DETAILED ACTION
Applicant' s arguments, filed 09/24/2025 have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 02/24/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-4, and 6-20 are the current claims hereby under examination.
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 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.
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 9-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites “two sensors coupled to and integral with the handheld screening device and in electronic communication with a processor” in lines 4-5 but it is unclear what structural relationship is meant to be conveyed by “coupled to and integral with”. It is unclear if a wired connection is considered integral or if the sensors need to be in a fixed location relative to the housing such that the housing encloses the sensors. For the purposes of this examination, any form of physical connection, such as wires, that allow data communication and establishes a physical link between the sensors and the associated processor will be considered sufficient to anticipate this limitation.
Claims 10-16 are rejected by virtue of their dependance on claim 9.
Claim 17 recites “two sensors directly coupled to and integral with the handheld screening device and in electronic communication with the housing” in lines 4-5 but it is unclear what structural relationship is meant to be conveyed by “coupled to and integral with”. It is unclear if a wired connection is considered integral or if the sensors need to be in a fixed location relative to the housing such that the housing encloses the sensors. It is further unclear what relationship is meant to be conveyed by “electronic communication with the housing” and if the sensors are in electronic communication with the housing or the processor. For the purposes of this examination, any form of physical connection, such as wires, that allow data communication and establishes a physical link between the sensors and the housing and associated processor will be considered sufficient to anticipate this limitation.
Claims 18-20 are rejected by virtue of their dependance on claim 17.
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 that the various processing steps are carried out in real time. The specification paragraph 0122 indicates that, in certain embodiments, the signals may be “real-time signals” but does not explicitly recite that the various analysis steps may be carried out in real-time. In particular, while the specification does describe the claimed analysis of signals, the analysis steps are not described as being carried out in real time and the recitation of paragraph 0122 that the signals may be real-time signals is not considered sufficient to support each of the claimed analysis steps being conducted in real-time. In particular, real-time acquisition of signals does not implicitly disclose the subsequent analysis of those signals also being conducted in real-time.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 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 in real-time
[C1] identify one or more raw data features from the one or more extracted values in real-time
[D1] perform spectral density analysis in real-time 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
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).
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.
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 in real-time
[C1] perform spectral density analysis on the EEG signals in real-time 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 and integral with the handheld screening device and in electronic communication with a processor
[C2] a processor
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).
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.
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 in real-time on the EEG signals
[C1] generate spectral density values for 10 Hz waves gathered over a period of time
[D1] output, in real-time, 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
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).
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.
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.
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 real-time calculation of delirium threshold scores which represents new and substantial uses of EEG technology in the treatment of delirium are not found to be persuasive.
In particular, the calculation of the recited metrics is not considered to improve the functionality of any 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 in real-time does not improve the function of the device itself, rather it is merely an operation of the program. The calculations being carried out in real-time is also not considered to be a specific improvement in the field because real-time analysis is still considered an abstract idea (i.e. a calculation or mental process can be performed in real-time as data is received) and thus cannot amount to significantly more than the abstract idea. Moreover, real-time analysis of EEG signals is known in the art and thus not considered an improvement as evidenced by:
Jordan US Patent Application Publication Number US 2004/0077967 A1: Paragraphs 0036, 0041, and 0062
Ryu US Patent Number US 6021346 A: Col 4 lines 10-26
John US Patent Number US 6052619 A: Claim 1
Furthermore, Applicant’s arguments are directed towards the amended language which is considered to be new matter.
Applicant’s amendments have overcome the previously presented 35 USC 112(b) rejections of claim 1 but not all of the previously presented rejections of claims 9 and 17.
In particular, claim 9 and 17 still recite “two sensors coupled to and integral with the handheld screening device” but it is unclear what sort of relationship is required by the limitation “integral with”. It is unclear if this language is meant to establish a particular type of connection or structural relationship between the sensors and screening device.
Claim 17 further still recites “two sensors … and in electronic communication with the housing” but it is unclear what type of communication this limitation is meant to establish since it would seem the “housing” is not capable of receiving signals from the sensors.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW ERIC OGLES whose telephone number is (571)272-7313. The examiner can normally be reached M-F 8:00AM - 5:30PM.
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791