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 of Species 1L, 2B, and 3A with traverse in the reply filed on May 26, 2026 is acknowledged.
The traversal of Species 1-3 is on the grounds that the pending claims do not presently distinguish among the species based on sensor architecture, sensor placement, and analyte analysis technique, do not presently recite the structural or operational distinctions among the species, and do not sufficiently identify how the species would result in a materially different search. Additionally, the traversal is on the grounds that the specification describes multiple disclosed sensing configurations that can be used in connection with the claimed analyte-related monitoring and associated processing functionalities.
Examiner notes that as discussed in the "Requirement for Restriction/Election" filed on May 26, 2026 the species are independent and distinct due to their mutually exclusive characteristics. In addition, these species are not obvious variants of each other based on the current record. For these reasons, the Election of Species requirement is maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 7-9, 11-12, 14-17, and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-9, 12, 14-17, 19-20, 23 of co-pending Application No. 18/636,224 in view of Shen et al. (US 2022/0125354).
This is a provisional nonstatutory double patenting rejection. The claims of the instant application and the claims of the reference application are compared in the table below.
Instant Application: 18/636,210
Reference Application: 18/636,224
Claim 1: A monitoring system, comprising:
a continuous analyte sensor configured to generate a first set of analyte measurements associated with analyte levels of a host; and
a sensor electronics module coupled to the continuous analyte sensor and
configured to receive and process the first set of analyte measurements.
Claim 3: The monitoring system of claim 1, wherein:
the continuous analyte sensor comprises a continuous lactate sensor, and
the first set of analyte measurements include lactate measurements.
Claim 4: The monitoring system of claim 3, further comprising:
one or more memories comprising executable instructions;
one or more processors in data communication with the one or more memories and configured to execute the executable instructions to:
classify a host as a metabolically unfit host based on the first set of analyte measurements obtained during a trial exercise session or input received from the host; and
optimize an exercise session for the host based on the classification of the host.
Claim 1: A monitoring system, comprising:
a continuous analyte sensor configured to generate a first set of analyte measurements associated with lactate levels of a host during a first exercise session, wherein the first set of analyte measurements include lactate measurements;
a sensor electronics module coupled to the continuous analyte sensor and configured to receive and process the first set of analyte measurements:
one or more memories comprising executable instructions; and
one or more processors in data communication with the one or more memories and configured to execute the executable instructions to:
determine at least one of an exercise intensity or a time in the first exercise session at which the host reaches a lactate threshold meeting predefined criteria;
correlate one or more of the exercise intensity, the time, or the lactate threshold of the lactate measurements with a metabolic fitness level for the host, wherein the correlating is based on a relationship among two or more of the exercise intensity, the time, and the lactate threshold; and
classify the host according to the metabolic fitness level based on the correlation.
Claim 3: The monitoring system of claim 1, wherein:
the continuous analyte sensor comprises a continuous lactate sensor
Claim 4: The monitoring system of claim 3, wherein the one or more processors are further configured to:
optimize an exercise session for the host based on the classification of the host.
Claim 2: The monitoring system of claim 1, wherein the continuous analyte sensor comprises:
a substrate,
a working electrode disposed on the substrate,
a reference electrode disposed on the substrate,
wherein the first set of analyte measurements generated by the continuous analyte sensor correspond to an electromotive force at least in part based on a potential difference generated between the working electrode and the reference electrode.
Claim 2: The monitoring system of claim 1, wherein the continuous analyte sensor comprises:
a substrate,
a working electrode disposed on the substrate,
a reference electrode disposed on the substrate,
wherein the first set of analyte measurements generated by the continuous analyte sensor correspond to an electromotive force at least in part based on a potential difference generated between the working electrode and the reference electrode.
Claim 7: The monitoring system of claim 4,
wherein the classifying the host as a metabolically unfit host is further based on non-analyte data obtained from a non-analyte sensor during the trial exercise session,
wherein the non-analyte data includes accelerometer data, heart rate data, heart rate variability data, oxygen saturation data, blood pressure data, or body temperature data.
Claim 7: The monitoring system of claim 1,
wherein the classifying the host is further based on non-analyte data obtained from a non-analyte sensor during the trial exercise session,
wherein the non-analyte data includes accelerometer data, heart rate data, heart rate variability data, oxygen saturation data, blood pressure data, or body temperature data.
Claim 8: The monitoring system of claim 4,
wherein the input received from the host include self classification information, health goals of the host, exercise goals of the host, or historical exercise data of the host.
Claim 8: The monitoring system of claim 4,
wherein the input received from the host includes self classification information, health goals of the host, exercise goals of the host, or historical exercise data of the host.
Claim 9: The monitoring system of claim 4,
wherein optimizing the exercise session for the host comprises:
determining exercise parameters for the exercise session based on the classification of the host or the first set of analyte measurements obtained during the trial exercise session; and
transmitting an electronic signal to an exercise machine to cause the exercise machine to operate based on the determined exercise parameters.
Claim 9: The monitoring system of claim 4,
wherein optimizing the exercise session for the host comprises:
determining exercise parameters for the exercise session based on the classification of the host
Claim 23: The monitoring system of claim 14, wherein instructing the host to exercise according to the determined exercise parameters comprises
transmitting an electronic signal to an exercise machine to cause the exercise machine to operate based on the determined exercise parameters
Claim 11: The monitoring system of claim 4,
wherein optimizing the exercise session further comprises: providing feedback to the host on an effectiveness of the exercise session.
Claim 12: The monitoring system of claim 1,
wherein the one or more processors are further configured to provide an indication of an effectiveness of an exercise session to the host, according to one or more of a set of analyte measurements for the exercise session and the classification of the host
Claim 12: The monitoring system of claim 11,
wherein the effectiveness of the exercise session is determined based on a caloric burn and an overall energy expenditure following the exercise session.
Claim 19: The monitoring system of claim 12,
wherein the effectiveness of the exercise session is determined based on a caloric burn and an overall energy expenditure following the exercise session.
Claim 14: The monitoring system of claim 4,
wherein optimizing the exercise session for the host comprises:
determining exercise parameters for the exercise session based on the classification of the host or the first set of analyte measurements obtained during the trial exercise session; and
instructing the host to exercise according to the determined exercise parameters.
Claim 14: The monitoring system of claim 4,
wherein optimizing an exercise session for the host comprises:
determining exercise parameters for an exercise session based on the classification of the host or the first set of analyte measurements obtained during the trial exercise session; and
instructing the host to exercise according to the determined exercise parameters.
Claim 15: The monitoring system of claim 14,
wherein instructing the host to exercise according to the determined exercise parameters comprises
the host manually adjusting a current exercise parameter on an exercise machine to reach the determined exercise parameters.
Claim 15: The monitoring system of claim 14,
wherein instructing the host to exercise according to the determined exercise parameters comprises
the host manually adjusting a current exercise parameter to reach the determined exercise parameters.
Claim 16: The monitoring system of claim 15,
wherein exercise parameters comprise speed, incline, resistance, repetitions, or weight.
Claim 16: The monitoring system of claim 15,
wherein the exercise parameters comprise speed, incline, resistance, repetitions, or weight.
Claim 17: The monitoring system of claim 14,
wherein optimizing the exercise session further comprises:
monitoring a second set of analyte measurements of the host during the exercise session;
determining the second set of analyte measurements is within a defined range for the exercise session; and
instructing the host to maintain the exercise parameters for a specified duration of time.
Claim 17: The monitoring system of claim 14,
wherein optimizing the exercise session further comprises:
monitoring a second set of analyte measurements of the host during the exercise session after providing the determined exercise parameters; and
adjusting the determined exercise parameters based on the second set of analyte measurements.
Claim 19: The monitoring system of claim 18,
wherein the effectiveness of the exercise session is determined based on a caloric burn and an overall energy expenditure following the exercise session.
Claim 19: The monitoring system of claim 12,
wherein the effectiveness of the exercise session is determined based on a caloric burn and an overall energy expenditure following the exercise session.
Claim 20: The monitoring system of claim 18,
wherein the one or more processors are further configured to:
optimize a future exercise session based on the second set of analyte measurements and non-analyte data of the host during the exercise session.
Claim 20: The monitoring system of claim 12,
wherein the one or more processors are further configured to:
optimize a future exercise session based on the effectiveness of the exercise session.
Claim 1, 3, and 4
Claim 1, 3, and 4 of the reference copending application recites all limitations of claims 1, 3, and 4 of the instant application except for classifying a host “as a metabolically unfit host”. However, Shen et al. (US 2022/0125354) teaches a system that measures lactate concentration during exercise [0026] and can determine whether a user is healthy or unhealthy based on the measured lactate concentration [0068].
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to classify a host as being healthy or unhealthy based on lactate measurements during exercise, as disclosed by Shen, within the system of claim 1, 3, and 4 of the reference copending application, to allow for the monitoring system to determine whether the user is fit or unfit so that the exercise parameters could be adjusted for each user.
Claim 2, 7, 8, 14, 15, 16, 17, 19, and 20
Claims 2, 7, 8, 14, 15, 16, 17, 19, and 20 of the reference copending application recite the same limitations as claims 2, 7, 8, 14, 15, 16, 17, 19, and 20 of the instant application, respectively.
Claim 9
Claims 9 and 23 of the reference copending application recites the same limitations as claim 9 of the instant application.
Claim 11
Claim 12 of the reference co-pending application recites the same limitations as claim 11 of the instant application.
Claim 12
Claim 19 of the reference co-pending application recites the same limitations as claim 12 of the instant application.
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.
In re claim 1: “sensor electronics module”
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 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 9-10, 12, and 19 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.
In re claim 9, the limitation “transmitting an electrical signal to an exercise machine to cause the exercise machine to operate based on the determined exercise parameters” raises a question about whether or not the “exercise machine” is positively recited in the claim. As written the claim does not require the system to comprise an exercise machine, it simply states that the system can be used to control one.
In re claim 10, see above (In re claim 9).
In re claim 12, the limitation “wherein the effectiveness of the exercise session is determined based on a caloric burn and an overall energy expenditure following the exercise session” is unclear. Specifically, it is unclear how the effectiveness of the exercise session can be based on a caloric burn or overall energy expenditure as neither has been calculated previously and it is unclear what part of the system is calculating the caloric burn or overall energy expenditure. For examination purposes, as best understood, the limitation “based on a caloric burn and an overall energy expenditure following the exercise session” will be interpreted to mean the device has an additional sensor or way of calculating caloric burn or overall energy expenditure besides just the lactate sensor.
In re claim 19, see above (In re claim 12).
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-20 do not include additional elements that integrate the exception into a practical application of the exception 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, p. 50, January 7, 2019).
Step 1: Independent claim 1 is directed to a system for receiving and processing analyte measurements from a continuous analyte sensor. Thus, they are directed to statutory categories of invention.
Step 2A, Prong 1:
Claim 1 recites the following claim limitations which are directed to abstract ideas, specifically mental processes (see MPEP 2106.04(a)(2)):
In re claim 1:
“to receive and process the first set of analyte measurements” (fall under one of observation, evaluation, judgement, or opinion and mathematical concepts)
These limitations are drawn to an abstract idea because they are, under their broadest reasonable interpretation, mere steps that are capable of being mentally performed or with a pen and paper. For example, processing the first set of analyte measurements is a matter of observation, evaluation, judgement, and opinion recognized by the courts as mental processes.
Step 2A, Prong 2:
Claims 1, 2, and 3 recite the following additional elements:
In re claim 1, “comprising
a continuous analyte sensor configured to generate a first set of analyte measurements associated with analyte levels of a host; and (data gathering)
a sensor electronics module coupled to the continuous analyte sensor” (generic computer component)
In re claim 2, “wherein the continuous analyte sensor comprises:
a substrate, a working electrode disposed on the substrate, a reference electrode disposed on the substrate” (generic component for data gathering)
In re claim 3, “the continuous analyte sensor comprises
a continuous lactate sensor” (generic component for data gathering)
The above limitations do not integrate the exception into a practical application of the exception because the elements are directed to mere data gathering and generic computer components.
The limitations “a continuous analyte sensor” which includes a substrate, working electrode, and reference electrode, for measuring lactate are directed towards pre-solution activity (see MPEP 2106.05(g)) since they are used to obtain information about the user (i.e. mere data gathering).
The limitation “sensor electronic module” are merely reciting computer components at a high level of generality. In other words, the computer components are being used as a tool to carry out the system’s function (see MPEP 2106.05(f)).
The judicial exception does not integrate the claims as a whole into a practical application. The combination of these additional elements is no more than generic computer components and pre-solution activity. Accordingly, even in combination, these additional elements do not integrate the idea into a practical application.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements in the claim amount to no more than generic computer components and components used for pre-solution activity.
The “continuous analyte sensor” including the substrate with a working electrode and a reference electrode for measuring lactate is well known, routine, and conventional as is evidenced by the references below; see Simpson et al. (US 2016/0324463) teaches a system for continuous analyte monitoring (fig 47) that comprises a substrate ([0487]: “first layer”), a working electrode [0487], and a reference electrode [0501] that can be used to detect lactate (fig 53: 656). Additionally, Shen et al. (US 2022/0125354) teaches a device for monitoring lactate concentrations using a sensing system (abstract) that comprises a substrate ([0041]; fig 3A: 212), a working electrode ([0041]; fig 3A: 214), and a reference electrode ([0041]; fig 3A: 216).
The “sensor electronics module” comprises only well known, routine, and conventional generic computer components as evidenced in the Applicant’s instant specification [0100-0102].
Thus, none of claims 1-20 amount to significantly more than the abstract idea itself. Accordingly, claims 1-20 are not patent eligible and are rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al., MPEP 2106.04(a)(2), MPEP 2106.04(d)(2), and MPEP 2106.05(g).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simpson et al. (US 2016/0324463).
In re claim 1, Simpson discloses a monitoring system (fig 47), comprising:
a continuous analyte sensor (fig 54: 700; [0483]: “continuous analyte sensor 700”) configured to generate a first set of analyte measurements associated with analyte levels of a host [0038]; and
a sensor electronics module (fig 46: 518)
coupled to the continuous analyte sensor (524; [0377]) and
configured to receive and process the first set of analyte measurements ([0379]: first and last sentence).
In re claim 3, Simpson discloses wherein:
the continuous analyte sensor comprises a continuous lactate sensor (fig 53: 656), and
the first set of analyte measurements include lactate measurements [0532].
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Simpson et al. (US 2016/0324463) in view of Heinz-Erian et al. (US 2020/0309726).
In re claim 2, Simpson discloses wherein the continuous analyte sensor comprises:
a substrate ([0487]: “first layer”; fig 56: 712),
a working electrode disposed on the substrate [0487],
a reference electrode disposed on the substrate ([0501]: “reference electrode 714”; fig 56),
Simpson lacks
wherein the first set of analyte measurements generated by the continuous analyte sensor correspond to an electromotive force at least in part based on a potential difference generated between the working electrode and the reference electrode.
Heinz-Erian teaches a method for determining concentration of an analyte, such as sodium, to detect whether the patient has an overload or depletion of that analyte [0001] by finding the potential difference between two electrodes, which is the electromotive force, and determining the concentration of the analyte based on the electromotive force [0087].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Simpson by determining analyte measurements from calculating the potential difference between a reference and working electrode as taught by Heinz-Erian, as doing so is a known way to calculate the concentration of an analyte in a given sample.
Claims 4, 7-8, 11-12, 14-15, 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Simpson et al. (US 2016/0324463) in view of Shen et al. (US 2022/0125354).
In re claim 4, Simpson discloses further comprising:
one or more memories comprising executable instructions ([0186: “monitoring device 21 may further include non-transitory computer readable memory”);
one or more processors in data communication with the one or more memories ([0567]: “processor in the computing device to implement the method”) and
configured to execute the executable instructions to ([0555]: “instructions being executable by one or more processors”):
classify a host as a metabolically unfit host based on input received from the host ([0009]: “user selects a program”; [0010]: “users, including Type I diabetics, Type II diabetics…”); and
optimize an exercise session for the host based on the classification of the host [0010].
Simpson lacks
classify a host as a metabolically unfit host based on the first set of analyte measurements obtained during a trial exercise session or
Shen teaches a system that measures lactate concentrations during exercise [0026] and can determine whether a user is healthy or not based on the measured lactate concentration [0068].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Simpson by classifying whether a host is healthy or not based on their analyte measurements during exercise as taught by Shen, as it is known that lactate levels and lactate clearance can be examined during exercise to determine a user’s fitness which could allow the system to classify the user and provide more personalized recommendations for improving their health based on their actual analyte measurements.
In re claim 7, the proposed combination (all mapping directed to Simpson) yields
wherein the classifying the host as a metabolically unfit host is further based on non-analyte data obtained from a non-analyte sensor during the trial exercise session ([0039]: “monitoring other user data”),
wherein the non-analyte data includes accelerometer data, heart rate data, heart rate variability data, oxygen saturation data, blood pressure data, or body temperature data ([0039]: activity data can be received from an accelerometer, heart rate monitor; [0185]: “body temperature”).
In re claim 8, the proposed combination (all mapping directed to Simpson) yields
wherein the input received from the host (fig 45: 502) include
self classification information ([0009]: “user selects a program”; [0010]: “users, including Type I diabetics, Type II diabetics”),
health goals of the host ([0370]: “goal may be to cause a physiological quantity to achieve a certain level”),
exercise goals of the host ([0370]: “the goal may be to cause a level of muscle building”), or
historical exercise data of the host [0394].
In re claim 11, the proposed combination (all mapping directed to Simpson) yields
wherein optimizing the exercise session further comprises: providing feedback to the host on an effectiveness of the exercise session ([0527]: “real-time information on the effectiveness of diets or exercise”).
In re claim 12, the proposed combination (all mapping directed to Simpson) yields
wherein the effectiveness of the exercise session is determined based on a caloric burn and an overall energy expenditure following the exercise session ([0418]: energy expenditure and caloric barn can be measured and calculated to help people optimize their exercise routines).
In re claim 14, the proposed combination (all mapping directed to Simpson) yields
wherein optimizing the exercise session for the host comprises:
determining exercise parameters for the exercise session based on the classification of the host ([0372]: “providing initial guidance”) or the first set of analyte measurements obtained during the trial exercise session ([0394]: “results can be evaluated and the program can be modified”); and
instructing the host to exercise according to the determined exercise parameters [0419].
In re claim 15, the proposed combination (all mapping directed to Simpson) yields
wherein instructing the host to exercise according to the determined exercise parameters comprises the host manually adjusting a current exercise parameter on an exercise machine to reach the determined exercise parameters ([0418]: first sentence; [0419]: “user may be instructed to work out at an intensity”).
In re claim 17, the proposed combination (all mapping directed to Simpson) yields
wherein optimizing the exercise session further comprises:
monitoring a second set of analyte measurements of the host during the exercise session ([0383]: “lactate (as well as potential other analytes) is monitored”);
determining the second set of analyte measurements is within a defined range for the exercise session ([0387]: “data may be evaluated to determine if the lactate level reached the desired threshold”; [0229]: “a threshold for hypoglycemia and a threshold for hyperglycemia”); and
The proposed combination lacks
instructing the host to maintain the exercise parameters for a specified duration of time.
Shen teaches a system that measures lactate concentrations during exercise [0026] and that can instruct the user to adjust the intensity or duration of their exercise depending on their measured analyte levels [0065].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of the proposed combination with instructing the user to maintain exercise for a specified duration as taught by Shen, as this would allow for a specific training goal to be met based off of the user’s measured analyte levels.
In re claim 18, the proposed combination (all mapping directed to Simpson) yields
wherein optimizing the exercise session further comprises: providing feedback to the host on an effectiveness of the exercise session ([0527]: “real-time information on the effectiveness of diets or exercise”).
In re claim 19, the proposed combination (all mapping directed to Simpson) yields
wherein the effectiveness of the exercise session is determined based on a caloric burn and an overall energy expenditure following the exercise session ([0418]: energy expenditure and caloric barn can be measured and calculated to help people optimize their exercise routines).
In re claim 20, the proposed combination (all mapping directed to Simpson) yields
wherein the one or more processors are further configured to:
optimize a future exercise session based on the second set of analyte measurements and non-analyte data of the host during the exercise session ([0392]: “for sports or exercise optimization… inputs may include those from a lactate sensor, a movement/motion sensor”; ([0394]: “after following the program, results can be evaluated and the program can be modified”).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Simpson et al. (US 2016/0324463) in view of Shen et al. (US 2022/0125354) in view of Crapnell et al. (Crapnell, R.D et al. “Evaluating the possibility of translating technological advances in non-invasive continuous lactate monitoring into critical care.” Sensors, 2021, 21, 879. https://doi.org/10.3390/s21030879).
In re claim 5, the proposed combination lacks
wherein the classifying the host as a metabolically unfit host based on the first set of analyte measurements comprises
detecting a starting lactate level of 3 millimolar and
a lactate trough in the first set of analyte measurements during the trial exercise session.
Crapnell teaches that a healthy individual’s lactate should fall within the range of 0.5-2.2 mmol/L (pg 1, section 1, first paragraph) and that hyperlactatemia is commonly associated with underlying diseases, drugs or toxins, or congenital errors of metabolism (Pg 3, Table 1).
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of the proposed combination that a user having higher than 2.2mmol/L could be a sign of being metabolically unfit as taught by Crapnell, as it is known that a healthy individual’s lactate value should fall within a specific range and if their lactate levels are higher than the normal range it can be a sign of underlying diseases or issues.
Additionally, it also would have been obvious to one of ordinary skill in the art at the time the instant invention was filed to provide the recited values in the proposed system since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum features or workable ranges involves only routine skill in the art.
Shen teaches classifying a user as fit or unfit based on lactate concentration [0026, 0068] and the rate of *lactate clearance which can examined during an exercise event [0072] and can be used to determine a person’s fitness ([0003]: last sentence). A baseline lactate concentration can be determined for each user [0003].
*Note: lactate clearance is similar to the lactate trough in that it calculates the rate of change in lactate levels and the trough corresponds to a user having a low rate of change in their lactate levels according to the Applicant’s instant specification [0171].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of the proposed combination by finding a starting lactate concentration, determining if the user had a low lactate clearance, and correlating the lactate clearance levels with an exercise parameter to determine if the user is metabolically unfit as taught by Shen, as determining the baseline lactate concentration and the lactate clearance during exercise would be able to determine if the user is fit or unfit and would allow the user to determine future exercise programs to achieve their individual goals.
In re claim 6, the proposed combination yields (all mapping directed to Shen)
wherein the classifying the host as a metabolically unfit host based on the first set of analyte measurements comprises
correlating the lactate trough of the first set of analyte measurements with an exercise parameter to classify the host as the metabolically unfit host
Claims 9-10, 13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Simpson et al. (US 2016/0324463) in view of Shen et al. (US 2022/0125354) in view of Smith (US 2019/0192906).
In re claim 9, the proposed combination (all mapping directed to Simpson) yields
wherein optimizing the exercise session for the host comprises:
determining exercise parameters for the exercise session based on the classification of the host ([0372]: “providing initial guidance”) or the first set of analyte measurements obtained during the trial exercise session ([0394]: “results can be evaluated and the program can be modified”); and
The proposed combination lacks
transmitting an electronic signal to an exercise machine to cause the exercise machine to operate based on the determined exercise parameters.
Smith teaches an adaptive training system (abstract) that can transmit workout settings to a workout apparatus [0326]. The settings can include parameters such as speed, duration, and incline [0086].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of the proposed combination with being able to transmit a signal to control an exercise machine based on determined parameters as taught by Smith, as this would allow for automatic adjustment of the training program based on the user’s fitness which would make the exercise program more individualized based on whether the user was fit or unfit.
In re claim 10, Simpson discloses
wherein optimizing the exercise session further comprises:
monitoring a second set of analyte measurements of the host during the exercise session ([0383]: “lactate (as well as potential other analytes) is monitored”);
determining the second set of analyte measurements is within a defined range for the exercise session ([0387]: “data may be evaluated to determine if the lactate level reached the desired threshold”; [0229]: “a threshold for hypoglycemia and a threshold for hyperglycemia”);
determining to maintain the exercise program for a specified duration of time [0018]; and
Simpson lacks
determining to maintain the exercise parameters for a specified duration of time; and
causing the exercise machine to continue to operate based on the determined exercise parameters for a specified duration of time.
Smith teaches an adaptive training system (abstract) that can transmit workout settings to a workout apparatus [0326]. The settings can include parameters such as speed, incline, and duration of the workout [0086].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Simpson with determining exercise parameters and maintaining them for a specified duration of time and having the exercise machine continue to operate based on the exercise parameters as taught by Smith, as being able to control both the exercise parameters and duration of the exercise parameters during exercise would allow for the exercise programs to be more adaptable based on a user’s needs and fitness.
In re claim 13, the proposed combination (all mapping directed to Simpson) yields
wherein the one or more processors are further configured to:
optimize a future exercise session based on the second set of analyte measurements and non-analyte data of the host during the exercise session ([0392]: “for sports or exercise optimization… inputs may include those from a lactate sensor, a movement/motion sensor”; ([0394]: “after following the program, results can be evaluated and the program can be modified”).
In re claim 16, the proposed combination lacks
wherein exercise parameters comprise speed, incline, resistance, repetitions, or weight.
Smith teaches an adaptive training system (abstract) that uses exercise parameters such as speed, incline, resistance, repetitions, and weight [0020].
It would have been obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Simpson with the exercise parameters of Smith, as these are known exercise parameters that can be adjusted in a user’s workout program so that they can achieve certain results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Huang (US 2015/0208970) teaches a method for measuring lactate concentrations and if the lactate value goes above a certain threshold, informs the user to reduce the exercise intensity (abstract).
Duvall et al. (US 2023/0293060) teaches a system to measure one or more analyte levels in a user and then analyze the analyte levels to determine current health, predict future health, and monitoring metabolic conditions [0003].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALEY N. PRUITT whose telephone number is (571)272-1955. The examiner can normally be reached M-T, 7:30 AM -5 PM. F, 7:30-4.
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/HALEY N PRUITT/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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