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 1-21 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 1-21 are directed to statutory subject matter as the claim(s) recite(s) a method and a system for monitoring physiological signals.
Step 2A, Prong One
Claim 1 recites the following steps or instructions for “collecting… measurements…”, “transmitting…measurements…”, “receiving, the measurements and a local device identifier…”, “classifying each of the measurements…”, “assigning a corresponding tag…”, “verifying the classification….”, “presenting the measurements and verified classifications….”, which is grouped as a mental process in MPEP 2106.04(a)(2)(III).
Claim 20 recites the following steps or instructions for “measuring physiological signals…”, “generating an output…”, “receiving said output”, “generating a personalized output”, “receive and process said personalized output..”, “automatically classify the first measurement”, “assign a corresponding tag….”, “present the first measurement for verification”, and “present the verified first measurement…”, which is grouped as a mental process in MPEP 2106.04(a)(2)(III).
The claimed limitations concern physiologic data collection, data receipt, data analysis and classification, data verification, and visually presenting the results of data analysis, where these steps are directed to mental processes of performing concepts in a human mind or by a human using a pen and paper. These limitations are nothing more than a medical professional receiving measurement data, classifying that data based on the value and then assigning a tag to that data set or value, verifying that classification before visually presenting by hand the measurements for access by a clinician.
Accordingly, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
In addition, Claims 1 and 20 recite additional elements of “a monitoring device”, “a local device”, “a remote server”, “a processing module”, “a review(er) portal”, and “a clinician portal”.
Step 2A, Prong Two
The above-identified abstract idea in each of independent Claims 1 and 20 (and their respective dependent) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claims 1 and 20), 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 monitoring device”, “a local device”, “a remote server”, “a processing module”, “a review(er) portal”, and “a clinician portal” are generically recited computer elements in independent Claims 1 and 20 (and their respective dependent claims) 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 20 (and their 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) using rules (e.g., computer instructions) executed by a computer (e.g., “a monitoring device”, “a local device”, “a remote server”, and “a processing module” 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 20 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims 1 and 20 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B
Claims 1 and 20 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 monitoring device”, “a local device”, “a remote server”, “a processing module”, “a review(er) portal”, and “a clinician portal”. 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.
Per Applicant’s specification:
¶¶ 29 – “….direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable media produce an article of manufacture including instruction means which implement the function/act specified in the flowchart illustrations and/or block diagram block or blocks.”
¶¶ 42 – “the local device 120 may be a mobile computing device, such as a mobile phone or a laptop computer.”
¶¶ 57 – “the described remote server 130 may be provided as a cloud computing environment and may include the described processing module 140, review portal 150, and clinician portal 160 as virtual machines such as may be accessible to a reviewer and/or clinician by means of a suitable computing device, for example desktop computer, laptop computer or mobile device as would be understood from the current disclosure by one skilled in the art. For example, a clinician may access the clinician portal 160 using an application executed on a mobile device or smartphone.”
Accordingly, in light of Applicant’s specification, “a monitoring device”, “a local device”, “a remote server”, “a processing module”, “a review(er) portal”, and “a clinician portal” and their function are considered well-understood routine and conventional in the art.
Additionally, the claimed terms “a monitoring device”, “a local device”, “a remote server”, “a processing module”, “a review(er) portal”, and “a clinician portal” 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 “a monitoring device”, “a local device”, “a remote server”, “a processing module”, “a review(er) portal”, and “a clinician portal”. 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 20 (and respective dependent claims) 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 system of Claims 1 and 20 (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 and 20 (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.
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 1-19 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 pre-AIA the applicant regards as the invention. In claim 1, the collecting and transmitting steps appear to be claimed as optional; therefore, it is unclear how these steps can be optional of the rest of the steps derive from the measurements collected in these steps, and further it would appear that the entire method would therefore default to optional and no steps would be performed if the option was chosen to not collect measurements. Further clarification is required.
Claims 2-19 are rejected under the same rationale as being dependent upon claim 1 and its limitations.
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 1-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haddad et al. (US 2020/0357517; hereinafter “Haddad”).
Regarding claim 1, Haddad teaches a method for monitoring a physiological condition from physiological signals collected from a body, the method comprising: optionally, collecting, by a monitoring device, measurements representing said physiological signals of the body (e.g. ¶¶ 23-25; Fig. 1, #10 – monitoring device); optionally, transmitting the measurements from the monitoring device to a local device (e.g. ¶¶ 24 – local device is external device 12); receiving, at a remote server, the measurements and a local device identifier from the local device (e.g. ¶¶ 26); automatically classifying each of the measurements as one of an artifact, a potential problem or a normal measurement (e.g. ¶¶ 82 – “classify the episode as, among other classifications, premature ventricular contraction, premature atrial contraction, and artifact/noise”) and assigning a corresponding tag to the respective measurement at a processing module of the remote server (e.g. ¶¶ 83 – “may label a premature depolarization as a premature ventricular contraction or a premature atrial contraction based on the likelihood values corresponding in time to the premature depolarization meeting (e.g., exceeds) a threshold”); verifying the classification of the measurements at a reviewer portal of the remote server accessible to a review technician and presenting the measurements and verified classifications at a clinician portal accessible to a clinician (e.g. ¶¶ 51-52 – where the software allows a portal for review and annotation along with analysis and visual plots).
Regarding claim 20, Haddad discloses a health monitoring system, the monitoring system comprising: a monitoring device arranged for measuring physiological signals from a body and generating an output including at least a first measurement (e.g. ¶¶ 23-25; Fig. 1, #10 – monitoring device); a local device arranged for receiving said output and generating a personalized output including at least the first measurement and a local device identifier (e.g. ¶¶ 24 – local device is external device 12); a remote server configured to receive and process said personalized output (e.g. ¶¶ 26), said remote server comprising: a processing module arranged to automatically classify the first measurement as an artifact, a potential problem or as having no apparent evidence of abnormality (NAEOA) (e.g. ¶¶ 82 – “classify the episode as, among other classifications, premature ventricular contraction, premature atrial contraction, and artifact/noise”), the processing module configured to assign a corresponding tag to the first measurement according to said classification (e.g. ¶¶ 83 – “may label a premature depolarization as a premature ventricular contraction or a premature atrial contraction based on the likelihood values corresponding in time to the premature depolarization meeting (e.g., exceeds) a threshold”) ; a review portal arranged to present the first measurement and the corresponding tag for verification and a clinician portal arranged to present the verified first measurement and the corresponding tag (e.g. ¶¶ 51-52 – where the software allows a portal for review and annotation along with analysis and visual plots).
Regarding claim 2, Haddad discloses the monitoring device is a wearable device (e.g. ¶¶ 20).
Regarding claim 3, Haddad discloses the monitoring device comprises at least one sensor configured for collecting the measurements representing said physiological signals of the body (e.g. ¶¶ 23-25).
Regarding claim 4, Haddad discloses the monitoring device and the local device are operatively connected by a first communication network (e.g. Fig. 1 – where the local device 12 is on a first communication network with monitoring device 10).
Regarding claim 5, Haddad discloses the local device and the remote server are operatively connected by a second communication network (e.g. Fig. 1 – where local device 12 is connected by a second network 25 to the remote server 24).
Regarding claim 6, Haddad discloses the local device is configured to add a timestamp to the measurements transmitted by the monitoring device (e.g. ¶¶ 7 – where the data is collected over time and is correlated with a timestamp for analysis).
Regarding claim 7, Haddad discloses the local device is arranged to provide the measurements to the remote server at a predetermined interval (e.g. ¶¶ 20 – “periodically transmit collected data”)
Regarding claim 8, Haddad discloses the predetermined interval is less than 24 hours (e.g. ¶¶ 32 – “when patient 4 experiences one or more symptoms of arrhythmia and inputs a command to external device 12 instructing IMD 10 to upload the data for analysis by a monitoring center”).
Regarding claim 9, Haddad discloses the monitoring device comprises at least two redundant sensors for collecting the measurements (e.g. ¶¶ 35).
Regarding claim 19, Haddad discloses the measurements collected by the at least two redundant sensors comprise at least a first measurement and a second measurement, at least the first measurement and the second measurement being provided as overlay data (e.g. ¶¶ 30).
Regarding claim 13, Haddad discloses the predetermined interval is between 6 and 12 hours (e.g. ¶¶ 25).
Regarding claim 14, Haddad discloses the predetermined interval is between 3 and 5 hours (e.g. ¶¶ 25).
Regarding claim 15, Haddad discloses the predetermined interval is between 1 and 2 hours (e.g. ¶¶ 25).
Regarding claim 10, Haddad discloses the step of verifying the classification of the measurements at the reviewer portal of the remote server comprises verifying at least the potential problem classification of the measurements (e.g. ¶¶ 51-52, 83, etc.).
Regarding claim 11, Haddad discloses the step of verifying the classification of the measurements at the reviewer portal of the remote server comprises changing classification of at least one of the measurements (e.g. ¶¶ 51-52, 83, etc.).
Regarding claim 12, Haddad discloses the measurements collected by the monitoring device comprise electrocardiogram (ECG) measurements (e.g. ¶¶ 3).
Regarding claim 16, Haddad discloses the local device is arranged to continuously provide the measurements to the remote server (e.g. ¶¶ 33).
Regarding claim 17, Haddad discloses the step of automatically classifying each of the measurements as one of an artifact, a potential problem or a normal measurement and assigning a corresponding tag to the respective measurement at the processing module of the remote server is based on a set of predetermined measurement parameters set at the processing module (e.g. ¶¶ 83).
Regarding claim 18, Haddad discloses the set of predetermined parameters for automatically classifying each of the measurements is selected based on the local device identifier (e.g. ¶¶ 65).
Regarding claim 21, Haddad discloses the system of claim 20 is configured to perform the method of claims 1-19 based on the same rationale and citations in each of the claims above.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796