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 .
Specification
The disclosure is objected to because of the following informalities: the first paragraph of the specification should be updated to indicate the present status of the priority application.
Appropriate correction is required.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 1/17/25 has/have been acknowledged and is/are being considered by the Examiner.
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.
Claim(s) 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1- Claim 11
Claim 11 and dependent claims 12-20 are drawn to a method and thus meet the requirements for step 1.
Step 2a (prong 1) - Claim 11
Claims 11 recites the steps of “receiving, using a processor, electrocardiogram data of the user”. The claim does not put any limits on how the ECG data is received, but the background supports the plain meaning of “ECG data” as encompassing receiving the data remotely over a network and therefore constitutes data gathering.
Claim 11 further recites the step of “automatically analyze, the electrocardiogram data using a machine learning model”. The claim also does not limit the plain meaning of “analyzing,” which, as explained in the background, includes any known discretization method, including binning and clustering, as well as numerical discretization, such as rounding continuous data values or performing other basic mathematical calculations that can be performed mentally. Under the broadest reasonable interpretation, this step covers a concept capable of being performed in the human mind, and thus falls within the mental processes grouping of abstract ideas.
Claim 11 further recites the step of “analyzing at least a feature from the electrocardiogram”. The claim does not provide any details about how the model is analyzing the data, and the plain meaning of “analyzing” encompasses mental observations or evaluations, e.g., a computer programmer’s mental identification of an anomaly in a data set.
Claim 11 further recites the step of “determining a potassium level associated with the ECG data”. The claim does not provide any details about how the model is analyzing the data, and the plain meaning of “determining” encompasses mental observations or evaluations, e.g., a computer programmer’s mental identification of an anomaly in a data set.
Claim 11 further recites the step of “outputting a potassium level.” The step requires a generic output. The claim does not impose any limits on how the data is output or require any particular components that are used to output the data.
Accordingly, claim 11 recites an abstract idea.
Step 2a (prong 2) – Claim 11
The judicial exception is not integrated into a practical application. Claim 11 recites the additional elements of:
Receiving EGG data is insignificant extra-solution activity (i.e., data gathering),
Further, limitations regarding analyzing and determining reciting “using machine learning model” provide nothing more than mere instructions to implement an abstract idea on a generic computer. See MPEP 2106.05(f). MPEP 2106.05(f) provides the following considerations for determining whether a claim simply recites a judicial exception with the words “apply it” (or an equivalent), such as mere instructions to implement an abstract idea on a computer: (1) whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished; (2) whether the claim invokes computers or other machinery merely as a tool to perform an existing process; and (3) the particularity or generality of the application of the judicial exception.
Displaying a potassium level is recited at a high level of generality (i.e., as generic devices, a “computer-implemented” method, performing generic computer functions like sending, receiving, and visually displaying data) is insignificant extra-solution activity (i.e., data output).
These steps do not integrate the abstract idea into a practical application because they are insignificant extra solution activity.
Step 2b- Claim 11
This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. See MPEP 2106.05.
As explained with respect to Step 2A, Prong Two, there are three additional elements.
The additional element of “using a machine learning model” in the analyzing the determining steps are at best mere instructions to “apply” the abstract ideas, which cannot provide an inventive concept. See MPEP 2106.05(f).
Additional elements regarding the data input and output were both found to be insignificant extra-solution activity in Step 2A, Prong Two, because they were determined to be insignificant limitations as necessary data gathering and outputting. However, a conclusion that an additional element is insignificant extra-solution activity in Step 2A, Prong Two should be re-evaluated in Step 2B. See MPEP 2106.05, subsection I.A. At Step 2B, the evaluation of the insignificant extra-solution activity consideration takes into account whether or not the extra-solution activity is well understood, routine, and conventional in the field. See MPEP 2106.05(g).
As discussed in Step 2A, Prong Two above, the recitations of “displaying the potassium level” is recited at a high level of generality. These elements amount to receiving or transmitting data over a network and are well-understood, routine, conventional activity. See MPEP 2106.05(d), subsection II.
As discussed in Step 2A, Prong Two above, the recitation of a computer to perform limitations amounts to no more than mere instructions to apply the exception using a generic computer component.
Even when considered in combination, these additional elements represent mere instructions to implement an abstract idea or other exception on a computer and insignificant extra-solution activity, which do not provide an inventive concept. (Step 2B: NO).
Claim 11 is thus considered to be directed to an abstract idea without significantly more.
Claims 12-20 depend from claim 1. The devices utilized to collect the data as stated in claim 12 is stated at a high level of generality in applicant' s specification (“a smart watch; a touchpad device; a steering wheel; a smart handheld device; a waveform analysis kiosk; and a connected device”) and are merely used as a tool to carry out the data gathering. The type of instructions in claims 13-15 and 17-20, are at best mere instructions to “apply” the abstract ideas, which cannot provide an inventive concept. See MPEP 2106.05(f). The device utilized to display the data as stated in claim 16 is stated at a high level of generality and is used as a tool to display the output. Thus, the dependent claims do not change the overall analysis that claims 12-20 are also directed to an abstract idea.
Claims 1-10
Independent claim 1 is directed to a system containing limitations similar to that for claim 11 and further includes a processor. Analyzing the processor claim 1 under step 2a, prong 1, the processor is recited at a high level of generality and merely use the computer elements (the processor and memory) as a tool. When analyzed under step 2a, prong 2, the processor performs generic computer functions like storing and processing data. Further, when the analysis is extended to step 2b, the processor is considered to use the computer elements as tools, MPEP 2106.05(d)(II). Thus, claim 1 is also considered to be patent ineligible subject matter. Dependent claims 2-10 are similar to dependent claims 12-20 and are rejected on the exact same grounds.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-2, 6-12 and 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Friedman et al. (U.S. Pub. 2018/0350468 hereinafter “Friedman”).
Regarding claims 1 and 11, Friedman a system comprising: a processing device (e.g. ¶35) operatively connected to the electrocardiogram sensor (e.g. ¶7), the processing device configured to (e.g. ¶37): receive electrocardiogram data of a user from an electrocardiogram sensor (e.g. ¶37); automatically analyze, the electrocardiogram data using a machine learning model trained using feature learning using historical electrocardiogram data and historical analyte levels, wherein analyzing the electrocardiogram data (e.g. ¶¶34, 42) comprises: analyzing at least a feature from the electrocardiogram data (e.g. ¶¶34, 42); and determining a potassium level associated with the electrocardiogram data as a function of the at least an output (e.g. ¶¶34, 42); and display, using a user interface of a device, the potassium level (e.g. ¶68).
Regarding claims 2 and 12, Friedman further discloses wherein the electrocardiogram data comprises a 1 lead sensor electrocardiogram data, wherein the 1 lead sensor electrocardiogram data is collected from a remote device, wherein the remote device comprises a smart watch (e.g. ¶70; [single lead]).
Regarding claims 6 and 16, Friedman further discloses a display device, wherein the display device is configured to display the potassium level using at least a visual element within a graphical user interface of the device (e.g. ¶68).
Regarding claims 7 and 17, Friedman further discloses wherein the processing device further comprises preprocessing the electrocardiogram data of the user by removing noise (e.g. ¶¶54, 69).
Regarding claims 8 and 18, Friedman further discloses wherein the at least a feature comprises one or more of a T-wave amplitude and a T wave morphology (e.g. ¶58).
Regarding claims 9 and 19, Friedman further discloses wherein the machine learning model has been trained using training data comprising: a first measurement of the potassium level at a first time and a set of estimated values of the potassium level over a time period subsequent to the first time based in part on the level of the potassium level at the first time (e.g. ¶91).
Regarding claims 10 and 20, Friedman further discloses wherein the set of estimated values of the potassium level over a time period subsequent has been derived from the first measurement of the potassium level at a first time and a second measurement of the potassium level at a second time (e.g. ¶91).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 3-5 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Friedman as applied to claims 1-2, 6-12 and 16-20 above, and further in view of Gotthardt (U.S. Pub. 2011/0225114).
Regarding claims 3-5 and 13-15, Friedman discloses the claimed invention including determining the potassium level in comparison to the ECG but fails to generate an alert to a remote device to contact a doctor. However, Gotthardt teaches that it is known to use external alerts to contact a physician as set forth in Paragraphs 125-126 and 280 to provide an alert so that medically significant changes happened in the past or are predicted to happen in the future can be tended to in an appropriate time frame. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Friedman, with providing alerts to an external device to contact a physician as taught by Gotthardt, since such a modification would provide the predictable results of to providing an alert so that medically significant changes happened in the past or are predicted to happen in the future can be tended to in an appropriate time frame.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9 and 15 of U.S. Patent No. 11,915,825. Regarding claim 1, although the claims at issue are not identical, they are not patentably distinct from each other because Claims 1 and 6 of the ‘825 patent combined teach analyzing ECG data using machine learning to determine potassium level.
Regarding claim 11, although the claims at issue are not identical, they are not patentably distinct from each other because Claims 9 and 15 of the ‘825 patent combined teach analyzing ECG data using machine learning to determine potassium level.
Claims 1 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 11,103,194. Regarding claims 1 and 11, although the claims at issue are not identical, they are not patentably distinct from each other because Claims 1 and 6 of the ‘194 patent combined teach analyzing ECG data using machine learning to determine potassium level.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Friedman (U.S. Pub. 2016/0256063) – analyzes analytes and ECG to determine possible arrhythmia risks.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/Primary Examiner, Art Unit 3796
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