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 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 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 1-20 are directed to statutory subject matter as the claim(s) recite(s) a method and a system of determining apnea risk based on cardiac information.
Step 2A, Prong One
Claims 1 and 12 recite the following steps or instructions for “receive/receiving cardiac information…”, “detect/detecting bradycardia…”, “determine/determining a bradycardia burden…”, “determine/determining an apnea risk…”, and “provide/providing the determined apnea risk…”, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) and/or or mathematical concept in MPEP 2106.04(a)(2)(I).
These limitations concern cardiac data collection, data analysis, further assessment, interpretation, and diagnosis of the analysis, which could be done mentally or by hand with pen and paper, and is directed to mental processes of performing concepts in a human mind or by a human using a pen and paper and mathematical concepts. For example, these limitations are nothing more than a medical professional receiving cardiac information, analyzing the data for bradycardia and the level of severeness, and provide an assessment of its relation to apnea risk.
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 “sleep apnea risk stratification circuit” and “output unit”.
Step 2A, Prong Two
The above-identified abstract idea in each of independent Claims 1 and 13 (and their respective dependent Claims 2-12 and 14-20) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claims 1 and 13), 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: “sleep apnea risk stratification circuit” and “output unit” are generically recited computer elements in independent Claims 1 and 13 (and their respective dependent Claims 2-12 and 14-20) which do 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 Claims 1 and 13 (and their respective dependent Claims 2-12 and 14-20) 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. “a sleep apnea risk stratification circuit” and “output circuit” 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 Claims 1 and 13 (and their respective dependent Claims 2-12 and 14-20) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims 1 and 13 (and their respective dependent Claims 2-12 and 14-20) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B
Claims 1 and 13 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:
These claims require the additional elements of: “a sleep apnea risk stratification circuit” and “output circuit”, which is a generically claimed computer component which enables 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.
Claim 1 recites the additional elements of “a sleep apnea risk stratification circuit” and “output circuit”; however, these elements and their function are well understood routine and conventional in the art.
A “sleep apnea risk stratification circuit” is described in the disclosure as a component that is generic and conventionally used and known in the art: “The sleep apnea stratification system 300 may include one or more of a patient data receiver 310, a processor 320, and a user interface 330.” [¶¶ 56 – published app].
An “output circuit” is described in the disclosure as a component that is generic and conventionally used and known in the art: “The output unit may include a printer for printing hard copies of the detection information” [¶¶ 65 – published app].
Accordingly, in light of Applicant’s specification, “a sleep apnea risk stratification circuit” and “output circuit” and their function are considered well-understood routine and conventional in the art.
Additionally, the claimed “a sleep apnea risk stratification circuit” and “output circuit” 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, 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 “a sleep apnea risk stratification circuit” and “output circuit”. 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 and 13 (and their respective dependent Claims 2-12 and 14-20) 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, the method and systems of Claims 1 and 13 (and their respective dependent Claims 2-12 and 14-20) 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 and 13 (and their respective dependent Claims 2-12 and 14-20) 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 2-12 and 14-20, the limitations of these claims further define limitations directed to the abstract idea. As such, claim 1-20 when analyzed as a whole, do not appear to be patent eligible for the reasons set forth above.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Waugh et al. (US 2023/0190184; hereinafter “Waugh”).
Regarding claim 1, Waugh discloses a system for monitoring a subject for risk of sleep apnea, the system comprising: a sleep apnea risk stratification circuit (e.g. ¶¶ 54) configured to: receive cardiac information of the subject (e.g. ¶¶ 24); detect bradycardia from the received cardiac information during a monitoring period (e.g. Fig. 3, #320); determine a bradycardia burden based on the detected bradycardia, the bradycardia burden representing accumulated time or relative time of the subject being in the bradycardia during the monitoring period (e.g. ¶¶ 25 – “apnea events are indicated as beginning only after a threshold time (e.g., 20 seconds) during which a cessation of breathing was identified and bradycardia and oxygen desaturation occurred”); and determine an apnea risk based on the bradycardia burden (e.g. ¶¶ 42, 46, 59-60, etc.); and an output unit configured to provide the determined apnea risk to a user or a process (e.g. Fig. 3, #360).
Regarding claim 13, Waugh teaches a method of monitoring a subject for risk of sleep apnea, the method comprising: receiving cardiac information of the subject (e.g. ¶¶ 24); detecting bradycardia from the received cardiac information during a monitoring period (e.g. Fig. 3, #320); determining a bradycardia burden based on the detected bradycardia, the bradycardia burden representing accumulated time or relative time of the subject being in the bradycardia during a monitoring period (e.g. ¶¶ 25 – “apnea events are indicated as beginning only after a threshold time (e.g., 20 seconds) during which a cessation of breathing was identified and bradycardia and oxygen desaturation occurred”); and determining an apnea risk based on the bradycardia burden using a sleep apnea risk stratification circuit (e.g. ¶¶ 42, 46, 59-60, etc.); and providing the determined apnea risk to a user or a process (e.g. Fig. 3, #360).
Regarding claim 2, Waugh discloses an ambulatory medical device configured to collect the cardiac information including a surface or subcutaneous electrocardiogram from the subject, the ambulatory medical device including the sleep apnea risk stratification circuit (e.g. Fig. 4, 420A).
Regarding claim 3, Waugh discloses to detect the bradycardia includes to determine a duration of a bradycardia episode, the bradycardia episode including one or more of a sinus pause episode, a sinus bradycardia episode, or an atrioventricular (AV) disturbance or AV block episode (e.g. ¶¶ 16).
Regarding claims 4 and 14, Waugh discloses the sleep apnea risk stratification circuit is configured to determine the bradycardia burden based on the bradycardia detected during a nighttime monitoring period (e.g. ¶¶ 55 – where sleep apnea necessarily is monitored during nighttime and further where the period of recording includes nighttime).
Regarding claims 5 and 15, Waugh discloses the sleep apnea risk stratification circuit is configured to determine the bradycardia burden based on the bradycardia detected during a time period when the subject is asleep (e.g. ¶¶ 55 - where sleep apnea necessarily is monitored when the subject is asleep and further where the period of recording encompasses the time when a subject would be asleep).
Regarding claim 6, Waugh discloses a sleep detector configured to detect a sleep or awake state of the subject, wherein the sleep apnea risk stratification circuit is configured to determine the bradycardia burden based on the bradycardia detected when the detected sleep or awake state indicates that the subject is asleep (e.g. ¶¶ 55 - where sleep apnea necessarily is monitored when the subject is asleep and further where the period of recording encompasses the time when a subject would be asleep).
Regarding claims 7 and 16, Waugh discloses the sleep apnea risk stratification circuit is configured to detect one or more bradycardia episodes each satisfying a rate or duration requirement, and to determine the bradycardia burden based on a count of the detected one or more bradycardia episodes that satisfy the rate or duration requirement during the monitoring period (e.g. ¶¶ 25 – “apnea events are indicated as beginning only after a threshold time (e.g., 20 seconds) during which a cessation of breathing was identified and bradycardia and oxygen desaturation occurred”).
Regarding claims 8 and 17, Waugh discloses the one or more bradycardia episodes include one or more sinus pause episodes each lasting at least a threshold duration (e.g. ¶¶ 40-43).
Regarding claims 9 and 18, Waugh discloses the one or more bradycardia episodes include one or more sinus bradycardia episodes each having an average heart rate below a threshold heart rate (e.g. ¶¶ 40-43).
Regarding claims 10 and 19, Waugh discloses the sleep apnea risk stratification circuit is configured to trend the bradycardia burden over time, and to determine the apnea risk based on the trended bradycardia burden (e.g. ¶¶ 40-43).
Regarding claims 11 and 20, Waugh discloses the output unit is configured to generate an alert or a recommendation of apnea evaluation or treatment in response to the determined apnea risk exceeding a risk threshold (e.g. ¶¶ 46).
Regarding claim 12, Waugh discloses the output unit is configured to generate a control signal to a respiration-based apnea detector to trigger sleep apnea detection in response to the determined apnea risk exceeding a risk threshold (e.g. ¶¶ 43 – “a cessation of breathing with bradycardia”).
Conclusion
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
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