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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/09/2025 and 01/15/2026 are being considered by the examiner.
The information disclosure statement filed 05/29/2025 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language (NPL titled: “Taiwanese Office Action and Search Report for Taiwanese Application No. 113151470, dated April 18, 2025”). It has been placed in the application file, but the information referred to therein has not been considered.
Specification
The use of the term Bluetooth, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1, 8, and 15 are objected to because of the following informalities:
Claim 1, line 6 reads "interference" should read "an interference".
Claim 8, line 8 reads "interference" should read "an interference".
Claim 15, line 11 reads “interference” should read “an interference”.
Appropriate correction is required.
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.
The following claim limitations are found in claims 8 and 15:
first filtering module
correlation evaluation module
second filtering module
physiological parameter generation module
The following claim limitations are found in claim 15:
electrical stimulation signal providing module
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.
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.
Claim 15 is 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. Claim limitation “electrical stimulation signal providing module” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Upon review of the applicant’s specification, the recited module has no corresponding hardware structure disclosed (see paragraph [0084]).
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 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim limitation “electrical stimulation signal providing module” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Upon review of the applicant’s specification, the recited module has no corresponding hardware structure disclosed (see paragraph [0084]). Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The term “sufficiently” in claims 1,is a relative term which renders the claim indefinite. The term “sufficiently” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification does not disclose what.
Dependent claims 2-7, 9-14, and 16-20 inherit the same deficiencies.
Claim 7 recites the limitation "electrical stimulation" in line 2. There is insufficient antecedent basis for this limitation in the 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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Independent claims 1, 8, and 15 recite a method, a physiological signal processing device, and an electrical stimulation therapy system. Thus, they are directed to statutory categories of invention.
Step 2A, prong 1:
Claims 1, 8, and 15 recite the following claim limitations:
“using a standard physiological signal to perform match filtering on an original physiological signal of a subject”
“performing a correlation evaluation [to determine] whether interference has been sufficiently eliminated”
“using a personal physiological signal of the subject to perform a second match filtering”
These limitations under their broadest reasonable interpretation, cover concepts that can be practically performed mathematically in the human mind, i.e., using pen and paper. These limitations describe mathematical operations involving filtering, correlation analysis, and evaluation of results. Such operations constitute an abstract idea because they involve mathematical relationships and mental evaluation of information. Thus, the claims recite limitations which fall within the ‘mental processes’ grouping of abstract ideas.
Step 2A, prong 2:
When analyzing the claim as a whole to determine whether the claim recites additional elements that integrate the judicial exception into a practical application, besides the abstract
idea, claims 1, 8, and 15 recite “generating a physiological parameter”. These claimed elements fail to recite any additional element or combination of additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. As recited, generating a physiological parameter merely provides output data from the mathematical filtering operations, for display. This additional limitation does not impose any meaningful structural limitations on the apparatus used to implement the judicial exception. The recitation “generating a physiological parameter” in the claims does not integrate the judicial exception into a practical application because the claim merely provides output data from the abstract idea. Thus, the additional element does not integrate the abstract idea into a practical application. The claim is direct to an abstract idea.
Step 2B:
Claims 8 and 15 recite the following additional elements:
first filtering module (claims 8 and 15)
correlation evaluation module (claims 8 and 15)
second filtering module (claims 8 and 15)
physiological parameter generation module (claims 8 and 15)
electrical stimulation signal providing module (claim 15)
Claims 8 and 15 recite a “first filtering module”, “correlation evaluation module”, “second filtering module”, and a “physiological parameter generation module”. These claimed elements fail to recite any additional element or combination of additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Upon review of the applicant's specification, the modules recited are a processor in conjunction with an algorithm for collecting data (see paragraph [0073]). A processor is a conventional component that does not impose any meaningful structural limitations on the apparatus used to implement the judicial exception. The recitation of the modules listed in the claims do not integrate the judicial exception into a practical application because the claims merely use the recited modules as a tool to perform the abstract idea.
The recitation of a processor is not sufficient to amount to significantly more than the judicial
exception because they are recited at a high level of generality, there is no meaningful
limitation, such as a particular or unconventional structure that distinguishes the elements
from well-known, routine, and/or conventional elements. Recitation of a processor as a tool to
perform the abstract idea does not add significantly more than what is well-known, routine,
and/or conventional in view of Alice Corp. Pty. Ltd. V. CLS Bank Int'l, 573 U.S. 208, 223, 110
USPQ2d 1976, 1983 (2014).
Claim 15 further recites an “electrical stimulation signal providing module”. The claimed element fails to recite an any additional element or combination of additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. As recited the electrical stimulation signal providing module, which upon review of the applicant’s specification, has no corresponding hardware structure disclosed (see paragraph [0084]). There is no clear indication of corresponding structure, the recitation appears to send data waves that is not actually providing stimulation.
For these reasons, there is no inventive concept. The claims are not patent eligible. Even when viewed as whole, nothing in the claims add significantly more to the abstract idea.
Dependent claims
Claims 2 and 9 merely adds an electrical stimulation signal based on the generated physiological parameter, which amounts to insignificant post-solution activity following the abstract analysis, which does effect a particular treatment or prophylaxis for a disease or medical condition.
Claims 3-4, 10-11, and 16-17 merely specifies when the electrical stimulation signal or personal physiological signal is obtained, which amounts to the timing of data gathering.
Claims 5, 12, and 18 further limit the abstract idea by introducing mathematical concepts (correlation values, comparing thresholds).
Claims 6, 13, and 19 merely specifies examples of physiological signals (ECG, EEG, PPG) and further limits the abstract idea by introducing mathematical concepts (HRV, SDNN, RMSSD).
Claims 7, 14, and 20 merely specifies an input signal but has no corresponding structure.
Allowable Subject Matter
Claims 1, 8, and 15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph and 101, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art is to Geva et al. (US 20040073098 A1), hereinafter Geva and Barnes et al. (US 20090322485 A1), hereinafter Barnes.
Regarding claim 1, Geva teaches a method for processing a physiological signal (para. 0017 (a method for monitoring normal/abnormal physiological events in patients by analyzing his biomedical signals)), comprising:
using a standard physiological signal (Fig. 1a, para. 0237 (universal heartbeat – UHB)) as a first template to perform a first match filtering on an original physiological signal of a subject under test (Fig. 2, element 202 – Beat Under Test (BUT), para. 0237 (first monitored BUT is compared to the UHB)), thereby obtaining a first filtered physiological signal;
performing a correlation evaluation on the first filtered physiological signal and determining, based on an evaluation result (para. 0237 (Matched Filter (MF) is configured to identify predefined signal pattern… resulting decision involves a correlation factor, the value of which may be between 0.0 and 1.0. The higher the value of the correlation factor, the more the examined pattern resembles the predefined template of the MF).
Geva does not teach performing a correlation evaluation on the first filtered physiological signal and determining, based on an evaluation result, whether interference has been sufficiently eliminated;
when determining that the interference has not been sufficiently eliminated, using a personal physiological signal of the subject under test as a second template to perform a second match filtering on the first filtered physiological signal, thereby obtaining a second filtered physiological signal;
and generating a physiological parameter of the subject under test based on the second filtered physiological signal.
It would not have been obvious to a person of ordinary skill in the art to teach the combination of elements now recited, with the pertinent piece of prior art. Although Geva teaches a correlation evaluation on a first filtered physiological signal, the correlation is used to determine how closely the first template matches the original physiological signal. The correlation evaluation is not conducted for determine whether interference has been sufficiently eliminated. Geva teaches discarding signals obtained under noisy environment conditions (para. 0248). Barnes teaches match filtering a received signal with a reference signal and detecting noise faults based on noise fault thresholds (para. 0131 (received signal [unmodulated electromagnetic signals] is match filtered with reference signals to determine the signal magnitude), 0133 (noise faults may be detected when the matched filter output during the noise detection portion is greater than a noise fault threshold)). However, Barnes determines whether the received signal exceeds a noise threshold and does not disclose or suggest conducting a correlation evaluation to determine whether noise/interference has been eliminated.
Regarding claim 8, Geva teaches a first filtering module, configured to use a standard physiological signal as a first template to perform a first match filtering on an original physiological signal of a subject under test, thereby obtaining a first filtered physiological signal;
a correlation evaluation module, configured to perform a correlation evaluation on the first filtered physiological signal and determine, based on an evaluation result (para. 0237 (Matched Filter (MF) is configured to identify predefined signal pattern… resulting decision involves a correlation factor, the value of which may be between 0.0 and 1.0. The higher the value of the correlation factor, the more the examined pattern resembles the predefined template of the MF).
Geva does not teach a physiological signal processing device, comprising:
a correlation evaluation module, configured to perform a correlation evaluation on the first filtered physiological signal and determine, based on an evaluation result, whether interference has been sufficiently eliminated;
a second filtering module, configured to, when determining that the interference has not been sufficiently eliminated, use a personal physiological signal of the subject under test as a second template to perform a second match filtering on the first filtered physiological signal, thereby obtaining a second filtered physiological signal.
It would not have been obvious to a person of ordinary skill in the art to teach the combination of elements now recited, with the pertinent piece of prior art. Although Geva teaches a correlation evaluation on a first filtered physiological signal, the correlation is used to determine how closely the first template matches the original physiological signal. The correlation evaluation is not conducted for determine whether interference has been sufficiently eliminated. Geva teaches discarding signals obtained under noisy environment conditions (para. 0248). Barnes teaches match filtering a received signal with a reference signal and detecting noise faults based on noise fault thresholds (para. 0131 (received signal [unmodulated electromagnetic signals] is match filtered with reference signals to determine the signal magnitude), 0133 (noise faults may be detected when the matched filter output during the noise detection portion is greater than a noise fault threshold)). However, Barnes determines whether the received signal exceeds a noise threshold and does not disclose or suggest conducting a correlation evaluation to determine whether noise/interference has been eliminated.
Regarding claim 15, Geva teaches an electrical stimulation therapy system (para. 0002 (biomedical analyzing systems)), comprising:
a first filtering module, configured to use a standard physiological signal as a first template to perform a first match filtering on an original physiological signal of the subject under test, thereby obtaining a first filtered physiological signal;
a correlation evaluation module, configured to perform a correlation evaluation on the first filtered physiological signal and determine, based on an evaluation result (para. 0237 (Matched Filter (MF) is configured to identify predefined signal pattern… resulting decision involves a correlation factor, the value of which may be between 0.0 and 1.0. The higher the value of the correlation factor, the more the examined pattern resembles the predefined template of the MF).
Geva does not teach an electrical stimulation signal providing module, configured to provide an electrical stimulation signal to a subject under test; and
a physiological signal processing device, comprising:
a correlation evaluation module, configured to perform a correlation evaluation on the first filtered physiological signal and determine, based on an evaluation result, whether interference has been sufficiently eliminated;
a second filtering module, configured to, when determining that the interference has not been sufficiently eliminated, use a personal physiological signal of the subject under test as a second template to perform a second match filtering on the first filtered physiological signal, thereby obtaining a second filtered physiological signal; and
a physiological parameter generation module, configured to generate a physiological parameter of the subject under test based on the second filtered physiological signal;
wherein the electrical stimulation signal providing module is further configured to adjust or terminate the electrical stimulation signal based on the physiological parameter.
It would not have been obvious to a person of ordinary skill in the art to teach the combination of elements now recited, with the pertinent piece of prior art. Although Geva teaches a correlation evaluation on a first filtered physiological signal, the correlation is used to determine how closely the first template matches the original physiological signal. The correlation evaluation is not conducted for determine whether interference has been sufficiently eliminated. Geva teaches discarding signals obtained under noisy environment conditions (para. 0248). Barnes teaches match filtering a received signal with a reference signal and detecting noise faults based on noise fault thresholds (para. 0131 (received signal [unmodulated electromagnetic signals] is match filtered with reference signals to determine the signal magnitude), 0133 (noise faults may be detected when the matched filter output during the noise detection portion is greater than a noise fault threshold)). However, Barnes determines whether the received signal exceeds a noise threshold and does not disclose or suggest conducting a correlation evaluation to determine whether noise/interference has been eliminated.
In reference to independent claims 1, 8, and 15 the prior arts made of record, individually or in any combination, failed to teach, render obvious, or fairly suggest to one of ordinary skill in the art at the time of the filing the combination of claimed features in claims 1, 8, and 15.
Claims 2-7, 9-14, and 16-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EILEEN ROBLES whose telephone number is (571)429-9383. The examiner can normally be reached Monday-Friday: 8:00 - 5:00 PM.
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/EILEEN ROBLES/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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