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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 21-26 and 28-35, in the reply filed on 10 July 2026 is acknowledged.
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 32 and 33 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 term “about” in claims 32 and 33 is a relative term which renders the claims indefinite. The term “about” is not defined by the claims, 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. For this examination, any deviation above a baseline lactate concentration will be considered “about 0.5 mM” or “about 1 mM” above the baseline.
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 21-23, and 28-33 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al.’885 (US Pub No. 2021/0219885 – cited by Applicant) in view of Guthrie et al.’480 (US Pub No. 2015/0359480).
Regarding claims 21 and 28, Wang et al.’885 discloses an analyte sensor for detecting glucose and lactate in vivo (section [0045]), the sensor comprising: a proximal portion configured to be positioned above a user’s skin and a distal portion configured to be transcutaneously positioned through the user’s skin such that the distal portion is in contact with the user’s interstitial fluid to detect glucose and lactate in vivo (section [0052]); the distal portion comprising: a substrate (section [0056], and see Figures 5A-5D, 5G, and 5H, and descriptions thereof); a first working electrode located on the substrate (section [0056], and see Figures 5A-5D, 5G, and 5H, and descriptions thereof); a second working electrode located on the substrate (section [0056], and see Figures 5A-5D, 5G, and 5H, and descriptions thereof); a lactate-responsive sensing area disposed on a surface of the first working electrode (section [0045]); and a glucose-responsive sensing area disposed on a surface of the second working electrode (section [0045]); a first membrane that is permeable to lactate overcoating the lactate-responsive area (sections [0063-0064]); and a second membrane that is permeable to glucose overcoating the glucose-responsive sensing area and the lactate-responsive sensing area (sections [0063-0064]).
Wang et al.’885 teaches using the analyte sensor to continuously determine a glucose concentration and a lactate concentration in interstitial fluid (sections [0045], [0048], [0050], [0053], [0121]). Wang et al.’885 further teaches that (1) continuously measuring signals indicative of lactate concentrations in a biological fluid allows an individual or a physician to proactively address abnormal analyte levels (section [0004]), and (2) lactate levels vary in response to exercise, and that it is desirable to measure an individual’s lactate levels continuously in the case of rapidly fluctuating lactate levels (section [0010]). As such, it would have been obvious to one of ordinary skill in the art to have used the analyte sensor of Wang et al.’885 to continuously measure signals indicative of lactate concentrations in a biological fluid in the individual. Continuously measuring signals indicative of lactate concentrations in biological fluid of the individual would allow an individual or physician to proactively address abnormal analyte levels and/or rapidly fluctuating lactate levels during exercise.
Wang et al.’885 fails to disclose a method comprising communicating the signals indicative of lactate concentrations measured by the analyte sensor to a processor and determining an anaerobic threshold or an aerobic threshold based on the signals indicative of lactate concentrations. Guthrie et al.’480 teaches a method of determining both an anaerobic threshold and an aerobic threshold in an individual wherein continuously measured signals indicative of lactate concentrations in a biological fluid in the individual are communicated to a processor, the anaerobic threshold and aerobic threshold both being determined based on the signals indicative of lactate concentrations (sections [0026], [0033]). Guthrie et al.’480 teaches performing these steps in order to provide an individual real-time feedback during exercise, the real-time feedback configured to encourage the individual to maintain a desired level of intensity for training efficiency (see ABSTRACT, sections [0002], [0015], [0017]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the invention of Wang et al.’885 such that its analyte sensor is used to communicate the signals indicative of lactate concentrations measured by the analyte sensor to a processor and to determine an anaerobic threshold and an aerobic threshold based on the signals indicative of lactate concentrations, as Guthrie et al.’480 teaches that determining an anaerobic threshold and an aerobic threshold based on signals indicative of lactate concentrations can be used to provide the individual with real-time, training efficiency feedback during exercise.
Regarding claims 22, 23, 29, and 30, Guthrie et al.’480 teaches that the individual performs a lactate threshold step test with incremental increases in power in order to determine the anaerobic threshold and the aerobic threshold (section [0033]).
Regarding claim 31, Figure 3 of Guthrie et al.’480 shows that the aerobic threshold is defined as a fixed value (2.0 millimoles/liter boundary between Zone 2 and Zone 3; also disclosed in section [0033]).
Regarding claims 32 and 33, section [0033] of Guthrie et al.’480 teaches that the aerobic threshold is defined as a baseline lactate concentration plus about 0.5 mM lactate or about 1 mM lactate (“When the lactate concentration deviates from the baseline lactate concentration, (e.g., when an inflection point in a lactate concentration curve is detected) the training module 116 can define the aerobic threshold, which is typically around 2.0 millimoles/liter.” (emphasis added)).
Claims 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al.’885 in view of Guthrie et al.’480, as applied to claim 21, further in view of Bentley et al. (Incremental Exercise Test…).
Regarding claim 24, Wang et al.’885 in view of Guthrie et al.’480 discloses all of the elements of the current invention, as discussed in paragraph 6 above, except for the anaerobic threshold being determined using a broken-stick model. Bentley et al. teaches using a broken-stick model to determine an anaerobic threshold (page 582, left column beginning with “Traditionally, the LT was determined…”: LT is the “lactate threshold”, which is the same as an anaerobic threshold). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Wang et al.’885 in view of Guthrie et al.’480 such that the anaerobic threshold is determined using a broken-stick model, as taught by Bentley et al. The modification to Wang et al.’885 in view of Guthrie et al.’480 would merely be combining prior art elements according to known methods to yield predictable results.
Regarding claim 25, Wang et al.’885 in view of Guthrie et al.’480 discloses all of the elements of the current invention, as discussed in paragraph 6 above, except for the anaerobic threshold being determined using a Dmax method. Bentley et al. teaches using a Dmax method to determine an anaerobic threshold (page 582, left column beginning with “The DMax is an alternative objective marker for estimating the LT”). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Wang et al.’885 in view of Guthrie et al.’480 such that the anaerobic threshold is determined using a DMax method, as taught by Bentley et al. The modification to Wang et al.’885 in view of Guthrie et al.’480 would merely be combining prior art elements according to known methods to yield predictable results.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al.’885 in view of Guthrie et al.’480, as applied to claim 21, further in view of Fell (The modified D-max is a valid…).
Wang et al.’885 in view of Guthrie et al.’480 discloses all of the elements of the current invention, as discussed in paragraph 6 above, except for the anaerobic threshold being determined using a modified Dmax method. Fell teaches using a modified Dmax method to determine an anaerobic threshold in ageing athletes (pages 462-463, beginning with last paragraph on page 462 “In conclusion, the modified D-max lactate threshold…”). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Wang et al.’885 in view of Guthrie et al.’480 such that the anaerobic threshold is determined using a modified DMax method, as taught by Fell. The modification to Wang et al.’885 in view of Guthrie et al.’480 would merely be combining prior art elements according to known methods to yield predictable results. Furthermore, the modification would allow for determining an appropriate anaerobic threshold for ageing athletes.
Claims 34 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al.’885 in view of Gurthrie et al.’480, as applied to claim 28, further in view of Beaver et al. (Improved detection of lactate threshold…).
Regarding claim 34, Wang et al.’885 in view of Guthrie et al.’480 discloses all of the elements of the current invention, as discussed in paragraph 6 above, except for the aerobic threshold being determined using a log-log model. Beaver et al. teaches using a log-log model to determine a transition threshold based on lactate concentration data (see TITLE, and page 1938, right column, last full paragraph: “The log-log model provides a better fit in this region (Fig. 3B), which suggests that the log-log transform is the better model than the semilog model for calculating the lactate threshold.”). Beaver et al. further teaches that using a log-log model to determine a threshold defines a threshold “with a resolution that is considerably better than the data-point interval.” (first full paragraph of DISCUSSION section). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Wang et al.’885 in view of Guthrie et al.’480 such that the aerobic threshold is determined using a log-log model. The modification to Wang et al.’885 in view of Guthrie et al.’480 would merely be combining prior art elements according to known methods to yield predictable results.
Regarding claim 35, Wang et al.’885 in view of Guthrie et al.’480 discloses all of the elements of the current invention, as discussed in paragraph 6 above, except for the aerobic threshold being determined using a segmented regression analysis. Beaver et al. teaches using a segmented regression analysis to determine a transition threshold based on lactate concentration data (pages 1937-1938, paragraph beginning with “The data points are divided into two segments…” and the paragraph beginning with “The data for all 10 subjects were analyzed individually by this linear regression method…”). Beaver et al. further teaches that using a two-segment linear regression analysis provides a better fit of data than a one-segment regression It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Wang et al.’885 in view of Guthrie et al.’480 such that the aerobic threshold is determined using a segmented regression analysis. The modification to Wang et al.’885 in view of Guthrie et al.’480 would merely be combining prior art elements according to known methods to yield predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Each reference cited in the attached PTO-892 that is not relied upon above discloses using lactate concentration measurements to determine an aerobic threshold and/or an anaerobic threshold. A number of the references discuss particular methods by which the thresholds are determined (e.g., Dmax, modified Dmax).
Hess et al.’671 (WO 2013/053671) specifically teaches that “The anaerobic threshold can be determined by well known methods, e.g. by measuring lactate threshold in blood samples obtained during a ramp test where the exercise intensity is progressively increased.”
Czuba et al. (Lactate Threshold (D-Max Method)…) specifically teaches using a Dmax method to determine an anaerobic threshold using lactate concentration data.
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