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 .
Claim Objections
Claims 1-4, 8, 16-20 are objected to because of the following informalities:
Claim 1: “de time” should instead read as “DE time” or “D-E time” since abbreviations in lower case are generally reserved for Latin or special units (e.g., i.e., etc., a.m., kg, km).
Claim 1: “d wave” should instead read as “”d” wave” or “d-wave.” A similar correction should be performed for “e wave” as well.
Claim 2: “de time” should instead read as “DE time” or “D-E time” since abbreviations in lower case are generally reserved for Latin or special units (e.g., i.e., etc., a.m., kg, km).
Claim 3: “de time” should instead read as “DE time” or “D-E time” since abbreviations in lower case are generally reserved for Latin or special units (e.g., i.e., etc., a.m., kg, km).
Claim 4: “ae time” should instead read as “AE time” or “A-E time” since abbreviations in lower case are generally reserved for Latin or special units (e.g., i.e., etc., a.m., kg, km).
Claim 4: “a wave” should instead read as “”a” wave” or “a-wave” in order to prevent confusion with the usage of the “a” and “an” as articles. A similar correction should be performed for “e wave” as well.
Claim 8: “a wave” should instead read as “”a” wave” or “a-wave” in order to prevent confusion with the usage of the “a” and “an” as articles. A similar correction should be performed for “b wave,” “c wave,” and “d wave” as well.
Claim 8: “a, b, c, and d” should instead read as “”a,” “b”, “c”, and “d.”
Claim 16: “de time” should instead read as “DE time” or “D-E time” since abbreviations in lower case are generally reserved for Latin or special units (e.g., i.e., etc., a.m., kg, km).
Claim 17: “de time” should instead read as “DE time” or “D-E time” since abbreviations in lower case are generally reserved for Latin or special units (e.g., i.e., etc., a.m., kg, km).
Claim 17: “d wave” should instead read as “”d” wave” or “d-wave.” A similar correction should be performed for “e wave” as well.
Claim 18: “de time” should instead read as “DE time” or “D-E time” since abbreviations in lower case are generally reserved for Latin or special units (e.g., i.e., etc., a.m., kg, km).
Claim 19: “de time” should instead read as “DE time” or “D-E time” since abbreviations in lower case are generally reserved for Latin or special units (e.g., i.e., etc., a.m., kg, km).
Claim 20: “ae time” should instead read as “AE time” or “A-E time” since abbreviations in lower case are generally reserved for Latin or special units (e.g., i.e., etc., a.m., kg, km).
Claim 20: “a wave” should instead read as “”a” wave” or “a-wave” in order to prevent confusion with the usage of the “a” and “an” as articles. A similar correction should be performed for “e wave” as well.
Appropriate correction is required.
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.
Claim 7 is 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.
Re. Claim 7: Claim 7 recites: “acquiring a height, via a heart…” It is unclear how height may be acquired via (“by way of” or “through”) the heart. Examiner recommends amending claim 7 to instead recite “acquiring a height from a heart of the subject,” following the process described at Paragraphs 0026, 0027.
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 without significantly more. Each claim has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of the claims recites steps or instructions for blood pressure estimation, which is grouped as a mental process. Accordingly, each of the claims recites an abstract idea.
Independent claim 1 recites:
acquiring, by a biological information measurement system, a photoplethysmographic signal of a blood vessel of a periphery of a subject with a photoplethysmographic sensor (additional element; data-gathering);
calculating, by the biological information measurement system, a peripheral blood pressure index as an index of a magnitude of a blood pressure of a capillary or an arteriole of the periphery based on a steepness of rising of the photoplethysmographic signal (additional element; abstract evaluation); and
estimating, by the biological information measurement system, a magnitude of a blood pressure of the subject via a de time and the peripheral blood pressure index, the de time being a peak time difference between a d wave and an e wave in an acceleration pulse wave signal obtained by performing second-order differentiation on the photoplethysmographic signal (additional element; abstract evaluation).
Independent claim 17 recites:
a sensing device including a photoplethysmographic sensor configured to acquire a photoplethysmographic signal of a blood vessel of a periphery of a subject (additional element; data-gathering); and
a signal processing device configured to calculate a peripheral blood pressure index as an index of a magnitude of a blood pressure of a capillary or an arteriole of the periphery based on a steepness of rising of the photoplethysmographic signal, and to estimate a magnitude of a blood pressure of the subject by using a de time and the peripheral blood pressure index, wherein the de time is a peak time difference between a d wave and an e wave in an acceleration pulse wave signal obtained by performing second-order differentiation on the photoplethysmographic signal (additional element; abstract evaluation).
As indicated above, each independent claim recites at least one step or instruction grouped as a mental process. Therefore, each of the independent claims recites an abstract idea. Each limitation, aside from language reciting a generic computer components, can be grouped as a mental process (see italicized portions above), and is addressed as follows:
In both independent claims 1 and 17, the calculate[ing] and estimate[ing] steps are recited as no more than mere evaluation on collected data. The human mind is capable of observing gathered data (e.g., a time series of a plethysmographic waveform amplitude values) and deriving a “peripheral blood pressure index” based on such values. The human mind may also perform second-order differentiation to attain an acceleration pulse wave signal, and then identifying some relation to blood pressure using features therefrom. No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.
Alternatively or additionally, these steps describe the concept of using implicit mathematical formula(s) (i.e., evaluation of implicit equations and differentiation of signals) to derive a conclusion based on input of medical data, which corresponds to concepts identified as abstract ideas by the courts, such as in Diamond v. Diehr. 450 U.S. 175, 209 U.S.P.Q. 1 (1981), Parker v. Flook. 437 U.S. 584, 19 U.S.P.Q. 193 (1978), and In re Grams. 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989). The concept of the recited steps above is not meaningfully different than those mathematical concepts found by the courts to be abstract ideas.
The dependent claims merely include limitations that either further define the abstract idea or extra-solution activity (e.g. limitations relating to particulars of the data gathered or steps which are entirely embodied in the mental process) and amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they are merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Thus, these concepts are similar to court decisions of abstract ideas of itself: collecting, displaying, and manipulating data (Int. Ventures v. Cap One Financial), collecting information, analyzing it, and displaying certain results of the collection and analysis (Electric Power Group), collection, storage, and recognition of data (Smart Systems Innovations).
Step 2A, Prong 2
The above-identified abstract idea is not integrated into a practical application because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use.
More specifically:
Independent claim 1 recites the following additional elements:
a biological information measurement system with a photoplethysmographic sensor.
Independent claim 17 recites the following additional elements:
a sensing device including a photoplethysmographic sensor;
a signal processing device.
Such additional element are a generically recited elements which do not improve the functioning of a computer or any other technology or technical field. The claim recites merely acquiring data from generically recited sensors (i.e., a plethysmographic sensor), having no operative connection to the a biological information measurement system or signal processing device besides communication of obtained data, which amounts to insignificant, extra-solution activity in the form of mere data gathering, which does not constitute an integration into a practical application.
Applicant states that a biological information measurement system “includes a sensing device 20 that measures biological information of a user who is a subject and a computer 30 that is configured to be communicable with the sensing device 20” (Paragraph 0037). Throughout Applicant’s Specification, the term “computer 30” is not further defined; thus, the biological information measurement system is reasonably construed as a generic computer processing data from a plethysmographic sensor. Recitation of a computer processor at a high-level of generality (i.e., encompassing generic processors and memory performing a generic computer function of performing calculations and storing data, respectively) amounts no more than mere instructions to apply the exception using a generic computer component.
The broadest reasonable interpretation of a sensing device including a photoplethysmographic sensor is any device which senses and also has a photoplethysmographic sensor. Although the sensors may imply particular structure, their use in the mental process is merely extra-solution. See MPEP 2106.05(b).III:
“Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citations omitted)”
Applicant states that a signal processing device “includes a processor 321, a memory 322, and an input/output interface 323” (Paragraph 0045). Such components of a signal processing device are encompassed components known from a generic computer. The limitation signal processing device therefore amounts no more than mere instructions to apply the exception using a generic computer component.
Thus, such additional elements do not serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment (i.e., plethysmographic signal processing), such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified generically recited elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea is not integrated into a practical application.
Moreover, the above-identified abstract idea is not integrated into a practical application under because the claimed method and system merely implements the above-identified abstract idea using rules (e.g., computer instructions) executed by a computer. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract ideas identified above in the independent claims (and their respective dependent claims) are not integrated into a practical application.
Dependent claims 2-8, 12-16 and 18-20 recite limitations directed to further steps of the abstract idea or particulars of the data gathered, and do not recite elements in addition to the abstract idea which could integrate claimed abstract processes into a practical application.
Dependent claims 9-11 recite further particulars of data-gathering structures, which amounts to details of insignificant extra-solution activity.
Accordingly, the claims are each directed to an abstract idea.
Step 2B
None of the claims include additional elements that, when viewed as a whole, are sufficient to amount to significantly more than the abstract idea for at least the following reasons:
Independent claim 1 recites the following additional elements:
a biological information measurement system with a photoplethysmographic sensor.
Independent claim 17 recites the following additional elements:
a sensing device including a photoplethysmographic sensor;
a signal processing device.
As analyzed in Step 2A, Prong Two, a biological information measurement system with a photoplethysmographic sensor is no more than a generic computer in communication with a plethysmographic sensor. Additionally, a photoplethysmographic sensor is considered well-understood, routine, and conventional by at least:
Ross-Howe et al. (US 11872053 B1) (hereinafter – Ross-Howe) – Col. 27, lines 11-20: “The volumetric change in blood flow measured through optical sensors is referred to as Photoplethysmography (PPG). PPG channels are often measured at 660 nm (red), 940 nm (infrared), and 525 nm (green) wavelengths. PPG sensors are either reflective (commonly placed on the forehead and wrist locations), or transmittance-based (commonly placed on the fingers, toes, ear lobes, and nasal cavity)”
In light of the citation above, a sensing device including a photoplethysmographic sensor as recited in claim 17 is also considered well-understood, routine, and conventional, and a signal processing device is also considered directed to a generic computer.
Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear from the claims themselves and the specification that these limitations require no improved computer resources and merely utilize already available computers with their already available basic functions to use as tools in executing the claimed process.
Dependent claims 2-8, 12-16 and 18-20, as analyzed in Step 2A, Prong Two, recite limitations directed to further steps of the abstract idea or particulars of the data gathered, and do not recite elements in addition to the abstract idea which could amount to significantly more.
Examiner notes that the dependent claims recite limitations which are extra-solution or part of the abstract idea itself do not constitute significantly more. See MPEP 2106.05(a):
It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.
Dependent claim 9 requires controlling the photoplethysmographic sensor to emit light in a wavelength band from blue to yellow-green from a first light source, and to emit light in a wavelength band from red to near-infrared from a second light source. The use of such wavelengths for PPG measurement are known from the citations of Ross-Howe above, as well as:
Monti et al. (US 20200305736 A1) (hereinafter – Monti) – Paragraph 0012: “Photoplethysmography (PPG) technology can provide noninvasive hemodynamic information. The PPG sensor is typically placed on the finger pad where a source emits red, green or IR light (λ=1-10.sup.3 μm) (or light at any appropriate wavelength, e.g., red, green, IR, or combinations of these)…”
Gladshtein et al. (US 20200305736 A1) (hereinafter – Gladshtein) – Paragraph 0063: “Following explanation is for short illustration of ability for skilled in the art to measure signals from mainly region of smaller arteries and mainly region of arterioles, belong to same artery tree of blood circulation… For example, two transmitters of optical radiation—of green light 530 nm and IR light 940 nm are placed relatively to measured region of tissue by way, enabling to optical receiver measurement of two non-identical physiologic layers of tissue, one—closer to skin surface from green light source and another region—deeper than the first one—from IR radiation source.
Dependent claim 10 requires the PPG sensor to have a particular distance between a first light source and a light receiving element and another particular distance between a second light source and a light receiving element of. The use of simultaneous multiple PPG channels of distinct wavelengths are known from citations of Ross-Howe, Monti, and Gladshtein as above. The consideration of distinct separation distances between light sources of differing wavelengths and a light detector is recited as “typical,” with the absorption properties of biological tissue well-apprised to the skilled artisan being known from at least:
Mycek et al. (US 20180008172 A1) (hereinafter – Mycek) – Paragraph 0098: “The separation or distance between the first 120 and second 122 light sources (with the detector 124 between them) may be referred to as a center-to-center spacing or source-detector separation (SDS). By controlling the center-to-center spacing or source-detector separation, one can also control a penetration depth of light. Typically, the maximum light penetration depth is half of a given SDS in biological tissues. However, maximum light penetration depth may also be affected by the absorption properties of the tissue. Hemoglobin is one of the chromophores that attenuates an incident light and its absorption characteristics is dependent on the wavelength and oxygen-binding status. Hemoglobin absorption is much lower in a near-infrared (NIR) wavelength range (700 to 900 nm) than a visible wavelength range (400 to 700 nm). Accordingly, the maximum SDS of the sensing unit 110 using visible light (such as red and blue) may be limited to a few millimeters, an NIR LED could have a significantly larger SDS leading to deeper penetration and larger tissue interrogation volume.”
The recitation of the above-identified additional limitations in the claims amount to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
For at least the above reasons, the claims are directed to applying an abstract idea on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. In other words, none of the claims provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in the independent claims do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment (processing of multi-channel PPG sensor data). That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, the claims merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself, or (ii) provide a technical solution to a problem in a technical field.
Therefore, none of the claims amounts to significantly more than the abstract idea itself.
Accordingly, the claims are 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.
Conclusion
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/JUSTIN XU/Primary Examiner, Art Unit 3791
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