I. ACKNOWLEDGEMENTS
This Office Action addresses U.S. Application No. 18/767560 (“’560 Application” or “instant application”). Based upon a review of the instant application, the actual filing date of the instant application is July 9, 2024.
II. STATUS OF CLAIMS
Claims 1-20 were filed with the application
a. Claim 1-20 (“Pending Claims”).
b. Claim 1-20 are examined (“Examined Claims”)
II. PRIORITY AND CONTINUING DATA
The ‘560 application claim the benefit of provisional application 63/526092, filed July 11, 2023. The ‘560 application claims no other priority. Because the earliest possible effective filing date is after March 16, 2013, the first to file provision of the AIA , apply to this proceeding.
IV. REJECTIONS UNDER 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 USC 101 because the claimed invention is directed to an abstract idea without significantly more (See MPEP 2106.04(a)).
Claim 1 recites the limitations:
A signal processing device of a patient management system, the device comprising:
a communication circuit configured to receive a cardiac signal from an AMD, wherein the received cardiac signal is a frequency filtered cardiac signal produced from a broader frequency band cardiac signal sensed using the AMD; and
signal processing circuitry configured to:
restore the received cardiac signal to the broader frequency band cardiac signal;
detect an elevated ST segment in the restored broader frequency band cardiac signal; and generate an alert of myocardial infarction in response to detecting the elevated ST segment.
The first step in the 101 analysis, step 1 in MPEP 2106, is whether the claimed invention is in one of the 4 statutory classes of invention. Here, the claim is drawn to a signal processing device, which is one of the 4 statutory classes of invention. Hence, step 1 is satisfied.
The next step in the analysis, step 2A prong one, is whether the claim is directed to judicial exception, i.e. a law of nature, a natural phenomenon, or an abstract idea. The detecting step is a mental process that can be performed mentally after receiving the inputs. Mental processes are recognized as judicial exceptions that recite an abstract idea. See MPEP 2164
In Step 2A, prong two of the analysis, the claim is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application.
The claim has several additional elements. First, the communication circuit is data gathering, as it receives the signal from the AMD. In addition, the step of restoring is also data gathering, as it is pre-processing to provide a signal for the process. Data gathering is pre-solution activity which does not integrate the claim into a practical application. In addition, the step of generating an alarm is post solution activity, which does not integrate the exception into a practical application. Therefore, the additional elements and steps do not integrate the claim into a practical application. Further, to the extent that structure is recited, it is recited at a high level of generality. As such, the answer to step 2A, prong 2, is no.
The final step of the analysis, step 2B, where the claim is evaluated to determine whether the recited additional elements amount to significantly more than the judicial exception. Here, the additional steps and structure are simply well-understood, routine, and conventional processing steps and structure. Hence, the step does not recite an inventive concept.
As such, claim 1 is directed to an abstract idea and is not patent eligible.
As to claims 2-7 the claims do not add anything that changes the analysis and hence, are also drawn to an abstract idea.
Claims 9-20 are directed to an abstract idea for the same reasons claims 1-7.
V. ART REJECTIONS
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) 1, 2, 4, 9-10, 12, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Boileau et al US P PUB 2008/0033499 in view of Grass et al US P PUB 2021/0118569.
As to claim 1, Boileau teaches an AMD 10 that senses cardiac signals, where the processor 60 receives a filtered IEGM and restores the low frequency information in the signals (see paragraph 0092]). Then, the system uses the restored signal to extract ST information, and diagnose ischemia based on an elevated ST segment, which is a precursor to a myocardial infarction. It does actually identify myocardial infarction. However, in a similar device, Grass determines myocardial infarction based on an elevated ST segment (see paragraph [0035]) and provides an indication thereof. As such, it would have been obvious to modify Boileau to detect infarction, to provide a more complete picture of the patient’s condition and increase safety of the patient.
As to claim 2, the process described in paragraph [0092] of Boileau is reverse filtering.
As to claim 4, Boileau has a memory that stress baseline ST signals and diagnoses an elevated ST segment based on a comparison to the baseline (paragraph [0125]). In addition, Grass teaches the same process of comparison to a baseline to diagnose infarction ([0035]).
Claims 9, 10, 12, 19 are rejected for the reasons given above.
As to claim 15, the received signal is high pass filtered and restoring restores the low pass information, as discussed above.
Claim(s) 3, 11, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Boileau et al US P PUB 2008/0033499 in view of Grass, as applied to claims 1, 2, 4, 9-10, 12, 15, and 19 above, further in view of Schookin et al US Patent 6,161,038.
The combination does not phase correct the restored signal. However, Schookin teaches in claim 3, for example, that phase correcting a signal reduces distortion in the signal. As such, it would have been obvious to modify the combination to include phase correction to reduce distortion.
Claim(s) 5, 7, 8, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Boileau et al US P PUB 2008/0033499 in view of Grass, as applied to claims 1, 2, 4, 9-10, 12, 15, and 19 above, further in view of Chen et al US Patent 11,134,882.
As to claim 5, Boileau does not have the signal processing in a server of a patient management system. However, Chen teaches in column 12, lines 55+ that the processing in an AMD can be on the AMD or on an external server. As such, it would have been obvious to modify the combination to perform the processing in an external server, as it is merely the substitution of one known processing device for another.
As to claim 7, the signal processor processes the signal received from the AMD by high pass filtering and restoring restores the low pass information.
As to claim 8, Boileau communicates with an external device through telemetry device 100 and receives instructions therefrom (paragraph [0061]). In combination with Chen it would also send the filtered signal to the external device.
Claims 16 and 17 are rejected for the reasons given above.
Claim(s) 6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Boileau et al US P PUB 2008/0033499 in view of Grass, as applied to claims 1, 2, 4, 9-10, 12, 15, and 19 above, further in view of Audet et al US PG PUB 2008/0228094
As to claims 6 and 13, the combination does not also use hearts sounds to diagnose an infarction. However, Audet teaches in paragraphs [0037]-[0039] detecting an infarction both using heart sounds and by using an elevated ST segment. As such, it would have been obvious to modify the combination to also use heart sounds, to provide a more accurate diagnosis.
Claim(s) 14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Boileau et al US P PUB 2008/0033499 in view of Grass, as applied to claims 1, 2, 4, 9-10, 12, 15, and 19 above, further in view of Levine US PG PUB 2009/0259134.
The combination does not have the patient trigger, as claimed. However, Levine teaches in paragraph [0024] initiating a measurement by a patient when symptoms are present. As such, it would have been obvious to modify the combination to use such a trigger, to provide urgent care when needed.
VIII. CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT L NASSER whose telephone number is (571)272-4731. The examiner can normally be reached M-F 8-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Kosowski can be reached at (571) 272-3744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT L NASSER/Primary Examiner, Art Unit 3992