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 § 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) 1-7, 9-18, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rajput et al. (US 2021/0027891 A1) in view of Helfenbein et al. (US 2011/0092838 A1).
With regard to claim 1, Rajput discloses An interactive remote drug dose guidance and physiologic response monitoring system for a patient (Fig. 1), the system comprising: a first module (10) configured to interface with the patient using a secured communication ([0065], [0066], collects patient data via various sensors providing secured communication with the patient), wherein the first module is adapted to receive periodically, through the secured communication, electrocardiogram (ECG) data from the patient for a predetermined time period until completion of a drug load ([0023], [0067], [0086]); a second module to receive ECG data (30 receives measurements from the ECG data), and a third module configured to provide said one or more dosage recommendations (50, [0065] generates reports based on the inputted information and therapy can be updated based on the inputs provided including those from the ECG. Alternatively module 20 can be considered the third module configured to provide one or more dosage recommendations [0065] analytics engine processes input data and generates and updates a personalized physiology signature 250 for the patient [0073]).
However, Rajput does not explicitly disclose generating one or more corrected QT interval (QTc).
Helfenbein teaches a similar system including a module for receive ECG data from a patient for a predetermined time period until completion of a drug load ([0027]-[0028], [0031], [0032]) and a module configured to generate one or more corrected QT interval (QTc) measurements based on the periodically received ECG data ([0030]), wherein at least one of said one or more QTc measurements meets a threshold value ([0031]); and a third module configured to provide said one or more dosage recommendations derived from said one or more QTc measurements generated by the second module ([0035][0036], the different alarm levels based on the QTc number can be considered a recommendation about the dosage as it indicates the drug therapy is either too prolonged giving a higher QTc number with a louder alarm, [0006] also teaches guidance providing recommendations for QT interval monitoring patients on potentially proarrhythmic drugs), within the predetermined time period, with each dosage recommendation provided in a sequential manner based on said one or more QTc measurements (the recommendations are considered to provided in sequential manner because it follows the measured of the ECG and the calculation and monitoring the QTc prior to providing a recommendation, [0035], [0036], [0006]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Rajput with the generation of the QTc as taught by Helfenbein for the purpose of monitoring for proarrhthmic effects of taking certain medications ([0006]).
With regard to claim 2, Rajput discloses wherein the first module comprises an interface (10, [0065]) configured to receive from the patient ([0065]), through the secured communication, one or more inputs in relation to dosing of a drug ([0065]).
With regard to claim 3, Rajput discloses wherein said one or more inputs comprise personal information of the patient and a selection of drugs for dosing or a stage of dosing for a dosed drug ([0065] the inputs can be physiological, contextual, behavioral, and clinical which would include personal information of the patient or would include dosing information).
With regard to claim 4, Rajput discloses wherein the interface is configured to display said one or more inputs or store said one or more input for display at a later time (50, [0092], a display is provided and would be configured to display the inputs).
With regard to claim 5, Rajput discloses the interface (50).
However, Rajput does not disclose the corrected QT interval.
Helfenbein teaches a display is configured to display a graphical representation of said one or more corrected QT interval (QTc) measurements ([0035], shown in fig. 6, element 74, also measurements shown in Fig. 9, element 108).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Rajput the interface for displaying the QTc interval as taught by Helfenbein for the purpose of QT monitoring ([0035]).
With regard to claim 6, Rajput discloses the claimed invention except for the QTc.
Helfenbein teaches wherein a QT segment of said one or more QTc measurements is visually demarcated on the graphical representation (shown in Fig. 9 ,element 108 and also [0033] where all five QTc are displayed).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Rajput the interface for displaying the QTc interval as taught by Helfenbein for the purpose of QT monitoring ([0035]).
With regard to claim 7, Rajput discloses the claimed invention except for the QTc.
Helfenbein teaches wherein each QTc measurement is annotated with annotations that are automated measurements ([0033], [0007], clinicians can annotate the QT intervals) and the annotations are togglable on the graphical representation ([0033], [0031], the claim limitation is functional and therefore the display interface must only be capable of toggling between annotations).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Rajput the interface for displaying the QTc interval as taught by Helfenbein for the purpose of QT monitoring ([0035]).
With regard to claim 9, Rajput discloses wherein the second module is configured to: cleanse the received ECG data ([0078], pre-processing module for processing the ECG signals, element 210); extract ECG segments from cleansed electrocardiographic data based on ECG channel electrode(s) of interest ([0081], [0086], element 214); provide one or more baseline models trained with annotated segments to generate interpreted heart rhythm or rate based on the extracted ECG segments ([0082], [0088]); select an image or signal processing model based on the interpreted heart rhythm or rate (element 230, [0086]).
However, Rajput does not disclose the QTc measurements.
Helfenbein teaches applying the selected image or signal processing model to the cleansed electrocardiographic data to generate said one or more QTc measurements ([0030]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Rajput with the generation of the QTc as taught by Helfenbein for the purpose of monitoring for proarrhthmic effects of taking certain medications ([0006]).
With regard to claim 10, Rajput discloses the claimed invention except for the QTc measurements.
Helfenbein teaches wherein said one or more provided dosage recommendations are generated based on said one or more QTc measurements ([0006, [0035], [0036]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Rajput with the generation of the QTc as taught by Helfenbein for the purpose of monitoring for proarrhthmic effects of taking certain medications ([0006]).
With regard to claim 11, Rajput discloses the claimed invention except for the QTc measurements.
Helfenbein teaches wherein the system is configured to provide dosage recommendations by referencing said one or more QTc measurements and one or more clinical metrics ([0006], [0035], [0036]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Rajput with the generation of the QTc as taught by Helfenbein for the purpose of monitoring for proarrhthmic effects of taking certain medications ([0006]).
With regard to claim 12, Rajput discloses wherein the first module is configured to transmit patient- related input to and from a third-party application using the secured communication ([0065]-[0068]).
With regard to claim 13, Rajput discloses wherein the patient-related input is displayed to the patient ([0073], [0092]).
With regard to claim 14, Rajput discloses wherein the first module is configured to transmit ECG data to and from a third-party application ([0065]-[0068]).
However, Rajput does not disclose the QTc measurements.
Helfenbein teaches applying the selected image or signal processing model to the cleansed electrocardiographic data to generate said one or more QTc measurements ([0030]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Rajput with the generation of the QTc as taught by Helfenbein for the purpose of monitoring for proarrhthmic effects of taking certain medications ([0006]).
With regard to claim 15, Rajput discloses wherein the first module is configured to receive and transmit information to and from a third party through the secured communication ([0065]-[0068]), wherein said information relates to said one or more dosage recommendations, a drug, and/or physical or psychological condition of a patient ([0065]-[0068], [0070], [0096]-[0097]).
With regard to claim 16, Rajput discloses wherein the second module is configured to receive and process one or more user inputs ([0077]),
However, Rajput does not disclose QTc measurements.
Helfenbein teaches wherein said one or more provided dosage recommendations are generated based on said one or more QTc measurements ([0006, [0035], [0036]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Rajput with the generation of the QTc as taught by Helfenbein for the purpose of monitoring for proarrhthmic effects of taking certain medications ([0006]).
With regard to claim 17, Rajput discloses further comprising: a selection module configured to select an ECG lead using one or more machine learning (ML) models ([0080], [0086]).
With regard to claim 18, Rajput discloses wherein the selection module is further configured to select, from the ECG data, data that are associated with a preferred heartbeat displayed on the interface for approval ([0086], [0092]).
With regard to claim 20, Rajput discloses A system for clinical decision-making using a mobile cardiac telemetry (MCT) device, the system comprising: one or more modules configured to interface with a patient via a secured communication (10, [0065], [0066], collects patient data via various sensors providing secured communication with the patient), wherein said one or more modules are adapted to receive, through the secured communication, electrocardiogram (ECG) telemetry data from the patient for a predetermined time period until a clinical decision is made ([0065]-[0068]), and wherein said one or more modules are further configured to exhibit arrhythmia information to an interface based on input from the MCT device ([0065]-[0067], [0086]), wherein the MCT device is adapted to provide the arrhythmia information in accordance with the clinical decision ([0065]-[0067], [0086]).
However, Rajput does not disclose QTc measurements.
Helfenbein teaches a similar system including a module for receive ECG data from a patient for a predetermined time period until completion of a drug load ([0027]-[0028], [0031], [0032]) and a module configured to generate one or more corrected QT interval (QTc) measurements based on the periodically received ECG data ([0030]), wherein at least one of said one or more QTc measurements meets a threshold value ([0031]); and based on the received ECG data and arrhythmia information to provide clinical decision- making based on said one or more QTc measurements within the predetermined time period ([0035][0036], the different alarm levels based on the QTc number can be considered a recommendation about the dosage as it indicates the drug therapy is either too prolonged giving a higher QTc number with a louder alarm, [0006] also teaches guidance providing recommendations for QT interval monitoring patients on potentially proarrhythmic drugs), within the predetermined time period, with each dosage recommendation provided in a sequential manner based on said one or more QTc measurements (the recommendations are considered to provided in sequential manner because it follows the measured of the ECG and the calculation and monitoring the QTc prior to providing a recommendation, [0035], [0036], [0006]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Rajput with the generation of the QTc as taught by Helfenbein for the purpose of monitoring for proarrhthmic effects of taking certain medications ([0006]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rajput et al. (US 2021/0027891 A1) in view of Helfenbein et al. (US 2011/0092838 A1) and in further view of Brown et al. (WO 2014/176529 A2).
With regard to claim 8, Rajput/Helfenbein teaches the claimed invention except for performing safety checks based on cardiac physiology.
Brown teaches a module that is capable of performing safety checks based on cardiac physiology of the patient prior to dosing ([0053]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Rajput/Helfenbein with the safety checks as taught by Brown for the purpose of gaining the advantage of providing mechanisms for remote monitoring of a patient so as to confirm safety and efficacy of the treatment ([0020]).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rajput et al. (US 2021/0027891 A1) in view of Lebowvitz (US 2012/0265556 A1) and in further view of Helfenbein et al. (US 2011/0092838 A1).
With regard to claim 19, Rajput discloses A computer-implemented method of providing remote antiarrhythmic drug (AAD) initiation using a defibrillator device, the method comprising: receiving electrocardiographic data from at least one electrocardiogram (ECG) source ([0065]-[0067]); cleansing said electrocardiographic data ([0079], pre-processing module); extracting ECG segments from cleansed electrocardiographic data based on ECG channel electrode(s) of interest ([0081], [0086], clean data 214); providing one or more baseline models trained with annotated segments to generate interpreted heart rhythm or rate based on the extracted ECG segments ([0082], [0086]); selecting an image processing model based on the interpreted heart rhythm or rate (module 230, [0082], [0086]); applying the selected image processing model to the cleansed electrocardiographic data ([0081], [0086], applying module 230 to the clean data 214),
However Rajput does not disclose a defibrillator.
Lebovitz teaches using a defibrillator device ([0128]) wherein the defibrillator is configured to utilize pulse sensor data to distinguish between perfusing and pulseless ventricular arrhythmias in relation to the QTc measurement (the defibrillator includes sensing means to sense various heart rates during perfusion and pulseless ventricular arrythmias, [0158]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Rajput with the defibrillator as taught by Lebovitz for the purpose of inducing electrical shot to the patient in order to reactivate their cardiovascular system ([0123]).
However, Rajput/Lebovitz does not explicitly disclose generating one or more corrected QT interval (QTc).
Helfenbein teaches wherein the image processing model outputs a corrected QT interval (QTc) measurement ([0030]), wherein the corrected QTc measurement meets a threshold value ([0031]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Rajput/Lebovitz with the generation of the QTc as taught by Helfenbein for the purpose of monitoring for proarrhthmic effects of taking certain medications ([0006]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783