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 .
Response to Arguments
Applicant’s arguments combined with the claim amendments have been fully considered but are not found persuasive with respect to the previous rejections.
Regarding the rejection under 35 USC 112, applicant contends that the specification teaches the invention can use wearable PPG sensors and further asserts it is well known that photoplesmythography involves illumination of skin with light and detection of light, with a plurality of 3rd party references to support this position. The examiner does not disagree with this position; however, the claims do not require the light source is part of a wearable PPG sensor – but simply a light source/sensor in a noninvasive wearable device, which would include a plurality of devices outside of the scope of the invention which specifies a wearable PPG sensor. Applicant’s arguments would be found persuasive if the claims recited the light source/sensor in a noninvasive wearable PPG device or sensor, but the claims recite limitations broader than that which is not supported by the disclosure as originally filed.
Regarding the rejection under 35 USC 101, applicant contends the claims are limited to a practical application; however, as noted in the rejection below, simply applying well understood, routine, and conventional elements to acquire data is considered pre-solution activity and the abstract idea involving performing determinations and analysis on that data to come to an assessment of volume status of a waveform, amounts to an abstract idea which falls under a mental process involving steps which involve mathematical concepts and calculations using data that can be performed by hand, without any additional or resultant steps that amount to significantly more than the abstract idea. Applicant contends that the additional elements cannot be “extra solution activity” since the operation of the hardware systems is required before any solution can be obtained. The examiner notes that all aspects of the claim do not fall within the abstract idea, presolution and extrasolution activity involves steps which fall outside the abstract idea, especially when involving data collection or data visualization, using well understood, routine and conventional elements. In this scenario, the additional elements in the independent claims (in the case of claim 1, would be steps (a) and (c)) are simply presolution/extra solution activity elements which gather data using well understood, routine, and conventional light sources and sensors.
Accordingly, the rejection is maintained below.
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 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are determined to be directed to a judicial exception, specifically an abstract idea, without significantly more.
Step 1
The claimed inventions in claims 1-12 are directed to statutory subject matter as the claim(s) recite(s) a method and an apparatus for assessing photoplethysmography data.
Step 2A, Prong One
Claim 1 recites the following steps or instructions for “directing light…”, “detecting light…”, determining a first pulse waveform as a photoplethysmogram…”, “detecting a positional change…”,“directing light…”, “detecting light…”, “determining a second pulse waveform as a photoplethysmogram…”, “determining a first duration of ventricular ejection…”, “determining a second duration of ventricular ejection”, “determining a measure of variation…”, and “assessing volume status…”, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) and/or mathematical concept in MPEP 2106.04(a)(2)(I). For example, these limitations concern data collection (directing/detecting light, determining a first/second pulse waveform as a ppg, and detecting a positional change) and data analysis (“determining a first duration of ventricular ejection…”, “determining a second duration of ventricular ejection”, “determining a measure of variation…”, and “assessing volume status…”), directed to mental processes of performing concepts in a human mind or by a human using pen and paper and mathematical concepts.
Claims 2 recites the following steps or instructions for “measuring a first pulse waveform…”, “measuring a second pulse waveform…”, “determining a first duration of ventricular ejection…”, “determining a second duration of ventricular ejection”, “determining a measure of variation…”, and “assessing volume status…”, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) and/or mathematical concept in MPEP 2106.04(a)(2)(I). For example, these limitations concern data collection (“measuring a first pulse waveform…” and “measuring a second pulse waveform…”) and data analysis (“determining a first duration of ventricular ejection… “, “determining a second duration of ventricular ejection”, “determining a measure of variation…”, and “assessing volume status…”), directed to mental processes of performing concepts in a human mind or by a human using pen and paper and mathematical concepts.
Claims 3 recites the following steps or instructions to “measure a first pulse waveform…”, “measure a second pulse waveform…”, “determine a first duration of ventricular ejection…”, “determine a second duration of ventricular ejection”, and “determine a measure of variation…” which is grouped as a mental process in MPEP 2106.04(a)(2)(III) and/or mathematical concept in MPEP 2106.04(a)(2)(I). For example, these limitations concern data collection (“measure a first pulse waveform…”, “measure a second pulse waveform…”) and data analysis (“determine a first duration of ventricular ejection…”, “determine a second duration of ventricular ejection”, and “determine a measure of variation…”), directed to mental processes of performing concepts in a human mind or by a human using pen and paper and mathematical concepts.
In these independent claims, the limitations are nothing more than a medical professional using a known photoplethysmography device (which produces, directs, and senses/detects light) to obtain a pulse waveform of a patient, and perform analysis on that pulse waveform using well known mathematical concepts of wavelet analysis. Accordingly, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
In addition, Claim 1 recites additional elements of a “light source” and “a light sensor”.
In addition, Claim 3 recites additional elements of “pulse detection system” comprising a “light source” and “light sensor to detect light”; “measurement control system”; and “analysis system”.
Step 2A, Prong Two
The above-identified abstract idea in each of independent claims 1-3 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) and appear to be extra solution activity where data to be analyzed by the abstract idea is acquired or obtained.
More specifically, the additional elements of: a “pulse detection system”; “measurement control system”; and “analysis system” are generically recited computer elements in independent Claim 3 which does not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) 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 according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claim 3 (and respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and using mathematical concepts) using rules (e.g., computer instructions) executed by a computer (e.g., “pulse detection system”; “measurement control system”; and “analysis system” 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 according to MPEP 2106.05(f). 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 according to MPEP 2106.05(a). 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 idea identified above in independent claim 3 (and its respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims 1-3 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B
Claims 1-3 do not include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons:
Claim 3 requires the additional elements of: “pulse detection system”, “measurement control system”; and “analysis system”. The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Claims 1 and 3 also require the additional elements of a “light source” and “light sensor”.
Per Applicant’s specification, there is no support or recitation of a “light source” and “light sensor”, and the only element that appears to be described in the specification as being used as a light source/sensor is a photoplethysmography device (PPG) that is generic and conventionally used and known in the art. In addition, [0037] of the disclosure seems to describes all the components (“pulse detection system”, “measurement control system”; and “analysis system”) as commonly well understood and conventional devices in the art.
Accordingly, these elements and function are considered well-understood routine and conventional in the art, performing presolution activities that are merely data gathering steps or performing generic computing functions for the abstract idea in the independent claims above. 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, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “pulse detection system”, “light source”, “sensor to detect light”, “measurement control system”; and “analysis system”. 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 computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are 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 MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in Claims 1-3 amounts 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 (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with 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.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, 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. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, claims 1-3 (and respective dependent claims) are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing 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 according to MPEP 2106.04(d)(2) and 2106.05(e).
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 independent claims 1-3 (and respective dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). 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 according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements 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 according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, 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 according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Regarding dependent claims 4-12, the limitations of these claims further define limitations directed to the abstract idea.
As such, claim 1-12 when analyzed as a whole, do not appear to be patent eligible for the reasons set forth above.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 2-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first -paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1 and 3 require newly recited elements: “light source” and “light sensor”; however, these elements in combination with the other elements and language in the claim, fail to be supported by the originally filed disclosure.
Claims 4-12 are rejected under the same rationale as being dependent upon claims 1 and 3 and their limitations.
Conclusion
Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796