DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/15/2026 has been entered.
Claims 1-4, and 6-20 are the current claims hereby under examination.
Examiner’s Note: all references to Applicant’s specification are made using the paragraph numbers assigned in the US publication of the present application US 20240008795 A1.
Specification
The amendment filed 09/24/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
Paragraph 0122 of the specification has been amended to recite “In certain embodiments, the one or more signals may be real-time or near real-time streams of data. For the purposes of this disclosure, real-time applications refer to applications like the ongoing monitoring of a patient or the rapid testing of a patient or emergency situations. Such real-time applications are in contrast to discrete tests, where data is collected from a patient and the data is then sent off for analysis, typically by specialists rather than the treating medical staff. Similarly described, the current system and method are efficient enough to allow for point-of-care result delivery. In certain embodiments, the one or more signals may be measured and/or stored for a period of time before processing and/or analysis”
The amended language introduces new matter by stating that the generic real-time acquisition of signals previously set forth in paragraph 0122 is directed towards specific real-time applications of ongoing and rapid patient testing or emergency situations. The amended language further sets forth a particular distinction between real-time applications and discrete tests. Furthermore, the amended language of the specification sets forth that the described system and method are efficient enough to allow for point-of-care result delivery. Each of these items represents new matter by further adding particular functionality to the described system and particularly defining and terms that have otherwise been assigned their plain meaning.
Applicant is required to cancel the new matter in the reply to this Office Action.
Applicant’s reply filed 04/15/2026 indicates that the added language has been cancelled and states that a marked up and clean specification are attached to the reply to be entered but it would seem that no such attachments are present in the reply entered on 04/15/2026. As such, the objection is maintained until the amended specification is provided and entered.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 lines 19-20 it appears that “the ratio“ should read “a ratio”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “the ratio of the spectral density at 3Hz spectral density features to the spectral density features spectral density at 10Hz” but it is unclear if “spectral density features” of the 3 and 10 Hz spectral densities are being used for the ratio or if the ratio to between the spectral densities at 3 and 10 Hz themselves. It is unclear what the spectral density features entail since it would seem the features of the spectral density would be distinct from the spectral density itself. For the purposes of this examination, the limitation is interpreted as the ratio being between the spectral density features as 3Hz and the spectral density features at 10Hz and such features being any features extracted or derived from the respective spectral densities.
Claims 2-8 are rejected by virtue of their dependence on claim 1.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 9, and 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 9, and 17 have been amended to recite “wherein the processor is configured to extract one or more values, identify one or more raw data features, perform spectral density analysis, and output data all in less than 10 minutes”. It would seem such a limitation would require an explicit recitation in the specification that the processing steps are all carried out within a given timeframe. The specification does not appear to describe carrying out the recited processing steps within a given timeframe. In particular, paragraph 0045 recites “For example, as shown generally in FIG. 1, in certain implementations a 2-lead “bispectral electroencephalography” (BSEEG) screening system 1 is employed, which can be performed with a handheld screening device 10 by applying two leads 12A, 12B to the forehead of a patient 30 for less than 10 minutes.” Which appears to indicate that the electrodes are attached for less than 10 minutes rather than indicating that the screening processes including the analysis of the acquired data and output of results in completed within the 10 minute timeframe. Similarly, paragraphs 0074, 0083, and 0087 each contain limitations drawn towards the duration of EEG recording and/or the duration of windows utilized rather than being directed towards the time taken to process the acquired data. Paragraphs 0044 and 0113 of the US publication, corresponding to 044 and 0116 of Applicant’s specification, as referenced by Applicant do not appear to provide sufficient support for the processing steps being carried out within a particular timeframe. In particular, neither paragraph references a timeframe in which the processing is performed but are rather directed towards situations where the claimed device may be useful. As such, the specification is not considered to support the claim limitations drawn towards the processing and output being performed within 10 minutes as recited in claims 1, 9, and 17 and such limitations are considered new matter.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 and 6-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-4 and 6-20 are directed to a method of processing brain signals using a computational algorithm, which is an abstract idea. Claims 1-4 and 6-20 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a machine.
Step 2A — Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] record one or more brain signals
[B1] extract one or more values for recorded 3 Hz waves and recorded 10 Hz waves over a period of time from the one or more brain signals
[C1] identify one or more raw data features from the one or more extracted values
[D1] perform spectral density analysis on the one or more extracted values from the recorded brain signals to determine a spectral density at 3Hz and a spectral density at 10Hz
[E1] output data presenting an indication of the presence, absence, or likelihood of the subsequent development of encephalopathy
[F1] the output above is based on a comparison step of the ratio of the spectral density at 3Hz to the spectral density at 10Hz compared to a threshold ratio value
These elements [A1]-[F1] of claim 1 are drawn to an abstract idea since they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations.
Step 2A — Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] a handheld screening device
[B2] two sensors configured to record one or more brain signals
[C2] a housing
[D2] a processor configured for electronic communication with the two sensors
[E2] wherein the processor is configured to extract one or more values, identify one or more raw data features, perform spectral density analysis, and output data all in less than 10 minutes and without the need for a neurologist
These elements [A2]-[D2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the element [B2] is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the elements [A2], [C2], and [D2] are merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). Additionally, the element [E2] merely adds the words “apply it” (or an equivalent) with the judicial exception.
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “two sensors configured to record one or more brain signals and extract one or more values for recorded 3 Hz waves and recorded 10 Hz waves over a period of time” is merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the data acquirer is nothing more than an EEG sensor for recording brainwaves. Such EEG sensors are conventional as evidenced by:
U.S. Patent No. US 6052619 A (John) discloses that head electrodes are generally used in conventional EEG instruments (Col 3 lines 23-26 of John);
U.S. Patent Application Publication No. US 2016/0143541 A1 (He) discloses that EEG electrodes are conventional (paragraph 0056 of He);
U.S. Patent Application Publication No. US 2010/0168532 A1 (Waziri) discloses that scalp electrodes are conventional for deriving EEG signals (paragraph 0085 of Waziri); and
U.S. Patent Application Publication No. US 2013/0079659 A1 (Akhadov) discloses that scalp electrodes are utilized in conventional EEG monitoring (paragraph 0005 of Akhadov).
Further, the elements [A2] and [C2] do not qualify as significantly more because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
As addressed above these elements taken individually do not amount to significantly more than the abstract idea because they are each well-known, routine, and/or conventional. Furthermore, these elements taken as a whole, that is as a handheld screening device comprising two sensors in electronic communication with a housing containing a processor is also well-known in the art as evidenced by:
US Patent Number US 6052619 A (John) teaches a small preferably handheld device in communication with EEG electrodes. Depending upon the application the system may use between 1 and 16 electrodes which includes the use of two electrodes (Col 3 lines 16-44).
US Patent Number US 5999846 A (Pardey) which teaches a small self-contained portable unit to continually acquire and analyze EEG signals (Col 7 lines 1-5). The device includes EEG sensors which include two electrodes attached to the user’s head and an optional third electrode used as a reference (Col 7 lines 21-37).
US Patent Application Publication Number US 2011/0245702 A1 (Clark) teaches a hand-held EEG sensor probe comprising two sensors for acquiring electrical signals from the scalp (Paragraph 0066).
US Patent Application Publication Number US 2012/0065536 A1 (Causevic) teaches a patient sensor operatively coupled to a handheld base which processes brain electrical signals, wherein the sensor comprises at least on reference and at least one sensing electrode (Paragraph 0008).
US Patent Application Publication Number US 2016/0287125 A1 (Weinberg) teaches a smartphone mobile device in communication with and for processing the output of two EEG electrodes (Paragraph 0040).
It is asserted that the above references establish that a generic handheld device comprising a housing and a processor and in electrical communication with two sensors for detecting brain signals was well-known in the art prior to the effective filing date of the invention.
Finally, the element [E2] is directed towards a particular speed of computation achieved by implementing the abstract idea onto a computer. As per MPEP 2106.05(f): claiming the improved speed or efficiency inherent with applying the abstract idea on a computer does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures | LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). MPEP 2106.05(f)(2). As such elements drawn towards a particular speed of computation achieved by implementing the abstract idea onto a computer are not considered to amount to significantly more than the abstract idea itself.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 2-4 and 6-8 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claim 3: a ground lead;
Claim 4: a display; and
Claim 6: a validation module.
Each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the ground lead is nothing more than a typical EEG sensor being utilized as a ground. Such sensors are conventional as evidenced by John, He, Waziri, and Akhadov (as provided above with respect to the rejection of claim 1).
Also, the limitations from claims 4 and 6 are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions (that is, one of display and processing) that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
The analysis of all subsequent claims is done in light of the analysis of claim 1 and may be abbreviated where limitations are similar.
The analysis of claim 9 is as follows:
Step 1: Claim 9 is drawn to a machine.
Step 2A — Prong One: Claim 9 recites an abstract idea. In particular, claim 9 recites the following limitations:
[A1] record electroencephalogram (EEG) signals
[B1] identify one or more raw data features from the EEG signals
[C1] perform spectral density analysis on the EEG signals to establish a ratio of 3 Hz waves spectral intensity to 10 Hz wave spectral intensity
[D1] output data presenting an indication of the presence, absence, or likelihood of the subsequent development of encephalopathy
[E1] comparison of the ratio to a threshold ratio value
These elements [A1]-[E1] of claim 9 are drawn to an abstract idea since they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations.
Step 2A — Prong Two: Claim 9 recites the following limitations that are beyond the judicial exception:
[A2] a handheld screening device comprising a housing
[B2] two sensors coupled to the handheld screening device and in electronic communication with a processor
[C2] a processor
[D2] wherein the processor is configured to extract one or more values, identify one or more raw data features, perform spectral density analysis, and output data all in less than 10 minutes and without the need for a neurologist
These elements [A2]-[C2] of claim 9 do not integrate the exception into a practical application of the exception. In particular, the element [B2] is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the elements [A2] and [C2] are merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). Additionally, the element [D2] merely adds the words “apply it” (or an equivalent) with the judicial exception
Step 2B: Claim 9 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “two sensors configured to record electroencephalogram (EEG) signals” is merely insignificant extrasolution activity to the judicial
exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the data acquirer is nothing more than an EEG sensor for recording brainwaves. Such EEG sensors are conventional as evidenced by John. He, Waziri, and Akhadov as presented in the above rejection of claim 1.
Further, the elements [A2] and [C2] do not qualify as significantly more because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
As described in the above rejection of claim 1, these components as a whole are not considered to amount to significantly more because such a device is well-known in the art. While not all of the above cited references explicitly state that the electrodes are “coupled to” the housing, a generic, well-known wired connection is considered sufficient to render this limitation as obvious such as is described in Causevic paragraph 0033.
Finally, the element [D2] is directed towards a particular speed of computation achieved by implementing the abstract idea onto a computer. As per MPEP 2106.05(f): claiming the improved speed or efficiency inherent with applying the abstract idea on a computer does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures | LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). MPEP 2106.05(f)(2). As such elements drawn towards a particular speed of computation achieved by implementing the abstract idea onto a computer are not considered to amount to significantly more than the abstract idea itself.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely
provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 10-16 depend from claim 9, and recite the same abstract idea as claim 9. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claim 16: a display;
This limitation from claim 16 is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions (that is, one of display) that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
The analysis of claim 17 is as follows:
Step 1: Claim 17 is drawn to a machine.
Step 2A — Prong One: Claim 17 recites an abstract idea. In particular, claim 17 recites the following limitations:
[A1] record electroencephalogram (EEG) signals
[B1] perform spectral density analysis on the EEG signals
[C1] generate spectral density values for 10 Hz waves gathered over a period of time
[D1] output data presenting an indication of the presence, absence, or likelihood of the subsequent development of encephalopathy
[E1] a comparison of a ratio of the spectral density values of 3 Hz waves to the spectral density values of 10 Hz waves to a threshold ratio value
These elements [A1]-[E1] of claim 9 are drawn to an abstract idea since they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations.
Step 2A — Prong Two: Claim 9 recites the following limitations that are beyond the judicial exception:
[A2] a handheld screening device comprising a housing
[B2] two sensors
[C2] wherein the processor is configured to extract one or more values, identify one or more raw data features, perform spectral density analysis, and output data all in less than 10 minutes and without the need for a neurologist.
These elements [A2]-[B2] of claim 17 do not integrate the exception into a practical application of the exception. In particular, the element [B2] is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the element [A2] is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). Additionally, the element [C2] merely adds the words “apply it” (or an equivalent) with the judicial exception
Step 2B: Claim 17 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “two sensors configured to record electroencephalogram (EEG) signals” is merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the data acquirer is nothing more than an EEG sensor for recording brainwaves. Such EEG sensors are conventional as evidenced by John. He, Waziri, and Akhadov as presented in the above rejection of claim 1.
Further, the element [A2] does not qualify as significantly more because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
As described in the above rejection of claim 1, these components as a whole are not considered to amount to significantly more because such a device is well-known in the art. While not all of the above cited references explicitly state that the electrodes are “coupled to” the housing, a generic, well-known wired connection is considered sufficient to render this limitation as obvious such as is described in Causevic paragraph 0033.
Finally, the element [C2] is directed towards a particular speed of computation achieved by implementing the abstract idea onto a computer. As per MPEP 2106.05(f): claiming the improved speed or efficiency inherent with applying the abstract idea on a computer does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures | LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). MPEP 2106.05(f)(2). As such elements drawn towards a particular speed of computation achieved by implementing the abstract idea onto a computer are not considered to amount to significantly more than the abstract idea itself.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 18-20 depend from claim 17, and recite the same abstract idea as claim 17. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Prior Art
The claims are not presently rejected over the prior art because none of the prior art of record performs spectral density analysis to establish a ratio between 3Hz and 10Hz brainwave signals to determine the presence of encephalopathy.
The closes prior art of record is considered to be:
Rautee US Patent Application Publication Number US 20060009709 A1 hereinafter Rautee which teaches a system and method for the detection of encephalopathy based on EEG signal data obtained from a patient. A first signal component is derived from the EEG signal data, the first signal component representing low frequencies of the EEG signal data. A first parameter indicative of disorder in the first signal component and a second parameter indicative of disorder in EEG signal data representing a first frequency band are then computed, wherein the first frequency band includes higher frequencies than said low frequencies. An indicator of encephalopathy is then determined based on the first parameter and the second parameter (Abstract). Rautee teaches the collection of EEG data from the patient which is then divided into frequency bands for the determination of features therefrom. In particular the Delta band and the Theta band (Paragraphs 0049-0051). Features that represent an amount of disorder or complexity are calculated from these bands. The feature values are then used to determine an indicator of encephalopathy by finding a difference between the features or determining a ratio between the features (Paragraphs 0052-0053 and 0069)
Kooi US Patent Application Publication Number US 20160228028 A1 hereinafter Kooi teaches systems and methods for determining a parameter which is indicative for whether a patient is delirious mor not, or is at risk of becoming delirious or not. The method comprises the steps of: providing electroencephalography (EEG) data comprising recording signals from at least two electrodes located on different locations on the patient's scalp during a predetermined time period, for instance at least 10 seconds, wherein at least one of the signals is recorded from the frontal half on the scalp; processing said EEG data for obtaining a deviation signal from the two recording signals from the electrodes; analyzing said deviation signal in the frequency spectrum for establishing slowing of said deviation signal and defining the parameter as the degree of slowing of said deviation signal which in combination with the locations of the recordings on the patient's scalp is indicative whether said patient is delirious or not, or is at risk of becoming delirious or not (Abstract). Kooi teaches the recording of EEG signals using two recording electrodes on the scalp (Paragraph 0063). The recorded signals are filtered and parameters are extracted therefrom. The parameters include the power of brainwaves in the delta band (Paragraphs 0065-0066).
Neither of Rautee or Kooi nor any other prior art of record determines a parameter based on features of the 3Hz waves and the 10Hz waves. The prior art of record is directed towards using frequency bands which may include the claimed waves but also include additional frequency waves. The prior art of record provides no teaching or motivation to extract features from only a single frequency of the frequency bands being utilized. Thus, the prior art of record is not considered to teach or reasonably suggest the determination of encephalopathy indicator parameters using only a ratio between features of the 3Hz waves and features of the 10Hz waves.
Response to Arguments
Applicant's arguments filed 09/24/2025 have been fully considered but they are not persuasive.
In particular, Applicant’s arguments that the systems of claims 1, 9, and 17 represent an improvement in the technology by allowing fast, automated screening without the need for interpretation by a skilled medical professional. Applicant contends that the claimed invention allows for the deployment of EEG for diagnosis of encephalopathy or delirium in new, flexible situations without the need for a neurologist for interpretation and that the present claims comply with the analysis of Bandai to amount to significantly more than the abstract idea itself.
In particular, the calculation of the recited metrics is not considered to improve the functionality of the device itself. Rather, the device is still merely a tool to carry out the calculations of the abstract idea. The particular calculations or program being run within a given timeframe does not improve the function of the device itself, rather it is merely an operation of the program. The calculations being carried out within the timeframe are also not considered to be a specific improvement in the field because claiming the speed of computation achieved by implementing an abstract idea on a computer does not amount to significantly more than the abstract idea itself as per MPEP 2106.05(f).
Applicant’s arguments that the invention allows for the deployment of EEG for diagnosis of encephalopathy or delirium in new, flexible situations without the need for a neurologist is not considered to an improvement in the art because various systems already exist for detecting encephalopathy and delirium from EEG signals and Applicant’s specification does not provide specific benefits as to the speed and/or accuracy, and evidence thereof, for the diagnosis that would be considered to amount to an improvement in the technology. The present case does not follow the analysis set forth of Bandai as the present invention does not set forth an automated solution to something that could not previously be automated. See for example US 20060009709 A1 paragraphs 0047-0056 which provides an automated system for encephalopathy detection from EEG signals using a threshold value compared to spectral features.
Applicant’s amendments have overcome the previously presented 35 USC 112 rejections but new grounds of rejection have been issued.
Conclusion
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
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