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 .
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 1-5, 9-14, 16, and 62-67 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (US 20150208970 A1-Previously cited) in view of Felker et al. (US 20180161658 A1-Previously cited), hereinafter Felker, Guthrie (US 20150359480 A1-Previously cited), and Simpson et al. (US 20160328991), hereinafter Simpson.
Regarding claim 1, Huang teaches a method (see ABSTRACT) comprising: measuring a plurality of lactate concentrations in a biological fluid in vivo with a sensing system comprising a lactate-responsive sensor partially inserted into transdermal tissue for continuous monitoring lactate concentrations within interstitial fluid (¶ [0018], “a continuous transdermal microneedles sensor with pricking through skin to sample tissue fluid for measuring lactate concentration in painless and minimally-invasive way”) over at least a period of time while the lactate concentrations are decreasing flowing a peak lactate level reached in conjunction with a first exercise event (¶ [0017,0019,0021], “a continuous transdermal microneedles sensor comprising a lactate measuring device with pricking through skin to sample tissue fluid for measuring lactate concentration" during exercise; the concentrations are measured continuously thereby including peaks, increases, and decreases in lactate);
determining a rate of lactate clearance in a recovery period using the sensing system and the plurality of lactate concentrations (¶ [0021], lactate concentration rate is continuously monitored, including during recovery period; one of ordinary skill in the art would understand that change in lactate concentration is also the rate of clearance), wherein determining the rate of clearance comprises calculating a curve slope (one of ordinary skill in the art understands that calculating a rate, e.g., lactate, heart rate, of change is equivalent to calculating the slope of a curve);
and adjusting, based on the plurality of lactate concentrations and the rate of the lactate clearance, the intensity, of a second exercise event be conducted after the recovery period in which the lactate level has fallen to a predetermined concentration, the recovery period interceding between the first exercise event and the second exercise event (¶ [0017,0021], based on lactate concentration meeting a predetermined threshold, the level of the first exercise can be reduced, so that concentration levels are less than predetermined levels, once lower than predetermined levels during a recovery/reduced level period, the user is informed to increase intensity–second exercise event; ¶ [0021], based on the lactate clearance rate increasing and/or decreasing, the intensity of the exercise is adjusted– “The exercise intensity may be reduced when the lactate concentration value is higher than the predetermined value and the lactate concentration change rate increased”).
Huang fails to teach wherein the sensor is partially inserted into the user’s subcutaneous tissue.
Felker teaches a body tissue integrated biosensor for subcutaneous placement and configured to measured lactate concentrations of a user (¶ [0034, 0081]).
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 device of Huang, such that the sensor is partially inserted into the user’s subcutaneous tissue, as taught by Felker, as it would merely be substituting one known element (transdermal sensor) for another (subcutaneous sensor) to obtain predictable results.
Huang fails to teach wherein the method comprises measuring a lactate level above a baseline concentration being reached in the first exercise event. It is noted that Huang does teach measuring when the lactate is above a predetermined threshold concentration.
Guthrie teaches a method for optimizing physical training based on real-time blood lactate monitoring (see ABSTRACT). The method comprises establishing a baseline lactate concentration level to aid in defining a training regimen, and establishing an aerobic/anaerobic threshold for training regimens. The thresholds can also be indicative of lactate being produced by muscles faster than the body can metabolize the produced lactate (¶ [0033]).
It would have been obvious to one of ordinary skill in the art at the time invention was effectively filed to have modified the device of Huang-Felker, such that a baseline concentration is established, as taught by Guthrie, to aid in defining a regimen protocol by establishing thresholds for exercise events.
Therefore, the combination of Huang-Felker-Guthrie teaches measuring a lactate level above a baseline concentration being reached in the first exercise event.
Huang-Felker-Guthrie fail to teach wherein the predetermined concentration is a percentage of the peak lactate level.
Simpson teaches a system and method for teaching a user the effects of various aspects of their lifestyle on their health, how food and/or exercise affects their physiological parameters, and about their health (abstract). The system is configured to determine lactate concentration correlated to a percentage of the user’s of their threshold level (¶[0388]). The percentage is then compared to a desired percentage threshold that can be indicative of an exercise performance (¶[0388], “a program (step 528) may include an attempt to perform exercise in such a way that the user's lactate level is a certain percentage, e.g., 80-98%, of their lactate threshold level. Data may then be tracked, particularly lactate data, and optionally other data such as activity data, meal data, heart rate data, and so on (step 536). The tracked data may then be evaluated against the selected program. For example, the data may be evaluated to determine if the lactate level reached the desired percentage. . . . the displayed output may correspond to any of the outputs discussed above in connection with FIGS. 4-36.” ¶[0229,0291-92], “analyte level 88 is plotted with respect to time, with one or more threshold levels shown, e.g., a threshold 94 for hypoglycemia and a threshold 92 for hyperglycemia. A textual indication 96 is displayed, indicating conveniently to the user a present summary status. Potential lifestyle modifications 98 are shown, in the form of tips, such as to “get up at lunch” and/or perform “exercises”. In this case the potential lifestyle modifications may be personalized to the user, as well as to time of day. For example, exercises may be suggested (not shown) which are appropriate for the workplace, if the output is being displayed during the workday. Users may also enter preferred exercises, and such may then be preferentially displayed. For example, a user may enter a preference for walking for 45 minutes rather than swimming four laps” and “a program to try different types of breakfasts, and then phase 2 may be for the user to try different exercise routines or regimes”(emphasis added)).
Accordingly, it is obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Huang-Felker-Guthrie, such that the predetermined concentration is a percentage of the peak lactate level, as taught by Simpson, to provide users information about the effects of food and exercise on their lives (¶[0293] of Simpson).
Huang fails to teach displaying on a reader device the intensity, duration, or timing of the second exercise event to be conducted after the recovery period.
Guthrie teaches that outputting via a display feedback to a user regarding the intensity or duration of an exercise event (¶ [0031,0040-46], “output module 115 can be operable to cause a visual output to be presented via a display device” and “the output module 115 can be operable to cause cues, feedback, encouragement, tracking data, and/or any other suitable information to be presented to the user”).
As such, 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 device of Huang-Felker-Guthrie-Simpson, such that a reader device display intensity or duration of an exercise event to be conducted, taught by Huang, as it would merely applying a known technique (displaying on a reader device the intensity, duration, or timing of the exercise event to be conducted) to improve similar methods (physiological measuring device for exercise training) in the same way. Additionally, the modification
As such, the combination of Huang-Felker-Guthrie-Simpson teaches displaying on a reader device the intensity or duration of the second exercise to be conducted after the recovery period (¶ [0031,0040-46] of Guthrie).
Regarding claim 2, Huang teaches wherein a lactate threshold is exceeded in the first exercise event (¶ [0017], lactate threshold exceeded by a predetermined value).
Regarding claim 3, Huang teaches wherein the peak lactate level is above the lactate threshold (¶ [0021],the peak is considered when the lactate concentration has been identified of being higher than the predetermined threshold).
Regarding claim 4, Huang teaches wherein a reduced level of exercise is conducted during the recovery period (¶ [0017], reduced level of exercise required after exceeding threshold).
Regarding claim 5, Huang-Guthrie teaches wherein the predetermined concentration is at or above the baseline concentration (¶ [0033] of Huang, the baseline of Guthrie is described as the concentration when exercise begins and thresholds are set when the intensity has been increased therefore the predetermined threshold as described by Huang would be above the baseline; ¶[0388] of Simpson, “the data may be evaluated to determine if the lactate level reached the desired percentage”).
Regarding claim 9, Huang teaches determining, based on the plurality of lactate concentrations, that a reduced level of exercise be performed during the recovery period to adjust the rate of lactate clearance (¶ [0021], "The exercise intensity may be reduced when the lactate concentration value is higher than the predetermined value and the lactate concentration change rate increased" indicating that a reduction in exercise is correlated to an adjusted rate of lactate clearance).
Regarding claim 10, Huang teaches communicating a signal from the lactate-responsive sensor to a processor located in a local terminal (¶ [0044], the sensor 20 communicates with a signal processing unit 41 in a local terminal); wherein the processor determines, based upon the plurality of lactate concentrations, a rate of lactate clearance and a training protocol selected from the group consisting of intensity of the second exercise event (¶ [0021], the second exercise after the concentration and rate exceed the threshold followed by a rest period and an indication increase the intensity).
Huang-Felker-Simpson fail to teach wherein the processor determines, a training protocol selected from the group consisting of a duration of the second exercise event, timing of the second exercise event, and combinations thereof, and informs an individual wearing the lactate-responsive sensor or another part once the training protocol is available.
Guthrie teaches generating a training protocol that defines/informs durations of exercise events (first, second, third, etc.) and timing of the exercise events, based on the lactate concentrations of the user (¶ [0030]).
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 device of Huang-Felker-Guthrie-Simpson, such that the user is informed of duration and timing of the second exercise events based on the training protocol, as taught by Guthrie, to aid in developing a structured training regimen for a particular individual that requires insight into the body’s function (¶ [0005] of Guthrie).
Regarding claim 11, Huang teaches wherein the plurality of lactate concentrations includes one or more lactate level (¶ [0017,0021], the concentrations are continuously measured capturing when one or multiple concentrations are higher than the threshold (reaching peak level)).
Regarding claim 12, Huang teaches wherein a single lactate-responsive sensor measures the plurality of lactate concentrations over the period of time (¶ [0018], "provide a lactate measuring device, with which a continuous transdermal microneedles sensor with pricking through skin" indicates a singular sensor for continuous measurement over time).
Regarding claim 13, Huang teaches wherein the lactate-responsive sensor comprises a working electrode that is insertable in a tissue (¶ [0018,0023], implantable sensor with a working electrode).
Regarding claim 14, Huang teaches wherein the working electrode has a sensing region disposed thereupon (¶ [0019,0035] and fig. 11), and wherein the sensing region comprises a lactate-responsive enzyme and a polymer (¶ [0019,0056], “the present invention is based on lactate sensing enzymes” and “polyether sulfone (SPEES/PES) membrane is formed on the surface of the electrodes”).
Regarding claim 16, Huang teach wherein the lactate-responsive enzyme is lactate dehydrogenase or lactate oxidase (¶ [0058]).
Regarding claims 62-64, Huang-Guthrie-Simpson fail to teach wherein adjusting the intensity, duration, and timing of the second exercise event includes determining how long the second exercise event should take place in order to meet a specified training goal.
Felker teaches a method for optimizing a user’s muscle group performance (see abstract). The method requires measuring a user’s lactate clearance levels (¶ [0033]) among a plurality of biometric parameters to adjust the duration, intensity, and frequency/real-time of an exercise to maximize a performance or a health goal (¶ [0035,0049,0085,0092]).
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 Huang-Felker-Guthrie-Simpson, such that adjusting the duration, intensity and timing/frequency of the exercise event should take place in order to meet a specified training goal, as taught by Felker, to aid in increasing total body exercise capacity, including but not limited to VO.sub.2 max; shifting lactate threshold curves to the right; maximizing intracerebral oxygen delivery to prevent, treat, or maintain a functional level wherein the exerciser suffers from a degree of a degenerative neurologic condition such as age-related cognitive decline, dementia, Alzheimer's disease, Parkinsonism, or Parkinsonism (¶ [0092] of Felker).
Regarding claims 65-67¸Felker teaches wherein the specified training goal comprises at least increasing an individuals lactate threshold (¶ [0092], “shifting lactate threshold curves to the right”).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Felker, Guthrie, and Simpson, as applied to claim 14, and further in view of Feldman et al. (US 20100282616 A1-Previously cited), hereinafter Feldman.
Regarding claim 15, Huang teaches wherein the lactate-responsive enzyme is bonded to the polymer (¶ [0056], the lactate enzyme is used to coat a polymer based surface formed on the electrode).
Huang-Felker-Guthrie-Simpson fail to teach wherein the bond is a covalent bond.
Feldman teaches wherein an electrode for determining analyte concentrations comprises an analyte-responsive enzyme covalently bonded with a polymer (¶ [0054] and claims 23-24).
It would have been obvious to one of ordinary skill in the art at time the invention was effectively filed to have modified the device of Huang-Felker-Guthrie-Simpson, such that the bond is a covalent bond, as taught by Feldman, because Huang requires bonding/coating the enzyme with the polymer, but fails to disclose details, and Feldman teaches that it can be accomplished by covalently bonding the two.
Response to Arguments
Applicant's arguments filed 01/03/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to amended claim 1 has been considered but are moot because the amendments require new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gray teaches modern athletic training programs are based upon exertion expressed as a percentage of an individual's lactate threshold. US 20160270725
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791
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