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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 06/22/2026. As directed by the amendment: Claims 1 and 6-7 have been amended, claims 3 and 8-13 have been cancelled, and claims 14-16 have been added. Thus, claims 1-2, 4-7, and 14-16 are presently under consideration in this application.
Response to Arguments
Applicant's arguments, see page 7, filed 06/22/2026, regarding 35 U.S.C. 112(b) have been fully considered and are persuasive. Amendments obviate the rejection of record. Therefore, the rejections are withdrawn.
Applicant's arguments, see pages 7, filed 06/22/2026, regarding 35 U.S.C. 112(a) have been fully considered and are persuasive. Amendments obviate the rejection of record. Therefore, the rejection is maintained.
Applicant's arguments, see pages 10-11, filed 06/22/2026, regarding 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant argues on pages 10-11 that “the features of the claimed configuration provide an improvement in the technical field of physiological information acquisition in that it is possible to prompt a user to take any suitable actions to prevent the erroneous alarm from being frequently issued, such as replacement or rearrangement of the sensor. In this way, the claims analogous to the claims found the claims to be patent eligible in CardioNet, LLC V. InfoBionic, Inc., 955 F.3d 1358, 1368-69 (Fed. Cir. 2020), which are also directed to functional features that provide a technical improvement.
Moreover, the claimed invention similar to the claims in Core Wireless Licensing S.A.R.L. V. LG Elecs., Inc., 880 F.3d 1356, 1363 (Fed. Cir. 2018), in which the Federal Circuit found a specific interface to be patent eligible because the claims "recite a specific improvement over prior systems, resulting in an improved user interface for electronic devices" and are directed to "a particular manner of summarizing and presenting information in electronic devices" and that the claims do not "us[e] conventional user interface methods to display a generic index on a computer." The Core Wireless decision was based on a problem with smaller, portable display devices. Likewise, the present claims are directed an improvement in computer functionality, and specifically solve a problem specific to alarms/notifications in a physiological information acquisition device. The claimed invention makes it possible to cause a physiological information acquisition device to issue a notification when the predicted probability that the physiological parameter is erroneously calculated exhibits a rising trend, even if the alarm condition is not satisfied. That is, the claimed invention provides an improved and particular manner of notification that was not previously achievable (i.e., the claimed invention enables the device to perform in a way that it could not before). Therefore, the claimed invention is directed to a non-abstract improvement in computer functionality and is not merely directed to an abstract idea (NO in Prong 1 in USPTO Step 2A)”.
Examiner disagrees. Applicant is asserting the abstract idea itself as the improvement. However, the abstract idea cannot be an “additional element” that shows integration into a practical application. The order of calculations and the particular calculations claimed do not make the abstract idea any less abstract. The claims are currently structured as simply using a generic computer to implement the abstract idea (mental process), which is not enough to show a practical application.
The claims for CardioNet are directed to atrial flutter whereas the instant claims are directed to erroneous signal acquisition, which are not analogous art. Furthermore, each case turns on its own facts. The CardioNet case cited by Applicant was found to be eligible due to an unsupported assertion that the claims merely computerize pre-existing techniques for diagnosing atrial fibrillation and atrial flutter (see p. 16 of the decision). No such assertion is made in the present application and thus the facts of that case are not pertinent or related to the fact pattern presented in the present application. Desjardins also is directed to the improvement of storage, and also not pertinent to the fact patterns of the instant case.
Therefore, the rejection is maintained.
Applicant’s arguments, see pages 8-10, filed 06/22/2026, with respect to the rejection(s) of the claim(s) under 35 U.S.C. 103 have been fully considered and are persuasive. Amendments to the claims obviate the rejection of record. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rantala et al. (US 20110291838)(Hereinafter Rantala) in view of Freeseman-Freeman et al. (US 20200214648) (Hereinafter Freeseman).
Claim Objections
Claim 7 is objected to because of the following informalities: the phrase “A non-transitory computer-readable medium having stored a computer program adapted to be executed by a processor of a processing device configured to process physiological information of a subject, the computer program being configured to, when executed, the processing device to:” is repetitive as “executed” is repeated twice and incoherent as to what is being “configured” to be done. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“the predictor is configured to output prediction data” in claims 1 and 6-7. Examiner notes that the instant specification fails to recite structure for the phrase “predictor” Examiner will interpret the predictor to be a processor capable of using machine learning for calculating a probability.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-2, 4-7, and 14-16 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 claims 1, and 6-7, it is unclear what the predictor may be and how it is possible to be implemented on a processor and stored in a memory. It is unclear if the predictor is a processor.
Regarding claims 1, and 6-7, it is unclear if the physiological parameter being “not normally acquired” and “erroneously calculated” the same or different events from one another.
Claims 2, 4-5, and 14-16 are rejected due to their dependency on rejected claims 1, 6, and 7.
Claim Rejections - 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 1-2, 4-7, and 14-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject
matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claims 1 and 6 is directed to a system (i.e. machine) and thus meets the step 1 requirements.
Claim 7 is directed to a tangible non-transitory computer-readable medium (i.e. a product), and
thus, meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claims 1 and 6-7, the following step is an abstract idea:
“a probability that the physiological parameter is erroneously calculated at each of a plurality of points in time of the measured waveform in response to input of the waveform data”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. A human can also predict whether or not the physiological parameter is erroneously calculated at different points by doing a probability calculation, which is a evaluation done by the human mind.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claims 1 and 6-7, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “reception interface”, “predictor”, and “processor” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “sensor” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “waveform”, “feature quantity”, “alarm condition”, “physiological alarm”, “waveform data”, “measured waveform”, “plurality of points”, “rising trend of the probability”, “prediction data”, “condition”, “predictor”, “physiological parameter”, “quality”, “notification”, and “notifier/alarm” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
Step 2B – significantly more/inventive concept
The following claim elements do not add any meaningful limitation to the abstract idea:
- “reception interface”, “predictor”, and “processor” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “sensor” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “waveform”, “feature quantity”, “alarm condition”, “physiological alarm”, “waveform data”, “measured waveform”, “plurality of points”, “rising trend of the probability”, “prediction data”, “condition”, “predictor”, “physiological parameter”, “quality”, “notification”, and “notifier/alarm” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
The additional elements of claims 1 and 6-7, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, processor and reception interface, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The ECG sensor and EKG sensor are claimed very generically and are used only to gather the data they are designed for. These are well-understood, routine and conventional structure since the diagnostic art in Zhao et al (US 20170258356) teaches the use of ECG/EKG sensors to collect ECG signals ([0006]).
Dependent claims 2, 4-5, and 14-16 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 1 and 6-7. The dependent claim limitations are directed to extra-solution activity and generic gathering structure (claims 2, 4-5, and 14-16), which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional.
In summary, claims 1-2, 4-7, and 14-16 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
Claim Interpretation
Regarding claims 1, 6, and 7, the phrase “determined that the physiological parameter is not normally acquired” can be interpreted to mean that an abnormal signal is acquired based relating to a health issue, that the waveform/physiological signal/parameter is poor and unreliable, or that the waveform has too much noise/artifact. In the instant rejection, Examiner interprets the phrase to mean that an abnormal signal was acquired relating to poor health of a patient/user.
Claim Rejections - 35 USC § 103
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, 6-7, and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rantala et al. (US 20110291838)(Hereinafter Rantala) in view of Freeseman-Freeman et al. (US 20200214648) (Hereinafter Freeseman).
Regarding claims 1, and 6-7, Rantala teaches A physiological information acquisition device/processing device/non-transitory computer readable medium (Abstract “a physiological monitoring apparatus, a physiological monitoring apparatus, and a computer program product for a physiological monitoring apparatus are disclosed.”), comprising:
a reception interface configured to receive waveform data corresponding to a measured waveform of a physiological parameter of a subject from a sensor ([0018] “a physiological monitoring apparatus/system 10 for monitoring a subject 100. A monitoring apparatus/system normally acquires a plurality of physiological signals 11 from the subject, where one physiological signal corresponds to one measurement channel… one or more measurement channels, such as heart rate [physiological parameter] derived from an ECG signal or an SPO.sub.2 value [physiological parameter] derived from a plethysmographic signal”);
a notifier (Abstract “A method for generating alarms in a physiological monitoring apparatus,”);
a processor configured to cause the notifier to output an alarm in a case where an alarm condition that the physiological parameter is not normally acquired is satisfied ([0007] “Since the confidence level of the parameter may be lowered due to lowered quality of the respective physiological signal(s) or due to factors lowering the quality of the parameter determination process, the quality measure may be derived from the physiological signal(s) from which the parameter is derived and/or from the parameter determination process…Through quality based control of the alarm escalation the number of alarms caused by such events may be greatly reduced, since the control hampers the escalation of such alarms to higher priority alarms that would be clinically irrelevant.” Examiner notes that the alarm de-escalates during poor quality signals, which means that the alarm is still functioning. Examiner also notes that the claim recites a single alarm, “an alarm”, which supports Examiner’s interpretation of the use of the escalation and de-escalation of the alarm based on the quality of the signal, while also turning on the same alarm when a threshold of abnormality is surpassed. ([0024] “Since no alarm is detected before that, no escalation is used until the physiological parameter crosses the first alarm limit (cf. step 21).” [0027] “since the heart rate has not yet reached the first alarm limit (Th1), no alarm escalation is applied, cf. step 32 of FIG. 3. At time instant T1, the heart rate reaches the first alarm limit.”); and
a predictor is configured output prediction data indicating that a probability the physiological parameter is erroneously calculated at each of a plurality of points in time of the measured waveform in response to input of the waveform data ([0039] “the confidence index [probability] may be determined based on a first measure indicative of the quality of the physiological signal(s) or based on a second measure indicative of the quality/reliability of the physiological parameter, or based on a combination of the first and second measures. It is obvious that the quality of a physiological signal affects the confidence level of a parameter derived from the said signal.” [0027] “The signal quality algorithm may be such that the index value maintains at 100 as long as the signal/parameter quality exceeds a predefined level, but begins to drop gradually as the quality drops below the level.” Figs. 4-6 (T1-T6) shows the plurality of time points where CI [probability] is calculated at each point.).
Although Rantala teaches the rising trend of probability (See rising trend before the alarm issued, which is the decrease in CI beginning between before T1 to T1, and then continuing from the start of the alarm to T3 in Fig. 4, in which the time of escalation of the alarm of Fig. 6 still occurs, even during a low CI.), Rantala does not teach the processor is configured to cause the notifier to perform a notification to a user, in a case where the alarm condition is not satisfied but a probability corresponding to the prediction data outputted from the predictor satisfies a notification condition associated with a rising trend of the probability. Freeseman, in the same field of endeavor, teaches determining risks of deterioration of monitored physiological data and health (Abstract), and further teaches wherein the processor is configured to cause the notifier to perform a notification to a user, in a case where the alarm condition is not satisfied but a probability corresponding to the prediction data outputted from the predictor satisfies a notification condition associated with a rising trend of the probability ([0051] “Systems can analyze electronic patient medical records accessed by the system from one or more distributed sources and identify trends associated with an increased rate of deterioration among a first subset of patients, compared to an earlier rate of deterioration, for example. In embodiments, identifying one or more trends (or individual changes in SOI scores between two data sets or time points) includes applying a first multivariate logistic regression.” [0053] “In some cases, more than one threshold is used, for example a first threshold [notification condition] for providing an alert that a patient needs an increased level of care (or for placing a warning, order, or command to transfer a patient), and a second-tier threshold [alarm condition] for providing an alert or recommendation that a patient needs increased monitoring (or for causing an order or instruction to collect electronic medical data more frequently).” [0052] “Subtle changes in EMR data for certain types of patients may cause a warning or alert even earlier for an ill or elderly patient, for example. In other cases, changes in EMR data for a healthy patient can trigger an alert sooner due to fewer expected changes.”) to detect deterioration of a patient sooner ([0008]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Rantala, with the processor is configured to cause the notifier to perform a notification to a user, in a case where the alarm condition is not satisfied but a probability corresponding to the prediction data outputted from the predictor satisfies a notification condition associated with a rising trend of the probability of Freeseman, because such a modification would allow to detect deterioration of a patient sooner.
Regarding claim 2, Rantala in view of Freeseman teaches the invention of claim 1. Rantala does not teach the processor is configured to cause the notifier to perform the notification based on a frequency that the probability exceeds a threshold value. Freeseman, in the same field of endeavor, teaches determining risks of deterioration of monitored physiological data and health (Abstract), and further teaches teaches wherein the processor is configured to cause the notifier to perform the notification based on a frequency that the probability exceeds a threshold value ([0051] “Systems can analyze electronic patient medical records accessed by the system from one or more distributed sources and identify trends associated with an increased rate of deterioration among a first subset of patients, compared to an earlier rate of deterioration, for example. In embodiments, identifying one or more trends (or individual changes in SOI scores between two data sets or time points) includes applying a first multivariate logistic regression.” [0053] “In some cases, more than one threshold is used, for example a first threshold [notification condition] for providing an alert that a patient needs an increased level of care (or for placing a warning, order, or command to transfer a patient), and a second-tier threshold [alarm condition] for providing an alert or recommendation that a patient needs increased monitoring (or for causing an order or instruction to collect electronic medical data more frequently).” [0052] “Subtle changes in EMR data for certain types of patients may cause a warning or alert even earlier for an ill or elderly patient, for example. In other cases, changes in EMR data for a healthy patient can trigger an alert sooner due to fewer expected changes.”) to detect deterioration of a patient sooner ([0008]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Rantala, with the processor is configured to cause the notifier to perform the notification based on a frequency that the probability exceeds a threshold value of Freeseman, because such a modification would allow to detect deterioration of a patient sooner.
Regarding claim 4, Rantala teaches wherein the physiological parameter is a heart rate ([0018] “a physiological monitoring apparatus/system 10 for monitoring a subject 100. A monitoring apparatus/system normally acquires a plurality of physiological signals 11 from the subject, where one physiological signal corresponds to one measurement channel… one or more measurement channels, such as heart rate [physiological parameter] derived from an ECG signal or an SPO.sub.2 value [physiological parameter] derived from a plethysmographic signal”).
Regarding claims 14-16, Rantala in view of Freeseman teaches the invention of claim 1. Rantala does not teach the notification comprises a preliminary prompt to take action to prevent the alarm condition from being satisfied. Freeseman, in the same field of endeavor, teaches determining risks of deterioration of monitored physiological data and health (Abstract), and further teaches wherein the notification comprises a preliminary prompt to take action to prevent the alarm condition from being satisfied ([0053] “a first threshold for providing an alert that a patient needs an increased level of care (or for placing a warning, order, or command to transfer a patient [preliminary prompt to take action])”) to detect deterioration of a patient sooner ([0008]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Rantala, with the processor is configured to cause the notification comprises a preliminary prompt to take action to prevent the alarm condition from being satisfied of Freeseman, because such a modification would allow to detect deterioration of a patient sooner.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rantala et al. (US 20110291838)(Hereinafter Rantala) in view of Freeseman-Freeman et al. (US 20200214648) (Hereinafter Freeseman) and Gargiulo et al. (US 20120108989)(Hereinafter Gargiulo).
Regarding claim 5, Rantala and Freeseman teach the invention of claim 1. Although Rantala teaches the leads off state, meaning electrodes must be used to gather the ECG ([0038]), Rantala does not explicitly teach the sensor includes a plurality of electrodes adapted to be attached to the subject to measure an electrocardiogram and wherein the predictor is configured to calculate the probability for the waveform data associated with each of lead waveforms included in the electrocardiogram received from the plurality of electrodes. Gargiulo, in the same field of endeavor, the obtaining of physiological parameters (Abstract) and determining signal quality ([0076]), and further teaches wherein the sensor includes a plurality of electrodes adapted to be attached to the subject to measure an electrocardiogram ([0058] “The sensors 14 are electrodes able to be placed relative to the animal without any preparatory work being done on the animal's body.” [0078] “This can be identified at the level of individual electrode sensors 14. A further type of loss of quality might be an ECG signal which is swamped by excessive electromyograph (EMG) signals arising from muscle movement in the animal close to the electrode sensors 14.”); and
wherein the predictor is configured to calculate the probability for the waveform data associated with each of lead waveforms included in the electrocardiogram received from the plurality of electrodes ([0084] “The outputs of these parallel diagnostic methods 56 are then combined using a classifier 60 which makes the final decision 46 on diagnosis. This classifier 60, sometimes called a “committee of experts”, uses methods such as Bayesian statistics to allocate a weight or importance to the outcome, based upon the signal quality, the known reliability of the method and a knowledge of prior probabilities of accuracy.” [0025] “The method may include detecting the presence of one or more cardiac signals”) to determine the probability of accuracy of the signal ([0084]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Rantala in view of Freeseman, with the sensor includes a plurality of electrodes adapted to be attached to the subject to measure an electrocardiogram and wherein the predictor is configured to calculate the probability for the waveform data associated with each of lead waveforms included in the electrocardiogram received from the plurality of electrodes of Gargiulo, because such a modification would allow to determine the probability of accuracy of the signal.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796