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 § 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 2, 3 and 9 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.
Regarding Claim 2, the term “wide” is a relative term which renders the claim indefinite. The term “wide” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Likewise, regarding claim 9, the term “narrow” is a relative term which renders the claim indefinite. The term “narrow” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 5-8, 10-13 and 16-19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Nallathambi et al. (2022/0001184).
Regarding Claims 1, 12 and 13, Nallathambi discloses a sensing apparatus 200 configured to monitor cardiac electrical activity (ECG) of a patient (Fig. 1, step 10; Fig. 2); a computing apparatus comprising one or more processors (par. [0032, 0051, 0054]; see also PSEEP in Fig. 2) and operatively coupled to the sensing apparatus, the computing apparatus configured to monitor cardiac electrical activity using the sensing apparatus (ECG signals 241 on M sensing channels, par. [0038]); detect a pacing artifact in the cardiac signal (via direct select logic 244 or indirect select logic 245, see par. [0039-0040]); determine to account for the pacing artifact (by actually detecting the pacing artifact) based on at least one pacing artifact characteristic (the pacing artifact is selected based on sample values, e.g. characteristics, of the signal, see par. [0039-0040] and the pacing artifact is accounted for when it is found to exist); accounting for the pacing artifact by removing the artifact from the cardiac signal between a first data point at time T1 and a second data point at time T2; and replacing the removed pacing artifact with replacement data points disposed along a straight line that extends between the first data point and the second data point to provide an optimized signal (once the artifact is identified, a fixed rejection algorithm 262 is executed that removes the artifact between a first point (a k-1 point, which equates to Applicant’s T1) and a second point (a k+ 1 point, which equates to Applicant’s T2) and replaces the artifact with a series of three “fixed” values, such as zero, which would create a straight line, see par. [0043]).
In regard to Claim 2, Nallathambi discloses utilizing a bandpass filter prior to detecting the pacing artifact (par. [0032, 0040])
Regarding Claims 5 and 16, Nallathambi discloses taking the difference of two successive samples over a window, wherein one sample would be greater than the other making it a local maximum (par. [0039]).
With regard to Claims 6, 7, 17 and 18, Nallathambi discloses identifying and replacing the artifact in the signal, thus indicating the position of the artifact is marked and removed from the signal (par. [0043]).
Regarding Claims 8 and 19, Nallathambi discloses sampling the signal at 125Hz which means a sample is taken every 8 ms (1/125). Therefore a time between a first sample (k-1) and a sample two points later (k+1) would be 16 ms, which is within the claimed range.
In regard to Claim 10, Nallathambi discloses the process can be implemented with an implantable pacemaker (par. [0007]).
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.
Claim(s) 3 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nallathambi et al. (2022/0001184) in view of Rowlandson (PGPUB 2023/0346293). Nallathambi discloses utilizing a bandpass filter but fails to disclose the bandwidth of the filter. In the same field of endeavor of cardiac monitoring, Rowlandson discloses utilizing a bandpass filter having a bandwidth between 250 Hz and 15kHz for the purpose of isolating a pacing signal originating from an implantable pacemaker (par. [0050]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Nallathambi reference to include a bandwidth of 250 Hz to 15 kHz for the bandpass filter, as taught and suggested by Rowlandson, for the purpose of isolating a pacing signal originating from an implantable pacemaker.
Furthermore, while the combination of Nallathambi and Rowlandson disclose a bandwidth of 250 Hz to 15 kHz and not a smaller range of 400 Hz to 2 kHz, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a range of 400 Hz to 2 kHz, since it has been held that where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 191 USPQ 90.
Claim(s) 4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Nallathambi et al. (2022/0001184) in view of Grievous et al. (5,127,401). Nallathambi discloses identifying a pacing artifact based on a difference of successive samples of an ECG signal (which implies a change over time, see par. [0039-0040]) but Nallathambi fails to go so far as state the artifact is based on a rate of change of the samples. However, Grievous discloses utilizing a derivative of the ECG signal to more accurately determine a pacing artifact (col. 4, lines 1-7). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Nallathambi reference to include determining a derivative as the comparison threshold for an artifact, as taught and suggested by Grevious, for the purpose of more accurately identifying the pacing artifact.
While Nallathambi and Grievous disclose utilizing a derivative, the combination of reference fails to disclose the exact range of 0.1 V/sec to 1000 V/sec. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a derivative threshold of 0.1 V/sec to 1000 V/sec, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Ultimately, a pacing artifact is a spik and the teaching of Grievous discloses identifying a spike based on a rapid rate of change. Identifying the exact magnitude of that derivative would only require routine skill in the art.
Claim(s) 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Nallathambi et al. (2022/0001184) in view of Babaeizadeh (2022/0000435). Nallathambi discloses all of the claimed invention except for sampling the optimized signal with a narrow bandpass filter. However, Babaeizadeh, in the same field of endeavor of ECG signal generation, discloses sampling the ECG signal at the output end with a narrow bandpass filter for the purpose of generating an evenly sampled signal (par. [0078]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Nallathambi reference to include a narrow bandpass filter, as taught and suggested by Babaeizadeh, for the purpose of generating an evenly sampled signal.
Conclusion
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/ALLEN PORTER/Primary Examiner, Art Unit 3796