DETAILED ACTION
This office action is responsive to original claims filed on 04/26/2024. Presently, Claims 1 - 16 remain pending.
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 .
Claim Objections
Claims 1-16 are objected to because of the following informalities:
Claims 1-16 recite “cervical body”. The term “cervical” can relate to the cervix, which is the lower part of uterus. To avoid potential misunderstanding, the recited “cervical body” should be changed to either “cervical vertebra” or “cervical spine”.
Claim 1, Line 4, recites “on cervical vertebra recognition area”, which should be changed to “on a cervical vertebra recognition area”.
Appropriate correction is required.
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 cervical vertebral area processing unit” in Claim 1
A review of the Specification discloses that the corresponding structure for the “cervical vertebral area processing unit” is formed of “at least one pressure sensor, and preferably a plurality of pressure sensor … formed in an N x M matrix” (Para 0042), may include “both a temperature sensor and a pressure sensor” (Para 0044), or include “only a temperature sensor without a pressure sensor” (Para 0045).
“a temperature distribution analysis unit” in Claim 1
A review of the Specification discloses that the corresponding structure for the “temperature distribution analysis unit” is formed of “at least one temperature sensor” (Para 0048), and may include “machine learning” for defining on each of the segmented areas based on the measured pressure values (Para 0051).
“a body temperature change measurement unit” in Claim 1
A review of the Specification discloses that the corresponding structure for the “body temperature change measurement unit” may include “accumulatively storing the temperature distribution map” for each segmented area (Para 0054), “deriving a body temperature change for each of the segmented areas and comparing the derived body temperature change with a preset reference” (Para 0055), selecting of “a reference temperature distribution map” and obtaining of “the amount of temperature change in each segmented area as time-series information” (Para 0055), comparing of “the obtained treatment effect and an expected effect to further derive a personal treatment effect” (Para 0056), “using, in addition to time-series information, a method for analyzing other profiles for the segmented areas” (Para 0057), and determining of “the extent of the effect of the treatment provided to the pertinent user by cumulatively storing the treatment effects for other users” and identifying of “an optimal method using the profiles of other users showing similar treatment effects” (Para 0058).
“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” is formed of algorithm that “express the body temperature distribution information of the entire cervical vertebra recognition area in two dimensions using the body temperature distribution information measured in each of the segmented areas” (Para 0050), and comprises “machine learning” to “perform defining on each of the segmented areas” (Para 0051).
“a segmented area profile generation module” in Claim 6.
A review of the Specification discloses that the corresponding structure for the “segmented area profile generation module” is formed of a method of “cumulatively storing the temperature distribution map ... include time-series information” (Para 0054).
“a treatment effect analysis module” in Claim 6.
A review of the Specification discloses that the corresponding structure for the “treatment effect analysis module” is formed of a method of “deriving a body temperature change for each of the segmented areas and comparing the derived body temperature change with a preset reference” (Para 0055), a method of comparing such treatment effect with “the expected effect corresponding to a treatment method that is pre-entered by a treatment practitioner” (Para 0056), and a method of “comparing the left and right profiles of a cervical vertebral area for each segmented area … and with other users’ profiles for each segmented area” (Para 0057).
“a cervical vertebral area processing step” in Claim 9
A review of the Specification discloses that the corresponding structure for the “cervical vertebral area processing step” is formed of “at least one pressure sensor, and preferably a plurality of pressure sensor … formed in an N x M matrix” (Para 0063).
“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” is formed of “at least one temperature sensor” (Para 0067), and may include “machine learning” for defining on each of the segmented areas based on the measured pressure values (Para 0070).
“a body temperature change measurement performing step” in Claim 9
A review of the Specification discloses that the corresponding structure for the “body temperature change measurement performing step” may include “cumulatively storing the temperature distribution map” for each segmented area (Para 0072), “deriving a body temperature change for each of the segmented areas and comparing the derived body temperature change with a preset reference” (Para 0073), selecting of “a reference temperature distribution map” and obtaining of “the amount of temperature change in each segmented area as time-series information” (Para 0073), comparing of “the obtained treatment effect and an expected effect” to “derive a personal treatment effect” (Para 0074), “using, in addition to time-series information, a method for analyzing other profiles for the segmented areas” (Para 0075), and determining of “the extent of the effect of the treatment provided to the pertinent user” by “cumulatively storing the treatment effects for other users” and identifying of “an optimal treatment method” using “the profiles of other users showing similar treatment effects” (Para 0075).
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 § 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 - 16 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 1-8:
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 …” and “derives a treatment effect …” 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, “includes a definition for each of the segmented areas through machine learning” in Claim 5, “derives the treatment effect by analyzing the profile …” in Claim 6, “the profile … is generated by using the temperature distribution map …” in Claim 7, and “deriving the change in the body temperature … and comparing the derived change … with a preset reference” in Claim 8. 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 body temperature in Claim 1, including at least one temperature sensor in each segmented area in Claim 3, acquiring body temperature distribution information using temperature sensor in Claim 4, and cumulatively storing temperature distribution map in Claim 6, 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 1-8 are not patent eligible.
With regard to Claims 9-16:
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 …” and “deriving a treatment effect …” 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, “includes a definition for each of the segmented areas through machine learning” in Claim 13, “deriving the treatment effect by analyzing the profile …” in Claim 14, “the profile … is generated by using the temperature distribution map …” in Claim 15, and “deriving the change in the body temperature … and comparing the derived change … with a preset reference” in Claim 16. 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 body temperature in Claim 9, including at least one temperature sensor in each segmented area in Claim 11, acquiring body temperature distribution information using temperature sensor in Claim 12, and cumulatively storing temperature distribution map in Claim 14, 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 9-16 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, 6-12 and 14-16 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).
With regard to Claim 1, Meftah discloses a body 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 …” ) using at least one pressure sensor (Meftah, 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);
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 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.”); and
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).
Fig. 3A of Meftah
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Meftah does not clearly and explicitly disclose determining whether the cervical vertebra is recognized.
Wu in the same field of endeavor discloses determining whether the cervical vertebra is recognized (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 or localize 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”).
With regard to Claim 2, Meftah and Wu disclose the cervical body 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 and Wu disclose the cervical body 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), and each of the segmented areas is formed to include at least one temperature sensor (Meftah, Para 0028; “One or more coupling sensors 16 may be associated with one or more temperature sensors, including but not limited using a 1-to-1 association (e.g. for co-located sensor pairs of a temperature sensor and a coupling sensor).”).
With regard to Claim 4, Meftah and Wu disclose the cervical body 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 6, Meftah and Wu disclose the cervical body temperature change monitoring system as claimed in Claim 1. Meftah further discloses wherein the body temperature change measurement unit (Meftah, Para 0051; “… a tracking module 114 configured to track changed in the coupling reliability index of individual vital state sensors over time.”) comprises:
a segmented area profile generation module that cumulatively stores the temperature distribution map to generate a profile for each segmented area (Meftah, Para 0055; “… the end temperatures (i.e. the right-most temperatures depicted) from graph 49 (FIG. 5) are depicted as the current temperatures in temperature map 62 in FIG. 6A. Temperature map 62 may be 2-dimensional or more-than-2-dimensional, for example 3-dimensional.” This disclosure indicates that the temperature map can be recorded along the time axis); and
a treatment effect analysis module that derives the treatment effect by analyzing the profile for each segmented area (Meftah, 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 analysis can be performed for a particular part or area, and by comparing the measured temperature to a target temperature, the system can derive the effect of the treatment and determine if more therapy (i.e. heating or cooling) is needed).
With regard to Claim 7, Meftah and Wu disclose the cervical body temperature change monitoring system as claimed in Claim 6. Meftah further discloses wherein the profile for each segmented area is generated by using the temperature distribution map from the moment the body temperature is first measured to the moment the treatment is completed (Meftah, Para 0061; “Responsive to a determination that a brain temperature falls outside of the corresponding target temperature range, system 10 may be configured to (attempt to) adjust the relevant temperature of subject 12, as described elsewhere herein.” This disclosure indicate that the temperature adjustment (by heating or cooling) starts in response to an abnormal reading of temperature, and ends when the temperature becomes normal; in other words, the profile of measurements for evaluating treatment effect spans from the start of the treatment to the end of the treatment).
With regard to Claim 8, Meftah and Wu disclose the cervical body temperature change monitoring system as claimed in Claim 7. Meftah further discloses wherein the treatment effect is derived by deriving the change in the body temperature for each of the segmented areas (Meftah, 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.”) and comparing the derived change in the body temperature with a preset reference (Meftah, Para 0060; “tracking module 114 may be configured to determine whether one or more temperatures and/or changes in temperatures indicate significant information pertinent to diagnostic purposes … For example, a programmed relation, value, or threshold may be referred to as predetermined.” This disclosure indicates that to determine a change in temperature to be diagnostically significant, such change is evaluated based on a predetermined reference).
With regard to Claim 9, Meftah discloses a body temperature change monitoring method (Meftah, Abstract; “Systems and methods for non-invasive monitoring of vital signs of a subject use multiple coupling sensors and vital sign sensors in order to determine multiple vital sign states of the subject … Positional information/mapping of temperature information can be derived …”; 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 (coupling module 111) using at least one pressure sensor (Meftah, 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 above. With the matrix or grid arrangement, measurement in each element is performed independently, thus forming a plurality of segmented areas as claimed by Application);
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.”); and
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).
Meftah does not clearly and explicitly disclose determining whether the cervical vertebra is recognized.
Wu in the same field of endeavor discloses determining whether the cervical vertebra is recognized (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 or localize 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”).
With regard to Claim 10, Meftah and Wu disclose the cervical body 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 and Wu disclose the cervical body 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), and each of the segmented areas is formed to include at least one temperature sensor (Meftah, Para 0028; “One or more coupling sensors 16 may be associated with one or more temperature sensors, including but not limited using a 1-to-1 association (e.g. for co-located sensor pairs of a temperature sensor and a coupling sensor).”).
With regard to Claim 12, Meftah and Wu disclose the cervical body 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.”).
With regard to Claim 14, Meftah and Wu disclose the cervical body temperature change monitoring method as claimed in Claim 9. Meftah further discloses wherein the body temperature change measurement performing step comprises:
cumulatively storing the temperature distribution map to generate a profile for each segmented area (Meftah, Para 0055; “… the end temperatures (i.e. the right-most temperatures depicted) from graph 49 (FIG. 5) are depicted as the current temperatures in temperature map 62 in FIG. 6A. Temperature map 62 may be 2-dimensional or more-than-2-dimensional, for example 3-dimensional.” This disclosure indicates that the temperature map can be recorded along the time axis); and
deriving the treatment effect by analyzing the profile for each segmented area (Meftah, 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 analysis can be performed for a particular part or area, and by comparing the measured temperature to a target temperature, the system can derive the effect of the treatment and determine if more therapy (i.e. heating or cooling) is needed).
With regard to Claim 15, Meftah and Wu disclose the cervical body temperature change monitoring method as claimed in Claim 14. Meftah further discloses wherein the profile for each segmented area is generated by using the temperature distribution map from the moment the body temperature is first measured to the moment the treatment is completed (Meftah, Para 0061; “Responsive to a determination that a brain temperature falls outside of the corresponding target temperature range, system 10 may be configured to (attempt to) adjust the relevant temperature of subject 12, as described elsewhere herein.” This disclosure indicate that the temperature adjustment (by heating or cooling) starts in response to an abnormal reading of temperature, and ends when the temperature becomes normal; in other words, the profile of measurements for evaluating treatment effect spans from the start of the treatment to the end of the treatment).
With regard to Claim 16, Meftah and Wu disclose the cervical body temperature change monitoring method as claimed in Claim 15. Meftah further discloses wherein the treatment effect is derived by deriving the change in the body temperature for each of the segmented areas (Meftah, 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.”) and comparing the derived change in the body temperature with a preset reference (Meftah, Para 0060; “tracking module 114 may be configured to determine whether one or more temperatures and/or changes in temperatures indicate significant information pertinent to diagnostic purposes … For example, a programmed relation, value, or threshold may be referred to as predetermined.” This disclosure indicates that to determine a change in temperature to be diagnostically significant, such change is evaluated based on a predetermined reference).
Claims 5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Meftah and Wu, further in view of Main et al (US 20220087617 A1; hereafter Main).
With regard to Claim 5, Meftah and Wu disclose the cervical body 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 and Wu 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 and Wu, 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 and Wu disclose the cervical body 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 and Wu 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 and Wu, 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
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/L.Z./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798