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 .
Election/Restrictions
Claims 1-34 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/13/2026.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 35-38, 41-45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers (WO 2019191703 A1) in view of Rogers (2) (US 20210386300 A1).
Regarding claim 35, Rogers teaches a method for continuously monitoring a target region of a subject wherein the device comprises a probe ([00043] The wireless device of any of the above embodiments, selected to measure a thermal property from one or more of: a low penetration depth for a superficial skin layer hydration parameter; an intermediate penetration depth for a blood flow parameter; a high penetration depth for deep dermis and subcutaneous fat tissue for an infection parameter), measuring temperature and perfusion of the target region ([[00275] In vivo measurements of skin thermal transport changes due to trauma: Skin trauma is associated with changes in perfusion through near-surface microvessels such as capillaries and arterioles); and perfusion by the electronic module ([00294] Direct measurement of the body surface temperature and quantification of the thermal transport properties (i.e. thermal conductivity) associated with physiological conditions such as perfusion and hydration level are both possible, with clinical-grade accuracy) to identifying a surrogate marker for detecting graft-rejection associated inflammatory processes ([00171] thermal conductivity can also be used as a surrogate marker for skin inflammation and edema— thus, this technology can be utilized to assess skin injuries (e.g. extent of a sunburn) or to diagnose skin or deeper tissue infections (e.g. cellulitis). Finally, implantable (e.g. sub-dermal) version of this technology have the opportunity to service as a sentinel system of inflammation in deeper organs and tissues) in organ transplant ([00183] Any of the devices and methods provided herein may be used as an implantable device. Implantable versions of this technology may serve as early warning indicators of inflammation in a localized area of the body (e.g. transplanted organ). This information may then enable future prediction of organ transplant rejection prior to laboratory or imaging evidence— this would then trigger changes to immunosuppressant drug dosing) intra-operatively and/or post-operatively ([0006] Those parameters may be communicated at a distance for evaluation in real-time, or at a later time, such as by the user or a third party, such as a medical caregiver, friend or family member).
Rogers fails to fully teach continuously monitoring a target region of a subject in real time, comprising: attaching a device on the target region, and an electronic module coupled with the probe for wireless, real-time, and continuous measurements of physiological information of the target region; and processing the measured temperature.
However, Rogers (2) teaches a method for continuously monitoring a target region of a subject in real time ([0008] apparatus for non-invasively measuring physiological parameters of a mammal subject, which may be used as a vital sign monitoring system and/or a pediatric medical device, a method thereof, and applications thereof), comprising: attaching a device on the target region ([0079] The sensor systems 110 and 150 are time-synchronized and communicate with each other wirelessly and bidirectionally, and are respectively attached to the mammal subject. In certain embodiments, each of the sensor systems is an epidermal electronic system (EES). For example, FIG. 1 shows that the first sensor system 110 is attached to a first position 410 of the mammal subject for detecting a first signal of the mammal subject, and the second sensor system 150 is attached to a second position 420), and an electronic module coupled with the probe for wireless ([0039] FIGS. 2A-2D show schematic illustrations and photographic images of ultra-thin, skin-like wireless modules in the apparatus for measuring the physiological parameters), real-time, and continuous measurements of physiological information of the target region ([0040] FIG. 3A/B shows a flowchart of a method of non-invasively and continuously measuring physiological parameters of a mammal subject according to certain embodiments of the present invention); and processing the measured temperature ([0084] Further referring to FIG. 2A, the SoC 124 of the torso sensor system 110 includes, but is not limited to, a microprocessor unit, e.g., CPU, a near-field communication (NFC) interface, e.g., NFC ISO 15693 interface, general-purpose input/output (GPIO) ports, one or more temperature sensors (Temp. sensor), and analog-to-digital converters (ADCs) in communication with each other, for receiving data from the sensor member 123 and processing the received data) ([0103] each of the sensor systems further includes one or more of: an accelerometer for position or movement monitoring; and a temperature sensor for measuring temperature).
It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rogers to include continuously monitoring a target region of a subject in real time, comprising: attaching a device on the target region, and an electronic module coupled with the probe for wireless, real-time, and continuous measurements of physiological information of the target region; and processing the measured temperature. Doing so allows for real time and continuous measurements of signals for accurate assessment of the state of the target site and to predict warning signs of rejection episodes.
Regarding claim 36, Rogers teaches the method of claim 35, wherein the temperature is measured by measuring changes in resistance of the probe ([00197] The recorded data consist of temperature changes (DT, °C) inferred from measured changes in resistance as a function of time before and after thermal actuation), and the perfusion is measured via thermal anemometry ([[00193] During operation, the sensor acts as a thermal actuator upon application of direct electrical current (Keithley 6220, A Tektronix Co.). The device connects to the current source by bonding to a conductive ribbon (250 pm spacing, 3M) and small PC board (~2.5 cm x 5 cm). With thermal actuation, the resistive sensor undergoes self-heating where the resistance of the sensor linearly increases with temperature per the coefficient of resistance of the metal (Au), Fig. 19. Direct conversion between resistance and temperature is achieved by device calibration) ([[00275] In vivo measurements of skin thermal transport changes due to trauma: Skin trauma is associated with changes in perfusion through near-surface microvessels such as capillaries and arterioles), wherein current is injected through the probe with a thermal power ([00193] the sensor acts as a thermal actuator upon application of direct electrical current (Keithley 6220, A Tektronix Co.). The device connects to the current source by bonding to a conductive ribbon (250 pm spacing, 3M) and small PC board (~2.5 cm x 5 cm). With thermal actuation, the resistive sensor undergoes self-heating where the resistance of the sensor linearly increases with temperature per the coefficient of resistance of the metal (Au), Fig. 19. Direct conversion between resistance and temperature is achieved by device calibration), causing transient local Joule heating of the target region tissue by a value of temperature change, ∆T ([00185] The thermal sensor measurement described herein is based on the well-established transient plane source (TPS).sup.1 method. Briefly, the active element in the TPS approach delivers thermal power to the sample via Joule heating that results from application of DC current. The same device simultaneously enables time-dependent measurements of resulting changes in temperature through the temperature coefficient of resistance (TCR) of the metal), wherein the magnitude of ∆T depends on the perfusion ([00185] the temperature approximately saturates to a value that depends mainly on the thermal conductivity and only weakly on the thermal diffusivity) ([00294] Direct measurement of the body surface temperature and quantification of the thermal transport properties (i.e. thermal conductivity) associated with physiological conditions such as perfusion and hydration level are both possible).
Regarding claim 37, Rogers teaches the method of claim 36, wherein the thermal power is chosen such that ∆T<20C (Fig 29; [0089] (a) Representative plot of the linear relationship between temperature and resistance for a given device (b) Representative plot of the linear relationship between the change in temperature as a function of power density of four separate measurements after identical transient heating times) (∆T<20C). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the thermal power is chosen such that ∆T<20C, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 38, Rogers teaches the method of claim 35, wherein said processing the measured temperature and perfusion comprises identifying unique temperature signatures ([0006] Those parameters may be communicated at a distance for evaluation in real-time, or at a later time, such as by the user or a third party, such as a medical caregiver, friend or family member) ([00275] [00275] In vivo measurements of skin thermal transport changes due to trauma: Skin trauma is associated with changes in perfusion through near-surface microvessels such as capillaries and arterioles. We examined two representative cases of skin trauma, burns and skin inflammation associated with blunt impact) for different rejection-related biological processes/mechanisms ([00183] Any of the devices and methods provided herein may be used as an implantable device. Implantable versions of this technology may serve as early warning indicators of inflammation in a localized area of the body (e.g. transplanted organ). This information may then enable future prediction of organ transplant rejection prior to laboratory or imaging evidence— this would then trigger changes to immunosuppressant drug dosing. Other embodiments can include interrogation of infection in implantable orthopedic or soft tissue implants).
Regarding claim 41, Rogers teaches the method of claim 35, further comprising inferring a degree of damage that occurs ([00189] Noninvasive methods for precise characterization of the thermal properties of soft biological tissues such as the skin can yield vital details about physiological health status including at critical intervals during recovery following skin injury. Here, we introduce quantitative measurement and characterization methods that allow rapid, accurate determination of the thermal conductivity of soft materials using thin, skin-like resistive sensor platforms) during ischemia-reperfusion injury (IRI) and the possible recovery based on the perfusion ([00130] “Thermally interfacing”, therefore, refers to the ability of the device to affect a thermal challenge on underlying tissue, and to detect a response thereto, such as a change in temperature over time, including for a time period after the thermal input ends. In this manner, one or more tissue parameters may be determined, such as tissue hydration, inflammation, blood flow, EiV damage) ([00191] Results show that the near-surface thermal conductivity changes in a manner that can be used for non-invasive monitoring of erythema recovery, of utility for diagnostic and prognostic purposes).
Regarding claim 42, Rogers teaches the method of claim 35, further comprising wirelessly transmitting the processed temperature and perfusion to an external device by the electronic module ([00134] “ Two-way communication” refers to the ability to wirelessly communicate with the device, such that power, commands or queries are sent to, and acted on, the device and the device itself can send information or diagnostics to an external controller that is wirelessly connected to the device).
Regarding claim 43, Rogers teaches the method of claim 35, further comprising alerting the subject and/or a physician of possible injury to the graft, based on the surrogate marker (0062] 54. The method of any of the above embodiments, further comprising the step of: a. alerting a user to an adverse skin condition. [0063] 55. The method of embodiment 54, wherein the alerting step comprises: a. a haptic signal; or b. an alert by the external controller) ([00164] “Haptic feedback element” refers to a device component that generates a physically-detectable stimulus by a user, such as be a haptic feedback element that is selected from the group consisting of a vibrator, an optical light source, or an electrode) ([00167] A haptic feedback element 170 may be incorporated into the system to provide the user a convenient and readily understood signal (e.g., vibration, shock, light, and the like). As desired, an additional sensor 430 may be incorporated into the system).
Regarding claim 44, Rogers teaches the method of claim 35, wherein the target region is an organ or transplanted organ ([00171] implantable (e.g. sub-dermal) version of this technology have the opportunity to service as a sentinel system of inflammation in deeper organs and tissues. For instance, this technology could be placed overlying a transplanted organ and act as a surveillance system for kidney rejection).
Regarding claim 45, Rogers teaches the method of claim 44, wherein the organ or transplanted organ is a kidney, a liver, a lung a heart, or other organ ([00171] implantable (e.g. sub-dermal) version of this technology have the opportunity to service as a sentinel system of inflammation in deeper organs and tissues. For instance, this technology could be placed overlying a transplanted organ and act as a surveillance system for kidney rejection).
Claim(s) 39 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers (WO 2019191703 A1) in view of Rogers (2) (US 20210386300 A1), further in view of Anderson (US 20200121243 A1) and Blahnik (US 20180345078 A1).
Regarding claim 39, Rogers teaches the method of claim 38, wherein the temperature not only provides early warning of rejection episodes ([00183] Implantable versions of this technology may serve as early warning indicators of inflammation in a localized area of the body (e.g. transplanted organ). This information may then enable future prediction of organ transplant rejection prior to laboratory or imaging evidence— this would then trigger changes to immunosuppressant drug dosing. Other embodiments can include interrogation of infection in implantable orthopedic or soft tissue implants) but also helps personalized dosing strategies including correct dosing ([00183] Any of the devices and methods provided herein may be used as an implantable device. Implantable versions of this technology may serve as early warning indicators of inflammation in a localized area of the body (e.g. transplanted organ). This information may then enable future prediction of organ transplant rejection prior to laboratory or imaging evidence— this would then trigger changes to immunosuppressant drug dosing), dosing regimens, and efficacy of different drugs and therapies ([00183]) through monitoring of the magnitude ([00148] “Sensing” refers to detecting the presence, absence, amount, magnitude or intensity of a physical and/or chemical property) of and time between different features in the temperature ([00197] The recorded data consist of temperature changes (DT, °C) inferred from measured changes in resistance as a function of time before and after thermal actuation).
Rogers fail to fully teach including the inflection point, temperature peak, and half-day frequency.
However, Anderson teaches including the inflection point ([0110] This temperature gradient was chosen because it occurs at a natural inflection point at which cellulitis becomes the more likely diagnosis (i.e. probability equals 50%)), temperature peak ([0063] In some aspects the computer system 100 may identify the maximum temperature in the affected area, and use the maximum temperature in the affected area while calculating the temperature differences above). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rogers to include the inflection point, temperature peak. Doing so allows for the assessment of the state of recovery and accurate warning signs of rejection episodes.
Further, Blahnik teaches half-day frequency ([0034] In other examples, device 100 can operate over different lengths of time, such as a half day, two days, a week, two weeks, a month, or the like, that can be adjustable by a user of device 100). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Rogers to include half-day frequency. Doing so allows the device to be monitored by over days for a thorough assessment of recovery and of the state of the tissue.
Regarding claim 40, Rogers teaches the method of claim 39, wherein the surrogate marker is temperature variations on the surface of the target region ([00176] Changes in thermal conductivity and surface temperature has diagnostic value for conditions such as cellulitis or serve as a surrogate marker for wound formation that may not be apparent clinically).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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