DETAILED ACTION
This action is pursuant to claims filed on 06/02/2023. Claims 10-20 are pending. A first action on the merits of claims 10-20 is as follows.
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 10-12, 14, and 19-20 are objected to because of the following informalities:
In claim 10, “determine the hemodynamic state and the effort capacity” should read “determine a hemodynamic state and an effort capacity”
In claim 10, “the environment in which the method is taking place” should read “an environment in which the method is taking place”
In claim 11, “through thermal images” should read “through the thermal images”
In claim 12, “the infraorbital region” should read “an infraorbital region”
In claim 12, “a hand” should read “the hand”
In claim 14, “and infraorbital region” should read “and the infraorbital region”
In claim 19, “the right atrial” should read “a right atrial”
In claim 20, “the right atrial” should read “a right atrial”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 10-20 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.
Regarding claim 10, the claim recites the limitation “entering the thermal images on a magnetic medium to be analyzed” and “entering on a magnetic medium additional data”. The magnetic medium is not disclosed in the specification or the parent application, nor do the steps of entering the thermal images and the additional data onto a magnetic medium, therefore these limitations do not comply with the written description requirement. Claims 11-20 are also rejected due to their dependency on claim 10.
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 10-20 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.
Regarding claim 10, the claim recites the limitation “magnetic medium”. It is unclear what this is and how it is incorporated in the invention, as it is not described in the specification. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, any kind of magnetic medium will teach on this limitation. Claims 11-20 are also rejected due to their dependency on claim 10.
Further regarding claim 10, it is noted that the conditional step of “analyzing the acquired data obtained through the previous steps by means of predictive Machine Learning (ML) techniques in order to predict the results of: i) a distance walked by the individual if subjected to a Six-Minute Walk Test (6MWT), or ii) a Cardiac Index (CI) and Systemic Vascular Resistance (SVR) of the individual if subjected to hemodynamic monitoring with Swan-Ganz catheter, if the individual is subjected to either of tests i) and ii).” may never occur. In particular, claim 10 does not positively recite the condition precedent (i.e. the Six-Minute Walk Test or the individual being subjected to hemodynamic monitoring), actually occurs, or is ever required to occur, within the broadest reasonable interpretation. Since the recited “if” conditions need not be satisfied to meet the claim, the recited steps of determining need not occur to satisfy the claim. As such, the Examiner need not present evidence establishing the obviousness of the conditional "if step of claims …, because it is not required to be performed under the broadest reasonable interpretation of the claim. One skilled in the art would not necessarily have the ability to ascertain the metes and bounds of the particular claim limitation. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claims 11-20 are also rejected due to their dependency on claim 10.
Regarding claim 11, the claim recites the limitation “wherein the temperature values are determined through thermal images from the front and the lateral side of the individual's face, and the palm of the individual's hand”. It is not possible for the temperature values being determined from the front side of the face, the lateral side of the face, and the palm of the hand, since not all these measurements are required to be taken in claim 10. It is not clear how the temperature values are determined from all three of these measurements if one of the measurements is not taken in the measurement step of claim 10. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is not required for all three locations to be used to determine the temperature values. Claim 12 is also rejected due to its dependency on claim 11.
Regarding claim 12, the claim recites the limitation “wherein the temperature values are determined from the captured thermal images in regions of the front and lateral side of the individual's face selected from a left eye, a right eye, a nose, an interciliar region, a dihedral angle formed by the nose and the infraorbital region, an ear canal and a pinna, and in regions of the individual's palm of a hand selected from a wrist, a central region of the palm and fingertips”. It is not possible for the temperature values being determined from all these locations, as it is not required that all these measurements are to be taken in claim 10. It is not clear how the temperature values are determined from all of these measurements if one of the measurements is not taken in the measurement step of claim 10. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is not required for all locations to be used to determine the temperature values.
Regarding claim 15, the claim recites the limitation “wherein the coldest points from the nose (NRF) and the interciliar regions (ICF)”. It is unclear what this limitation is intended to say, as it does not clarify or further limit anything. It is unclear what happens wherein the coldest points from the nose and interciliar regions, or what is intended to be read from this limitation. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as any situation wherein the points can be selected from the nose and interciliar regions.
Regarding claim 16, the claim recites the limitation “wherein when the 6MWT is predicted, thermal gradients are established a) between the temperature values of the right eye and the nose (NO gradient), b) between the temperature values of ear canal and the pinna (CP gradient), and c) between the temperature values of distinctive points of the hand”. It is unclear how this limitation is performed, since the 6MWT is not required to be performed, and additionally, it is not possible for the temperature values being determined from all these locations, as it is not required that all these measurements are to be taken in claim 10. It is not clear how the temperature values are determined from all of these measurements if one of the measurements is not taken in the measurement step of claim 10. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is not required for all locations to be used to determine the temperature values, and the thermal gradients can be established between any of the temperature values.
Regarding claim 17, the claim recites the limitation “wherein when the CI and SVR are predicted, thermal averages are established a) between the ICF, the NRF and the ADEC, b)at the OP, and c) between ADEC and ICF”. It is unclear how this limitation is performed, since the Ci and SVR is not required to be predicted, and additionally, it is not possible for the temperature values being determined from all these locations, as it is not required that all these measurements are to be taken in claim 10. It is not clear how the temperature values are determined from all of these measurements if one of the measurements is not taken in the measurement step of claim 10. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is not required for all locations to be used to determine the temperature values, and the thermal gradients can be established between any of the temperature values.
Regarding claim 19, the claim recites the limitation “the patient”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 10-12 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kostopoulos (US PG Pub 20190323895) in further view of Tzvieli (US PG Pub 20170035344).
Regarding independent claim 10, Kostopoulos teaches a non-invasive diagnostic method of diagnosing cardiovascular performance by clinical testing to determine the hemodynamic state and the effort capacity of an individual subjected to trial ([0003]: “a computer-implemented method for thermal sensing of a biological subject includes receiving infrared data about the biological subject from an infrared sensor and a thermal image about the biological subject from an imaging sensor. The method includes identifying at least one feature in the thermal image using a machine learning process, and determining a diagnostic output based on the infrared data corresponding to the at least one feature”), the method comprising the steps of:
capturing thermal images utilizing an infrared thermographic camera ([0027]: “the imaging sensor is a thermographic camera that can detect radiation in the long-infrared range of the electromagnetic spectrum (roughly 9,000-14,000 nanometers or 9-14 μm) and produce images of that radiation (e.g., thermograms, thermal image)”) from one of a) a face and a hand of the individual, and b) a front and lateral side of the face of the individual ([0044]: “the imaging sensor S.sub.2 can capture images of the head of the biological being including the face of the biological being. FIG. 6A illustrates an exemplary image 600 (e.g., acquired by the imaging sensor S.sub.2) of a biological being 602. Here, the image 600 is a thermogram including the head of the biological being 602 according to a frontal view of the face of the biological being.”; [0042]: “the method 400 includes identifying areas of interests of the biological being based on the biometric data. In some embodiments, identifying the areas of interest includes identifying multiple physiological structures of the biological being”);
entering the thermal images on a magnetic medium to be analyzed ([0077]: ““Computer-readable medium,” as used herein, refers to a non-transitory computer readable storage medium that stores instructions and/or data … Common forms of a computer-readable medium can include, but are not limited to, … magnetic medium”);
on the captured thermal images, determining temperature values of a series of specific preselected points in established regions of the individual ([0072]: “the processor 108 also determines the diagnostic output based on the infrared data corresponding to the at least one feature. For example, the processor 108 can determine a core body temperature based on the feature identified in the thermal images”);
analyzing said temperature values through a library of code and software of the infrared thermographic camera, which allows an interpretation of infrared color spectrum ([0034]: “The processor 124 can include a graphics processing unit (GPU), logic circuitry (not shown) with hardware, firmware, and software architecture frameworks for facilitating biometric data measurement and processing with the components of the computing device 108, the thermal sensing device 102, the external server architecture 104, the portable device 110, and other components of the architecture 100”; [0027]: “the imaging sensor is a thermographic camera that can detect radiation in the long-infrared range of the electromagnetic spectrum (roughly 9,000-14,000 nanometers or 9-14 μm) and produce images of that radiation (e.g., thermograms, thermal image)”).
However, Kostopoulos does not disclose translating the temperature in degrees centigrade.
Tzvieli teaches detection of an allergic reaction using thermal measurements of the face. Specifically, Tzvieli teaches translation into temperature in degrees centigrade ([0106]: “an onset may be detected if the rise in the temperature of an ROI in the nasal area and/or the mouth exceeds a certain threshold value such as, 0.5° C., 0.8° C., 1.0° C., or some other value greater than 0.5° C. and lower than 2.0° C”). Kostopoulos and Tzvieli are analogous arts as they are both related to taking thermal images of the user to determine health conditions.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the temperature units from Tzvieli into the method from Kostopoulos as Kostopoulos is silent on the units of the temperature measurements, and Tzvieli disclose suitable units in an analogous art.
The Kostopoulos/Tzvieli combination teaches entering on a magnetic medium additional data consisting of general parameters of the individual and the environment in which the method is taking place (Kostopoulos, [0077]: ““Computer-readable medium,” as used herein, refers to a non-transitory computer readable storage medium that stores instructions and/or data … Common forms of a computer-readable medium can include, but are not limited to, … magnetic medium”; [0040]: “in addition to the biometric data, other types of data about the biological being can be received. For example, demographic information, an identity of the biological being, among others. The demographic information can be received for example via input to the thermal sensing device 102 and/or received as stored data from, for example, the memory 126 and/or the disk 128”; [0071]: “the input thermal images can be obtained using a thermal imaging camera (e.g., the imaging sensor S.sub.1) at various acclimation times, wherein each acclimation time is an amount of time in which each respective febrile biological subject or afebrile biological subject resides in a controlled temperature environment prior to capturing the respective thermal input image for the respective febrile biological subject or afebrile biological subject in the controlled temperature environment”); and
analyzing the acquired data obtained through the previous steps by means of predictive Machine Learning (ML) techniques (Kostopoulos, [0002]: “The processor identifies at least one feature in the thermal image using a machine learning process, determines the diagnostic output based on the infrared data corresponding to the at least one feature, and controls the display to provide the diagnostic output”) in order to predict the results of:i) a distance walked by the individual if subjected to a Six-Minute Walk Test (6MWT), or ii) a Cardiac Index (CI) and Systemic Vascular Resistance (SVR) of the individual if subjected to hemodynamic monitoring with Swan-Ganz catheter, if the individual is subjected to either of tests i) and ii).
Regarding claim 11, the Kostopoulos/Tzvieli combination teaches the method of claim 10, wherein the temperature values are determined through thermal images from the front and the lateral side of the individual's face, and the palm of the individual's hand (Kostopoulos, [0044]: “the imaging sensor S.sub.2 can capture images of the head of the biological being including the face of the biological being. FIG. 6A illustrates an exemplary image 600 (e.g., acquired by the imaging sensor S.sub.2) of a biological being 602. Here, the image 600 is a thermogram including the head of the biological being 602 according to a frontal view of the face of the biological being.”; [0042]: “the method 400 includes identifying areas of interests of the biological being based on the biometric data. In some embodiments, identifying the areas of interest includes identifying multiple physiological structures of the biological being”).
Regarding claim 12, the Kostopoulos/Tzvieli combination teaches the method of claim 11, wherein the temperature values are determined from the captured thermal images in regions of the front and lateral side of the individual's face selected from a left eye, a right eye, a nose, an interciliar region, a dihedral angle formed by the nose and the infraorbital region, an ear canal and a pinna, and in regions of the individual's palm of a hand selected from a wrist, a central region of the palm and fingertips (Kostopoulos, [0046]: “The method 500 includes localizing the areas of interests and/or the physiological structures based on the output from the segmentation model. For example, the images captured from the imaging sensor S.sub.2 can be processed for feature extraction and/or facial recognition by the area of interest segmentation module”, see Table 1 for examples of facial feature points).
Regarding claim 18, the Kostopoulos/Tzvieli combination teaches the method of the claim 10, wherein the general parameters from the individual are at least one of a gender, a size, a weight and a cardiac frequency, a blood pressure, a functional class, a vasodilator drugs the patient is taking and an oxygen saturation (Kostopoulos, [0024]: “Biometric information can include, but is not limited to, thermal data (e.g., temperature data, thermograms), heart rate, blood pressure, blood flow, photoplethysmogram, oxygen content”; [0040]: “in addition to the biometric data, other types of data about the biological being can be received. For example, demographic information, an identity of the biological being, among others”).
Regarding claim 19, the Kostopoulos/Tzvieli combination teaches the method of the claim 10, wherein the general parameters from the individual are at least one of a gender, a use of intravenous vasoconstrictor or vasodilator drugs, an awake or an asleep state, and an approximative value of central venous pressure (PVC) in the right atrial (Kostopoulos, [0040]: “in addition to the biometric data, other types of data about the biological being can be received. For example, demographic information, an identity of the biological being, among others”).
Regarding claim 20, the Kostopoulos/Tzvieli combination teaches the method of the claim 10, wherein the additional general parameters from the individual are at least one of gender, use of intravenous vasoconstrictor or vasodilator drugs, awake or asleep state, and an approximative value of central venous pressure (PVC) in the right atrial (Kostopoulos, [0040]: “in addition to the biometric data, other types of data about the biological being can be received. For example, demographic information, an identity of the biological being, among others”).
Claims 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over the Kostopoulos/Tzvieli combination as applied to claim 12 above, and further in view of Bowling (US Patent 3245402).
Regarding claim 13, the Kostopoulos/Tzvieli combination teaches the method of the claim 12.
However, the Kostopoulos/Tzvieli combination does not teach wherein only a hottest point and a coldest point of each region are considered to determine the temperature values.
Bowling discloses a process of diagnosis by infrared thermography. Specifically, Bowling teaches wherein only a hottest point and a coldest point of each region are considered to determine the temperature values (Column 1, lines 30-41: “All infrared thermographs require two controls; one determines the range from hottest to coldest recorded object, and is expressed usually in the form of a range of temperatures or exposures which cover a gray scale on the final thermogram itself. The other necessary control is to fix the average temperature to reproduce as a particular gradation on the gray scale. These two functions must be performed in order to carry out the process of the present invention, and must be capable of individual adjustment. This can well be realized by the fact that the average temperature of the scene may vary greatly”). Kostopoulos, Tzvieli, and Bowling are analogous arts as they are all related to taking thermal measurements of the user to determine health conditions.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include using only the hottest and coldest points from Bowling into the Kostopoulos/Tzvieli combination as it allows the method to only require two points to determine the temperature, which can provide easier calculations and quicker computations.
Regarding claim 14, the Kostopoulos/Tzvieli/Bowling combination teaches the method of the claim 13, wherein the hottest points are elected from the left eye (Oi), the right eye (Od), a tip of the nose (Na), the dihedral angle formed between the nose and infraorbital region (ADEC), the ear canal (Ca), and the pinna (Pa), the wrist, the central region of the palm of the hand and the fingertips (Kostopoulos, [0046]: “The method 500 includes localizing the areas of interests and/or the physiological structures based on the output from the segmentation model. For example, the images captured from the imaging sensor S.sub.2 can be processed for feature extraction and/or facial recognition by the area of interest segmentation module”, see Table 1 for examples of facial feature points).
Regarding claim 15, the Kostopoulos/Tzvieli/Bowling combination teaches the method of the claim 13, wherein the coldest points from the nose (NRF) and the interciliar regions (ICF) (Kostopoulos, [0046]: “The method 500 includes localizing the areas of interests and/or the physiological structures based on the output from the segmentation model. For example, the images captured from the imaging sensor S.sub.2 can be processed for feature extraction and/or facial recognition by the area of interest segmentation module”, see Table 1 for examples of facial feature points).
Regarding claim 16, the Kostopoulos/Tzvieli/Bowling combination teaches the method of claim 13, wherein when the 6MWT is predicted, thermal gradients are established a) between the temperature values of the right eye and the nose (NO gradient), b) between the temperature values of ear canal and the pinna (CP gradient), and c) between the temperature values of distinctive points of the hand (Kostopoulos, [0044]: “The gradient variations shown in the image 600 correspond to variations in temperature as emitted amounts of radiation”; [0049]: “the biological value can be a temperature or a thermal gradient of the area of interests and/or multiple physiological structures”; [0052]: “As an illustrative example, X1 can be a temperature value or a thermal gradient derived from an image associated with the nose of the biological being, X2 can be a temperature value or a thermal gradient derived from an image and associated with the forehead of the biological being, and X3 can be a temperature value or a thermal gradient derived from an image associated with the ear of the biological being”).
Regarding claim 17, the Kostopoulos/Tzvieli/Bowling combination teaches the method of claim 13, wherein when the CI and SVR are predicted, thermal averages are established a) between the ICF, the NRF and the ADEC, b)at the OP, and c) between ADEC and ICF (Kostopoulos, [0044]: “The gradient variations shown in the image 600 correspond to variations in temperature as emitted amounts of radiation”; [0049]: “the biological value can be a temperature or a thermal gradient of the area of interests and/or multiple physiological structures”; [0052]: “As an illustrative example, X1 can be a temperature value or a thermal gradient derived from an image associated with the nose of the biological being, X2 can be a temperature value or a thermal gradient derived from an image and associated with the forehead of the biological being, and X3 can be a temperature value or a thermal gradient derived from an image associated with the ear of the biological being”).
Conclusion
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/E.K.M./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791