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 § 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 1-20 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.
Claim 1 now calls for “evaluating the test statistic using multiple threshold tests simultaneously with different monitoring durations of the movement data”. Initially, it is unclear how or why one would evaluate the test statistic which is used to analyze the data – as presented, it appears that the different thresholds and durations are used to evaluate whether the statistic is useful or accurate? How is a result of “evaluating” the test statistic expressed – by opting to keep or replace the test statistic? As only one test statistic is included, it is unclear why or how this would be “evaluated” without providing any alternative for a negative evaluation.
Further, the use of “different monitoring durations” is unclear – the method does not call for actively performing monitoring at any time, such that it is unclear how this relates to the received data that is received for “a period of time” but there is no clear relationship between receipt of data and active monitoring of data. Further, as the data is merely received and then analyzed, it is unclear how any changes to a duration of monitoring could be implemented retroactively. It is unclear if the intent is to use different durations or windows within the received data, or to actively perform monitoring over different durations as part of performance of the method.
Still further, claim 1 initially defines “multiple threshold tests simultaneously with different monitoring durations” but then refers to “one of the threshold tests for one of the monitoring durations”, such that it is unclear how these input are linked and used.
Still further, the claim recites “if one of the threshold tests for one of the monitoring duration indicates the onset of a stroke”; it is unclear how this could take place, when the threshold tests and duration are defined as being used to evaluate the test statistic, not to evaluate physical conditions or, particularly, identify a stroke, nor does the claim make remotely clear how this would be identified, whether identification of onset of a stroke is actually related to evaluation of the test statistic or if this is some other type of analysis. It is entirely unclear what aspect of evaluating the test statistic would lead to identification of onset of a stroke.
The above issues are also found in claims 8 and 15. Clarification is required.
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 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a method, which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 1 recites a method comprising using a “stroke detector” implemented on a processor to receive movement data from accelerometers that are attached to a patient for a period of time, analyzing the movement data using a test statistic which is robust to motion distribution covariate shift to enable passive monitoring of the patient, the test statistic being evaluated using multiple threshold tests over different durations of data, detecting onset of a stroke if so indicated by one of the tests, and outputting an alarm signal in response to detecting a stroke using the movement data.
The dependent claims (claims 2-7) appear to be encompassed by the abstract idea of the independent claims since they merely indicate acquiring the data (claims 4, 5), processing the data (claims 2, 3, 6), and outputting the result (claim 7)
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of obtaining and storing model data to report biometric information; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the following grouping(s) of subject matter:
Mathematical concepts (e.g., relationships, formulas, equations, and/or calculations) – as based on use of a test statistic which is evaluated using a number of inputs as part of the analysis;
Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion) as based on the analyzing data to enable passive monitoring and detecting onset of a stroke from the data – a judgment or opinion regarding the patient’s condition.
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are that claim 1 recites a “stroke detector” implemented on a processor as apparently performing the activities using received data, and outputting an alarm. These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition, implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity.
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility.
The activity of “receiving… movement data” does not add anything significantly more as it merely calls for the insignificant extrasolution activity of data gathering which is necessary for all uses of the recited judicial exception, where that data is obtained from a well-understood, routine, and conventional monitoring device of accelerometers that is not positively recited as performing the data gathering, only serving as a source of data (See MPEP 2106.05(d), where determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional.)
The activity of “outputting… an alarm signal” also does not add anything significantly more, as it is no more than the insignificant postsolution activity of outputting a result without even providing a device for doing so beyond generating some signal to an unidentified recipient using the recited processor (see MPEP 2106.05 - Presenting data, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93 - another type of activity that the courts have found to be well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity)
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself or the computer components performing the abstract idea; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Claims 8-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a method, which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 8 recites a system comprising a “stroke detector” implemented on a processor that is configured to receive movement data from accelerometers that are attached to a patient for a period of time, analyze the movement data using a test statistic which is robust to motion distribution covariate shift to enable passive monitoring of the patient, the test statistic being evaluated using multiple threshold tests over different durations of data, and outputting an alarm signal in response to detecting a stroke using the movement data.
The dependent claims (claims 9-14) appear to be encompassed by the abstract idea of the independent claims since they merely indicate acquiring the data (claims 11, 12), processing the data (claims 9, 10, 13), and outputting the result (claim 14)
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of obtaining and storing model data to report biometric information; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the following grouping(s) of subject matter:
Mathematical concepts (e.g., relationships, formulas, equations, and/or calculations) – as based on use of a test statistic which is evaluated using a number of inputs as part of the analysis;
Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion) as based on the analyzing data to enable passive monitoring and possibly detecting a stroke from the data – a judgment or opinion regarding the patient’s condition.
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are that claim 8 recites a “stroke detector” implemented on a processor as apparently performing the activities using received data, and outputting an alarm. These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition, implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity.
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility.
The activity of “receiving movement data” does not add anything significantly more as it merely calls for the insignificant extrasolution activity of data gathering which is necessary for all uses of the recited judicial exception, where that data is obtained from well-understood, routine, and conventional monitoring devices of accelerometers that are not positively recited as part of the system, only serving as a source of data (See MPEP 2106.05(d), where determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional.)
The activity of “outputting an alarm signal” also does not add anything significantly more, as it is no more than the insignificant postsolution activity of outputting a result without even providing a device for doing so beyond generating some signal to an unidentified recipient using the recited processor (see MPEP 2106.05 - Presenting data, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93 - another type of activity that the courts have found to be well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity)
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself or the computer components performing the abstract idea; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Claims 15-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a manufacture, which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 15 recites a non-transitory computer readable medium storing instructions that are configured to control a processor of a computer to receive movement data from accelerometers that are attached to a patient for a period of time, analyze the movement data using a test statistic which is robust to motion distribution covariate shift to enable passive monitoring of the patient, the test statistic being evaluated using multiple threshold tests over different durations of data, and outputting an alarm signal in response to detecting a stroke using the movement data.
The dependent claims (claims 16-20) appear to be encompassed by the abstract idea of the independent claims since they merely indicate acquiring the data (claims 18, 19), and processing the data (claims 16, 17, 20)
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of obtaining and storing model data to report biometric information; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the following grouping(s) of subject matter:
Mathematical concepts (e.g., relationships, formulas, equations, and/or calculations) – as based on use of a test statistic which is evaluated using a number of inputs as part of the analysis;
Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion) as based on the analyzing data to enable passive monitoring and possibly detecting a stroke from the data – a judgment or opinion regarding the patient’s condition.
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are that claim 15 recites a medium as storing the activities and a processor as being used for performing the activities using received data and to output a signal. These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition, implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity.
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility.
The activity of “receiving movement data” does not add anything significantly more as it merely calls for the insignificant extrasolution activity of data gathering which is necessary for all uses of the recited judicial exception, where that data is obtained from well-understood, routine, and conventional monitoring devices of accelerometers that are not positively recited as performing the data gathering, only serving as a source of data (See MPEP 2106.05(d), where determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional.)
The activity of “outputting an alarm signal” also does not add anything significantly more, as it is no more than the insignificant postsolution activity of outputting a result without even providing a device for doing so beyond generating some signal to an unidentified recipient using the recited processor (see MPEP 2106.05 - Presenting data, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93 - another type of activity that the courts have found to be well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity)
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself or the computer components performing the abstract idea; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Please see the Subject Matter Eligibility (SME) guidance and instruction materials at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility, which includes the latest guidance, memoranda, and update(s) for further information.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 4-8, 11-15, 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ackland (WO 2016/103198, cited by Applicant).
As per claim 1, Ackland discloses a method for detecting stroke (page 16, lines 1-8; page 53, lines 21-28), the method comprising:
receiving, for a period of time at a “stroke detector” implemented on at least one processor (element 104; p. 65, lines 7-16), movement data (p. 44, lines 4-17) from a first accelerometer attached to a first upper limb of a patient and a second accelerometer attached to a second upper limb of the patient (element 102; as shown in fig 1; page 16, lines 31-32, “one or more”; page 16, line 34; page 17, line 10);
analyzing, at the stroke detector, the movement data using a test statistic robust to motion distribution covariate shift to enable passive monitoring of the patient (the test statistic is robust to degree of activity (motion distribution covariate shift) which enables activity status (passive) monitoring; page 57, line 21; page 60, line 35; page 64, lines 26-28; the Examiner notes that no other aspect of the test statistic beyond the intended effect of somehow being robust to covariate shift due to motion distribution has been specified, nor is there any specificity as to how this “robustness” is achieved or level of “robustness” required), wherein analyzing the movement data includes evaluating the test statistic using multiple threshold tests simultaneously with different monitoring durations of the movement data (pp. 3-4, “compare at least some of the cardiovascular and cardiac data with at least one threshold range; and on detecting a threshold set of cardiovascular and cardiac data lying within the at least one threshold range within a third time interval; generate a stability alert associated to the cardiovascular and cardiac data”; p. 4 “adjust the at least one threshold range”, “adjust the duration of the third time interval”; p. 50, “It is preferred in fact to have variations on the threshold criteria (and zones) for each individual as the system may be calibrated to their specific ability and needs.”) and detecting onset of a stroke if one of the threshold tests for one of the monitoring durations indicates the onset of a stroke (page 53, lines 21-28), and
outputting, at the stroke detector, an alarm signal in response to one of the threshold tests indicating the onset of a stroke (page 18, line 13; page 53, lines 21-28).
As per claim 4, Ackland further discloses that the first accelerometer is mounted on a wrist of the first upper limb of the patient and receiving the movement data comprises receiving the movement data via a first wireless signal from the first wrist-mounted accelerometer (as shown in fig 1).
As per claim 5, Ackland further discloses that the second accelerometer is mounted on a wrist of the second upper limb of the patient and receiving the movement data comprises receiving the movement data via a second wireless signal from the second wrist-mounted accelerometer (as shown in fig 1; page 16, lines 31-32, “one or more”; page 16, line 34; page 17, line 10).
As per claim 6, Ackland further discloses wherein receiving the movement data comprises pre-processing the movement data to remove an effect of rotation/sliding of the accelerometers and bias (page 17, lines 18-19; page 18, lines 16-21; p. 55, lines 11-30).
As per claim 7, Ackland further discloses wherein outputting the alarm signal
comprises displaying an alarm message on a display screen (page 61, lines 27-36).
As per claim 8, Ackland discloses a system for detecting stroke (page 16, lines 1-8; page 53, lines 21-28; fig 1 ), the system comprising:
at least one processor (page 65, lines 7-16); and
a “stroke detector” (element 104) implemented on the at least one processor and configured to perform operations comprising:
receiving movement data for a period of time (p. 44, lines 4-17) from a first accelerometer attached to a first upper limb of a patient and a second accelerometer attached to a second upper limb of the patient (element 102; as shown in fig 1; page 16, lines 31-32, “one or more”; page 16, line 34; page 17, line 10);
analyzing the movement data using a test statistic robust to motion distribution covariate shift to enable passive monitoring of the patient (the test statistic is robust to degree of activity (motion distribution covariate shift) which enables activity status (passive) monitoring; page 57, line 21; page 60, line 35; page 64, lines 26-28), wherein analyzing the movement data includes evaluating the test statistic using multiple threshold tests simultaneously with different monitoring durations of the movement data (pp. 3-4, “compare at least some of the cardiovascular and cardiac data with at least one threshold range; and on detecting a threshold set of cardiovascular and cardiac data lying within the at least one threshold range within a third time interval; generate a stability alert associated to the cardiovascular and cardiac data”; p. 4 “adjust the at least one threshold range”, “adjust the duration of the third time interval”; p. 50, “It is preferred in fact to have variations on the threshold criteria (and zones) for each individual as the system may be calibrated to their specific ability and needs.”) and detecting onset of a stroke if one of the threshold tests for one of the monitoring durations indicates the onset of a stroke (page 53, lines 21-28); and
outputting an alarm signal in response one of the threshold tests indicating the onset of a stroke (page 18, line 13; page 53, lines 21-28).
As per claim 11, Ackland further discloses the system comprising the first accelerometer, wherein the first accelerometer comprises a wrist mountable device configured to wirelessly transmit the movement data to the stroke detector (as shown in fig 1).
As per claim 12, Ackland further discloses the system comprising the second accelerometer, wherein the second accelerometer comprises a wrist mountable device configured to wirelessly transmit the movement data to the stroke detector (as shown in fig 1; page 16, lines 31-32, “one or more”; page 16, line 34; page 17, line 10).
As per claim 13, Ackland further discloses wherein receiving the movement data comprises pre-processing the movement data to remove the effect of rotation/sliding of the accelerometers and bias (page 17, lines 18-19; page 18, lines 16-21; p. 55, lines 11-30).
As per claim 14, Ackland further discloses wherein outputting the alarm signal comprises displaying an alarm message on a display screen (page 61, lines 27-36).
As per claim 15, Ackland discloses a non-transitory computer readable medium storing executable instructions (page 65, lines 7-16; element 104; page 16, lines 1-8; page 53, lines 21-28; fig 1) that, when executed by at least one processor of a computer, control the computer to perform operations comprising:
receiving movement data for a period of time (p. 44, lines 4-17) from a first accelerometer attached to a first upper limb of a patient and a second accelerometer attached to a second upper limb of the patient (element 102; as shown in fig 1; page 16, lines 31-32, “one or more”; page 16, line 34; page 17, line 10);
analyzing the movement data using a test statistic robust to motion distribution covariate shift to enable passive monitoring of the patient (the test statistic is robust to degree of activity (motion distribution covariate shift) which enables activity status (passive) monitoring; page 57, line 21; page 60, line 35; page 64, lines 26-28), wherein analyzing the movement data includes evaluating the test statistic using multiple threshold tests simultaneously with different monitoring durations of the movement data (pp. 3-4, “compare at least some of the cardiovascular and cardiac data with at least one threshold range; and on detecting a threshold set of cardiovascular and cardiac data lying within the at least one threshold range within a third time interval; generate a stability alert associated to the cardiovascular and cardiac data”; p. 4 “adjust the at least one threshold range”, “adjust the duration of the third time interval”; p. 50, “It is preferred in fact to have variations on the threshold criteria (and zones) for each individual as the system may be calibrated to their specific ability and needs.”) and detecting onset of a stroke if one of the threshold tests for one of the monitoring durations indicates the onset of a stroke (page 53, lines 21-28); and
outputting an alarm signal in response to detecting the onset of a stroke using the movement data (page 18, line 13; page 53, lines 21-28).
As per claim 18, Ackland further discloses that the first accelerometer is mounted to a first wrist of the first upper limb of the patient and receiving the movement data comprises receiving the movement data via a first wireless signal from the first wrist-mounted accelerometer (as shown in fig 1).
As per claim 19, Ackland further discloses that the second accelerometer is mounted to a second wrist of the second upper limb of the patient and receiving the movement data comprises receiving the movement data via a second wireless signal from the second wrist-mounted accelerometer (as shown in fig 1; page 16, lines 31-32, “one or more”; page 16, line 34; page 17, line 10).
As per claim 20, Ackland further discloses wherein receiving the movement data comprises pre-processing the movement data to remove the effect of rotation/sliding of the accelerometer and bias (page 17, lines 18-19; page 18, lines 16-21; p. 55, lines 11-30).
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) 2, 9, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ackland in view of Weimer (J. Weimer, R. Ivanov, A. Roederer, S. Chen and I. Lee, "Parameter-Invariant Design of Medical Alarms," in IEEE Design & Test, vol. 32, no. 5, pp. 9-16, Oct. 2015, doi: 10.1109/MDAT.2015.2451083.).
Ackland does not disclose wherein analyzing the movement data using the test statistic comprises analyzing the movement data using parameter invariant ("PAIN") statistics. Weimer discloses wherein analyzing physiological data using a test statistic comprises analyzing the movement data using parameter invariant "PAIN" statistics (“Parameter-invariant alarm design” section, p. 10-13). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have modified the method of Ackland to include wherein analyzing the movement data using the test statistic comprises analyzing the movement data using parameter invariant ("PAIN") statistics, as taught by Weimer, in order to gain the advantages of providing that unknown events and system variability minimally affect the monitor performance and rate of false alarms (see Weimer, p. 9, right column).
Claim(s) 3, 10, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ackland in view of Stephens (Stephens, M.A. (1992). Introduction to Kolmogorov (1933) On the Empirical Determination of a Distribution. In: Kotz, S., Johnson, N.L. (eds) Breakthroughs in Statistics. Springer Series in Statistics. Springer, New York, NY. https://doi.org/10.1007/978-1-4612-4380-9_9).
Ackland does not disclose the test statistic being a Kolmogorov-Smirnov statistic; Stephens teaches using a Kolmogorov-Smirnov statistic to evaluate distribution and fit of samples (Introduction; Summary of the Paper). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have followed Ackland using a Kolmogorov-Smirnov statistical test, as taught by Stephens, as this statistical test is well-known in the field of statistics for evaluating distribution and goodness of fit of samples (see Stephens, sections 1 and 9).
Response to Arguments
Applicant's arguments filed 14 July 2026 have been fully considered but they are not persuasive.
Regarding the rejections under 101, Applicant merely asserts that the abstract idea of the invention as claimed cannot be practically performed by a human without including an analysis of the claim limitations, identification of any particular limitation which would preclude this, or anything beyond a general assertion. As this is not the case, set forth above, this wholly unsupported general allegation of subject matter eligibility is entirely unpersuasive.
Regarding the art rejections, regarding the newly added limitations directed to evaluating the test statistic using different threshold tests and different monitoring durations, Applicant argues only that Ackland does not disclose “setting different monitoring durations for the same type of data” as part of evaluating movement data – this has not been claimed, only using different monitoring durations as part of evaluating the test statistic. Ackland does disclose this, as set forth above.
The remainder of Applicant’s remarks addressing Weimer and Stephens merely refer to this supposed deficiency in Ackland; as this is not the case these remarks are moot.
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.
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/KAREN E TOTH/ Examiner, Art Unit 3791
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