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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 26, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on April 14, 2023 are accepted.
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 claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1: Claim limitation “a linear relationship storage portion storing previously stored linear relationships between a plurality of transmural pressures of the artery that are pressure differences between an arterial pressure within the artery and a plurality of compression pressures of the cuff, and” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “portion” coupled with functional language “storing” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “portion”.
Claim 1: Claim limitation “a blood pressure measurement portion measuring a real arterial pressure of the person to be measured, based on a pulse synchronous wave from the artery obtained in a pressure lowering process after compressing the site to be compressed of the person to be measured with a compression pressure higher than a systolic arterial pressure of the person to be measured;” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “portion” coupled with functional language “measuring” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “portion”.
Claim 1: Claim limitation “a proper relationship generation portion applying, for the person to be measured, the real arterial pressure, real compression pressures in the low pressure section, and real pulse wave propagation velocities based on propagation time between the pulse waves obtained respectively under the real compression pressures, to thereby generate a proper relationship on the person to be measured among the real arterial pressures of the person to be measured, the real compression pressures, and the real pulse wave propagation velocities; and” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “portion” coupled with functional language “applying” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “portion”.
Claim 1: Claim limitation “a blood pressure estimation portion applying, for the person to be measured, the real compression pressures in the low pressure section and the real pulse wave propagation velocities obtained under the real compression pressures, to the proper relationship on the person to be measured, to thereby estimate the estimated arterial pressure.” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “portion” coupled with functional language “applying” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “portion”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Claim 1: the portions are part of the electronic control device as disclosed in FIG. 5 and [0052 - 0053] as computer processing components/CPU/processors.
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to “an apparatus” which describes one of the four statutory categories of patentable subject matter, i.e. a machine or manufacture.
Each of Claims 1-16 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claim 1 recites (“sets forth” or “describes”) the abstract idea of “mathematical concepts” (MPEP 2106.04(a)(2).I.), substantially as follows: “the blood pressure monitoring apparatus repeatedly estimating an estimated arterial pressure of the person to be measured, the blood pressure monitoring apparatus comprising:
a linear relationship storage portion storing previously stored linear relationships between a plurality of transmural pressures of the artery that are pressure differences between an arterial pressure within the artery and a plurality of compression pressures of the cuff, and
squared values of pulse wave propagation velocities respectively detected under the plurality of compression pressures of the cuff in a low pressure section lower than a diastolic arterial pressure of a living body;
a blood pressure measurement portion measuring a real arterial pressure of the person to be measured, based on a pulse synchronous wave from the artery obtained in a pressure lowering process after compressing the site to be compressed of the person to be measured with a compression pressure higher than a systolic arterial pressure of the person to be measured;
a proper relationship generation portion applying, for the person to be measured, the real arterial pressure, real compression pressures in the low pressure section, and real pulse wave propagation velocities based on propagation time between the pulse waves obtained respectively under the real compression pressures, to thereby generate a proper relationship on the person to be measured among the real arterial pressures of the person to be measured, the real compression pressures, and the real pulse wave propagation velocities; and
a blood pressure estimation portion applying, for the person to be measured, the real compression pressures in the low pressure section and the real pulse wave propagation velocities obtained under the real compression pressures, to the proper relationship on the person to be measured, to thereby estimate the estimated arterial pressure.”
In claim 1, the above recited steps are mathematical concepts, which is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. The Specification teaches the calculations for calculating the blood pressure/arterial pressure. Spec. page 27-28. Computing these based on the feature points encompasses the use of mathematical equations, which has been recognized as an abstract idea (i.e., a mathematical concept). Patent Eligibility Guidance, 84 Fed. Reg. at 52. In sum, we determine that Prong 1 recites a judicial exception, and proceed to Step 2A, Prong 2.
Therefore, each of the above steps are grouped as mathematical concepts, hence an abstract idea.
Claim 1 recites (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), substantially as follows: “the blood pressure monitoring apparatus repeatedly estimating an estimated arterial pressure of the person to be measured, the blood pressure monitoring apparatus comprising:
a linear relationship storage portion storing previously stored linear relationships between a plurality of transmural pressures of the artery that are pressure differences between an arterial pressure within the artery and a plurality of compression pressures of the cuff, and
squared values of pulse wave propagation velocities respectively detected under the plurality of compression pressures of the cuff in a low pressure section lower than a diastolic arterial pressure of a living body;
a blood pressure measurement portion measuring a real arterial pressure of the person to be measured, based on a pulse synchronous wave from the artery obtained in a pressure lowering process after compressing the site to be compressed of the person to be measured with a compression pressure higher than a systolic arterial pressure of the person to be measured;
a proper relationship generation portion applying, for the person to be measured, the real arterial pressure, real compression pressures in the low pressure section, and real pulse wave propagation velocities based on propagation time between the pulse waves obtained respectively under the real compression pressures, to thereby generate a proper relationship on the person to be measured among the real arterial pressures of the person to be measured, the real compression pressures, and the real pulse wave propagation velocities; and
a blood pressure estimation portion applying, for the person to be measured, the real compression pressures in the low pressure section and the real pulse wave propagation velocities obtained under the real compression pressures, to the proper relationship on the person to be measured, to thereby estimate the estimated arterial pressure.”
In claim 1, the above recited steps can be practically performed in the human mind, with the aid of a pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. If a person were to visually examine, i.e., perform an observation, the waveform data, either in a printout or an electronic format, he/she would be able to perform the calculations to obtain the arterial pressures via pen and paper. There is nothing recited in the claim to suggest an undue level of complexity in how the waveforms, the peaks and the bio-information to be identified. Therefore, a person would be able to perform the identification of peaks mentally or with a generic computer.
Prong Two: Claim 1 does not include additional elements that integrate the mental process into a practical application.
This judicial exception is not integrated into a practical application. In particular, the claims recites (1) “a cuff wrapped around a site to be compressed of a person to be measured to compress an artery of the person to be measured, the cuff having a plurality of inflatable bladders forming independent air chambers juxtaposed across width,”
(2) “estimate arterial pressure/output”.
(3) “CPU/processors in the ‘portion’ claimed that are interpreted as computer components as discussed in the claim interpretation section”.
The steps in (1) represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools (see below Step IIB for further details).
The step in (2) represents merely notification outputting by a processor as a post-solution activity and is recited at a high level of generality.
The steps in (3) merely recite generic computer components used to implement the abstract idea on, as tools.
As a whole, the additional elements merely serve to gather and feed information to the abstract idea and to output a notification based on the abstract idea, while generically implementing it on conventionally used tools. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the estimated bio-information is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claims recite additional steps of (1) “a cuff wrapped around a site to be compressed of a person to be measured to compress an artery of the person to be measured, the cuff having a plurality of inflatable bladders forming independent air chambers juxtaposed across width,”
(2) “estimate arterial pressure/output”.
(3) “CPU/processors in the ‘portion’ claimed that are interpreted as computer components as discussed in the claim interpretation section”.
These steps represents mere data gathering, data outputting or pre/post/extra-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality.
The waveform information is obtained from a cuff. These additional limitations merely represent insignificant, conventional pre-solution activities well-understood in the industry of blood pressure estimation, as the sensors recited are well understood, routine and conventional, as evidenced by Umeda et al. (US-20130190629-A1) (“Umeda”) [0020] and [0058] discussing conventional cuffs and oscillometric methods. Fuke et al. (US-20140142441-A1) (“Fuke”) additionally discloses standard measurements devices including cuff sphygmomanometers as conventional, see [0014].
Note that the pulse transit time (PTT)/pulse wave velocity (PWV) is known in the field of art as a mathematical variant of the pulse wave signal (or vibration waveforms), i.e., it can be derived from pulse wave signals via mathematical operations routinely practiced in the field of art. Accordingly, these additional steps and tools for measuring a pulse wave signal, and outputting a notification amount to no more than insignificant conventional extra-solution activity. Mere insignificant conventional extra-solution activity cannot provide an inventive concept.
The recited processors and computer-readable storage medium are generic computer elements (i.d. para. [0052] describing generic computers).
Therefore, none of the Claim 1 amounts to significantly more than the abstract idea itself.
Accordingly, Claim 1 is not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
Dependent Claims
The following dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons:
Claims 2-15 recitations further limits the abstract idea above, merely further defines the mental process or mathematical equations discussed above.
The following dependent claims merely further describe the extra-solution activities and therefore, do not amount to significantly more than the judicial exception or integrate the abstract idea into a practical application for similar reasons:
Claims 16 further define the sensors used for insignificant extra-solution activity (data collection). The sensors recited are well understood, routine and conventional, as evidenced by Umeda et al. (US-20130190629-A1) (“Umeda”) [0020] and [0058] discussing conventional cuffs and oscillometric methods. Fuke et al. (US-20140142441-A1) (“Fuke”) additionally discloses standard measurements devices including cuff sphygmomanometers as conventional, see [0014].
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fuke et al. (US-20140142441-A1) (“Fuke”) and Hasegawa (US-20070016083-A1) (“Hasegawa”). Fuke and Hasegawa disclose similar apparatuses for blood pressure estimation. Fuke and Hasegawa disclose linear regression involving the pulse wave velocities and arterial pressures. Arterial stiffness and the relationships between pulse wave velocity and arterial pressures are analyzed by Fuke and Hasegawa but using differing equations and not squaring the pulse wave propagation velocities for the proper relationship comparisons as claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.A.T./Examiner, Art Unit 3791
/MAY A ABOUELELA/Primary Examiner, Art Unit 3791