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 .
Status of Claims
Claims 1-20 are currently pending and under consideration.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the abstract idea of “of detecting a plurality of QRS complexes based on the plurality of ECG signals, determining a heart rate of the patient based on an R-R interval between two QRS complexes, detecting if the patient is experiencing potential ventricular fibrillation based on the heart rate and optionally a width of the QRS complexes, calculating a plurality of measurements based on the QRS complexes, and determining whether the potential ventricular fibrillation is actual ventricular fibrillation or noise based on the plurality of measurements” without significantly more.
Step 1
The claims recite a device, and there, it is a product and falls within the statutory category.
Step 2A. Prong One
Claims 1, 8 and 15 recite a limitation of detecting a plurality of QRS complexes based on the plurality of ECG signals, determining a heart rate of the patient based on an R-R interval between two QRS complexes, detecting if the patient is experiencing potential ventricular fibrillation based on the heart rate and optionally a width of the QRS complexes, calculating a plurality of measurements based on the QRS complexes, and determining whether the potential ventricular fibrillation is actual ventricular fibrillation or noise based on the plurality of measurements. The QRS complex detection, heart rate determination, potential ventricular defibrillation detection, plurality of measurement calculation, and noise determination limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers a mental process (MPEP 2106.04(a)(2)(III)) and mathematical concepts (MPEP 2106.04(a)(2)(I)). That is, the claimed elements as mentioned above, can be practically performed in the human mind or using mathematical concepts. For example, the QRS complex detection, heart rate determination, potential ventricular defibrillation detection, plurality of measurement calculations, and noise determination is nothing more than a medical professional visually examining recorded ECG signals and finding the QRS complexes within the ECG signals to calculate heart rate and determine whether or not ventricular fibrillation is detected. For the limitation of calculating a plurality of measurements based on the QRS complexes, the plurality of measurements would include a plurality of heart rates that would require mathematical calculation by determining time between R-R intervals between QRS complexes (i.e., subtracting time between R-R intervals).
Step 2A. Prong Two
The claim recites additional elements: “a processor” used to perform the QRS complex detection, heart rate determination, potential ventricular defibrillation detection, plurality of measurement calculation, and noise determination steps.
The “processor”, is recited at a high level of generality, i.e., as a generic processor, performing a generic computer function of processing data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional limitation does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B
As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept in Step 2B.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The specification in paragraph [0066] does not provide any indication that the computer processor is anything other than a generic, off-the-shelf computer component. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
Dependent claims 2-20 further limits the QRS complex detection, heart rate determination, potential ventricular defibrillation detection, plurality of measurement calculation, and noise determination. Therefore, these claims further limit the abstract idea already indicated in independent claims 1, 8 and 15 and they are ineligible for the same reasons provided for claims 1, 8 and 15 above.
For these reasons, there is no inventive concept in the claim and thus it is ineligible.
If the claims can include an additional limitation of “the external defibrillator may initiate defibrillation or hold-off defibrillation or similarly pacing, based on a combination of a variety of inputs”, which is disclosed in [0025], claims would be eligible.
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, 8, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sullivan et al. (US 11154230 B2 issued 10/26/2021, hereinafter referred to as Sullivan).
Regarding claim 1, Sullivan teaches a wearable medical system (Col. 2, line 13), the system comprising: a support structure configured to be worn by a patient (Col. 2, lines 13-15); a plurality of ECG electrodes to sense a plurality of ECG signals of the patient (Col. 2, lines 18-20); and a processor in communication with the plurality of ECG electrodes (Col. 2, lines 22), the processor configured to: receive the plurality of ECG signals (Col. 2, lines 22-23); detect a plurality of QRS complexes based on the plurality of ECG signals (Col. 10, lines 14-17); determine a heart rate of the patient based on an R-R interval between two QRS complexes (Col. 9, lines 9-10); detect if the patient is experiencing potential ventricular fibrillation based on the heart rate and optionally a width of the QRS complexes (Col. 7, lines 22-24); calculate a plurality of measurements based on the QRS complexes (Col. 12, lines 43-45); and determine whether the potential ventricular fibrillation is actual ventricular fibrillation or noise based on the plurality of measurements (Col. 2, lines 22-24).
Regarding claim 8, Sullivan teaches a method for detecting ventricular fibrillation (Example 30, col. 19, lines 61-64), the method comprising: receiving a plurality of ECG signals from a plurality of ECG electrodes worn by a patient (Col. 2, lines 18-22); detecting a plurality of QRS complexes based on the plurality of ECG signals (Col. 10, lines 14-17); determining a heart rate of the patient based on an R-R interval between two QRS complexes (Col. 9, lines 9-10); detecting that the patient is experiencing potential ventricular fibrillation based on the heart rate and optionally a width of the QRS complexes (Col. 7, lines 22-24); calculating a plurality of measurements based on the QRS complexes (Col. 12, lines 43-45); and determining whether the potential ventricular fibrillation is actual ventricular fibrillation or noise based on the plurality of measurements (Col. 2, lines 22-24).
Regarding claim 15, Sullivan teaches a non-transitory computer-readable medium (Col. 7, lines 61-64, encoded with instructions for detecting ventricular fibrillation stored thereon, that when executed by a computing device cause the computing device to perform operations for detecting ventricular fibrillation (Col. 7-8, lines 64-4), the operations comprising: receiving a plurality of ECG signals from a plurality of ECG electrodes worn by a patient (Col. 2, lines 18-22); detecting a plurality of QRS complexes based on the plurality of ECG signals (Col. 10, lines 14-17); determining a heart rate of the patient based on an R-R interval between two QRS complexes (Col. 9, lines 9-10); detecting that the patient is experiencing potential ventricular fibrillation based on the heart rate and optionally a width of the QRS complexes (Col. 7, lines 22-24); calculating a plurality of measurements based on the QRS complexes (Col. 12, lines 43-45); and determining whether the potential ventricular fibrillation is actual ventricular fibrillation or noise based on the plurality of measurements (Col. 2, lines 22-24).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 9, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan in view of Xi et. al (US 2009/0264783 published 10/22/2009, hereinafter referred to as Xi).
Regarding claims 2, 9 and 16, Sullivan teaches the wearable medical system, method, and non-transitory computer-readable medium for detecting ventricular fibrillation recited in claims 1, 8 and 15 as set forth above. Sullivan further teaches that noise may also be determined in additional ways on the ECG signal (Col. 11, lines 66-67). If labeled as noise, the QRS complex could be rejected and not used for heart rate calculations, avoiding possible disturbances to the heart rate (Col. 12, lines 10-13).
However, Sullivan does not teach the plurality of measurements comprising one or more of a minimum heart rate, a predicted heart rate, a predicted organization, a predicted baseline shift, and a minimum median absolute deviation.
Xi teaches systems and methods for analyzing electrocardiogram (ECG) data of a patient using a substantial amount of ECG data (Abstract). Xi teaches that the minimum heart rate is not necessarily the lowest heart rate measured but instead may be a heart rate that is close to the lowest measured rate in order to account for possible noise ( [0105]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the minimum heart rate measurement of Xi in the system, method, and non-transitory computer-readable medium of Sullivan in order to account for possible noise in ECG measurements, which would result in more accurate heart rate determination and avoid disturbances to the heart rate.
Claims 3, 4, 10, 11, 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan in view of Xi as applied to claims 2, 9, and 16 above, and further in view of Sullivan (US 2021/0205618 A1, published 08/07/2021, hereinafter referred to as Sullivan 2).
Regarding claims 3, 10 and 17, Sullivan and Xi teach the wearable medical system, method, and non-transitory computer-readable medium for detecting ventricular fibrillation recited in claims 2, 9 and 16 as set forth above.
However, Sullivan and Xi do not teach the plurality of ECG electrodes comprising a first set of ECG electrodes corresponding to a first channel for QRS detection, a second set of ECG electrodes corresponding to a second channel for QRS detection, a third set of ECG electrodes corresponding to a third channel for QRS detection, and a fourth set of ECG electrodes corresponding to a fourth channel for QRS detection.
Sullivan 2 teaches a wearable medical device containing a processor that monitors ECG signals (Abstract). Sullivan 2 teaches that the signals from four ECG electrodes can be combined to form up to six different vectors, and in some embodiments, wearable cardioverter defibrillator (WCD) uses four vectors for QRS complex analysis and/or heart rate analysis to determine if a shock should be applied ([0044]). The ECG analysis algorithm includes provisions for excluding vectors that have noise or when a leads-off condition or situation is detected ([0043]). Monitoring four vectors rather than monitoring two vectors is believed to contribute to enhanced ECG signal analysis and processing of the shock application algorithm to reduce the number of false shock events ([0043]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to use four electrodes corresponding to QRS detection channels as taught by Sullivan 2 with the sensing electrodes of Sullivan for enhanced ECG signal analysis and processing.
Regarding claims 4, 11 and 18, in the modified device of Sullivan, Sullivan teaches the processor that may determine noise in some embodiments by detecting a correlation between a channel receiving the ECG signal and a physical sensor (Col. 11, lines 36-38). The processor flags the ECG channel as having noise when there is a high correlation with any of these signals. This channel may then be ignored for analysis or the whole ECG signal may be flagged as noisy (Col. 11, lines 46-50).
Claims 5, 6, 12, 13, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan in view of Xi and Sullivan 2 as applied to claims 4, 11, and 18 above, and further in view of Rindskopf et. al (International Encyclopedia of Education, 3rd Edition, 2010, p. 267-273), hereinafter referred to as Rindskopf).
Regarding claims 5, 12 and 19, Sullivan, Xi, and Sullivan 2 teach the wearable medical system, method, and non-transitory computer-readable medium for detecting ventricular fibrillation recited in claims 4, 11 and 18 as set forth above.
In the modified device of Sullivan, Sullivan teaches a processor that can be a detection module, including a ventricular fibrillation (VF) detector (Col. 7, lines 21-24), wherein the processor is configured to determine noise on the ECG signal in segments, each segment including a time period of ECG signal, which may be any desired time period, such as 4.8 seconds (Col. 12, lines 2-7). Sullivan teaches wherein the processor identifies QRS complexes within the ECG to compute the patient's heart rate (Col. 10, lines 15-18), determines whether there have been ten qualified R-R intervals in the last fourteen R-R intervals (Col. 12, lines 39-43), avoids a possible disturbance to the heart rate calculations (Col. 12, lines 9-13), calculates the heart rate of the patient using the ten qualified R-R intervals in operation (Col. 12, lines 43-47), and detects a baseline shift by looking at the unfiltered ECG signal (Col. 10, lines 45-52). Sullivan teaches the processor configured to perform a rhythm analysis using heart rate, QRS width, and QRS organization from the ECG data to make a shock decision (Col. 9, lines 65-67), and determine if the unfiltered ECG signal changes in amplitude by more than approximately 5 mV in the vicinity of a QRS detection - after a QRS complex is detected, processor may look at the unfiltered ECG signal and compare it to an amplitude threshold to determine if the change in amplitude in the vicinity of the detected QRS complex is greater than the amplitude threshold, if then change in amplitude is greater than the amplitude threshold, the detected QRS complex is flagged as noise (Col. 10, lines 20-34), and the process determines if five consecutive segments have been received without noise at operation (Col. 15, lines 27-30).
Sullivan, Xi, and Sullivan 2 teach all of the elements disclosed in claims 5, 12, and 19 as stated above except for the minimum median absolute deviation of the R-R intervals.
Rindskopf teaches an alternative way to summarize variance of data by using the statistic known as the median absolute deviation (MAD) (Rindskopf et. al, International Encyclopedia of Education, 3rd Edition, 2010, p. 267-273). Rindskopf teaches that MAD is a resistant measure of variability as it relies on the median as the estimate of the center of the distribution, and on the absolute difference rather than the squared difference, and that the clear advantage of MAD is the avoidance of influence by outliers (Rindskopf et. al, International Encyclopedia of Education, 3rd Edition, 2010, p. 267-273).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to use outlier determination using minimum MAD as taught by Rindskopf in the wearable medical system, method, and non-transitory computer-readable medium of Sullivan because in order to account for possible noise in ECG measurements, which would result in more accurate heart rate determination and avoid disturbances to the heart rate.
Regarding claims 6, 13, and 20, Sullivan teaches a plurality of segments from the plurality of QRS complexes within a segment agreement threshold, wherein each segment is about every 3 seconds to about every 5 seconds (“processor is configured to determine noise on the ECG signal in segments, each segment including a time period of ECG signal, which may be any desired time period, such as 4.8 seconds “, Col. 12, lines 2-7), and wherein the segment agreement threshold removes one or more noisy segments (Col. 10, lines 29-31).
Claims 7 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan in view of Xi as applied to claims 2 and 9 above, and further in view of Cordero et. al (US 2020/0197715, published 06/25/2020, hereinafter referred to as Cordero).
Regarding claims 7 and 14, Sullivan and Xi teach the wearable medical system, method, and non-transitory computer-readable medium for detecting ventricular fibrillation recited in claims 2 and 9 as set forth above.
However, Sullivan and Xi do not teach wherein the processor is configured to provide an alarm to a patient or medical personnel when the processor determines actual ventricular fibrillation.
Cordero teaches an implantable medical device that processes and analyzes detected cardiac signals (Abstract). Cordero teaches if the value of “window energy” is less than said specific value “limit energy VF”, a ventricular fibrillation is detected and an alarm is triggered ([0129]). Defibrillation operation is triggered following the detection of ventricular fibrillation ([0130]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to add the ventricular fibrillation alarm as taught by Cordero in the wearable medical system of Sullivan because it is well known in the art that the implementation of an alarm when ventricular fibrillation is occurring will help to alert medical professionals to administer a defibrillation operation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FIONA M KOWALKOWSKI whose telephone number is (571)272-2790. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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/F.M.K./Patent Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792