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 .
Claim Interpretation
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “evaluation device” in claim 1, “stimulation device” in claims 7-11, and “comparison device” in claim 14.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
According to the specification, all of the evaluation device, stimulation device, and comparison device are a computer-controlled device, i.e., having a computer which executes a computer program.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 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 1-16, 19, and 20 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 claim 1, the originally filed disclosure fails to provide adequate written support for determining at last one physiological parameter of a living being from calculated at least bipolar and quadrupolar field components. While the specification makes note of a “physiological parameter”/“determined parameter”/”determined physiological parameter” throughout, it fails to provide any description of what the parameter is or may be, or how it is determined.
Regarding claim 3, the originally filed disclosure fails to provide an adequate written description for how a direction of field components is determined.
Regarding claims 7-11, the claims recite that the system of claim 1 comprises both an evaluation device and a stimulation device. According to paragraph [0069] of the published specification, the evaluation device and the stimulation device are the same device (“Accordingly, the central unit 10 has the function of the evaluation device. In the second-mentioned case, the electrodes are used as stimulation electrodes. In this case, the central unit 10 has the function of the stimulation device. In the combined device, the electrodes can be used both to pick up the EEG signals and to output the stimulation pulses. In this case, the central unit 10 has both the function of the evaluation device and of the stimulation device”) (emphasis added). Based on this paragraph, the specification does not provide support for a single system that comprises an evaluation device and a separate stimulation device.
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 2-16, 19, and 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.
Regarding claim 2, it is unclear how a bipolar field component would be calculated by a superposition of respective bipolar EEG signals. Clarification is requested. For examination purposes, claim 2 is being interpreted such that quadrupolar field components are calculated by superposition of respective bipolar EEG signals.
Regarding claim 3, it is unclear how “the direction of field components” is determined. As noted in paragraph 4 above, the specification fails to provide guidance on how this is performed. For examination purposes, any system that determines a direction of data/information (e.g., trend data, direction of a vector) will read on the limitation.
Regarding claim 4, the phrase “the determined physiological parameter” lacks proper antecedent basis as claim 1 recites “at least one physiological parameter”. When more than one physiological parameter is determined, to which of the plurality of physiological parameters is “the determined physiological parameter” referring?
Regarding claim 5, the phrase “and/or any polar field component higher than a monopolar or octopolar field” renders the claim indefinite. With this limitation, claim 5 includes both a broad limitation (“any polar field component higher than a monopolar or octopolar field”) and a narrower limitation (“monopolar”, “octopolar”), as well as a broad range (“any polar field component higher than a monopolar field”) and a narrower range (“any polar field higher than an octopolar field”). As the claim recites “monopolar … and/or any polar field component higher than a monopolar or octopolar field” (emphasis added), claim 5 is being interpreted such that any type of polar field component is calculated.
Regarding claim 6, it is unclear what is meant by “deriving the stimulation signals” in step b). It is also unclear how a bipolar electrical field, a quadrupolar electrical field, or a superposition of bipolar and quadrupolar electrical fields would be generated by stimulation signals. Clarification is requested.
Regarding claim 7, the phrase “the stimulation device” in line 1 lacks proper antecedent basis. Further regarding claim 7, step a) is unclear. How are field components of an electrical field calculated from specification parameters?
Regarding claim 8, the phrase “the stimulation device” in line 1 lacks proper antecedent basis. Further regarding claim 8, it is unclear what is meant by a stimulation device being configured to “emulate a direction”. Clarification is requested.
Regarding claim 10, the phrase “the stimulation device” in line 1 lacks proper antecedent basis. Further regarding claim 10, as with claim 5, the phrase “and/or any polar field component higher than a monopolar or octopolar field” renders the claim indefinite. With this limitation, claim 10 includes both a broad limitation (“any polar field component higher than a monopolar or octopolar field”) and a narrower limitation (“monopolar”, “octopolar”). As the claim recites “monopolar … and/or any polar field component higher than a monopolar or octopolar field” (emphasis added), claim 10 is being interpreted such that any type of polar field component is calculated.
Regarding claim 11, the phrase “of the electrical field to be generated by the stimulation signals in the tissue of the living being” in the last two lines of the claim is unclear in the context of the claim as a whole. Clarification is requested. Further regarding claim 11, the phrase “the stimulation device” in line 4 lacks proper antecedent basis.
Regarding claim 12, it is unclear if the “dedicated subsystem for sensing EEG signals” is the system of claim 1. The limitations set forth in claim 12 include the same limitations set forth in claim 1 (e.g., multiple EEG electrodes, at least one evaluation device configured to perform steps a) and b)). Further regarding claim 12, the phrase “the at least one evaluation device” lacks proper antecedent basis as it is unclear if the phrase is referring to the at least one evaluation device recited in claim 1, or to the at least one evaluation device recited in claim 12. Per claim 15, the subsystem of claim 12 “incorporates the features of claim 1 as a functional component within the overall system”. In combination with claim 15, it seems as if claim 12 is a subsystem that includes the elements of claim 1. This adds to the indefiniteness of claim 12 in that it appears that the claim is reciting a system that comprises itself.
Regarding claim 13, claim 1 recites “determining at least one physiological parameter”. When only one physiological parameter is determined, the phrase “the determined physiological parameters” in claim 13 (plural) lacks proper antecedent basis. Further regarding claim 13, the phrase “the determination of the stimulation signals” lacks proper antecedent basis. It is also unclear how a single deviation would be determined between a plurality of determined physiological parameters and a single “corresponding desired physiological parameter”.
Regarding claim 14, the claim recites calculating field components (plural) as a physiological parameter (singular). It is unclear how a plurality of values would be a single value. Clarification is requested.
Regarding claim 15, it is unclear what further limitation the claim provides to the claimed invention. The claim merely recites that a subsystem of a system includes parts of the system.
Regarding claim 19, the phrase “the surrounding electrodes” in lines 3 and 4 lacks proper antecedent basis, as does the phrase “the central electrode” in line 4. For examination purposes, the claim is being interpreted as being dependent on claim 18.
Regarding claim 20, the phrase “the stimulation electrodes” lacks proper antecedent basis as there is no previous recitation of the system comprising stimulation electrodes in claim 1.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
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 1-16, 19, and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a system for sensing EEG signals. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The machine is configured to perform the steps of calculating at least bipolar and quadrupolar field components of an electrical field, and determining at least one physiological key value of a living being from the calculated field components. These steps set forth judicial exceptions. These steps describe both a mathematical calculation (calculating bipolar and quadrupolar field components), and a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mathematical Concept and to a Mental Process, which are each an Abstract Idea. The claim recites an evaluation device configured to perform these two steps, the evaluation device being a computer system. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites determining at least one physiological parameter, but does nothing further with the determined parameter. The determination of the at least one parameter does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the determined at least one parameter, nor is the at least one physiological parameter determined using a particular machine. It is noted that the pseudo-Laplacian arrangement/configuration of the electrodes does not make the system a particular machine. Arranging EEG electrodes in a pseudo-Laplacian configuration is known in the art.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites the additional step of recording EEG signals from EEG electrodes. The recited EEG electrodes are recited at a high level of generality such that they, and their intended function (picking up EEG signals), amount to generic components configured to perform insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering equipment used by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of an additional function such as the recording step does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The dependent claims also fail to add something more to the abstract independent claim as they generally recite functions of the evaluation device pertaining to data gathering and further mathematical calculations. The recording, calculating, and determining functions recited in the independent claim maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4, 5, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Turnbull et al.’996 (US Pub No. 2013/0109996) in view of Vorwerk et al. (The multipole approach…) further in view of Boyden et al.’505 (US Pub No. 2008/0319505) further in view of Remmert et al.’308 (US Pub No. 2018/0117308 – previously cited).
Regarding claim 1, Figure 1 of Turnbull et al.’996 discloses a system for sensing EEG signals generated by a living being, the system comprising multiple EEG electrodes for recording electrical signals from the living being (section [0022]) and at least one evaluation device connected to the EEG electrodes (devices 12, 14, 28, sections [0021-0022], [0026]), wherein the at least one evaluation device is configured to perform at least the following steps: recording EEG signals from the EEG electrodes (sections [0021-0022]), and determining at least one physiological parameter from the recorded EEG signals (sections [0031-0032]: source localization).
Turnbull et al.’996 discloses all of the elements of the current invention, as discussed above, except for the at least one evaluation device calculating at least bipolar and quadrupolar field components of an electrical field within the living being by computation evaluation of the EEG signals based on a multipole expansion. It is noted that sections [0026] and [0028-0029] of Turnbull et al.’996 disclose that use of a forward model enables source localization, and that the system can select one of a plurality of different forward models for source localization. Vorwerk et al. teaches a forward model used to determine EEG source localization, the forward model configured to computationally evaluate EEG signals based on a multipole expansion (section 2.2. The multipole approach). Vorwerk et al. discloses that use of the multipole expansion provides higher numerical accuracies that currently used methods of source localization (see ABSTRACT), leads to reduced numerical errors (last paragraph of section 1. Introduction), and allows a system to model quadrupolar sources, which provides an advantage as studies have shown that the inclusion of higher order sources may improve source localization for EEG (last paragraph of section 1. Introduction). Section 5. Discussion teaches that the multipole approach improves the numerical accuracy and stability of FEM EEG forward solutions. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have used the multipole expansion model of Vorwerk et al. as the forward model of Turnbull et al.’996, as it would merely be combining prior art elements according to known methods to yield predictable results. Furthermore, as taught by Vorwerk et al., the modification to Turnbull et al.’996 would result in more accurate source localization results. It is noted that in the combination of Turnbull et al.’996 in view of Vorwerk et al., the at least one physiological parameter would be determined based on the calculated at least bipolar and quadrupolar field components.
Turnbull et al.’996 in view of Vorwerk et al. discloses all of the elements of the current invention, as discussed above, except for the EEG electrodes being fixedly attached to one another in a pseudo-Laplacian configuration. Boyden et al.’505 teaches using EEG electrodes to provide transcranial electrical stimulation to targeted areas of a living being’s brain based on a determined state of the living being (see ABSTRACT, sections [0002], [0006-0007], [0010], [0019]). Section [0035] teaches that the device can be used to disrupt epileptic seizures (section [0027] of Turnbull et al.’996 teaches that its system can be used to perform source localization in epileptic subjects). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Turnbull et al.’996 in view of Vorwerk et al. to include EEG electrodes also configured to stimulate the living being’s brain based on the analyzed bipolar and quadrupolar field components, as it would allow the system to disrupt epileptic seizures experienced by the living being.
Remmert et al.’308 teaches arranging stimulation electrodes in a fixed geometrical arrangement (a pseudo-Laplacian arrangement) in order to provide for the best current depth penetration of stimulation pulses into the tissue of a living being (sections [0031], [0036], [0053]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the stimulation electrodes of Turnbull et al.’996 in view of Vorwerk et al. further in view of Boyden et al.’505 such that they are fastened in a pseudo-Laplacian arrangement, as taught by Remmert et al.’308, as this would allow for the best current depth penetration of the stimulation pulses generated by the stimulation electrodes.
Regarding claim 4, in the combination of Turnbull et al.’996 in view of Vorwerk et al. further in view of Boyden et al.’505 further in view of Remmert et al.’308, the at least one evaluation device is configured to generate a trigger signal for a stimulation system (the stimulating electrodes).
Regarding claim 5, in the combination of Turnbull et al.’996 in view of Vorwerk et al. further in view of Boyden et al.’505 further in view of Remmert et al.’308, the at least one evaluation device is configured to calculate further field components of the electric field including monopolar or any polar field component higher than a monopolar field (as taught by Vorwerk et al.).
Regarding claim 19, section [0022] of Turnbull et al.’996 discloses that the position and number of EEG electrode units can vary. Figure 10 of Turnbull et al.’996 shows individual electrode unit locations on a living being’s scalp. Each electrode unit can be considered an auxiliary electrode unit to the other electrode units. Section [0073] of Turnbull et al.’996 discloses that each electrode unit need not be fastened to the other electrode units.
Regarding claim 20, the electrodes (both EEG and stimulation) of Turnbull et al.’996 in view of Vorwerk et al. further in view of Boyden et al.’505 further in view of Remmert et al.’308 are capable of being arranged between the skull and the scalp of the living being.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Turnbull et al.’996 in view of Vorwerk et al. further in view of Boyden et al.’505 further in view of Remmert et al.’308, as applied to claim 1, in view of Imran’305 (US Pub No. 2010/0191305 – previously cited).
Turnbull et al.’996 in view of Vorwerk et al. further in view of Boyden et al.’505 further in view of Remmert et al.’308 discloses all of the elements of the current invention, as discussed in paragraph 10 above, except for the evaluation device being configured to determine the direction of field components of the electrical field in the living being from the at least bipolar and quadrupolar field components. Imran’305 teaches an evaluation device that is configured to determine a direction of field components of an electrical field in a living being (section [0060]). Imran’305 determines the direction of field components in order to detect patterns indicative of pre-ictal or seizure activity (section [0060]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the evaluation device of Turnbull et al.’996 in view of Vorwerk et al. further in view of Boyden et al.’505 further in view of Remmert et al.’308 to be configured to determine the direction of field components of the electrical field in the living being from the at least bipolar and quadrupolar field components, as Imran’305 teaches that determining the direction of field components would aid in detecting pre-ictal and seizure activity in the EEG signals.
Response to Arguments
Applicant’s arguments filed 16 January 2026 have been fully considered and are not entirely persuasive.
Regarding the rejection of the claims under 35 U.S.C. 112(a), the amendment changing “key value” to “parameter” does not overcome the rejection. Applicant has not provided an explanation as to why the specification provides support for how a physiological parameter is determined from the calculated at least bipolar and quadrupolar field components. Applicant has also not provided a reason as to why the amendments to claim 1, in combination with Figures 4 and 5, provide support for determining a direction of field components.
Regarding the rejections of the claims under 35 U.S.C. 112(b), while the amendments have overcome some of the previous indefiniteness issues within the claims, as discussed in paragraph 6 above, indefiniteness issues remain. It is noted that with specific regard to claim 2, Applicant has not provided clarification as to how a bipolar field component would be calculated by a superposition of respective bipolar EEG signals. With specific regard to claim 6, Applicant has not provided clarification as to how a bipolar electrical field, a quadrupolar electrical field, or a superposition of bipolar and quadrupolar electrical fields would be generated by stimulation signals.
Regarding the Abstract Idea rejection of the claims under 35 U.S.C. 101, Applicant’s arguments are not persuasive. Applicant argues that the claims provide specific technological improvements in EEG analyses, but fails to provide details or evidence of the improvements. Applicant argues that the claimed invention improves the functionality of an EEG system, but fails to provide details or evidence of how. The mere assertion of an improvement is not persuasive. Regarding Applicant’s argument that the claimed invention requires “specific hardware”, the Examiner notes that no specific hardware is recited in the claims. The claims require an EEG electrode unit comprise a plurality of EEG electrodes arranged in a pseudo-Laplacian configuration (this is well known in the art), and an evaluation device (a processor). The combination of an electrode unit and a processor is not a “particular machine”/ “specific hardware”.
Applicant’s arguments regarding the previous prior art rejections of the claims are moot as the amendments to the claims have warranted new prior art rejections.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Onarheim et al.’133 (US Pub No. 2019/0001133) teaches an EEG electrode configured to both record EEG signals and provide stimulation to surrounding tissue, the EEG electrode having one smaller surface in the center of the electrode and a surrounding annulus (section [0085]). Onarheim et al.’133 also teaches providing non-invasive electrical stimulation to a living being through the scalp (sections [0002], [0136-0140]).
Kramer’268 (US Pub No. 2021/0106268) teaches computationally evaluating EEG signals based on a multipole expansion (sections [0016], [0057-0062]).
Beltrachini, L. (A Finite Element Solution…) teaches using multipolar source models to analyze EEG signals and EMG signals (ABSTRACT, II. METHODS). The reference further discloses that the use of multipolar expansion provides statistically significant improvements over standard equivalent dipolar models (IV. DISCUSSION).
Hallez et al. (Review on solving the forward problem…) teaches using a multipole expansion to solve the inverse EEG problem for the purpose of EEG source localization. It discloses that the multipole expansion takes monopole, dipole, quadrupole, and octupole moments into consideration, adding flexibility to a dipole model used to solve the inverse problem (first paragraph of page 10).
Molnar et al.’521 (US Pub No. 2011/0144521 – previously cited) teaches the elements of claim 1 (sections [0120-0122]).
Nitzert et al.’479 (US Pub No. 2019/0240479 – previously cited) teaches an advantage of using a pseudo-Laplacian electrode array in an EEG system (section [0085]).
Dearing et al.’629 (US Pub No. 2020/0163629 – previously cited) teaches an EEG system that allows a user to select particular EEG electrodes for an EEG montage, including a monopolar montage and/or a bipolar montage.
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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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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