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 .
Response to Amendment
The amendment filed on 05/27/2026 has been entered. Claims 1-5 and 9-13 have been amended. Claims 6-8 and 14-16 have been cancelled. Claims 1-5 and 9-13 remain pending.
The previously raised objections for Claims 1-5 and 9-13 are withdrawn because the issues have been properly corrected.
Response to Arguments
On Pages 8-13 of Remarks, Applicant argues that, regarding Claims 1-5 and 9-13, the claims are not directed to an abstract idea, even if considered to include abstract idea, integrate it into a practical application, and recite significantly more than any abstract idea. Specifically, Applicant argues that the claims require features such as (1) a plurality of pressure sensors formed in an N × M matrix, (2) temperature sensors, (3) generation of 2D temperature distribution maps, and (4) cumulative monitoring of body temperature changes; therefore, the amended claims are directed to a specific technological implementation. Examiner respectfully disagrees. The listed features are merely sensors or sensor arrays, or storing measurement results (in a two-dimension form or cumulatively), which are routinely implemented by health monitoring devices and methods, so can be regarded as extra-solution activities. Furthermore, Applicant argues that the amended claims integrate the alleged abstract idea into a practical application, i.e. a practical physiological monitoring system that physically measures body temperatures from segmented cervical vertebral regions and generates 2D temperature maps, and recite significantly more than abstract idea. Examiner respectfully disagrees. The recited additional elements, including the N × M sensor arrays and storing the temperature results, are recited in a high level of generality. For example, the pressure sensor array can be any type or size of sensor array that gives a plurality of measurements, not necessarily corresponding to any anatomical regions as argued. Further, the claimed temperature measurements, which are arranged in 2D form and are accumulated as claimed, are merely more measurements across space and time, when compared to single-point measurement.
On Pages 15-16 of Remarks, Applicant argues that the combination of references Meftah and Wu does not disclose the claimed limitations of “generate a profile for each segmented area of …”, “select a reference temperature map …”, and “derive an amount of temperature change in each segmented area …”. On Page 17 of Remarks, Applicant argues that reference Main does not disclose the above limitations either. Examiner respectfully disagrees on Applicant’s argument that “the subject disclosed in Meftah is not a segmented area in a particular subject” (Page 16, Para 2 of Remarks). First, with regard to the claimed limitation of “segmented area”, Claim 1, Lines 4-5, recites “… performs segmentation on a … recognition area to generate a plurality of segmented areas of …”. Regarding how such segmentation is performed, Specification merely discloses in Para 0047, “the segmented areas may be formed by using a preset number of or a preset reference wideness of segmented areas, and each of the segmented areas may be formed to include at least one temperature sensor.”. For the claimed segmented areas obtained by the disclosed segmentation, Meftah discloses a temperature matrix 38 “comprising of interconnected coupling sensors 16 and temperature sensors 18 configured to determine the temperature of a subject 12” (Meftah, Para 0035) and also shown in Fig. 3A, and further discloses in Para 0045, “a coupling level may indicate whether the output signal from a sensor should be discarded, e.g. in favor of stronger and/or more reliable signals from other sensors”, i.e. the coupling sensors are to identify areas where the subject and the sensor array are coupled, and the identified or coupled areas are naturally formed of a plurality of segmented areas, each comprising a temperature sensor as indicated by Fig. 3A. Second, Meftah discloses vital sign state determination module 112 and map module 115 to generate “temperature map” where temperatures for different body parts such as the brain, the heart, the abdomen and the chest are determined and displayed, with examples shown in Fig. 6A. In other words, the disclosed different body parts are segmented in the identified area by the coupling sensors and/or temperature sensors. Furthermore, Meftah’s Fig. 6B discloses a way of depicting regions of a subject having similar temperatures, which corresponds to the thresholding method for segmenting images in the field of image processing. The arguments regarding the other claimed limitations listed above are moot in view of the new grounds of rejection which relies on the combination of Metah and new reference Linders et al (US 20200113510 A1) to disclose these limitations in the claims.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
“a temperature distribution analysis unit” in Claim 1
A review of the Specification discloses that the corresponding structure for the “temperature distribution analysis unit” may include “machine learning” for defining on each of the segmented areas based on the measured pressure values (Para 0051).
“an area segmentation module” in Claim 2.
A review of the Specification discloses that the corresponding structure for the “area segmentation module” is based on the formed NxM matrix of a plurality of pressure sensors (Para 0042).
“a temperature distribution map generation module” in Claim 4.
A review of the Specification discloses that the corresponding structure for the “temperature distribution map generation module” comprises “machine learning” to “perform defining on each of the segmented areas” (Para 0051).
“a temperature distribution analysis performing step” in Claim 9
A review of the Specification discloses that the corresponding structure for the “temperature distribution analysis performing step” may include “machine learning” for defining on each of the segmented areas based on the measured pressure values (Para 0070).
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 and 9-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, Line 30, and Claim 9, Line 27, recite “comparing left and right profiles for the each of the plurality of segmented areas”. It is unclear what “left and right” refer to. For present purposes of examination, the recited “left and right” is interpreted to refer to different locations in a segmented area.
Claims 2-5 and 10-13 are also rejected under 35 U.S.C. 112(b) because they inherit the indefiniteness of the claim(s) they respectively depend upon.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5 and 9-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1, Line 30, and Claim 9, Line 27, recite “comparing left and right profiles for the each of the plurality of segmented areas”. Specification does not provide any details on what “left and right” refer to. For present purposes of examination, the recited “left and right” is interpreted to refer to different locations in a segmented area.
Claims 2-5 and 10-13 are also rejected under 35 U.S.C. 112(a) because they inherit the deficiencies of the claim(s) they respectively depend upon.
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 1-5 and 9-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
With regard to Claims 1-5:
Step 1: the claims are drawn to a system/apparatus, one of the four statutory categories.
Step 2A, Prong One:
The claims recite the limitations of “determines whether the cervical vertebra is recognized …”, “performs segmentation …”, “expresses body temperature distribution information … in two dimensions …”, “derives a treatment effect …”, “select a reference temperature distribution map”, “derive an amount of temperature change”, “comparing left and right profiles”, “comparing the amount of temperature change with a preset reference” in Claim 1, “determines whether the cervical vertebra is recognized …” and “generates at least two segmented areas by performing segmentation …” in Claim 2, “generates the temperature distribution map …” in Claim 4, and “includes a definition for each of the segmented areas through machine learning” in Claim 5. These limitations are, under their broadest reasonable interpretation, limitations that cover performance of the limitation in the mind and/or by mathematical calculations. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind and/or mathematical calculations, then it falls within the “Mental Processes” and/or “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Step 2A, Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements – measuring and storing body temperature, and displaying results in Claim 1, including at least one temperature sensor in each segmented area in Claim 3, and acquiring body temperature distribution information using temperature sensor in Claim 4, which are all extra-solution activities of data gathering or storing. The units, modules and sensors in the claims are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic acquisition or processing unit. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using generic units, modules and/or sensors to acquire, process or store data, as clamed, amount to no more than mere instructions to apply the exception using generic computer and sensor components. Mere instructions to apply an exception using generic computer and sensor components cannot provide an inventive concept.
For the reasons set forth above, Claims 1-5 are not patent eligible.
With regard to Claims 9-13:
Step 1: the claims are drawn to a method, one of the four statutory categories.
Step 2A, Prong One:
The claims recite the limitations of “determining whether the cervical vertebra is recognized …”, “performing segmentation …”, “expresses body temperature distribution information … in two dimensions …”, “deriving a treatment effect …”, “select a reference temperature distribution map …”, “derive an amount of temperature change …”, “comparing left and right profiles …” and “comparing the amount of temperature change with a preset reference” in Claim 9, “determining whether the cervical vertebra is recognized …” and “generating at least two segmented areas by performing segmentation …” in Claim 10, “generating the temperature distribution map …” in Claim 12, and “includes a definition for each of the segmented areas through machine learning” in Claim 13. These limitations are, under their broadest reasonable interpretation, limitations that cover performance of the limitation in the mind and/or by mathematical calculations. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind and/or mathematical calculations, then it falls within the “Mental Processes” and/or “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Step 2A, Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements – measuring and storing body temperature, and displaying results in Claim 9, including at least one temperature sensor in each segmented area in Claim 11, and acquiring body temperature distribution information using temperature sensor in Claim 12, which are all extra-solution activities of data gathering or storing. The units and sensors in the claims are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic acquisition or processing unit. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using generic units and/or sensors to acquire, process or store data, as clamed, amount to no more than mere instructions to apply the exception using generic computer and sensor components. Mere instructions to apply an exception using generic computer and sensor components cannot provide an inventive concept.
For the reasons set forth above, Claims 9-13 are not patent eligible.
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 1-4 and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Meftah et al (US 20170000347 A1; hereafter Meftah), in view of Wu et al (US 20220180521 A1; hereafter Wu) and Linders et al (US 20200113510 A1; hereafter Linders).
With regard to Claim 1, Meftah discloses a temperature change monitoring system (Meftah, Para 0022; “FIG. 1A illustrates (a top-view of) measuring system 10 for non-invasive determination of one or more vital sign states of subject 12 … non-invasive determination of one or more temperatures of subject 12”; Para 0025; “A subject support structure may be a mattress, a bed, a pad, a blanket, a wrap, a pillow, an incubator, and/or other structure suitable to engage and/or support a subject 12 …”. The disclosed “wrap” and “pillow” can both be used to monitor the cervical vertebral area) comprising:
an area processing unit (Meftah, Para 0042; “… processor 110 is configured to execute … one or more of a coupling module 111 …” ) that determines whether an area is recognized using a pressure sensor (Meftah, Para 0005; “The coupling module is configured to determine coupling levels for individual ones of the vital sign sensors based on the coupling signals generated by the coupling sensors”; Para 0028; “… coupling sensor(s) may include one or more magnetic field sensors, one or more pressure sensors and/or one or more capacitive sensors.”) and performs segmentation on recognition area to generate a plurality of segmented areas (Meftah, Para 0035; “FIG. 3A illustrates a temperature matrix 38 comprising of interconnected coupling sensors 16 ... comprise individual elements 40” The disclosed “matrix” is shown in Fig. 3A as cited below. With the matrix or grid arrangement, measurement in each element is performed independently, thus forming a plurality of segmented areas as claimed by Application. Furthermore, information from coupling sensors can be segmented to identify different body parts of a subject, as in Para 0054; “… measuring system 10 may include one or more sensors configured to generate output signals conveying positional information of subject 12. Positional information of subject 12 may include information about the relative position of subject 12 (and/or one or more body parts of subject 12) as compared to one or more of measuring system 10 …”, with examples shown in Fig. 6);
wherein the pressure sensor includes a plurality of pressure sensors formed in an N × M matrix (Meftah, Para 0035; “The temperature matrix 38 may comprise individual elements 40. Each element 40 may include one or more temperature sensors 18 and/or one or more coupling sensors 16.”. In the example of cited Fig. 3A, the matrix is 8 × 8), and each of the segmented areas is formed to include at least one temperature sensor (one or more temperature sensors 18 for each element 40);
a temperature distribution analysis unit (map module 115) that measures a body temperature in the recognition area (Meftah, Para 0027; “Temperature sensor(s) 18 may be configured to generate output signals conveying temperatures of a subject”) using the at least one temperature sensor (temperature sensors 18) and generates a temperature distribution map using the measurement results (Meftah, Para 0055; “… a temperature map of subject 12 based on temperatures determined by vital sign state determination module 112 and/or positional information of subject 12.”),
wherein the temperature distribution map expresses body temperature distribution information of the recognition area in two dimensions (Meftah, Para 0055; “Temperature map 62 may be 2-dimensional …”. Examples are shown in Figs. 5 and 6) using body temperature distribution information measured in each of the plurality of segmented areas (Meftah, Para 0056; “… a temperature map of subject 12 may be based on a (parameterized) model using multiple determined temperatures of subject 12.”);
a body temperature change measurement unit (Meftah, Para 0059; “Tracking module 114 of system 10 in FIG. 2 may be further configured to track changes in one or more temperatures over time”) that derives a treatment effect by using the temperature distribution map (Meftah, Para 0061; “Determined temperatures (e.g. by vital sign state determination module 112) may be compared to one or more target temperatures and/or target temperature ranges”; Para 0062; “… responsive to a comparison between a target temperature and a corresponding determined temperature, control module 117 may be configured to increase or decrease a particular body part, organ, area, and/or region of subject 12. This may be referred to as heating or cooling, respectively.” This disclosure indicates that, by comparing the measured temperature to a target temperature, the effect of treatment (heating or cooling) is derived, and determines if more treatment is necessary),
wherein the body temperature change measurement unit is configured to:
generate a profile for the each of the plurality of segmented areas including time-series information (Meftah, Para 0055; “… the term “temperature map” may be used interchangeably with the terms “temperature profile” … Temperature map 62 may, by way of non-limiting example, include the same or similar temperatures as depicted in FIG. 5, including temperatures for the brain, chest, abdomen, hands, feet, and ambient temperature.”. Fig. 5 shows the temperature profile for the different body parts over time), by cumulatively storing the temperature distribution map at a preset cycle from a moment the body temperature is first measured until a moment the treatment is completed (Meftah, Para 0059; “Tracking module 114 of system 10 in FIG. 2 may be further configured to track changes in one or more temperatures over time.” Para 0044; “Sensors in this disclosure may be configured to generate output signals in an ongoing manner …”. As the disclosed measurement is in an ongoing manner, the measurement and tracking should start when the disclosed system is engaged with a subject, and stop when the system is disengaged),
derive an amount of temperature change in the each of the plurality of segmented areas (Meftah, Para 0052; “Vital sign state determination module 112 may be configured to determine multiple temperatures of subject 12 over time. By way of non-limiting example, FIG. 4 illustrates a graph 49 including multiple temperatures (in ° C.) measured over time (along the X-axis), including temperatures for the brain (50), chest (52), abdomen (54), hands (56), feet (58), and ambient temperature (60).”) as time-series information (Meftah, Para 0059; “Tracking module 114 of system 10 in FIG. 2 may be further configured to track changes in one or more temperatures over time. … a particular temperature (e.g. determined by vital sign state determination module 112) may rise or fall outside an acceptable and/or preferred range for such a temperature.”), and
derive the treatment effect by comparing left and right profiles for the each of the plurality of segmented areas (Meftah, Para 0052; “User interface 120 may be configured to display multiple temperatures of the subject 12. For example, temperature measurement 46a may be the measured core temperature … and temperature measurement 46b may be the measured peripheral temperature, such as feet temperature 58 or hands temperature 56.”; Para 0059; “… tracking module 114 may be configured to determine whether the peripheral temperatures of the extremities are more than a predetermined maximum difference threshold apart from each other.”. In these disclosures, the disclosed “peripheral temperature 46b” can be analyzed by comparing temperatures of different extremities, e.g. left hand vs. right hand) and comparing the amount of temperature change with a preset reference (Meftah, Para 0059; “… a particular temperature (e.g. determined by vital sign state determination module 112) may rise or fall outside an acceptable and/or preferred range for such a temperature.”); and
a display device (user interface 120 of Fig. 4) configured to display the treatment effect and the temperature distribution map (Meftah, Para 0052; “user interface 120, of FIG. 4, may be configured to facilitate display of the graph 49 depicted in FIG. 5. User interface 120 may be configured to display multiple temperatures of the subject 12.”; Para 0055; “The model may facilitate display of a temperature map of subject 12 on user interface 120 of FIG. 4.” The disclosed user interface 120 displays measured temperatures in both temporal and spatial dimensions).
Fig. 3A of Meftah
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Meftah does not clearly and explicitly disclose
the area to be recognized and segmented being the cervical vertebra,
selecting a reference temperature distributed map among a plurality of temperature distribution maps included in the profile, and
using the selected reference temperature distributed map to derive temperature change as time-series information.
Wu in the same field of endeavor discloses the area to be recognized and segmented being the cervical vertebra (Wu, Para 0042; “… the objects in the to-be-processed image include a first object … For the first object such as the cervical vertebra … a core segmentation region of each vertebra is obtained after the segmentation, thereby localizing each vertebra.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Meftah, as suggested by Wu, in order to recognize and segment the cervical vertebra. One of ordinary skill in the art would have been motivated to make the modification as a prerequisite for monitoring health status or diagnosis of vertebral diseases (Wu, Para 0026; “Localization and segmentation on the vertebra are the key steps for diagnosis and treatment of vertebral diseases such as vertebral slip, degeneration of intervertebral disc/vertebra, and spinal stenosis. The vertebra segmentation is also the pretreatment step for diagnosis of scoliosis, osteoporosis and other spinal lesions”).
Meftah and Wu do not clearly and explicitly disclose
selecting a reference temperature distributed map among a plurality of temperature distribution maps included in the profile, and
using the selected reference temperature distributed map to derive temperature change as time-series information.
Linders in the same field of endeavor discloses
selecting a reference temperature distributed map among a plurality of temperature distribution maps included in the profile (Linders, Para 0044; “To measure foot temperature, the platform 16 has a receiving region 17 … the receiving region 17 has an array, matrix, or other prescribed arrangement of temperature sensors 26 …”; Para 0109; “Illustrative embodiments measure and store the foot temperature at a baseline time reference.” These disclosures indicate measuring and storing a temperature measurement map at a baseline time point (by the disclosed array or matrix of temperature sensors)), and
using the selected reference temperature distributed map to derive temperature change as time-series information (Linders, Para 0109; “… for a later time t, this embodiment measures the foot temperature again and compares the temperatures at time t with the temperatures at baseline and determines if any location has changed in temperature from the baseline more than a predetermined threshold.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Meftah and Wu, as suggested by Linders, in order to select one measured temperature map and use it as reference for monitoring temperature change. One of ordinary skill in the art would have been motivated to make the modification for the benefit of utilizing change of temperature in tissue or organ of interest for diagnosing chronic and acute disease conditions (Linders, Para 0107;“In some pathologies, the absolute temperature at a given time is not as informative as the change in temperatures over time. Chronic conditions may present as slow changes over a long time and acute conditions may present as fast onset or short-lived patterns.”).
With regard to Claim 2, Meftah, Wu and Linders disclose the cervical vertebra temperature change monitoring system as claimed in Claim 1. Meftah further discloses wherein the cervical vertebral area processing unit (coupling module 111) comprises:
a cervical vertebra recognition determination module that determines whether the cervical vertebra is recognized using the pressure sensor (coupling sensors(s), which may be one or more pressure sensors); and
an area segmentation module that, when the user's cervical vertebra is recognized, generates at least two segmented areas by performing segmentation on the cervical vertebra recognition area (Meftah, Para 0035; “FIG. 3A illustrates a temperature matrix 38 comprising of interconnected coupling sensors 16 ... comprise individual elements 40 …”. The disclosed “matrix” segments the skin area that the system is applied to, and agrees with the Application’s disclosure in Para 0042: “… a plurality of pressure sensors may be formed in an N x M matrix. This is for performing area segmentation by means of the area segmentation module 113 …”), which is an area in which the cervical vertebra is recognized (Meftah, Para 0030; “… coupling information from coupling sensor 16a may be used to qualify information from temperature sensor 18a. Information from temperature sensor 18a may be deemed useful and/or reliable based on the information from coupling sensor 16a.” The disclosed “coupling information” indicates which elements are coupled to a target skin area and which are not, so corresponds to the recognized area of Application).
With regard to Claim 3, Meftah, Wu and Linders disclose the cervical vertebra temperature change monitoring system as claimed in Claim 2. Meftah further discloses wherein the segmented areas are formed by using a preset number of or a preset reference wideness of segmented areas (Meftah, Fig. 3A: as shown in the figured cited above, the segmented area has a preset number).
With regard to Claim 4, Meftah, Wu and Linders disclose the cervical vertebra temperature change monitoring system as claimed in Claim 1. Meftah further discloses wherein the temperature distribution analysis unit (map module 115) comprises:
a body temperature information acquisition module that acquires body temperature distribution information as a measurement result of the body temperature using the temperature sensor provided in the cervical vertebra recognition area (Meftah, Para 0053; “… vital sign state determination module 112 may be configured to determine one or more temperatures of subject 12 without using or needing coupling information.”); and
a temperature distribution map generation module that generates the temperature distribution map for the cervical vertebra recognition area using the segmented areas (Meftah, Para 0054; “… positional information may be derived from and/or based on coupling information.” The disclosed “coupling information” indicates which elements (i.e. segmented area of Application) are reliably coupled with the skin region) and the body temperature distribution information (temperatures determined by vital sign state determination module 112) (Meftah, Para 0055; “… a vital sign state profile of subject 12 may include a temperature map of subject 12 based on temperatures determined by vital sign state determination module 112 and/or positional information of subject 12.”).
With regard to Claim 9, Meftah discloses a temperature change monitoring method (Meftah, Para 0022; “FIG. 1A illustrates (a top-view of) measuring system 10 for non-invasive determination of one or more vital sign states of subject 12 … non-invasive determination of one or more temperatures of subject 12”; Para 0025; “A subject support structure may be a mattress, a bed, a pad, a blanket, a wrap, a pillow, an incubator, and/or other structure suitable to engage and/or support a subject 12 …”. The disclosed “wrap” and “pillow” can both be used to monitor the cervical vertebral area) comprising:
an area processing step of an area processing unit (Meftah, Para 0042; “… processor 110 is configured to execute … one or more of a coupling module 111 …” ) determining whether an area is recognized using at least one pressure sensor (Meftah, Para 0005; “The coupling module is configured to determine coupling levels for individual ones of the vital sign sensors based on the coupling signals generated by the coupling sensors”; Para 0028; “… coupling sensor(s) may include one or more magnetic field sensors, one or more pressure sensors and/or one or more capacitive sensors.”) and performing segmentation on recognition area to generate a plurality of segmented areas (Meftah, Para 0035; “FIG. 3A illustrates a temperature matrix 38 comprising of interconnected coupling sensors 16 ... comprise individual elements 40” The disclosed “matrix” is shown in Fig. 3A as cited below. With the matrix or grid arrangement, measurement in each element is performed independently, thus forming a plurality of segmented areas as claimed by Application. Furthermore, information from coupling sensors can be segmented to identify different body parts of a subject, as in Para 0054; “… measuring system 10 may include one or more sensors configured to generate output signals conveying positional information of subject 12. Positional information of subject 12 may include information about the relative position of subject 12 (and/or one or more body parts of subject 12) as compared to one or more of measuring system 10 …”, with examples shown in Fig. 6), wherein the at least one pressure sensor includes a plurality of pressure sensors formed in an N × M matrix (Meftah, Para 0035; “The temperature matrix 38 may comprise individual elements 40. Each element 40 may include one or more temperature sensors 18 and/or one or more coupling sensors 16.”. In the example of cited Fig. 3A, the matrix is 8 × 8), and each of the segmented areas is formed to include at least one temperature sensor (one or more temperature sensors 18 for each element 40);
a temperature distribution analysis performing step of a temperature distribution analysis unit (map module 115) measuring a body temperature in the recognition area (Meftah, Para 0027; “Temperature sensor(s) 18 may be configured to generate output signals conveying temperatures of a subject”) using at least one temperature sensor (temperature sensors 18) and generating a temperature distribution map using the measurement results (Meftah, Para 0055; “… a temperature map of subject 12 based on temperatures determined by vital sign state determination module 112 and/or positional information of subject 12.”), wherein the temperature distribution map expresses body temperature distribution information of the recognition area in two dimensions (Meftah, Para 0055; “Temperature map 62 may be 2-dimensional …”. Examples are shown in Figs. 5 and 6) using body temperature distribution information measured in each of the plurality of segmented areas (Meftah, Para 0056; “… a temperature map of subject 12 may be based on a (parameterized) model using multiple determined temperatures of subject 12.”);
a body temperature change measurement performing step of a body temperature change measurement unit (Meftah, Para 0059; “Tracking module 114 of system 10 in FIG. 2 may be further configured to track changes in one or more temperatures over time”) deriving a treatment effect by using the temperature distribution map (Meftah, Para 0061; “Determined temperatures (e.g. by vital sign state determination module 112) may be compared to one or more target temperatures and/or target temperature ranges”; Para 0062; “… responsive to a comparison between a target temperature and a corresponding determined temperature, control module 117 may be configured to increase or decrease a particular body part, organ, area, and/or region of subject 12. This may be referred to as heating or cooling, respectively.” This disclosure indicates that, by comparing the measured temperature to a target temperature, the effect of treatment (heating or cooling) is derived, and determines if more treatment is necessary),
wherein the body temperature change measurement unit cumulatively stores the temperature distribution map at a preset cycle from a moment the body temperature is first measured until a moment the treatment is completed (Meftah, Para 0059; “Tracking module 114 of system 10 in FIG. 2 may be further configured to track changes in one or more temperatures over time.” Para 0044; “Sensors in this disclosure may be configured to generate output signals in an ongoing manner …”. As the disclosed measurement is in an ongoing manner, the measurement and tracking should start when the disclosed system is engaged with a subject, and stop when the system is disengaged) to generate a profile for the each of the plurality of segmented areas including time-series information (Meftah, Para 0055; “… the term “temperature map” may be used interchangeably with the terms “temperature profile” … Temperature map 62 may, by way of non-limiting example, include the same or similar temperatures as depicted in FIG. 5, including temperatures for the brain, chest, abdomen, hands, feet, and ambient temperature.”. Fig. 5 shows the temperature profile for the different body parts over time), derive an amount of temperature change in the each of the plurality of segmented areas (Meftah, Para 0052; “Vital sign state determination module 112 may be configured to determine multiple temperatures of subject 12 over time. By way of non-limiting example, FIG. 4 illustrates a graph 49 including multiple temperatures (in ° C.) measured over time (along the X-axis), including temperatures for the brain (50), chest (52), abdomen (54), hands (56), feet (58), and ambient temperature (60).”) as time-series information (Meftah, Para 0059; “Tracking module 114 of system 10 in FIG. 2 may be further configured to track changes in one or more temperatures over time. … a particular temperature (e.g. determined by vital sign state determination module 112) may rise or fall outside an acceptable and/or preferred range for such a temperature.”), and derive the treatment effect by comparing left and right profiles for the each of the plurality of segmented areas (Meftah, Para 0052; “User interface 120 may be configured to display multiple temperatures of the subject 12. For example, temperature measurement 46a may be the measured core temperature … and temperature measurement 46b may be the measured peripheral temperature, such as feet temperature 58 or hands temperature 56.”; Para 0059; “… tracking module 114 may be configured to determine whether the peripheral temperatures of the extremities are more than a predetermined maximum difference threshold apart from each other.”. In these disclosures, the disclosed “peripheral temperature 46b” can be analyzed by comparing temperatures of different extremities, e.g. left hand vs. right hand) and comparing the amount of temperature change with a preset reference (Meftah, Para 0059; “… a particular temperature (e.g. determined by vital sign state determination module 112) may rise or fall outside an acceptable and/or preferred range for such a temperature.”); and
displaying the treatment effect and the temperature distribution map (Meftah, Para 0052; “user interface 120, of FIG. 4, may be configured to facilitate display of the graph 49 depicted in FIG. 5. User interface 120 may be configured to display multiple temperatures of the subject 12.”; Para 0055; “The model may facilitate display of a temperature map of subject 12 on user interface 120 of FIG. 4.” The disclosed user interface 120 displays measured temperatures in both temporal and spatial dimensions) on a display device (user interface 120 of Fig. 4).
Meftah does not clearly and explicitly disclose
the area to be recognized and segmented being the cervical vertebra,
selecting a reference temperature distributed map among a plurality of temperature distribution maps included in the profile, and
using the selected reference temperature distributed map to derive temperature change as time-series information.
Wu in the same field of endeavor discloses the area to be recognized and segmented being the cervical vertebra (Wu, Para 0042; “… the objects in the to-be-processed image include a first object … For the first object such as the cervical vertebra … a core segmentation region of each vertebra is obtained after the segmentation, thereby localizing each vertebra.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Meftah, as suggested by Wu, in order to recognize and segment the cervical vertebra. One of ordinary skill in the art would have been motivated to make the modification as a prerequisite for monitoring health status or diagnosis of vertebral diseases (Wu, Para 0026; “Localization and segmentation on the vertebra are the key steps for diagnosis and treatment of vertebral diseases such as vertebral slip, degeneration of intervertebral disc/vertebra, and spinal stenosis. The vertebra segmentation is also the pretreatment step for diagnosis of scoliosis, osteoporosis and other spinal lesions”).
Meftah and Wu do not clearly and explicitly disclose
selecting a reference temperature distributed map among a plurality of temperature distribution maps included in the profile, and
using the selected reference temperature distributed map to derive temperature change as time-series information.
Linders in the same field of endeavor discloses
selecting a reference temperature distributed map among a plurality of temperature distribution maps included in the profile (Linders, Para 0044; “To measure foot temperature, the platform 16 has a receiving region 17 … the receiving region 17 has an array, matrix, or other prescribed arrangement of temperature sensors 26 …”; Para 0109; “Illustrative embodiments measure and store the foot temperature at a baseline time reference.” These disclosures indicate measuring and storing a temperature measurement map at a baseline time point (by the disclosed array or matrix of temperature sensors)), and
using the selected reference temperature distributed map to derive temperature change as time-series information (Linders, Para 0109; “… for a later time t, this embodiment measures the foot temperature again and compares the temperatures at time t with the temperatures at baseline and determines if any location has changed in temperature from the baseline more than a predetermined threshold.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Meftah and Wu, as suggested by Linders, in order to select one measured temperature map and use it as reference for monitoring temperature change. One of ordinary skill in the art would have been motivated to make the modification for the benefit of utilizing change of temperature in tissue or organ of interest for diagnosing chronic and acute disease conditions (Linders, Para 0107;“In some pathologies, the absolute temperature at a given time is not as informative as the change in temperatures over time. Chronic conditions may present as slow changes over a long time and acute conditions may present as fast onset or short-lived patterns.”).
With regard to Claim 10, Meftah, Wu and Linders disclose the cervical vertebra temperature change monitoring method as claimed in Claim 9. Meftah further discloses wherein the cervical vertebral area processing step comprises:
determining whether the cervical vertebra is recognized using the pressure sensor (coupling sensors(s), which may be one or more pressure sensors); and
when the user's cervical vertebra is recognized, generating at least two segmented areas by performing segmentation on the cervical vertebra recognition area (Meftah, Para 0035; “FIG. 3A illustrates a temperature matrix 38 comprising of interconnected coupling sensors 16 ... comprise individual elements 40” The disclosed “matrix” segments the skin area that the system is applied to, and agrees with the Application’s disclosure in Para 0042: “… a plurality of pressure sensors may be formed in an N x M matrix. This is for performing area segmentation by means of the area segmentation module 113 …”), which is an area in which the cervical vertebra is recognized (Meftah, Para 0030; “… coupling information from coupling sensor 16a may be used to qualify information from temperature sensor 18a. Information from temperature sensor 18a may be deemed useful and/or reliable based on the information from coupling sensor 16a.” The disclosed “coupling information” indicates which elements are coupled to a target skin area and which are not, so corresponds to the recognized area of Application).
With regard to Claim 11, Meftah, Wu and Linders disclose the cervical vertebra temperature change monitoring method as claimed in Claim 10. Meftah further discloses wherein the segmented areas are formed by using a preset number of or a preset reference wideness of segmented areas (Meftah, Fig. 3A: as shown in the figured cited above, the segmented area has a preset number).
With regard to Claim 12, Meftah, Wu and Linders disclose the cervical vertebra temperature change monitoring method as claimed in Claim 9. Meftah further discloses wherein the temperature distribution analysis performing step comprises:
acquiring body temperature distribution information as a measurement result of the body temperature using the temperature sensor provided in the cervical vertebra recognition area (Meftah, Para 0053; “… vital sign state determination module 112 may be configured to determine one or more temperatures of subject 12 without using or needing coupling information.”); and
generating the temperature distribution map for the cervical vertebra recognition area using the segmented areas (Meftah, Para 0054; “… positional information may be derived from and/or based on coupling information.” The disclosed “coupling information” indicates which elements (i.e. segmented area of Application) are reliably coupled with the skin region) and the body temperature distribution information (temperatures determined by vital sign state determination module 112) (Meftah, Para 0055; “… a vital sign state profile of subject 12 may include a temperature map of subject 12 based on temperatures determined by vital sign state determination module 112 and/or positional information of subject 12.”).
Claims 5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Meftah, Wu and Linders, further in view of Main et al (US 20220087617 A1; hereafter Main).
With regard to Claim 5, Meftah, Wu and Linders disclose the cervical vertebra temperature change monitoring system as claimed in Claim 4. Meftah further discloses wherein the temperature distribution map is generated using the segmented areas (Meftah, Para 0054; “… positional information may be derived from and/or based on coupling information.” The disclosed “coupling information” indicates which elements (i.e. segmented area of Application) are reliably coupled with the skin region) and the body temperature distribution information (temperatures determined by vital sign state determination module 112) (Meftah, Para 0055; “… a vital sign state profile of subject 12 may include a temperature map of subject 12 based on temperatures determined by vital sign state determination module 112 and/or positional information of subject 12.”).
Meftah, Wu and Linders do not clearly and explicitly disclose including a definition for each of the segmented areas through machine learning.
Main in the same field of endeavor discloses including a definition for each of the segmented areas through machine learning (Main, Para 0122; “The computer (e.g., via the machine learning engine 146) may use one or more machine learning models and other data processing techniques to deduce joint locations 540 of the person”; Para 0123; “… the rectangle 543 shown in the heatmap 530 demonstrates how a region of the body can be selected (lumbar) using the joint detection system (convolutional neural network with pre and post processing).” Fig. 5B shows the joint locations 540 and the rectangle 543 that are identified as segmented areas by machine learning in a pressure map). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Meftah, Wu and Linders, as suggested by Main, in order to use machine learning to segment a pressure map. One of ordinary skill in the art would have been motivated to make the modification for the benefit of accurate monitoring of physiologic status of important body regions by intelligently identifying and segmenting such regions from a large pressure map (Main, Para 0123; “Data generated from the weight support device 110 allows a computer to intelligently identify selected areas of the body and extract bio-signals from certain target areas. Both the body and joint locations may be used to identify regions on the body which are then monitored to detect physiological signals. This identification procedure significantly reduces signal noise and allows for more accurate monitoring”).
With regard to Claim 13, Meftah, Wu and Linders disclose the cervical vertebra temperature change monitoring method as claimed in Claim 12. Meftah further discloses wherein the temperature distribution map is generated using the segmented areas (Meftah, Para 0054; “… positional information may be derived from and/or based on coupling information.” The disclosed “coupling information” indicates which elements (i.e. segmented area of Application) are reliably coupled with the skin region) and the body temperature distribution information (temperatures determined by vital sign state determination module 112) (Meftah, Para 0055; “… a vital sign state profile of subject 12 may include a temperature map of subject 12 based on temperatures determined by vital sign state determination module 112 and/or positional information of subject 12.”).
Meftah, Wu and Linders do not clearly and explicitly disclose including a definition for each of the segmented areas through machine learning.
Main in the same field of endeavor discloses including a definition for each of the segmented areas through machine learning (Main, Para 0122; “The computer (e.g., via the machine learning engine 146) may use one or more machine learning models and other data processing techniques to deduce joint locations 540 of the person”; Para 0123; “… the rectangle 543 shown in the heatmap 530 demonstrates how a region of the body can be selected (lumbar) using the joint detection system (convolutional neural network with pre and post processing).” Fig. 5B shows the joint locations 540 and the rectangle 543 that are identified as segmented areas by machine learning in a pressure map). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Meftah, Wu and Linders, as suggested by Main, in order to use machine learning to segment a pressure map. One of ordinary skill in the art would have been motivated to make the modification for the benefit of accurate monitoring of physiologic status of important body regions by intelligently identifying and segmenting such regions from a large pressure map (Main, Para 0123; “Data generated from the weight support device 110 allows a computer to intelligently identify selected areas of the body and extract bio-signals from certain target areas. Both the body and joint locations may be used to identify regions on the body which are then monitored to detect physiological signals. This identification procedure significantly reduces signal noise and allows for more accurate monitoring”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Tremblay et al (US 20230043342 A1) discloses acquiring thermal images of human faces and identifying different facial regions such as eyes, nose and mouth. Christensen et al (US 11219371 B1) discloses acquiring infrared-based images of subjects and monitoring temperature changes based on a baseline image.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI ZHANG whose telephone number is (571)272-7172. The examiner can normally be reached Monday-Friday 8am-5pm E.T..
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/L.Z./ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
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