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
Applicant’s election of Species d, claims 1, 5, and 9-14, in the reply filed on June 15, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 2-4 and 6-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 June 15, 2026.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 2/8/2024 has/have been acknowledged and is/are being considered by the Examiner.
Drawings
The Applicant is reminded to carefully review the drawing figures and the accompanying specification to ensure that all reference numerals present in the drawing figures are defined within the specification.
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 10 and 14 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.
The term “influence” in claim 10 is a relative term which renders the claim indefinite. The term “influence” 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. It is not clear what the metes and bounds of the term “influence” is in the context of the claim and invention. What would be considered “an external influence” or “irregular external influence” in the context of the claim? Furthermore, specifically regarding the “irregular external influence” recited in the claim, it is unclear what the metes and bounds are of the term “irregular” in the context of the claim.
Claim 14 recites the limitation "the processing unit of the external device" in line 4. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1, 5, and 9-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Min et al. (U.S. Patent No. 7,155,282, cited by Applicant). Regarding claim 1, Min discloses a method for monitoring an implantable device ("A threshold sensing control for use in an implantable cardiac stimulation device", Abstract), comprising: receiving at least one cardiac vector signal ("To sense left atrial and ventricular cardiac signals and to provide left chamber pacing therapy, the stimulation device 10 is coupled to a "coronary sinus" lead 24 designed for placement in the "coronary sinus region" via the coronary sinus ostium for positioning a distal electrode adjacent to the left ventricle and/or additional electrode(s) adjacent to the left atrium.", col. 3, ln. 47-53), wherein the at least one cardiac vector signal is acquired by the implantable device between at least one pair of electrodes ("The housing 40 for the stimulation device 10, shown schematically in FIG. 2, is often referred to as the "can", "case" or "case electrode" and may be programmably selected to act as the return electrode for all "unipolar" modes. The housing 40 may further be used as a return electrode alone or in combination with one or more of the coil electrodes, 28, 36 and 38, for shocking purposes. The housing 40 further includes a connector (not shown) having a plurality of terminals, 42, 44, 46, 48, 52, 54, 56, and 58 (shown schematically and, for convenience, the names of the electrodes to which they are connected are shown next to the terminals). As such, to achieve right atrial sensing and pacing, the connector includes at least a right atrial tip terminal (A.sub.R TIP) 42 adapted for connection to the atrial tip electrode 22.", col. 4, ln. 21-34); extracting two or more separate features from the at least one cardiac vector signal by signal processing ("For arrhythmia detection, the device 10 utilizes the atrial and ventricular sensing circuits, 82 and 84, to sense cardiac signals to determine whether a rhythm is physiologic or pathologic. As used herein "sensing" is reserved for the noting of an electrical signal, and "detection" is the processing of these sensed signals and noting the presence of an arrhythmia. The timing intervals between sensed events (e.g., P-waves, R-waves, and depolarization signals associated with fibrillation which are sometimes referred to as "F-waves" or "Fib-waves") are then classified by the microcontroller 60", col. 5, ln. 57-67); deriving a hardware status (pnoise) of the implantable device based at least in part on a classification of the extracted two or more separate features ("As previously mentioned, the threshold of the sensing circuit 84 is controlled over line 88 to enable the sensing circuit 84 to sense R waves while also enabling the sensing circuit 84 to avoid sensing noise and most importantly T waves which may otherwise be mistaken for R waves. In one illustrative embodiment, the threshold control 62 processes data collected from a sensed and rectified electrogram of a previous cardiac cycle to determine the threshold control during a current cardiac cycle.", col. 7, ln. 42-50, where the threshold of the sensing circuit is considered to satisfy the broadest reasonable interpretation for "hardware status").
Regarding claim 5, Min discloses that at least one of the extracted two or more separate features is based at least in part on applying a statistical analysis to the at least one cardiac vector signal (" The morphological characteristics of intrinsic activity may be averaged for the comparison. The threshold control may compare most recently determined morphological characteristics to prior averaged determined morphological characteristics prior to varying the sensing threshold.", col. 2, ln. 21-27, where an average is considered a statistical analysis given its broadest reasonable interpretation).
Regarding claim 9, Min discloses that at least one of the extracted two or more separate features comprises at least one of the following features associated with the at least one cardiac vector signal: a number of events in a refractory period, a complexity of a binary vector string, a VF-filter leakage, a kurtosis, a heart rate, an R-R interval, a maximum of a signal amplitude, a sum of signal values, a sum of signal values normalized by a maximum of the signal amplitude, a number of samples with a signal amplitude within a certain range after bandpass filtering, a first spectral moment, a mean of a frequency distribution divided by a reference peak, a maximum of an absolute autocorrelation function, a variance of a binary vector string, a number of transitions from "0" to "1" in a binary vector string, a maximum number of "0"s and/or of "1"s in a binary vector string, a phase space, a proportion of an area covered in a phase space plot, a Pearson correlation coefficient of an absolute autocorrelation function, a proportion of an area contained within a certain frequency range, a fundamental frequency ("Once the electrogram 120 is digitally stored in memory 94, the morphology detector 64 measures the peak amplitude and location of the T wave 122. In one embodiment, an event is identified as a T wave peak as long as its location defines a QT interval greater than a predetermined minimum QT interval (QT min). Preferably, the peak amplitude and location of the R wave 124 are measured.", col. 7, ln. 60-67).
Regarding claim 10, Min discloses that the derived hardware status comprises at least one of the following: a likelihood of a hardware deviation (the broadest reasonable interpretation for "a likelihood of a hardware deviation" is considered to be satisfied by the threshold of the sensing circuit, as set forth in Min, as the hardware deviation would be a result from the threshold of the sensing circuit), a sustained technical malfunction, an electrode breakage, an intermittent technical malfunction, an external influence (the communication with an external device, as described at col. 6, ln. 33-38, is considered "external influence"), an irregular external influence (the communication with an external device, as described at col. 6, ln. 33-38, is considered "irregular external influence" when it is not on a set schedule), an external noise, an electric hum, an interference by a medical equipment, an interference from magnetic resonance imaging.
Regarding claim 11, Min discloses that the deriving is performed by an artificial intelligence system (the programmer and controller are considered to satisfy the broadest reasonable interpretation for "an artificial intelligence system" because they are the application of a computer system to perform tasks or produce output normally requiring human intelligence) and/or machine learning system that has been trained with cardiac vector signals acquired by well-functioning and/or malfunctioning implantable devices.
Regarding claim 12, Min discloses means for performing the method according to claim 1 (the detector and processing system of Min).
Regarding claim 13, Min discloses a system for monitoring an implantable device, comprising: an implantable device 10 for acquiring at least one cardiac vector signal; an external device 102; wherein the implantable device and/or the external device comprises the processing unit (PU) of claim 12 ("Advantageously, the operating parameters of the implantable device 10 may be non-invasively programmed into the memory 94 through a telemetry circuit 100 in telemetric communication with the external device 102, such as a programmer, transtelephonic transceiver, or a diagnostic system analyzer. The telemetry circuit 100 is activated by the microcontroller by a control signal 106. The telemetry circuit 100 advantageously allows intracardiac electrograms and status information relating to the operation of the device 10 (as contained in the microcontroller 60 or memory 94) to be sent to the external device 102 through an established communication link 104.", col. 6, ln. 33-44).
Regarding claim 14, Min discloses that the implantable device is configured to transmit data of at least a part of the cardiac vector signal, or data of at least a feature extracted from the cardiac vector signal to the external device, wherein the processing unit of the external device is configured to evaluate the data of at least a part of the cardiac vector signal, or data of at least a feature extracted from the cardiac vector signal ("Advantageously, the operating parameters of the implantable device 10 may be non-invasively programmed into the memory 94 through a telemetry circuit 100 in telemetric communication with the external device 102, such as a programmer, transtelephonic transceiver, or a diagnostic system analyzer. The telemetry circuit 100 is activated by the microcontroller by a control signal 106. The telemetry circuit 100 advantageously allows intracardiac electrograms and status information relating to the operation of the device 10 (as contained in the microcontroller 60 or memory 94) to be sent to the external device 102 through an established communication link 104.", col. 6, ln. 33-44).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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