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 . 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 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.
Claim Objections
Claim 9 is objected to because of the following informalities: the recitation of “method comprising” should instead read –the method comprising--.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 limitation(s) is/are: “sensing device” in claims 1, 4-9, and 13-15.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/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 this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/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 limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/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 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 1-15 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.
Regarding claims 1, 4-9, and 13-15, they contain 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, claim element “sensing device” invokes 35 USC 112(f). However, the written description fails to disclose the corresponding structure, material, or acts for the claimed functions. It is unclear what the structure that e.g. determines exertion is, especially via breath flow (claim 4), contact with skin (claim 6), etc. See the 35 USC 112(b) and 35 USC 112(f) analysis herein.
Regarding claims 2-15, they are rejected because they depend on rejected claims.
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 1-15 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 pre-AIA the applicant regards as the invention.
Regarding claims 1, 4-9, and 13-15, they contain 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, claim element “sensing device” invokes 35 USC 112(f). However, the written description fails to disclose the corresponding structure, material, or acts for the claimed functions. It is unclear what the structure that e.g. determines exertion is, especially via breath flow (claim 4), contact with skin (claim 6), etc. See the 35 USC 112(a) and 35 USC 112(f) analysis herein. Therefore, the claims are indefinite and are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Regarding claims 2 and 3, there is insufficient antecedent basis for the recitations of “the set of possible scores.”
The term “sleep related” in claim 13 is a relative term which renders the claim indefinite. The term “sleep related” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear what makes a condition sleep related.
Claims 2-15 are rejected because they depend on rejected claims.
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1-15 are directed to a “method,” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1 and 9 recite (“set forth” or “describe”) the abstract idea of a mental process and a mathematical concept, substantially as follows:
(a) determining a respiratory exchange ratio (RER) of the subject, (b) determining whether the subject is in a state of exertion or has a physiological condition which affects the correlation between RER and the likelihood that the subject is in ketosis, and (c) taking at least one measurement from act (b), and using the RER measured in the act (a) to determine a score that is associated with the likelihood that the subject is in ketosis, wherein the score is one of a predetermined set of possible values.
The determining steps can be practically performed in the human mind, with the aid of a pen and paper, but for performance on a generic computer, in a computer environment, or merely using the computer as a tool to perform the steps. If a person were to see a printout of e.g. the measured exhaled breath and the measurement from the sensing device, they would be able to determine RER, a state of exertion, and a score based thereon. There is nothing to suggest an undue level of complexity in the determinations. Therefore, a person would be able to perform the steps mentally or with pen and paper.
The determining steps also involve the mathematical concepts of determination/calculation of variables. These steps correspond to “[w]ords used in a claim operating on data to solve a problem [that] can serve the same purpose as a formula.” See MPEP 2106.04(a)(2)(I).
Prong Two: Claims 1 and 9 do not include additional elements that integrate the mental process or mathematical concept into a practical application. Therefore, the claims are “directed to” the mental process and mathematical concept. The additional elements merely:
recite the words “apply it” (or an equivalent) with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g. using a sensing device, etc.), and
add insignificant extra-solution activity (the pre-solution activity of: measuring exhaled breath, taking a measurement using the sensing device, etc.).
As a whole, the additional elements merely serve to gather and feed information to the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the determined score is not outputted in any way such that a diagnostic benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1 and 9 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above.
Dependent Claims
The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
further describe the abstract idea (e.g. what the scores are (claims 2 and 3), using a plurality of values (claim 8), modifying the blood pressure signal based on behavior pattern information (claim 10), etc.),
further describe the pre-solution activity (or the structure used for such activity) (e.g. what the sensing device measures and related details (claims 4-7 and 13-15), the pulse detection circuitry comprising light-emission sub-circuitry (emitting a particular wavelength of light), photosensing sub-circuitry, and a first signal processing circuitry for processing a light signal (claims 2 and 6), etc.), and
describe field-of-use context (e.g. what the condition is (claims 10-12), etc.).
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves another technology or technical field, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2020/0020247 (“Simpson”) in view of US Patent Application Publication 2020/0152080 (“Wu”).
Regarding claim 1, Simpson teaches [a] method of determining a likelihood that a subject is in, or approaching, ketosis (users may learn about how food and/or exercise affects their glucose level and other physiological parameters, as well as overall health - on the basis of pattern recognition - determining how a user could improve a detected pattern in some way. In this way, users such as type II diabetics or even users who are only prediabetic or non-diabetic may learn healthy habits to benefit their health, Abstract, para [0009]-[0013], VO2 and VCO2 parameters and their ratio can be determined and employed in fat burn optimization - the ratio of VCO2 and VO2 (VCO2/VO2 is often referred to as the respiratory exchange ratio, "RER", or just "R") is different between fat metabolism and carbohydrate metabolism. In particular, R is substantially 1.0 for carbohydrate metabolism or glucose metabolism, and R is substantially 0.70 for fat metabolism. The parameters are generally calculated by measuring the concentration of oxygen and carbon dioxide that is inhaled and exhaled, para [0411]-[0416] – also see para [0407], likelihood of fat metabolism), the method comprising acts of: (a) measuring exhaled breath and determining a respiratory exchange ratio (RER) of the subject (the ratio of VCO2 and VO2 (VCO2/VO2 is often referred to as the respiratory exchange ratio, ''RER", or just "R") is different between fat metabolism and carbohydrate metabolism. In particular, R is substantially 1.0 for carbohydrate metabolism or glucose metabolism, and R is substantially 0.70 for fat metabolism. The parameters are generally calculated by measuring the concentration of oxygen and carbon dioxide that is inhaled and exhaled, para [0411 ]-[0416]); (b) using a sensing device to determine whether the subject is in a state of exertion or has a physiological condition which affects the correlation between RER and the likelihood that the subject is in ketosis (activity data is received from an accelerometer or GPS device - activity data may indicate an activity level - sleeping, sedentary, light activity, medium activity, or strenuous activity. The evaluating may include evaluating an effect of the activity data on the glucose concentration data. The displaying may include displaying the effect of the activity data on the glucose concentration data. The data may include data about one or more other analytes, such as ketones, lactic acid, lactate, glycerol, triglycerides, cortisol, and testosterone, para [0009]-[0013], para [0411]-[0416], etc. – also see ¶ 0420, using accelerometers and heart rate monitors to determine a degree of exertion); and (c) taking at least one measurement of the sensing device from act (b), and using the RER measured in the act (a) to determine a score that is associated with the likelihood that a subject is in ketosis (¶¶s 0411-0413, 0418-0422, etc., accelerometer, heart rate, and RER data for fat burn optimization and exercise guidance, including determination of when the user is metabolizing fat) … .
Simpson does not appear to explicitly teach wherein the score that is associated with the likelihood that the subject is in ketosis is one of a predetermined set of possible values.
However, Wu in analogous art discloses taking at least one measurement of the sensing device from act (b), and using the RER measured in the act (a) to determine a "score" that is associated with the likelihood that the subject is in ketosis, wherein the score is one of a predetermined set of possible values (determining a level of ketosis of a user includes an acetone detector that includes an inlet for receiving a breath of a user, a sensor for sensing an amount of acetone in the breath of the user - receiving from the acetone detector measurements of an amount of acetone in breath of a user, receiving from the acetone detector the calibration values, determining a ketosis score based on at least one of the measurements, the calibration values, and predetermined thresholds that are associated with levels of ketosis, wherein the ketosis score is an estimate of a level of ketosis of the user, and displaying the ketosis score to the user, Abstract, ketosis score of "low" or a low number may be associated with breath acetone levels for test subjects who recently consumed carbohydrates and, thus, are likely metabolizing little if any fat. A score of "very high" or a high number may be associated with breath acetone levels for test subjects that have unhealthy levels of ketones in their bloodstream, such as subjects experiencing diabetic ketoacidosis, para [0095]-[0106]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add Wu’s sensor and ketosis score to Simpson’s method so that its app may use the ketosis score to generate recommendations for the user, which are then displayed to the user. Recommendations can include dietary recommendations, exercise recommendations, breath analyzer usage recommendations, and any other suitable recommendation – very low carbohydrate meals may be suggested to a user that has a trend of ketosis low scores (e.g., previous and current), whereas meals with moderate amounts of carbohydrates may be suggested to a user that has a good trend of ketosis score (see Wu: para [0106]-[0111]).
Regarding claim 9, Simpson teaches [a] method of determining a likelihood that a subject is in, or approaching, a physiological state, condition or disorder (users may learn about how food and/or exercise affects their glucose level and other physiological parameters, as well as overall health - on the basis of pattern recognition - determining how a user could improve a detected pattern in some way. In this way, users such as type II diabetics or even users who are only prediabetic or non-diabetic may learn healthy habits to benefit their health, Abstract, para [0009]-[0013], VO2 and VCO2 parameters and their ratio can be determined and employed in fat burn optimization - the ratio of VCO2 and VO2 (VCO2/VO2 is often referred to as the respiratory exchange ratio, "RER", or just "R") is different between fat metabolism and carbohydrate metabolism. In particular, R is substantially 1.0 for carbohydrate metabolism or glucose metabolism, and R is substantially 0.70 for fat metabolism. The parameters are generally calculated by measuring the concentration of oxygen and carbon dioxide that is inhaled and exhaled, para [0411]-[0416] – also see para [0407], likelihood of fat metabolism), method comprising: (a) measuring exhaled breath and determining a respiratory exchange ratio (RER) of the subject (the ratio of VCO2 and VO2 (VCO2/VO2 is often referred to as the respiratory exchange ratio, ''RER", or just "R") is different between fat metabolism and carbohydrate metabolism. In particular, R is substantially 1.0 for carbohydrate metabolism or glucose metabolism, and R is substantially 0.70 for fat metabolism. The parameters are generally calculated by measuring the concentration of oxygen and carbon dioxide that is inhaled and exhaled, para [0411 ]-[0416]); (b) using a sensing device to determine an indicator of the subject’s degree of exertion, physical activity, or excitation (activity data is received from an accelerometer or GPS device - activity data may indicate an activity level - sleeping, sedentary, light activity, medium activity, or strenuous activity. The evaluating may include evaluating an effect of the activity data on the glucose concentration data. The displaying may include displaying the effect of the activity data on the glucose concentration data. The data may include data about one or more other analytes, such as ketones, lactic acid, lactate, glycerol, triglycerides, cortisol, and testosterone, para [0009]-[0013], para [0411]-[0416], etc. – also see ¶ 0420, using accelerometers and heart rate monitors to determine a degree of exertion); and (c) taking at least one measurement of the sensing device from act (b), and using the RER measured in the act (a) to determine a score that is associated with the likelihood that the subject is in the physiological state (¶¶s 0411-0413, 0418-0422, etc., accelerometer, heart rate, and RER data for fat burn optimization and exercise guidance, including determination of when the user is metabolizing fat) … .
Simpson does not appear to explicitly teach wherein the score that is associated with the likelihood that the subject is in a physiological state is one of a predetermined set of possible values.
However, Wu in analogous art discloses taking at least one measurement of the sensing device from act (b), and using the RER measured in the act (a) to determine a "score" that is associated with the likelihood that the subject is in ketosis, wherein the score is one of a predetermined set of possible values (determining a level of ketosis of a user includes an acetone detector that includes an inlet for receiving a breath of a user, a sensor for sensing an amount of acetone in the breath of the user - receiving from the acetone detector measurements of an amount of acetone in breath of a user, receiving from the acetone detector the calibration values, determining a ketosis score based on at least one of the measurements, the calibration values, and predetermined thresholds that are associated with levels of ketosis, wherein the ketosis score is an estimate of a level of ketosis of the user, and displaying the ketosis score to the user, Abstract, ketosis score of "low" or a low number may be associated with breath acetone levels for test subjects who recently consumed carbohydrates and, thus, are likely metabolizing little if any fat. A score of "very high" or a high number may be associated with breath acetone levels for test subjects that have unhealthy levels of ketones in their bloodstream, such as subjects experiencing diabetic ketoacidosis, para [0095]-[0106]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add Wu’s sensor and ketosis score to Simpson’s method so that its app may use the ketosis score to generate recommendations for the user, which are then displayed to the user. Recommendations can include dietary recommendations, exercise recommendations, breath analyzer usage recommendations, and any other suitable recommendation – very low carbohydrate meals may be suggested to a user that has a trend of ketosis low scores (e.g., previous and current), whereas meals with moderate amounts of carbohydrates may be suggested to a user that has a good trend of ketosis score (see Wu: para [0106]-[0111]).
Regarding claim 2, Simpson-Wu teaches all the features with respect to claim 1, as outlined above. Simpson-Wu further teaches where the set of possible scores comprises numerical values within a range between a minimum value and a maximum value (Wu: Ketosis score - may be a number from 1-3, 1-5, 1-6, 1-8, 1-10, 1-15, 1-20, 1-50, or any other suitable range of numbers. Each score may be associated with lower and upper thresholds. For example, a score of 1 may be associated with PPM
values that are below 5 PPM, a score of 2 may be associated with PPM values from 5 to 10, a score of 3, may be associated with PPM values from 10-15, and so on. In some embodiments, the scores are qualitative, rather than quantitative. For example, a range of scores may be low, moderate, high, and very high, para [0096]).
Regarding claim 3, Simpson-Wu teaches all the features with respect to claim 1, as outlined above. Simpson-Wu further teaches where the set of possible scores comprises one or more of a percentage, a word, a name, an alphanumeric label, a graphic representation, an icon, and a color (Wu: Ketosis score - the scores are qualitative, rather than quantitative. For example, a range of scores may be low, moderate, high, and very high, para [0096]).
Regarding claim 4, Simpson-Wu teaches all the features with respect to claim 1, as outlined above. Simpson-Wu further teaches where the sensing device measures of flow, a rate, a frequency or a volume of breath (Wu: sensor for sensing an amount of acetone in the breath of the user – receiving from the acetone detector measurements of an amount of acetone in breath of a user, Abstract, para [0082]-[0083], etc.).
Regarding claim 5, Simpson-Wu teaches all the features with respect to claim 1, as outlined above. Simpson-Wu further teaches where the sensing device detects a concentration of a bio-effluent in the exhaled breath associated with ketosis, including but not limited to ketones (Wu: determining a level of ketosis of a user includes an acetone detector that includes an inlet for receiving a breath of a user, a sensor for sensing an amount of acetone in the breath of the user - receiving from the acetone detector
measurements of an amount of acetone in breath of a user, receiving from the acetone detector the calibration values, determining a ketosis score based on at least one of the measurements, the calibration values, and predetermined thresholds that are associated with levels of ketosis, wherein the ketosis score is an estimate of a level of ketosis of the user, and displaying the ketosis score to the user, Abstract).
Regarding claims 6 and 14, Simpson-Wu teaches all the features with respect to the corresponding claims 1 and 9, as outlined above. Regarding claim 6, Simpson-Wu further teaches where the sensing device is in contact with the subject's skin (Simpson: plurality of sensor devices each configured for insertion through the skin, para [0061]).
Claim 14 is rejected in like manner.
Regarding claim 7, Simpson-Wu teaches all the features with respect to claim 1, as outlined above. Simpson-Wu further teaches where the sensing device measures motion or acceleration (Simpson: activity data is received from an accelerometer or GPS device, para [0009]-[0013]).
Regarding claim 8, Simpson-Wu teaches all the features with respect to claim 1, as outlined above. Simpson-Wu further teaches where a plurality or sequence of values of the RER or of the sensing device, measured over a certain time interval, are used in determining a score (Wu: App may use the previously generated ketosis score, a ketosis score generated around the same time the previous day, a ketosis score generated on the same day the previous week, or a ketosis score from any other
suitable period, para [0106]-[0112]).
Regarding claim 10, Simpson-Wu teaches all the features with respect to claim 9, as outlined above. Simpson-Wu further teaches where the condition is one of an anaerobic metabolism or post-anaerobic recovery (Simpson: FIG. 8 is expanded into various zones 110, e.g., a low fat burning zone 136 (low physical activity), a maximum fat burn zone 134 (optimal fat burn, lipid metabolism), a maximum carbohydrate burning zone 132 (optimal cardiovascular intensity, aerobic carbohydrate metabolism), and a burnout zone 128 (anaerobic metabolism due to lactate buildup), para [0231]).
Regarding claim 11, Simpson-Wu teaches all the features with respect to claim 9, as outlined above. Simpson-Wu further teaches where the condition is a metabolic irregularity including but not limited to ketosis, diabetes, prediabetes and metabolic syndrome (Wu: ketosis score of "low" or a low number may be associated with breath acetone levels for test subjects who recently consumed carbohydrates and, thus, are likely metabolizing little if any fat. A score of "very high" or a high number may be associated with breath acetone levels for test subjects that have unhealthy levels of ketones in their bloodstream, such as subjects experiencing diabetic ketoacidosis, para [0096]-[0098]).
Regarding claim 12, Simpson-Wu teaches all the features with respect to claim 9, as outlined above. Simpson-Wu further teaches where the condition is neurological or sleep related (Simpson: para [0009]-[0013], characteristic features involve looking at glucose curve trace rises, plateaus, falls, associations with known data about events, e.g., meal data, exercise data, sleep data, and so on, and the construction or calculation of numerical deductions and inferences therefrom, para [0355] – also see ¶ 0189).
Regarding claim 13, Simpson-Wu teaches all the features with respect to claim 9, as outlined above. Simpson-Wu further teaches where the sensing device measures a flow, a rate, a frequency or a volume of breath or a presence of a particular bio-effluent in the breath (Wu: determining a level of ketosis of a user includes an acetone detector that includes an inlet for receiving a breath of a user, a sensor for sensing an amount of acetone in the breath of the user - receiving from the acetone
detector measurements of an amount of acetone in breath of a user, receiving from the acetone detector the calibration values, determining a ketosis score based on at least one of the measurements, the calibration values, and predetermined thresholds that are associated with levels of ketosis, wherein the ketosis score is an estimate of a level of ketosis of the user, and displaying the ketosis score
to the user, Abstract, para [0082]-[0083]).
Regarding claim 15, Simpson-Wu teaches all the features with respect to claim 9, as outlined above. Simpson-Wu further teaches where the sensing device is mechanical, electrical or optical (Simpson: glucose sensor can use any method of glucose measurement, including enzymatic, chemical, physical, electrochemical, optical, optochemical, fluorescence-based, spectrophotometric, spectroscopic (e.g., optical absorption spectroscopy, Raman spectroscopy, etc.), polarimetric, calorimetric,
iontophoretic, radiometric, and the like, para [0167]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson, can be reached at telephone number (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791