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 .
DETAILED ACTION
The arguments filed September 21, 2026 in response to the Office Action of June 24, 2026 have been acknowledged and entered.
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, 6-13, and 15 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, 6-13, and 15 are directed to a system for assisting in and supporting improvement of quality of chewing, which is an abstract idea. Claims 1, 6-13, and 15 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a system for assisting in and supporting improvement of quality of chewing.
Step 2A: Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations: “chewing information storage means that stores information about chewing quality; muscle activity obtaining means that obtains a muscle activity signal of masticatory muscle of a person; analysis means that frequency-analyzes the muscle activity signal obtained by the muscle activity obtaining means, and analyzes chewing behavior based on the frequency-analyzed muscle activity signal; quality determination means that determines quality of the chewing behavior based on information of the chewing behavior analyzed by the analysis means; and extraction means that extracts assistance information corresponding to the chewing quality determined by the quality determination means, from the chewing information storage means, wherein the analysis means analyzes the chewing behavior based on an envelope obtained by performing, for each block, fast Fourier transform of electromyogram data as the muscle activity signal, by using the envelope as a change state of a power value in a specific frequency band, and determines that chewing is determined to be performed when an integral value calculated as the change state from the envelope exceeds a predetermined threshold value”.
These elements of claim 1 are drawn to an abstract idea since (1) they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations; and/or (2) 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: The memory (i.e., “chewing information storage means”) limitation does not integrate the exception into a practical application since it 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).
The processing unit (i.e., “muscle activity obtaining means”, “analysis means”, “quality determination means”, and “extraction means”) limitation does not integrate the exception into a practical application since it 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 recitation “chewing information storage means”, “muscle activity obtaining means”, “analysis means”, “quality determination means”, and “extraction means”
do not qualify as significantly more because this limitation is merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well-known elements or simply displaying the results of the algorithm that uses conventional, routine, and well-known elements. In particular, the data acquirer is nothing more than an electromyograph detecting a patient’s chewing behavior. Such a conventional electromyograph is known by one of skill in the art as evidenced by:
EP 0043569 (Radke) discloses conventional mandibular electromyographs that utilize conventional electrodes placed on the surface of the skin to pick up electric potentials generated by contraction of the muscles beneath the skin. (Page 1, lines 9-12, 20-24).
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. Thus, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101.
Claims 6-13 and 15 depend from claim 1, recite the same abstract idea as claim 1, and fail to cure the deficiencies of the independent claim by merely reciting additional abstract ideas or further limitations on the abstract idea already recited.
They contain no claim limitations that integrate the exception into a practical application or that recite additional elements that amount to significantly more than the judicial exception itself. 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.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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:
Claim 1: Claim limitation “chewing information storage means that stores”, “muscle activity obtaining means that obtains”, “analysis means that frequency-analyzes”, “quality determination means that determines”, and “extraction means that extracts” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 sixth paragraph, because it uses a generic placeholder “means” coupled with functional language “stores/obtains/frequency-analyzes/determines/extracts” without reciting sufficient structure to achieve the function.
Because this 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 is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Claim 1: “chewing information storage means that stores” refers to the Specification as filed, Paragraph [0029], storage means includes a memory 3; “muscle activity obtaining means that obtains” refers to the Specification as filed, Paragraph [0030] a processing unit 2 includes a muscle activity obtaining unit 21; “analysis means that frequency-analyzes” refers to the Specification as filed, Paragraph [0030] a processing unit 2 includes an analysis unit 22, “quality determination means that determines” refers to the Specification as filed, Paragraph [0030] a processing unit 2 includes an quality determination unit 23, and “extraction means that extracts” refers to the Specification as filed, Paragraph [0030] a processing unit 2 includes an information extraction unit 24.
See MPEP 2181.II.A. The disclosure of the structure (or material or acts) may be implicit or inherent in the specification if it would have been clear to those skilled in the art what structure (or material or acts) corresponds to the means- (or step-) plus-function claim limitation. See id. at 1380, 53 USPQ2d at 1229; In re Dossel, 115 F.3d 942, 946-47, 42 USPQ2d 1881, 1885 (Fed. Cir. 1997).
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.
For more information, see MPEP 2173 et seq. and Supplementary Examination Guidelines for
Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Examiner’s Note
No art is applied to claims 1, 6-13, and 15 because the prior art does not specifically teach to “determines that chewing is determined to be performed when an integral value calculated as the change state from the envelope exceeds a predetermined threshold value”.
However, the claims are not in condition for allowance due to the rejections under 35 U.S.C. 101.
Response to Arguments
Applicant argues that the claimed frequency analysis, generation of an envelope from a power value in a specific frequency band, and determination of chewing based on an integral value exceeding a threshold constitute specific improvements that go beyond “well-understood, routine, conventional activit[ies].” Applicant further relies on paragraphs [0033], [0034], and [0050] of the Specification to contend that the claimed processing provides more accurate chewing analysis and permits weak chewing sections to be excluded.
The arguments are not persuasive.
The claimed limitations directed to frequency-analyzing the electromyogram signal, generating an envelope representing a change state of a power value in a particular frequency band, calculating an integral value from the envelope, and comparing the integral value to a predetermined threshold recite mathematical concepts and mental processes. In particular, the claimed frequency analysis and envelope generation involve mathematical calculations performed on signal data, while determining whether an integral value exceeds a predetermined threshold involves evaluating the resulting information to make a determination regarding the occurrence or quality of chewing. Under their broadest reasonable interpretation, these limitations therefore fall within the mathematical concepts and mental process groupings of abstract ideas.
Applicant's reliance on the alleged increased accuracy of the analysis does not change this conclusion. An improvement in the manner in which information is mathematically analyzed is not, by itself, an improvement to the functioning of a computer or other technology. The claims do not recite a particular improvement to the operation of the electromyographic sensor, processor, computer, or other technological component. Rather, the claims specify what information is mathematically calculated from the obtained muscle activity signal and how the resulting information is evaluated to determine chewing behavior.
The disclosure cited by Applicant confirms this characterization. Paragraph [0033] explains that the analysis unit “frequency-analyzes” the muscle activity signal and analyzes chewing behavior based on a change state of a power value in a specific frequency band, allegedly allowing the analysis to be performed more accurately. Paragraph [0034] further describes performing fast Fourier transform, obtaining an average power value, generating an envelope of the power value, and storing the resulting values. Paragraph [0050] describes calculating a surface integral for an envelope and comparing the integral value to an integration threshold value so that a short, weak section can be excluded from the chewing determination.
Thus, the cited passages describe improvements in the analysis of information, rather than a technological improvement in the underlying computer or other equipment. The claimed invention takes an electromyogram signal as input, performs mathematical processing on that signal, and uses the resulting values to make an evaluation regarding chewing behavior. The fact that the particular mathematical processing may provide a more accurate or reliable result than another mathematical technique does not, without more, remove the claim from the judicial exception.
Furthermore, the claim does not integrate the recited judicial exception into a practical application. The additional elements, including obtaining a muscle activity signal from a masticatory muscle, performing the claimed analysis using the obtained signal, determining the quality of chewing behavior, and extracting assistance information corresponding to the determined chewing quality, do not impose a meaningful technological limitation on the mathematical and evaluative processes. Obtaining the muscle activity signal constitutes data gathering. The claimed analysis then operates on the obtained data by performing the recited mathematical calculations and evaluating the resulting information. Such data gathering and analysis do not meaningfully limit the judicial exception because the same mathematical processing can be applied to the obtained signal without requiring a particular technological implementation.
Likewise, determining chewing quality based on the analyzed information and extracting corresponding assistance information constitute the use of the results of the abstract analysis. These limitations do not specify a particular technological operation that is improved by the claimed analysis. Instead, they merely use the result of the mathematical/evaluative process for its intended informational purpose.
The recitation of particular mathematical operations—such as FFT processing, calculation of a power value in a particular frequency band, generation of an envelope, calculation of an integral value, and comparison with a threshold—provides specificity as to how the information is analyzed but does not demonstrate that the claim integrates the abstract idea into a practical application. The claim remains focused on the mathematical analysis and evaluation of information.
Accordingly, the additional elements, considered individually and in combination, do not integrate the recited judicial exception into a practical application
Applicant also has not established that the additional elements, individually or in combination, amount to significantly more than the recited judicial exception.
The claimed processing of the electromyogram signal using FFT, frequency-band power values, an envelope, an integral calculation, and a threshold comparison represents the implementation of the mathematical analysis itself. Merely specifying particular mathematical calculations does not provide an inventive concept where the claim remains directed to the mathematical analysis and evaluation of information.
Furthermore, the recited acquisition of muscle activity data is conventional data gathering, and the subsequent use of the analyzed information to determine chewing behavior and provide corresponding assistance information does not supply an inventive concept. These limitations amount to applying the mathematical analysis to a particular type of information and using the resulting determination for its intended purpose.
Applicant's argument that the claimed approach produces a more accurate determination of chewing behavior does not establish an inventive concept. The specification describes the alleged advantage as resulting from selecting and processing particular signal information—for example, using a power value in a specific frequency band and excluding a short weak section based on an integration threshold. These are improvements in the mathematical analysis or decision-making process itself, rather than additional technological elements that transform the claim into a patent-eligible application.
In this respect, the present claim is analogous to a claim that performs a mathematical calculation using a particular set of inputs and then evaluates the calculated result to make a determination. Even if the selected calculation produces a more accurate or useful result, the claim does not thereby recite an improvement to the underlying computing technology.
Accordingly, the identified additional elements, considered individually and in combination, do not amount to significantly more than the judicial exception.
Therefore, Applicant's arguments regarding the alleged accuracy and specificity of the claimed frequency analysis, envelope generation, integral calculation, and threshold determination are not persuasive. The claims remain directed to mathematical concepts and mental processes for analyzing information and determining chewing behavior, without integrating those exceptions into a practical application or reciting additional elements that amount to significantly more than the exceptions. The rejection under 35 U.S.C. § 101 is therefore maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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/OM PATEL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
