DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments filed 5/11/2026 with respect to the objections to Claims 1 and 5-15 have been fully considered and are persuasive. The Examiner agrees that Applicant’s amendments have resolved the cited deficiencies. The objections to Claims 1 and 5-15 are withdrawn.
Applicant’s arguments regarding the rejection of Claim 1 under 35 USC 112(b) have been fully considered and are persuasive. The Examiner agrees that the amendments to Claim 1 have resolved the cited indefiniteness issues. The rejection is withdrawn.
Applicant’s arguments with respect to Independent Claim 1 under 35 U.S.C. 103 as being unpatentable over Hartley Caroline Et Al.: “Nociceptive brain activity as a measure of analgesic efficacy in infants,” Science Translational Medicine, Vol. 9, No. 388, 3 May 2017 (2017-05-03), pages 1-24 (“Hartley”) in view of US 2018/0000409 A1 to Jensen et al. (“Jensen”) have been fully considered and are persuasive. Applicant argues that the combination of Hartley and Jensen does not reasonably teach the Claim 1 limitations “combining the EEG scaling factor and the heart rate change to generate a score indicative of a response of the subject to the event” and “wherein combining the EEG scaling factor and the heart rate change comprises using the heart rate change to modulate the EEG scaling factor.” The Examiner agrees. Therefore, the rejection is withdrawn.
Applicant’s arguments highlight the generating score itself, and purport that this difference distinguishes Claim 1 from the combination of Hartley and Jensen. The Examiner does not agree with this line of argument. Applicant states that “…the theoretical possibility of generating a score corresponding to that in claim 1 from measured parameters in the cited prior art does not mean such a score is actually generated in Jensen” (5/11/2026 Remarks at Pg. 11). However, Jensen indeed “actually generates” a score (i.e., Jensen’s “final index”). Further, Jensen teaches deriving such a score by broadly “combining” Hartley’s EEG scaling factor with heart rate change (Claim 11, “…(i) combining the extracted EEG, EMG, ECG, and ICG data into a final index of nociception represented by a scale from 0 to 99…”) based on how the “scaling factor” of Claim 1 is derived. That is, since Jensen teaches that EEG and ECG readings influence its score, and the ECG scaling factor of Claim 1 is derived using EEG readings (i.e., Claim 1 recites “scaling an EEG template to fit event EEG data”), Jensen’s “final index” is such a combination as claimed.
The persuasive distinction lies in the particulars of how the claimed score is derived. Amended Claim 1 elaborates on this via the limitation “wherein combining the EEG scaling factor and the heart rate change comprises using the heart rate change to modulate the EEG scaling factor.” Jensen’s index does not reasonably envision such modulation using heart rate change of the “scaling factor” itself as the term “modulation” is used in the Present Specification. By its definition at Pg. 13, Ln. 24-34 of the Present Specification, the term “modulation” has a specific definition (reproduced below) that neither Jensen nor Hartley disclose. While the term “modulate” as used in Claim 1 is far broader than this specific definition, Jensen’s incorporation of heart rate data into Jensen’s “final index” is flatly inconsistent with any fair reading of the term “modulate” as used in the Present Specification. That is to say, the term “modulate” requires something more than Jensen or the existing art fairly suggest.
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The Examiner notes that while no new art has been applied and the previous rejection withdrawn, the persuasively narrowing limitation stands rejected for various written description issues under 35 USC 112(a) pertaining to its scope. The true scope of the term “modulate” as used in Claim 1 is unable to be discerned. Clearly, its meaning falls somewhere on the spectrum between the definition set forth at Pg. 13, Ln. 24-34 of the Present Specification and something slightly narrower than such broad “combining” as previously recited. By the Examiner’s reading of the limitation as it is currently worded, there is no art whose teachings can be fairly read to fall within this spectrum. That is to say, the term “modulate” requires something more than Jensen or the existing art fairly suggest, but in view of the written description issues under 35 USC 112(a), it is not clear precisely how much more is required.
However, were Claim 1 to be amended such that scope of this spectrum were to be expanded, there may be art that applies.
Applicant’s arguments regarding the art-based rejections if dependent Claims 2-4 are based on Applicant’s arguments regarding Independent Claim 1, and are persuasive for the same reasons. The rejections are withdrawn.
Applicant’s arguments regarding the rejection of Claims 1-4 under 35 USC 101 have been fully considered but are not persuasive. Applicant argues that the Claim 1 limitation “wherein combining the EEG scaling factor and the heart rate change comprises using the heat rate change to modulate the EEG scaling factor” “demonstrate[es] that the present claim 1 is not merely ‘recite a mathematical calculation’ but has a practical application and further demonstrate[es] that these are not steps of the type that people can go through in their minds or by mathematical algorithms, without more” (Remarks at Pg. 10). Accordingly, Applicant concludes that “the claims do not merely recite a mental process because the steps are not practically performed in the human mind and have a practical application.” The Examiner respectfully disagrees.
The Examiner does not allege any Claim 1 element to be a mental process, but instead characterizes several Claim 1 elements as mathematical concepts. Thus, whether these elements can be practically performed in the human mind does not influence whether the claim recites abstract ideas. See MPEP 2106.04(a)(2)(III). As Claim 1 recites mathematical concepts, Claim 1 recites abstract ideas. See MPEP 2106.04(a)(2)(I).
Claim 1 does not recite any additional elements that integrate the recited abstract ideas into a practical application. “Prong Two asks does the claim recite additional elements that integrate the judicial exception into a practical application?” MPEP 2106.04(II)(A)(2). Claim 1 recites as additional elements “acquiring, using an electroencephalography (EEG) monitoring system, EEG data from a subject” and “acquiring, using a heart rate monitoring system, heart rate data from the subject.” Each is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application because it amounts to mere data gathering. As a whole, Claim 1 is directed to a mathematical method for generating a score indicative of a subject’s response to an event based on data.
The limitation “wherein combining the EEG scaling factor and the heart rate change comprises using the heat rate change to modulate the EEG scaling factor” further limits the manner of mathematical operation of “combining…,” but does not change that the combining is a mathematical operation. This position is supported by Pg. 13, Ln. 24-34 of the Present Specification.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “using the heat rate” at Ln. 14, but should recite --using the heart rate--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5-6, 8, and 17-18, and Claims 2-4, 7, and 9-16 by dependency, 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.
Regarding Independent Claim 1, Claim 1 recites “wherein combining the EEG scaling factor and the heart rate change comprises using the heat rate change to modulate the EEG scaling factor.”
The Present Specification does not describe the meaning of the term “modulate” in the context of its use in Claim 1 such that a person of ordinary skill in the art would be apprised of its meaning. Thus, the true scope of the term “modulate” as used in Claim 1 is unable to be discerned. The Present Specification sets forth a very particular, equation-based definition of the term “modulate” at Pg. 13, Ln. 24-34. However, such a narrowly limited reading of the term is unwarranted based on the breadth of its recitation in Claim 1. Clearly, its meaning falls somewhere on the spectrum between the definition set forth at Pg. 13, Ln. 24-34 of the Present Specification and something slightly narrower than such broad “combining” as previously recited by Claim 1 (which broad “combining” has been further limit to include the subject modulating). However, where on that spectrum the “modulating” of Claim 1 falls is not discernable from the Present Specification. The Present Specification thus fails to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed.
The Examiner notes that dependent Claim 10 further limits Claim 1 in a manner consistent with the description of Pg. 13, Ln. 24-34 of the Present Specification. These further limitations support the Examiner’s position that the “modulating” of Claim 1 is broader than that described at Pg. 13, Ln. 24-34 of the Present Specification.
The Examiner further notes that by the Examiner’s reading of the above Claim 1 limitation as it is currently worded, there is no art whose teachings can be fairly read to fall within this spectrum. However, were Claim 1 to be amended such that scope of this spectrum were to be expanded, there may be art that applies.
The term “modulate” claims a broad genus which includes the particular species of modulating described at Pg. 13, Ln. 24-34 of the Present Specification. “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice…, reduction to drawings…, or by disclosure of relevant, identifying characteristics… sufficient to show the inventor was in possession of the claimed genus….” MPEP 2163(II)(A)(ii). The Present Specification describes only a single species: that described at Pg. 13, Ln. 24-34 of the Present Specification. The single, specific species of modulating described at Pg. 13, Ln. 24-34 is not a representative number of adequately described species for the genus “modulate.”1 “If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.” Id. The Present Specification does not support the Claim 1 limitation “wherein combining the EEG scaling factor and the heart rate change comprises using the heat rate change to modulate the EEG scaling factor” because the broad genus “modulate” is not adequately described. A person skilled in the art would not understand from the disclosure the inventor to have invented and been in possession of the invention as broadly claimed.
Regarding Claims 5-6, 8, and 17-18, Claims 5-6, 8, and 17-18 recite a similar limitation to that discussed above with respect to Independent Claim 1, and are rejected for the same reasons.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 5-6, 8, and 17-18, and Claims 2-4, 7, and 9-16 by dependency 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.
Regarding Independent Claim 1, Claim 1 recites “wherein combining the EEG scaling factor and the heart rate change comprises using the heat rate change to modulate the EEG scaling factor.” The scope of the term “modulate” as used in Claim 1 is unable to be discerned, and Claim 1 is therefore indefinite. The Present Specification sets forth a very particular, equation-based definition of the term “modulate” at Pg. 13, Ln. 24-34. However, such a narrowly limited reading of the term is unwarranted based on the breadth of its recitation in Claim 1. Clearly, its meaning falls somewhere on the spectrum between the definition set forth at Pg. 13, Ln. 24-34 of the Present Specification and something slightly narrower than such broad “combining” as previously recited by Claim 1 (which broad “combining” has been further limit to include the subject modulating). However, where on that spectrum the “modulating” of Claim 1 falls is not discernable.
For purposes of this Office Action, the limitation “wherein combining the EEG scaling factor and the heart rate change comprises using the heart rate change to modulate the EEG scaling factor” is being interpreted to mean that the scaling factor is adjusted as a function of change in heart rate.
Regarding Claims 5-6, 8, and 17-18, Claims 5-6, 8, and 17-18 recite a similar limitation to that discussed above with respect to Independent Claim 1 which are being interpreted similarly and are indefinite for the same reasons.
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 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Eligibility Step 1 – The Four Categories of Statutory Subject Matter
Claims 1-14 and 16-18 each fall within one of the four categories of statutory subject matter.
Claim 15 does not fall within one of the four categories of statutory subject matter. Claim 15 recites “A computer programme product….” A “computer programme product” is software per-se, and as such is not directed to any of the statutory categories. See MPEP 2106.03(I) (“Non-limiting examples of claims that are not directed to any of the statutory categories include: Products that do not have a physical or tangible form, such as information (often referred to as “data per se”) or a computer program per se (often referred to as “software per se”)….”).
The Examiner notes that this issue could be resolved by clarifying that the “computer programme product” is stored in a non-transitory computer readable medium, or is somehow otherwise embodied in a physical structure (provided the Specification supports this).
Eligibility Step 2A, Prong One
Claims 1-18 recite abstract ideas:
Regarding Independent Claim 1:
“scaling an EEG template to fit event EEG data, the EEG template scaled at a specified latency following the event to derive an EEG scaling factor” recites a mathematical concept, and more particularly a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2)(I). “A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation.” MPEP 2106.04(a)(2)(I)(C). Determining a rate of change is a mathematical operation, and thus recites a mathematical calculation when afforded its broadest reasonable interpretation in light of the Specification
“determining a heart rate change due to the event using the heart rate data” recites a mathematical concept, and more particularly a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2)(I). “A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation.” MPEP 2106.04(a)(2)(I)(C). Determining heart rate change is a mathematical operation, and thus recites a mathematical calculation when afforded its broadest reasonable interpretation in light of the Specification.
“and combining the EEG scaling factor and the heart rate change to generate a score indicative of a response of the subject to the event” recites a mathematical concept, and more particularly a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2)(I). “A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation.” MPEP 2106.04(a)(2)(I)(C). Such combining to generate a score is a mathematical operation, and thus recites a mathematical calculation when afforded its broadest reasonable interpretation in light of the Specification.
The limitation “wherein combining the EEG scaling factor and the heart rate change comprises using the heat rate change to modulate the EEG scaling factor” further limits the manner of combining, but does not change that the combining is a mathematical operation. This position is supported by Pg. 13, Ln. 24-34 of the Present Specification.
Regarding Claim 2:
“selecting the EEG template from a set of age-dependent templates to obtain an age- appropriate EEG template, said selection being based on an age of the subject” recites a mental process when afforded its broadest reasonable interpretation. The claimed selecting could practically be performed in the human mind. See MPEP 2106.04(a)(2)(III). For example, a human could observe data reflective of a subjects age, observe a set of age-dependent templates, and exercise judgment to select an “age appropriate” template based on those observations.
Regarding Claim 3:
“wherein the selection is made using a weighted probability function” recites a mathematical concept, and more particularly a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2)(I). “A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation.” MPEP 2106.04(a)(2)(I)(C). Using a weighted probability function is a mathematical operation, and thus recites a mathematical calculation when afforded its broadest reasonable interpretation in light of the Specification.
Regarding Claim 4:
“deriving a goodness-of-fit between the EEG template and the event EEG data;” recites a mathematical concept, and more particularly a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2)(I). “A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation.” MPEP 2106.04(a)(2)(I)(C). Deriving a goodness-of-fit is a mathematical operation, and thus recites a mathematical calculation when afforded its broadest reasonable interpretation in light of the Specification.
“and weighting the EEG scaling factor using the goodness-of-fit to produce a weighted EEG scaling factor” recites a mathematical concept, and more particularly a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2)(I). “A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation.” MPEP 2106.04(a)(2)(I)(C). Weighting a scaling factor using a goodness-of-fit is a mathematical operation, and thus recites a mathematical calculation when afforded its broadest reasonable interpretation in light of the Specification.
Regarding Claim 5:
“modulating the EEG scaling factor using the baseline EEG data to obtain a modulated EEG scaling factor” recites a mathematical concept, and more particularly a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2)(I).
Regarding Claim 6, Claim 6 further limits the abstract ideas recited by Claims 1 and 5, and recites a judicial exception for the same reasons as do Claims 1 and 5.
Regarding Claim 7:
“deriving, for each of the plurality of baseline EEG time periods, a goodness-of-fit between the EEG template and the scaled baseline EEG data” recites a mathematical concept, and more particularly a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2)(I).
“weighting, for each of the plurality of baseline EEG time periods, the scaled baseline EEG data using the derived goodness-of-fit to produce weighted scaled baseline EEG data” recites a mathematical concept, and more particularly a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2)(I).
“calculating the mean and the standard deviation of the weighted scaled baseline EEG data” recites a mathematical concept, and more particularly a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2)(I).
“and standardising the EEG scaling factor using:…” recites a mathematical concept, and more particularly a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2)(I).
Regarding Claim 8:
“modulating the heart rate change due to the event using the baseline heart rate data” recites a mathematical concept, and more particularly a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2)(I).
Regarding Claim 9:
“determining a pre-event heart rate change for each of the plurality of baseline heart rate time periods” recites a mathematical concept, and more particularly a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2)(I).
“standardising the heart rate change due to the event by subtracting the mean of the pre-event heart rate changes from the heart rate change due to the event and dividing the result by the standard deviation of the pre-event heart rate changes” recites a mathematical concept, and more particularly a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2)(I).
Regarding Claim 10, Claim 10 further limit the abstract ideas recited by Claim 1, and recite a judicial exception for the same reasons as does Claim 1.
Regrading Claim 11:
“discretising the score” recites a mathematical concept, and more particularly a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2)(I).
Regarding Claims 12-15, Claims 12-15 further limit the abstract ideas recited by Claim 1, and recite a judicial exception for the same reasons as does Claim 1
Regarding Claim 16:
“deriving a goodness-of-fit between the EEG template and the event EEG data” recites a mathematical concept, and more particularly a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2)(I).
“weighting the EEG scaling factor using the goodness-of-fit to produce a weighted EEG scaling factor” recites a mathematical concept, and more particularly a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2)(I).
Regarding Claim 17:
“modulating the EEG scaling factor using the baseline EEG data to obtain a modulated EEG scaling factor” recites a mathematical concept, and more particularly a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2)(I).
Regarding Claim 18:
“modulating the heart rate change due to the event using the baseline heart rate data” recites a mathematical concept, and more particularly a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2)(I).
Eligibility Step 2A, Prong Two
Claims 1-18 do not recite additional elements that integrate the judicial exception into a practical application:
Regarding Independent Claim 1:
“acquiring, using an electroencephalography (EEG) monitoring system, EEG data from a subject” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application because it amounts to mere data gathering.
“acquiring, using a heart rate monitoring system, heart rate data from the subject” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application because it amounts to mere data gathering.
Regarding Claims 2-4, Claims 2-4 do not recite any additional elements.
Regarding Claim 5:
“acquiring, using the EEG monitoring system, baseline EEG data from the subject” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application because it amounts to mere data gathering.
Regarding Claims 6 and 7, Claims 6 and 7 do not recite any additional elements.
Regarding Claim 8:
“acquiring, using the heart rate monitoring system, baseline heart rate data from the subject” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application because it amounts to mere data gathering.
Regarding Claims 9-12, Claims 9-12 do not recite any additional elements.
Regarding Claim 13:
“A system for quantifying pain experienced by a subject in response to an event” (i.e., that the method is implemented via a physical system) is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application. The recited system amounts to merely reciting the words “apply it.” The recited system is what allows the recited judicial exceptions to be performed by the system. Accordingly, the recited judicial exceptions are applied by processing circuitry. “As the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception does not guarantee eligibility. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1983-84 (2014) (‘The fact that a computer “necessarily exist[s] in the physical, rather than purely conceptual, realm,” is beside the point’).” MPEP 2106.04(d)(I). Thus, the fact that the physical component “a system” is used to carry out the recited judicial exception is not sufficient to integrate the judicial exception into a practical application.
“a processor operable to carry out the method” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application for the same reasons as explained above with respect to the recited “system.” Additionally, “a processor” is a generic computer structure for performing a generic computer function, and thus simply amounts to using a computer as a tool to implement the abstract idea. See MPEP 2106.05(f).
Regarding Claim 14:
“an EEG monitoring system operable to acquire EEG data from the subject” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application because it amounts to mere data gathering.
“a heart rate monitoring system operable to acquire heart rate data from the subject” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application because it amounts to mere data gathering.
Regarding Claim 15:
“A computer programme product” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application. The recited “computer programme product” amounts to merely reciting the words “apply it.” The recited system is what allows the recited judicial exceptions to be performed by the system. Accordingly, the recited judicial exceptions are applied by processing circuitry. “As the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception does not guarantee eligibility. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1983-84 (2014) (‘The fact that a computer “necessarily exist[s] in the physical, rather than purely conceptual, realm,” is beside the point’).” MPEP 2106.04(d)(I).
The claim elements “a processor of a system” and “a system” are not affirmatively recited, and are accordingly not being interpreted as additional elements. However, were these elements to be affirmatively recited, they would be interpreted similarly to the similar elements of Claim 13.
Regarding Claim 16, Claim 16 does not recite any additional elements.
Regarding Claim 17:
“acquiring, using the EEG monitoring system, baseline EEG data from the subject” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application because it amounts to mere data gathering.
Regarding Claim 18:
“acquiring, using the heart rate monitoring system, baseline heart rate data from the subject” is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application because it amounts to mere data gathering.
Eligibility Step 2B
Claims 1-18 do not amount to significantly more than the abstract ideas recited therein:
Regarding Independent Claim 1:
“acquiring, using an EEG monitoring system, EEG data from a subject” does not contribute an inventive concept. Such acquiring EEG signals is well-understood, routine and conventional in the art. See, e.g., US 2013/0096440 A1 at Para. [0007] (“Recording of EEG signals is generally known in the medical arts.”).
“acquiring, using a heart rate monitoring system, heart rate data from the subject” does not contribute an inventive concept. Such acquiring heart rate data is well-understood, routine and conventional in the art. See, e.g., US 2016/0113591 A1 at Para. [0045] (“Likewise, heart rate sensors are known in the art and known sensors include an electrocardiogram (ECG) sensor and a photoplethysmograph (PPG) sensor.”).
Regarding Claims 2-4, Claims 2-4 do not recite any additional elements.
Regarding Claim 5:
“acquiring, using the EEG monitoring system, baseline EEG data from the subject” does not contribute an inventive concept. Such acquiring EEG data is well-understood, routine and conventional in the art. See, e.g., US 2013/0096440 A1 at Para. [0007] (“Recording of EEG signals is generally known in the medical arts.”).
Regarding Claims 6 and 7, Claims 6 and 7 do not recite any additional elements.
Regarding Claim 8:
“acquiring, using the heart rate monitoring system, baseline heart rate data from the subject” does not contribute an inventive concept. Such acquiring heart rate data is well-understood, routine and conventional in the art. See, e.g., US 2016/0113591 A1 at Para. [0045] (“Likewise, heart rate sensors are known in the art and known sensors include an electrocardiogram (ECG) sensor and a photoplethysmograph (PPG) sensor.”).
Regarding Claims 9-12, Claims 9-12 do not recite any additional elements.
Regarding Claim 13:
“A system for quantifying pain experienced by a subject in response to an event” (i.e., that the method is implemented via a physical system) does not contribute an inventive concept. The recited system amounts to adding the words “apply it” as explained above, and thus does not contribute an inventive concept. See MPEP 2106.05(I)(A).
“a processor operable to carry out the method does not contribute an inventive concept. The recited “processor” amounts to adding the words “apply it” as explained above, and thus does not contribute an inventive concept. See MPEP 2106.05(I)(A).
Regarding Claim 14:
“an EEG monitoring system operable to acquire EEG data from the subject” does not contribute an inventive concept. Such acquiring EEG data is well-understood, routine and conventional in the art. See, e.g., US 2013/0096440 A1 at Para. [0007] (“Recording of EEG signals is generally known in the medical arts.”).
“a heart rate monitoring system operable to acquire heart rate data from the subject” does not contribute an inventive concept. Such acquiring heart rate data is well-understood, routine and conventional in the art. See, e.g., US 2016/0113591 A1 at Para. [0045] (“Likewise, heart rate sensors are known in the art and known sensors include an electrocardiogram (ECG) sensor and a photoplethysmograph (PPG) sensor.”).
Regarding Claim 15:
“A computer programme product” does not contribute an inventive concept. The recited “computer programme product” amounts to adding the words “apply it” as explained above, and thus does not contribute an inventive concept. See MPEP 2106.05(I)(A).
The claim elements “a processor of a system” and “a system” are not affirmatively recited, and are accordingly not being interpreted as additional elements. However, were these elements to be affirmatively recited, they would be interpreted similarly to the similar elements of Claim 13.
Regarding Claim 16, Claim 16 does not recite any additional elements.
Regarding Claim 17:
“acquiring, using the EEG monitoring system, baseline EEG data from the subject” does not contribute an inventive concept. Such acquiring EEG data is well-understood, routine and conventional in the art. See, e.g., US 2013/0096440 A1 at Para. [0007] (“Recording of EEG signals is generally known in the medical arts.”).
Regarding Claim 18:
“acquiring, using the heart rate monitoring system, baseline heart rate data from the subject” does not contribute an inventive concept. Such acquiring heart rate data is well-understood, routine and conventional in the art. See, e.g., US 2016/0113591 A1 at Para. [0045] (“Likewise, heart rate sensors are known in the art and known sensors include an electrocardiogram (ECG) sensor and a photoplethysmograph (PPG) sensor.”).
Explanation of Limitations to Which No Art is Applied
As is discussed above, Independent Claim 1 (and, as a consequence, dependent Claims 2-18) has not had art applied as a grounds of rejection herein. The Examiner elaborates on the reasoning for this below.
Claim 1 recites “combining the EEG scaling factor and the heart rate change to generate a score indicative of a response of the subject to the event” and “wherein combining the EEG scaling factor and the heart rate change comprises using the heart rate change to modulate the EEG scaling factor.” The prior art does not fairly teach, disclose or suggest such combining as recited by Independent Claim 1, as such combining is best understood by the Examiner in light of the foregoing written description rejection under 35 USC 112(a).
The closest prior art is Hartley Caroline Et Al.: “Nociceptive brain activity as a measure of analgesic efficacy in infants,” Science Translational Medicine, Vol. 9, No. 388, 3 May 2017 (2017-05-03), pages 1-24 (“Hartley”) in view of US 2018/0000409 A1 to Jensen et al. (“Jensen”). Hartley describes “an electroencephalography-based measure of infant nociceptive brain activity that is evoked by acute noxious stimulation” (Hartley at Abstract) which uses scaled template (Hartley at Pg. 1, Right Column, Second Paragraph through Pg. 2, Left Column, First Paragraph; Pg. 2, Fig. 1 Caption) that is quite similar to Claim 1, with the exception that Hartley does not consider heart rate. Jensen describes an “Apparatus for the Assessment of the Level of Pain and Nociception During General Anesthesia Using Electroencephalogram, Plethysmographic Impedance Cardiography, Heart Rate Variability and the Concentration or Biophase of the Analgesics” (Title), and teaches the use of heart rate in conjunction with such electroencephalogram as used by Hartley.
The combination of Hartley and Jensen do not fairly teach “combining the EEG scaling factor and the heart rate change to generate a score indicative of a response of the subject to the event, wherein combining the EEG scaling factor and the heart rate change comprises using the heart rate change to modulate the EEG scaling factor” (emphasis added). While Hartley as modified by Jensen reasonably teaches such broad “combining” as claimed, the particular manner of combining is not taught by either. Jensen’s index does not reasonably envision such modulation using heart rate change of the “scaling factor” itself as the term “modulation” is used in the Present Specification. By its definition at Pg. 13, Ln. 24-34 of the Present Specification, the term “modulation” has a specific definition (reproduced below) that neither Jensen nor Hartley disclose. While the term “modulate” as used in Claim 1 is far broader than this specific definition, Jensen’s incorporation of heart rate data into Jensen’s “final index” is flatly inconsistent with any fair reading of the term “modulate” as used in the Present Specification. That is to say, the term “modulate” requires something more than Jensen or the existing art fairly suggest. It requires more than Jensen’s single index which considers heart-rate a single time to arrive at a single index fairly teaches. This requirement is compounded by Jensen’s different methodology which does not employ such templates as that from which the scaling factor of Claim 1 is derived.
Although the impact on heart rate on nociception is well known in the art (see, e.g., US 2019/0022397 A1 at Abstract and Para. [0045], US 2006/0004296 A1 at Paras. [0025] and [0026], US 2006/0217614 A1 at Paras. [0008] and [0010], US 2007/0010723 A1 at Paras. [0008] and [0010]), this general knowledge falls short of such “using the heart rate change to modulate the EEG scaling factor” as required by Claim 1. It would not have been obvious to modify Hartley’s template-based index with the teachings of Jensen, US 2019/0022397 A1, US 2006/0004296 A1, US 2006/0217614 A1, US 2007/0010723 A1, or any other similar teachings such that heart rate change is used “to modulate the EEG scaling factor” as required by Claim 1.
The template-derived index of Claim 1 is important to the scope of the claim. Hartley teaches a very similarly methodology, but the bulk of the existing art utilizes different methods (see, e.g., Somayeh Afrasiabi et al., "An EEG based hierarchical classification strategy to differentiate five intensities of pain," Expert Systems with Applications, Volume 180, Artile 115010, Pg. 1-14, October 15, 2021 at Pg. 2, Right Column, Third Paragraph; Enrico Schulz, Elisabeth S. May, Martina Postorino, Laura Tiemann, Moritz M. Nickel, Viktor Witkovsky, Paul Schmidt, Joachim Gross, Markus Ploner, Prefrontal Gamma Oscillations Encode Tonic Pain in Humans, Cerebral Cortex, Volume 25, Issue 11, November 2015, Pages 4407–4414 at Pg. 4409, Right Column, Third Paragraph; Huishi Zhang, C., Sohrabpour, A., Lu, Y. and He, B. (2016), Spectral and spatial changes of brain rhythmic activity in response to the sustained thermal pain stimulation. Hum. Brain Mapp., 37: 2976-2991 at Abstract; US 20140066739 A1 at Abstract, Para. [0052], Para. [0017]. Fig. 4). Absent such template use with ECG additionally included (which ECG use Hartley lacks), “using the heart rate change to modulate the EEG scaling factor” would require substantial redesign and would alter the principal of operation of prior art methods.
The Examiner notes again for abundant clarity that that while no new art has been applied and the previous rejection withdrawn, the persuasively narrowing limitation stands rejected for various written description issues under 35 USC 112(a) pertaining to its scope. The true scope of the term “modulate” as used in Claim 1 is unable to be discerned. Clearly, its meaning falls somewhere on the spectrum between the definition set forth at Pg. 13, Ln. 24-34 of the Present Specification and something slightly narrower than such broad “combining” as previously recited. By the Examiner’s reading of the limitation as it is currently worded, there is no art whose teachings can be fairly read to fall within this spectrum. That is to say, the term “modulate” requires something more than Jensen or the existing art fairly suggest, but in view of the written description issues under 35 USC 112(a), it is not clear precisely how much more is required. Were Claim 1 to be amended such that scope of this spectrum were to be expanded, there may be art that applies.
Art Considered Relevant but Not Relied Upon the Rejection
The Examiner makes note of the following prior, which is considered relevant despite not being relied upon in any outstanding rejection:
Somayeh Afrasiabi et al., "An EEG based hierarchical classification strategy to differentiate five intensities of pain," Expert Systems with Applications, Volume 180, Artile 115010, Pg. 1-14, October 15, 2021 “…investigate[s] the alpha band and its role in determining the amount of pain and providing a robust and generalized pain intensity index” (Pg. 2, Right Column, Third Paragraph).
Enrico Schulz, Elisabeth S. May, Martina Postorino, Laura Tiemann, Moritz M. Nickel, Viktor Witkovsky, Paul Schmidt, Joachim Gross, Markus Ploner, Prefrontal Gamma Oscillations Encode Tonic Pain in Humans, Cerebral Cortex, Volume 25, Issue 11, November 2015, Pages 4407–4414 “…investigate[s] the neurophysiological encoding of subjective pain intensity and objective stimulus in tensity during tonic painful stimulation” to determine “a statistical estimate of the strength of the relationship between brain activity and pain/ stimulus intensity” (Pg. 4409, Right Column, Third Paragraph).
Huishi Zhang, C., Sohrabpour, A., Lu, Y. and He, B. (2016), Spectral and spatial changes of brain rhythmic activity in response to the sustained thermal pain stimulation. Hum. Brain Mapp., 37: 2976-2991 “…investigate[s] the neurophysiological correlates of pain caused by sustained thermal stimulation” with the aim of “provid[ing] an objective measure for better pain management in clinical applications” (Pg. 2976, Abstract).
Misra G, Wang WE, Archer DB, Roy A, Coombes SA. Automated classification of pain perception using high-density electroencephalography data. J Neurophysiol. 2016 Nov 30;117(2):786-795 discusses EEG-based methodology for “…discriminating low-pain states from high-pain states in healthy adults” P(g. 794, Left Column, Second Paragraph).
US 2019/0022397 A1 to Srivastava describes the influence of electrocardiography (ECG) morphology on pain (Para. [0045]) in the context of generating a pain score (Abstract).
US 2006/0004296 A1 to Huiki et al. (“Huiki”) describes “Monitoring Subcortical Responsiveness Of A Patient” (Title) using two physiological signals to determine an indicator “indicative of the patient's level of antinociception” (Abstract). Huiki uses EEG and ECG for Huiki’s signals (Para. [0010] and Para. [0012]), and describes various influences gleaned from ECG at Paras. [0025] and [0026].
US 2006/0217614 A1 to Takala et al. (“Takala”) describes “…an uncomplicated method for monitoring the clinical state of a subject and for accomplishing a diagnostic scale, such as a nociception scale, on which a certain reading corresponds to the same level for all patients…” via which a “diagnostic index dependent on the normalized measurement signal” is formed. (Abstract). Takala’s index is based on EEG and ECG (Paras. [0008] and [0010]).
US 2007/0010723 A1 to Uutela (“Uutela”) describes “the determination of the clinical state of a subject” to form “a diagnostic index …, which is dependent on the transformed measurement signal(s) and serves as a measure of the clinical state of the subject” (Abstract). Uutela’s index is based on EEG and ECG (Paras. [0008] and [0010]).
US 2014/0066739 A1 to He et al. describes “A method for computing a quantitative metric indicative of pain experienced by a subject using an electrophysiological signal detection…” (Abstract), uses “frequency modulation” (Para. [0017]), and broadly describes the relevance of ECG signals (Para. [0052]).
US 2022/0183611 A1 to Phua et al. describes “a process for identifying and extracting pain-related electroencephalogram (EEG) signals” (Abstract) and incorporates ECG data broadly (Para. [0192]).
US 2018/0193651 A1 to Annoni et al. describes “PAIN MANAGEMENT BASED ON BRAIN ACTIVITY MONITORING” (Title) using EEG (Para. [0044]) to derive a pain score (Abstract), and broadly discusses ECG data as pertinent at Para. [0057].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.J.M./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
1 See MPEP 2163(II)(A)(ii) citing LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005) (“The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 “merely by clearly describing one embodiment of the thing claimed.”); see also LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005) (holding a generic method of making a seamless discrete wavelet transformation (DWT) invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method).
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