DETAILED ACTION
Claims 10-21 are hereby the present claims under consideration.
Examiner’s Note: all references to the specification are made using the paragraph numbers assigned in the US publication of the present application US 20250213923 A1.
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 .
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
In particular the references section on page 12 or paragraph 0114 includes an embedded hyperlink.
Claim Objections
Applicant is advised that should claim 10 be found allowable, claim 12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
In the instant case, claims 10 and 12 recite identical method steps (a) – (e). Step (f) of claims 10 and 12 do not recite identical wording but they are not considered to be patentably distinct from each other because the optimization performed in claim 12 is considered to be some form of adjustment to the exercise intensity, volume, and/or frequency based on the determination of step (e). Claim 10 also sets forth an adjustment of the same parameters based on the same determination and thus the claims are not considered to be patentably distinct. Claims 10 and 12 are also both considered to be drawn towards methods. While claim 12 recites “A non-therapeutic computer system” in the preamble, this language is merely considered to be an indication that the method is a computer-implemented method since the computer system itself is not defined or described in the claim. Thus claims 10 and 12 are also both drawn towards methods, one being computer implemented is further not considered a patentable distinction.
Claims 10-12, 14-17, and 19-21 are objected to because of the following informalities:
Claim 10 it appears that “increasing or decreasing the exercise intensity, exercise frequency, and/or exercise volume” should recite “increasing or decreasing the subject’s exercise intensity, exercise frequency, and/or exercise volume” to better align with the language from step (c)
Claim 11 it appears that “(f) feeding deviation data” should read “(f) feeding the deviation(s)”
Claim 12 it appears that “(f) optimizing the exercise intensity/volume” should read “(f) optimizing the subject’s exercise intensity”
Claim 14 line 3 it appears that ”72 h” should read “72 hours”
Claim 15 it appears that “wherein the samples in steps (a) and (c) are provided from a subject who has, on the day immediately preceding the day of providing the sample, eaten at least 3 grams of carbohydrates per kg bodyweight” should read “wherein for each of the samples provided in steps (a) and (c) respectively, the subject has eaten at least 3 grams of carbohydrates per kilogram of bodyweight on a day immediately preceding a day of providing the respective sample” or the like.
Claim 16 it appears that “wherein each sample is” should read “wherein each of the samples from steps (a) and (c) are”
Claim 17 line 2 it appears that the term “dromedary” is redundant as the term “camel” encompasses both dromedary (one hump camels) and Bactrian (two hump camels).
Claim 19 it appears that “the exercise intensity or exercise frequency” should read “the subject’s exercise intensity or exercise frequency” to better match claim 10
Claim 20 line 4 it appears that “the same level” should read “the same level as expressed in step (c)”
Claim 21 it appears that each of the limitations HPLC/UPLC, ELISA, and RIA should have their full name written out followed by the acronym in parenthesis such as “Enzyme-linked immunosorbent assays (ELISA)”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10-21 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Claim 10 recites “an exercising subject” in line 3 but it is unclear if this subject is the same as, related to, or different from “a subject” of line 2. For the purposes of this examination, all references to “subject” will be interpreted as the same subject.
Claim 10 recites “an exercising subject not experiencing negative effects of exercise” in lines 3-4. It is unclear what the meets and bound of a subject not experiencing negative effects entails. In particular, paragraphs 0042-0044 of the specification provide an open definition of conditions that may be indicative of a “negative effect” of exercise but such an open definition does not clearly establish the meets and bounds of criteria that would define a subject who is experiencing negative effects of exercise. Since the definition provided in the specification is open ended and the term “negative” is subjective, it is unclear what the meets and bounds of “experiencing negative effects of exercise”. For the purposes of this examination, the limitation will be interpreted as any exercising subject. This rejection and interpretation are similarly applied to the similar limitations in claims 11 and 12.
Claim 10 recites the limitations "the concentrations" and “the group” in line 5, the limitations “the deviation(s)” in line 12. There is insufficient antecedent basis for these limitations in the claim.
Claim 10 recites “the sample provided” in line 7. It is unclear if this limitation is meant to refer to the sample provided in step (a) or the sample provided in step (c). For the purposes of this examination, the limitation will be interpreted as referring to the sample of step (a). This rejection and interpretation is similarly applied to the similar recitations of claims 11 and 12.
Examiner’s Note: It would seem that the different sample limitations should be clarified to distinctly point out which sample is being referenced. It would seem that amending the claim to recite “(a) providing a first sample” and “(c) providing a second sample” would help distinguish the samples from each other and provide a clear way to identify which sample is being analyzed in each step such as in step (b) which may recite “the first sample provided” and in step (d) which may recite “measuring the second sample ex vivo”. This suggestion is further applicable to claims 11 and 12.
Claim 10 recites “(d) measuring ex vivo the concentration of the same metabolite(s) as in step (b)” but it is unclear what sample is being measured in this step. In particular, it is unclear if the sample from step (a) or the sample from step (c) is being measured. It is further unclear if “the concentration(s)” of this limitation are meant to refer to “the concentrations” of step (b) or if this limitation is meant to denote different concentrations of the metabolites. For the purposes of this examination, this limitation is interpreted as “(d) measuring ex vivo a concentration of the same metabolite(s) as in step (b) from the sample from the subject, after the subject's exercise intensity, exercise frequency and/or exercise volume has been increased, or when experiencing negative effects of exercise” This rejection and interpretation is similarly applied to the similar recitations of claims 11 and 12.
Claim 10 recites “(c) providing a sample from the subject, after the subject's exercise intensity, exercise frequency and/or exercise volume has been increased” but it is unclear from what level these parameters have been increased from. The claim does not set forth a baseline or first level for these parameters and thus it is unclear what the increase is relative to. For the purposes of this examination, the limitation is interpreted as the exercise parameters being increased with respect to the exercise being performed in step (a). This rejections and interpretation are similarly applied to claims 11 and 12.
Claim 10 recites “increasing or decreasing the exercise intensity, exercise frequency, and/or exercise volume, or to stay at the same level as expressed in step (c)” but it is unclear what “the same level as expressed in step (c) is intended to refer to. It is unclear if the “level” is intended to refer to a respective value for each of, or a subset of, exercise intensity, exercise frequency, and exercise volume or some other parameter. For the purposes of this examination, the limitation is interpreted as referring to an increase, decrease, or no change in exercise intensity, exercise frequency, and/or exercise volume with respect to the parameters values at step (c).
Claim 11 recites the limitations "the concentrations" and “the group” in line 3, the limitations “the deviation(s)” in line 9. There is insufficient antecedent basis for these limitations in the claim.
Claim 12 recites the limitations "the concentrations" and “the group” in line 5, the limitations “the deviation(s)” in line 12. There is insufficient antecedent basis for these limitations in the claim.
Claims 13-21 are rejected by virtue of their dependence on claim 10.
Claim 13 recites the limitation "the day" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the last time the subject exercised" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites “a subject” in line 2. It is unclear if this subject is the same subject of claim 10 line 2 or a different subject. For the purposes of this examination, the subject of claim 15 is interpreted as the same subject of claim 10.
Claim 15 recites the limitations "the day immediately preceding" and “the day of providing’ in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 and 20 each further define circumstances that may be measured and how those circumstances indicate what changes should be made to the exercise. However neither of these claims set forth what step is being limited. It is thus unclear how the situations set forth by claims 19 and 20 are meant to further limit the claimed method. For the purposes of this examination, claims 19 and 20 are interpreted as being drawn towards further limiting step (f) of claim 10.
Claim 20 recites “when none of the metabolites exhibit a change in relation to baseline as expressed, exercise intensity or exercise frequency or exercise volume should be increased, when 1 or 2 of the metabolites exhibit a change as expressed, exercise should be maintained at the same level, and when 3 or 4 of the metabolites exhibit a change as expressed, exercise intensity or exercise frequency or exercise volume should be decreased” however this limitation appears to directly contradict claim 19 from which it depends. Claim 19 sets forth “deviation(s) of any of the metabolite(s) concentrations from baselines amounting to at least a 10% increase for citrate, at least a 15% increase for alpha-hydroxybutyrate, at least a 15% increase for beta-hydroxybutyrate, and below 95% of baseline for L-cysteine, indicates that the exercise intensity or exercise frequency should be reduced” which appears to indicate that if any of the set forth differences are detected then the exercise intensity or frequency should be reduced. For the purposes of this examination, claim 19 will be interpreted as setting forth the differences being considered to be significant and claim 20 will be interpreted as setting forth when and how the exercise is changed based on the detected deviations.
Claim 20 recites “a change in relation to baseline as expressed” in line 2, and “a change as expressed in lines 3-4, and 5. It is unclear if these recited “changes” are meant to refer to the change criteria set forth in claim 19 or any change with respect to the baseline values. For the purposes of this examination, the limitations will be interpreted as referring to the deviations set forth in claim 19.
Claim 20 recites “exercise intensity or exercise frequency or exercise volume” in lines 2-3, “exercise” in line 4, and “exercise intensity or exercise frequency or exercise volume” in line 5. It is unclear if each of these limitations are the same as related to, or different from each other and/or “the subject’s exercise intensity, exercise frequency and/or exercise volume” of claim 10. For the purposes of this examination, each of these limitations will be interpreted as referring to the same parameters of the subject’s exercise.
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 10-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 10-21 are directed to a method of determining an optimal exercise dose, which is an abstract idea. Claims 10-21 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019) and the 2024 Update on Subject Matter Eligibility (Federal Register, Vol 89, No. 137, page 58128, July 17, 2024).
The analysis of claim 10 is as follows:
Step 1: Claim 10 is drawn to a process
Step 2A – Prong One: Claim 10 recites an abstract idea. In particular, claim 10 recites the following limitations:
[A1] (e) determining the deviation(s) of the concentration(s) in d) from the baseline(s)
[B1] (f) making a decision, based on the deviation(s) in step (e), as to increasing or decreasing the exercise intensity, exercise frequency, and/or exercise volume, or to stay at the same level as expressed in step (c)
These elements [A1]-[B1] of claim 10 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 10 recites the following limitations that are beyond the judicial exception:
[A2] (a) providing a sample from an exercising subject not experiencing negative effects of exercise;
[B2] (b) measuring ex vivo the concentration(s) of one or more metabolite(s) from the group comprising or consisting of citrate, alpha-hydroxybutyrate, beta-hydroxybutyrate, and L- cysteine, in the sample provided, to obtain a baseline or baselines
[C2] (c) providing a sample from the subject, after the subject's exercise intensity, exercise frequency and/or exercise volume has been increased, or when experiencing negative effects of exercise;
[D2] (d) measuring ex vivo the concentration of the same metabolite(s) as in step (b);
These elements [A2]-[D2] of claim 10 do not integrate the exception into a practical application of the exception. In particular, the elements [A2]-[D2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: Claim 10 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitations of [A2]-[D2] do not qualify as significantly more because these recitations do not incorporate the gathering of the sample as part of the claimed invention. Additionally, these recitations do not incorporate any particular sensors or measurement equipment to perform the measurement of the samples. Additionally, the measurement of the recited metabolites uses routine and conventional equipment and one of ordinary skill in the art would be well equipped to perform such a measurement as stated by Applicant in paragraph 0045. Thus, these steps are drawn towards mere data gathering using nothing more than routine, conventional, and/or well known sample analysis methods and sensors
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Thus, the additional elements are not considered to amount to significantly more than the abstract idea itself.
Claims 13-21 depend from claim 10, and recite the same abstract idea as claim 10. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claim 21: wherein the measurements of the metabolite(s) in steps (b) and (d) are performed by way of mass spectrometry, HPLC/UPLC, enzymatic assays using spectroscopic methods, ELISA, RIA, or fluoro-immunoassay;
Each of these claim limitations does not integrate the exception into a practical application. In particular, the elements of claims 21 are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Additionally, the elements of claim 21 merely describe how the measurement is performed. Claim 21 does not incorporate any particular sensor into the claimed method and, as describe in paragraph 0045 of the specification, one of ordinary skill in the art would recognize these techniques as conventional and suitable for performing the recited measurements.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Thus, the additional elements are not considered to amount to significantly more than the abstract idea itself.
The below analysis of claims 11 and 12 are done in light of the above presented analysis of claim 10 and is abridged where limitations are similar.
The analysis of claim 11 is as follows:
Step 1: Claim 11 is drawn to a process
Step 2A – Prong One: Claim 11 recites an abstract idea. In particular, claim 11 recites the following limitations:
[A1] (e) determining the deviation(s) of the concentration(s) in d) from the baseline(s)
[B1] (f) feeding deviation data from step (e) into a database
These elements [A1]-[B1] of claim 11 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 11 recites the following limitations that are beyond the judicial exception:
[A2] (a) providing a sample from an exercising subject not experiencing negative effects of exercise;
[B2] (b) measuring ex vivo the concentration(s) of one or more metabolite(s) from the group comprising or consisting of citrate, alpha-hydroxybutyrate, beta-hydroxybutyrate, and L- cysteine, in the sample provided, to obtain a baseline or baselines
[C2] (c) providing a sample from the subject, after the subject's exercise intensity, exercise frequency and/or exercise volume has been increased, or when experiencing negative effects of exercise;
[D2] (d) measuring ex vivo the concentration of the same metabolite(s) as in step (b);
These elements [A2]-[D2] of claim 11 do not integrate the exception into a practical application of the exception. In particular, the elements [A2]-[D2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: These additional elements do not qualify as significantly more for the same reasons set forth above in the analysis of claim 10.
The analysis of claim 12 is as follows:
Step 1: Claim 12 is drawn to a process
Step 2A – Prong One: Claim 12 recites an abstract idea. In particular, claim 12 recites the following limitations:
[A1] (e) determining the deviation(s) of the concentration(s) in d) from the baseline(s)
[B1] optimizing the exercise intensity/volume, exercise frequency, and/or exercise volume, based on the deviation(s) in step (e)
These elements [A1]-[B1] of claim 12 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 12 recites the following limitations that are beyond the judicial exception:
[A2] (a) providing a sample from an exercising subject not experiencing negative effects of exercise;
[B2] (b) measuring ex vivo the concentration(s) of one or more metabolite(s) from the group comprising or consisting of citrate, alpha-hydroxybutyrate, beta-hydroxybutyrate, and L- cysteine, in the sample provided, to obtain a baseline or baselines
[C2] (c) providing a sample from the subject, after the subject's exercise intensity, exercise frequency and/or exercise volume has been increased, or when experiencing negative effects of exercise;
[D2] (d) measuring ex vivo the concentration of the same metabolite(s) as in step (b);
[E2] a non-therapeutic computer system
These elements [A2]-[D2] of claim 12 do not integrate the exception into a practical application of the exception. In particular, the elements [A2]-[D2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the element [E2] is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: These additional elements do not qualify as significantly more for the same reasons set forth above in the analysis of claim 10.
Further, the element [E2] does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
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 10-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Lewis US Patent Application Publication Number US 20180249966 A1 hereinafter Lewis in view of Cardosi International Patent Application Publication Number WO 2016174454 A1 hereinafter Cardosi.
Examiner’s Note: the below presented rejections are applied to the claims as best understood in light of the above presented 35 U.S.C. 112 rejections.
Regarding claim 10, Lewis disclose a non-therapeutic method of preventing overtraining in a subject, or of determining the appropriate amount of exercise for a subject (Abstract; Paragraph 0035: tracking and managing user’s redox homeostasis to prevent injury or illness. Illness includes overtraining syndrome), comprising the steps of:
(a) providing a sample from an exercising subject not experiencing negative effects of exercise (Paragraphs 0062-0064 and 0103: the samples collected during steady state of a healthy individual);
(b) measuring ex vivo the concentration(s) of one or more biomarkers (Paragraphs 0034 and 0063-0064 and 0066: the measurement of the baseline values such as using FORD and FORT assays)
(c) providing a sample from the subject, after the subject's exercise intensity, exercise frequency and/or exercise volume has been increased, or when experiencing negative effects of exercise (Paragraphs 0034 and 0067-0069: the collection of additional samples after establishing a baseline);
(d) measuring ex vivo the concentration of the same metabolite(s) as in step (b) (Paragraphs 0034 and 0067-0069: the analysis of the additional samples);
(e) determining the deviation(s) of the concentration(s) in d) from the baseline(s) (Paragraphs 0034 and 0066-0069: comparing the additional samples to the user’s individualized thresholds which are based on the baseline values); and
(f) making a decision, based on the deviation(s) in step (e), as to increasing or decreasing the exercise intensity, exercise frequency, and/or exercise volume, or to stay at the same level as expressed in step (c) (Fig. 1; Paragraphs 0068-0069, 0077-0082, and 0107: based on the comparison the system may generate alerts including alerts indicating a need to manage a training load and recovery requirements or maintain a load and recovery. The action taken is dependent upon the severity of the relationship between the measured biomarkers and the user’s personalized thresholds).
Lewis fails to further disclose the method wherein the biomarkers are metabolite(s) from the group comprising or consisting of citrate, alpha-hydroxybutyrate, beta-hydroxybutyrate, and L- cysteine, in the sample provided, to obtain a baseline or baselines.
Cardosi teaches a computer-implemented method in a device for measuring one or more parameters related to fitness is provided. The method comprises: (i) determining a pre-exercise analyte concentration of at least one analyte in a fluid sample of a user before a period of exercise; (ii) receiving at the device a pre-exercise analyte parameter related to the pre-exercise analyte concentration; (iii) receiving at the device a set of first optimization parameters; (iv) determining a post-exercise analyte concentration of the at least one analyte in a fluid sample of the user after the period of exercise; (v) receiving at the device a post-exercise analyte parameter related to the post- exercise analyte concentration; and (vi) identifying as a function of the set of first optimization parameters a relationship parameter between the pre-exercise analyte parameter and the post-exercise analyte parameter (Abstract).
Cardosi teaches the use of beta-hydroxybutyrate as a biomarker related to exercise (page 6). Cardosi further teaches the optimization of the exercise by adjusting parameters such as exercise intensity based on the biomarker (Pages 6-7)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method of Lewis to further analyze beta-hydroxybutyrate as one of the biomarkers for use in monitoring a user and managing their load and/or recovery because Cardosi teaches that such a metabolite may be used for optimizing an exercise and teaches that such an analyte is a parameter related to fitness (Page 2) and thus monitoring this parameter may be beneficial to Lewis by providing additional insight into the user’s fitness state to be considered when managing a user’s training.
Examiner’s Note: each of dependent claims 13-19 and 21 are rejected with the understanding that modified Lewis as presented above is considered to teach the analysis of beta-hydroxybutyrate as a biomarker.
Regarding claim 11, Lewis discloses a non-therapeutic data collection method (Abstract) comprising the steps of:
(a) providing a sample from an exercising subject not experiencing negative effects of exercise (Paragraphs 0062-0064 and 0103: the samples collected during steady state of a healthy individual);
(b) measuring ex vivo the concentration(s) of one or more biomarkers (Paragraphs 0034 and 0063-0064 and 0066: the measurement of the baseline values such as using FORD and FORT assays)
(c) providing a sample from the subject, after the subject's exercise intensity, exercise frequency and/or exercise volume has been increased, or when experiencing negative effects of exercise (Paragraphs 0034 and 0067-0069: the collection of additional samples after establishing a baseline);
(d) measuring ex vivo the concentration of the same metabolite(s) as in step (b) (Paragraphs 0034 and 0067-0069: the analysis of the additional samples);
(e) determining the deviation(s) of the concentration(s) in d) from the baseline(s) (Paragraphs 0034 and 0066-0069: comparing the additional samples to the user’s individualized thresholds which are based on the baseline values); and
(f) feeding deviation data from step (e) into a database (paragraphs 0065 and 0093: new data from each of the modules can be added to a database).
Lewis fails to further disclose the method wherein the biomarkers are metabolite(s) from the group comprising or consisting of citrate, alpha-hydroxybutyrate, beta-hydroxybutyrate, and L- cysteine, in the sample provided, to obtain a baseline or baselines.
Cardosi teaches the use of beta-hydroxybutyrate as a biomarker related to exercise (page 6). Cardosi further teaches the optimization of the exercise by adjusting parameters such as exercise intensity based on the biomarker (Pages 6-7)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method of Lewis to further analyze beta-hydroxybutyrate as one of the biomarkers for use in monitoring a user and managing their load and/or recovery because Cardosi teaches that such a metabolite may be used for optimizing an exercise and teaches that such an analyte is a parameter related to fitness (Page 2) and thus monitoring this parameter may be beneficial to Lewis by providing additional insight into the user’s fitness state to be considered when managing a user’s training.
Regarding claim 12 Lewis discloses a non-therapeutic computer system configured to perform a performance optimization method (Abstract; Paragraph 0092: the method may be implemented on a computer), the method comprising steps of:
(a) providing a sample from an exercising subject not experiencing negative effects of exercise (Paragraphs 0062-0064 and 0103: the samples collected during steady state of a healthy individual);
(b) measuring ex vivo the concentration(s) of one or more biomarkers (Paragraphs 0034 and 0063-0064 and 0066: the measurement of the baseline values such as using FORD and FORT assays)
(c) providing a sample from the subject, after the subject's exercise intensity, exercise frequency and/or exercise volume has been increased, or when experiencing negative effects of exercise (Paragraphs 0034 and 0067-0069: the collection of additional samples after establishing a baseline);
(d) measuring ex vivo the concentration of the same metabolite(s) as in step (b) (Paragraphs 0034 and 0067-0069: the analysis of the additional samples);
(e) determining the deviation(s) of the concentration(s) in d) from the baseline(s) (Paragraphs 0034 and 0066-0069: comparing the additional samples to the user’s individualized thresholds which are based on the baseline values); and
and (f) optimizing the exercise intensity/volume, exercise frequency, and/or exercise volume, based on the deviation(s) in step (e) (Fig. 1; Paragraphs 0068-0069, 0077-0082, and 0107: based on the comparison the system may generate alerts including alerts indicating a need to manage a training load and recovery requirements or maintain a load and recovery. The action taken is dependent upon the severity of the relationship between the measured biomarkers and the user’s personalized thresholds).
Lewis fails to further disclose the method wherein the biomarkers are metabolite(s) from the group comprising or consisting of citrate, alpha-hydroxybutyrate, beta-hydroxybutyrate, and L- cysteine, in the sample provided, to obtain a baseline or baselines.
Cardosi teaches the use of beta-hydroxybutyrate as a biomarker related to exercise (page 6). Cardosi further teaches the optimization of the exercise by adjusting parameters such as exercise intensity based on the biomarker (Pages 6-7)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method of Lewis to further analyze beta-hydroxybutyrate as one of the biomarkers for use in monitoring a user and managing their load and/or recovery because Cardosi teaches that such a metabolite may be used for optimizing an exercise and teaches that such an analyte is a parameter related to fitness (Page 2) and thus monitoring this parameter may be beneficial to Lewis by providing additional insight into the user’s fitness state to be considered when managing a user’s training.
Regarding claims 13-15, Lewis in view of Cardosi teaches the non-therapeutic method according to claim 10. Modified Lewis fails to further teach the method wherein in step (c) the subject's exercise intensity, exercise frequency and/or exercise volume has been increased during a time period of at least 5 consecutive days, as compared to the day immediately preceding the time period; wherein the samples provided in steps (a) and (c) are provided in the morning, after the subject has fasted from midnight, and within 72 h from the last time the exercising subject exercised; and/or wherein the samples in steps (a) and (c) are provided from a subject who has, on the day immediately preceding the day of providing the sample, eaten at least 3 grams of carbohydrates per kg bodyweight
Modified Lewis is considered to at least suggest that the subject's exercise intensity, exercise frequency and/or exercise volume has been increased in subsequent samples relative to baseline and is further considered to at least suggest particular requirements for sampling such as sampling time, fasting requirements, chronological relationship between sampling time and previous exercise time, and dietary requirements. These suggestions are made in at least paragraphs 0034, 0062-0069 and 0103 where Lewis discloses that the baseline samples are obtained when the user is healthy at a steady-state. Such a teaching in combination with the subsequent teachings regarding comparing additional samples to the threshold determined from the baselines is considered sufficient to at least suggest that the additional samples are samples taken during higher periods of exercise intensity since the objective of Lewis is to balance exercise intensity with risk and as illustrated in Fig. 1, exercise benefits are only obtained above a certain level of intensity and below another level of intensity. Additionally, paragraphs 0131, 0135, and 0158 each recite restrictions to sampling time and subject activity including exercise and diet prior to sample collection. It would seem that the particular requirements in regarding to exercise level, subject activity, and sampling time are all matters of routine optimization and experimentation configurable to optimize the samples depending on a variety of factors such as the particular biomarker being measured, type of subject including age, fitness, sex, and other factors, particular patient needs, sampling requirements of the clinician, types of exercises being performed, and other factors which may confound the results if not controlled and accounted for. Thus, while modified Lewis is not considered to explicitly disclose all the particular sampling requirements set forth in claims 13-15, modified Lewis is considered to teach that these factors may be controlled for measurement accuracy and thus the specific parameters for each of these factors (duration of increased exercise activity, sampling time, fasting duration and timing, chronological relationship between sample time and last exercise time, and dietary requirements) are all considered matters of routine optimization and experimentation and thus obvious in light of the teachings of modified Lewis as the specific sampling parameters set forth are not considered to produce a surprising technical effect but are rather considered specific sampling parameters that have been optimized for the claimed method.
Regarding claim 16, Lewis in view of Cardosi teaches the non-therapeutic method according to claim 10. Modified Lewis further teaches the method, wherein each sample is in the form of blood, urine, sweat, interstitial fluid, saliva or exhaled breath condensate (Paragraph 0038: sample types may include blood, saliva, urine, extracellular fluid, and/or perspiration).
Regarding claim 17, Lewis in view of Cardosi teaches the non-therapeutic method according to claim 10. Modified Lewis further teaches the method, wherein the subject is a human, horse, dog, camel, dromedary, bird, or cattle (Paragraph 0006: the subject is a person)
Regarding claim 18, Lewis in view of Cardosi teaches the non-therapeutic method according to claim 17. Modified Lewis further teaches the method, wherein the human is an athlete, a member of the general public, or a recovering subject (Paragraph 0006: the subject may be an athlete or recovering patient).
Regarding claim 19, Lewis in view of Cardosi teaches the non-therapeutic method according to claim 10. Modified Lewis further teaches the method, wherein, as applicable, deviation(s) of any of the metabolite(s) concentrations from baselines amounting to at least a 10% increase for citrate, at least a 15% increase for alpha-hydroxybutyrate, at least a 15% increase for beta-hydroxybutyrate, and below 95% of baseline for L-cysteine (Paragraphs 0034, 0064, and 0066-0069: comparing the additional samples to the user’s individualized thresholds which are based on the baseline values and may be particular multiples thereof. The biomarker being beta-hydroxybutyrate is taught by modified Lewis as presented in the above rejection of claim 10. Additionally, the specific value of the critical threshold is considered a matter of routine optimization and experimentation based on the needs of the specific individual, the biomarker being analyzed, and the risk tolerance of the system with respect to injury and illness. Lewis recites a 17% increase as an example threshold (the multiple 1.17) and thus the threshold being a 15% increase is considered to be obvious in view of Lewis and a matter of routine optimization and experimentation), indicates that the exercise intensity or exercise frequency should be reduced (Paragraphs 0068-0069, 0077-0082, and 0107: based on the comparison the system may generate alerts including alerts indicating a need to manage a training load and recovery requirements or maintain a load and recovery. The action taken is dependent upon the severity of the relationship between the measured biomarkers and the user’s personalized thresholds; Paragraph 0088: when the critical threshold values are exceeded, training load must decrease)
Regarding claim 21, Lewis in view of Cardosi teaches the non-therapeutic method according to claim 10. Modified fails to Lewis further teach the method, wherein the measurements of the metabolite(s) in steps (b) and (d) are performed by way of mass spectrometry, HPLC/UPLC, enzymatic assays using spectroscopic methods, ELISA, RIA, or fluoro-immunoassay.
An obvious variation of Lewis in view of Cardosi would be to measure the beta-hydroxybutyrate metabolite by way of mass spectrometry, HPLC/UPLC, enzymatic assays using spectroscopic methods, ELISA, RIA, or fluoro-immunoassay. Such a variation is considered obvious because Applicant’s specification paragraph 0045 sets forth that these methods are known analytical methods and that “The skilled person, having average skills in analytical methods suitable for analyzing metabolites, is well equipped to choose, and set up a suitable analytical method” and thus, by Applicant’s own admission, one of ordinary skill in the art would recognize that the claimed measurement modalities are obvious for use in the measurement of beta-hydroxybutyrate as required by modified Lewis and for other metabolites.
Claim 20 is not presently rejected over the prior art.
Regarding claim 20, Modified Lewis does teach establishing personalized thresholds at a given multiple of, or percentage difference from, the baseline value (paragraph 0064) and renders obvious the specific percentage differences for each of the metabolites (see the obviousness rationale set forth in the above rejection of claim 19). However claim 20 depends from an interpretation of claim 19 that requires all of the listed metabolites to be measured. The prior art of record does not teach or reasonably suggest the analysis of all the recited metabolites and their evaluation against particular thresholds.
None of the prior art of record is considered to teach or reasonably suggests the use of citrate, L-cysteine, and/or alpha-hydroxybutyrate as biomarkers for modified a user’s exercise intensity, frequency, and/or volume.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication Number US 20110077472 A1 hereinafter Kalns teaches methods and compositions for identifying a subject in a fatigued state, a subject recovering from a fatigued state and/or a subject having an increased likelihood of performing a physical activity at a sufficient level by detecting and/or quantitating, in a sample from the subject, one or more biomarkers associated with fatigue and/or physical performance capability (Abstract). Kalns teaches the evaluation of biomarkers with respect to a baseline value to determine the level of fatigue in a subject. The biomarker changes with the amount of effort being applied to the exercise (Paragraphs 0006-0007). Kalns teaches that a ratio between two peptides is used to determine a fatigued state of the subject. The peptides are measured in a rested state to determine a biomarker index for a state of rest and subsequently measured during exercise to determine the level of fatigue (Paragraphs 00017-0019)
US Patent Application Publication Number US 20190320935 A1 hereinafter Taylor teaches an apparatus and a method of monitoring fat burning in a subject non-invasively (Abstract). Taylor teaches that beta-hydroxybutyrate increases with fasting and starvation, Taylor further teaches that exercise can also increase beta-hydroxybutyrate (paragraph 0015). Thus, Taylor teaches that beta-hydroxybutyrate is a biomarker associated with exercise.
US Patent Application Publication Number US 20160047829 A1 hereinafter Fuhrmann teaches a method for determining a clearance normalized amount of a metabolite disease biomarker in a sample (Abstract). Fuhrmann teaches that healthy patients and heart failure patients have significantly different levels of citrate at the peak of exercise (Page 11 table 3). Thus, Taylor teaches that citrate is a biomarker associated with exercise.
Cadegiani “Diagnosis of Overtraining Syndrome: Results of the Endocrine and Metabolic Responses on Overtraining Syndrome Study: EROS-DIAGNOSIS” published by Journal of Sports Medicine on 04/22/2020, pages 1-17 hereinafter Cadegiani teaches that overtraining syndrome is a common dysfunction among athletes and teaches that a plurality of biomarkers may be used to identify such a condition (Page 1: Abstract). Cadegiani teaches that a single biomarker was unable to distinguish all overtrained athletes from healthy athletes but that a combination of different parameters can distinguish all overtrained from healthy athletes. In particular Cadegiani teaches that there are more than 4000 different combinations of biomarkers which can be used to successfully distinguish all the overtrained from healthy athletes (Page 12 right column paragraph 2). Cadegiani teaches the evaluation of a variety of different biomarkers including biochemical and hormonal biomarkers (Page 3 table 1).
Urhausen “Diagnosis of Overtraining: What Tools do we Have?” published by Springer Nature on 11/02/2002, pages 1-8 hereinafter Urhausen teaches that a variety of tools are available to diagnose overtraining but they have varying degrees of accuracy and practical applicability (Page 1: Abstract). Urhausen teaches a variety of different methods or potential methods of diagnosing overtraining using a number of different measurement types including blood lactate, plasma ammonia, hormone levels, and/or catecholamines (pages 4-6: Tools Diagnosing OTS during Exercise – Current Recommendations)
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