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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/22/2026 has been entered.
Response to Arguments
Applicant’s arguments, see pages 8-9, filed 05/22/2026, with respect to 35 U.S.C. 101 rejections have been fully considered but they are not persuasive. The Applicant argues that independent claim 1, as amended, recites a sensor-driven, image-processing-driven, threshold-triggered monitoring workflow that no clinician can perform in the human mind or with pen and paper. The Applicant argues that a clinician cannot, in the human mind, convert sensor output from a sensor matrix into a pressure distribution image, perform key-point detection on that image, track key-point movement to derive body posture data, compute time-indexed average pressure data over a region around the key point, produce three modality-specific AI predictions, and generate a threshold-triggered alarm signal. The Applicant argues that the claim recites computational and signal-processing operations that are tied to specific hardware components, namely the plurality of pressure sensors and the alarm output, and that produce a defined output action rather than a number reported by a generic computer. The Applicant argues that amended claim 1 now recites a plurality of pressure sensors arranged in a matrix and configured to output respective pressure values to the processor, real-time data collection, average pressure data at predetermined time intervals, and a real time change-rate computation feeding the alarm trigger, with the alarm signal causing an alerting device coupled to the processor to output an alarm. The Applicant argues that these features place the claim outside the scope of operations that can be practically be performed in the human mind or with pen and paper. The Applicant argues that the amended claim integrates any judicial exception into a practical application under MPEP 2106.04(d) and 2106.05(a). The Applicant argues that the claim provides a technological solution to a technological problem, namely the limitation of single-modality, subjective pressure-ulcer assessment described in the background of the specification. The Applicant argues that the solution is a multi-modal prediction architecture coupled to a real-time threshold-triggered alarm. The Applicant argues that under MPEP 2106.04(d)(1), the improvement need not be explicitly recited; it need only be apparent to a person of ordinary skill in the art reading the claim in light of the specification. The Applicant argues the improvement is apparent here. The Applicant argues that the same eligibility analysis applies to claim 10.
This is not found persuasive. The Examiner maintains the 35 U.S.C. 101 rejection to the claims, as amended. The Examiner notes that the 35 U.S.C. 101 rejections have been updated hereinbelow to reflect the Applicant’s claim amendments and to further clarify the 35 U.S.C. 101 rejections. The Examiner maintains that the claims recite abstract ideas (i.e., mental processes and mathematical concepts) that can be performed mentally or with pen and paper when given their broadest reasonable interpretation. The specific limitations that recite abstract ideas are indicated hereinbelow in the 35 U.S.C. 101 section. The hardware components recited in the claims (i.e., computing device, alerting device, processor) are recited with a high level of generality in the Applicant’s specification and their involvement is insignificant extra-solution activity in that they amount to generic computer implementation of the abstract idea [MPEP 2106.04(a)(2)(III)(C)]. The pressure sensors recited in the claim and their functionality is found to be an example of insignificant pre-solution activity (i.e., mere data gathering) [MPEP 2106.05(g)]. It is also noted that the limitation involving the pressure sensors is not found to amount to anything more than what is well-understood, routine, and conventional. Please see 35 U.S.C. 101 rejections below. The limitation involving an alarm is found to amount to merely outputting data, which is insignificant extra-solution activity [MPEP 2106.05(g)]. The limitation involving the alarm is also not found to amount to anything more than what is well-understood, routine, and conventional. Please see 35 U.S.C. 101 rejections below. The Examiner maintains that the claims are directed to an abstract idea without a practical application and without significantly more. With regards to Applicant’s recitation of “real-time” and other limitations involving time, the Examiner maintains that the claims are not limited in quantity or time to preclude the claim from being directed to an abstract idea that cannot be performed in the human mind or with pen and paper. The Examiner maintains the 35 U.S.C. 101 rejection over claim 10 for similar reasons. Pending claims 1-3, 7, 9-13, and 16-20 are all rejected under 35 U.S.C. 101. Please see 35 U.S.C. 101 rejections hereinbelow.
Claim Interpretation
It is noted that the 35 U.S.C. 112(f) claim interpretation has been removed and obviated due to Applicant’s amendments to the claims.
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 1-3, 7, 9-13, and 16-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental processes and mathematical concepts of analyzing information (e.g., making calculations) and making a prediction based on the analysis of collected information) without significantly more.
Step 1
Independent claim 1 is directed to a method of predicting pressure ulcers (i.e., method/process) and thus meets the requirements for step 1. Independent claim 10 is directed to a computing device for predicting pressure ulcers (i.e., system/apparatus) and thus meets the requirements for step 1.
Step 2A, Prong 1
Regarding claims 1 and 10, the following steps recite an abstract idea:
“predicting, using a first artificial intelligence model including at least one of a support vector machine and a k-nearest neighbor model, occurrence of pressure ulcers of the patient …, based on body data of the patient” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could make a prediction (i.e., judgement) on the occurrence of pressure ulcers of a patient. Additionally, this limitation is a mathematical concept when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(I), the mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. In the instant case, predicting occurrence of pressure ulcers using a first artificial intelligence model is considered mathematical calculations/algorithms because the limitation involves mathematical operations or an act of calculating using mathematical methods (i.e., artificial intelligence models SVM and k-nearest neighbor) to determine a variable or number [MPEP 2106.04(a)(2)(I)(C)].
“converting the whole-body pressure data into a pressure distribution image” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could make a mental judgement (or with pen and paper) of a pressure distribution image from whole-body pressure data. For instance, a human could be given a body pressure value for the patient’s leg, back, neck, etc., and create a mental (or with pen and paper) pressure distribution image of these pressure values.
“detecting, from the pressure distribution image, a key point corresponding to a pressure-ulcer region of the patient” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could mentally determine a key point corresponding to a pressure-ulcer region of the patient from the pressure distribution image. For instance, a human could detect a key point/pressure-ulcer region if the pressure distribution image indicates a location on the body (e.g., leg, back, neck, etc.) with a pressure value above a certain threshold indicating a pressure ulcer.
“tracking the detected key point and position movement of the detected key point to detect body posture data of the patient” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could mentally track the detected key point and position movement of the detected key point to detect body posture data. In other words, a human could observe the detected key point and position movement of the detected key point and make a judgement on body posture data of the patient.
“calculating average pressure data, representing an average value of pressure values distributed in a region including the detected key point, at predetermined time intervals” is a mathematical concept when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(I), the mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. In the instant case, calculating average pressure data is considered a mathematical calculation because this limitation involves a mathematical operation (i.e., averaging) or an act of calculating using mathematical methods to determine a variable or number (i.e., average pressure data) [MPEP 2106.04(a)(2)(I)(C)].
“predicting, using a second artificial intelligence model including a recurrent neural network and a long short-term memory model, occurrence of pressure ulcers of the patient …, based on the body posture data and the average pressure data changed over the predetermined time intervals” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could predict (i.e., evaluate) occurrence of pressure ulcers of a patient. Additionally, this limitation is a mathematical concept when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(I), the mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. In the instant case, predicting occurrence of pressure ulcers using a second artificial intelligence model is considered mathematical calculations/algorithms because the limitation involves mathematical operations or an act of calculating using mathematical methods (i.e., artificial intelligence models recurrent neural network and a long short-term memory model) to determine a variable or number [MPEP 2106.04(a)(2)(I)(C)].
“predicting, using a third artificial intelligence model including at least one of a convolutional neural network, a support vector machine, and a k-nearest neighbor, occurrence of pressure ulcers of the patient …, based on skin image data of the patient” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could predict (i.e., evaluate) occurrence of pressure ulcers of a patient. Additionally, this limitation is a mathematical concept when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(I), the mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. In the instant case, predicting occurrence of pressure ulcers using a third artificial intelligence model is considered mathematical calculations/algorithms because the limitation involves mathematical operations or an act of calculating using mathematical methods (i.e., artificial intelligence models convolutional neural network, a support vector machine, and a k-nearest neighbor) to determine a variable or number [MPEP 2106.04(a)(2)(I)(C)].
Step 2A – Prong 2
Regarding claims 1 and 10, the claims do not include any additional elements that integrate the abstract idea into a practical application. The following elements do not add any meaningful limitation to the abstract idea:
processor – The processor is recited with a high level of generality. The Applicant’s specification explains that the processor may be implemented as, for example, at least one central processing unit (CPU), at least one GPU, at least one application processor, at least one system on chip (SoC), or at least one micro controller unit (MCU) (Par. [0084]). The involvement of the processor is insignificant extra-solution activity in that they amount to generic computer implementation of the abstract idea [MPEP 2106.04(a)(2)(III)(C)].
a computing device - The computing device is recited with a high level of generality. The Applicant’s specification explains that the computing device may include, for example, at least one of a smartphone, a tablet personal computer (PC), a desktop PC, a laptop PC, a netbook PC, a workstation, a server, a personal digital assistant (PDA), a portable multimedia player (PMP), an MP3 player, a camera, and a wearable device (Par. [0038]). The involvement of the computing device is insignificant extra-solution activity in that they amount to generic computer implementation of the abstract idea [MPEP 2106.04(a)(2)(III)(C)].
collecting, in real time, whole-body pressure data of a patient from a plurality of pressure sensors arranged in a matrix and configured to output respective pressure values to the processor – insignificant pre-solution activity, i.e. mere data gathering [MPEP 2106.05(g)]
output first prediction result data – amounts to merely outputting data, which is insignificant extra-solution activity [MPEP 2106.05(g)]
output second prediction result data – amounts to merely outputting data, which is insignificant extra-solution activity [MPEP 2106.05(g)]
output third prediction result data – amounts to merely outputting data, which is insignificant extra-solution activity [MPEP 2106.05(g)]
concatenating the first to third prediction result data to output final prediction result data – amounts to merely outputting data, which is insignificant extra-solution activity [MPEP 2106.05(g)]
alerting device – The Applicant’s specification explains that a GUI screen on the computing device may be configured to provide an alarm function (Par. [0066]). Therefore, the “alerting device” is presumed to be the same as the alerting device, which is recited with a high level of generality. The involvement of the computing device is insignificant extra-solution activity in that they amount to generic computer implementation of the abstract idea [MPEP 2106.04(a)(2)(III)(C)].
generating an alarm signal, and causing an alerting device coupled to the processor to output an alarm based on the alarm signal, when a change rate of the average pressure data exceeds a threshold value during a specific time interval – amounts to merely outputting data, which is insignificant extra-solution activity [MPEP 2106.05(g)]
Therefore, the claims are directed to an abstract idea without a practical application.
Step 2B
The additional elements of claims 1 and 10, when considered either individually or in an ordered combination, are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the “processor”, “computing device”, and “alerting device”, along with their associated functions and components, are recited with a high level of generality and simply amount to implementing the abstract idea on a computer. The additional elements that were considered insignificant extra-solution activity have been re-analyzed and do not amount to anything more than what is well-understood, routine, and conventional. Also, simply appending well-understood, routine, and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not indicative of an inventive concept [MPEP 2106.05(d)].
collecting, in real time, whole-body pressure data of a patient from a plurality of pressure sensors arranged in a matrix and configured to output respective pressure values to the processor – Nourani, et al. (US 2013/0090571): In an embodiment of the invention, in order to measure pressure over the entire body, pressure sensors are distributed over the bed's surface in an array format. Resistive and capacitive sensors are the two main types of commercially available surface pressure sensors (Par. [0032]). Also, MPEP 2106.05(d)(II)(“i. Receiving or transmitting data over a network)
output first/second/third prediction result data – Faustino, et al. (US 2004/0225620): output device 104 is a conventional rendering means for either printing, transmitting (e.g., email) or displaying results based on results generated by the PSVE software which may be enhanced by input generated and provided by neural network 108 (Par. [0022])
concatenating the first to third prediction result data to output final prediction result data – Kristal, et al. (US 2022/0344060): Data/feature level fusion (e.g., merging datasets) is the simplest in execution (e.g., concatenating two or more sets of data, such as measurements including genes and clinical parameters), is well-understood, and such approaches lend themselves to the subsequent use of well-defined and powerful mathematical techniques (e.g., ensemble classifiers, penalized regression, classification trees, or other familiar statistical/informatics analyses and approaches)—a combination that generally makes them the approach of choice for IF (Par. [0050])
generating an alarm signal, and causing an alerting device coupled to the processor to output an alarm based on the alarm signal, when a change rate of the average pressure data exceeds a threshold value during a specific time interval – Roff, et al. (US 2005/0204476): The sensor 8 and control means can be used to display the number of times the patient has moved on the support and sound an alarm if the patient has not moved or initiate contact with a third party by means of conventional communications devices (Par. [0025]).
Therefore, the claims are directed to an abstract idea without a practical application and without significantly more.
Dependent claims
Regarding dependent claims 2-3, the limitations only further define insignificant extra-solution activity of gathering data.
Regarding dependent claims 9, 12-13, the limitations only further define the abstract idea.
Regarding dependent claims 7, 11, and 16-20, the limitations only further define insignificant extra-solution activity of outputting data.
Therefore claims 1-3, 7, 9-13, and 16-20 are unpatentable under 35 U.S.C. 101.
Prior Art
Claims 1-3, 7, 9-13, and 16-20 are currently free of the prior art.
The following is a statement of reasons for the indication of the claims being free of the prior art:
The prior art of record (namely Dunn, et al.) does not disclose or fairly suggest either singly or in combination the claimed invention of independent claims 1 and 10 when taken as a whole, comprising, in addition to the other recited claim elements, predicting, using a first artificial intelligence model including at least one of a support vector machine and a k-nearest neighbor model, occurrence of pressure ulcers of the patient to output first prediction result data, based on body data of the patient;
converting the whole-body pressure data into a pressure distribution image;
detecting, from the pressure distribution image, a key point corresponding to a pressure- ulcer region of the patient;
tracking the detected key point and position movement of the detected key point to detect body posture data of the patient;
calculating average pressure data, representing an average value of pressure values distributed in a region including the detected key point, at predetermined time intervals;
predicting, using a second artificial intelligence model including a recurrent neural network and a long short-term memory model, occurrence of pressure ulcers of the patient to output second prediction result data, based on the body posture data and the average pressure data changed over the predetermined time intervals;
predicting, using a third artificial intelligence model including at least one of a convolutional neural network, a support vector machine, and a k- nearest neighbor model, occurrence of pressure ulcers of the patient to output third prediction result data, based on skin image data of the patient; and
concatenating the first to third prediction result data to output final prediction result data. No other prior art reference could be found that teaches or renders obvious the limitations of instant claims 1 and 10. Due to their dependency on independent claims 1 and 10, instant claims 2-3, 7, 9, 11-13, and 16-20 are also considered to be free of the prior art.
Therefore, in view of the prior art and its deficiencies, the claimed invention as a whole is rendered novel and non-obvious, and thus, is free of the prior art as claimed.
As claims have been indicated as being free of the prior art, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a). In particular, the 35 U.S.C. 101 rejections hereinabove must be overcome.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Linders, et al. (US 2021/0386297)
Shr, et al. (US 2023/0381040)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
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/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796
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