal, as disclosed by Ludving in order to predictably improve the method by allowing a provider easily access the reference data to enable comparison and monitoring over time and between a user and other users to determine severity of a condition or progress in treatment (See Ludving- paragraph 0034; paragraph 0036).
Conclusion
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/ANNA ROBERTS/Examiner, Art Unit 3791
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