DETAILED ACTION
Applicant' s arguments, filed 09/04/2026 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 12/20/2024, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-4 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 20250204864 A1.
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 .
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 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 are directed to a method of processing brain wave and pulse wave signals using a computational algorithm, which is an abstract idea. Claims 1-4 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) and the 2024 Update on Subject Matter Eligibility (Federal Register, Vol 89, No. 137, page 58128, July 17, 2024).
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] filter the brain waves and the pulse waves into at least one predetermined frequency band
[B1] perform Hilbert transformation on each of the brain waves and the pulse waves filtered in the frequency band
[C1] calculate instantaneous values including an instantaneous logarithmic amplitude corresponding to a logarithm of an amplitude term of a complex waveform equation obtained by performing the Hilbert transformation on each of the brain waves and the pulse waves and an instantaneous frequency corresponding to a time differential value of a phase term of the complex waveform equation
[D1] calculate a probability density distribution of the instantaneous values and calculate feature amounts including a mean value and a variance value of the probability density distribution
[E1] extract the instantaneous values when |μe-μb|<(σe+σb)/η is met
[F1] estimate an abnormality in a physiological state related to autonomic nerves from the feature amounts of the instantaneous values that have been extracted
These elements [A1]-[F1] of claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] a brain wave measurement device that includes a first sensor and a first main body unit
[B2] a pulse wave measurement device that includes a second sensor and a second main body unit
[C2] a processor
These elements [A2]-[C2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the elements [A2] and [B2] are 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 [C2] 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 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitations of [A2] and [B2] 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. The brain wave / pulse wave measurement units are recited with a high degree of generality and require only a sensor and a corresponding main body unit. The main body unit is not particularly defined and thus any housing of a sensor is considered to anticipate such a main body unit. In particular, the data acquirers are nothing more than a scalp electrode for recording EEG signals and having some form of housing and a PPG device including a sensor and housing for recording pulse wave data. Such sensors are conventional as evidenced by:
U.S. Patent Application Publication No. US 20120226176 A1 (Li) discloses that it is well-known to one of ordinary skill in the art that sensors may be disposed in cases such as an upper case and a lower case, (paragraph 0019 of Li);
U.S. Patent Application Publication No. US 2006/0173510 A1 (Besio) discloses that EEG electrodes are conventional (paragraph 0013 of Besio);
U.S. Patent No. US 3993046 A (Fernandez) discloses that EEG signals are conventionally derived from electrodes (Col 1 lines 31-56 of Fernandez);
U.S. Patent Application Publication No. US 2010/0286549 A1 (John) discloses that conventional EEG biosensors may take a variety of forms and may be integrated into caps, or a body unit, and may also be wireless and thus comprise wireless communication circuitry within an attachable electrode, (paragraph 0014of John);
U.S. Patent Application Publication No. US 2017/0099711 A1 (Polley) discloses that conventional PPG sensors include the well-known pulse oximeter (paragraph 0005-0006 of Polley);
U.S. Patent Application Publication No. US 2002/0029000 A1 (Ohsaki) discloses that pulse wave sensors are well-known (paragraph 0030 of Ohsaki).
U.S. Patent Application Publication No. US 20030036685 A1 (Goodman) discloses that PPG sensors are well-known (paragraph 0004 of Goodman).
U.S. Patent Application Publication No. US 20240412874 A1 (Aman) discloses that PPG sensors are well-known and presents an example of a known PPG sensor which includes optical sensors in a housing of either a “C” shaped shell or in a rectangular housing for reflection type PPG as illustrated in Fig. 4C (paragraph 0081 and Fig. 4C of Aman).
Further, the element [C2] does not qualify as significantly more because this limitation 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 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)). In particular, the various “units” are considered to indicate that the associated steps are performed by a computer rather than requiring distinct physical elements to perform each function.
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.
Claim 2 depends 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).
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.
Claims 3 and 4 recite the same abstract idea as claim 1 and are rejected on the same basis as claim 1. Additionally, claims 3 and 4 do not recite any additional elements not already addressed in the above rejection of claim 1. In particular the non-transitory computer readable medium and computer of claim 4 are mere recitations to implement the abstract idea onto a computer which does not amount to significantly more than the abstract idea itself as described above.
Prior Art
In regards to claim 1, none of the prior art of record is considered to teach or reasonably suggest “calculate instantaneous values including an instantaneous logarithmic amplitude corresponding to a logarithm of an amplitude term of a complex waveform equation obtained by performing the Hilbert transformation on each of the brain waves and the pulse waves and an instantaneous frequency corresponding to a time differential value of a phase term of the complex waveform equation, the brain waves corresponding to measurement results with eyes open and eyes closed for the frequency band; calculate a probability density distribution of the instantaneous values and calculate feature amounts including a mean value and a variance value of the probability density distribution; extract the instantaneous values when |μe-μb|<(σe+σb)/η is met, where a mean value of the instantaneous frequency of the brain waves in the predetermined frequency band is denoted by μe, a variance value of the instantaneous frequency of the brain waves in the predetermined frequency band is denoted by σe, a mean value of the instantaneous frequency of the pulse waves in the predetermined frequency band is denoted by μb, a variance value of the instantaneous frequency of the pulse waves in the predetermined frequency band is denoted by σb, and a parameter of an integer equal to or greater than 3 is denoted by η” in combination with the other claimed elements.
Claim 2 depends from claim 1 and is thus not rejected over the prior art by virtue of its dependence.
Claims 3 and 4 recite similar limitations to claim 1 and are thus also not rejected over the prior art.
The closest prior art of record is considered to be:
US Patent Application Publication Number US 20220160288 A1 hereinafter Hayashi which teaches an autonomic nerve index calculation system for calculating an autonomic nerve index (Abstract). Hayashi teaches the measurement of pulse waves and the filtering of pulse waves into various frequency bands (Paragraphs 0098-0099). The waveform of each band is then subject to a Hilbert transformation (Paragraph 0100). The resultant data may then be compared to a normal Gaussian distribution to detect various parameters (Paragraphs 0112-0120).
US Patent Application Publication Number US 20220225920 A1 hereinafter Read teaches a system for processing biological signals. The system may comprise a sensing module comprising one or more sensors for detecting at least one of a biological parameter of a subject and one or more biological signals of the subject, and an additional sensor for detecting ambient conditions associated with a surrounding environment of the subject (Abstract). Read teaches a system with a plurality of sensors including EEG and heartbeat sensors (Paragraphs 0115-0116). The sensors data may undergo a Hilbert transform and may be detrended using a 1/f absolute power spectrum to determine statistical averages of the wave for each frequency range. The transformed signals may be used to determine various biomarkers (Paragraphs 0134-0136). The biomarkers may be tracked and compared to thresholds which may trigger or reduce stimulation of therapy (Paragraphs 0145-0148).
Neither Hayashi nor Read teach or reasonably suggest the extraction of brain wave and pulse wave features from instantaneous values that satisfy the equation of claim 1.
Response to Arguments
Applicant's arguments filed 09/04/2026 have been fully considered but they are not persuasive.
The previously presented argument under 35 SUC 112 have been overcome by Applicant’s amendments and are withdrawn.
Applicant’s arguments directed towards the rejection presented under 35 USC 101 have been fully considered but are not found to be persuasive.
In particular, Applicant argues that the amended claims now recite the physical elements of the pulse wave and brain wave sensors which each comprise a sensor and main body unit and thus the claims are not directed towards an abstract idea but a physical system.
These arguments are not found to be persuasive because the brain wave and pulse wave sensors are each recited with a high degree of generality. In particular, the sensors are nothing more than conventional sensor is a generic “main body unit” which is any type of conventional housing for containing the elements of a sensor. Such sensor configurations are well-known as evidenced by newly cited Li, John, and/or Aman presented above. The claims are considered to be directed towards the abstract idea and the added sensors are recitations drawn towards mere data gathering outside of the abstract idea but do not amount to significantly more than the abstract idea itself or implement the abstract idea into a practical application.
Applicant argues that the claimed process cannot reasonably be performed in the human mind using nothing more than pen and paper. Applicant asserts that the claim imposes meaningful limits on practicing the abstract idea and cannot be interpreted as a mere instruction to implement an abstract idea onto a computer. Applicant further argues that the claims when viewed as an ordered combination amount to significantly more than the abstract idea. Applicant asserts that the estimation of an abnormality in a physiological state by performing the claimed measurements and the claimed processing amount to a non-conventional arrangement and ordered combination of the elements and that when viewed in its entirety, do not constitute routine and conventional activity in the field.
These arguments are not found to be persuasive. In particular, the claimed abstract idea recites only data processing steps with no claimed speed, accuracy, or quantity of data being processed. The claimed processing steps are each capable of being performed in the human mind using nothing more than pen and paper. The abstract idea itself may be novel but elements and/or configurations of the abstract idea cannot amount to more than the abstract idea itself as per MPEP 2106.04(I). The additional elements of the system (the brain/pulse wave measurement devices and the processor) are not considered to amount to significantly more than the abstract idea itself because the measurement devices are well-known, routine, and/or conventional as evidenced in the above presented analysis of claim 1 and the processor is a mere recitation to perform the abstract idea on a computer. These elements taken as a whole are not considered to amount to significantly more than the abstract idea because there is not non-conventional configuration claimed. Each of the sensors are used in their conventional manner and provide data to the processor for processing as is conventional for data analysis. Additionally, the claims do not include any effect outside of the data gathering and processing and are thus not considered to be implemented into a practical application. The abstract idea appears to be novel in light of the lack of rejections under 35 USC 102/103 but a novel abstract idea does not amount to significantly more than the abstract idea itself.
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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/MATTHEW ERIC OGLES/ Examiner, Art Unit 3791
/JASON M SIMS/ Supervisory Patent Examiner, Art Unit 3791
