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 .
Status of Claims
Applicant' s arguments, filed 10/15/2025 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 10/15/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-19 are the current claims hereby under examination.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the reference characters in figures 9 and 16 are not legible. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: PB2. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because it is two paragraphs long. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The disclosure is objected to because of the following informalities: “SA”, “DA1”, “DA2”, and “DA3” in paragraph [0014] does not match the format of the corresponding reference characters in the drawings. These reference characters should have subscripts.
Appropriate correction is required.
The use of the terms Wi-Fi, LTE, and IaaS, which are trade names or marks used in commerce, has been noted in this application. The terms 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.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities: "in a second hemodynamic signal using the second channel" should read "in a second hemodynamic signal detected using the second channel", "a periodicity at which respective component signals of the first plurality of component signals " should read "a periodicity at each respective component signal of the first plurality of component signals", "output by the processor" should read "outputted by the processor", and "the periodicity of each of the first plurality of component signals" should read "the periodicity of each respective component signal of the first plurality of component signals" for claim language consistency. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: "the second hemodynamic signal into the second plurality of signals" should read "the second hemodynamic signal into the second plurality of component signals" and "into a plurality of component signals" should be deleted. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: "wherein decompose the hemodynamic signal" should read "wherein to decompose the hemodynamic signal" and "the processor is configured to decompose the the first hemodynamic signal" should read "the processor is configured to decompose the first hemodynamic signal". Appropriate correction is required.
Claim 16 is objected to because of the following informalities: "the head" should read "the head of the organism" for claim language consistency. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: "a periodicity at which respective component signals of the first plurality of component signals " should read "a periodicity at each respective component signal of the first plurality of component signals", "output by the processor" should read "outputted by the processor", and "the periodicity of each of the first plurality of component signals" should read "the periodicity of each respective component signal of the first plurality of component signals" for claim language consistency. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: "a second hemodynamic signal using a second detector channel" should read "a second hemodynamic signal detected using a second detector channel", “decomposing, by the proessor” should read “decomposing, by the processor”, "a periodicity at which respective component signals of the first plurality of component signals " should read "a periodicity at each respective component signal of the first plurality of component signals", "output by the processor" should read "outputted by the processor", and "the periodicity of each of the first plurality of component signals" should read "the periodicity of each respective component signal of the first plurality of component signals" for claim language consistency. 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. Such claim limitation(s) is/are: “detection unit” in claims 9, 10, 12, 13, and 16, “light emitting unit” and “light receiving unit” in claim 10, “light receiving unit” in claim 11, “correction unit” in claim 14, and “correction information generation unit” in claim 17.
Three prong analysis for “detection unit”:
“unit” has been interpreted as a generic placeholder for “means”
“that detects the first hemodynamic signal and the second hemodynamic signal” has been interpreted as functional language
There is not sufficient structure recited to perform the aforementioned function. Therefore, the claim limitation is being interpreted under 35 U.S.C 112(f).
Three prong analysis for “light emitting unit”:
“unit” has been interpreted as a generic placeholder for “means”
“that irradiates the organism with light” has been interpreted as functional language
There is not sufficient structure recited to perform the aforementioned function. Therefore, the claim limitation is being interpreted under 35 U.S.C 112(f).
Three prong analysis for “light receiving unit”:
“unit” has been interpreted as a generic placeholder for “means”
“that detects light produced as a result of irradiating the organism with the light” has been interpreted as functional language
There is not sufficient structure recited to perform the aforementioned function. Therefore, the claim limitation is being interpreted under 35 U.S.C 112(f).
Three prong analysis for “correction unit”:
“unit” has been interpreted as a generic placeholder for “means”
“the blood flow velocity corrected” has been interpreted as functional language
There is not sufficient structure recited to perform the aforementioned function. Therefore, the claim limitation is being interpreted under 35 U.S.C 112(f).
Three prong analysis for “correction information generation unit”:
“unit” has been interpreted as a generic placeholder for “means”
“the correction information generated” has been interpreted as functional language
There is not sufficient structure recited to perform the aforementioned function. Therefore, the claim limitation is being interpreted under 35 U.S.C 112(f).
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. Detection unit is herein interpreted to be an external computer device included or separate from the biological information obtainment device, or any equivalents thereof. Correction information generation unit and correction unit are herein interpreted to be processors, algorithms executed by processors, or any 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.
Claims 1-19 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 Claims 1, 18, and 19, the claims recite “respective component signals of the second plurality of component signals are decomposed”. Paragraphs [0058] and [0143] of the specification as filed disclose a second hemodynamic signal is decomposed into a plurality of component signals. However, the specification as filed, fails to disclose the plurality of component signals of the second hemodynamic signals being further decomposed. As such, there is lack of adequate written description for the aforementioned claim limitation and claims 1, 18, and 19 are rejected. Claims 2-17 are rejected due to their dependence on claim 1.
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 1-19 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 1, the claim recites "receive the hemodynamic signals from the detector via a first channel, and a second channel, of the at least two detector channels". Based on this claim construction, it is unclear if the at least two detector channels each have a first and second channel. For the purposes of examination, "receive the hemodynamic signals from the detector via a first channel, and a second channel, of the at least two detector channels" is herein interpreted to be receive the hemodynamic signals from the detector via each of the at least two detector channels. The claim also recites "the periodicity of each of the second plurality of component signals". There is insufficient antecedent basis for this limitation. The claim does not recite periodicity is calculated for each of the second plurality of component signals instead the claim recites "respective component signals of the second plurality of component signals are decomposed and output by the processor". Due to the insufficient antecedent basis for “the periodicity of each of the second plurality of component signals", it is unclear how a correlation can be determined. Also, it is unclear how the respective component signals of the second plurality of component signals are decomposed further. For the purposes of examination, "calculate a periodicity at which respective component signals of the first plurality of component signals and respective component signals of the second plurality of component signals are decomposed and output by the processor" is herein interpreted to mean calculate a periodicity of each respective component signal of the first plurality of component signals and each respective component signal of the second plurality of component signals. Based on this interpretation of aforementioned claim limitation, it is unclear how a hemodynamic element can be identified based on a correlation between the periodicity of each of the first plurality of component signals and the periodicity of each of the second plurality of component signals because there are more than two periodicities. A correlation is calculated between two things. For the purposes of examination, “identify a hemodynamic element based on a correlation between: the periodicity of the first plurality of component signals; and the periodicity of each of the second plurality of component signals” is herein interpreted to be identify a hemodynamic element based on a correlation between any two of: the periodicity of the first plurality of component signals; and the periodicity of each of the second plurality of component signals. Due to the aforementioned reasons, claim 1 is rendered indefinite. Claims 2-17 are rejected due to their dependence on claim 1.
Regarding Claim 2, the claim recites “the first hemodynamic signal… and the second hemodynamic signal… detected from at least two locations of the organism”. It is unclear if the first hemodynamic signal and the second hemodynamic signal are each detected from at least two locations of the organism. For the purposes of examination, the claim limitation is herein interpreted to mean the first hemodynamic signal and the second hemodynamic signal, collectively, are collected from at least two locations of the organism (one signal from one location). Therefore, claim 2 is rendered indefinite.
Regarding Claim 10, the claim limitations “light emitting unit” and “light receiving unit” invoke 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. The specification states the light may be coherent light or laser light in paragraph [0048]. However, the specification fails to disclose any structure that would emit coherent or laser light. The specification also fails to disclose any structure that would receive the coherent or laser light. 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. Claim 11 is rejected due to its dependence on claim 10.
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.
Regarding Claim 14, the claim recites “the blood flow velocity corrected by the correction unit”. There is insufficient basis for “the correction unit”. For the purposes of examination, this limitation is herein interpreted to be the corrected blood flow velocity. Therefore, claim 14 is rendered indefinite.
Regarding Claim 15, the claim recites “the first hemodynamic signal and the second hemodynamic signal detected from at least two locations of the organism”. It is unclear if the first hemodynamic signal and the second hemodynamic signal are each detected from at least two locations of the organism. For the purposes of examination, the claim limitation is herein interpreted to mean the first hemodynamic signal and the second hemodynamic signal, collectively, are collected from at least two locations of the organism (one signal from one location). Therefore, claim 15 is rendered indefinite.
Regarding Claim 18, the claim recites “the first hemodynamic signal”. There is insufficient antecedent basis for this claim limitation. For the purposes of examination, “the first hemodynamic signal” is herein interpreted to be a first hemodynamic signal. The claim also recites "the periodicity of each of the second plurality of component signals". There is insufficient antecedent basis for this limitation. The claim does not recite periodicity is calculated for each of the second plurality of component signals instead the claim recites "respective component signals of the second plurality of component signals are decomposed and output by the processor". Due to the insufficient antecedent basis for “the periodicity of each of the second plurality of component signals", it is unclear how a correlation can be determined. Also, it is unclear how the respective component signals of the second plurality of component signals are decomposed further. For the purposes of examination, "calculate, using an autocorrelation, a periodicity at which respective component signals of the first plurality of component signals and respective component signals of the second plurality of component signals are decomposed and output by the processor" is herein interpreted to mean calculate, using an autocorrelation, a periodicity of each respective component signal of the first plurality of component signals and each respective component signal of the second plurality of component signals. Based on this interpretation of aforementioned claim limitation, it is unclear how a hemodynamic element can be identified based on a correlation between the periodicity of each of the first plurality of component signals and the periodicity of each of the second plurality of component signals because there are more than two periodicities. A correlation is calculated between two things. For the purposes of examination, “identify a hemodynamic element based on a correlation between: the periodicity of the first plurality of component signals; and the periodicity of each of the second plurality of component signals” is herein interpreted to be identify a hemodynamic element based on a correlation between any two of: the periodicity of the first plurality of component signals; and the periodicity of each of the second plurality of component signals. Due to the aforementioned reasons, claim 18 is rendered indefinite.
Regarding Claim 19, the claim recites “receiving, a processor and via a detector, hemodynamic signals”. It is unclear how a processor can be received. For the purposes of examination, “receiving, a processor and via a detector, hemodynamic signals” is herein interpreted to be receiving, via a processor and via a detector, hemodynamic signals. The claim also recites "the periodicity of each of the second plurality of component signals". There is insufficient antecedent basis for this limitation. The claim does not recite periodicity is calculated for each of the second plurality of component signals instead the claim recites "respective component signals of the second plurality of component signals are decomposed and output by the processor". Due to the insufficient antecedent basis for “the periodicity of each of the second plurality of component signals", it is unclear how a correlation can be determined. Also, it is unclear how the respective component signals of the second plurality of component signals are decomposed further. For the purposes of examination, "calculating, by the processor, a periodicity at which respective component signals of the first plurality of component signals and respective component signals of the second plurality of component signals are decomposed and output by the processor" is herein interpreted to mean calculating, by the processor, a periodicity of each respective component signal of the first plurality of component signals and each respective component signal of the second plurality of component signals. Based on this interpretation of aforementioned claim limitation, it is unclear how a hemodynamic element can be identified based on a correlation between the periodicity of each of the first plurality of component signals and the periodicity of each of the second plurality of component signals because there are more than two periodicities. A correlation is calculated between two things. For the purposes of examination, “identifying, by the processor, a hemodynamic element based on a correlation between: the periodicity of the first plurality of component signals; and the periodicity of each of the second plurality of component signals” is herein interpreted to be identifying, by a processor, a hemodynamic element based on a correlation between any two of: the periodicity of the first plurality of component signals; and the periodicity of each of the second plurality of component signals. Due to the aforementioned reasons, claim 19 is rendered indefinite.
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 1-19 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 19 follows.
STEP 1
Regarding claim 19, the claim recites a series of steps or acts, including receiving a first hemodynamic signal detected using a first detector channel. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of identifying, by the processor, a hemodynamic element based on a correlation between: the periodicity of each of the first plurality of component signals; and the periodicity of each of the second plurality of component signals sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
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 19 fails to recite any additional elements that integrate the judicial exception into a practical application. The identification of a hemodynamic element 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 identified hemodynamic element, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
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 additional steps of receiving, a processor and via a detector, hemodynamic signals from an organism, wherein receiving the hemodynamic signals comprises: receiving a first hemodynamic signal detected using a first detector channel; and receiving a second hemodynamic signal using a second detector channel; decomposing, by the processor, the hemodynamic signals detected from the organism into a first plurality of component signals included in the first hemodynamic signal; and a second plurality of component signals included in the second hemodynamic signal; calculating, by the processor, a periodicity of each at which respective component signals of the first plurality of component signals and respective component signals of the second plurality of component signals are decomposed and output by the processor. Receiving signals is merely pre-solution activity. Decomposing signals (a hemodynamic signal) in order to determine what a signal (component signals) is indicative of (hemodynamic element) is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the calculating step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data processing 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 processing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do 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)). The recitation of a processor does not add any meaning limitation to the exception. A processor is a generic computational device and the human mind can be considered a processor.
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.
Regarding claims 1 and 18, the device/system recited in the claims is a generic device comprising generic components configured to perform the abstract idea. The recited detector is a generic device configured to gather data and the recited processor is a generic device configured to perform data processing activity and the Abstract Idea. 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.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and data processing. The decomposing and calculating steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims. Dependent claims 6 and 7 recite a particular formula used to perform the calculating steps of the independent claims. However, those claims recite mathematical concepts and therefore, fail to add something more to the abstract independent claims. Claim 10 recites more structural elements including “a detection unit”, “a light emitting unit”, and “a light receiving unit”. The recited components are generic computer elements used to perform pre-solution data gathering activity that fail to add something more to the abstract independent claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5, 9-11, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Demirtas et al. (US Patent Pub. No. 20180000424 – previously cited) hereinafter Demirtas in view of Baker, JR. et al. (US Patent Pub. No. 20110245628 – previously cited) hereinafter Baker, and further in view of Mohler et al. (US Patent Pub. No. 20030229289) hereinafter Mohler.
Regarding Claim 1, Demirtas discloses a biological information obtainment device (heart rate measuring apparatus [0018; 0027]; fig 1 & 2) comprising:
a detector configured to detect hemodynamic signals directly from an organism (the apparatus of FIG. 2 may include a light source 102 and an optical sensor 104. The light source can be a light emitting diode (LED), or any suitable component for emitting light. The light emitted by the light source 102 for measuring heart rate (e.g., blood volume) can be any suitable wavelength depending on the application. The apparatus can include a plurality of light sources emitting a range of wavelengths of light. The optical sensor 104 may be the same device as the light source 102, or the optical sensor 104 may be provided near the light source 102 to measure light near the optical sensor 104, e.g., to measure absorption of light emitted by the light source 102 in the skin to implement PPG. [0028]);
and a processor operably coupled to the detector (An analog front end module 204, which could include e.g. one or more integrated circuits, may be provided to drive the light source 102 and provide an analog front end to receive signals provided by the optical sensor 104, accelerometer 110, and other sensors 202. In some embodiments, the analog front end 204 can convert (if desired) analog input signals to data samples of the analog input signal. The analog front end can communicate with a processor 206 to provide the data samples, which the processor 206 would process to determine the heart rate. [0028]; fig 2), wherein the processor is configured to:
receive the hemodynamic signals from the detector via a channel (a light source 102 and an optical sensor 104… The light emitted by the light source 102 for measuring heart rate (e.g., blood volume) can be any suitable wavelength depending on the application. [0028]; fig 1);
calculate a periodicity of the hemodynamic signals (computation of an autocorrelation function (AF) or a Square Difference Function (SDF) which yields results similar to those of the autocorrelation function [0033]; a computed autocorrelation is indicative of the similarity between observations as a function of the time lag between them and is often used as a mathematical tool for finding repeating patterns, such as the presence of a periodic signal obscured by noise, or identifying the missing fundamental frequency in a signal implied by its harmonic frequencies [0043]);
and identify a hemodynamic element based the periodicity (first HR estimator 210 may be configured to implement functions related to processing data samples of the input signal based on the decision(s) in the signal checker 208 to provide an estimate of the HR using a first method. Such a first method may involve computation of an autocorrelation function (AF) or a Square Difference Function (SDF) which yields results similar to those of the autocorrelation function [0033]).
Demirtas fails to disclose a detector configured to detect hemodynamic signals directly from an organism and using at least two detector channels; and a processor operably coupled to the detector, wherein the processor is configured to: receive the hemodynamic signals from the detector via a first channel, and a second channel, of the at least two detector channels;
decompose the hemodynamic signals into:
a first plurality of component signals included in a first hemodynamic signal detected using the first channel;
and a second plurality of component signals included in a second hemodynamic signal using the second channel;
calculate a periodicity of each respective component signals of the first plurality of component signals
and each respective component signals of the second plurality of component signals;
and identify a hemodynamic element based on a correlation between any two of: the periodicity of each of the first plurality of component signals; and the periodicity of each of the second plurality of component signals.
However, Baker teaches a biological information obtainment device (systems and methods of processing physiological signals corresponding to blood flow in a patient [0013]) comprising:
a processor that decomposes a hemodynamic signal detected from an organism into a plurality of component signals (processor 32 may apply algorithms such as empirical mode decomposition (EMD) algorithms, to extract frequency components from the physiological signal [0022]; a process 70 for applying an empirical mode decomposition (EMD) algorithm to obtain intrinsic mode functions from a physiological signal is provided as a flow chart in FIG. 3. The process 70 may be applied to any physiological signal X(t) 72, including a pulse oximetry signal, a plethysmographic signal, or any other signal corresponding to blood flow in a patient. [0023]; Using EMD may be particularly useful for physiological signals which may include frequency variations attributable to any number of physiological causes (e.g., pulse variations, respiratory variations, etc.). Such variations in a physiological signal may occur at specific times or in specific intervals, and analyzing the variations in the time domain may enable the determination of different causes for the variations in the physiological signal. Thus, EMD techniques may provide further physiological information not available under other methods of signal processing which transform time-domain signals out of the time domain and into the frequency domain or wavelet domain. For example, time information may not be preserved when using Fourier transforms, and certain physiological information may not be attainable by using only Fourier transforms to analyze a physiological signal. [0015]).
Baker is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the device of Demirtas such that the processor is configured to decompose a hemodynamic signal detected from an organism into a plurality of component signals, as taught by Baker, because decomposing the hemodynamic signal would provide more physiological information than analyzing the hemodynamic signal alone.
The modified device of Demirtas in view of Baker fails to teach a detector configured to detect hemodynamic signals directly from an organism and using at least two detector channels; and a processor operably coupled to the detector, wherein the processor is configured to: receive the hemodynamic signals from the detector via a first channel, and a second channel, of the at least two detector channels;
decompose the hemodynamic signals into:
a first plurality of component signals included in a first hemodynamic signal detected using the first channel;
and a second plurality of component signals included in a second hemodynamic signal using the second channel;
calculate a periodicity of each respective component signals of the first plurality of component signals
and each respective component signals of the second plurality of component signals;
and identify a hemodynamic element based on a correlation between any two of: the periodicity of each of the first plurality of component signals; and the periodicity of each of the second plurality of component signals.
However, Mohler teaches acquiring hemodynamic signals from multiple locations of an organism to better capture signals from the heart (As is illustrated in FIG. 2, the cardiovascular sound signals acquired from one location on the patient's percordium include a plurality (at least two) heart cycle signals 92 to define one heart waveform signal 94. Similar waveforms of other cardiovascular sound signals may be acquired from other areas of the body... More particularly, and as is illustrated in FIG. 3, the sensor 110 is placed at nine locations R1, R2, R3, S1, S2, S3, L1, L2, and L3 on the patient's precordium that form a 3.times.3 grid roughly over the patient's heart. Hence, the sensor 110 will acquire cardiovascular sound signals having nine different heart waveform signals 94, where each heart waveform signal has a plurality of heart cycles 92. [0098]; because the heart is not isolated from the body, the acquired cardiovascular sound signals will typically include other sounds as well, such as the sounds of air moving through the lungs [0099]), calculating a periodicity of the hemodynamic signals (Referring again to FIG. 7, the smoothed cardiovascular sound waveform generated in step 2205 is then convolved with itself in a step 2210 to generate an autocorrelation that can be used as an initial estimate of the start point of each heart cycle signal within the acquired cardiovascular sound signals. [0123]), and identifying a hemodynamic element based on a correlation between the periodicities of the hemodynamic signals (Once the correlations are carried out, an analysis of the peaks is then conducted to isolate those peaks that most likely belong to the heartbeat sequence. During this analysis, a parsing score is carried along with the peak analysis results to quantify the quality of the process of predicting the start points of each heart cycle. If the parsing score for the peak analysis process based on the peak detect envelope reflects that detected peaks do not accurately align with all of the actual cardiovascular sound signals, then additional processing is carried out. [0120]; In one embodiment, step 2220 ends here if a parsing score of 1.00 is achieved, indicating no anomalies in the peaks from the correlation function. In some cases, however, the peaks are not so clear, such as when the heartbeat waveforms are distorted from various physical disorders of the heart. [0142]; Referring to FIG. 7, at a step 2240, a parsing score is calculated based on the expected start points in the start point table determined in step 2308. FIG. 25 details step 2240. [0154]; fig 7 & 25).
Mohler is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the device of Demirtas in view of Baker such that the detector is configured to detect hemodynamic signals from the organism using at least two detector channels at least two locations and the hemodynamic element is identified based on a correlation between the two detected hemodynamic signals, as taught by Mohler, because it would allow for acquiring different heart waveform signals to better isolate signals originating from the heart.
The modified device of Demirtas in view of Baker and further in view of Mohler teaches a processor operably coupled to the detector, wherein the processor is configured to: receive the hemodynamic signals from the detector via a first channel, and a second channel, of the at least two detector channels;
decompose the hemodynamic signals into:
a first plurality of component signals included in a first hemodynamic signal detected using the first channel;
and a second plurality of component signals included in a second hemodynamic signal using the second channel;
calculate a periodicity of each respective component signals of the first plurality of component signals
and each respective component signals of the second plurality of component signals;
and identify a hemodynamic element based on a correlation between any two of: the periodicity of each of the first plurality of component signals; and the periodicity of each of the second plurality of component signals.
Regarding Claim 2, Demirtas in view of Baker and further in view of Mohler teaches the invention as discussed above in claim 1. The modified device of Demirtas in view of Baker and further in view of Mohler teaches wherein to decompose the hemodynamic signals, the processor is configured to decompose: the first hemodynamic signal into the first plurality of component signals; and the second hemodynamic signal into the second plurality of signals, detected from at least two locations of the organism. The sections of Demirtas in view of Baker and further in view of Mohler cited above for claim 1 teach the limitations set forth in this claim.
Regarding Claim 3, Demirtas in view of Baker and further in view of Mohler teaches the invention as discussed above in claim 1. Demirtas in view of Baker and further in view of Mohler teaches the hemodynamic element includes at least one of heartbeat component, a vasomotion component, and a pseudo-blood flow component (provide an estimate of the HR [0033 of Demirtas]; each intrinsic mode function decomposed from a physiological signal may correspond to a physiological condition of the patient, including, for example, a pulse rate, respiratory rate, respiratory effort, sympathetic nervous activity, or any other repetitive variation affecting the patient's blood flow characteristics [0013 of Baker]; the processor 150, processes the received cardiovascular signals to eventually generate at a step 5000 the probability indicator indicative of the likelihood that the patient has cardiovascular disease (also referred to herein as the Flow Murmur Score) [0108 of Mohler]).
Regarding Claim 4, Demirtas in view of Baker and further in view of Mohler teaches the invention as discussed above in claim 1. Demirtas in view of Baker and further in view of Mohler teaches wherein to decompose the hemodynamic signals, the processor is configured to use empirical mode decomposition (processor 32 may apply algorithms such as empirical mode decomposition (EMD) algorithms, to extract frequency components from the physiological signal [0022 of Baker]).
Regarding Claim 5, Demirtas in view of Baker and further in view of Mohler teaches the invention as discussed above in claim 1. Demirtas in view of Baker and further in view of Mohler teaches wherein to calculate the periodicity, the processor is further configured to use an autocorrelation (a computed autocorrelation is indicative of the similarity between observations as a function of the time lag between them and is often used as a mathematical tool for finding repeating patterns, such as the presence of a periodic signal obscured by noise, or identifying the missing fundamental frequency in a signal implied by its harmonic frequencies [0043 of Demirtas]).
Regarding Claim 9, Demirtas in view of Baker and further in view of Mohler teaches the invention as discussed above in claim 1. Demirtas in view of Baker and further in view of Mohler teaches wherein the detector includes: a detection unit that detects the first hemodynamic signal and the second hemodynamic signal (a light source 102 and an optical sensor 104… The light emitted by the light source 102 for measuring heart rate (e.g., blood volume) can be any suitable wavelength depending on the application. [0028 of Demirtas]; fig 1 of Demirtas).
Regarding Claim 10, Demirtas in view of Baker and further in view of Mohler teaches the invention as discussed above in claim 9. Demirtas in view of Baker and further in view of Mohler teaches the detection unit includes: a light emitting unit that irradiates the organism with light (light emitted by the light source 102 in the skin [0028 of Demirtas]; fig 1 of Demirtas); and a light receiving unit that detects light produced as a result of irradiating the organism with the light (the optical sensor 104 may be provided near the light source 102 to measure light near the optical sensor 104, e.g., to measure absorption of light emitted by the light source 102 in the skin [0028 of Demirtas]; fig 1 of Demirtas).
Regarding Claim 11, Demirtas in view of Baker and further in view of Mohler teaches the invention as discussed above in claim 10. The sections of Demirtas in view of Baker and further in view of Mohler cited above for claims 1 and 10 teach the limitations set forth in this claim. It is to be noted, the modified device of Demirtas in view of Baker and further in view of Mohler teaches the detection unit includes at least two of the light receiving units because the detection unit has at least two detector channels, meaning at least two light receiving units.
Regarding Claim 19, Demirtas discloses a biological information obtainment method (Heart Rate Measuring Apparatus and Method [0026]), comprising:
receiving, via a processor (An analog front end module 204, which could include e.g. one or more integrated circuits, may be provided to drive the light source 102 and provide an analog front end to receive signals provided by the optical sensor 104, accelerometer 110, and other sensors 202. In some embodiments, the analog front end 204 can convert (if desired) analog input signals to data samples of the analog input signal. The analog front end can communicate with a processor 206 to provide the data samples, which the processor 206 would process to determine the heart rate. [0028]; fig 2) and via a detector, hemodynamic signals from an organism (the apparatus of FIG. 2 may include a light source 102 and an optical sensor 104. The light source can be a light emitting diode (LED), or any suitable component for emitting light. The light emitted by the light source 102 for measuring heart rate (e.g., blood volume) can be any suitable wavelength depending on the application. The apparatus can include a plurality of light sources emitting a range of wavelengths of light. The optical sensor 104 may be the same device as the light source 102, or the optical sensor 104 may be provided near the light source 102 to measure light near the optical sensor 104, e.g., to measure absorption of light emitted by the light source 102 in the skin to implement PPG. [0028]), wherein receiving the hemodynamic signals comprises:
receiving the hemodynamic signals from the detector via a channel (a light source 102 and an optical sensor 104… The light emitted by the light source 102 for measuring heart rate (e.g., blood volume) can be any suitable wavelength depending on the application. [0028]; fig 1);
calculating, by the processor, a periodicity of the hemodynamic signals (computation of an autocorrelation function (AF) or a Square Difference Function (SDF) which yields results similar to those of the autocorrelation function [0033]; a computed autocorrelation is indicative of the similarity between observations as a function of the time lag between them and is often used as a mathematical tool for finding repeating patterns, such as the presence of a periodic signal obscured by noise, or identifying the missing fundamental frequency in a signal implied by its harmonic frequencies [0043]);
and identifying, by the processor, a hemodynamic element based the periodicity (first HR estimator 210 may be configured to implement functions related to processing data samples of the input signal based on the decision(s) in the signal checker 208 to provide an estimate of the HR using a first method. Such a first method may involve computation of an autocorrelation function (AF) or a Square Difference Function (SDF) which yields results similar to those of the autocorrelation function [0033]).
Demirtas fails to disclose wherein receiving the hemodynamic signals comprises:
receiving a first hemodynamic signal using a first detector channel;
and receiving a second hemodynamic signal detected using a second detector channel;
decomposing, by the processor, the hemodynamic signals detected from the organism into:
a first plurality of component signals included in the first hemodynamic signal;
and a second plurality of component signals included in the second hemodynamic signal;
calculating, by the processor, a periodicity of each respective component signal of the first plurality of component signals and each respective component signal of the second plurality of component signals;
and identifying, by the processor, a hemodynamic element based on a correlation between any two of:
the periodicity of the first plurality of component signals; and the periodicity of each of the second plurality of component signals.
However, Baker teaches a biological information obtainment device (systems and methods of processing physiological signals corresponding to blood flow in a patient [0013]) comprising:
a processor that decomposes a hemodynamic signal detected from an organism into a plurality of component signals (processor 32 may apply algorithms such as empirical mode decomposition (EMD) algorithms, to extract frequency components from the physiological signal [0022]; a process 70 for applying an empirical mode decomposition (EMD) algorithm to obtain intrinsic mode functions from a physiological signal is provided as a flow chart in FIG. 3. The process 70 may be applied to any physiological signal X(t) 72, including a pulse oximetry signal, a plethysmographic signal, or any other signal corresponding to blood flow in a patient. [0023]; Using EMD may be particularly useful for physiological signals which may include frequency variations attributable to any number of physiological causes (e.g., pulse variations, respiratory variations, etc.). Such variations in a physiological signal may occur at specific times or in specific intervals, and analyzing the variations in the time domain may enable the determination of different causes for the variations in the physiological signal. Thus, EMD techniques may provide further physiological information not available under other methods of signal processing which transform time-domain signals out of the time domain and into the frequency domain or wavelet domain. For example, time information may not be preserved when using Fourier transforms, and certain physiological information may not be attainable by using only Fourier transforms to analyze a physiological signal. [0015]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Demirtas such that it includes decomposing, by the processor, the hemodynamic signals detected from the organism into a plurality of component signals, as taught by Baker, because decomposing the hemodynamic signal would provide more physiological information than analyzing the hemodynamic signal alone.
The modified method of Demirtas in view of Baker fails to teach wherein receiving the hemodynamic signals comprises:
receiving a first hemodynamic signal using a first detector channel;
and receiving a second hemodynamic signal detected using a second detector channel;
decomposing, by the processor, the hemodynamic signals detected from the organism into:
a first plurality of component signals included in the first hemodynamic signal;
and a second plurality of component signals included in the second hemodynamic signal;
calculating, by the processor, a periodicity of each respective component signal of the first plurality of component signals and each respective component signal of the second plurality of component signals;
and identifying, by the processor, a hemodynamic element based on a correlation between any two of:
the periodicity of the first plurality of component signals; and the periodicity of each of the second plurality of component signals.
However, Mohler teaches acquiring hemodynamic signals from multiple locations of an organism to better capture signals from the heart (As is illustrated in FIG. 2, the cardiovascular sound signals acquired from one location on the patient's percordium include a plurality (at least two) heart cycle signals 92 to define one heart waveform signal 94. Similar waveforms of other cardiovascular sound signals may be acquired from other areas of the body... More particularly, and as is illustrated in FIG. 3, the sensor 110 is placed at nine locations R1, R2, R3, S1, S2, S3, L1, L2, and L3 on the patient's precordium that form a 3.times.3 grid roughly over the patient's heart. Hence, the sensor 110 will acquire cardiovascular sound signals having nine different heart waveform signals 94, where each heart waveform signal has a plurality of heart cycles 92. [0098]; because the heart is not isolated from the body, the acquired cardiovascular sound signals will typically include other sounds as well, such as the sounds of air moving through the lungs [0099]), calculating a periodicity of the hemodynamic signals (Referring again to FIG. 7, the smoothed cardiovascular sound waveform generated in step 2205 is then convolved with itself in a step 2210 to generate an autocorrelation that can be used as an initial estimate of the start point of each heart cycle signal within the acquired cardiovascular sound signals. [0123]), and identifying a hemodynamic element based on a correlation between the periodicities of the hemodynamic signals (Once the correlations are carried out, an analysis of the peaks is then conducted to isolate those peaks that most likely belong to the heartbeat sequence. During this analysis, a parsing score is carried along with the peak analysis results to quantify the quality of the process of predicting the start points of each heart cycle. If the parsing score for the peak analysis process based on the peak detect envelope reflects that detected peaks do not accurately align with all of the actual cardiovascular sound signals, then additional processing is carried out. [0120]; In one embodiment, step 2220 ends here if a parsing score of 1.00 is achieved, indicating no anomalies in the peaks from the correlation function. In some cases, however, the peaks are not so clear, such as when the heartbeat waveforms are distorted from various physical disorders of the heart. [0142]; Referring to FIG. 7, at a step 2240, a parsing score is calculated based on the expected start points in the start point table determined in step 2308. FIG. 25 details step 2240. [0154]; fig 7 & 25).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Demirtas in view of Baker such that a first and a second hemodynamic signal detected using a first and second detector channel, respectively, are received and the hemodynamic element is identified based on a correlation between the two detected hemodynamic signals, as taught by Mohler, because it would allow for acquiring different heart waveform signals to better isolate signals originating from the heart.
The modified device of Demirtas in view of Baker and further in view of Mohler teaches wherein receiving the hemodynamic signals comprises:
receiving a first hemodynamic signal using a first detector channel;
and receiving a second hemodynamic signal detected using a second detector channel;
decomposing, by the processor, the hemodynamic signals detected from the organism into:
a first plurality of component signals included in the first hemodynamic signal;
and a second plurality of component signals included in the second hemodynamic signal;
calculating, by the processor, a periodicity of each respective component signal of the first plurality of component signals and each respective component signal of the second plurality of component signals;
and identifying, by the processor, a hemodynamic element based on a correlation between any two of:
the periodicity of the first plurality of component signals; and the periodicity of each of the second plurality of component signals.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Demirtas et al. (US Patent Pub. No. 20180000424 – previously cited) hereinafter Demirtas in view of Baker, JR. et al. (US Patent Pub. No. 20110245628 – previously cited) hereinafter Baker, and view of Mohler et al. (US Patent Pub. No. 20030229289) hereinafter Mohler, as applied to claim 5 above, and further in view of Monti et al. (Monophonic Transcription With Autocorrelation – previously cited) hereinafter Monti.
Regarding Claim 6, Demirtas in view of Baker and further in view of Mohler teaches the invention as discussed above in claim 5. Demirtas in view of Baker and further in view of Mohler fails to teach an autocorrelation R(τ) is calculated according to Formula (1) below using a value v(i) of the component signal at time i, a delay time τ, and a number N of sampling data contained in the component signal.
PNG
media_image1.png
131
579
media_image1.png
Greyscale
However, Monti teaches a formula for “autocorrelation of an N-length sequence x(k)”, “where n is the lag, or the period length, and x(n) is a time domain signal” (see image below, pg. 1).
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media_image2.png
81
344
media_image2.png
Greyscale
Monti is considered analogous art to the present invention because it is reasonably pertinent to a problem faced by the inventors.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the device of Demirtas in view of Baker and further in view of Mohler such that the autocorrelation is performed using the formula taught by Monti, because Demirtas requires use of an autocorrelation function, but fails to discloses details of the autocorrelation function, and Monti provides details of an autocorrelation function that can be used by the device of Demirtas in view of Baker and further in view of Mohler.
Claim(s) 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Demirtas et al. (US Patent Pub. No. 20180000424 – previously cited) hereinafter Demirtas in view of Baker, JR. et al. (US Patent Pub. No. 20110245628 – previously cited) hereinafter Baker, and view of Mohler et al. (US Patent Pub. No. 20030229289) hereinafter Mohler, as applied to claim 1 above, and further in view of Hidaka et al. (US Patent. Pub. No. 20190167123 – previously cited) hereinafter Hidaka and Takahashi et al. (US Patent Pub. No. 20110098582 – previously cited) hereinafter Takahashi.
Regarding Claim 12, Demirtas in view of Baker and further in view of Mohler teaches the invention as discussed above in claim 1. The modified device of Demirtas in view of Baker and further in view of Mohler teaches a detection unit, attached to a head, that detects the first hemodynamic signal and the second hemodynamic (The light source shines a light onto a part 106 of a living being 106…Various parts of the living being can be used as part 106, e.g., a finger, an arm, a forehead [0020 of Demirtas]; a light source 102 and an optical sensor 104… The light emitted by the light source 102 for measuring heart rate (e.g., blood volume) can be any suitable wavelength depending on the application. [0028 of Demirtas]; fig 1 of Demirtas).
Demirtas in view of Baker and further in view of Mohler fails to teach the processor is further configured to: measure an amount of change in a position of the detection unit;
generate correction information for a blood flow velocity based on the amount of change in the position;
and correct a blood flow velocity included in the first hemodynamic signal and the second hemodynamic signal detected by the detection unit.
However, Hidaka teaches a biological information obtainment device (a biological information measurement device 100 [0026]) comprising:
a detection unit, attached to a head, that detects the hemodynamic signal (measurement portion 110 measures biological information in a state in which the biological information measurement device 100 is worn on a human head [0028]; fig 1);
and a processor that measures an amount of change in a position of the detection unit (controller 101 includes a processor that controls and manages the entire sensor 111 [0071]; second sensor 111d includes an acceleration sensor 111e and a gyro sensor 111f, and detects movement of the wearer. The acceleration sensor 111e detects acceleration of the wearer. The gyro sensor 111f detects angular velocity or angular acceleration of the wearer. [0053]; second sensor 111d may be located in the sensor 111 [0056]; measurement portion 110 includes a sensor 111 [0049]; fig 15).
Hidaka also teaches “The sensor 111 according to an embodiment of the present disclosure detects the movement of the wearer by the second sensor 111d, and corrects for the influence of the movement of the wearer on the biological information based on the detected movement. Consequently, the sensor 111 can accurately measure the biological information, without being affected by the movement of the wearer” [0056] and “The biological information measured by the measurement portion 110 includes any biological information that can be measured by detecting the state of blood flowing through a blood vessel. Examples of the biological information measured by the measurement portion 110 include the blood flow volume of blood flowing through a blood vessel, oxygen content in hemoglobin in red blood cells, pulse wave, pulse, pulse wave velocity, blood oxygen saturation level, and blood oxygen level. [0028]; Because blood is a substance having a weight, when a person moves, the speed of blood flow may increase or decrease with the movement. Thus, the sensor 111 may be unable to accurately measure biological information when the wearer of the biological information measurement device 100 moves [0055].
Hidaka is considered analogous art to the present invention because it directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the biological information obtainment device of Demirtas in view of Baker and further in view of Mohler such that the processor is further configured to measure an amount of change in a position of the detection unit, as taught by Hidaka, because doing so would allow for more accurate measurements of biological information of the user. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Demirtas in view of Baker in view of Mohler and further in view of Hidaka fails to teach the processor is further configured to: generate correction information for a blood flow velocity based on the amount of change in the position; and correct a blood flow velocity included in the first hemodynamic signal and the second hemodynamic signal detected by the detection unit.
However, Takahashi teaches a biological information obtainment device (a pulse detector 2 [0078]; fig 1) comprising:
a processor configured to measure an amount of change in a position (A motion sensor 30 is configured by an acceleration sensor or the like and measures a motion signal of the subject. [0092]; fig 1);
and generate correction information for a pulse wave based on the amount of change in the position (The adaptive filter is configured by an FIR filter and calculates an estimated value of the body motion component. [0093]);
and correct a blood flow velocity included in a hemodynamic signal detected by a detection unit (The subtractor subtracts the estimated value from the second pulse wave signal. [0093]).
Takahashi is considered analogous art to the present invention because it directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the biological information obtainment device of Demirtas in view of Baker and further in view of Hidaka such that the processor is further configured to generate correction information for a blood flow velocity based on the amount of change in the position; and correct a blood flow velocity included in the first hemodynamic signal and the second hemodynamic signal detected by the detection unit, as taught by Takahashi, because it would correct for the influence of the movement of the wearer on the biological information based on the detected movement, as taught by Hidaka. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Regarding Claim 13, Demirtas in view of Baker in view of Mohler and further in view of Hidaka, and further in view of Takahashi teaches the invention as discussed above in claim 12. Demirtas in view of Baker in view of Mohler and further in view of Hidaka, and further in view of Takahashi teaches the amount of change is an amount of change in a tilt of the detection unit or an amount of change in a height of the detection unit (The acceleration sensor 111e detects acceleration of the wearer. The gyro sensor 111f detects angular velocity or angular acceleration of the wearer. [0053 of Hidaka]).
Regarding Claim 14, Demirtas in view of Baker in view of Mohler and further in view of Hidaka, and further in view of Takahashi teaches the invention as discussed above in claim 12. Demirtas in view of Baker in view of Mohler and further in view of Hidaka, and further in view of Takahashi further teaches wherein to decompose the hemodynamic signals, the processor is configured to decomposes the hemodynamic signals (processor 32 may apply algorithms such as empirical mode decomposition (EMD) algorithms, to extract frequency components from the physiological signal [0022 of Baker]) including the blood flow velocity (The biological information measured by the measurement portion 110 includes any biological information that can be measured by detecting the state of blood flowing through a blood vessel. Examples of the biological information measured by the measurement portion 110 include the blood flow volume of blood flowing through a blood vessel, oxygen content in hemoglobin in red blood cells, pulse wave, pulse, pulse wave velocity, blood oxygen saturation level, and blood oxygen level. [0028 of Hidaka]; Because blood is a substance having a weight, when a person moves, the speed of blood flow may increase or decrease with the movement. [0055 of Hidaka]) corrected by the correction unit (The subtractor subtracts the estimated value from the second pulse wave signal. [0093 of Takahashi]) into a plurality of component signals, and the processor is further configured to identify the hemodynamic element based on a correlation between the first plurality of component signals and the second plurality of component signals and the correction information (an autocorrelation of data samples of the first signal over a first time period (T1); processing (408) a second signal to evaluate motion of the heartbeat sensor during the first time period... determining (422) the heart rate based on the first estimate and the second estimate [0111 of Demirtas]; fig 4 of Demirtas).
Regarding Claim 15, Demirtas in view of Baker in view of Mohler and further in view of Hidaka, and further in view of Takahashi teaches the invention as discussed above in claim 12. Demirtas in view of Baker in view of Mohler and further in view of Hidaka, and further in view of Takahashi teaches wherein to decompose the hemodynamic signals, the processor is configured to decompose the first hemodynamic signal and the second hemodynamic signal detected from at least two locations of the organism into the first plurality of component signals and the second plurality of component signals (the sections of Demirtas in view of Baker and further in view of Mohler cited above for claim 1 teaches the limitations set forth in the aforementioned claim limitation), and the processor is further configured to identify
the hemodynamic element based on the correlation (an autocorrelation of data samples of the first signal over a first time period (T1); processing (408) a second signal to evaluate motion of the heartbeat sensor during the first time period... determining (422) the heart rate based on the first estimate and the second estimate [0111 of Demirtas]; first HR estimator 210 may be configured to implement functions related to processing data samples of the input signal based on the decision(s) in the signal checker 208 to provide an estimate of the HR using a first method. Such a first method may involve computation of an autocorrelation function (AF) or a Square Difference Function (SDF) which yields results similar to those of the autocorrelation function [0033 of Demirtas]).
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Demirtas et al. (US Patent Pub. No. 20180000424 – previously cited) hereinafter Demirtas in view of Baker, JR. et al. (US Patent Pub. No. 20110245628 – previously cited) hereinafter Baker, and view of Mohler et al. (US Patent Pub. No. 20030229289) hereinafter Mohler, and further in view of Hidaka (US Patent. Pub. No. 20190167123 – previously cited) and Takahashi (US Patent Pub. No. 20110098582 – previously cited) as applied to claim 12 above, and further in view of Ishikawa (US Patent Pub. No. 20180146926 – previously cited).
Regarding Claim 16, Demirtas in view of Baker in view of Mohler and further in view of Hidaka, and further in view of Takahashi teaches the invention as discussed above in claim 12. Demirtas in view of Baker in view of Mohler and further in view of Hidaka, and further in view of Takahashi teaches wherein to generate the correction information, the processor is configured to generate the correction information based on: the amount of change in the position (The adaptive filter is configured by an FIR filter and calculates an estimated value of the body motion component. [0093 of Takahashi]).
Demirtas in view of Baker in view of Mohler and further in view of Hidaka, and further in view of Takahashi fails to teach wherein to generate the correction information, the processor is configured to generate the correction information based on: a position characteristic correction parameter set based on a relationship between the position of the detection unit and an amount of fluctuation in the blood flow velocity, and/or a transient characteristic correction parameter pertaining to transient characteristics of the blood flow velocity, wherein the position characteristic correction parameter and/or transient characteristic correction parameter are set or updated according to the organism whose blood flow is to be measured by the biological information obtainment device, and wherein the transient characteristic correction parameter is representative of changes in the blood flow velocity changes with a time delay relative to a change in the position of the detection unit attached to the head.
However, Ishikawa teaches a biological information obtainment device (a biological information processing device [0047]; fig 1) comprising: a detection unit (a PPG sensor (a pulse wave sensor) 1 [0048]; fig 1), and a processor that can measure position change amount (an acceleration sensor (a body motion sensor) 2 [0048]; fig 1), correction information (a noise reduction processing unit 6 [0048]; noise reduction processing unit 6 includes an adaptive filter 62, an IIR filter 64, and a subtractor 65 [0064]; fig 1). Ishikawa teaches the processor generates the correction information based on: the amount of change in the position; and a position characteristic correction parameter set based on a relationship between the position of the detection unit and an amount of fluctuation in the blood flow velocity, and/or a transient characteristic correction parameter pertaining to transient characteristics of the blood flow velocity (use of an FIR filter coefficient, as the adaptive filter coefficient (w), that has been calculated in advance in consideration of the influence of the body motion on the blood flow [0066]; Instead of using the body motion signal as the input signal (x) as it is, the influence of the body motion on the blood flow is modeled as a noise model 61 and the transfer function (the FIR filter coefficient) of the body motion to the blood flow is calculated and recorded in advance. The body motion signal and a model coefficient are inputted into the noise model 61. [0069]), wherein the position characteristic correction parameter and/or transient characteristic correction parameter are set or updated according to an organism whose blood flow is to be measured by the biological information obtainment device (In the NLMS algorithm, an adaptive filter coefficient (w) of the adaptive filter 62 is updated by the following updating expression (2). It is to be noted that the present embodiment involves use of an FIR filter coefficient, as the adaptive filter coefficient (w), that has been calculated in advance in consideration of the influence of the body motion on the blood flow as described later. [0066]) and wherein the transient characteristic correction parameter is representative of changes in the blood flow velocity changes with a time delay relative to a change in the position of the detection unit (In general, time correlation of the instantaneous pulse rate is very high. Accordingly, in a case where the time change of the instantaneous pulse rate is larger than a preset threshold value, the feedback factor calculating section 82 controls the feedback factor of the IIR filter 81 to increase (to a value close to, for example, 1.0), thus making it possible to extrapolate the past instantaneous pulse rate as it is and to modify (reduce) a false detection. In addition, the feedback factor calculating section 82 controls the feedback factor of the IIR filter 81 to have a value smaller than 1.0, for example, about 0.5 during exercise, thus making it possible to stabilize the instantaneous pulse rate. [0095]; fig 13). Ishikawa also teaches “The adaptive filter 62 utilizes results of FIR filtering on the body motion signal as the input signal (x) to allow the convergence time to be improved. In the convergence time, an optimum coefficient is obtained when the body motion intensity and the body motion frequency are changed.” [0069].
Ishikawa is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary art at the time of the effective filing date to have further modified the biological information obtainment device of Demirtas in view of Baker in view of Mohler and further in view of Hidaka, and further in view of Takahashi such that the processor is further configured to generate the correction information based on: the amount of change in the position; and a position characteristic correction parameter set based on a relationship between the position of the detection unit and an amount of fluctuation in the blood flow velocity, and/or a transient characteristic correction parameter pertaining to transient characteristics of the blood flow velocity, wherein the position characteristic correction parameter and/or transient characteristic correction parameter are set or updated according to the organism whose blood flow is to be measured by the biological information obtainment device, and wherein the transient characteristic correction parameter is representative of changes in the blood flow velocity changes with a time delay relative to a change in the position of the detection unit attached to the head, as taught by Ishikawa, because convergence time would be improved. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Regarding Claim 17, Demirtas in view of Baker in view of Mohler in view of Hidaka in view of Takahashi, and further in view of Ishikawa teaches the invention as discussed above in claim 16. Demirtas in view of Baker in view of Mohler in view of Hidaka in view of Takahashi, and further in view of Ishikawa teaches wherein the processor is further configured to update the position characteristic correction parameter and/or the transient characteristic correction parameter based at least in part on the correction information generated by the correction information generation unit (In the NLMS algorithm, an adaptive filter coefficient (w) of the adaptive filter 62 is updated by the following updating expression (2). It is to be noted that the present embodiment involves use of an FIR filter coefficient, as the adaptive filter coefficient (w), that has been calculated in advance in consideration of the influence of the body motion on the blood flow as described later. [0066 of Ishikawa]).
Examiner’s Notes
The following is a statement of reasons for the lack of prior art rejections:
Regarding Claim 7, none of the prior art teaches or suggests, either alone or in combination, a device wherein the processor is configured to calculate an evaluation value E of the correlation through Formula (3) using an evaluation value PA1 of the periodicity of a component signal DA1 included in the first plurality of component signals of the first hemodynamic signal SA, an evaluation value PB1 of the periodicity of a component signal DB1 included in the second plurality of component signals of the second hemodynamic signal SB, and a number N of sampling data contained in the first plurality of component signals and the second plurality of component signals, in combination with the other claimed elements. Claim 8 lacks prior art rejections due to its dependence on claim 7.
Regarding Claim 18, none of the prior art teaches or suggests, either alone or in combination, a system wherein the processor is configured to calculate an evaluation value E of the correlation through Formula (3) using an evaluation value PA1 of the periodicity of a component signal DA1 included in the first plurality of component signals of the first hemodynamic signal SA, an evaluation value PB1 of the periodicity of a component signal DB1 included in the second plurality of component signals of the second hemodynamic signal SB, and a number N of sampling data contained in the first plurality of component signals and the second plurality of component signals, in combination with the other claimed elements.
Response to Arguments
Applicant has failed to address the objections to the drawings and the objections to the specification as set forth in the Non-Final Rejection filed 09/25/2025. As such, these objections are being maintained.
Applicant’s arguments, see page 10 of Remarks, filed 10/15/2025, with respect to the objection(s) of claim(s) 2, 14, and 18 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments.
Applicant's arguments, see page 10 of Remarks, filed 10/15/2025, with respect to the 112(f) interpretations have been fully considered but they are not persuasive. Applicant argues the amendments to the claims no longer invoke 112(f). However, as stated above in 112(f) section, some claims still recite language that invokes 112(f).
Applicant’s arguments, see page 11 of Remarks, filed 10/15/2025, with respect to the 112(b) rejections have been fully considered and are only partially persuasive. Applicant argues that claim amendments address all 112(b) issues. However, this is not the case. Some previously applied 112(b) rejections have been maintained and new 112(b) rejections have been made as necessitated by Applicant’s amendments.
Applicant’s arguments, see pages 11-12, filed 10/15/2025, with respect to the rejection(s) of claim(s) 1-19 under 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant argues amended independent claim 19 (Applicant states claim 1 in the response but Examiner believes claim 19 is the claim to which they refer) “provides a process that uses a particular machine (a detector for detecting the hemodynamic signals), and it also integrates any such abstract idea into a practical application.” Applicant argues the technical problem being addressed is “measuring a health state and/or a psychological state based on a composite hemodynamic signal results in a drop in accuracy.” Furthermore, Applicant argues amended claim 19 integrates any abstract idea/judicial exception into a practical application because “the use of periodicities at which respective component signals of the first and second plurality of component signals of the first and second hemodynamic signals identify a hemodynamic element based on a correlation between the aforementioned periodicities provides for tangible, practical outcomes in the real world, such as enhancing the accuracy of assessing a ‘mental/physical state of a human’ by, for example, ‘cutaneous blood flow rhythm ... to evaluate autonomous nerve system activity, confirm the effects of autonomic blockade surgery, and the like.’” Examiner respectfully disagrees. The recited detector is a generic device well known in the art and identifying a hemodynamic element based on a correlation can be performed in the Human Mind. The independent claims fail to recite any practical application based on the identified hemodynamic element. There is no particular treatment that is affected nor is there a particular change made based on the identified hemodynamic element. Additionally, the intended use of "enhancing accuracy of assessing mental/physical state of a human" is not considered when examining as it is not positively recited. Therefore, the 101 rejections have been maintained and updated as necessitated by Applicant’s amendments.
Applicant’s arguments, see pages 13-16, filed 10/15/2025, with respect to the prior art rejection(s) of claim(s) 1-6 and 9-19, have been considered and they are not persuasive and are moot in view of the newly applied rejections as necessitated by Applicant’s amendments. Applicant argues that “the methods disclosed by Demirtas necessarily do not utilize both first and second hemodynamic signals obtained directly from an organism in a manner that is even remotely suggestive of any of the signal processing steps as now recited by claim 1.” However, this argument is based on the amendments made to claim 1 and have been appropriately addressed by the newly applied rejection.
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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/JANKI M BAVA/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791