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 .
Election/Restrictions
Claims 5-6, 10-12, and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/27/26.
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 1-4, 7-9, 13-14, 16-21, and 23 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, line 5, “one or more channels” is vague and inferentially included. It is unclear if the claim is positively reciting/claiming the channels or if the channels are meant as an intended/functional use recitation. As claims 18 and 19 set forth additional channels, it is suggested to first state the system has the channels before they are used in the claim.
In claims 18. 19, and 21, the claims sets forth 7, 12 or 162 channels and it is unclear if they are being positively recited/claimed or functionally recited. It is suggested to first state “wherein the one or more channels comprises at least seven channels” in claim 18 and similarly, “at least 12 channels” in claim 19 and 16 channels in claim 21. The examiner has interpreted the claims as containing this many channels as the dependent claims state the signals are sensed concurrently along those channels, and the claims should be amended accordingly.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-4, 7-8, 13, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Volpe et al (10960213) in view of McClure (5623936). Volpe discloses the claimed limitations as follows:
--a support structure (e.g. figure 1, element 110, etc.)
--ECG sensing electrodes (e.g. figure 1, element 112a/b; figure 2, element 222, etc.)
--a unit (figure 1, element 120, etc.)
--an energy storage module (e.g. figure 2, element 202, etc.)
--a therapy electrode (e.g. figure 1, 114, figure 2, element 220, etc.)
--a memory (e.g. figure 2, element 204, etc.) to store the sampled ECG values (e.g. col. 12, lines 1-46, col. 17, lines 42-43, etc.)
--a processor (e.g. figured 2, element 218, etc.)
--a communication module to transfer the sampled ECG values to a remote device (e.g. figure 2, element 206, col. 12, lines 1-45—in the alternative, see the 103 rejection below, etc.)
where the processor takes a first sample of ECG values (e.g. figure 6A, element 602, etc.) and a second sample of ECG values (e.g. figured 6A, element 614, col. 9, lines 5-24, etc.) for concurrent storage in the memory (e.g. col. 12, lines 1-46, col. 17, lines 42-43,etc.).
Volpe does not state that the second ECG samples are sampled at a rate of at least twice to five times (e.g. claims 2, 16, etc.) the samples of the first ECG and at a rate of at least 740 Hz (e.g. claim 17), and in the alternative, communicating both ECG samples to a remote device. McClure teaches that when sampling two ECGs for determining the heart condition, that the second ECG samples are taken at least twice, and up to five times the first ECG samples, such as at a rate of at least 740 Hz (e.g. col. 8, lines 22-46, high frequency of 2000Hz or 250-8000 bps, and low frequency of 500 Hz or 50 to 2000bps) to better discriminate between ECG waveforms and heart conditions. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the system and method as taught by Volpe, with the second ECG samples being sampled at a rate of at least twice to five times the samples of the first ECG and at a rate of at least 740 Hz as taught by McClure, and in the alternative, communicating the first and second ECG signals to a remote device, as is well known and common knowledge in the art (mpep 2144I, 2144.03), since it would provide the predictable results of better discriminating between different ECG waveforms and heart conditions to know when to shock the patient, and allowing a remote physician or computer to analyze the ECG data to know when and why a shock was delivered to the patient.
For claim(s): 4, as the claim says “portions” of the ECG are stored in different sectors, the system of Volpe will necessarily store “portions” in different non-interspersed sections as the data is taken separately at different times and only requires any amount of data, such as two bits to meet the “portions” (in the alternative, see the 103 rejection below); 7, as the system does continuously monitor and store information for a day or days (e.g. col., 12, lines 1-46, etc.) it will store the second ECG within 10 seconds after shock discharge; 8, the system does detect a starting condition to start storing the second set of ECG values (e.g. figure 6A, element 606/608/610 to start second ECG 614, etc.); 13, detect when a stopping condition is met to stop monitoring ECG values (e.g. therapy cannot be delivered, monitoring stops, col. 35, lines 24-25, etc.).
Claims 4, 14, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Volpe et al in view of McClure (i.e. “modified Volpe”). Modified Volpe discloses the claimed invention and storing the ECG information in memory using multiple electrodes for sensing the ECG, but does not disclose storing the first ECG in one sector of the memory and storing the second ECG in another sector of the memory not interspersed among the first sector (e.g. claim 4), a motion detector so that the processor can stop the recording when the motion detector detects unrest (e.g. claim 14), and using 12 ECG electrodes (e.g. claim 23). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the system and method as taught by modified Volpe, with storing the first ECG in one sector of the memory and storing the second ECG in another sector of the memory not interspersed among the first sector, stopping the second ECG recording when a motion detector detects unrest, and using 12 ECG electrodes, as is well known and common knowledge in the art (mpep 2144I, 2144.03), since it would provide the predictable results of preventing the mix-up of data in the memory between the 2 different ECG signals so that the ECG signals are stored with only their respective signal, preventing noise artifacts from being recorded due to the ECG electrodes moving over the skin during patient motion and unrest so that a false diagnosis is not made or so a shock is not delivered due to the noise, and allowing a more complete picture of the heart’s condition by sensing different heart vectors with more electrodes.
Allowable Subject Matter
Claims 9, 18-20 and 21 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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/George R Evanisko/Primary Examiner, Art Unit 3792 6/22/26
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