DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 56-63, specifically independent claim 56, are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Please see the below analysis providing the details as to why the invention is directed towards non-statutory subject matter.
Step 1:
Claim 56 is directed to a device, which is a product. Therefore, the claim falls within a statutory category of invention.
Step 2A, prong 1:
Claim 56 recites the device having a plurality of ECG sensing electrodes, a signal acquisition circuit having a plurality of inputs, and a monitoring circuit configured to:
“…instruct the signal acquisition circuit to select…a first plurality of different pairings…”
“…make a determination that a particular ECG sensing electrode…(a) has at least partially fallen off…(b) forms part of an electrode pair that is providing a diminished ECG signal…
“…instruct the signal acquisition circuit to select…a second plurality of different pairings…”
“…an arrhythmia detection circuit configured to determine whether an arrhythmia condition is present in the signals provided…”
Under the broadest interpretation, claim 56 recites a series of steps that are practically performable in the human mind. A human could receive sensor data, determine a body location, determine a processing parameter vector, perform a data analytics sequence, and compute a health and safety measure. Therefore, it would be practical to perform the steps in a human’s mind, or with a pen and paper, to utilize the claimed sensor data.
Claim 56 recites method steps comprising mental processes (i.e. instruct, make a determination, etc.). Thus, since claim 56 recites limitations that fall within the mental processes concept of abstract ideas, and the claims are directed to an abstract idea.
Step 2A, prong 2:
Claim 56 recites the following additional elements, which for the reasons set forth below, do not integrate the abstract idea into a practical application:
“…a plurality of electrocardiogram (ECG) sensing electrodes…” which is directed to data gathering, see MPEP 2106.05(g).
“…a signal acquisition circuit…” which is directed to data gathering, see MPEP 2106.05(g).
“…a monitoring circuit being configured to…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
“…an arrhythmia detection circuit configured to…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
Step 2B
The claim as a whole fails to recite an inventive concept. The additional elements, when considered individually and in combination, do not recite significantly more than the abstract idea for the reasons as set forth above in Step 2A, Prong 2. Upon re-evaluating the limitation that was previously identified as insignificant extra-solution activity in Step 2A, Prong 2, the following evidence to show that the limitation is well-understood, routine and conventional:
real-time discrete data obtained from a medical device/data previously collected from a medical device (i.e. sensing electrodes, signal acquisition circuit) Presenting offers and gathering statistics, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93; Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network).
producing at said computer processor a human-readable output (i.e. monitoring circuit, arrhythmia detection circuit) of the analysis of the gathered data, this is also WURC, as evidenced by Electric Power Group, LLC v. Alstom S.A., 830F.3d 1350, 119 USPQ2d 1739 (Fed.Cir. 2016), which discusses “conventional computer, network, and display technology” and states that “nothing in the patent contains any suggestion that the displays needed for that purpose are anything but readily available. We have repeatedly held that such invocations of computers and networks that are not even arguably inventive are “insufficient to pass the test of an inventive concept in the application” of an abstract idea”.” Similarly, there is nothing in Applicant’s specification that indicates that the device that is “producing at said computer processor a human-readable output indicating” the findings of the analysis is anything but readily available.
The examiner also notes that the limitations of the dependent claims, Claims 57-63, further limits claim limitations already indicated above as being directed to an abstract idea. Therefore, the above dependent claims are directed to patient-ineligible subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 44-63 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Volpe et al. (US 2008/0312709) in view of Chen et al. (US 2010/0041975).
Volpe et al. discloses:
Claim 44
A wearable ambulatory medical device for monitoring and treating a heart of a patient, the device comprising: a plurality of electrocardiogram (ECG) sensing electrodes configured to be
disposed about a body of the patient, the plurality of ECG sensing electrodes comprising a plurality of electrode pairs configured to provide a corresponding plurality of ECG signals;
E.G. via the disclosed wearable defibrillator comprising sensing electrodes 10a-d {[0028] & (Fig 1)}.
a plurality of therapy electrodes configured to be disposed about the body of the patient;
E.G. via the disclosed therapy pads/treatment devices 18 {[0028] & (Fig 1)}.
a signal acquisition circuit configured to be electrically coupled to the plurality of ECG sensing electrodes, and further configured to sense the plurality of ECG signals;
E.G. via the disclosed node 11 that receives the signals from said sensing electrodes 10a-d and accelerometer data from the accelerometers 16,17/23/31 also directly associated with said node 11 {[0028]-[0030] & (Fig 1)}.
and at least one processor that is coupled to the signal acquisition circuit and that is configured to: make a determination that a particular ECG sensing electrode (a) has at least partially fallen off the body of the patient and/or (b) an electrode pair that is providing a diminished ECG signal due to presence of noise signals;
E.G. via the disclosed microcontroller 22 and/or the system computer 32 of the monitor 30 that utilizes the data obtained from said node, including data from the sensors 10a-d and the accelerometers, wherein the output from said sensors may include ‘fall-off’ event data , wherein the data can be used to determine information that can be used to reduce and possibly eliminate the fall-offs and/or the motion data from said accelerometers may be correlated with an ECG signal to determine if signal interference or ‘contamination’ exists [0036].
*Note that the examiner is interpreting the disclosed contamination is the claimed diminished ECG signa due to presence of noise signals [0036].
determine whether an arrhythmia condition is present in the ECG signals.
E.G. via the disclosed method including sensing a cardiac condition based on a confidence algorithm that helps to determine if a patient heart arrhythmias require defibrillation {[0013] & [0033]).
and initiate treatment of the heart in response to determining presence of the arrhythmia condition.
E.G. via the disclosed therapy pads/treatment devices 18 that provide treatment when a sensed condition indicates a preferred treatment [0028].
Volpe et al. discloses the claimed invention having a microcontroller 22 and/or the system computer 32 of the monitor 30 that utilizes the data obtained from a node, including data from the sensors 10a-d and the accelerometers, to determine information that can be used to reduce and possibly eliminate the fall-offs and/or the motion data from said accelerometers may be correlated with an ECG signal to determine if signal interference or ‘contamination’ exists and utilizing sensed cardiac data to determine if a patient heart arrhythmias require defibrillation ([0033] & [0036]), except wherein said processor may further select from a plurality of electrode pairs a first and a second plurality of monitored electrode pairs used to determine said fall-off data and whether an arrhythmia condition is present, respectfully.
Chen et al. teaches that it is known to use systems and methods for monitoring physiological data via a wearable pad 14 having an array of electrodes 24 that can be formed in various configurations on said pad, wherein the electrodes can be switched into said configuration via an automatic electrode selection algorithm to acquire a patient’s ECG in order to determine which electrodes to select to generate data ([0044]-[0046]).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the microcontroller and/or system computer of the monitor coupled to the sensors and accelerometers as disclosed by Volpe et al. with the automatic electrode selection algorithm to acquire a patient’s ECG as taught by Chen et al. since such a modification would provide the predictable results pertaining to effectively determining which electrodes to select to generate physiological data, such as an ECG signal, in order to further determine the adequacy of the captured ECG signal (Chen, [0044]-[0046]).
Claim 45:
The wearable ambulatory medical device of Claim 44, wherein the second plurality of monitored electrode pairs includes a new electrode pair, selected from the plurality of electrode pairs, that
was not in the first plurality of monitored electrode pairs; and excludes a particular electrode pair that includes the particular ECG sensing electrode.
E.G. via the disclosed step of determining in which electrodes to select in order to limit the number of false negative triggers that might force the system to switch electrodes prematurely (Chen, [0044]-[0046]).
Claim 46:
The wearable ambulatory medical device of Claim 44, wherein making
the determination that the particular ECG sensing electrode has at least partially fallen
off the body of the patient comprises comparing a driven ground electrode signal to a signal received from the particular ECG sensing electrode; and determining whether the driven ground electrode signal is present in the signal received from the particular ECG sensing electrode.
E.G. via the disclosed accelerator signals correlated with an ECG signals to determine if ECG signal contamination exists based on the accelerometer gathering data during certain failure states such as electrode fall-off detection (Volpe, [0036]-[0037] & [0040]-[0041]).
Claim 47:
The wearable ambulatory medical device of Claim 44, wherein making the determination that the particular ECG sensing electrode forms part of the electrode pair that is providing the diminished ECG signal comprises evaluating a signal-to-noise ratio of the diminished ECG signal.
E.G. via the disclosed correlated ECG signal and accelerometer being inputted into the belt node computer 54 that has a built in MUX and ADC, in which controls the signal parameters, such as signal-to-noise ratio (Volpe, [0067]-[0068]).
Claim 48 :
The wearable ambulatory medical device of Claim 44, wherein making the determination that the particular ECG sensing electrode has at least partially fallen off the body of the patient comprises making a determination that there is a lack of signal provided by a particular monitored electrode pair that is included in the first plurality of monitored electrode pairs.
E.G. (Volpe, [0036]-[0037] & [0040]-[0041]).
Claim 49:
The wearable ambulatory medical device of Claim 44, further comprising a holster and a control unit disposed within the holster, wherein the control unit comprises the signal acquisition circuit and the at least one processor, and wherein the control unit is electrically coupled to the plurality of ECG sensing electrodes and the plurality of therapy electrodes.
E.G. via the disclosed component of the wearable defibrillator 1 {Volpe, [0028] & (Fig. 1)}.
Claim 50:
The wearable ambulatory medical device of Claim 44, wherein selecting the second plurality of monitored electrode pairs comprises selecting at least one of the plurality of electrode pairs at least partially based on a phase difference between (a) the ECG signal provided by the selected at least one of the plurality of electrode pairs and (b) the ECG signal provided by another selected at least one of the plurality of electrode pairs.
E.G. (Chen, [0044]-[0046]).
Claim 51:
The wearable ambulatory medical device of Claim 44, further comprising a garment that is configured to be worn about the body of the patient, wherein at least some of the plurality of ECG sensing electrodes are integrated into the garment.
E.G. via the disclosed component of the wearable defibrillator 1 {Volpe, [0028] & (Fig. 1)}.
Claim 52:
The wearable ambulatory medical device of Claim 51, wherein the plurality of ECG sensing electrodes are not all located in a common plane.
E.G. {Volpe, [0028] & (Fig. 1)}.
Claim 53:
The wearable ambulatory medical device of Claim 51, wherein at least some of the plurality of therapy electrodes are integrated into the garment.
E.G. {Volpe, [0028] & (Fig. 1)}.
Claim 54:
The wearable ambulatory medical device of Claim 44, wherein the second plurality of monitored electrode pairs does not include the particular ECG sensing electrode.
E.G. (Chen, [0044]-[0046]).
Claim 55:
The wearable ambulatory medical device of Claim 44, wherein the second plurality of monitored electrode pairs includes a replacement pair of ECG sensing electrodes that was not included in the first plurality of monitored electrode pairs.
E.G. (Chen, [0044]-[0046]).
Claim 56:
A wearable ambulatory medical device for monitoring and treating a heart of a patient, the device comprising: a plurality of electrocardiogram (ECG) sensing electrodes configured to be
disposed about a body of the patient;
E.G. via the disclosed wearable defibrillator comprising sensing electrodes 10a-d {Volpe, [0028] & (Fig 1)}.
a signal acquisition circuit having a plurality of inputs, each respective input being
electrically coupled to a respective ECG sensing electrode of the plurality of ECG
sensing electrodes, the signal acquisition circuit being configured to sense a respective
signal provided by a plurality of different pairings of the plurality of ECG sensing
electrodes;
E.G. via the disclosed node 11 that receives the signals from said sensing electrodes 10a-d and accelerometer data from the accelerometers 16,17/23/31 also directly associated with said node 11 {Volpe, [0028]-[0030] & (Fig 1)}.
AND
E.G. via the disclosed systems and methods for monitoring physiological data via a wearable pad 14 having an array of electrodes 24 that can be formed in various configurations on said pad, wherein the electrodes can be switched into said configuration via an automatic electrode selection algorithm to acquire a patient’s ECG in order to determine which electrodes to select to generate data (Chen, [0044]-[0046]).
a monitoring circuit, electrically coupled to an output of the signal acquisition
circuit, the monitoring circuit being configured to: instruct the signal acquisition circuit to select, from the plurality of different pairings, a first plurality of different pairings, make a determination that a particular ECG sensing electrode that is included in the first plurality of different pairings (a) has at least partially fallen off the body of the patient and/or (b) forms part of an electrode pair that is providing a diminished ECG signal due to presence of noise signals, and instruct the signal acquisition circuit to select, from the plurality of different parings, a second plurality of different pairings; and an arrhythmia detection circuit configured to determine whether an arrhythmia condition is present in the signals provided by the second plurality of different pairings.
E.G. via the disclosed microcontroller 22 and/or the system computer 32 of the monitor 30 that utilizes the data obtained from said node, including data from the sensors 10a-d and the accelerometers, wherein the output from said sensors may include ‘fall-off’ event data , wherein the data can be used to determine information that can be used to reduce and possibly eliminate the fall-offs and/or the motion data from said accelerometers may be correlated with an ECG signal to determine if signal interference or ‘contamination’ exists [Volpe, 0036].
*Note that the examiner is interpreting the disclosed contamination is the claimed diminished ECG signa due to presence of noise signals [Volpe, 0036].
AND,
E.G. (Chen, [0044]-[0046]).
Claim 57:
The wearable ambulatory medical device of Claim 56, wherein making the determination that the particular ECG sensing electrode has at least partially fallen off the body of the patient comprises comparing a driven ground electrode signal to a signal received from the
particular ECG sensing electrode; and determining whether the driven ground electrode signal is present in the signal received from the particular ECG sensing electrode.
E.G. via the disclosed accelerator signals correlated with an ECG signals to determine if ECG signal contamination exists based on the accelerometer gathering data during certain failure states such as electrode fall-off detection (Volpe, [0036]-[0037] & [0040]-[0041]).
Claim 58:
The wearable ambulatory medical device of Claim 56, wherein making the determination that the particular ECG sensing electrode forms part of the electrode pair that is producing the diminished ECG signal comprises evaluating a signal-to-noise ratio of the diminished ECG signal.
E.G. via the disclosed correlated ECG signal and accelerometer being inputted into the belt node computer 54 that has a built in MUX and ADC, in which controls the signal parameters, such as signal-to-noise ratio (Volpe, [0067]-[0068]).
Claim 59:
The wearable ambulatory medical device of Claim 56, wherein making the determination that the particular ECG sensing electrode has at least partially fallen off the body of the patient comprises making a determination that there is a lack of signal provided by a particular monitored electrode pair that is included in the first plurality of different pairings.
E.G. (Volpe, [0036]-[0037] & [0040]-[0041]).
Claim 60:
The wearable ambulatory medical device of Claim 56, wherein the second plurality of different pairings does not include the particular ECG sensing electrode.
E.G. (Chen, [0044]-[0046]).
Claim 61:
The wearable ambulatory medical device of Claim 60, wherein the second plurality of different pairings includes a replacement pair of ECG sensing electrodes that was not included in the first plurality of different parings.
E.G. (Chen, [0044]-[0046]).
Claim 62:
The wearable ambulatory medical device of Claim 56, wherein the second plurality of different pairings includes a replacement pair of ECG sensing electrodes that was not included in the first plurality of different pairings.
E.G. (Chen, [0044]-[0046]).
Claim 63:
The wearable ambulatory medical device of Claim 56, further comprising a plurality of therapy electrodes configured to be disposed about the body of the patient; and at least one processor that is coupled to the arrhythmia detection circuit and the plurality of therapy electrodes, the at least one processor being configured to initiate treatment of the heart in response to determining presence of the arrhythmia condition.
E.G. via the disclosed therapy pads/treatment devices 18 that provide treatment when a sensed condition indicates a preferred treatment [Volpe, 0028].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796