DETAILED ACTION
Claims 1-20 are hereby under examination.
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 03/19/2025 is being considered by the examiner.
Claim Interpretation - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1: The claim limitation “light-receiving element that is configured to detect light …” 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 “element” coupled with functional language “configured to detect light …” 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 “element”.
Claim 1: The claim limitation “light emitted by a light-emitting element” 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 “element” coupled with functional language “light emitted by” 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 “element”.
Claim 1: The claim limitation “a pulse wave measurement unit configured to generate a pulse wave signal …” 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 “unit” coupled with functional language “configured to generate a pulse wave signal …” 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 “unit”.
Claim 1: The claim limitation “a peripheral blood pressure index calculation unit configured to calculate a peripheral blood pressure index …” 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 “unit” coupled with functional language “configured to calculate a peripheral blood pressure index …” 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 “unit”.
Claim 1: The claim limitation “a vascular endothelial function evaluation unit configured to evaluate a vascular endothelial function …” 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 “unit” coupled with functional language “configured to evaluate a vascular endothelial function …” 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 “unit”.
Claim 1: The claim limitation “an output unit configured to generate a display …” 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 “unit” coupled with functional language “configured to generate a display …” 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 “unit”.
Claim 15: The claim limitation “a reference pulse wave measurement unit configured to generate a reference pulse wave signal …” 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 “unit” coupled with functional language “configured to generate a reference pulse wave signal …” 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 “unit”.
Claim 17: The claim limitation “light-receiving element that is configured to detect light …” 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 “element” coupled with functional language “configured to detect light …” 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 “element”.
Claim 17: The claim limitation “light emitted by a light-emitting element” 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 “element” coupled with functional language “light emitted by” 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 “element”.
Claim 20: The claim limitation “acquiring a pulse wave signal based on light, detected by a light-receiving element” 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 “element” coupled with functional language “acquiring a pulse wave signal based on light, detected” 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 “element”.
Claim 20: The claim limitation “generating, by an output, a display …” 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 “output” coupled with functional language “generating … a display” 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 “output”.
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:
“a photodiode (PD) or phototransistor is used as the light-receiving element”, or equivalents thereof, as described in para. [0046] of the disclosure filed on 01/13/2025;
“light-emitting diodes (LEDs) or vertical-cavity surface-emitting lasers (VCSELs) are used as the light-emitting elements”, or equivalents thereof, as described in para. [0046] of the disclosure filed on 01/13/2025;
“pulse wave measurement unit … single integrated circuit”, or equivalents thereof, as described in para. [0043] of the disclosure filed on 01/13/2025;
“sever includes … vascular endothelial function evaluation unit …”, or equivalents thereof, as described in para. [0038] of the disclosure filed on 01/13/2025;
“sever includes … peripheral blood pressure index calculation unit …”, or equivalents thereof, as described in para. [0038] of the disclosure filed on 01/13/2025;
“output unit includes, for example, a display device …”, or equivalents thereof, as described in para. [0037] of the disclosure filed on 01/13/2025;
“single integrated circuit …” and “configuration and function of the … reference pulse wave measurement unit … identical to the configuration and function of … the pulse wave measurement unit …”, or equivalents thereof, as described in para. [0043] and para. [0142] of the disclosure filed on 01/13/2025;
“a photodiode (PD) or phototransistor is used as the light-receiving element”, or equivalents thereof, as described in para. [0046] of the disclosure filed on 01/13/2025;
“light-emitting diodes (LEDs) or vertical-cavity surface-emitting lasers (VCSELs) are used as the light-emitting elements”, or equivalents thereof, as described in para. [0046] of the disclosure filed on 01/13/2025;
“a photodiode (PD) or phototransistor is used as the light-receiving element”, or equivalents thereof, as described in para. [0046] of the disclosure filed on 01/13/2025; and
“output unit includes, for example, a display device …”, or equivalents thereof, as described in para. [0037] of the disclosure filed on 01/13/2025.
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 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 18 and 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 18, line 3 recites “the pulse wave sensor includes a light-emitting element …”. However, claim 17 recites “the pulse wave sensor including … light emitted by a light-emitting element”. In light of the specification, it is currently unclear if claim 18 is further defining the light-emitting element recited in claim 17 as being configured to emit in the specific wavelength range, or if claim 18 is further defining the pulse wave sensor as including a second light-emitting element. The instant specification recites in para. [0046] that two light-emitting elements are configured to output light in two separate wavelength ranges. For the purposes of examination, “a light-emitting element” recited in claim 18 is being interpreted as any light-emitting element of the pulse wave sensor. It is recommended to the Applicant to amend the claims to either clearly link or clearly differentiate the recitations of “light-emitting element” recited in claims 17 and 18.
The dependent claims of the above rejected claim are rejected due to their dependency.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Analysis of independent claims 1, 17, and 20:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a system, which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Claim 17 is directed to an apparatus, which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Claim 20 is directed to a method, which describes one of the four statutory categories of patentable subject matter, i.e., a process. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1, 17, and 20 recite an abstract idea. In particular, the claim recites the following:
Calculate a peripheral blood pressure index based on a steepness of a rise per beat of the pulse wave signal generated by the pulse wave measurement unit; and
Evaluate a vascular endothelial function based on a calculated value of the calculated peripheral blood pressure index from a time point of vascular occlusion release until an evaluation duration elapses.
These elements required of claims 1, 17, and 20 are drawn to an abstract idea since (1) they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations; and/or (2) they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Calculating a peripheral blood pressure index based on a steepness of a rise per beat of the pulse wave signal generated by the pulse wave measurement unit is drawn to a mental process that can practically be performed in the human mind, with the aid of pen and paper. For example, a person with ordinary skill in the art can reasonably view a pulse wave signal on a piece of paper, determine a steepness of the signal, and mentally calculate a peripheral blood pressure index. There is nothing to suggest an undue level of complexity in the calculating step. Further, calculating a peripheral blood pressure index based on a steepness of a rise per beat of the pulse wave signal generated by the pulse wave measurement unit is drawn to mathematical calculations, specifically calculating a steepness (i.e., derivatives) of the pulse wave signal.
Evaluating a vascular endothelial function based on a calculated value of the calculated peripheral blood pressure index from a time point of vascular occlusion release until an evaluation duration elapses is drawn to a mental process that can practically be performed in the human mind, with the aid of pen and paper. For example, a person with ordinary skill in the art can view signals on a piece of paper, including vascular occlusion time signals, to mentally evaluate the vascular endothelial function based on the mentally calculated index and the time signals. There is nothing to suggest and undue level of complexity in the evaluating step.
Prong Two: Claims 1, 17, and 20 do not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “peripheral blood pressure index calculation unit” (claim 1), “vascular endothelial function evaluation unit” (claim 1), “control terminal …” (claim 17), “light-receiving element …” (claim 20)), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “photoelectric pulse wave sensor including a light-receiving element … light-emitting element …” (claim 1), “pulse wave measurement device …” (claim 17), ); the post-solution activity of: (e.g. N/A); using generic data-outputting components (e.g. “output unit …” (claim 1), “output …” (claim 17), “generating, by an output …” (claim 20))).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, “light-receiving element” and “light-emitting element” are well-understood, routine, and conventional, as disclosed by Enari et al. (US 20190053768 A1) - para. [0061-0064].
Further, “pulse wave measurement unit”, “peripheral blood pressure index calculation unit”, and “control terminal” does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1, 17, and 20 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to pre-solution necessary data gathering steps, and generic post-solution outputting steps, which merely facilitate the abstract idea.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of the dependent claims:
Claims 2-16, 18, and 19 depend from the independent claim. The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“the vascular endothelial function evaluation unit is configured to evaluate the vascular endothelial function based on both a value of the calculated peripheral blood pressure index before vascular occlusion and a value of the calculated peripheral blood pressure index after vascular occlusion release” (claim 2), “the pulse wave measurement unit is configured to calculate the peripheral blood pressure index in synchronization with the timing of vascular occlusion and release of the cuff sphygmomanometer” (claim 5), “the peripheral blood pressure index calculation unit is configured to calculate the peripheral blood pressure index to include information regarding a peak value of wave a of an acceleration pulse wave obtained by calculating a second derivative of a waveform of the pulse wave signal generated by the pulse wave measurement unit, and an amplitude of the waveform of the pulse wave signal generated by the pulse wave measurement unit” (claim 7), “the peripheral blood pressure index calculation unit is configured to calculate the peripheral blood pressure index to include information regarding a difference between a peak value of wave a of an acceleration pulse wave obtained by calculating a second derivative of a waveform of the pulse wave signal generated by the pulse wave measurement unit and a peak value of wave d of the acceleration pulse wave, and a difference between the peak value of wave a and a peak value of wave b of the acceleration pulse wave” (claim 8), “the peripheral blood pressure index calculation unit is configured to calculate the calculate peripheral blood pressure index to include information regarding a width of a first peak that appears within one beat of a velocity pulse wave obtained by calculating a first derivative of a waveform of the pulse wave signal generated by the pulse wave measurement unit” (claim 9), “the vascular endothelial function evaluation unit is configured to evaluate the vascular endothelial function based additionally on a temporal change in an amplitude of the pulse wave signal generated by the pulse wave measurement unit from the time point of vascular occlusion release until a certain duration elapses” (claim 10), “the vascular endothelial function evaluation unit is configured to change the evaluation duration based on a vascular occlusion duration” (claim 13), “the vascular endothelial function evaluation unit is configured to evaluate the vascular endothelial function based additionally on a peripheral blood pressure index calculated based on the reference pulse wave signal generated by the reference pulse wave measurement unit” (claim 16)),
Further describe the pre-solution activity (or the structure used for such activity) (“a ring-shaped wearable member configured to be worn on a finger and that includes the photoelectric pulse wave sensor” (claim 3), “a cuff sphygmomanometer that is configured to pressurize the pressurization site of the user” (claim 4), “the photoelectric pulse wave sensor includes the light-emitting element and is configured to emit light in a wavelength range from blue to yellow- green” (claim 11), “the photoelectric pulse wave sensor is configured such that the light-emitting element is separated by a distance from the light-receiving element that is greater than or equal to 1 mm and less than or equal to 3 mm” (claim 12), “a reference pulse wave measurement unit configured to generate a reference pulse wave signal based on a measurement result from a reference pulse wave sensor attached to a site that is positioned symmetrically on the user to an attachment site of the photoelectric pulse wave sensor” (claim 15), “the pulse wave sensor includes a light-emitting element configured to emit the light in a wavelength range from blue to yellow-green, and the pulse wave sensor is configured such that the light-emitting element is separate by a distance from the light-receiving element that is greater than or equal to 1 mm and less than or equal to 3 mm” (claim 18), “the light-emitting element of the pulse wave sensor is configured to emit light at at least two different wavelengths, and the control unit is further configured to change the evaluation duration based on a wavelength of light used to acquire the pulse wave signal” (claim 19)),
Further describe the computer implementation (“the cuff sphygmomanometer and the pulse wave measurement unit are configured to wirelessly communicate with each other, the cuff sphygmomanometer is configured to notify the pulse wave measurement unit of a timing of vascular occlusion and release” (claim 5), “a control terminal that includes a processor configured to execute instructions on an electronic memory to: wirelessly communicate with the cuff sphygmomanometer and the pulse wave measurement unit, control an operation for vascular occlusion and release of the cuff sphygmomanometer, and receive the pulse wave signal from the pulse wave measurement unit and transmit the pulse wave signal to the peripheral blood pressure index calculation unit” (claim 6)), and
Further describe the post-solution activity (N/A) (recited at a high level of generality).
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional.
For example, “a cuff sphygmomanometer” is well-understood, routine, and conventional, as disclosed by Friedman et al. (US 20080119741 A1) - para. [0022].
Taken alone or 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. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. 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 subjection matter. Claims 1-20 are rejected.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 15-19 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 15, the claim recites “a reference pulse wave sensor attached to a site that is positioned symmetrically on the user …” which is directed to or encompasses a human organism. It is recommended to the Applicant to amend the claim to read along the lines of --a reference pulse wave sensor configured to be attached to a site that is positioned symmetrically on the user-- (emphasis added).
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claim 17, the claim recites “a pulse wave sensor attached to a site of a user …”, which is directed to or encompasses a human organism. It is recommended to the Applicant to amend the claim to read along the lines of --a pulse wave sensor configured to be attached to a site of a user-- (emphasis added).
The dependent claims of the above rejected claim are rejected due to their dependency.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1-4, 10, 13, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al. (US 20080119741 A1), hereinafter referred to as Friedman, in view of Enari et al. (US 20190053768 A1), hereinafter referred to as Enari.
The claims are generally directed to a system for evaluating vascular endothelial function, comprising: a photoelectric pulse wave sensor including a light- receiving element that is configured to detect light emitted by a light-emitting element and that passes through biological tissue of a user, the photoelectric pulse wave sensor being configured to attach to a site farther from a heart of the user than a pressurization site of the user that is pressurized for vascular occlusion; a pulse wave measurement unit configured to generate a pulse wave signal based on the light detected by the light- receiving element; a peripheral blood pressure index calculation unit configured to calculate a peripheral blood pressure index based on a steepness of a rise per beat of the pulse wave signal generated by the pulse wave measurement unit; a vascular endothelial function evaluation unit configured to evaluate a vascular endothelial function based on a calculated value of the calculated peripheral blood pressure index from a time point of vascular occlusion release until an evaluation duration elapses; and an output unit configured to generate a display relating to the vascular endothelial function.
Regarding claim 1, Friedman discloses a system for evaluating vascular endothelial function (Abstract), comprising:
a photoelectric pulse wave sensor (Fig. 5, element 72, element 74, Fig. 6, para. [0049], “finger probe … generates … plethysmography signal …), the photoelectric pulse wave sensor being configured to attach to a site farther from a heart of the user than a pressurization site of the user that is pressurized for vascular occlusion (Fig. 5, element 24, element 74, para. [0022], “pressure cuff is shown positioned around the forearm of the patient … occlude the radial artery”, para. [0049], “finger probe … distal from … pressure cuff …”);
a pulse wave measurement unit configured to generate a pulse wave signal (para. [0049], “finger probe … generates … plethysmography signal …);
a peripheral blood pressure index calculation unit configured to calculate a peripheral blood pressure index based on a steepness of a rise per beat of the pulse wave signal generated by the pulse wave measurement unit (Fig. 5, Fig. 6, para. [0053], “patient monitor can calculate the pulse wave velocity (PWV) … “);
a vascular endothelial function evaluation unit configured to evaluate a vascular endothelial function based on a calculated value of the calculated peripheral blood pressure index from a time point of vascular occlusion release until an evaluation duration elapses (para. [0005], “pulse wave velocity correlates well with arterial distensibility and stiffness and is a useful non-invasive index to assess arterial sclerosis and thus arterial endothelial dysfunction …”, para. [0008-0009], “following deflation of the cuff … determine the endothelial dysfunction of the patient …”, para. [0046], “flow rate of blood through the brachial artery can also be utilized to determine the endothelial dysfunction …”, para. [0053], “when combined … pulse wave velocity can provide another indication of the arterial health …”); and
an output unit configured to generate a display relating to the vascular endothelial function (para. [0021], “display the measurement of the endothelial dysfunction calculated …”, para. [0053]).
Friedman suggests, but does not explicitly disclose, the photoelectric pulse wave sensors includes a light-receiving element that is configured to detect light emitted by a light-emitting element and that passes through biological tissue of a user, and the pulse wave signal is generated based on the light detected by the light-receiving element. Friedman suggests this by disclosing the plethysmographic monitor is an optical monitor (para. [0048]).
Enari teaches an analogous photoelectric pulse wave sensor (Abstract, Fig. 4). Enari further teaches the photoelectric pulse wave sensor includes a light-receiving element that is configured to detect light emitted by a light-emitting element and that passes through biological tissue of a user, and the pulse wave signal is generated based on the light detected by the light-receiving element (Fig. 4, element 30A1, para. [0061-0065]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the photoelectric pulse wave sensor disclosed by Friedman to explicitly include a light-receiving element that is configured to detect light emitted by a light-emitting element and that passes through biological tissue of a user, and the pulse wave signal is generated based on the light detected by the light-receiving element, as taught by Enari. This is because Enari teaches a light-emitting element and a light-receiving element is a known and reliable method for determining blood flow rate of a user (para. [0065]).
Regarding claim 2, modified Friedman discloses the system for evaluating vascular endothelial function according to Claim 1, wherein the vascular endothelial function evaluation unit is configured to evaluate the vascular endothelial function based on both a value of the calculated peripheral blood pressure index before vascular occlusion and a value of the calculated peripheral blood pressure index after vascular occlusion release (para. [0010], “before the occlusion period and immediately following the occlusion period … be used to determine the pulse wave velocity …”, para. [0046], “prior to occlusion … following the occlusion …”).
Regarding claim 3, modified Friedman discloses the system for evaluating vascular endothelial function according to Claim 1, further comprising a ring-shaped wearable member configured to be worn on a finger and that includes the photoelectric pulse wave sensor (Fig. 5, element 74, para. [0049], “finger probe … sensor include within the finger probe … generates plethysmography signal …”).
Regarding claim 4, modified Friedman discloses the system for evaluating vascular endothelial function according to Claim 1, further comprising a cuff sphygmomanometer that is configured to pressurize the pressurization site of the user (Fig. 5, element 24, para. [0022], “blood pressure cuff … inflated and deflated for occluding an artery …”).
Regarding claim 10, modified Friedman discloses the system for evaluating vascular endothelial function according to Claim 1, wherein the vascular endothelial function evaluation unit is configured to evaluate the vascular endothelial function based additionally on a temporal change in an amplitude of the pulse wave signal generated by the pulse wave measurement unit from the time point of vascular occlusion release until a certain duration elapses (para. [0060], “calculate the pulse wave velocity and pulse wave transit time after the cuff has been deflated … calculates PWV and PWTT at regular intervals …”).
Regarding claim 13, modified Friedman discloses the system for evaluating vascular endothelial function according to Claim 1, wherein the vascular endothelial function evaluation unit is configured to change the evaluation duration based on a vascular occlusion duration (para. [0046], “determined prior to occlusion … following the occlusion …”).
Regarding claim 17, Friedman discloses an apparatus for evaluating vascular endothelial function (Abstract), comprising:
a pulse wave measurement device (Fig. 5, element 72, element 74, Fig. 6, para. [0049], “finger probe … generates … plethysmography signal …) configured to generate a pulse wave signal based on a measurement result from a pulse wave sensor attached to a site of a user that is farther from a heart of the user than a pressurization site that is pressurized for vascular occlusion (Fig. 5, element 24, element 74, para. [0022], “pressure cuff is shown positioned around the forearm of the patient … occlude the radial artery”, para. [0049], “finger probe … distal from … pressure cuff …”); and
a control terminal that includes a processor configured to execute instructions on an electronic memory (para. [0021], para. [0053]) to:
calculate a peripheral blood pressure index based on a steepness of a rise per beat of the pulse wave signal generated by the pulse wave measurement device (Fig. 5, Fig. 6, para. [0053], “patient monitor can calculate the pulse wave velocity (PWV) … “),
evaluate a vascular endothelial function based on a value of the calculated peripheral blood pressure index from a time point of vascular occlusion release until an evaluation duration elapses (para. [0005], “pulse wave velocity correlates well with arterial distensibility and stiffness and is a useful non-invasive index to assess arterial sclerosis and thus arterial endothelial dysfunction …”, para. [0008-0009], “following deflation of the cuff … determine the endothelial dysfunction of the patient …”, para. [0046], “flow rate of blood through the brachial artery can also be utilized to determine the endothelial dysfunction …”, para. [0053], “when combined … pulse wave velocity can provide another indication of the arterial health …”), and
output an evaluation result as a display relating to the evaluated vascular endothelial function (para. [0021], “display the measurement of the endothelial dysfunction calculated …”, para. [0053]).
Friedman suggests, but does not explicitly disclose, the photoelectric pulse wave sensors includes a light-receiving element that is configured to detect light emitted by a light-emitting element and that passes through biological tissue of the user for the measurement result. Friedman suggests this by disclosing the plethysmographic monitor is an optical monitor (para. [0048]).
Enari teaches an analogous photoelectric pulse wave sensor (Abstract, Fig. 4). Enari further teaches the photoelectric pulse wave sensor includes a light-receiving element that is configured to detect light emitted by a light-emitting element and that passes through biological tissue of the user for the measurement result (Fig. 4, element 30A1, para. [0061-0065]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the photoelectric pulse wave sensor disclosed by Friedman to explicitly include a light-receiving element that is configured to detect light emitted by a light-emitting element and that passes through biological tissue of the user for the measurement result, as taught by Enari. This is because Enari teaches a light-emitting element and a light-receiving element is a known and reliable method for determining blood flow rate of a user (para. [0065]).
Regarding claim 20, Friedman discloses a method for evaluating vascular endothelial function (Abstract), the method comprising:
performing vascular occlusion by pressurizing a part of a body of a user and subsequently releasing vascular occlusion (Fig. 5, element 24, para. [0022], “pressure cuff is shown positioned around the forearm of the patient … occlude the radial artery”);
acquiring a pulse wave signal at a site farther from a heart of the user than a pressurized site from a time point of vascular occlusion release until a certain duration elapses;
obtaining a temporal change in a peripheral blood pressure index based on a steepness of a rise per beat of the acquired pulse wave signal (Fig. 5, Fig. 6, para. [0053], “patient monitor can calculate the pulse wave velocity (PWV) … “, para. [0060], “change in the pulse wave velocity …”);
evaluating a vascular endothelial function based on the temporal change in the peripheral blood pressure index (para. [0005], “pulse wave velocity correlates well with arterial distensibility and stiffness and is a useful non-invasive index to assess arterial sclerosis and thus arterial endothelial dysfunction …”, para. [0008-0009], “following deflation of the cuff … determine the endothelial dysfunction of the patient …”, para. [0046], “flow rate of blood through the brachial artery can also be utilized to determine the endothelial dysfunction …”, para. [0053], “when combined … pulse wave velocity can provide another indication of the arterial health …”); and
generating, by an output, a display relating to the evaluated vascular endothelial function (para. [0021], “display the measurement of the endothelial dysfunction calculated …”, para. [0053]).
Friedman suggests, but does not explicitly disclose, the pulse wave signal is acquired based on light, detected by a light-receiving element, that passes through an arteriole or capillary. Friedman suggests this by disclosing the plethysmographic monitor is an optical monitor (para. [0048]).
Enari teaches an analogous photoelectric pulse wave sensor (Abstract, Fig. 4). Enari further acquiring a pulse wave signal based on light, detected by a light-receiving element, that passes through an arteriole or capillary (Fig. 4, element 30A1, para. [0061-0065]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the photoelectric pulse wave sensor disclosed by Friedman to explicitly acquire a pulse wave signal based on light, detected by a light-receiving element, that passes through an arteriole or capillary, as taught by Enari. This is because Enari teaches a light-emitting element and a light-receiving element is a known and reliable method for determining blood flow rate of a user (para. [0065]).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al. (US 20080119741 A1), hereinafter referred to as Friedman, in view of Enari et al. (US 20190053768 A1), hereinafter referred to as Enari as applied to claim 4 above, and further in view of Hermeling et al. (US 20210052169 A1), hereinafter referred to as Hermeling.
Regarding claim 5, modified Friedman discloses the system for evaluating vascular endothelial function according to Claim 4, wherein: the cuff sphygmomanometer is configured to notify the pulse wave measurement unit of a timing of vascular occlusion and release, and the pulse wave measurement unit is configured to calculate the peripheral blood pressure index in synchronization with the timing of vascular occlusion and release of the cuff sphygmomanometer (para. [0046], “determined prior to occlusion … following the occlusion …”).
However, modified Friedman does not explicitly disclose the cuff sphygmomanometer and the pulse wave measurement unit are configured to wirelessly communicate with each other.
Hermeling teaches an analogous system for evaluating vascular endothelial function (Abstract, para. [0002]). Hermeling further teaches a cuff sphygmomanometer and a pulse wave measurement unit wirelessly communicate (para. [0066]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by modified Friedman to explicitly wirelessly link the cuff sphygmomanometer and the pulse wave measurement unit, as taught by Hermeling. This is because Hermeling teaches wirelessly connecting parts of the system allow for synchronization across the system (para. [0066]).
Regarding claim 6, modified Friedman discloses the system for evaluating vascular endothelial function according to Claim 4, further comprising a control terminal that includes a processor configured to execute instructions on an electronic memory (Fig. 5, element 14, element 20, element 72, para. [0021], para. [0023]) to: control an operation for vascular occlusion and release of the cuff sphygmomanometer (para. [0023], “selectively inflate and deflate the pressure cuff …”), and receive the pulse wave signal from the pulse wave measurement unit and transmit the pulse wave signal to the peripheral blood pressure index calculation unit (para. [0021], para. [0048-0049], “pulse oximeter is connected to the patient monitor …”).
However, modified Friedman does not explicitly disclose the cuff sphygmomanometer and the pulse wave measurement unit are configured to wirelessly communicate with each other.
Hermeling teaches an analogous system for evaluating vascular endothelial function (Abstract, para. [0002]). Hermeling further teaches a cuff sphygmomanometer and a pulse wave measurement unit wirelessly communicate (para. [0066]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by modified Friedman to explicitly wirelessly link the cuff sphygmomanometer and the pulse wave measurement unit, as taught by Hermeling. This is because Hermeling teaches wirelessly connecting parts of the system allow for synchronization across the system (para. [0066]).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al. (US 20080119741 A1), hereinafter referred to as Friedman, in view of Enari et al. (US 20190053768 A1), hereinafter referred to as Enari as applied to claim 1 above, and further in view of Albert Maarek (US 20170224232 A1), hereinafter referred to as Maarek.
Regarding claim 7, modified Friedman discloses the system for evaluating vascular endothelial function according to Claim 1.
However, modified Friedman does not explicitly disclose wherein the peripheral blood pressure index calculation unit is configured to calculate the peripheral blood pressure index to include information regarding a peak value of wave a of an acceleration pulse wave obtained by calculating a second derivative of a waveform of the pulse wave signal generated by the pulse wave measurement unit, and an amplitude of the waveform of the pulse wave signal generated by the pulse wave measurement unit.
Maarek teaches an analogous system for evaluating vascular endothelial function (Abstract, para. [0007]). Maarek teaches calculating a peripheral blood pressure index based on a pulse wave signal (para. [0035], para. [0038]). Maarek further teaches a peripheral blood pressure index calculation unit is configured to calculate the peripheral blood pressure index to include information regarding a peak value of wave a of an acceleration pulse wave obtained by calculating a second derivative of a waveform of the pulse wave signal generated by the pulse wave measurement unit, and an amplitude of the waveform of the pulse wave signal generated by the pulse wave measurement unit (para. [0038], para. [0091-0093]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by modified Friedman to explicitly calculate the peripheral blood pressure index to include information regarding a peak value of wave a of an acceleration pulse wave obtained by calculating a second derivative of a waveform of the pulse wave signal generated by the pulse wave measurement unit, and an amplitude of the waveform of the pulse wave signal generated by the pulse wave measurement unit, as taught by Maarek. This is because Maarek teaches first and second derivatives and corresponding peaks, allow for endothelial dysfunction assessments to be made without requiring lengthy examinations (para. [0090]).
Regarding claim 8, modified Friedman discloses the system for evaluating vascular endothelial function according to Claim 1.
However, modified Friedman does not explicitly disclose wherein the peripheral blood pressure index calculation unit is configured to calculate the peripheral blood pressure index to include information regarding a difference between a peak value of wave a of an acceleration pulse wave obtained by calculating a second derivative of a waveform of the pulse wave signal generated by the pulse wave measurement unit and a peak value of wave d of the acceleration pulse wave, and a difference between the peak value of wave a and a peak value of wave b of the acceleration pulse wave.
Maarek teaches an analogous system for evaluating vascular endothelial function (Abstract, para. [0007]). Maarek teaches calculating a peripheral blood pressure index based on a pulse wave signal (para. [0035], para. [0038]). Maarek further teaches a peripheral blood pressure index calculation unit is configured to calculate the peripheral blood pressure index to include information regarding a difference between a peak value of wave a of an acceleration pulse wave obtained by calculating a second derivative of a waveform of the pulse wave signal generated by the pulse wave measurement unit and a peak value of wave d of the acceleration pulse wave, and a difference between the peak value of wave a and a peak value of wave b of the acceleration pulse wave (para. [0091-0093]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by modified Friedman to explicitly calculate the peripheral blood pressure index to include information regarding a difference between a peak value of wave a of an acceleration pulse wave obtained by calculating a second derivative of a waveform of the pulse wave signal generated by the pulse wave measurement unit and a peak value of wave d of the acceleration pulse wave, and a difference between the peak value of wave a and a peak value of wave b of the acceleration pulse wave, as taught by Maarek. This is because Maarek teaches differences in amplitudes provide insight into arterial stiffness (para. [0093]).
Regarding claim 9, modified Friedman discloses the system for evaluating vascular endothelial function according to Claim 1.
However, modified Friedman does not explicitly disclose wherein the peripheral blood pressure index calculation unit is configured to calculate the calculate peripheral blood pressure index to include information regarding a width of a first peak that appears within one beat of a velocity pulse wave obtained by calculating a first derivative of a waveform of the pulse wave signal generated by the pulse wave measurement unit.
Maarek teaches an analogous system for evaluating vascular endothelial function (Abstract, para. [0007]). Maarek teaches calculating a peripheral blood pressure index based on a pulse wave signal (para. [0035], para. [0038]). Maarek further teaches a peripheral blood pressure index calculation unit is configured to calculate the calculate peripheral blood pressure index to include information regarding a width of a first peak that appears within one beat of a velocity pulse wave obtained by calculating a first derivative of a waveform of the pulse wave signal generated by the pulse wave measurement unit (para. [0091-0093]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by modified Friedman to explicitly calculate the calculate peripheral blood pressure index to include information regarding a width of a first peak that appears within one beat of a velocity pulse wave obtained by calculating a first derivative of a waveform of the pulse wave signal generated by the pulse wave measurement unit, as taught by Maarek. This is because Maarek teaches calculating first derivatives of the pulse wave signal all for features to be extracted to determine different phases of the cardiac cycle to make a vascular endothelial function determination (para. [0092]).
Claims 11, 12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al. (US 20080119741 A1), hereinafter referred to as Friedman, in view of Enari et al. (US 20190053768 A1), hereinafter referred to as Enari as applied to claim 1 and claim 17 above, and further in view of Toru Shimuta (US 20190175033 A1), hereinafter referred to as Shimuta.
Regarding claim 11, modified Friedman discloses the system for evaluating vascular endothelial function according to Claim 1.
However, modified Friedman does not explicitly disclose wherein the photoelectric pulse wave sensor includes the light-emitting element and is configured to emit light in a wavelength range from blue to yellow-green.
Shimuta teaches an analogous photoelectric pulse wave sensor (Abstract, Fig. 1, para. [0047-0049]). Shimuta further teaches the photoelectric pulse wave sensor includes the light-emitting element and is configured to emit light in a wavelength range from blue to yellow-green (para. [0047-0050]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the photoelectric pulse wave sensor taught by modified Friedman to explicitly include the light-emitting element and is configured to emit light in a wavelength range from blue to yellow-green, as taught by Shimuta. This is because Shimuta teaches wavelengths ranging from blue to yellow-green allows for a larger photopethysmographic signal to be obtained (para. [0050]).
Regarding claim 12, modified Friedman discloses the system for evaluating vascular endothelial function according to Claim 11.
However, modified Friedman does not explicitly disclose wherein the photoelectric pulse wave sensor is configured such that the light-emitting element is separated by a distance from the light-receiving element that is greater than or equal to 1 mm and less than or equal to 3 mm.
Enari further teaches the photoelectric pulse wave sensor is configured such that the light-emitting element is separated by a distance from the light-receiving element that is greater than or equal to 1 mm and less than or equal to 3 mm (para. [0137]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the light-emitting element and the light-receiving element to be separated by a distance that is greater than or equal to 1 mm and less than or equal to 3 mm, as taught by Enari. This is because Enari teaches a distance between 0.5 mm and 2 mm allows for the highest signal to noise ratio in the received signal, allowing for more accurate results (para. [0137]).
Regarding claim 18, modified Friedman discloses the apparatus for evaluating vascular endothelial function according to Claim 17.
However, modified Friedman does not explicitly disclose wherein: the pulse wave sensor includes a light-emitting element configured to emit the light in a wavelength range from blue to yellow-green.
Shimuta teaches an analogous photoelectric pulse wave sensor (Abstract, Fig. 1, para. [0047-0049]). Shimuta further teaches the pulse wave sensor includes a light-emitting element configured to emit the light in a wavelength range from blue to yellow-green (para. [0047-0050]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the photoelectric pulse wave sensor taught by modified Friedman to explicitly include a light-emitting element configured to emit the light in a wavelength range from blue to yellow-green, as taught by Shimuta. This is because Shimuta teaches wavelengths ranging from blue to yellow-green allows for a larger photopethysmographic signal to be obtained (para. [0050]).
However, modified Friedman does not explicitly disclose the pulse wave sensor is configured such that the light-emitting element is separate by a distance from the light-receiving element that is greater than or equal to 1 mm and less than or equal to 3 mm.
Enari further teaches the photoelectric pulse wave sensor is configured such that the light-emitting element is separated by a distance from the light-receiving element that is greater than or equal to 1 mm and less than or equal to 3 mm (para. [0137]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the light-emitting element and the light-receiving element to be separated by a distance that is greater than or equal to 1 mm and less than or equal to 3 mm, as taught by Enari. This is because Enari teaches a distance between 0.5 mm and 2 mm allows for the highest signal to noise ratio in the received signal, allowing for more accurate results (para. [0137]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al. (US 20080119741 A1), hereinafter referred to as Friedman, in view of Enari et al. (US 20190053768 A1), hereinafter referred to as Enari as applied to claim 13 above, and further in view of Shirasaki et al. (US 20140081101 A1), hereinafter referred to as Shirasaki.
Regarding claim 14, modified Friedman discloses the system for evaluating vascular endothelial function according to Claim 13.
However, modified Friedman does not explicitly disclose wherein: the light-emitting element of the photoelectric pulse wave sensor is configured to emit light at at least two different wavelengths, and the vascular endothelial function evaluation unit is configured to change the evaluation duration based on a wavelength of light used to acquire the pulse wave signal.
Shirasaki teaches an analogous photoelectric pulse wave sensor (Abstract, Fig. 1, para. [0036-0037]). Shirasaki further teaches the light-emitting element of the photoelectric pulse wave sensor is configured to emit light at at least two different wavelengths, and the vascular endothelial function evaluation unit is configured to change the evaluation duration based on a wavelength of light used to acquire the pulse wave signal (para. [0036], para. [0050]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by modified Friedman to additionally emit light at at least two different wavelengths, and have the vascular endothelial function evaluation unit configured to change the evaluation duration based on a wavelength of light used to acquire the pulse wave signal, as taught by Shirasaki. This is because Shirasaki teaches emitting at least two different wavelengths allows for ratios between the two wavelengths to be determined for further processing (para. [0050-0051]).
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al. (US 20080119741 A1), hereinafter referred to as Friedman, in view of Enari et al. (US 20190053768 A1), hereinafter referred to as Enari as applied to claim 1 above, and further in view of Pandit et al. (US 20180279965 A1), hereinafter referred to as Pandit.
Regarding claim 15, modified Friedman discloses the system for evaluating vascular endothelial function according to Claim 1.
However, modified Friedman does not explicitly disclose the system further comprises: a reference pulse wave measurement unit configured to generate a reference pulse wave signal based on a measurement result from a reference pulse wave sensor attached to a site that is positioned symmetrically on the user to an attachment site of the photoelectric pulse wave sensor.
Pandit teaches an analogous system for vascular function (Abstract, para. [0008]). Pandit further teaches the system comprises a reference pulse wave measurement unit configured to generate a reference pulse wave signal based on a measurement result from a reference pulse wave sensor attached to a site that is positioned symmetrically on the user to an attachment site of the photoelectric pulse wave sensor (Fig. 12, para. [0066], para. [0076], para. [0083], para. [0085]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by modified Friedman to additionally include a reference pulse wave measurement unit configured to generate a reference pulse wave signal based on a measurement result from a reference pulse wave sensor attached to a site that is positioned symmetrically on the user to an attachment site of the photoelectric pulse wave sensor, as taught by Pandit. This is because Pandit teaches a reference pulse wave measurement unit on a symmetrically positioned attachment site of the user allows for differences in pulse arrival times of the left and right side of the subject to be accounted for (para. [0067]).
Regarding claim 16, modified Friedman discloses the system for evaluating vascular endothelial function according to Claim 15.
However, modified Friedman does not explicitly disclose wherein the vascular endothelial function evaluation unit is configured to evaluate the vascular endothelial function based additionally on a peripheral blood pressure index calculated based on the reference pulse wave signal generated by the reference pulse wave measurement unit.
Pandit further teaches a vascular endothelial function evaluation unit is configured to evaluate the vascular endothelial function based additionally on a peripheral blood pressure index calculated based on the reference pulse wave signal generated by the reference pulse wave measurement unit (Fig. 15, para. [0085], para. [0107-0108]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by modified Friedman to additionally be configured to evaluate the vascular endothelial function based additionally on a peripheral blood pressure index calculated based on the reference pulse wave signal generated by the reference pulse wave measurement unit, as taught by Pandit. This is because Pandit teaches the differential pulse arrival time can be determined by measuring two pulse waves on symmetrical body parts of the user (para. [0107]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al. (US 20080119741 A1), hereinafter referred to as Friedman, in view of Enari et al. (US 20190053768 A1), hereinafter referred to as Enari, in view of Toru Shimuta (US 20190175033 A1), hereinafter referred to as Shimuta as applied to claim 18 above, and further in view of Shirasaki et al. (US 20140081101 A1), hereinafter referred to as Shirasaki.
Regarding claim 19, modified Friedman discloses the apparatus for evaluating vascular endothelial function according to Claim 18.
However, modified Friedman does not explicitly disclose the light-emitting element of the pulse wave sensor is configured to emit light at at least two different wavelengths, and the control unit is further configured to change the evaluation duration based on a wavelength of light used to acquire the pulse wave signal.
Shirasaki teaches an analogous photoelectric pulse wave sensor (Abstract, Fig. 1, para. [0036-0037]). Shirasaki further teaches the light-emitting element of the photoelectric pulse wave sensor is configured to emit light at at least two different wavelengths, and the vascular endothelial function evaluation unit is configured to change the evaluation duration based on a wavelength of light used to acquire the pulse wave signal (para. [0036], para. [0050]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by modified Friedman to additionally emit light at at least two different wavelengths, and have the vascular endothelial function evaluation unit configured to change the evaluation duration based on a wavelength of light used to acquire the pulse wave signal, as taught by Shirasaki. This is because Shirasaki teaches emitting at least two different wavelengths allows for ratios between the two wavelengths to be determined for further processing (para. [0050-0051]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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