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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 2, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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 a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-20 are directed to a method, system, and device for monitoring subject ability using a computational algorithm, which is an abstract idea. Claims 1-20 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a process.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] – “A method for monitoring subject ability”; and
[B1] – “identifying a treatment protocol based on the subject ability score”.
These elements [A1]-[B1] of claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] – “transmitting, using a transmitting device, a signal from a subject performing a task, the signal indicating subject ability to be independent”;
[B2] – “acquiring, using a receiving device, data transmitted from the signal”;
[C2] – “processing the data by an ability analysis device, the ability analysis device configured to calculate a subject ability score”; and
[D2] – “outputting the subject ability score and the treatment protocol to a user device”.
These elements [A2]-[D2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the elements [A2], [B2], and [D2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering and output at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the element [C2] is merely an instruction 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 MPEP 2106.05(f).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “a signal from a subject performing a task, the signal indicating subject ability” does not qualify as significantly more because this limitation merely describes the nature of the signal data and does not incorporate any particular machine as part of the claimed invention. Also, the recitation “using a transmitting device”, “using a receiving device”, and “processing the data by an ability analysis device” are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well-known elements or simply displaying the results of the algorithm that uses conventional, routine, and well-known elements. In particular, the transmitting device, receiving device, and ability analysis device are merely generic devices that do not incorporate a particular machine into the claim.
Further, the element [C2] does not qualify as significantly more because this limitation is 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’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Claims 2-11 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claims 2 and 4-5: “assistive device”.
Each of these claims limitations does not integrate the exception into a practical application. In particular, the element of claims 2 and 4-5 merely describe the nature of the signal data and does not incorporate any particular machine as part of the claimed invention.
Also, each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (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.
The analysis of claim 12 is as follows:
Step 1: Claim 12 is drawn to a machine.
Step 2A – Prong One: Claim 12 recites an abstract idea. In particular, claim 12 recites the following limitations:
[A1] – “the ability analysis device configured to calculate a subject ability score and to identify a treatment protocol based on the subject ability score”.
This element [A1] of claim 12 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 12 recites the following limitations that are beyond the judicial exception:
[A2] – “a transmitting device for transmitting a signal from a subject performing a task, the signal indicating subject ability to be independent”;
[B2] – “a receiving device for acquiring data from the signal”;
[C2] – “an ability analysis device for processing the data”; and
[D2] – “a user device for outputting the subject ability score and the treatment protocol to a user”.
These elements [A2]-[D2] of claim 12 do not integrate the exception into a practical application of the exception. In particular, the elements [A2], [B2], and [D2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering and output at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the element [C2] is merely an instruction 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 MPEP 2106.05(f).
Step 2B: Claim 12 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “a signal from a subject performing a task, the signal indicating subject ability to be independent” does not qualify as significantly more because this limitation merely describes the nature of the signal data and does not incorporate any particular machine as part of the claimed invention. Also, the recitation “a transmitting device”, “a receiving device”, “an ability analysis device for processing the data”, and “a user device” are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well-known elements or simply displaying the results of the algorithm that uses conventional, routine, and well-known elements. In particular, the transmitting device, receiving device, ability analysis device, and user device are merely generic devices that do not incorporate a particular machine into the claim.
Further, the element [C2] does not qualify as significantly more because this limitation is 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’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Claims 13-17 depend from claim 12, and recite the same abstract idea as claim 12. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claims 13 and 16-17: “assistive device”.
Each of these claims limitations does not integrate the exception into a practical application. In particular, the element of claims 13 and 16-17 merely describe the nature of the signal data and does not incorporate any particular machine as part of the claimed invention.
Also, each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (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.
The analysis of claim 18 is as follows:
Step 1: Claim 18 is drawn to a machine.
Step 2A – Prong One: Claim 18 recites an abstract idea. In particular, claim 18 recites the following limitations:
[A1] – “calculate a subject ability score of the subject based on the processed data”.
This element [A1] of claim 18 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 18 recites the following limitations that are beyond the judicial exception:
[A2] – “An ability analysis device configured to process ability data of a subject obtained from a receiving device”;
[B2] – “output the subject ability score to a user device”.
These elements [A2]-[B2] of claim 18 do not integrate the exception into a practical application of the exception. In particular, the elements [A2-B2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering and output at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the element [A2] is merely an instruction 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 MPEP 2106.05(f).
Step 2B: Claim 18 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the element [A2] does not qualify as significantly more because this limitation is 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’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Claims 19-20 depend from claim 18, and recite the same abstract idea as claim 18. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claim 19: “transmitting device”; and
Claims 20: “assistive device”.
Each of these claim limitations does not integrate the exception into a practical application. In particular, the elements of claims 19 and 20 merely describe generic, well-understood and routine devices, that do not recite particular machines as part of the claimed invention.
Also, each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (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.
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 6-11 and 19-20 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.
The term “about” in claims 6, 7, and 8 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Per MPEP 2173.05(b), in determining the range encompassed by the term "about," one must consider the context of the term as it is used in the specification and claims of the application. Neither the specification nor the claims define what performing “about” 100% of the task means, which creates confusion as to when direct infringement would occur. Further clarification is required to define this term.
Claim 19 recites “The device of claim 18” in line 1. It is unclear which device is referenced by the term “device”, as there are multiple devices recites in claim 18. For the purpose of examination, “The device” is considered to be the “ability analysis device” of claim 18. Further clarification is required.
Claim 20 recites “The device of claim 19” and “the device” in line 1. It is unclear which device is referenced by the term “device”, as there are multiple devices recites in claims 18 and 19. For the purpose of examination, “The device” is considered to be the “ability analysis device” of claim 18. Further clarification is required.
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 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20210158965 A1 (Receveur et al.).
Regarding claim 18, Receveur teaches an ability analysis device configured to process ability data of a subject obtained from a receiving device, calculate a subject ability score of the subject based on the processed data ([0021] “The patient assessment device 102 operates to receive, process, and send information related to determining a patient's level of mobility and risk of falling. One or more assessments for mobility and risk of falling can be automatically implemented by the patient assessment device 102 using data received from one or more of the patient support system 104, patient monitoring computing device 110, camera 112, and EMR system 114.”; [0034] “The patient movement analyzer 152 operates to receive and analyze video and load sensor data for a plurality of patients on a plurality of patient support systems. The video and load sensor data is correlated by time to match activity recorded on the load sensors with visually confirmed patient movements.”; [0057] “As load sensor data is received over time, it is analyzed using the mobility model to detect patterns in the fluctuations of load that are detected on a patient support system. Particular patterns indicate that a patient is lying in bed, having difficulty getting out of bed, easily getting out of bed, or is currently out of the bed.”), and output the subject ability score to a user device ([0058] “a mobility level or score is output for the patient”; [0031] “patient fall risk scores, when above a predetermined threshold, trigger an alert from caregiver call system 118 that is sent to a computing device associated with a caregiver so that the caregiver is notified of the need to perform critical tasks based on the patient's fall risk.”).
Regarding claim 19, Receveur teaches the device of claim 18, wherein the receiving device is configured to receive the data from a transmitting device ([0021] “The patient assessment device 102 operates to receive, process, and send information related to determining a patient's level of mobility and risk of falling. One or more assessments for mobility and risk of falling can be automatically implemented by the patient assessment device 102 using data received from one or more of the patient support system 104, patient monitoring computing device 110, camera 112, and EMR system 114.”).
Regarding claim 20, Receveur teaches the device of claim 19, wherein the device is further configured to communicate with an assistive device in a vicinity of the subject, the assistive device configured to transmit information to the ability analysis device ([0020] “The system 100 includes a patient assessment device 102 and a patient support system 104 in communication with a network 106. In some embodiments, the patient support system 104 includes a plurality of load sensors 108.”; [0022] “The patient support system 104 operates to provide a surface for a patient to rest upon while under medical care. The patient support system 104 can be one or more of a bed, a chair, a lift, and/or a surgical table.”; [0025]).
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.
Claims 1-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over US 20230372456 A1 (Petryk et al.) in view of US 20210158965 A1 (Receveur et al.).
Regarding claim 1, Petryk teaches a method for monitoring subject ability comprising the steps of:
transmitting, using a transmitting device, a signal from a subject performing a task, the signal indicating subject ability to be independent ([0015] “The physical metric may be monitored using a wearable device, such a wearable device that includes an accelerometer. The wearable device may be configured to be worn on the arm (e.g., wrist), leg, or torso of the subject. The wearable device may track one or more biometric indicia of the subject.”; [0026-0027]; [0175] “As data is continuously monitored and measured by the wearable device, the data collected by the device may be transmitted to the peripheral device and stored on the peripheral device or on a cloud-based storage medium”),
acquiring, using a receiving device, data transmitted from the signal ([0026] “The peripheral device may be configured to run a software application (e.g., mobile application, e.g., smartphone application).”; [0175] “As data is continuously monitored and measured by the wearable device, the data collected by the device may be transmitted to the peripheral device and stored on the peripheral device or on a cloud-based storage medium. The peripheral device may be configured to run a software application (e.g., smartphone application) that provides navigable information to the subject in order to track changes in the subject's physiological indicia during the course of treatment (e.g., improvement over time)”),
calculate a subject ability score ([0101] “The walking speed and STS tests are scored firstly on the ability to complete the tasks and secondly time taken to complete each task. Each task is scored out of 4, with the scores from the 3 tests summed to give a total of a maximum of 12 and a minimum of 0. A higher score indicates a higher level of function, while lower scores indicate a lower level of function. Lower scores on the SPPB have been shown to be predictive of an increased risk of falling, loss of independence in ADLs, decreased mobility, disability, decline in health, rehospitalization; and increased hospital length of stay, nursing home admission, and death.”),
identifying a treatment protocol based on the subject ability score ([0007] “a method of treating a bone mineralization disorder in a human subject (e.g., an adult human subject) that exhibits a level in at least one biochemical, physical, quality of life, or bone metric that identifies the subject as in need of treatment for the bone mineralization disorder”; [0082] “simple daily activities, such as sitting down, standing up, or walking, can be difficult for an adult patient. Featured herein are methods of treatment that include monitoring changes in biochemical, physical, and/or quality of life metrics in order to establish a treatment regimen for a patient with a bone mineralization disorder, such as HPP, and in particular, for an adult HPP patient.”; [0083]).
Petryk does not explicitly teach processing the data by an ability analysis device, the ability analysis device configured to calculate a subject ability score; and outputting the subject ability score and the treatment protocol to a user device.
However,
Receveur teaches processing the data by an ability analysis device, the ability analysis device configured to calculate a subject ability score ([0021] “The patient assessment device 102 operates to receive, process, and send information related to determining a patient's level of mobility and risk of falling.”; [0034] “The patient movement analyzer 152 operates to receive and analyze video and load sensor data for a plurality of patients on a plurality of patient support systems. The video and load sensor data is correlated by time to match activity recorded on the load sensors with visually confirmed patient movements.”; [0057] “As load sensor data is received over time, it is analyzed using the mobility model to detect patterns in the fluctuations of load that are detected on a patient support system. Particular patterns indicate that a patient is lying in bed, having difficulty getting out of bed, easily getting out of bed, or is currently out of the bed.”); and
outputting the subject ability score and the treatment protocol to a user device ([0058] “a mobility level or score is output for the patient”; [0031] “patient fall risk scores, when above a predetermined threshold, trigger an alert from caregiver call system 118 that is sent to a computing device associated with a caregiver so that the caregiver is notified of the need to perform critical tasks based on the patient's fall risk.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Petryk to include processing data with an ability analysis device to calculate a subject ability score and outputting the score and treatment protocol. One would have been motivated to make this modification because calculating and outputting mobility and fall risk scores of a patient allows caregivers to perform critical tasks and implement safety measures for the patient, as suggested by Receveur ([0031], [0060]).
Regarding claim 2, Petryk teaches the method of claim 1, wherein the method further comprises:
identifying an assistive device in a vicinity of the subject ([0356] “it was documented whether the patient required an assistive device (e.g., crutches or a walker) to complete these assessments.”), and
detecting use of the assistive device by the subject when the subject is performing the task ([0085] “The methods may include tracking metrics such as decreased reliance on assistive devices (e.g., wheelchairs, wheeled walkers, and canes).”).
Regarding claim 3, Petryk teaches teaches the method of claim 2
Petryk does not explicitly teach wherein the method further comprises:
identifying a helper in a vicinity of the subject, and
detecting assistance provided by the helper when the subject is performing the task.
However,
Receveur teaches wherein the method further comprises:
identifying a helper in a vicinity of the subject ([0057] “In some embodiments, data is received from location monitoring devices configured to track locations of caregivers in order to determine whether a caregiver is present at the patient support device 104 at any time.”), and
detecting assistance provided by the helper when the subject is performing the task ([0032] “The location monitoring devices can help to ascertain whether load detected on a patient support system 104 is caused by a patient or a caregiver as well as determine whether a caregiver is present to aid a patient when the patient is getting off a patient support system 104.”; [0058] “If the patient is unable to rise without assistance, 4 risk points are output.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Petryk to include identifying a helper and detecting assistance provided by the helper. One would have been motivated to make this this modification because tracking caregivers can help ascertain whether signals are a result of the patient or a caregiver and patients that cannot perform a task without assistance are given lower mobility scores, as suggested by Receveur ([0032], [0058]).
Regarding claim 4, Petryk teaches the method of claim 3, wherein if the subject does not use the assistive device and does not use the assistance provided by the helper to perform the task, the subject is assigned a first ability score ([0085] “The SPPB may include tests, such as a repeated chair stand test. The methods may include tracking metrics such as decreased reliance on assistive devices (e.g., wheelchairs, wheeled walkers, and canes).”; [0101] “A higher score indicates a higher level of function, while lower scores indicate a lower level of function. Lower scores on the SPPB have been shown to be predictive of an increased risk of falling, loss of independence in ADLs, decreased mobility, disability, decline in health, rehospitalization; and increased hospital length of stay, nursing home admission, and death”; [0351] “Each performance measure was assigned to a categorical score ranging from 0 (inability to complete the test) to 4 (optimal performing). A summary score ranging from 0 (worst performers) to 12 (best performers) was calculated by summing the 3 component scores.”; [0352] “The 4M-Gait Speed is part of the SPPB. The participant had also to be able to walk unassisted without the use of a cane or walker”; [0363] “Seven of the evaluable patients required assistive devices to complete the 6MWT at baseline (three patients used crutches; four used a rolling walker). Two of these patients were able to complete the test unassisted later during the course of the study; one patient was able to complete the test unassisted from 3 months onwards, and another patient was able to complete the 12-month assessment without assistive devices”; [0368] “Four patients required an assistive device to complete this assessment at baseline; two of these completed the task unassisted as of 3 months of treatment, and another patient no longer required an assistive device to complete the test after 6 months of treatment. Median (IQR) time to complete the repeated chair rise test was 22.2 (16.2-30.8) s at baseline and 13.0 (10.8-22.4) s at 12 months of treatment (FIG. 3D). Changes compared with baseline were significant at 3, 6 and 12 months of treatment (all p=0.008) and corresponded to a 41% improvement.”).
Regarding claim 5, Petryk teaches the method of claim 4, wherein if the subject uses the assistive device and does not use the assistance provided by the helper to perform the task, the subject is assigned a second ability score lower than the first ability score ([0085] “The SPPB may include tests, such as a repeated chair stand test. The methods may include tracking metrics such as decreased reliance on assistive devices (e.g., wheelchairs, wheeled walkers, and canes)”; [0101] “The walking speed and STS tests are scored firstly on the ability to complete the tasks and secondly time taken to complete each task. Each task is scored out of 4, with the scores from the 3 tests summed to give a total of a maximum of 12 and a minimum of 0. A higher score indicates a higher level of function, while lower scores indicate a lower level of function.”).
Regarding claim 6, Petryk teaches the method of claim 5, wherein if the assistance provided by the helper is for safety purposes and the subject independently performs about 100% of the task, the subject is assigned a third ability score lower than the second ability score ([0101] “The walking speed and STS tests are scored firstly on the ability to complete the tasks and secondly time taken to complete each task. Each task is scored out of 4, with the scores from the 3 tests summed to give a total of a maximum of 12 and a minimum of 0. A higher score indicates a higher level of function, while lower scores indicate a lower level of function.”).
Regarding claim 7, Petryk teaches the method of claim 6, wherein if the assistance provided by the helper is for light touching and the subject independently performs about 100% of the task, the subject is assigned a fourth ability score lower than the third ability score ([0101] “The walking speed and STS tests are scored firstly on the ability to complete the tasks and secondly time taken to complete each task. Each task is scored out of 4, with the scores from the 3 tests summed to give a total of a maximum of 12 and a minimum of 0. A higher score indicates a higher level of function, while lower scores indicate a lower level of function.”).
Regarding claim 8, Petryk teaches the method of claim 7, wherein if the subject independently performs more than a first threshold percentage of the task and less than about 100% of the task, the subject is assigned the fourth ability score lower than the third ability score ([0030]; [0060] “A predetermined threshold may also be a value of a metric that is, e.g., 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, or more below the value for a normal or treated subject.”; [0083]; [0101] “The walking speed and STS tests are scored firstly on the ability to complete the tasks and secondly time taken to complete each task. Each task is scored out of 4, with the scores from the 3 tests summed to give a total of a maximum of 12 and a minimum of 0. A higher score indicates a higher level of function, while lower scores indicate a lower level of function. Lower scores on the SPPB have been shown to be predictive of an increased risk of falling, loss of independence in ADLs, decreased mobility, disability, decline in health, rehospitalization; and increased hospital length of stay, nursing home admission, and death. A change of 0.5 points on the SPPB is considered to be a small meaningful change, while a change of 1 point on the SPPB is considered to be a substantial meaningful change.”; [0103-0105]; [0252]; [0351] “Each performance measure was assigned to a categorical score ranging from 0 (inability to complete the test) to 4 (optimal performing). A summary score ranging from 0 (worst performers) to 12 (best performers) was calculated by summing the 3 component scores.”; [0352] “The 4M-Gait Speed is part of the SPPB. The participant had also to be able to walk unassisted without the use of a cane or walker.”).
Regarding claim 9, Petryk teaches the method of claim 8, wherein if the subject independently performs more than a second threshold percentage of the task and less than the first threshold percentage of the task, the subject is assigned a fifth ability score lower than the fourth ability score ([0030]; [0060] “A predetermined threshold may also be a value of a metric that is, e.g., 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, or more below the value for a normal or treated subject.”; [0083]; [0101] “The walking speed and STS tests are scored firstly on the ability to complete the tasks and secondly time taken to complete each task. Each task is scored out of 4, with the scores from the 3 tests summed to give a total of a maximum of 12 and a minimum of 0. A higher score indicates a higher level of function, while lower scores indicate a lower level of function. Lower scores on the SPPB have been shown to be predictive of an increased risk of falling, loss of independence in ADLs, decreased mobility, disability, decline in health, rehospitalization; and increased hospital length of stay, nursing home admission, and death. A change of 0.5 points on the SPPB is considered to be a small meaningful change, while a change of 1 point on the SPPB is considered to be a substantial meaningful change.”; [0103-0105]; [0252]; [0351] “Each performance measure was assigned to a categorical score ranging from 0 (inability to complete the test) to 4 (optimal performing). A summary score ranging from 0 (worst performers) to 12 (best performers) was calculated by summing the 3 component scores.”; [0352] “The 4M-Gait Speed is part of the SPPB. The participant had also to be able to walk unassisted without the use of a cane or walker.”).
Regarding claim 10, Petryk teaches the method of claim 9, wherein if the subject independently performs more than a third threshold percentage of the task and less than the second threshold percentage of the task, the subject is assigned a sixth ability score lower than the fifth ability score ([0030]; [0060] “A predetermined threshold may also be a value of a metric that is, e.g., 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, or more below the value for a normal or treated subject.”; [0083]; [0101] “The walking speed and STS tests are scored firstly on the ability to complete the tasks and secondly time taken to complete each task. Each task is scored out of 4, with the scores from the 3 tests summed to give a total of a maximum of 12 and a minimum of 0. A higher score indicates a higher level of function, while lower scores indicate a lower level of function. Lower scores on the SPPB have been shown to be predictive of an increased risk of falling, loss of independence in ADLs, decreased mobility, disability, decline in health, rehospitalization; and increased hospital length of stay, nursing home admission, and death. A change of 0.5 points on the SPPB is considered to be a small meaningful change, while a change of 1 point on the SPPB is considered to be a substantial meaningful change.”; [0103-0105]; [0252]; [0351] “Each performance measure was assigned to a categorical score ranging from 0 (inability to complete the test) to 4 (optimal performing). A summary score ranging from 0 (worst performers) to 12 (best performers) was calculated by summing the 3 component scores.”; [0352] “The 4M-Gait Speed is part of the SPPB. The participant had also to be able to walk unassisted without the use of a cane or walker.”).
Regarding claim 11, Petryk teaches the method of claim 10, wherein if the subject independently performs less than the third threshold percentage of the task, the subject is assigned a seventh ability score lower than the sixth ability score ([0030]; [0060] “A predetermined threshold may also be a value of a metric that is, e.g., 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, or more below the value for a normal or treated subject.”; [0083]; [0101] “The walking speed and STS tests are scored firstly on the ability to complete the tasks and secondly time taken to complete each task. Each task is scored out of 4, with the scores from the 3 tests summed to give a total of a maximum of 12 and a minimum of 0. A higher score indicates a higher level of function, while lower scores indicate a lower level of function. Lower scores on the SPPB have been shown to be predictive of an increased risk of falling, loss of independence in ADLs, decreased mobility, disability, decline in health, rehospitalization; and increased hospital length of stay, nursing home admission, and death. A change of 0.5 points on the SPPB is considered to be a small meaningful change, while a change of 1 point on the SPPB is considered to be a substantial meaningful change.”; [0103-0105]; [0252]; [0351] “Each performance measure was assigned to a categorical score ranging from 0 (inability to complete the test) to 4 (optimal performing). A summary score ranging from 0 (worst performers) to 12 (best performers) was calculated by summing the 3 component scores.”; [0352] “The 4M-Gait Speed is part of the SPPB. The participant had also to be able to walk unassisted without the use of a cane or walker.”).
Regarding claim 12, Petryk teaches a system for monitoring subject ability comprising:
a transmitting device for transmitting a signal from a subject performing a task, the signal indicating subject ability to be independent ([0015] “The physical metric may be monitored using a wearable device, such a wearable device that includes an accelerometer. The wearable device may be configured to be worn on the arm (e.g., wrist), leg, or torso of the subject. The wearable device may track one or more biometric indicia of the subject.”; [0026-0027]; [0175] “As data is continuously monitored and measured by the wearable device, the data collected by the device may be transmitted to the peripheral device and stored on the peripheral device or on a cloud-based storage medium”),
a receiving device for acquiring data from the signal ([0026] “The peripheral device may be configured to run a software application (e.g., mobile application, e.g., smartphone application).”; [0175] “As data is continuously monitored and measured by the wearable device, the data collected by the device may be transmitted to the peripheral device and stored on the peripheral device or on a cloud-based storage medium. The peripheral device may be configured to run a software application (e.g., smartphone application) that provides navigable information to the subject in order to track changes in the subject's physiological indicia during the course of treatment (e.g., improvement over time)”),
calculate a subject ability score and to identify a treatment protocol based on the subject ability score ([0007] “a method of treating a bone mineralization disorder in a human subject (e.g., an adult human subject) that exhibits a level in at least one biochemical, physical, quality of life, or bone metric that identifies the subject as in need of treatment for the bone mineralization disorder”; [0082] “simple daily activities, such as sitting down, standing up, or walking, can be difficult for an adult patient. Featured herein are methods of treatment that include monitoring changes in biochemical, physical, and/or quality of life metrics in order to establish a treatment regimen for a patient with a bone mineralization disorder, such as HPP, and in particular, for an adult HPP patient.”; [0083]; [0101] “The walking speed and STS tests are scored firstly on the ability to complete the tasks and secondly time taken to complete each task. Each task is scored out of 4, with the scores from the 3 tests summed to give a total of a maximum of 12 and a minimum of 0. A higher score indicates a higher level of function, while lower scores indicate a lower level of function. Lower scores on the SPPB have been shown to be predictive of an increased risk of falling, loss of independence in ADLs, decreased mobility, disability, decline in health, rehospitalization; and increased hospital length of stay, nursing home admission, and death.”).
Petryk does not explicitly teach an ability analysis device for processing the data, the ability analysis device configured to calculate a subject ability score; and a user device for outputting the subject ability score and the treatment protocol to a user.
However,
Receveur teaches an ability analysis device for processing the data, the ability analysis device configured to calculate a subject ability score ([0021] “The patient assessment device 102 operates to receive, process, and send information related to determining a patient's level of mobility and risk of falling.”; [0034] “The patient movement analyzer 152 operates to receive and analyze video and load sensor data for a plurality of patients on a plurality of patient support systems. The video and load sensor data is correlated by time to match activity recorded on the load sensors with visually confirmed patient movements.”; [0057] “As load sensor data is received over time, it is analyzed using the mobility model to detect patterns in the fluctuations of load that are detected on a patient support system. Particular patterns indicate that a patient is lying in bed, having difficulty getting out of bed, easily getting out of bed, or is currently out of the bed.”); and
a user device for outputting the subject ability score and the treatment protocol to a user ([0058] “a mobility level or score is output for the patient”; [0031] “patient fall risk scores, when above a predetermined threshold, trigger an alert from caregiver call system 118 that is sent to a computing device associated with a caregiver so that the caregiver is notified of the need to perform critical tasks based on the patient's fall risk.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system taught by Petryk to include processing data with an ability analysis device to calculate a subject ability score and outputting the score and treatment protocol. One would have been motivated to make this modification because calculating and outputting mobility and fall risk scores of a patient allows caregivers to perform critical tasks and implement safety measures for the patient, as suggested by Receveur ([0031], [0060]).
Regarding claim 13, Petryk teaches the system of claim 12, further comprising an assistive device in a vicinity of the subject, the assistive device configured to transmit information to the ability analysis device ([0085] “The methods may include tracking metrics such as decreased reliance on assistive devices (e.g., wheelchairs, wheeled walkers, and canes).”; [0356] “it was documented whether the patient required an assistive device (e.g., crutches or a walker) to complete these assessments.”).
Regarding claim 14, Petryk teaches the system of claim 12.
Petryk does not explicitly teach wherein the ability analysis device is configured to identify a helper in a vicinity of the subject, and to detect assistance provided by the helper when the subject is performing the task.
However,
Receveur teaches wherein the ability analysis device is configured to identify a helper in a vicinity of the subject, and to detect assistance provided by the helper when the subject is performing the task ([0032] “The location monitoring devices can help to ascertain whether load detected on a patient support system 104 is caused by a patient or a caregiver as well as determine whether a caregiver is present to aid a patient when the patient is getting off a patient support system 104.”; [0057] “In some embodiments, data is received from location monitoring devices configured to track locations of caregivers in order to determine whether a caregiver is present at the patient support device 104 at any time.”; [0058] “If the patient is unable to rise without assistance, 4 risk points are output.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system taught by Petryk to include identifying a helper and detecting assistance provided by the helper. One would have been motivated to make this this modification because tracking caregivers can help ascertain whether signals are a result of the patient or a caregiver and patients that cannot perform a task without assistance are given lower mobility scores, as suggested by Receveur ([0032], [0058]).
Regarding claim 15, Petryk teaches the system of claim 14.
Petryk does not explicitly teach wherein the ability analysis device is configured to determine if the helper is a caregiver or a member of the subject family.
However,
Receveur teaches wherein the ability analysis device is configured to determine if the helper is a caregiver or a member of the subject family ([0032] “determine whether a caregiver is present to aid a patient when the patient is getting off a patient support system 104.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system taught by Petryk to include identifying the presence of a caretaker. One would have been motivated to make this this modification because a caregiver is able to aid a patient and review recordings to assess a patient’s mobility level, as suggested by Receveur ([0032-0034]).
Regarding claim 17, Petryk teaches the system of claim 14, wherein the ability analysis device is configured to assign an ability score to the subject based on the use of the assistive device and the helper by the subject ([0085] “The SPPB may include tests, such as a repeated chair stand test. The methods may include tracking metrics such as decreased reliance on assistive devices (e.g., wheelchairs, wheeled walkers, and canes).”).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over US 20230372456 A1 (Petryk et al.) in view of US 20210158965 A1 (Receveur et al.), further in view of US 20210161462 A1 (Lafleche et al.).
Regarding claim 16, Petryk in view of Receveur teaches the system of claim 14.
Petryk in view of Receveur does not explicitly teach wherein the assistive device is configured to track contact points to predict pressure ulcers on the subject.
However,
Lafleche teaches wherein the assistive device is configured to track contact points to predict pressure ulcers on the subject ([0004] “the present disclosure provides a patient support apparatus that is adapted to provide improved data for preventing the development of pressure ulcers in occupants of the patient support apparatus … The mobility score provides a useful tool for assessing the risk of pressure ulcers developing and therefore enables caregivers assigned to the occupant to take appropriate steps to reduce the likelihood of pressure ulcer development.”; [0038]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system taught by Petryk in view of Receveur to include the assistive device tracking contact to predict pressure ulcers. One would have been motivated to make this modification because mobility scores can assess the risk of pressure ulcers, which enables caregivers to reduce pressure ulcer development, as suggested by ([0004], [0038]).
Conclusion
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/EVELYN GRACE PARK/Examiner, Art Unit 3791
/TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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