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 § 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 1-15 rejected under 35 U.S.C. 101 because of the following analysis:
Step 1: Do the claims recite one of the statutory categories of matter (i.e. method, apparatus, etc.)? YES, claims 1-7 recite an apparatus and claims 8-15 recite a method.
Step 2A Prong 1: Is there an abstract idea involved? YES, the claim language recites determining a respiration rate or indicate that a respiration rate data cannot be determined (analysis and judgment), determining whether the monitoring device is attached to the patient…(judgment). These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper.
Step 2a Prong 2: Do the claims recite additional elements that integrate the exception into a practical application? NO, the claims recite a monitoring device including an accelerometer, a processor, a wireless transmitter/transceiver. are recited at a high level of generality and is recited as performing generic computer functions. i.e., data processing and display. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea. The accelerometer and display are considered pre-processing and post-processing extrasolution activities of necessary data gathering and outputting (see MPEP 2106.05(g)).
The respective dependent claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process) and are recited at a high level of generality and is recited as performing generic computer functions. i.e., data processing and display. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)).
Step 2B: Do the additional elements amount to “Significantly More” than the judicial exception? NO, the emphasized elements cited above do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014)). In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
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.
Claim(s) 1-3, 8-11, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larson (US 2021/0134454 A1).
Regarding claims 1 and 8, Larson discloses a system (eg. Fig. 2A-Fig. 3, and associated paragraphs) comprising: a monitoring device (eg. 300) including an accelerometer (eg. 305), an on-board electronic processor (eg. 310), and a wireless transmitter or transceiver (eg. 340 and 345), the monitoring device configured to be attached to a patient and the accelerometer configured to measure accelerometer data (eg. Para. 58-63); and a clinical information system (eg. 335) including at least one electronic processor (eg. Para. 52 implied through a base station computer), the clinical information system operatively connected with the monitoring device via the wireless transmitter or transceiver of the monitoring device (eg. Fig. 3); wherein the on-board electronic processor of the monitoring device and the clinical information system cooperatively perform a health status monitoring method including: analyzing the accelerometer data to determine respiration rate data for the patient or an indication that respiration rate data cannot be determined from the accelerometer data (eg. Para. 58-63); determining whether the monitoring device is attached to the patient based at least on the whether the analyzing determines that respiration rate data cannot be determined from the accelerometer data (eg. Para. 58-63); and one of: in response to determining the monitoring device is attached to the patient, displaying health status information for the patient generated from the accelerometer data and the determined respiration rate data; or in response to determining the monitoring device is not attached to the patient, displaying an indication that the monitoring device is not attached to the patient (eg. Fig. 1, Para. 47-50, 58, 67).
Although Larson does not explicitly disclose the displaying of an indication, Larson discloses the system can detect if the orientation sensor is properly attached if the parameters fall within predefined values and provides an alert/notify the caregiver if the sensor is not properly attached (Eg. Para. 58). One of ordinary skill would have been able to modify the display to provide these alerts on the display as an obvious alternative design choice to provide information to the caregiver.
Regarding claims 2 and 10, analyzing the accelerometer data further determines heart rate data for the patient or an indication that heart rate data cannot be determined from the accelerometer data; and the determining of whether the monitoring device is attached to the patient is further based on whether the analyzing determines that heart rate data cannot be determined from the accelerometer data (eg. Para. 58, 64, 103-108).
Regarding claims 3 and 11, Larson discloses analyzing the accelerometer data further determines activity data for the patient or an indication that activity data cannot be determined from the accelerometer data; and the determining of whether the monitoring device is attached to the patient is further based on whether the analyzing determines that activity data cannot be determined from the accelerometer data (Eg. Para. 58-59).
Regarding claim 9, Larson discloses displaying the determined health status information for the patient on a display; and in response to the determination that the monitoring device is no longer attached to the patient, displaying an indication that the monitoring device is no longer attached to the patient (eg. Fig. 1, Para. 47-50, 58, 67).
Regarding claim 15, Larson discloses the patient data comprises accelerometer data acquired by an accelerometer of the wireless monitoring device (eg. Para. 58-63, accelerometer 305 Fig 3).
Claim(s) 4-7, 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larson (US 2021/0134454 A1) in view of Meger (US 2011/0112442 A1).
Regarding claims 4 and 12, Larson discloses the invention of claim 4, but does not disclose analyzing of the accelerometer data to determine respiration rate data for the patient or an indication that respiration rate data cannot be determined from the accelerometer data includes: determining a running average of respiration rate values over a predefined sliding time window from the accelerometer data, each respiration rate value being indicative of respiration rate of the patient or a predetermined value that is not indicative of respiration rate of the patient; and determining that respiration rate data cannot be determined from the accelerometer data based on a frequency of the predetermined values in the sliding time window of respiration rate values exceeding a threshold.
Meger teaches a sensor device that uses movement detection and correlation to determine a running average of a respiration signal over time windows and identifies and removes suspicious intervals and removes certain intervals associated with big movements, etc. (eg. Para. 307, 409-424).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Larson with the time window running average calculations and suspicious interval identification as taught by Meger as a common calculation in the art for improving the accuracy of discerning between normal and abnormal signals. One of ordinary skill would have been able to put an indication for suspicious and removed signals on display.
Regarding claims 5 and 13, the combined invention of Larson and Meger discloses the analyzing further includes determining heart rate data for the patient or an indication that heart rate data cannot be determined from the accelerometer data by operations including: determining a running average of heart rate values over a predefined sliding time window from the accelerometer data, each heart rate value being indicative of heart rate of the patient or a predetermined heart rate value that is not indicative of heart rate of the patient; and determining that heart rate data cannot be determined from the accelerometer data if a frequency of the predetermined heart rate values in the predefined sliding time window of heart rate values exceeding a second threshold; and the determining of whether the monitoring device is attached to the patient is further based on whether the analyzing determines that heart rate data cannot be determined from the accelerometer data (Eg. Larson Para. 58, 64, 103-108 and Meger Para. 307, 409-424).
Regarding claims 6 and 14, the combined invention of Larson and Meger discloses the analyzing further includes determining activity data for the patient or an indication that activity data cannot be determined from the accelerometer data by operations including: determining a running average of activity values over a predefined sliding time window from the accelerometer data, each activity value being indicative of activity of the patient or a predetermined activity value that is not indicative of activity of the patient; and determining that activity data cannot be determined from the accelerometer data if a frequency of the predetermined activity values in the predefined sliding time window of activity values exceeding a second threshold; and the determining of whether the monitoring device is attached to the patient is further based on whether the analyzing determines that activity data cannot be determined from the accelerometer data (eg. Larson, Para. 58-59).
Regarding claim 7, the combined invention of Larson and Meger discloses the predefined sliding time window comprises a range of 50-60 values (Eg. Larson Para. 58, 64, 103-108 and Meger Para. 307, 409-424). One of ordinary skill would have been able to arrive at 50-60 data points through routine experimentation to determine an appropriate sample size for determining if a signal is reliable or not.
Conclusion
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/MICHAEL J LAU/ Examiner, Art Unit 3796