3DETAILED 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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Element 80 in Fig. 8 is not referenced in the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 20 are objected to because of the following informalities: Claim 1 recites “NIRS,” but needs to be completely spelled out before abbreviation. Claim 20 recites “the injured limb,” but instead should recite --an injured limb--. Appropriate correction 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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 and 15 follows.
STEP 1
Regarding claim 1, the claim recites a series of steps or acts, including diagnosing one of DVT or absence thereof. Regarding claim 15, the claim recites a series of steps or acts, including comparing weight data. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of diagnosing one of DVT or absence thereof, and comparing weight data set forth judicial exceptions. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. The diagnosis or comparison does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the diagnosis or comparison, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of acquiring oxygen saturation and pressure data, using a shoe with a sole comprising NIRS and pressure sensors, and comparing the sets of data with predetermined data following a time period. Obtaining oxygen saturation data using generic NIRS sensors on standard items (shoes), obtaining pressure data, and comparing the obtained data to an existing dataset is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the acquiring, retrieving, and comparison steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 1, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited NIRS sensor is a generic sensor configured to perform pre-solutional data gathering activity, the postop show having a sole are standard items, and the computer system is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering, processing, and alarm transmission. The comparing and calculating steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-7 and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (Non-invasive diagnosis and continuous monitoring of thrombosis in clinics by near-infrared spectroscopy-2015), hereinafter Li, in view of Bechtel (US 20140200486), hereinafter Bechtel.
Regarding claim 1, Li teaches A system for detecting deep vein thrombosis (“DVT”) of a patient having an injured limb and a healthy limb (abstract), the system comprising: the system configured for the patient to wear on a part of the injured limb (see fig. 1 and 3.2 Diagnosis, “What’s more, no matter which measured site it is, the measurements of ▵[Hb] in DVT patients are distinctly higher than those healthy volunteers” (emphasis added) when referring to the legs of a subject); a NIRS sensor mounted to the device such that the NIRS sensor faces skin of the patient in a working configuration (fig. 1); a central processor in communication with the NIRS sensor (fig. 1, control module), the central processor including a dataset module storing a clinical dataset of oxygen saturation the central processor configured to receive oxygen concentration data from the NIRS sensor and compare the received oxygen concentration data to the clinical dataset of oxygen saturation and diagnose one of an indication of DVT and an absence of DVT (see 2.2 NIRS instrumentation, “NIRS is now a well-established modality to measure oxy- and deoxy- hemoglobin concentration variations in deep tissue (e.g., muscle) in situation.” see 2.3 Device Performance Test and data collection, “ NIRS, ▵[Hb] and ▵[HbO2] data were simultaneously acquired.” see Statistical Analysis, “To identify the potential of NIRS-measured ▵[Hb] and ▵[HbO2] in diagnosis/monitoring thrombosis in clinics, we performed comparisons between both-legs-DVT patients from healthy volunteers.” see 3.2 Diagnosis, “succeed in tracking and detecting one single leg DVT patient data. We all marveled at the different change of ▵[HbO2] value from his health leg and sick leg. The value of ▵[HbO2] in sick leg falling down fast when the patients got thrombolysis treatment in second day. But in the following days, it increased quickly, and moved closer to normal leg with the continuous treatment.” See conclusion “Our finding give a definitive information that we can use ▵[Hb] and ▵[HbO2] or their combined variable to diagnose DVT. Furthermore, we can use the change curve of ▵[HbO2] to observe embolization treatment process.”).
Li fails to teach that the system includes a post op shoe having a sole and configured to be worn on a foot of the subject, comprising NIRS sensor that measure oxygen concentration.
Bechtel teaches a system and method for monitoring the health of a human foot by measuring pressure and tissue oxygen concentration (abstract and ¶[0006,0017], “pertains to a method for determining a relationship between an amount of pressure experienced by a region of tissue and the risk of ulcer development in that region by measuring both the pressure experienced by that region and a tissue hemoglobin condition, such as total hemoglobin or the ratio of oxyhemoglobin to deoxyhemoglobin, in the region over a predetermined period”). The system uses a device that is configured as a shoe insole in a shoe, with a plurality of oxygen sensors (figs. 1-4 and ¶[0017,022,0049,0063], “Insole 100 may comprise an array of sensors . . . . An array may comprise between 5 and 50 sensors, 50 and 100 sensors, 100 and 150 sensors, or more” and “One or more perfusion sensors, oxygenation sensors, e.g. total hemoglobin sensors, temperature sensors, or other sensors can also be included in the sole”).
That is, Li teaches NIRS-based detection and monitoring of DVT by comparing oxygenation information between diseased and healthy limbs (see abstract and conclusion). Bechtel teaches embedding oxygenation sensors in a shoe insole for continuous monitoring (abstract and figs. 1-4).
Therefore, it would have been obvious to one ordinary skill in the art at the time the invention was effectively filed to have modified the system of Li, to incorporate the NIRS sensor system into the shoe of Bechtel, because both references require measuring oxygenation of tissue to determine tissue health, and Bechtel expressly discloses footwear-based implementations suitable for continuous monitoring of tissue health (¶[0006,0017,022,0049,0063]).
Regarding claim 2, Li-Bechtel teach that the NIRS sensor is mounted to the sole (fig. 1 of Bechtel).
Regarding claim 3, Li teaches wherein the NIRS sensor includes a NIRS transmitter and a NIRS receiver (fig. 1, detector and light source).
Regarding claim 4, Li fails to teach transmitting an alarm to the patient when the indication of DVT is diagnosed based on the comparison of the received oxygen concentration data to the clinical dataset of oxygen saturation.
Bechtel teaches that an alert can be generated when the measured physiological measurement exceeds a predetermined threshold (¶[0005]).
Therefore, it would have been obvious to on ordinary skill in the art at the time the invention was effectively filed to have modified the system of Li, such that an alarm is transmitted to the patient when the indication of DVT, as taught by Bechtel, to aid in providing a device tailored to in-home use for examining tissue health (¶[0017]).
Regarding claim 5, Li-Bechtel teach further comprising: a forefoot sensor mounted to a forefoot portion of the sole; a midfoot sensor mounted to a midfoot portion of the sole; and a hindfoot sensor mounted to a hindfoot portion of the sole, the forefoot, midfoot and hindfoot sensors comprised of pressure sensors (fig. 1 and ¶[0022] of Bechtel, over 100 pressure sensors can be arranged throughout the surface of the sole).
Regarding claim 6, Li-Bechtel teach wherein the forefoot sensor comprises first, second and third sensors, the midfoot sensor comprises fourth and sixth sensors and the hindfoot sensor comprises a fifth sensor (fig. 1 and ¶[0022] of Bechtel, over 100 pressure sensors can be arranged throughout the surface of the sole).
Regarding claims 7 and 9, Li fails to teach further comprising: a pressure sensor mounted to the sole, the pressure sensor in communication with the central processor, the central processor configured to receive weight data from the pressure sensor in the working configuration, the dataset module storing a predetermined weight, the central processor configured to compare the predetermined weight to the weight data and determine if a first weight of the weight data exceeds the predetermined weight.
Bechtel teaches a plurality of pressure sensors on the sole and configured to obtain weight/pressure measurements (¶[0022]). The system is configured to determine when the pressure exceeds a particular threshold indicating that the region is at-risk for a health event or when the weight data, corresponding to pressure, exceeds a threshold indicates that the rate of communication must be increased to improve device sensitivity (¶[0039,0072]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Li-Bechtel, such a pressure sensor mounted to the sole is configured to receive weight data that is used to analyze when the measurements exceed a threshold, as taught by Bechtel, to aid in providing a device tailored to in-home use for examining tissue health (¶[0017]).
Regarding claim 10, Li-Bechtel teach wherein the pressure sensor includes first, second, third, fourth, fifth, and sixth sensors (fig. 1 and ¶[0022] of Bechtel, over 100 pressure sensors can be arranged throughout the surface of the sole).
Regarding claim 11, Li teaches a healthy limb NIRS sensor, the central processor configured to receive healthy limb oxygen concentration data, the clinical dataset of oxygen saturation including the received healthy limb oxygen concentration data (see 2.3 Device Performance Test and data collection, and 2.4 Statistical Analysis, “All patients and healthy volunteers were measured” and “To identify the potential of NIRS-measured ▵[Hb] and ▵[HbO2] in diagnosis/monitoring thrombosis in clinics, we performed comparisons between both-legs-DVT patients from healthy volunteers”).
Regarding claim 12, Li teaches wherein the NIRS sensor includes a NIRS transmitter and a NIRS receiver (fig. 1, detector and light source).
Claims 8 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Bechtel, as applied to claim 7 and newly applied to claim 15, further in view of Avni et al. (US 6723863).
Regarding claim 8, Li-Bechtel fail to teach wherein the central processor is configured to transmit a weight alarm to the patient when the first weight exceeds the predetermined weight.
Avni teaches an adaptive wight bearing monitoring system for rehabilitation injuries to the lower extremities of patients (abstract and col. 1, lines [15-25]). The system is configured to analyze weight placement of the user and when it exceeds a threshold, an alarm is provided for the user to correct the weight distribution (col. 3, lines [34-50]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Li-Bechtel, such that the central processor is configured to transmit a weight alarm to the patient when the first weight exceeds the predetermined weight, as taught by Avni, to aid in real-time monitoring of weight bearing during rehabilitation and for improving rehabilitation without the requirement of continuous professional supervision (col. 3, lines [8-35]).
Regarding claim 15, Li teaches a method for monitoring a patient’s injured limb following surgery or other injury with a system having a central processor with a dataset module storing a clinical dataset of oxygen saturation including a predetermined normal oxygen saturation, a NIRS sensor, the method comprising: receiving initial oxygen concentration data from the NIRS sensor at the central processor (see fig. 1, 2.2 NIRS instrumentation and 3.2 Diagnosis).
Li fails to teach a first predetermined weight and a second predetermined weight and a postop shoe with a sole, a pressure sensor and comparing the weight data to a predetermined weight with the central processor; receiving second weight data from the pressure sensor following a predetermined period; comparing the second weight data to the second predetermined weight, the second predetermined weight being greater than the first predetermined weight.
Bechtel teaches a system and method for monitoring the health of a human foot by measuring pressure and tissue oxygen concentration (abstract and ¶[0006,0017], “pertains to a method for determining a relationship between an amount of pressure experienced by a region of tissue and the risk of ulcer development in that region by measuring both the pressure experienced by that region and a tissue hemoglobin condition, such as total hemoglobin or the ratio of oxyhemoglobin to deoxyhemoglobin, in the region over a predetermined period”). The system uses a device that is configured as a shoe insole in a shoe, with a plurality of oxygen sensors (fig. and ¶[0017,022,0049,0063], “Insole 100 may comprise an array of sensors . . . . An array may comprise between 5 and 50 sensors, 50 and 100 sensors, 100 and 150 sensors, or more” and “One or more perfusion sensors, oxygenation sensors, e.g. total hemoglobin sensors, temperature sensors, or other sensors can also be included in the sole”).
Therefore, it would have been obvious to one ordinary skill in the art at the time the invention was effectively filed to have modified the system of Li, such that the measuring device is placed in a post op shoe to measure oxygen concentration and pressure, as taught by Bechtel, to aid in providing a device tailored to in-home use for examining tissue health (¶[0017]). Moreover, Li explicitly teaches that the measurements at any measurement site on the legs measured are distinct between healthy and diseased limbs. Thus, the difference in this case is that the present invention obtains the measurement at lowest part of the leg (foot), but this would be “obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.
Avni teaches an adaptive wight bearing monitoring system for rehabilitation injuries to the lower extremities of patients (abstract and col. 1, lines [15-25]). The system is configured to analyze weight placement of the user and when it exceeds a threshold, an alarm is provided for the user to correct the weight distribution (col. 3, lines [34-50]). Additionally, the device is directed to improvement in rehabilitation, therefore, the steps continue to repeat themselves and the thresholds are updated accordingly to provide the user with more or less weight bearing restrictions (col. 7, lines [5-35], “the entire loop is repeated again, starting with reading the input sensor signals at step 404.”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Li-Bechtel, such that first and second weights are obtained and compared to thresholds, as taught by Avni, to aid in real-time monitoring of weight bearing during rehabilitation and for improving rehabilitation without the requirement of continuous professional supervision (col. 3, lines [8-35]).
Regarding claim 16, Avni teaches that the predetermined period is ten days to three weeks (col. 1, 7, 8, 9 lines [41-53,5-35,51-67, 1-6], “the entire loop is repeated again, starting with reading the input sensor signals at step 404” and “The system of the invention then measures the pressure applied on the limb, collects data over time, and decides how the patient should pace” indicating that the predetermined time period between the first threshold and the last threshold, can be days, weeks, months, depending on the injury type, severity, and physician’s order).
Regarding claim 17, Avni teaches wherein the first predetermined weight is twenty to thirty percent of a body weight of the patient and the second predetermined weight is forty-five to fifty-five percent of the body weight (col. 2, lines [41-62], “the physician's orders may be pound limits, percentages of body weight, or other phrases. Typically, the pound limits are rounded to the next lower setting on the ForceGuard weight-bearing monitor, where a typical setting is 20, 30, 50, 70, or 90 pounds. When the percentage of body weight limit is set, the setting is calculated by multiplying the total body weight by the percent ordered” and “partial weight bearing is interpreted as 30 percent of patient body weight.” As such, the percentage can be set by the physician and as the user progresses through rehab, the percentage will go up or down).
Regarding claim 18, Li fails to teach transmitting an alert when a first weight of the weight data exceeds the first predetermined weight during the predetermined period.
Avni teaches generating an alert when the weight data exceeds a threshold during the predetermined time period (col. 8, lines [46-49]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Li-Bechtel, such that an alert is transmitted when a weight bearing threshold has been exceeded, as taught by Avni, to aid in real-time monitoring of weight bearing during rehabilitation and for improving rehabilitation without the requirement of continuous professional supervision (col. 3, lines [8-35]). Moreover, when the weight is exceeded, the healing process is negatively impacted (col. 1, lines [49-51]).
Regarding claim 19, Li teaches comparing the initial oxygen concentration data to the clinical dataset of oxygen concentration (see 2.2 NIRS instrumentation, “NIRS is now a well-established modality to measure oxy- and deoxy- hemoglobin concentration variations in deep tissue (e.g., muscle) in situation.” see 2.3 Device Performance Test and data collection, “ NIRS, ▵[Hb] and ▵[HbO2] data were simultaneously acquired.” see Statistical Analysis, “To identify the potential of NIRS-measured ▵[Hb] and ▵[HbO2] in diagnosis/monitoring thrombosis in clinics, we performed comparisons between both-legs-DVT patients from healthy volunteers.” see 3.2 Diagnosis, “succeed in tracking and detecting one single leg DVT patient data. We all marveled at the different change of ▵[HbO2] value from his health leg and sick leg. The value of ▵[HbO2] in sick leg falling down fast when the patients got thrombolysis treatment in second day. But in the following days, it increased quickly, and moved closer to normal leg with the continuous treatment.” See conclusion “Our finding give a definitive information that we can use ▵[Hb] and ▵[HbO2] or their combined variable to diagnose DVT. Furthermore, we can use the change curve of ▵[HbO2] to observe embolization treatment process.”), but fails to teach transmitting an alert when a first oxygen concentration of the initial oxygen concentration data is less than the predetermined normal oxygen saturation.
Avni teaches generating an alert when physiological data exceeds a predetermined threshold (col. 8, lines [46-49]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Li-Bechtel, such that an alert is transmitted when physiological data exceeds a predetermined threshold, as taught by Avni, to aid in real-time monitoring of a physiological parameter without the requirement of continuous professional supervision (col. 3, lines [8-35]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Bechtel, as applied to claim 9, further in view of Abreu (US 20090105605) and Horst et al. (US 20130165817), hereinafter Horst.
Regarding claim 13, Li-Bechtel fail to teach a smart screen mounted to an upper side of the postop shoe, the smart screen configured to display a battery charge status and alerts from the central processor.
Abreu teaches a physiological monitoring device positioned on a shoe (abstract and fig. 95A). The shoe comprises a display to output biological information (¶[0730,0758,0831,0869,0874], module 2610, shoe is capable of obtaining tissue oxygen and pressure). The shoe is also capable of alerting the user through the screen (¶[0871], “It is understood that any sound can be produced or any visual indicia can be used to effortlessly and naturally inform the user about the biological parameter level”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Li-Bechtel, such that a smart screen mounted to an upper side of the postop shoe and configured to provide an alert, as taught by Abreu, to aid in providing a continuous and non-invasive device for monitoring physical parameters of a user. Moreover, the combination is merely combining prior art elements (shoes) according to known methods (with display and alerting means) to yield predictable results.
Horst teaches a foot sensor capable of measuring force (abstract). The system is configured to display a battery charge status (¶[0070]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Li-Bechtel, such that the smart screen configured to display a battery charge status, as taught by Horst, to aid in informing the user that charging is necessary. This feature is widely implemented in the field of electronic devices.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Bechtel, as applied to claim 9, further in view of Abreu.
Regarding claim 14, Li-Bechtel teach a battery mounted to the shoe the battery in communication with the central processor (fig. 1 of Li. ¶[0043] of Bechtel), but fail to teach a solar panel mounted to an upper side of the postop shoe; the battery connected to the solar panel and configured to receive electrical charge from the solar panel.
Abreu teaches a physiological monitoring device positioned on a shoe (abstract and fig. 95A). The shoe comprises a display to output biological information (¶[0730,0758,0831,0869,0874], module 2610, shoe is capable of obtaining tissue oxygen and pressure). The shoe is also capable of alerting the user through the screen (¶[0871], “It is understood that any sound can be produced or any visual indicia can be used to effortlessly and naturally inform the user about the biological parameter level”). Moreover, “It is also understood that any of the sensing devices and sensors of this invention can be powered by solar power or other renewable energy source” (¶[1027]). That is, the sensing device of the shoe 2600 comprises a solar panel and located to an upper side of the shoe (fig. 95A of Abreu).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Li-Bechtel, such that a solar panel mounted to an upper side of the postop shoe and configured to power the device, as taught by Abreu, to aid in providing a rechargeable device. This feature is widely implemented in the field of electronic devices.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Bechtel and Anvi, as applied to claim 19, further in view of Sundram et al. (US 20170213437), hereinafter Sundram.
Regarding claim 20, Li-Bechtel-Anvi fail to teach wherein the alert urges the patient to elevate the injured limb.
Sundram teaches elevating legs may lower the likelihood of developing DVT (¶[0005]). Sundram’s monitoring device (abstract) is configured to instruct the user to elevate their legs to reduce the risk (¶[0084]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Li-Bechtel-Anvi, such that the alert urges the patient to elevate the injured limb, as taught by Sundram, to aid in lowering the likelihood of developing DVT.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fenkell teaches diagnosing one of DVT or absence thereof. Regarding claim 15, the claim recites a series of steps or acts, including comparing weight data. US 20110130686
Freeman teaches methods and systems of hyperspectral and multispectral imaging of medical tissues. US 20070016079
Otsuki teaches a sensor is provided to detect a plurality of motion amounts in a walking motion of a trainee, and it is evaluated that, when one of the motion amounts matches one of abnormal walking criteria, that the walking motion is an abnormal walking pattern that meets the matched abnormal walking criterion. The data generation unit generates each of the pieces of rehabilitation data before and after a change in the results of evaluation of the abnormal walking pattern as learning data. The learning unit sequentially inputs each of the pieces of rehabilitation data as one data set, thereby performing machine learning.
Servati teaches a smart textile wearable devices according to other embodiments, including smart textile knee sleeves, smart textile shoe insoles and smart textile torso bands. US 20260041354
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