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
Claim 13 is objected to because of the following informalities: “obtained by receiving via a transmitter the pulse wave” should read as “obtained by receiving, via a transmitter, the pulse wave.” Examiner notes that delineating the clause “via a transmitter” using commas is more grammatically suitable. Appropriate correction is required.
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 1-14 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 ascertaining and processing data to assess quality of sleep of subject, which is grouped as a mental process. Accordingly, each of the claims recites an abstract idea.
Independent claim 1 recites an estimation system comprising:
at least one processor (additional element); and
at least one non-transitory medium connected to the at least one processor (additional element),
wherein the at least one processor is programmed to perform:
acquiring input information including a pulse wave of a first subject (additional element, data-gathering); and
estimating the blood glucose level or a glucose metabolism of the first subject based on an estimation expression, wherein the estimation expression is based on a blood glucose level and a pulse wave corresponding to the blood glucose level, and based on a result of regression analysis using an Augmentation Index given by a ratio of a magnitude of a forward wave of the pulse wave and a reflected wave emerging after the forward wave (evaluation and/or mathematical concept).
Independent claim 14 recites limitations of claim 1 mutatis mutandis as a method claim for an analogous system; thus, the analysis of claim 1 applies analogously to claim 14.
As indicated above, the independent claims recite 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:
The limitation of estimating the blood glucose level or a glucose metabolism of the first subject based on an estimation expression, wherein the estimation expression is based on a blood glucose level and a pulse wave corresponding to the blood glucose level, and based on a result of regression analysis using an Augmentation Index given by a ratio of a magnitude of a forward wave of the pulse wave and a reflected wave emerging after the forward wave encompasses an individual observing or gathering requisite data and performing regression analysis, which is an abstract process of evaluation capable of being performed either mentally or by pen-and-paper practice.
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 regression equations) 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 limitations relating to the data gathered 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 additional element(s) of non-transitory medium connected to the at least one processor. Such additional elements are generically recited computer elements which do not improve the functioning of a computer or any other technology or technical field. The above-identified abstract idea is not integrated into a practical application under because the claimed system and method merely implements the above-identified abstract idea using rules (e.g., computer instructions) executed by a computer (e.g., processor as claimed). 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.
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, 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.
Dependent claims 2-10 are directed to limitations that either further define the abstract idea or particulars of the data gathered or processing thereof.
Dependent claims 11-13 recite constructional details of the sensor. Even should a data-gathering element be understood to possess a particular structure, its use in the abstract process as presently claimed amounts to no more than mere extra-solution activity. 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)”
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 claims 1 and 14 recites the additional element(s) of non-transitory medium connected to the at least one processor.
Applicant’s disclosure is not particular regarding the particular structure of the generically claimed non-transitory medium connected to the at least one processor, and broadly describes particulars of such elements (Paragraph 0029: “The controller 143 includes a processor such as a CPU (Central Processing Unit) and so on, and executes a program specifying the details of a control procedure and a program that estimates the blood glucose level of the subject. These programs are stored upon a storage medium, such as for example the memory 145 or the like”).
No special programming or algorithms is indicated for how such generic computer elements operate. This lack of disclosure is acceptable under 35 U.S.C. 112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the medical technology arts. Thus, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the medical technology industry or medical technology arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional element because it describes such an additional element in a manner that indicates that the additional element is sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
Accordingly, in light of Applicant’s specification, the claimed terms interpretable as a processor are reasonably construed as a generic computing device.
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 claim 11 recites that the estimation system further comprises a sensor unit having a surface configured to contact against the first subject, wherein the sensor unit comprises an optical pulse wave sensor. Dependent 12 recites that the surface of the sensor unit protrudes towards the first subject. A sensor having a surface configured to contact against the first subject (i.e., also protruding relative to non-contacting portions of the sensor) and comprising an optical pulse wave sensor is considered routine, well-understood, and conventional by at least:
Futatsuyama et al. (US 20170014038 A1) – Paragraph 0003: “The following type of pulse wave measuring device has been known. Specifically, the known pulse wave measuring device includes a portion (hereinafter referred to as a contact portion), against which a fingertip of a user contacts at the time of measuring the pulse wave, a light emitting element and a light receiving element. The light emitting element emits the light to the fingertip that contacts the contact portion. The light receiving element receives a reflected light, which is reflected from the fingertip, or a transmitted light, which is transmitted through the fingertip. The pulse wave measuring device measures the pulse wave based on an oscillatory change in the amount of light that is received through the light receiving element (see, for example, JPH07-213498A).”
Kim et al. (US 9924880 B2) – Col. 8, lines 49-59: “Some cuff-less blood pressure sensors are based on five principles, namely, pulse wave analysis (PWA), pulse transit time (PTT) estimation, particle image velocimetry (NV), photo-acoustic and ultrasound based methods. In PWA, optical measurements such as tonometry permit recording of radial and carotid pressure waveforms. Through analysis of the waveform due to forward and reflective wave fronts, parameters relaying cardiovascular functional information can be extracted. PTT-based estimation involves the use of two sources related to the cardiac cycle, usually ECG and PPG to measure velocity [8].”
Phillips et al. (US 20120253154 A1) – Paragraph 0030: “Tonometry and photoplethysmography appear to be the two most promising pulse-wave sensing techniques for subject identification, and will serve to illustrate the invention. A piezoelectric transducer can perform tonometry, as shown in FIG. 3, and is core to the compact commercial instrument "PulsePen" marketed by DiaTecne s.r.l. of Milan, Italy. Two light-emitting diodes 32, 33 and a photodetector 34 can perform photoplethysmography as shown in FIG. 3, the dominant technology in the pulse-oximeter market.”
Dependent claim 13 recites wherein the input information is obtained by receiving via a transmitter the pulse wave obtained by the sensor unit. Examiner notes that transmission from pulse wave sensors is considered routine, well-understood, and conventional by at least:
Shah et al. (US 20220331065 A1) – Paragraph 0266: “… a standard pulse oximeter with Bluetooth capability), and a photo plethysmographic (PPG) sensor to measure respiratory effort (alternately could be a standard RIP belt to acquire the same parameter).”
Kim et al. (US 20030078505 A1) – Paragraph 0005: “An apparatus for measuring bio-information using an ear-receiver type Photo-electric pulse Plethysmograph (PPG) sensor, which is disclosed in Korean Patent Publication No. 1999-63100, and a real time bio-signal monitoring system using wireless communication networks, which is disclosed in Korean Patent Publication No. 1997-14722, are conventional portable bio-signal measuring apparatuses. However, such conventional apparatuses are disadvantageous in that they are not easy to attach to a human body, or in that it is inconvenient for people to move with them attached.”
Farringdon et al. (US 20050113703 A1) – Paragraph 0102: a list of generic devices are provided including plethysmographic devices, whereby wireless communication is regarded as “well known to those skilled in the art.”
De Haan (US 20150236740 A1) – Paragraph 0008: “In particular, the use of remote photoplethysmographic (PPG) analyses is envisaged. Photoplethysmography is a commonly known optical measurement approach which can be used to detect blood volume changes in the microvascular bed of tissue of a monitored subject. Conventional PPG approaches include so-called contact PPG. Contact PPG requires measurement components (e.g., light sources and photodetectors) which basically have to be attached to a subject's skin. Consequently, standard photoplethysmography comprises obtrusive measurements, e.g. via a transceiver unit being fixed to the subject's earlobe or fingertip. Therefore, remote PPG measurement is often experienced as being unpleasant.”
Negi et al. (US 20160192039 A1) – Paragraph 0004: “Other types of conventional HR monitors are also ECG based, but only have a watch on one hand and the user needs to pause to measure HR by touching it with the other hand. A Valencell™ brand product has a PPG (photoplethysmography) based solution for HR monitoring in earphones. PPG is an optical sensing technique that allows measurement of blood pulsation from the skin surface. The Valencell™ brand product has a sensor in the earbud and as digital signal processor (DSP) and Bluetooth™ radio in a medallion or other separate component connected to the earbuds. The user can clip the separate medallion on their clothes or wear the separate component. HR data is wirelessly transmitted periodically from the medallion or other separate component to an app in a mobile phone.”
Lamego et al. (US 20180110450 A1) – Paragraph 0029: wireless oximeters and photoplethysmograph amplitude measuring devices.
Each other dependent claim merely recites steps which further define the abstract idea and data/data-processing steps. 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.
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 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Wilkinson IB, MacCallum H, Rooijmans DF, Murray GD, Cockcroft JR, McKnight JA, Webb DJ. Increased augmentation index and systolic stress in type 1 diabetes mellitus. QJM. 2000 Jul;93(7):441-8. doi: 10.1093/qjmed/93.7.441. PMID: 10874053. (hereinafter – Wilkinson).
Wilkinson performs regression analysis using augmentation index (Aix); however, such a regression analysis is a multi-regression analysis using AIx as the dependent variable, with blood glucose concentration and a variety of other parameters as the independent variables, which, in a multi-regression analysis, are used to predict a AIx using two or more independent variables, assuming a linear and additive relationship. In order to encompass the claims, the regression requires blood glucose to be the dependent variable, with AIx being at least one independent variable, which is not taught or suggested by the closest prior arts of reference or the non-patent literature cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/Primary Examiner, Art Unit 3791
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