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 .
Amendment Entered
In response to the amendment filed on October 29th, 2025, amended claims 1-2, 5, 7-19, and new claims 20-22 are entered.
Response to Arguments
Applicant's remarks and amendments with respect to the specification objection have been fully considered but are not persuasive. The objection has been maintained, and further clarified below.
At Pg. 8 of the Reply, Applicant argues that “the incorporation by reference reflects the priority claim made under 37 C.F.R. § 1.55 by the application data sheet filed October 25, 2022 concurrent with the instant patent application. 37 C.F.R. § 1.57(b) states that "the [priority] claim under § 1.55 [] shall also be considered an incorporation by reference of the prior-filed application." (emphasis added) As such, the incorporation by reference merely reflects what is entailed by the Federal Regulation”. Examiner respectfully disagrees. Applicant seems to be misunderstanding 37 C.F.R. § 1.57(b). See below for a portion of the conditions and requirements of 37 C.F.R. § 1.57(b).
“II. CONDITIONS AND REQUIREMENTS OF 37 CFR 1.57(b)
The following conditions and requirements need to be met for an applicant to add omitted material to an application pursuant to 37 CFR 1.57(b):
(A) the application must have been filed on or after September 21, 2004;
(B) all or a portion of the specification or drawing(s) must have been inadvertently omitted from the application;
(C) a claim under 37 CFR 1.55 for priority of a prior-filed foreign application, or a claim under 37 CFR 1.78 for the benefit of a prior-filed provisional, nonprovisional, international, or international design application, must have been present on the filing date of the application”
Examiner would like to emphasize that 37 C.F.R. § 1.57(b) is used “for an applicant to add omitted material to an application”, not for complete incorporation by reference. For the incorporation by reference to be effective as a proper safeguard, the incorporation by reference statement must be filed at the time of filing of the later-filed application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a) ). Although, as discussed above, an incorporation by reference statement can be used as a safeguard against an omission of a portion of a prior application for which priority is claimed under 35 U.S.C. 119(a)-(d) or (f), or for which benefit is claimed under 35 U.S.C. 119(e) or 120, it should be noted that an incorporation by reference statement will not satisfy the specific reference requirement of 35 U.S.C. 119(e) or 120 or 37 CFR 1.78. See Droplets, Inc. v. E*TRADE Bank, 887 F.3d 1309, 126 USPQ2d 317 (Fed. Cir. 2018).
An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date. It should be borne in mind that the filing date of the international stage application is also the filing date for the national stage application. Specifically, 35 U.S.C. 363 provides that: An international application designating the United States shall have the effect, from its international filing date under Article 11 of the treaty, of a national application for patent regularly filed in the Patent and Trademark Office. See 1893.03(b).
The incorporation by reference of the international patent application PCT/EP2021/060709 and of the foreign patent application GB2006149.5 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of the associated PCT, in this case April 23rd, 2021, see MPEP 1893.03(b). Therefore, the specification amendment of October 25th, 2022 to include the incorporation by reference is new matter, per MPEP 608.01(p).
Applicant's remarks and amendments with respect to the claim objection have been fully considered. The objection is withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(d) have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant's arguments, filed on October 29th, 2025, with respect to the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive. The rejections are maintained, and further clarified, in view of the amendment.
At Pg. 9 of the Reply, Applicant argues that “independent claims 1 and 17-19 have been amended to clarify their respective focus on improved technology for measuring and displaying specific cardiovascular fitness metrics and to exclude the purported abstract ideas”. Examiner would like to clarify that although the limitations have been amended to include more details, there is still no clear improvement.
“The full scope of the claim under the BRI should be considered to determine if the claim reflects an improvement in technology (e.g., the improvement described in the specification).” MPEP 2106.05(a). “That is, the claim must include the components or steps of the invention that provide the improvement described in the specification.” Id.
“[I]n McRO, the court relied on the specification’s explanation of how the particular rules recited in the claim enabled the automation of specific animation tasks that previously could only be performed subjectively by humans, when determining that the claims were directed to improvements in computer animation instead of an abstract idea.” MPEP 2106.05 (a). There is no improvement to a computer or other technology. Unlike McRO, the claimed system invokes a computer as a tool to perform a mathematical concept and/or mental process.
Applicant further argues that “there is no reasonable interpretation of the present claims that would encompass any of the categories of ‘organizing human activity’ nor any process that could possibly be performed in the human mind”. Examiner respectfully disagrees, and would like to clarify that Claims 1-22 recite abstract ideas in the form of mental processes, as consistent with Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012). If a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer components, then it is still in the mental processes category unless the claim cannot practically be performed in the mind, see Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016). Furthermore, the manner in which the heart rate data is measured and the displays are generated are determined to be part of extra-solution activity, in the form of data-gathering (measuring heart rate data) and data-outputting (generating a display). Mere data-gathering and data-outputting are recognized by the court as insignificant, extra-solution activity. “As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978)” MPEP 2106.05(g).
Outside of data-gathering and data-outputting, the claims recite mental processes performed on a computer control system. The “Federal Circuit has explained, ‘[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind.’ Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015).” MPEP 2106.04(a)(2) III. There is no time limit recited for performing the steps. The claimed steps can be performed via pen and paper or in a person’s mind with no time limit. The computer is merely utilized as a tool to perform the mental steps.
Furthermore, as noted below, the claims fall under the mathematical concepts group and/or the mental processes group. “A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018).
Applicant's arguments, filed on October 29th, 2025, with respect to the rejections under 35 U.S.C. 102 and 103 have been fully considered but they are not persuasive. The rejections are maintained, and further clarified, in view of the amendment.
At Pg. 10 of the Reply, Applicant argues that “Sivaraj—whether individually or in any combination with NPL Wernhart, NPL Hansen, or Jian—fails to teach each and every element of the independent claims”. However, Applicant provides no reasoning behind this argument. Examiner would like to clarify that Sivaraj still teaches each and every element of the independent claims, as demonstrated below.
Sivaraj (U.S. Patent No. 9,737,761; previously cited) discloses generating a first type of display (display 225) during a fitness test exercise that includes a plurality of phases (The illustrative fitness protocol described above uses an intermittent ramp protocol—thereby creating the opportunity to measure heart rate recovery multiple times during the course of a fitness test. As described above, users cycle at a specific intensity for a set amount of time (e.g., 30 seconds) followed by a period of rest for a set amount of time (e.g., 30 seconds); Column 16 Lines 14-20), each phase associated with a predetermined duration and a different heart rate band (The illustrative fitness testing approach described herein is unique in using a novel intermittent 30-second ramp protocol to assess the user's fitness. After an initial warm-up is completed (at a pre-determined, personalized intensity & duration) the user then works out at a higher intensity for a set period of time (e.g., bike at 70 watts for 30 seconds). At the end of that period the user stops activity completely and rests for a predetermined period (e.g., 30 seconds) and then resumes activity but now at a higher intensity target (e.g., 100 watts for 30 seconds) and then rests again at the completion of this activity. This process is repeated with ever increasing intensity until voluntary exhaustion is reached or a pre-determined threshold is reached (e.g., 90% of estimated HR max). The user's heart rate and energy expenditure (e.g., power in watts)—as well as potentially other metrics such as VO2/VCO2 ratio, galvanic skin response etc. are measured throughout the fitness test; Column 14 Lines 22-38), wherein the first type of display instructs the subject to adjust their effort to attain a target heart rate associated with the respective heart rate band (should a user's heart rate not meet a predefined recovery threshold, window 1900 will be displayed to the user indicating that the next interval is not going to begin until the user's heart rate has met a predefined threshold; Column 13 Lines 26-30; Figure 19; should the fitness testing application detect that a user's heart rate has exceeded a preset maximum heart rate, then the warning indicator 2005 is displayed to inform the user to cease physical activity to enable their heart rate to recover. The warning indicator 2005 may also be coupled to other safety indicators. For example, an audio alert may be sounded body fitness testing application to provide a warning that the user should cease exercising. Further, in alternative embodiments, the fitness testing application may cause the bike trainer 160 to reduce providing resistance to reduce the workload being performed by the user; Column 13 Lines 49-59; Figure 20);
collecting a heart rate recovery value from heart rate data measured over a first time period using a heart rate monitor (heart rate monitor 165) worn by the subject, wherein the heart rate data is automatically measured upon detection of an end of the fitness test exercise completed by the subject (Heart rate is measured continuously—the difference between the heart rate achieved prior to the cessation of activity at the end of each bout of cycling and the heart rate 30 seconds after the cessation of activity at the end of each bout is averaged across all valid intervals to calculate an estimate of heart rate recovery for that user; Column 16 Lines 20-25);
predicting a VO2max measurement for the subject based on the heart rate recovery value (developing a personalized algorithm for each individual based on their initial fitness test—relating their ‘Estimated Peak Power’ at different intensities to their highest Achieved Peak Power during the fitness assessment. The relationship between the intensity at which they cycled and the estimated peak power at that intensity (which is a function of their heart rate at that intensity—methods described above) is typically log-linear. Personalizing this i.e. fitting a unique curve for each user results in a better fit (approaching an R_square of 0.99) compared to aggregating across individuals (which results in R-square values of 0.70 or less). Once this relationship is estimated from the initial fitness assessment it becomes fairly straightforward to subsequently estimate changes in the user's fitness during a regular exercise session. The user's heart rate to energy expenditure relationship is either captured by aggregating data across the entire session or by sampling specific points during the session or through a combination of both methods. This is then inputted into the personalized algorithm to generate a new estimate of the user's peak power (EPP). The resulting estimate of Peak Power (watts) is then converted into VO2Max values and METs based on methods described above using standard ACSM equations; Column 19 Lines 9-32; On completion the average power for each episode of activity (interval) is calculated…Once such a determination is made, VO2Max can be estimated by converting the aerobic component of peak energy expenditure from say watts or Joules to VO2 units based on well established equations…VO2Max is then estimated from the Aerobic Component of Peak Exercise Capacity basis previously published ACSM equations (e.g., (6.12*EPP+7)*1.8/(Weight(lbs)*0.453592)); Column 14 Line 39 – Column 15 Lines 46); and
generating a second type of display (display 225) that indicates the VO2max measurement (FIG. 10 is an exemplary screenshot illustrating a heart rate monitoring window 1000 in accordance with an illustrative embodiment of the present invention. Exemplary window 1000 provides a grasp of a heart rate 100 size and power worked 1010 during the various fitness sessions. Window 1000 also identifies a peak heart rate field 1015, a minimum heart rate field 1020, and average power field 1025, a recovery field 1030 and a fitness field 1035. Illustratively, the heart rate graph 1005 and actual power graph 1010 are shown along a time axis to enable user or administrator to view the relationship between heart rate and power worked by the user. The various display fields are utilized to display collected data during the fitness session. FIG. 11 is an exemplary screenshot illustrating a recovery window 1100 in accordance with an illustrative embodiment of the present invention. The recovery window 1100 displays a recovery percentage axis 1105 and a fitness level axis 1110. Illustratively, the fitness level is measured in METs. An exemplary data 0.1115 indicates that recovery is 4% while fitness is 15.9 METs. In accordance with an illustrative embodiment of the present invention, the fitness testing application 300 calculates appropriate values to be displayed to a user or administrator from the collected physiological data during a fitness session; Column 11 Line 49 – Column 12 Line 5; FIG. 12 is a screen shot illustrating an exemplary anaerobic threshold window 1200 in accordance with an illustrative embodiment of the present invention. Illustrative window 1200 computes anaerobic threshold ends displayed by the fitness testing application there illustratively, a maximum as was anaerobic threshold levels are displayed for power 1205, Mets 1210, VO2 1215 as well as road biking speed 1220…FIG. 15B is an exemplary screenshot illustrating an VO2Max benchmarks window in accordance with an illustrative embodiment of the present invention; Column 12 Lines 6-52).
Specification
The amendment filed October 25th, 2022 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The incorporation by reference of the international patent application PCT/EP2021/060709 and of the foreign patent application GB2006149.5 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of the associated PCT, in this case April 23rd, 2021, see MPEP 1893.03(b). Therefore, the specification amendment of October 25th, 2022 to include the incorporation by reference is new matter, per MPEP 608.01(p). Applicant is required to cancel the new matter in the reply to this Office Action.
In order to overcome the objection, Examiner suggests that the Applicant file an amendment to their specification that removes the statement “both of which are incorporated herein by reference in their entireties”.
Claim Objections
Claims 12, 19, and 22 are objected to because of the following informalities:
Claim 12 currently recites “claim 5 o,” in lines 1-2, but should read “claim 5,”
Claim 19 currently recites “subject; and;” in line 13, but should read “subject; and”
Claim 22 currently recites “data sets” in line 1 and “datasets” in line 4, but should read either “data sets” in both lines 1 and 4, or “datasets” in both lines 1 and 4
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.
Claim 22 is 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.
Claim 22 recites the limitation "the subset of data" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear as to whether the Applicant meant to have Claim 22 dependent on Claim 21, instead of Claim 1.
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 1-22 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. Each of Claims 1-22 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claims 1-16 and 20-22 recite a series of steps or acts. Thus, the claims are directed to a process, which is one of the statutory categories of invention.
Claims 17-19 recite a device, system, and medium, respectively. Thus, each of the claims are directed to a machine, which is one of the statutory categories of invention.
Step 2A, Prong 1
Each of Claims 1-22 recites at least one step or instruction for predicting a VO2max measurement, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Claims 1-22 recite abstract ideas in the form of mental processes, as consistent with Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012).
If a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer components, then it is still in the mental processes category unless the claim cannot practically be performed in the mind, see Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016). Predicting a VO2max measurement for the subject based on heart rate data may be performed by a human. The steps of collecting values from measured heart rate data is considered a data-gathering step and generating displays is considered a data-outputting, which is categorized as insignificant extra-solution activity.
Accordingly, each of Claims 1-22 recites an abstract idea.
Specifically, Independent Claim 1 recites:
generating a first type of display during a fitness test exercise that includes a plurality of phases, each phase associated with a predetermined duration and a different heart rate band, wherein the first type of display instructs the subject to adjust their effort to attain a target heart rate associated with the respective heart rate band;
collecting a heart rate recovery value from heart rate data measured over a first time period using a heart rate monitor worn by the subject, wherein the heart rate data is automatically measured upon detection of an end of the fitness test exercise completed by the subject,
predicting a VO2max measurement for the subject based on the heart rate recovery value; and
generating a second type of display that indicates the VO2max measurement.
Specifically, Independent Claim 17 recites:
a display screen configured to display a first type of display generated during a fitness test exercise that includes a plurality of phases, each phase associated with a predetermined duration and a different heart rate band, wherein the first display instructs a subject to adjust their effort to attain a target heart rate associated with the respective heart rate band;
a communication interface configured to collect a heart rate recovery value from heart rate data measured over a first time period using a heart rate monitor worn by the subject, wherein the heart rate data is automatically measured upon detection of an end of the fitness test exercise completed by the subject; and
a processor configured to execute instructions to predict a VO2max measurement for the subject based on the heart rate recovery value;
wherein the display screen is further configured to display a second type of display generated to indicate the VO2max measurement.
Specifically, Independent Claim 18 recites:
a display screen configured to display a first type of display generated during a fitness test exercise that includes a plurality of phases, each phase associated with a predetermined duration and a different heart rate band, wherein the first display instructs a subject to adjust their effort to attain a target heart rate associated with the respective heart rate band;
a heart rate monitor configured to be worn by the subject and to collect a heart rate recovery value from heart rate data measured over a first time period starting at an end of a fitness test exercise completed by the subject, wherein the heart rate data is automatically measured upon detection of an end of the fitness test exercise completed by the subject; and
a computing device configured to predict a VO2max measurement for the subject based on the heart rate recovery value;
wherein the display screen is further configured to display a second type of display generated to indicate the VO2max measurement.
Specifically, Independent Claim 19 recites:
A non-transitory, computer-readable storage medium having embodied thereon a computer program executable by a processor to perform a method for predicting a VO2max measurement for a subject, the method comprising:
generating a first type of display during a fitness test exercise that includes a plurality of phases, each phase associated with a predetermined duration and a different heart rate band, wherein the first type of display instructs the subject to adjust their effort to attain a target heart rate associated with the respective heart rate band;
collecting a heart rate recovery value from heart rate data measured over a first time period using a heart rate monitor worn by the subject, wherein the heart rate data is automatically measured upon detection of an end of the fitness test exercise completed by the subject; and;
predicting a VO2max measurement for the subject based on the heart rate recovery value; and
generating a second type of display that indicates the VO2max measurement.
Further, dependent Claims 2-16 and 20-22 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea (underlined above) in each of independent Claims 1 and 17-19 (and dependent Claims 2-16 and 20-22) is not integrated into a practical application under 2019 PEG because the additional elements (identified below in bold), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use.
The additional elements of: “first type of display”, “heart rate monitor”, “second type of display” in independent Claim 1; “display screen”, “communication interface”, “heart rate monitor”, “processor” in independent Claim 17; “display screen”, “heart rate monitor”, “computing device” in independent Claim 18; “non-transitory computer-readable medium”, “processor”, “first type of display”, “heart rate monitor”, “second type of display” in independent Claim 19 are generically recited elements, which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 1 and 17-19 (and dependent Claims 2-16 and 20-22) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., “computing device” as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1 and 17-19 (and dependent Claims 2-16 and 20-22) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 1 and 17-19 (and dependent Claims 2-16 and 20-22) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1-22 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “first type of display”, “heart rate monitor”, “second type of display” in independent Claim 1; “display screen”, “communication interface”, “heart rate monitor”, “processor” in independent Claim 17; “display screen”, “heart rate monitor”, “computing device” in independent Claim 18; “non-transitory computer-readable medium”, “processor”, “first type of display”, “heart rate monitor”, “second type of display” in independent Claim 19. The above-identified additional elements are generically claimed components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering, data-outputting, and computing, as demonstrated by the Applicant’s specification (e.g. Pages 8-9 and 16-17 of the Specification) which discloses that the “computing device” and/or “processor”, “heart rate monitor”, and “display” comprise generic computer components that are configured to perform the generic computer functions (e.g. calculating, data-gathering, and data-outputting, respectively) that are well-understood, routine, and conventional activities previously known to the pertinent industry; the Applicant’s Background in the specification; and the non-patent literature of record in the application.
Accordingly, in light of Applicant’s specification, the claimed term “computing device” and/or “processor” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “computing device” and/or “processor”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1-22 to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method, device, system, and medium of Claims 1-22 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1-22 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-22 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-22 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-22 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-2, 7, 11, and 13-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sivaraj (U.S. Patent No. 9,737,761; previously cited).
Regarding Claim 1, Sivaraj discloses a method of predicting a VO2max measurement for a subject (System and method for fitness testing, tracking and training; Abstract), the method comprising:
generating a first type of display (display 225) during a fitness test exercise that includes a plurality of phases (The illustrative fitness protocol described above uses an intermittent ramp protocol—thereby creating the opportunity to measure heart rate recovery multiple times during the course of a fitness test. As described above, users cycle at a specific intensity for a set amount of time (e.g., 30 seconds) followed by a period of rest for a set amount of time (e.g., 30 seconds); Column 16 Lines 14-20), each phase associated with a predetermined duration and a different heart rate band (The illustrative fitness testing approach described herein is unique in using a novel intermittent 30-second ramp protocol to assess the user's fitness. After an initial warm-up is completed (at a pre-determined, personalized intensity & duration) the user then works out at a higher intensity for a set period of time (e.g., bike at 70 watts for 30 seconds). At the end of that period the user stops activity completely and rests for a predetermined period (e.g., 30 seconds) and then resumes activity but now at a higher intensity target (e.g., 100 watts for 30 seconds) and then rests again at the completion of this activity. This process is repeated with ever increasing intensity until voluntary exhaustion is reached or a pre-determined threshold is reached (e.g., 90% of estimated HR max). The user's heart rate and energy expenditure (e.g., power in watts)—as well as potentially other metrics such as VO2/VCO2 ratio, galvanic skin response etc. are measured throughout the fitness test; Column 14 Lines 22-38), wherein the first type of display instructs the subject to adjust their effort to attain a target heart rate associated with the respective heart rate band (should a user's heart rate not meet a predefined recovery threshold, window 1900 will be displayed to the user indicating that the next interval is not going to begin until the user's heart rate has met a predefined threshold; Column 13 Lines 26-30; Figure 19; should the fitness testing application detect that a user's heart rate has exceeded a preset maximum heart rate, then the warning indicator 2005 is displayed to inform the user to cease physical activity to enable their heart rate to recover. The warning indicator 2005 may also be coupled to other safety indicators. For example, an audio alert may be sounded body fitness testing application to provide a warning that the user should cease exercising. Further, in alternative embodiments, the fitness testing application may cause the bike trainer 160 to reduce providing resistance to reduce the workload being performed by the user; Column 13 Lines 49-59; Figure 20);
collecting a heart rate recovery value from heart rate data measured over a first time period using a heart rate monitor (heart rate monitor 165) worn by the subject, wherein the heart rate data is automatically measured upon detection of an end of the fitness test exercise completed by the subject (Heart rate is measured continuously—the difference between the heart rate achieved prior to the cessation of activity at the end of each bout of cycling and the heart rate 30 seconds after the cessation of activity at the end of each bout is averaged across all valid intervals to calculate an estimate of heart rate recovery for that user; Column 16 Lines 20-25),
predicting a VO2max measurement for the subject based on the heart rate recovery value (developing a personalized algorithm for each individual based on their initial fitness test—relating their ‘Estimated Peak Power’ at different intensities to their highest Achieved Peak Power during the fitness assessment. The relationship between the intensity at which they cycled and the estimated peak power at that intensity (which is a function of their heart rate at that intensity—methods described above) is typically log-linear. Personalizing this i.e. fitting a unique curve for each user results in a better fit (approaching an R_square of 0.99) compared to aggregating across individuals (which results in R-square values of 0.70 or less). Once this relationship is estimated from the initial fitness assessment it becomes fairly straightforward to subsequently estimate changes in the user's fitness during a regular exercise session. The user's heart rate to energy expenditure relationship is either captured by aggregating data across the entire session or by sampling specific points during the session or through a combination of both methods. This is then inputted into the personalized algorithm to generate a new estimate of the user's peak power (EPP). The resulting estimate of Peak Power (watts) is then converted into VO2Max values and METs based on methods described above using standard ACSM equations; Column 19 Lines 9-32; On completion the average power for each episode of activity (interval) is calculated…Once such a determination is made, VO2Max can be estimated by converting the aerobic component of peak energy expenditure from say watts or Joules to VO2 units based on well established equations…VO2Max is then estimated from the Aerobic Component of Peak Exercise Capacity basis previously published ACSM equations (e.g., (6.12*EPP+7)*1.8/(Weight(lbs)*0.453592)); Column 14 Line 39 – Column 15 Lines 46); and
generating a second type of display (display 225) that indicates the VO2max measurement (FIG. 10 is an exemplary screenshot illustrating a heart rate monitoring window 1000 in accordance with an illustrative embodiment of the present invention. Exemplary window 1000 provides a grasp of a heart rate 100 size and power worked 1010 during the various fitness sessions. Window 1000 also identifies a peak heart rate field 1015, a minimum heart rate field 1020, and average power field 1025, a recovery field 1030 and a fitness field 1035. Illustratively, the heart rate graph 1005 and actual power graph 1010 are shown along a time axis to enable user or administrator to view the relationship between heart rate and power worked by the user. The various display fields are utilized to display collected data during the fitness session. FIG. 11 is an exemplary screenshot illustrating a recovery window 1100 in accordance with an illustrative embodiment of the present invention. The recovery window 1100 displays a recovery percentage axis 1105 and a fitness level axis 1110. Illustratively, the fitness level is measured in METs. An exemplary data 0.1115 indicates that recovery is 4% while fitness is 15.9 METs. In accordance with an illustrative embodiment of the present invention, the fitness testing application 300 calculates appropriate values to be displayed to a user or administrator from the collected physiological data during a fitness session; Column 11 Line 49 – Column 12 Line 5; FIG. 12 is a screen shot illustrating an exemplary anaerobic threshold window 1200 in accordance with an illustrative embodiment of the present invention. Illustrative window 1200 computes anaerobic threshold ends displayed by the fitness testing application there illustratively, a maximum as was anaerobic threshold levels are displayed for power 1205, Mets 1210, VO2 1215 as well as road biking speed 1220…FIG. 15B is an exemplary screenshot illustrating an VO2Max benchmarks window in accordance with an illustrative embodiment of the present invention; Column 12 Lines 6-52).
Regarding Claim 2, Sivaraj discloses wherein the heart rate bands are defined by a range of percentage of maximum heart rate (require the participant to ramp up their exercise intensity after a set time period and continue doing so until the user reaches exhaustion (or a pre-set HR threshold). Various measurements taken during this process allow an estimation of the user's cardio-respiratory fitness; Column 14 Lines 16-21; The proposed invention tracks the user's heart rate and waits for it to drop below a pre-set threshold before guiding the user to start the next interval. The heart rate recovery threshold could be an absolute value or a percentage of the user's max heart rate; Column 21 Lines 27-32), and wherein the fitness test exercise comprises a low intensity phase (warm-up phase) and a high intensity phase (This process is repeated with ever increasing intensity until voluntary exhaustion is reached or a pre-determined threshold is reached (e.g., 90% of estimated HR max); Column 14 Lines 32-35), the low intensity phase having a lower heart rate range than the high intensity phase (After an initial warm-up is completed (at a pre-determined, personalized intensity & duration) the user then works out at a higher intensity for a set period of time (e.g., bike at 70 watts for 30 seconds); Column 14 Lines 24-27; The intensity of the warm-up period is determined as a function of the user's cardio-respiratory fitness (e.g. 10% of the user's fitness level); Column 20 Lines 57-59), and wherein the low intensity phase is performed first in the fitness test exercise (After an initial warm-up is completed (at a pre-determined, personalized intensity & duration) the user then works out at a higher intensity for a set period of time (e.g., bike at 70 watts for 30 seconds)…this process is repeated with ever increasing intensity until voluntary exhaustion is reached or a pre-determined threshold is reached (e.g., 90% of estimated HR max); Column 14 Lines 22-38; The exercise plan consists of a warm-up phase—duration and intensity. e.g. cycle for 30 watts for 90 seconds, followed by an interval (short bout of cycling for a fixed time at a particular intensity e.g. cycle for 320 watts for 30 seconds); Column 20 Lines 51-59), and the high intensity phase is performed last in the fitness test exercise (This process is repeated with ever increasing intensity until voluntary exhaustion is reached or a pre-determined threshold is reached (e.g., 90% of estimated HR max); Column 14 Lines 32-35).
Regarding Claim 7, Sivaraj discloses wherein the method further comprises collecting a mass factor of the subject (a height field 650, weight field 655, body fat percentage field 660; Column 9 Lines 63-64; “BMI” in Figures 7 and 13), and wherein predicting the VO2max measurement includes using the mass factor (VO2Max is then estimated from the Aerobic Component of Peak Exercise Capacity basis previously published ACSM equations (e.g., (6.12*EPP+7)*1.8/(Weight(lbs)*0.453592)); Column 15 Lines 43-46).
Regarding Claim 11, Sivaraj discloses wherein the heart rate recovery value has a positive effect on the predicted VO2max measurement (VO2Max is then estimated from the Aerobic Component of Peak Exercise Capacity basis previously published ACSM equations (e.g., (6.12*EPP+7)*1.8/(Weight(lbs)*0.453592)); Column 15 Lines 43-46; Examiner’s Note: The heart rate recovery value is used to calculate EPP. Then the EPP is used to calculate VO2max via multiplication and addition, which would result in a “positive effect” on the predicted VO2max).
Regarding Claim 13, Sivaraj discloses wherein the first type of display further includes real-time heart data during each phase of the fitness test exercise (The window 900 illustratively includes an entertainment section 905, energy indicator 910, time remaining field 915, heart rate indicate 920…the heart rate indicator 920 indicates the user's current heart rate; Column 11 Lines 11-42; Figures 9, 18, and 19), the first type of display instructing the subject to adjust their efforts based on the real-time heart rate data in relation to the heart rate band corresponding to the respective phase of the fitness test exercise (should a user's heart rate not meet a predefined recovery threshold, window 1900 will be displayed to the user indicating that the next interval is not going to begin until the user's heart rate has met a predefined threshold; Column 13 Lines 26-30; Figure 19; should the fitness testing application detect that a user's heart rate has exceeded a preset maximum heart rate, then the warning indicator 2005 is displayed to inform the user to cease physical activity to enable their heart rate to recover. The warning indicator 2005 may also be coupled to other safety indicators. For example, an audio alert may be sounded body fitness testing application to provide a warning that the user should cease exercising. Further, in alternative embodiments, the fitness testing application may cause the bike trainer 160 to reduce providing resistance to reduce the workload being performed by the user; Column 13 Lines 49-59; Figure 20).
Regarding Claim 14, Sivaraj discloses wherein the first type of display further includes the respective heart rate band during each phase of the fitness test exercise (FIG. 9 is an exemplary screenshot illustrating a fitness testing window 900 in accordance with an illustrative embodiment of the present invention. The window 900 illustratively includes an entertainment section 905, energy indicator 910, time remaining field 915, heart rate indicate 920, activity indicator 925, workout intensity indicator 930, time indicator 935…The energy indicator 910 indicates the desired amount of work the user should be expending during a particular interval. In the displayed example of FIG. 9, the user should be exerting 310 watts. The related time remaining field 915 indicates that the time remaining in a particular interval. When read in conjunction with the energy indicator 910, a user may determine how much exertion and for how long remains for a particular interval. The heart rate indicator 920 indicates the user's current heart rate. Illustratively, the user's heart rate is obtained from heart rate monitor 165. The workout intensity indicator and time indicator 930, 935 indicate or provide a visual indication of the intensity that the user should be exercising as well as the duration of a particular interval during the exercise session; Column 11 Lines 11-42; interval timing indicator 930, interval indicator 930, status indicator 930; Figures 9, 17-19).
Regarding Claim 15, Sivaraj discloses wherein the method further comprises collecting the subject's heart rate during the fitness test exercise (a user (not shown) wears a heart rate monitor 165 during testing. The heart rate monitor 165 may comprise any of a number of form factors, including for example, a wrist worn heart monitor, chest mounted heart monitor, etc. Illustratively, the heart rate monitor is able to communicate with the fitness testing computer 200; Column 7 Lines 1-25).
Regarding Claim 16, Sivaraj discloses wherein collecting the heart rate recovery value comprises: detecting the end of the fitness test exercise completed by the subject, automatically measuring heart rate data over the first period (should a user's heart rate not meet a predefined recovery threshold, window 1900 will be displayed to the user indicating that the next interval is not going to begin until the user's heart rate has met a predefined threshold; Column 13 Lines 26-30; Figure 19; should the fitness testing application detect that a user's heart rate has exceeded a preset maximum heart rate, then the warning indicator 2005 is displayed to inform the user to cease physical activity to enable their heart rate to recover. The warning indicator 2005 may also be coupled to other safety indicators. For example, an audio alert may be sounded body fitness testing application to provide a warning that the user should cease exercising. Further, in alternative embodiments, the fitness testing application may cause the bike trainer 160 to reduce providing resistance to reduce the workload being performed by the user. As such, the description of a warning indicator 2005 being displayed should be taken as exemplary only; Column 13 Lines 49-61; The illustrative fitness testing approach described herein is unique in using a novel intermittent 30-second ramp protocol to assess the user's fitness. After an initial warm-up is completed (at a pre-determined, personalized intensity & duration) the user then works out at a higher intensity for a set period of time (e.g., bike at 70 watts for 30 seconds). At the end of that period the user stops activity completely and rests for a predetermined period (e.g., 30 seconds) and then resumes activity but now at a higher intensity target (e.g., 100 watts for 30 seconds) and then rests again at the completion of this activity. This process is repeated with ever increasing intensity until voluntary exhaustion is reached or a pre-determined threshold is reached (e.g., 90% of estimated HR max). The user's heart rate and energy expenditure (e.g., power in watts)—as well as potentially other metrics such as VO2/VCO2 ratio, galvanic skin response etc. are measured throughout the fitness test; Column 14 Lines 22-38; Figure 20), and calculating the heart rate recovery value (users cycle at a specific intensity for a set amount of time (e.g., 30 seconds) followed by a period of rest for a set amount of time (e.g., 30 seconds). Heart rate is measured continuously—the difference between the heart rate achieved prior to the cessation of activity at the end of each bout of cycling and the heart rate 30 seconds after the cessation of activity at the end of each bout is averaged across all valid intervals to calculate an estimate of heart rate recovery for that user; Column 16 Lines 17-25).
Regarding Claim 17, Sivaraj discloses a computing device (fitness testing computer 200; Figure 2), comprising:
a display screen (display 225) configured to display a first type of display generated during a fitness test exercise that includes a plurality of phases (The illustrative fitness protocol described above uses an intermittent ramp protocol—thereby creating the opportunity to measure heart rate recovery multiple times during the course of a fitness test. As described above, users cycle at a specific intensity for a set amount of time (e.g., 30 seconds) followed by a period of rest for a set amount of time (e.g., 30 seconds); Column 16 Lines 14-20), each phase associated with a predetermined duration and a different heart rate band (The illustrative fitness testing approach described herein is unique in using a novel intermittent 30-second ramp protocol to assess the user's fitness. After an initial warm-up is completed (at a pre-determined, personalized intensity & duration) the user then works out at a higher intensity for a set period of time (e.g., bike at 70 watts for 30 seconds). At the end of that period the user stops activity completely and rests for a predetermined period (e.g., 30 seconds) and then resumes activity but now at a higher intensity target (e.g., 100 watts for 30 seconds) and then rests again at the completion of this activity. This process is repeated with ever increasing intensity until voluntary exhaustion is reached or a pre-determined threshold is reached (e.g., 90% of estimated HR max). The user's heart rate and energy expenditure (e.g., power in watts)—as well as potentially other metrics such as VO2/VCO2 ratio, galvanic skin response etc. are measured throughout the fitness test; Column 14 Lines 22-38), wherein the first display instructs a subject to adjust their effort to attain a target heart rate associated with the respective heart rate band (should a user's heart rate not meet a predefined recovery threshold, window 1900 will be displayed to the user indicating that the next interval is not going to begin until the user's heart rate has met a predefined threshold; Column 13 Lines 26-30; Figure 19; should the fitness testing application detect that a user's heart rate has exceeded a preset maximum heart rate, then the warning indicator 2005 is displayed to inform the user to cease physical activity to enable their heart rate to recover. The warning indicator 2005 may also be coupled to other safety indicators. For example, an audio alert may be sounded body fitness testing application to provide a warning that the user should cease exercising. Further, in alternative embodiments, the fitness testing application may cause the bike trainer 160 to reduce providing resistance to reduce the workload being performed by the user; Column 13 Lines 49-59; Figure 20);
a communication interface configured to collect a heart rate recovery value from heart rate data measured over a first time period using a heart rate monitor (heart rate monitor 165) worn by the subject, wherein the heart rate data is automatically measured upon detection of an end of the fitness test exercise completed by the subject (Heart rate is measured continuously—the difference between the heart rate achieved prior to the cessation of activity at the end of each bout of cycling and the heart rate 30 seconds after the cessation of activity at the end of each bout is averaged across all valid intervals to calculate an estimate of heart rate recovery for that user; Column 16 Lines 20-25); and
a processor (processor 205) configured to execute instructions to predict a VO2max measurement for the subject based on the heart rate recovery value (developing a personalized algorithm for each individual based on their initial fitness test—relating their ‘Estimated Peak Power’ at different intensities to their highest Achieved Peak Power during the fitness assessment. The relationship between the intensity at which they cycled and the estimated peak power at that intensity (which is a function of their heart rate at that intensity—methods described above) is typically log-linear. Personalizing this i.e. fitting a unique curve for each user results in a better fit (approaching an R_square of 0.99) compared to aggregating across individuals (which results in R-square values of 0.70 or less). Once this relationship is estimated from the initial fitness assessment it becomes fairly straightforward to subsequently estimate changes in the user's fitness during a regular exercise session. The user's heart rate to energy expenditure relationship is either captured by aggregating data across the entire session or by sampling specific points during the session or through a combination of both methods. This is then inputted into the personalized algorithm to generate a new estimate of the user's peak power (EPP). The resulting estimate of Peak Power (watts) is then converted into VO2Max values and METs based on methods described above using standard ACSM equations; Column 19 Lines 9-32; On completion the average power for each episode of activity (interval) is calculated…Once such a determination is made, VO2Max can be estimated by converting the aerobic component of peak energy expenditure from say watts or Joules to VO2 units based on well established equations…VO2Max is then estimated from the Aerobic Component of Peak Exercise Capacity basis previously published ACSM equations (e.g., (6.12*EPP+7)*1.8/(Weight(lbs)*0.453592)); Column 14 Line 39 – Column 15 Lines 46);
wherein the display screen (display 225) is further configured to display a second type of display generated to indicate the VO2max measurement (FIG. 10 is an exemplary screenshot illustrating a heart rate monitoring window 1000 in accordance with an illustrative embodiment of the present invention. Exemplary window 1000 provides a grasp of a heart rate 100 size and power worked 1010 during the various fitness sessions. Window 1000 also identifies a peak heart rate field 1015, a minimum heart rate field 1020, and average power field 1025, a recovery field 1030 and a fitness field 1035. Illustratively, the heart rate graph 1005 and actual power graph 1010 are shown along a time axis to enable user or administrator to view the relationship between heart rate and power worked by the user. The various display fields are utilized to display collected data during the fitness session. FIG. 11 is an exemplary screenshot illustrating a recovery window 1100 in accordance with an illustrative embodiment of the present invention. The recovery window 1100 displays a recovery percentage axis 1105 and a fitness level axis 1110. Illustratively, the fitness level is measured in METs. An exemplary data 0.1115 indicates that recovery is 4% while fitness is 15.9 METs. In accordance with an illustrative embodiment of the present invention, the fitness testing application 300 calculates appropriate values to be displayed to a user or administrator from the collected physiological data during a fitness session; Column 11 Line 49 – Column 12 Line 5; FIG. 12 is a screen shot illustrating an exemplary anaerobic threshold window 1200 in accordance with an illustrative embodiment of the present invention. Illustrative window 1200 computes anaerobic threshold ends displayed by the fitness testing application there illustratively, a maximum as was anaerobic threshold levels are displayed for power 1205, Mets 1210, VO2 1215 as well as road biking speed 1220…FIG. 15B is an exemplary screenshot illustrating an VO2Max benchmarks window in accordance with an illustrative embodiment of the present invention; Column 12 Lines 6-52).
Regarding Claim 18, Sivaraj discloses a system for predicting a VO2max measurement for a subject (A system for adaptive fitness testing; Abstract), the system comprising:
a display screen (display 225) configured to display a first type of display generated during a fitness test exercise that includes a plurality of phases (The illustrative fitness protocol described above uses an intermittent ramp protocol—thereby creating the opportunity to measure heart rate recovery multiple times during the course of a fitness test. As described above, users cycle at a specific intensity for a set amount of time (e.g., 30 seconds) followed by a period of rest for a set amount of time (e.g., 30 seconds); Column 16 Lines 14-20), each phase associated with a predetermined duration and a different heart rate band (The illustrative fitness testing approach described herein is unique in using a novel intermittent 30-second ramp protocol to assess the user's fitness. After an initial warm-up is completed (at a pre-determined, personalized intensity & duration) the user then works out at a higher intensity for a set period of time (e.g., bike at 70 watts for 30 seconds). At the end of that period the user stops activity completely and rests for a predetermined period (e.g., 30 seconds) and then resumes activity but now at a higher intensity target (e.g., 100 watts for 30 seconds) and then rests again at the completion of this activity. This process is repeated with ever increasing intensity until voluntary exhaustion is reached or a pre-determined threshold is reached (e.g., 90% of estimated HR max). The user's heart rate and energy expenditure (e.g., power in watts)—as well as potentially other metrics such as VO2/VCO2 ratio, galvanic skin response etc. are measured throughout the fitness test; Column 14 Lines 22-38), wherein the first display instructs a subject to adjust their effort to attain a target heart rate associated with the respective heart rate band (should a user's heart rate not meet a predefined recovery threshold, window 1900 will be displayed to the user indicating that the next interval is not going to begin until the user's heart rate has met a predefined threshold; Column 13 Lines 26-30; Figure 19; should the fitness testing application detect that a user's heart rate has exceeded a preset maximum heart rate, then the warning indicator 2005 is displayed to inform the user to cease physical activity to enable their heart rate to recover. The warning indicator 2005 may also be coupled to other safety indicators. For example, an audio alert may be sounded body fitness testing application to provide a warning that the user should cease exercising. Further, in alternative embodiments, the fitness testing application may cause the bike trainer 160 to reduce providing resistance to reduce the workload being performed by the user; Column 13 Lines 49-59; Figure 20);
a heart rate monitor (heart rate monitor 165) configured to be worn by the subject and to collect a heart rate recovery value from heart rate data measured over a first time period starting at an end of a fitness test exercise completed by the subject, wherein the heart rate data is automatically measured upon detection of an end of the fitness test exercise completed by the subject (Heart rate is measured continuously—the difference between the heart rate achieved prior to the cessation of activity at the end of each bout of cycling and the heart rate 30 seconds after the cessation of activity at the end of each bout is averaged across all valid intervals to calculate an estimate of heart rate recovery for that user; Column 16 Lines 20-25); and
a computing device (fitness testing computer 200 illustratively comprises a processor 205; Column 7 Lines 39-40) configured to predict a VO2max measurement for the subject based on the heart rate recovery value (developing a personalized algorithm for each individual based on their initial fitness test—relating their ‘Estimated Peak Power’ at different intensities to their highest Achieved Peak Power during the fitness assessment. The relationship between the intensity at which they cycled and the estimated peak power at that intensity (which is a function of their heart rate at that intensity—methods described above) is typically log-linear. Personalizing this i.e. fitting a unique curve for each user results in a better fit (approaching an R_square of 0.99) compared to aggregating across individuals (which results in R-square values of 0.70 or less). Once this relationship is estimated from the initial fitness assessment it becomes fairly straightforward to subsequently estimate changes in the user's fitness during a regular exercise session. The user's heart rate to energy expenditure relationship is either captured by aggregating data across the entire session or by sampling specific points during the session or through a combination of both methods. This is then inputted into the personalized algorithm to generate a new estimate of the user's peak power (EPP). The resulting estimate of Peak Power (watts) is then converted into VO2Max values and METs based on methods described above using standard ACSM equations; Column 19 Lines 9-32; On completion the average power for each episode of activity (interval) is calculated…Once such a determination is made, VO2Max can be estimated by converting the aerobic component of peak energy expenditure from say watts or Joules to VO2 units based on well established equations…VO2Max is then estimated from the Aerobic Component of Peak Exercise Capacity basis previously published ACSM equations (e.g., (6.12*EPP+7)*1.8/(Weight(lbs)*0.453592)); Column 14 Line 39 – Column 15 Lines 46);
wherein the display screen (display 225) is further configured to display a second type of display generated to indicate the VO2max measurement (FIG. 10 is an exemplary screenshot illustrating a heart rate monitoring window 1000 in accordance with an illustrative embodiment of the present invention. Exemplary window 1000 provides a grasp of a heart rate 100 size and power worked 1010 during the various fitness sessions. Window 1000 also identifies a peak heart rate field 1015, a minimum heart rate field 1020, and average power field 1025, a recovery field 1030 and a fitness field 1035. Illustratively, the heart rate graph 1005 and actual power graph 1010 are shown along a time axis to enable user or administrator to view the relationship between heart rate and power worked by the user. The various display fields are utilized to display collected data during the fitness session. FIG. 11 is an exemplary screenshot illustrating a recovery window 1100 in accordance with an illustrative embodiment of the present invention. The recovery window 1100 displays a recovery percentage axis 1105 and a fitness level axis 1110. Illustratively, the fitness level is measured in METs. An exemplary data 0.1115 indicates that recovery is 4% while fitness is 15.9 METs. In accordance with an illustrative embodiment of the present invention, the fitness testing application 300 calculates appropriate values to be displayed to a user or administrator from the collected physiological data during a fitness session; Column 11 Line 49 – Column 12 Line 5; FIG. 12 is a screen shot illustrating an exemplary anaerobic threshold window 1200 in accordance with an illustrative embodiment of the present invention. Illustrative window 1200 computes anaerobic threshold ends displayed by the fitness testing application there illustratively, a maximum as was anaerobic threshold levels are displayed for power 1205, Mets 1210, VO2 1215 as well as road biking speed 1220…FIG. 15B is an exemplary screenshot illustrating an VO2Max benchmarks window in accordance with an illustrative embodiment of the present invention; Column 12 Lines 6-52).
Regarding Claim 19, Sivaraj discloses a non-transitory, computer-readable storage medium having embodied thereon a computer program executable by a processor to perform a method for predicting a VO2max measurement for a subject (The memory 230 comprises a plurality of locations that are addressable by the processors 205 and adapters 215, 220 for storing software programs and data structures associated with the embodiments described herein. The processor 205 may comprise necessary elements or logic adapted to execute the software programs and manipulate the data structures. An operating system 235, portions of which are typically resident in memory 230 and executed by the processor 205, functionally organizes the fitness testing computer 200 by, inter alia, invoking software processes and/or services or other applications executing thereon. A fitness testing application 300, described further below in reference to FIG. 3, implements, in conjunction with the fitness testing apparatus 105, the various embodiments of the present invention; Column 7 Line 56 – Column 8 Line 3), the method comprising:
generating a first type of display (display 225) during a fitness test exercise that includes a plurality of phases (The illustrative fitness protocol described above uses an intermittent ramp protocol—thereby creating the opportunity to measure heart rate recovery multiple times during the course of a fitness test. As described above, users cycle at a specific intensity for a set amount of time (e.g., 30 seconds) followed by a period of rest for a set amount of time (e.g., 30 seconds); Column 16 Lines 14-20), each phase associated with a predetermined duration and a different heart rate band (The illustrative fitness testing approach described herein is unique in using a novel intermittent 30-second ramp protocol to assess the user's fitness. After an initial warm-up is completed (at a pre-determined, personalized intensity & duration) the user then works out at a higher intensity for a set period of time (e.g., bike at 70 watts for 30 seconds). At the end of that period the user stops activity completely and rests for a predetermined period (e.g., 30 seconds) and then resumes activity but now at a higher intensity target (e.g., 100 watts for 30 seconds) and then rests again at the completion of this activity. This process is repeated with ever increasing intensity until voluntary exhaustion is reached or a pre-determined threshold is reached (e.g., 90% of estimated HR max). The user's heart rate and energy expenditure (e.g., power in watts)—as well as potentially other metrics such as VO2/VCO2 ratio, galvanic skin response etc. are measured throughout the fitness test; Column 14 Lines 22-38), wherein the first type of display instructs the subject to adjust their effort to attain a target heart rate associated with the respective heart rate band (should a user's heart rate not meet a predefined recovery threshold, window 1900 will be displayed to the user indicating that the next interval is not going to begin until the user's heart rate has met a predefined threshold; Column 13 Lines 26-30; Figure 19; should the fitness testing application detect that a user's heart rate has exceeded a preset maximum heart rate, then the warning indicator 2005 is displayed to inform the user to cease physical activity to enable their heart rate to recover. The warning indicator 2005 may also be coupled to other safety indicators. For example, an audio alert may be sounded body fitness testing application to provide a warning that the user should cease exercising. Further, in alternative embodiments, the fitness testing application may cause the bike trainer 160 to reduce providing resistance to reduce the workload being performed by the user; Column 13 Lines 49-59; Figure 20);
collecting a heart rate recovery value from heart rate data measured over a first time period using a heart rate monitor (heart rate monitor 165) worn by the subject, wherein the heart rate data is automatically measured upon detection of an end of the fitness test exercise completed by the subject (Heart rate is measured continuously—the difference between the heart rate achieved prior to the cessation of activity at the end of each bout of cycling and the heart rate 30 seconds after the cessation of activity at the end of each bout is averaged across all valid intervals to calculate an estimate of heart rate recovery for that user; Column 16 Lines 20-25); and;
predicting a VO2max measurement for the subject based on the heart rate recovery value (developing a personalized algorithm for each individual based on their initial fitness test—relating their ‘Estimated Peak Power’ at different intensities to their highest Achieved Peak Power during the fitness assessment. The relationship between the intensity at which they cycled and the estimated peak power at that intensity (which is a function of their heart rate at that intensity—methods described above) is typically log-linear. Personalizing this i.e. fitting a unique curve for each user results in a better fit (approaching an R_square of 0.99) compared to aggregating across individuals (which results in R-square values of 0.70 or less). Once this relationship is estimated from the initial fitness assessment it becomes fairly straightforward to subsequently estimate changes in the user's fitness during a regular exercise session. The user's heart rate to energy expenditure relationship is either captured by aggregating data across the entire session or by sampling specific points during the session or through a combination of both methods. This is then inputted into the personalized algorithm to generate a new estimate of the user's peak power (EPP). The resulting estimate of Peak Power (watts) is then converted into VO2Max values and METs based on methods described above using standard ACSM equations; Column 19 Lines 9-32; On completion the average power for each episode of activity (interval) is calculated…Once such a determination is made, VO2Max can be estimated by converting the aerobic component of peak energy expenditure from say watts or Joules to VO2 units based on well established equations…VO2Max is then estimated from the Aerobic Component of Peak Exercise Capacity basis previously published ACSM equations (e.g., (6.12*EPP+7)*1.8/(Weight(lbs)*0.453592)); Column 14 Line 39 – Column 15 Lines 46); and
generating a second type of display (display 225) that indicates the VO2max measurement (FIG. 10 is an exemplary screenshot illustrating a heart rate monitoring window 1000 in accordance with an illustrative embodiment of the present invention. Exemplary window 1000 provides a grasp of a heart rate 100 size and power worked 1010 during the various fitness sessions. Window 1000 also identifies a peak heart rate field 1015, a minimum heart rate field 1020, and average power field 1025, a recovery field 1030 and a fitness field 1035. Illustratively, the heart rate graph 1005 and actual power graph 1010 are shown along a time axis to enable user or administrator to view the relationship between heart rate and power worked by the user. The various display fields are utilized to display collected data during the fitness session. FIG. 11 is an exemplary screenshot illustrating a recovery window 1100 in accordance with an illustrative embodiment of the present invention. The recovery window 1100 displays a recovery percentage axis 1105 and a fitness level axis 1110. Illustratively, the fitness level is measured in METs. An exemplary data 0.1115 indicates that recovery is 4% while fitness is 15.9 METs. In accordance with an illustrative embodiment of the present invention, the fitness testing application 300 calculates appropriate values to be displayed to a user or administrator from the collected physiological data during a fitness session; Column 11 Line 49 – Column 12 Line 5; FIG. 12 is a screen shot illustrating an exemplary anaerobic threshold window 1200 in accordance with an illustrative embodiment of the present invention. Illustrative window 1200 computes anaerobic threshold ends displayed by the fitness testing application there illustratively, a maximum as was anaerobic threshold levels are displayed for power 1205, Mets 1210, VO2 1215 as well as road biking speed 1220…FIG. 15B is an exemplary screenshot illustrating an VO2Max benchmarks window in accordance with an illustrative embodiment of the present invention; Column 12 Lines 6-52).
Regarding Claim 20, Sivaraj discloses wherein predicting the VO2max measurement is further based on one or more prediction models (developing a personalized algorithm for each individual based on their initial fitness test—relating their ‘Estimated Peak Power’ at different intensities to their highest Achieved Peak Power during the fitness assessment. The relationship between the intensity at which they cycled and the estimated peak power at that intensity (which is a function of their heart rate at that intensity—methods described above) is typically log-linear. Personalizing this i.e. fitting a unique curve for each user results in a better fit (approaching an R_square of 0.99) compared to aggregating across individuals (which results in R-square values of 0.70 or less). Once this relationship is estimated from the initial fitness assessment it becomes fairly straightforward to subsequently estimate changes in the user's fitness during a regular exercise session. The user's heart rate to energy expenditure relationship is either captured by aggregating data across the entire session or by sampling specific points during the session or through a combination of both methods. This is then inputted into the personalized algorithm to generate a new estimate of the user's peak power (EPP). The resulting estimate of Peak Power (watts) is then converted into VO2Max values and METs based on methods described above using standard ACSM equations; Column 19 Lines 9-32; On completion the average power for each episode of activity (interval) is calculated…Once such a determination is made, VO2Max can be estimated by converting the aerobic component of peak energy expenditure from say watts or Joules to VO2 units based on well established equations…VO2Max is then estimated from the Aerobic Component of Peak Exercise Capacity basis previously published ACSM equations (e.g., (6.12*EPP+7)*1.8/(Weight(lbs)*0.453592)); Column 14 Line 39 – Column 15 Lines 46).
Regarding Claim 21, Sivaraj discloses wherein generating the second type of display is further based on a subset of data stored at a database, the subset corresponding to the subject (VO2Max is then estimated from the Aerobic Component of Peak Exercise Capacity basis previously published ACSM equations (e.g., (6.12*EPP+7)*1.8/(Weight(lbs)*0.453592)). This can also then be converted to METs from the following ratio 1 MET=3.5 VO2; Column 15 Lines 43-47); Exemplary fields 615-670 may include, for example, a first name field 615, a last name field 620, a username field 625, password field 630, birthdate field 635, male and female gender selection buttons 640, 645, a height field 650, weight field 655, body fat percentage field 660, waist size field 665 and an activity level field 670. An administrator may illustratively enter the name of a user in the first and last name fields 615, 620. Further, the user may be assigned a username in username field 625. A initial password may be entered in password field 630. The username and password may be utilized by the user to later log into the fitness testing application 300 to perform testing and/or have the fitness testing application track the user's individual fitness performance and progress. The date of birth of field 635 and gender fields 640, 645 enable the administrator to identify the age and gender of the user. Such information may be utilized by the fitness testing application and later calculation of metrics including, for example calculation of a maximum heart rate. As will be appreciated by those skilled in the art, a conventional maximum heart rate may be defined as 220 minus the age in years. The additional physiological fields 650-670 may be utilized to enter information regarding a user for use in calculating the fitness metrics, as described further below. It should be noted that wow window 600 illustrates a particular set of fitness or physiological factors, in alternative embodiments of the present invention additional and/or differing physiological factors may be recorded; Column 9 Line 60 – Column 10 Line 20).
Regarding Claim 22, Sivaraj discloses wherein the subset of data includes data sets associated with other individuals sharing one or more characteristics with the subject, and wherein the second type of display includes a comparison of the VO2max measurement for the subject with the datasets associated with the other individuals (Test participants typically end their session when they reach close to age specific heart rate (HR) max or fatigue and VO2Max is estimated by projecting HR/VO2 ratio at the end of the test to Max HR for that user; Column 3 Lines 56-60; Such information may be utilized by the fitness testing application and later calculation of metrics including, for example calculation of a maximum heart rate. As will be appreciated by those skilled in the art, a conventional maximum heart rate may be defined as 220 minus the age in years; Column 10 Lines 8-13; This expected fitness value could be calculated based on known age/gender averages or pre-existing information collected from other study participants or by using published algorithms (e.g. NASA method) that can estimate cardio-respiratory fitness from easily measured data about the individual (e.g. height, weight, age, gender, waist girth, fat mass and so on); Column 15 Lines 61-67).
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.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Sivaraj in view of NPL Wernhart et al (Wernhart, S., M. Guazzi, and M. Halle. "Correlation of heart rate recovery, aerobic physical activity and performance. A sub-analysis of the EURO-Ex trial." Deutsche Zeitschrift für Sportmedizin 71.1 (2020): 19-24.; cited by Applicant; previously cited).
Regarding Claim 3, Sivaraj discloses wherein the first period is at least 30 seconds (Heart rate is measured continuously—the difference between the heart rate achieved prior to the cessation of activity at the end of each bout of cycling and the heart rate 30 seconds after the cessation of activity at the end of each bout is averaged across all valid intervals to calculate an estimate of heart rate recovery for that user) and suggests that time frames can be varied between 30 seconds to 3 minutes (Traditionally heart rate recovery has been measured as a single point measure of the change in heart rate post the completion of a maximal exercise test. There have been varying time frames used to calculate the change—30 seconds to 3 minutes being the most common).
However, Sivaraj fails to specifically disclose wherein the first period is at least 1 minute.
In a similar technical field, NPL Wernhart teaches a method of predicting a VO2max measurement for a subject (Correlation of Heart Rate Recovery, Aerobic Physical Activity and Performance; Abstract), the method comprising:
collecting a heart rate recovery value (“Correlations between Heart Rate Recovery (HRR: 1, 3, and 5 Minutes after Exercise Termination) and Relative Oxygen Uptake at Peak Performance…as well as Maximal Power…and Physical Activity” in Table 2; “Heart rate recovery after one, three and five minutes was documented after exercise termination (HRR1, HRR3, HRR5)”; “Cardiopulmonary Testing” in Pages 20-21), measured over a first period starting at the end of a fitness test exercise completed by the subject (“an individualized ramp protocol with an exercise duration ranging from eight to twelve minutes”; “Study Design” Page 20), and calculating a predicted VO2max measurement using the heart rate recovery value (Table 2; “Relative VO2peak and Pmax were strongly correlated with heart rate recovery after one…three…and five…minutes”; “Results” Page 21);
wherein the first period is at least 1 minute (“Heart rate recovery after one, three and five minutes was documented after exercise termination (HRR1, HRR3, HRR5)”; “Cardiopulmonary Testing” in Pages 20-21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the time period teachings of NPL Wernhart into those of Sivaraj in order to correlate how heart rate recovery one minute, three minutes, and five minutes after exercise termination in cardiopulmonary testing correlates with performance and compare to one another (NPL Wernhart Page 19).
Regarding Claim 4, NPL Wernhart teaches wherein the first period is 3 minutes (“Heart rate recovery after one, three and five minutes was documented after exercise termination (HRR1, HRR3, HRR5)”; “Cardiopulmonary Testing” in Pages 20-21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the time period teachings of NPL Wernhart into those of Sivaraj in order to correlate how heart rate recovery one minute, three minutes, and five minutes after exercise termination in cardiopulmonary testing correlates with performance and compare to one another (NPL Wernhart Page 19).
Claims 5-6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Sivaraj in view of NPL Wernhart and NPL Hansen et al (Hansen, Dominique, et al. "Validation of a single‐stage fixed‐rate step test for the prediction of maximal oxygen uptake in healthy adults." Clinical physiology and functional imaging 36.5 (2016): 401-406.; cited by Applicant; previously cited).
Regarding Claim 5, Sivaraj fails to disclose wherein the method further comprises collecting a second heart rate recovery value measured over a second period starting at the end of the fitness test exercise, the second period being shorter than the first period.
In a similar technical field, NPL Wernhart teaches a method of predicting a VO2max measurement for a subject (Correlation of Heart Rate Recovery, Aerobic Physical Activity and Performance; Abstract), wherein the method further comprises collecting a second heart rate recovery value measured over a second period starting at the end of the fitness test exercise, the second period being shorter than the first period (“Correlations between Heart Rate Recovery (HRR: 1, 3, and 5 Minutes after Exercise Termination) and Relative Oxygen Uptake at Peak Performance…as well as Maximal Power…and Physical Activity” in Table 2; “Heart rate recovery after one, three and five minutes was documented after exercise termination (HRR1, HRR3, HRR5)”; “Cardiopulmonary Testing” in Pages 20-21; Examiner’s Note: The heart rate recovery is documented within three different time periods: one minute, three minutes, and five minutes. In this case, the second heart rate recovery value can be measured over one minute, while the first heart rate recovery value is measured over the first period, which can be three minutes or five minutes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the time period teachings of NPL Wernhart into those of Sivaraj in order to correlate how heart rate recovery one minute, three minutes, and five minutes after exercise termination in cardiopulmonary testing correlates with performance and compare to one another (NPL Wernhart Page 19).
Although NPL Wernhart teaches a strong correlation between the VO2 max measurement and the heart rate recovery after one, three, and five minutes and the usage of linear regression models to fit and correlate data, Sivaraj and NPL Wernhart fail to specifically teach wherein predicting the VO2max measurement includes using the second heart rate recovery value.
In a similar technical field, NPL Hansen teaches a method of predicting a VO2max measurement for a subject (prediction of maximal oxygen uptake in healthy adults; Abstract), wherein predicting the VO2max measurement includes using the second heart rate recovery value (The HR was recorded immediately after exercise (HRmax; measured immediately after 5 min or after early cessation because of physical exhaustion) and during recovery in sitting position between one min and 1:30 min after completing the step test (HR1), between 2 min and 2:30 min (HR2), and between 3 min and 3:30 min (HR3). A fitness index (F1) based on the step test data was calculated using the following formulae: duration of exercise in seconds X 100/(HR1 + HR2 + HR3) X 2; “Step Test” Page 403; The final equation to predict VOmax from step testing was as follows: 0-054(BMI) + 0-612(gender)* + 3.359 (height in m) +0-019 (fitness index) -0-012(HRmax)-0-011 (age)-3-475 (*0 = female, 1 male); “Prediction of VO2max” Page 404).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the calculation teachings of NPL Hansen into those of Sivaraj and NPL Wernhart in order to implement the measured data and subject characteristics, as they are relevant variables with significant correlations between them, into the determination of VO2max (NPL Hansen Page 403).
Regarding Claim 6, NPL Wernhart teaches wherein the second period is 1 minute (“Correlations between Heart Rate Recovery (HRR: 1, 3, and 5 Minutes after Exercise Termination) and Relative Oxygen Uptake at Peak Performance…as well as Maximal Power…and Physical Activity” in Table 2; “Heart rate recovery after one, three and five minutes was documented after exercise termination (HRR1, HRR3, HRR5)”; “Cardiopulmonary Testing” in Pages 20-21; Examiner’s Note: The heart rate recovery is documented within three different time periods: one minute, three minutes, and five minutes. In this case, the second heart rate recovery value is measured over one minute, while the first heart rate recovery value is measured over the first period, which can be three minutes or five minutes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the time period teachings of NPL Wernhart into those of Sivaraj in order to correlate how heart rate recovery one minute, three minutes, and five minutes after exercise termination in cardiopulmonary testing correlates with performance and compare to one another (NPL Wernhart Page 19).
Regarding Claim 12, NPL Hansen teaches a method of predicting a VO2max measurement for a subject (prediction of maximal oxygen uptake in healthy adults; Abstract), wherein the second heart rate recovery value (The HR was recorded immediately after exercise (HRmax; measured immediately after 5 min or after early cessation because of physical exhaustion) and during recovery in sitting position between one min and 1:30 min after completing the step test (HR1), between 2 min and 2:30 min (HR2), and between 3 min and 3:30 min (HR3). A fitness index (F1) based on the step test data was calculated using the following formulae: duration of exercise in seconds X 100/(HR1 + HR2 + HR3) X 2; “Step Test” Page 403; The final equation to predict VOmax from step testing was as follows: 0-054(BMI) + 0-612(gender)* + 3.359 (height in m) +0-019 (fitness index) -0-012(HRmax)-0-011 (age)-3-475 (*0 = female, 1 male); “Prediction of VO2max” Page 404) has a negative effect of the predicted VO2 max measurement (Examiner’s Note: The higher the value of HR2 is, the higher the value of the denominator will be, which will have a negative effect on the predicted VO2max measurement).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the calculation teachings of NPL Hansen into those of Sivaraj and NPL Wernhart in order to implement the measured data and subject characteristics, as they are relevant variables with significant correlations between them, into the determination of VO2max (NPL Hansen Page 403).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Sivaraj in view of Jian (U.S. Publication No. 2016/0278717; previously cited).
Regarding Claim 8, Sivaraj fails to disclose wherein the method further comprises collecting an ethnicity value, wherein the ethnicity value is a numerical value dependent on an ethnicity of the subject and wherein predicting the VO2max measurement includes using the ethnicity value.
In a similar technical field, Jian teaches arterial pressure-based determination of cardiovascular parameters (Abstract), wherein the method further comprises collecting an ethnicity value, wherein the ethnicity value is a numerical value dependent on an ethnicity of the subject (the compliance factor is based on at least one of a race, an age, a gender, or a body surface area of a person; [0015]) and wherein predicting the VO2max measurement includes using the ethnicity value (At block 30, the process flow comprises determining, using a computing device processor, a compliance factor associated with the blood pressure data. At block 40, the process flow comprises determining, using a computing device processor, a function associated with the blood pressure data. At block 50, the process flow comprises determining, using a computing device processor, the cardiac output based on the standard deviation, the pulse rate, the compliance factor, and the function; [0068]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the compliance factor teachings of Jian into those of Sivaraj in order to implement patient-specific data into the determination of the cardiovascular parameters, as different groups may be at higher risk for certain vascular events or more prone to specific health conditions (Jian [0015] and [0068]).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Sivaraj in view of NPL Hansen.
Regarding Claim 9, Sivaraj discloses wherein predicting the VO2max measurement comprises: applying a respective weighting to each of the collected values (VO2Max is then estimated from the Aerobic Component of Peak Exercise Capacity basis previously published ACSM equations (e.g., (6.12*EPP+7)*1.8/(Weight(lbs)*0.453592); Column 15 Lines 43-46); Examiner’s Note: The collected values are equivalent to EPP—the EPP is calculated using the user’s heart rate data and heart rate recovery data—and Weight. Therefore, a respective weighting is applied to each of the collected values).
Sivaraj fails to teach wherein predicting the VO2max measurement further comprises adding the weighted values.
In a similar technical field, NPL Hansen teaches a method of predicting a VO2max measurement for a subject (prediction of maximal oxygen uptake in healthy adults; Abstract), wherein predicting the VO2max measurement further comprises adding the weighted values (The final equation to predict VOmax from step testing was as follows: 0-054(BMI) + 0-612(gender)* + 3.359 (height in m) +0-019 (fitness index) -0-012(HRmax)-0-011 (age)-3-475 (*0 = female, 1 male); “Prediction of VO2max” Page 404).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the calculation teachings of NPL Hansen into those of Sivaraj in order to implement the measured data and subject characteristics, as they are relevant variables with significant correlations between them, into the determination of VO2max (NPL Hansen Page 403).
Regarding Claim 10, Sivaraj discloses wherein predicting the VO2max measurement further comprises: adding a baseline value (VO2Max is then estimated from the Aerobic Component of Peak Exercise Capacity basis previously published ACSM equations (e.g., (6.12*EPP+7)*1.8/(Weight(lbs)*0.453592); Column 15 Lines 43-46; Examiner’s Note: “+ 7” can be considered as adding a baseline value).
Conclusion
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 CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHANEL J YOON/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791