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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “means adapted to detect the extension of the material, in particular a fabric, it is made of” recited in claim 20 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Such claim limitation(s) is/are:
“means adapted to detect the extension of the material it is made of” in claim 6
“means for measuring the respiratory rate of said individual” in claim 17
“means adapted to detect the extension of the material, in particular a fabric, it is made of” in claim 20
These limitations raise 112 issues, please see 112 rejection section for how these limitations were interpreted.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a module for detecting GPS signals” recited in claim 18
“a module adapted to detect the heart rate” recited in claim 18
“a module adapted to filter the detected signal” recited in claim 18
These limitations raise 112 issues, please see 112 rejection section for how these limitations were interpreted.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-5, 7-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 4-5 and 7-21
“wherein said information is made available on a device, in particular a
smartwatch, a smartphone, a tablet, an iPad, said wearable device or a cloud.” in claim 4
“wherein said wearable device comprises a wearable garment, in particular a
chest belt” in claim 5
“c) detecting, through a wearable device, in particular a chest belt, a respiratory rate of said individual by subjecting him/her to a dynamic test, in particular requiring him/her to run on a treadmill or to pedal on a bicycle ergometer, in accordance with said predefined protocol” in claim 7
“wherein said characteristic curves are classified on the basis of anthropometric data of the subjects, in particular sex, height, weight and age of the subject” in claim 10
“wherein the identification of the first characteristic curves of said individual of step e) is accomplished by using statistical techniques, in particular the least residual or highest verisimilitude ones, or machine learning techniques, in particular the K-Means algorithm or neural networks.” in claim 11
“wherein said information is made available on a device, in particular a smartwatch, a smartphone, a tablet, an iPad, said wearable device or a cloud” in claim 14
“wherein said wearable device comprises a wearable garment, in particular a chest belt.” in claim 15
“power supply means, in particular a Li-Po battery” in claim 17
“an integrated circuit, in particular a dedicated ASIC” in claim 17
“a data transceiving module, in particular of the wireless or bluetooth type” in claim 17
“c) detecting, through a wearable device, in particular a chest belt, a respiratory rate of said individual by subjecting him/her to a dynamic test, in particular requiring him/her to run on a treadmill or to pedal on a bicycle ergometer, in accordance with said predefined protocol” in claim 17
“wherein said chest belt is adapted to measure the respiratory rate of said individual through means adapted to detect the extension of the material, in particular a fabric, it is made of.” recited in claim 20
“a wearable garment, in particular a chest belt” recited in claim 21
These limitations are indefinite. It’s not clear if the claims are requiring the further limitation(s) define by “in particular” or not. To clarify, using claim 4 as an example, is the limitation requiring the information be available on a device or the information be available on the more specific devices of a smartwatch, a smartphone, a tablet, an iPad? For this examination the limitation(s) defined by “in particular” are interpreted as not being required as this is the broadest reasonable interpretation. Therefore, using claim 4 as the example, the limitation is requiring the information be available on a device. The other limitations have been interpreted the “in particular” limitations similarly as claim 4. Regardless if this is the intended interpretation or not, applicant should make clear what is being claimed here. Claims 8-15 and 17-21 are also rejected based on dependency to claim 7 and/or claim 16.
Regarding claims 6 and 17-21:
Claim 6’s limitation “means adapted to detect the extension of the material it is made of” and Claim 20’s limitation “means adapted to detect the extension of the material, in particular a fabric, it is made of” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The closest support in the specification is described para 57 of applicant’s specification received on 12/15/2022 (hereafter referred to as applicant’s specification) which states the following:
“Even more preferably, the wearable device 150 is a chest belt that measures the
subject's respiratory rate via means adapted to detect the extension of the material, e.g., a fabric, it is made of. Chest belts of this kind are known, for example, from patent documents no. CN204133468U, WO2018037855 and EP2578141.”
The specification is devoid of adequate structure to perform the claimed function. In particular, the specification merely repeats the placeholder and states the belt of which the means is a part of is similar to belts in three other specific patent documents which don’t appear to be incorporated as part of the specification. Therefore, the limitation is indefinite and the claim is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For this examination any structure that can detect the extension of the material is interpreted as reciting the claimed means plus function limitation.
Claim 17’s limitation “means for measuring the respiratory rate of said individual” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The closest support in the specification is described in Fig. 5 and para 55 of applicant’s specification which states the following:
“In order to monitor in real time the athletic performance of a subject, in particular
an athlete, he/ she will have to wear the wearable garment 150 comprising means 152 for measuring at least his/her respiratory rate.”
The specification is devoid of adequate structure to perform the claimed function. In particular, the specification merely repeats the placeholder. Fig. 5 just shows element 152 (i.e. the means) as a box. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For this examination any structure that can measure the respiratory rate of said individual is interpreted as reciting the claimed means plus function limitation.
Claim 18’s limitations of:
“a module for detecting GPS signals” recited in claim 18
“a module adapted to detect the heart rate” recited in claim 18
“a module adapted to filter the detected signal” recited in claim 18
invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The closest support in the specification is described in Fig. 5 and para 60 of applicant’s specification which states the following:
“The wearable device may further comprise one or more of the following modules:
- a module 164 for detecting GPS signals;
- a module 166 adapted to detect the heart rate;
- a module 168 adapted to filter the detected cardiac or respiratory signal.”
The specification is devoid of adequate structure to perform the claimed function. In particular, the specification merely repeats the placeholder. Fig. 5 just shows element 164, 166, 168 (i.e. the means) as a box. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For this examination any structure that can measure the respiratory rate of said individual is interpreted as reciting the claimed means plus function limitation.
Also claims 18-21 are rejected based on dependency to one or more of these claims.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 6 and 17-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. As outlined above, the disclosure is devoid of structure and does not provide adequate structure to perform the claimed functions for the following means plus function limitations:
means adapted to detect the extension of the material it is made of” in claim 6
“means for measuring the respiratory rate of said individual” in claim 17
“a module for detecting GPS signals” recited in claim 18
“a module adapted to detect the heart rate” recited in claim 18
“a module adapted to filter the detected signal” recited in claim 18
“means adapted to detect the extension of the material, in particular a fabric, it is made of” in claim 20
Thus, the specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention. Also, claims 18-21 are rejected based on dependency to one or more of the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 4, 7-9, 12, 14 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korhonen et al (EP 3643227 cited reference 4 under foreign patent documents on IDS received on 12/15/2022 with a copy in English provided by applicant) hereafter known as Korhonen in view of Ross et al (US 20040186390) hereafter known as Ross.
Independent claim
Regarding claim 1:
Korhonen discloses:
A method for providing real-time information about the cardiac and/or respiratory performance of an individual [see abstract… “The invention relates to a method for providing an approximation of a minimum heart rate. (minHR) from collected heart rate data of a user.” And paras 20-21… “Segmentation may enable providing segments including physiologically coherent data. Segments may be categorized in order to provide reliable results on bodily states.”], comprising the steps of:
c) detecting, through a wearable device [see para 59… “The apparatus of figure may comprise a controller CTRL, or a heart rate module, configured to receive a signal from a pulse sensor or a heart rate sensor. The heart rate sensor may be attached to a user. An (external) apparatus configured to monitor heart rate may comprise a monitor device, a heart rate monitor, a pulse rate monitor, a biometric device, a personal monitor, a portable monitor or a wearable monitor.”], the current respiratory rate of said individual [see para 20…. “The phys-iological phenomena may be a respiration rate, oxygen consumption (VO2) and/or an excess post-exercise oxygen consumption (EPOC). For example, the respiration rate may be derived from the collected heart rate data, for example as a beat-by-beat derived respiration rate.];
d) determining, based on the current respiratory rate of said individual, the other current cardiac or respiratory parameters of said individual [see para 20…. “The oxygen consumption (VO2) may be estimated based on collected heart rate data, the derived respiration rate and/or on/off response information derived from the collected heart rate data, such that an exercise intensity (%VO2max) may be calculated first, and the absolute oxygen consumption (ml/kg/min or ml/min) after that by multiplying intensity with person's VO2max. Intensity may be calculated alternatively by dividing movement based VO2 estimate by person's VO2max. If the oxygen consumption (VO2) is measured, respiration rate may not be needed at all, in which case, it may be that only the oxygen consumption (VO2) and EPOC are used. Alternatively, all three may be utilized. The excess post-exercise oxygen consumption (EPOC) may be estimated based on the collected data of the heart rate measurement. The excess post-exercise oxygen consumption (EPOC) may be estimated based on intensity and duration of an exercise.”];
e) providing real-time information about the cardiac and/or respiratory performance of said individual on the basis of the other current cardiac or respiratory parameters determined at step d) [see para 2… “The measured heart rate reactions and heart rate variability may be analyzed in order to provide further information, for example on different bodily states of a user. Bodily slates of a user may relate to stress, recovery and physical activity. Information on bodily states may be utilized widely to explore and improve well-being, health and performance.” And para 21… “Further analysis may be used to provide reliable results on bodily states Segmentation may be utilized in offline analysis. Segmentation may enable providing segments including physiologically coherent data. Segments may be categorized in order to provide reliable results on bodily states. The bodily states may relate to physical activity, to a recovery state, to a stress state and/or to any other bodily state. Some segments may remain unrecognized, without a detected bodily state. For on-line measurement, where the collected data ls handled in real time, data points me handled instead of segments.” And para 20… “The phys-iological phenomena may be a respiration rate” and para 7… “A minimum heart rate is a physical characteristic of a person. The minimum heart rate represents the lowest heart rate a person can achieve, as opposite to maximal heart rate representing the highest heart rate a person can achieve. The minimum heart rate value approximation may enable for example accurate evaluation of normal physiological range of heart rate parameters for a given person. which may be utilized in various physiological analytics related to heart rate parameters as well as reflect person's health status and performance. A high minimum heart rate may reflect suboptimal health status of a person, such as elevated stress, blood pressure. or increased risk of cardiovascular diseases. A low minimum heart rate may be indicative to big size of heart, high stroke volume, and high parasympathetic modulation of the heart related to a relaxed body state”]
However, while Korhonen is directed to analyzing a body state related to physical activity and/or the recovery state [see para 21… “Further analysis may be used to provide reliable results on bodily states Segmentation may be utilized in offline analysis. Segmentation may enable providing segments including physiologically coherent data. Segments may be so categorized in order to provide reliable results on bodily states. The bodily states may relate to physical activity, to a recovery state, to a stress state and/or to any other bodily state.”], Korhonen is silent as to all the details of the physical activity and how it is used specifically to determine respiration parameters. Thus, Korhonen fails to disclose “a) subjecting said individual to a cardiopulmonary stress test suitable for detecting, over time, a respiratory rate and other cardiac or respiratory parameters of said individual” or “b) determining respective characteristic curves of said individual, with said respiratory rate as dependent variable and one of said other cardiac or respiratory parameters as independent variable”. Also as Korhonen fails to disclose step (d), Korhonen fails to fully disclose “d) determining, based on the current respiratory rate of said individual and said characteristic curves obtained at step b ), the other current cardiac or respiratory parameters of said individual”
Ross discloses in the analogous art of respiratory and/or cardiac diagnostics [see para 2… “This invention relates to respiratory analyzers and metabolic rate measurements, for example to indirect calorimeters” and para 143… “The computation module may be a modified device, such as a cell phone, physiological monitor, watch, heart rate sensor disposed on a strap, other accessory, activity monitor mounted on a belt or otherwise supported by the body of a subject, or some other device.”] a known way to use a diagnostic device to determine respiration rate based on physical activity with a wearable heart monitor includes specifically using a predetermined calibration function (i.e. characteristic curves) of a heart rate and that this function (i.e. characteristic curves) can be found by measuring both a physiological parameter simultaneously with a heart rate as an individual undergoes different speeds of exercise/ physical activity (i.e. subjecting an individual to a cardiopulmonary stress test) [see paras 210-219… “Using a predetermined calibration function between heart rate and other physiological parameter (such as metabolic rate, respiratory quotient, fat burning rate, and the like), the other physiological parameter can be determined from a heart rate measurement. The calibration of a heart rate monitor allows a physiological parameter (other than heart rate) to be determined from a measured heart rate using a calibration function. The calibration function can be found by measuring the physiological parameter and heart rate simultaneously as a subject is at rest and/or exercises at one or more levels of exercise intensity.” And “Hence, a physiological parameter (such as metabolic rate) of a subject can be monitored using a heart rate monitor alone by providing a heart rate monitor to the subject having the calibration function stored in the memory of the heart rate monitor, determining a heart rate of the subject, and providing a software application program to determine the corresponding value of the physiological parameter using the calibration function and the determined heart rate.” And “For example, a wrist-mounted heart rate monitor can be calibrated by determining a calibration function between heart rate and metabolic rate, the latter determined by the respiratory analyzer. A calibration function can be established between heart rate and other physiological parameters, such as respiratory parameters” and para 149… “A respiratory analyzer according to the present invention may be provided with a software application program, for example executable by a processor within the computation module, to calculate flow volumes, oxygen consumption, carbon dioxide production, metabolic rate, ventilatory equivalents, fat burning rate, fat burning total, carbohydrate burning rate, other metabolic parameters, respiratory frequency,”] and discloses using multiple of these calibration functions to find a plurality of respiratory parameters (i.e. missing feature of step d) [see para 219… “For example, the physiological signal may be heart rate, heart rate and other physiological data, or some other data. The first and second calibration functions can be determined during a calibration session, for example by having a subject breathe through a respiratory analyzer while performing one or more exercises. During the calibration session, physiological signals may be stored in memory, and metabolic rate, oxygen consumption, or some other parameter or combination of parameters transmitted from the respiratory analyzer to the computing device.”]. Ross further discloses this physical activity occurs on a treadmill [see para 173… “Exercises of one or more intensity levels (for example at different treadmill belt speeds and gradients) can be performed.”]
Since Korhonen is silent as to all the details of how physical activity is used to determine respiration parameters, and Ross discloses a known way by applying a stress test to determine characteristic curves for multiple respiratory parameters including respiratory rate, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Korhonen to apply a stress test and determine characteristic curves to determine the respiration rate similar to Ross (i.e. thereby reciting steps a and b and fully reciting step d) as this is a known way in the analogous field of respiratory and/or cardiac diagnostics to use physical activity to determine respiration parameters.
Independent claim
Regarding claim 7:
Korhonen discloses:
A method for providing real-time information about the cardiac and/or respiratory performance of an individual [see abstract… “The invention relates to a method for providing an approximation of a minimum heart rate. (minHR) from collected heart rate data of a user.” And paras 20-21… “Segmentation may enable providing segments including physiologically coherent data. Segments may be categorized in order to provide reliable results on bodily states.”], comprising the steps of:
c) detecting, through a wearable device [see para 59… “The apparatus of figure may comprise a controller CTRL, or a heart rate module, configured to receive a signal from a pulse sensor or a heart rate sensor. The heart rate sensor may be attached to a user. An (external) apparatus configured to monitor heart rate may comprise a monitor device, a heart rate monitor, a pulse rate monitor, a biometric device, a personal monitor, a portable monitor or a wearable monitor.”], in particular a chest belt, a respiratory rate of said individual by subjecting him/her to a dynamic test, in particular requiring him/her to run on a treadmill or to pedal on a bicycle ergometer, in accordance with said predefined protocol [see para 20…. “The phys-iological phenomena may be a respiration rate, oxygen consumption (VO2) and/or an excess post-exercise oxygen consumption (EPOC). For example, the respiration rate may be derived from the collected heart rate data, for example as a beat-by-beat derived respiration rate.];
f) detecting, through said wearable device [see para 59… “The apparatus of figure may comprise a controller CTRL, or a heart rate module, configured to receive a signal from a pulse sensor or a heart rate sensor. The heart rate sensor may be attached to a user. An (external) apparatus configured to monitor l1eart rate may comprise a monitor device, a heart rate monitor, a pulse rate monitor, a biometric device, a personal monitor, a portable monitor or a wearable monitor.”], the current respiratory rate of said individual [see para 20…. “The phys-iological phenomena may be a respiration rate, oxygen consumption (VO2) and/or an excess post-exercise oxygen consumption (EPOC). For example, the respiration rate may be derived from the collected heart rate data, for example as a beat-by-beat derived respiration rate.];
g) determining, based on the current respiratory rate of said individual, the other current cardiac or respiratory parameters of said individual [see para 20…. “The oxygen consumption (VO2) may be estimated based on collected heart rate data, the derived respiration rate and/or on/off response information derived from the collected heart rate data, such that an exercise intensity (%VO2max) may be calculated first, and the absolute oxygen consumption (ml/kg/min or ml/min) after that by multiplying intensity with person's VO2max. Intensity may be calculated alternatively by dividing movement based VO2 estimate by person's VO2max. If the oxygen consumption (VO2) is measured, respiration rate may not be needed at all, in which case, it may be that only the oxygen consumption (VO2) and EPOC are used. Alternatively, all three may be utilized. The excess post-exercise oxygen consumption (EPOC) may be estimated based on the collected data of the heart rate measurement. The excess post-exercise oxygen consumption (EPOC) may be estimated based on intensity and duration of an exercise.”];
h) providing real-time information about the cardiac and/or respiratory performance of said individual on the basis of the other current cardiac and/or respiratory parameters determined at step g) ) [see para 2… “The measured heart rate reactions and heart rate variability may be analyzed in order to provide further information, for example on different bodily states of a user. Bodily states of a user may relate to stress, recovery and physical activity. Information on bodily states may be utilized widely to explore and improve well-being, health and performance.” And para 21… “Further analysis may be used to provide reliable results on bodily states Segmentation may be utilized in offline analysis. Segmentation may enable providing segments including physiologically coherent data. Segments may be categorized in order to provide reliable results on bodily states. The bodily states may relate to physical activity, to a recovery state, to a stress state and/or to any other bodily state. Some segments may remain unrecognized, without a detected bodily state. For on-line measurement, where the collected data ls handled in real time, data points me handled instead of segments.” And para 20… “The phys-iological phenomena may be a respiration rate” and para 7… “A minimum heart rate is a physical characteristic of a person. The minimum heart rate represents the lowest heart rate a person can achieve, as opposite to maximal heart rate representing the highest heart rate a person can achieve. The minimum heart rate value approximation may enable for example accurate evaluation of normal physiological range of heart rate parameters for a given person. which may be utilized in various physiological analytics related to heart rate parameters as well as reflect person's health status and performance. A high minimum heart rate may reflect suboptimal health status of a person, such as elevated stress, blood pressure. or increased risk of cardiovascular diseases. A low minimum heart rate may be indicative to big size of heart, high stroke volume, and high parasympathetic modulation of the heart related to a relaxed body state”].
However, while Korhonen is directed to analyzing a body state related to physical activity and/or the recovery state [see para 21… “Further analysis may be used to provide reliable results on bodily states Segmentation may be utilized in offline analysis. Segmentation may enable providing segments including physiologically coherent data. Segments may be so categorized in order to provide reliable results on bodily states. The bodily states may relate to physical activity, to a recovery state, to a stress state and/or to any other bodily state.”], Korhonen is silent as to all the details of the physical activity and how it is used specifically to determine respiration parameters. Thus, Korhonen fails to disclose the steps of:
a) subjecting a plurality of subjects to a cardiopulmonary stress test according to a predefined protocol, said cardiopulmonary stress test being adapted to detect, over time, a respiratory rate and other cardiac or respiratory parameters of said plurality of subjects;
b) for each one of said subjects, determining respective characteristic curves, with said respiratory rate as dependent variable and one of said other cardiac or respiratory parameters as independent variable;
d) determining respective second characteristic curves of said individual, with said respiratory rate as dependent variable and one of said other cardiac or respiratory parameters as independent variable;
e) identifying first characteristic curves of said individual, said first characteristic curves of said individual being, among all the characteristic curves of said subjects, those belonging to a subject which approximate most closely those of said individual;
And because Korhonen fails to disclosed determining or identifying characteristic curves, Korhonen fails to fully disclose the steps of: “g) determining, based on the current respiratory rate of said individual and said first characteristic curves of said individual, the other current cardiac or respiratory parameters of said individual” as claimed.
Ross discloses in the analogous art of respiratory and/or cardiac diagnostics [see para 2… “This invention relates to respiratory analyzers and metabolic rate measurements, for example to indirect calorimeters” and para 143… “The computation module may be a modified device, such as a cell phone, physiological monitor, watch, heart rate sensor disposed on a strap, other accessory, activity monitor mounted on a belt or otherwise supported by the body of a subject, or some other device.”] a known way to use a diagnostic device to determine respiration rate based on physical activity / exercise with a wearable heart monitor includes using predetermined calibration functions (i.e. step d’s second characteristic curves) of a heart rate which is found by measuring both a physiological parameter simultaneously with a heart rate as individuals undergo different speeds of exercise/physical activity (i.e. step a and step b) [see paras 210-219… “Using a predetermined calibration function between heart rate and other physiological parameter (such as metabolic rate, respiratory quotient, fat burning rate, and the like), the other physiological parameter can be determined from a heart rate measurement. The calibration of a heart rate monitor allows a physiological parameter (other than heart rate) to be determined from a measured heart rate using a calibration function. The calibration function can be found by measuring the physiological parameter and heart rate simultaneously as a subject is at rest and/or exercises at one or more levels of exercise intensity.” And “Hence, a physiological parameter (such as metabolic rate) of a subject can be monitored using a heart rate monitor alone by providing a heart rate monitor to the subject having the calibration function stored in the memory of the heart rate monitor, determining a heart rate of the subject, and providing a software application program to determine the corresponding value of the physiological parameter using the calibration function and the determined heart rate.” And “For example, a wrist-mounted heart rate monitor can be calibrated by determining a calibration function between heart rate and metabolic rate, the latter determined by the respiratory analyzer. A calibration function can be established between heart rate and other physiological parameters, such as respiratory parameters” and para 149… “A respiratory analyzer according to the present invention may be provided with a software application program, for example executable by a processor within the computation module, to calculate flow volumes, oxygen consumption, carbon dioxide production, metabolic rate, ventilatory equivalents, fat burning rate, fat burning total, carbohydrate burning rate, other metabolic parameters, respiratory frequency,”] and Ross discloses further correcting specific terms in function or the functions based on the demographic of the groups for the individual (i.e. step e’s identifying first characteristic curves) [see para 258… “the ratio of RHR to MHR, or the individual terms, may be adjusted by a correction term, for example scaled by a power coefficient or multiplied by a numerical coefficient. Such correction terms can be determined for the individual or for demographic groups.”] and discloses using multiple of these calibration functions to find a plurality of respiratory parameters (i.e. missing feature of step g) [see para 219… “For example, the physiological signal may be heart rate, heart rate and other physiological data, or some other data. The first and second calibration functions can be determined during a calibration session, for example by having a subject breathe through a respiratory analyzer while performing one or more exercises. During the calibration session, physiological signals may be stored in memory, and metabolic rate, oxygen consumption, or some other parameter or combination of parameters transmitted from the respiratory analyzer to the computing device.”]. Finally, Ross further discloses this physical activity occurs on a treadmill [see para 173… “Exercises of one or more intensity levels (for example at different treadmill belt speeds and gradients) can be performed.”]
Since Korhonen is silent as to all the details of how physical activity is used to determine respiration parameters, and Ross discloses a known way by applying a stress test is to determine second characteristic curves for multiple respiratory parameters including respiratory rate and to adjust using data from first characteristic curves, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Korhonen to apply a stress and determine characteristic curves similar to Ross (i.e. thereby reciting steps a, b, d, e and fully reciting step g) as this is a known way in the analogous field of respiratory and/or cardiac diagnostics to use physical activity to determine respiration parameters.
Independent claim
Regarding claim 17:
A device wearable by an individual [see Fig. 4 and para 59….“The heart rate sensor may be attached to a user. An (external) apparatus configured to monitor heart rate may comprise a monitor device, a heart rate monitor, a pulse rate monitor, a biometric device, a personal monitor, a portable monitor or a wearable monitor.”], comprising:
-means for measuring the respiratory rate of said individual [see Fig. 4 “pulse sensor” and para 20];
-power supply means, in particular a Li-Po battery [see Fig. 4 and para 60-62. For a controller and/or microprocessor and/or circuit elements of the device to operate as described in these sections they must inherently be powered by some type of power source (i.e. battery, AC outlet etc). Therefore, while not explicitly disclosed, it is understood that a power source is inherently disclosed];
- an integrated circuit, in particular a dedicated ASIC [see Fig. 4 element APPL and para 62… “Moreover, it is noted that all or selected modules of the apparatus Figures 3 and 4 may be implemented using an integral circuit, for example an application specific integrated circuit (ASIC)”];
- a microcontroller [see Fig. 4 “µP’ and para 56… “The minimum heart rate approximation module APPL may be configured to process the received signal, with aid of the microprocessor μP and data stored/recorded to the memory MEM.”];
- a data transceiving module, in particular of the wireless or bluetooth type [see para 60… “Apparatus of figure 4 and figure 3 may comprise a web service, a computer, a mobile phone, a server for storing and processing the data. The communication may be realized via wired or wireless communications.”];
- memory means adapted to implement characteristic curves of cardiac and/or respiratory parameters of said individual [see Fig. 4 element MEM and para 61… “The mm HR approximation module APPL may be implemented as an application computer program stored m a memory, for example to the at least one memory MEM.”]
However, while Korhonen is directed to analyzing a body state related to physical activity and/or the recovery state [see para 21… “Further analysis may be used to provide reliable results on bodily states Segmentation may be utilized in offline analysis. Segmentation may enable providing segments including physiologically coherent data. Segments may be so categorized in order to provide reliable results on bodily states. The bodily states may relate to physical activity, to a recovery state, to a stress state and/or to any other bodily state.”], Korhonen is silent as to all the details of the physical activity and how it is used specifically to determine respiration parameters. Thus, Korhonen fails to disclose the memory means as reciting the steps of:
“a) subjecting said individual to a cardiopulmonary stress test suitable for detecting, over time, a respiratory rate and other cardiac or respiratory parameters of said individual”; and
“b) determining respective characteristic curves of said individual, with said respiratory rate as dependent variable and one of said other cardiac or respiratory parameters as independent variable” as recited by claim 17
Ross discloses in the analogous art of respiratory and/or cardiac diagnostics [see para 2… “This invention relates to respiratory analyzers and metabolic rate measurements, for example to indirect calorimeters” and para 143… “The computation module may be a modified device, such as a cell phone, physiological monitor, watch, heart rate sensor disposed on a strap, other accessory, activity monitor mounted on a belt or otherwise supported by the body of a subject, or some other device.”] a known way to use a diagnostic device to determine respiration rate based on physical activity with a wearable heart monitor includes using a predetermined calibration function (i.e. characteristic curves) of a heart rate and that this function (i.e. characteristic curves) can be found by measuring both physiological parameters simultaneously with a heart rate as an individual undergoes different speeds of exercise/physical activity (i.e. subjecting an individual to a cardiopulmonary stress test) [see paras 210-219… “Using a predetermined calibration function between heart rate and other physiological parameter (such as metabolic rate, respiratory quotient, fat burning rate, and the like), the other physiological parameter can be determined from a heart rate measurement. The calibration of a heart rate monitor allows a physiological parameter (other than heart rate) to be determined from a measured heart rate using a calibration function. The calibration function can be found by measuring the physiological parameter and heart rate simultaneously as a subject is at rest and/or exercises at one or more levels of exercise intensity.” And “Hence, a physiological parameter (such as metabolic rate) of a subject can be monitored using a heart rate monitor alone by providing a heart rate monitor to the subject having the calibration function stored in the memory of the heart rate monitor, determining a heart rate of the subject, and providing a software application program to determine the corresponding value of the physiological parameter using the calibration function and the determined heart rate.” And “For example, a wrist-mounted heart rate monitor can be calibrated by determining a calibration function between heart rate and metabolic rate, the latter determined by the respiratory analyzer. A calibration function can be established between heart rate and other physiological parameters, such as respiratory parameters” and para 149… “A respiratory analyzer according to the present invention may be provided with a software application program, for example executable by a processor within the computation module, to calculate flow volumes, oxygen consumption, carbon dioxide production, metabolic rate, ventilatory equivalents, fat burning rate, fat burning total, carbohydrate burning rate, other metabolic parameters, respiratory frequency,”] Ross further discloses this physical activity occurs on a treadmill [see para 173… “Exercises of one or more intensity levels (for example at different treadmill belt speeds and gradients) can be performed.”]
Since Korhonen is silent as to all the details of how physical activity is used to determine respiration parameters, and Ross discloses a known way by applying a stress test to determine characteristic curves for multiple respiratory parameters including respiratory rate, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Korhonen to apply a stress test and determine characteristic curves to determine the respiration rate similar to that disclosed by Ross (i.e. thereby reciting steps a and b) as this is a known way in the analogous field of respiratory and/or cardiac diagnostics to use physical activity to determine respiration parameters.
Dependent claims:
Regarding claims 2, 12:
Korhonen in view of Ross discloses the invention substantially as claimed including all the limitations of claims 1 and 7 above. Additionally, Korhonen in view of Ross discloses obtaining other respiratory parameters that comprise maximum oxygen consumption, heart rate, end-expiratory partial oxygen pressure [see para 20 of Korhonen… “The physiological phenomena may be a respiration rate, oxygen consumption (VO2) and/or an excess post-exercise oxygen consumption (EPOC). For example, the respiration rate may be derived from the collected heart rate data, for example as a beat-by-beat derived respiration rate. The HR and the respiration rate have a correlation with the oxygen consumption (VO2). The oxygen consumption (VO2) may be estimated based on collected heart rate data, the derived respiration rate and/or on/off response information derived from the collected heart rate data, such that an exercise intensity (%VO2max) may be calculated first, and the absolute oxygen consumption (ml/kg/min or ml/min) after that by multiplying intensity with person's VO2max. Intensity may be calculated alternatively by dividing movement based VO2 estimate by person's VO2max. If the oxygen consumption (VO2) is measured, respiration rate may not be needed at all, in which case, it may be that only the oxygen consumption (VO2) and EPOC are used. Alternatively, all three may be utilized. The excess post-exercise oxygen consumption (EPOC) may be estimated based on the collected data of the heart rate measurement. The excess post-exercise oxygen consumption (EPOC) may be estimated based on intensity and duration of an exercise.”]
However, Korhonen in view of Ross fails to disclose said other cardiac or respiratory parameters include the additional parameters of “current volume; maximum carbon dioxide consumption; end-expiratory partial carbon dioxide pressure” as recited by claims 2 and 11
Ross further discloses using the calibration functions (i.e. using the characteristic curves) to obtain additional respiration parameters including current volume, maximum carbon dioxide consumption and end-expiratory partial carbon dioxide pressure [para 213… “A calibration function can be established between heart rate and other physiological parameters, such as respiratory parameters (oxygen consumption, carbon dioxide production, respiratory quotient, end tidal oxygen, end tidal carbon dioxide, concentration of other respiratory components such as acetone, other ketones, and the like)” and para 213… “A calibration function can be established between heart rate and other physiological parameters, such as respiratory parameters (oxygen consumption, carbon dioxide production, respiratory quotient, end tidal oxygen, end tidal carbon dioxide, concentration of other respiratory components”] to help provide feedback to customize programs to help individuals [see para 178… “Respiratory analyzers according to embodiments of the present invention can be used in health improvement programs for cardiac patients and other recuperating subjects… A cardiac rehabilitation program can be modified by the results, or the pace of a rehabilitation program correlated with determined oxygen consumption or cardiac output of the patients.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Korhonen in view of Ross by additionally, using the calibration function to analyze volume and carbon dioxide in the respiration and the parameters related to carbon dioxide similarly to that disclosed by Ross (thereby reciting current volume, maximum carbon dioxide consumption and end-expiratory partial carbon dioxide pressure) because this will help further improve the feedback as to a user’s respiration.
Regarding claims 4 and 14, see para 60 of Korhonen [see “Apparatus of figure 4 and figure 3 may comprise a web service, a computer, a mobile phone, a server for storing and processing the data. The communication may be realized via wired or wireless communications”] and para 13 of Korhonen [see “Figure 3 illustrates a method for an applied function according to an embodiment. illustrates an apparatus for approximating a minimum heart rate according to an embodiment. Figure 4 illustrates an apparatus for approximating a minimum heart rate according to an embodiment.”] which describe Korhonen in view of Ross as presenting the information on a smartphone
Regarding claim 8:
Korhonen in view of Ross discloses the invention substantially as claimed including all the limitations of claim 7 and different speeds on a treadmill [see rejection to claim 7 above].
However, Korhonen in view of Ross fails to disclose “starting from a speed of 8 km/h” or “whereon said dynamic test is carried with a speed increment of 1 km/h per minute until physical exhaustion of the individual” of claim 8.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Korhonen in view of Ross to recite the claimed features of “starting from a speed of 8 km/h” and “whereon said dynamic test is carried with a speed increment of 1 km/h per minute until physical exhaustion of the individual” of claim 8 because as explained previously Korhonen in view of Ross discloses a stress test in the form of using a exertion on treadmill with different changes in speed; therefore, absent unpredictable results one of ordinary skill would expect to achieve the claimed features through routine experimentation through the application of known factors to achieve a known result when optimizing the stress test.
Regarding claim 9:
Korhonen in view of Ross discloses the invention substantially as claimed including all the limitations of claim 7 as outlined above.
However, Korhonen in view of Ross fails to disclose “wherein said characteristic curves of each one of said subjects are collected in a database” as recited by claim 9.
Ross further discloses data related to the cardiac and/or respiratory performance of an individual being stored on a database for analysis and review at a remote computer [see para 50… “The computation module also (optionally) receives data from physiological sensor 58, activity monitor 60, and diet log recording 62, and data may be transmitted over communications network 54 for storage, analysis, or review at remote computer 56. The remote computer may provide a database for storage of respiratory parameters, metabolic rate, or other physiological parameters.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Korhonen in view of Ross by storing the cardiac and/or respiratory performance data (i.e. including the reference curves) on a database similar to that disclosed by Ross (i.e. thereby reciting claim 9) so that the data can be further analyzed at any location.
Regarding claim 18, see Fig. 4 element labelled “pulse sensor” of Korhonen and para 20 of Korhonen [see “For example, the respiration rate may be derived from the collected heart rate data, for example as a beat-by-beat derived respiration rate.”] which discloses a module adapted to detect the heart rate as recited by this claim.
Claim(s) 3, 11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korhonen in view of Ross as applied to claims 1 and 7 above, and further in view of Yamaji et al (US 20170231576) hereafter known as Yamaji.
Korhonen in view of Ross discloses the invention substantially as claimed including all the limitations of claims 1 and 7 as outlined above.
However, Korhonen in view of Ross fails to disclose “wherein said respective characteristic curves of said individual comprise second-degree or third-degree polynomial functions respectively obtained through a second-degree or third-degree polynomial fitting of a respective cardiac or respiratory parameter.” as recited by claims 3 and 13 or “wherein the identification of the first characteristic curves of said individual of step e) is accomplished by using statistical techniques, in particular the least residual or highest verisimilitude ones, or machine learning techniques, in particular the K-Means algorithm or neural networks.” as recited by claim 11.
Yamaji discloses in the analogous art of respiratory and/or cardiac diagnostics [see para 2… “The embodiment(s) discussed herein is related to a sensor information processing apparatus.” and abstract… “A filter to cut at least a harmonic component of a frequency component derived from breathing of a person to be observed is applied to a detected signal of a wireless sensor, and a heartbeat component of the person is detected in a signal having passed through the filter.”] using the statistic technic of curve fitting (i.e. claim 11) in the form of fitting a second degree polynomial (i.e. claims 3 and 13) to fit the heart beat data to derive specific relational equations (i.e. characteristic curves) that determine the breathing rate (i.e. respiration rate) from the heart rate [see para 228-231].
Since Korhonen in view of Ross is directed to determining the respiration rates based on heart rate using determined functions (i.e. characteristic curves) as discussed in rejections to independent claims 1 and 7 above, but does not disclose all the details as to how these functions are found and Yamaji discloses using the technique of curve fitting second degree polynomials as a known way to determine these functions, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Korhonen in view of Ross’s method to include the use this curve fitting to determine these functions because this is a known technique in the field of respiratory and/or cardiac diagnostics to produce a known result.
Claim(s) 5-6, 15-16, 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korhonen in view of Ross as applied to claims 1, 7 and 17 above, and further in view of Nam et al (EP 3318179 cited reference 5 under foreign patent documents on IDS received on 12/15/2022 with a copy in English provided by applicant)
Regarding claims 5-6, 15-16 and 19-20
Korhonen in view of Ross disclose the invention substantially as claimed including all the limitations of claim 1, 7 and 17 as outlined above which includes a wearable device.
However, Korhonen in view of Ross fails to disclose “wherein said wearable device comprises a wearable garment, in particular a chest belt” as recited by claims 5 and 15, “wherein said chest belt measures said respiratory rate of the individual through means adapted to detect the extension of the material it is made of” as recited by claim 6, “wherein said chest belt measures said respiratory rate of the individual by detecting the extension of the material it is made of” as recited by claim 16, “wherein said device comprises a chest belt” as recited by claim 19, “wherein said chest belt is adapted to measure the respiratory rate of said individual through means adapted to detect the extension of the material, in particular a fabric, it is made of” as recited by claim 20.
Nam discloses in the analogous art of respiratory and/or cardiac diagnostics [see para 1… “The present invention relates to a method for simultaneously measuring a respiration rate and a heart rate using dual cameras of a smartphone.”] using cameras with impedance belts worn around the abdomen and chest (i.e. means adapted to detect the extension of material) as a known way to determine respiration rate of a human [see paras 15-16… “As shown in FIGS. 1a and 1b for a method for measuring a respiration rate and a heart rate using dual cameras of a smartphone according to an embodiment of the present invention, a smartphone 110, a chest impedance belt 130, an abdomen impedance belt 140, and a monitoring device 150 are provided. First, a human wears impedance belts on the chest and abdomen to collect data. The chest and abdomen impedance belts 130 and 140 are intended to measure an actual respiration rate of a human, and are coupled to the monitoring device 150”.]
Since Korhonen in view of Ross discloses one independent way to determine respiration rate (i.e. using heart rate with calculated curves) and Nam discloses another independent way to determine respiration (i.e. using cameras with impedance belts), it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Korhonen in view of Ross by including cameras with impedance belts similarly to that disclosed by Nam (i.e. thereby reciting claims 5-6, 15-16 and 19-20) to determine respiration rate because absent unpredictable results the combination of two independent ways to determine respiration rate would be expected to lead to a more accurate respiration rate (and if not the same level of accuracy) than either independent way alone.
Regarding claim 21:
Korhonen in view of Ross discloses:
A system for providing real-time information about the cardiac and/or respiratory performance of an individual [see Fig. 4 and para 13… “Figure 4 illustrates an apparatus for approximating a minimum heart rate according to an embodiment.”], comprising a wearable device according to claim 17 [see rejection to claim 17 above].
However, Korhonen in view of Ross fails to disclose “a wearable garment, in particular a chest belt, adapted to transmit a signal indicative of the respiratory rate of said individual” to the wearable device according to claim 17 as recited by claim 21.
Nam discloses in the analogous art of respiratory and/or cardiac diagnostics [see para 1… “The present invention relates to a method for simultaneously measuring a respiration rate and a heart rate using dual cameras of a smartphone.”] using cameras with impedance belts worn around the abdomen and chest (i.e. wearable garment) as a known way to determine respiration rate of a human [see paras 15-16… “As shown in FIGS. 1a and 1b for a method for measuring a respiration rate and a heart rate using dual cameras of a smartphone according to an embodiment of the present invention, a smartphone 110, a chest impedance belt 130, an abdomen impedance belt 140, and a monitoring device 150 are provided. First, a human wears impedance belts on the chest and abdomen to collect data. The chest and abdomen impedance belts 130 and 140 are intended to measure an actual respiration rate of a human, and are coupled to the monitoring device 150”.]
Since Korhonen in view of Ross discloses one independent way to determine respiration rate (i.e. using heart rate with calculated curves) and Nam discloses another independent way to determine respiration (i.e. using cameras with impedance belts), it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Korhonen in view of Ross by including cameras with impedance belts similarly to that disclosed by Nam (i.e. thereby reciting claim 21) to determine respiration rate because absent unpredictable results the combination of two independent ways to determine respiration rate would be expected to lead to a more accurate respiration rate (and if not the same level of accuracy) than either independent way alone.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korhonen in view of Ross as applied to claims 7 and 9 above, and further in view of Gazit et al (US 20080114232) hereafter known as Gazit.
Korhonen in view of Ross discloses the invention substantially as claimed including all the limitations of claims 7 and 9 as outlined above which includes a stress test on a treadmill.
However, Korhonen in view of Ross fails to disclose “wherein said characteristic curves are classified on the basis of anthropometric data of the subjects, in particular sex, height, weight and age of the subject” as recited by claim 10.
Gazit discloses in the analogous art of respiratory and/or cardiac diagnostics [see para 1… “More specifically, the present invention relates to an electrodes belt for use in electrocardiogram (ECG) stress test (hereinafter called Ergometry)”] that stress tests are known to load a patient with work until a set pulse level is reached and that this pulse level is dependent on age [see para 3… “The ECG Stress test is a very common test used to detect Ischemic Heart Disease. In the test, the examined patient has to make a physical effort like running on a treadmill or riding a bicycle, while his pulse, blood pressure and ECG are monitored continuously. The load of the patient work is elevated gradually according to a protocol (several protocols are commonly used) until the patient reaches the target pulse level (that is calculated for every patient based on age, sex and physical condition).”]
Since the end goal of a stress test is to reach a set pulse rate and a set pulse rate is known to be dependent on a user’s age as taught by Gazit it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Korhonen in view of Ross by incorporate a user’s age into the application of the stress (thereby having the resulting characteristic curves classified on the basis of the anthropometric data of the subject in the form of age) because this is a known relationship used to reach a known outcome.
Conclusion
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792