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 claims recite mental processes that include additional routine and conventional elements (i.e. electrodes and associated circuitry) and does not integrate the abstract idea into practical application.
Step 2A, Prong 1:
Claim 1 recites limitations of “determine a T-wave morphology associated with a T-wave in the ECG; based on the T-wave morphology, determine an estimate of serum potassium in blood of the patient; determine that the estimate of serum potassium in the blood satisfies a threshold” The limitations, as drafted, describe a process that, under its broadest reasonable interpretation, includes performance of the limitation in the mind except for the recitation of “sensing circuitry.” The sensing circuitry is a generic device that is routine and conventional. Other than reciting that processing circuitry is performing the other tasks, nothing in the claim precludes the steps from practically being performed in the human mind. MPEP 2106.04(a)(2)(III) states that the courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. For example, aside from the recitation of “a processing unit” language, the claim encompasses the user determining mathematic areas and ratios of those areas based on an image. These limitations can be considered a mathematical relationship or a mental process.
Step 2A Prong 2:
The claims recite “processing circuitry” to perform the abstract steps. These components read on a computer implemented system and are recited at a high level of generality, i.e., as a generic processor, performing a generic computer function of processing data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional limitation does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B:
As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept in Step 2B.
The limitation “generate an indication for output that is based at least in part on the estimate of serum potassium in the blood satisfying the threshold” does not integrate the abstract idea into practical application. First, it doesn’t actually require any output; it is merely an indication for output. Furthermore, if an output was required, simply communication the results of such a determination to a user could be done by the human mind and using a pen and paper. Furthermore, the term “indication” is broad and does not show what sort of improvement/benefit is realized as it could indicate anything based on the estimate.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1 – 4, 7, 10, 12 – 14, 17, 20, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kharam et al. (US PGPUB 2020/0196960 – in IDS).
Regarding claims 1, 10, and 20, Kharam discloses a medical device system and method comprising: a plurality of electrodes (e.g. ¶ 88); sensing circuitry configured to sense an electrocardiogram (ECG) of a patient (e.g. ¶ 46, 88, 90); and processing circuitry configured to: determine a T-wave morphology associated with a T-wave in the ECG (e.g. ¶ 90, 109 – 110); based on the T-wave morphology, determine an estimate of serum potassium in blood of the patient (e.g. ¶ 90; the control circuit can be configured to determine a serum potassium); determine that the estimate of serum potassium in the blood satisfies a threshold (e.g. ¶ 79); and based on the estimate of serum potassium in the blood satisfying the threshold, generate an indication for output that is based at least in part on the estimate of serum potassium in the blood satisfying the threshold (e.g. ¶ 80).
Regarding claims 2, 12, and 21, Kharam discloses the processing circuitry is further configured to: determine an R-wave morphology associated with an R-wave in the ECG, the R-wave preceding the T-wave; and normalize the T-wave morphology based on the R-wave morphology prior to determining the estimate of serum potassium in the blood (e.g. ¶ 83).
Regarding claims 3 and 13, Kharam discloses the processing circuitry is further configured to average the normalized T-wave morphology across a plurality of successive heart beats (e.g. ¶ 64).
Regarding claims 4 and 14, Kharam discloses the indication comprises at least one of an alert or a recommendation of remedial action (e.g. ¶ 80).
Regarding claims 7 and 17, Kharam discloses determining the estimate of the serum potassium in the blood comprises applying at least one of a patient specific machine learned model or a population averaged machine learned model to the morphology of the T-wave (e.g. ¶ 70).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5, 6, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kharam et al. in view of Soykan et al. (US PGPUB 2013/0274642 – in IDS).
Regarding claims 5, 6, 16, and 16, Kharam discloses the claimed invention as described above, but fails to explicitly recite based on the estimate of serum potassium in the blood satisfying the threshold, control the sensing circuitry to increase a sampling rate of the ECG; and monitor the ECG for arrythmia of a heart of the patient and to determine an arrythmia of the heart of the patient; and based on determining the arrythmia of the heart of the patient, perform at least one of control the medical device system to pace the heart of the patient or generate an indication of arrythmia for output.
Soykan teaches it is known that potassium fluctuations could lead to cardiac arrhythmias (e.g. ¶ 219) and using ECG signals to monitor cardiovascular parameters (e.g. ¶ 277). Furthermore, it is well known in the art to increase ECG sampling rate when a cardiac event has been detected. It would have been obvious to one having ordinary skill in the art to modify the invention as taught by Kharam with the increasing a sampling rate to identify and treat an arrhythmia as taught by Soykan, since such a modification would provide the predictable results of better treating a patient in the event of the determined potassium fluctuations.
Claim(s) 8, 9, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kharam et al. in view of Mayo Foundation (WO 2017/091736 – in IDS).
Regarding claims 8, 9, 18, and 19¸ Kharam discloses the claimed invention as discussed above, but fails to explicitly recite determining, based at least in part on an accelerometer signal, a posture of the patient; and determine, based at least in part on the posture of the patient, the estimate of serum potassium in blood of the patient, wherein the posture is supine.
Mayo teaches it is known to use an accelerometer to determine a posture of the patient and to use ECG signals to determine levels of serum potassium (e.g. ¶ 97). It would have been obvious to one having ordinary skill in the art to modify the invention as taught by Kharam with the accelerometer and posture determination as taught by Mayo, since such a modification would provide the predictable results of providing more information about the patient in order to better diagnose and treat the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796
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