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.
This Office Action is being issued following Applicant’s response of 5/20/2026, which included 1) claim amendments and 2) arguments.
II. STATUS OF CLAIMS
Claims 1-20 were filed with the application. The amendment of 5/20/2026 cancels claims 19 and 20 and adds claims 21-22. As of the date of this Office Action, the status of the claims is:
a. Claims 1-18, and 21-22 (“Pending Claims”).
b. Claims 1-18 and 21-22 are examined (“Examined Claims”)
III. 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. 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, and 15 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]). 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, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Boileau in view of Grass, as applied to claims 1, 2, 4, 9-10, 12, and 15 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 in view of Grass, as applied to claims 1, 2, 4, 9-10, 12, and 15 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 in view of Grass, as applied to claims 1, 2, 4, 9-10, 12, and 15 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 in view of Grass, as applied to claims 1, 2, 4, 9-10, 12, and 15 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.
V. ALLOWABLE SUBJECT MATTER
Claims 21 and 22 are allowable in that none of the art transitions from a lower power mode to a higher power mode upon detecting an elevated ST segment.
VI. ANSWER TO ARGUMENTS
Applicant’s arguments with respect to the rejection under 35 USC 101 have been found convincing and the rejection is therefore withdrawn.
Applicant has asserted that Grass does not generate an alert of myocardial infarction. The Examiner notes that Boileau detects ischemia and provides an alert to the patient when an ischemic event occurs (see paragraph [0015] for example). Grass is merely provided to teach that it would have been obvious to modify Boileau to also detect a myocardial infarction. Since Boileau alerts the patient when a medical condition is detected, the device, as modified by Boileau would also alert the patient. Therefore, whether or not Grass alerts the patient, it is the Examiner’s opinion that the combination does.
Applicant has argued that the Examiner’s proposed rationale for the combination is generic, conclusory, and insufficient to establish obviousness. According to Applicant, it does not identify a deficiency in Boileau that Grass is meant to rectify. The Examiner notes that there simple is no requirement in the patent laws that the teaching reference correct an identified deficiency. There simply needs to be an articulated rationale that would motivate the combination. At present, for a patient wearing an implantable device, like that of Boileau, it would be desirable to alert the patient of any medical condition needing attention. Grass teaches that it is known to identify infarction in manner similar to the manner of detecting ischemia in Boileau. As such, a person of ordinary skill would indeed to be motivate to monitor infarction as well as ischemia, to improve the overall care and treatment of the patient. Therefore, it is the Examiner’s position that ample motivation in a similar manner to identifying ischemia
As to claim 8, the Examiner recognizes that paragraph [0007] states that the external device initiates the communication. However, the Examiner notes that the telemetry circuit 100 is activated by a signal 106 from the microprocessor 94 (see paragraph [0061]. It is unclear how a command could be received if the telemetry circuit were not activated. As such, it appears to the Examiner that communication is initiated via the control signal 106 from the implantable device.
As to claims 16 and 17, Applicant has argued that sending the frequency filtered signal to the remote device requires a fundamental redesign of the signal path. It is the Examiner’s position that such a modification would fall under the category of routine experimentation for one of ordinary skill in the art.
Applicant has further asserted that using Chen to teach the external processing is inconsistent with using Boileau for the base claim. The Examiner notes that nothing in base claim mentions an external circuit or a device remote from the AMD that receives the signal. As such, this argument is not understood.
Applicant has asserted with respect to claims 6 and 13 that Audet detects ischemia not infarction. Paragraph [0039] of Audet clearly mentions determining if infarction is occurring. Furthermore, claim 40 discusses detecting infarction. Further, the Examiner notes that Audet teaches in paragraph [0037] that the fourth heart sound indicates infarction and in paragraph [0039] that an elevated ST segment indicates infarction.
VII. CONCLUSION
Zhou et al US PG PUB 2012/0185008 has a device that monitors a combination of conditions to indicate infarction including ST elevation and heart sound changes (paragraph [0131]).
Lee et al US PG PUB 2010/0022902 uses ST segment deviations and heart sounds to detect infarction.
Sigg et al US PG PUB 2010/0016740 uses ST segment deviations and heart sounds to detect infarction (paragraph [0024]).
VIII. CONCLUSION
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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