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 .
Status of the Claims
Claims 1-17 are currently pending and under exam herein.
Claims 1-17 are rejected.
Priority
The instant application claims is a 371 of PCT/JP2021/041177 which claims priority from foreign application JP2020-193644 filed on 11/20/2020. Thus, the effective filing date of the instant application is 11/20/2020.
Drawings
The Drawings filed on 05/17/2023 were considered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/17/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite: (a) mathematical concepts, (e.g., mathematical relationships, formulas or equations, mathematical calculations); and (b) mental processes, i.e., concepts performed in the human mind, (e.g., observation, evaluation, judgement, opinion).
Subject matter eligibility evaluation in accordance with MPEP 2106:
Eligibility Step 1: Claims 1-17 are directed to a method for managing health condition of grown-up cattle
[Step 1: YES]
Eligibility Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if
so, then it is determined in Prong Two whether the recited judicial exception is integrated into a
practical application of that exception.
Eligibility Step 2A Prong One: In determining whether a claim is directed to a judicial exception,
examination is performed that analyzes whether the claim recites a judicial exception, i.e., whether a
law of nature, natural phenomenon, or abstract idea is set forth or described in the claim.
Independent claim 1 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
calculating at least one (hereinafter referred to as beat values) of average values of the beat intervals, variations in the beat intervals, beat numbers, HFs, or LF/HFs based on the beat intervals (mathematical concept)
obtaining a regression formula of the beat values and the accelerations, and obtaining a beat value when an acceleration is 0 (hereinafter referred to as a time A0) using the regression formula; and (mathematical concept)
determining that the grown-up cattle is in a fasting state when a magnitude relationship of at least one of following formulae (1) to (5) is satisfied, and determining that the grown-up cattle is in a non-fasting state when none of magnitude relationships of following formulae (1) to (5) is satisfied: the average value of beat intervals at the time A 0 >A 1 (1), the variation in beat intervals at the time A 0 >A 2 (2), the beat number at the time A 0 <A 3 (3), the HF at the time A 0 >A 4 (4), the LH/HF at the time A 0 <A 5 (5) (mathematical concept)
in the formulae (1) to (5), A1 to A5 are constants, provided that, each LF is a value obtained by performing definite integration of a power spectrum from frequencies Lf1 to Lf2, the power spectrum being obtained by including a step of performing frequency spectrum conversion on beat intervals, and each HF is a value obtained by performing definite integration of the power spectrum from frequencies Hf1 to Hf2, where Hf1>Lf1 and Hf2>Lf2 are satisfied. (mathematical concept)
Dependent claim 2 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
comprising setting, as negative acceleration, a value obtained by multiplying acceleration in a body height direction at a time of standing of the grown-up cattle by −1 when the acceleration in the body height direction is a positive value, setting a negative value as the negative acceleration when the acceleration is the negative value, and determining that the grown-up cattle is in a sufficient side-lying state when a time during which the negative acceleration is a constant T or more (hereinafter, referred to as a side-lying time) is a constant L or more, and determining that the grown-up cattle is in an insufficient side-lying state when the side-lying time is less than the constant L. (mathematical concept)
Dependent claim 3 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
comprising creating a two-dimensional coordinate system with the beat value at the time A0 and the side-lying time as axes, and fractionating the two-dimensional coordinate system into four regions below: (mathematical concept)
Region 1: a region in which the beat value at the time A0 does not satisfy any of the magnitude relationships of the formulae (1) to (5) and the side-lying time is the constant L or more (mathematical concept)
Region 2: a region in which the beat value at the time A0 does not satisfy any of the magnitude relationships of the formulae (1) to (5) and the side-lying time is less than the constant L (mathematical concept)
Region 3: a region in which the beat value at the time A0 satisfies at least one of the magnitude relationships of the formulae (1) to (5) and the side-lying time is the constant L or more (mathematical concept)
Region 4: a region in which the beat value at the time A0 satisfies at least one of the magnitude relationships of the formulae (1) to (5) and the side-lying time is less than the constant L. (mathematical concept)
Dependent claim 4 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
wherein each of the average values of the beat intervals is an average value of RRIs each of which is an interval between an R wave and an R wave in an electrocardiographic signal. (mathematical concept)
Dependent claim 5 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
wherein each of the beat numbers is a heart rate or a pulse rate. (mathematical concept)
Dependent claim 6 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
wherein each of the variations in the beat intervals is at least one of SDNN, RMSSD, CVRR, NN50, or pNN50, provided that, the SDNN is a standard deviation of an RRI that is an interval between an R wave and an R wave in an electrocardiographic signal, the RMSSD is a square root of an average value of squares of differences between consecutive adjacent RRIs, the CVRR is a value obtained by dividing a value of the SDNN by an average value of RRIs and multiplying the obtained value by 100, the NN50 is a value indicating a total number of times in which the differences between the consecutive adjacent RRIs exceed 50 ms, and the pNN50 is a value indicating a ratio of heartbeats in which the differences between the consecutive adjacent RRIs exceed 50 ms. (mathematical concept)
Independent claim 9 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
calculating at least one (hereinafter referred to as beat values) of average values of the beat intervals, variations in the beat intervals, beat numbers, HFs, or LF/HFs based on the beat intervals (mathematical concept)
obtaining a regression formula of the beat values and the accelerations, and obtaining a beat value when an acceleration is 0 (hereinafter referred to as a time A0) using the regression formula; and (mathematical concept)
determining that the grown-up cattle is in a fasting state when a magnitude relationship of at least one of following formulae (1) to (5) is satisfied, and determining that the grown-up cattle is in a non-fasting state when none of magnitude relationships of following formulae (1) to (5) is satisfied: the average value of beat intervals at the time A 0 >A 1 (1), the variation in beat intervals at the time A 0 >A 2 (2), the beat number at the time A 0 <A 3 (3), the HF at the time A 0 >A 4 (4), the LH/HF at the time A 0 <A 5 (5) (mathematical concept)
in the formulae (1) to (5), A1 to A5 are constants, provided that, each LF is a value obtained by performing definite integration of a power spectrum from frequencies Lf1 to Lf2, the power spectrum being obtained by including a step of performing frequency spectrum conversion on beat intervals, and each HF is a value obtained by performing definite integration of the power spectrum from frequencies Hf1 to Hf2, where Hf1>Lf1 and Hf2>Lf2 are satisfied. (mathematical concept)
Dependent claim 10 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
wherein the calculation unit sets, as negative acceleration, a value obtained by multiplying acceleration in a body height direction at a time of standing of the grown-up cattle by −1 when the acceleration in the body height direction is a positive value, sets a negative value as the negative acceleration when the acceleration is the negative value, and calculates a time during which the negative acceleration is a constant T or more (hereinafter, referred to as a side-lying time), and the determination unit determines that the grown-up cattle is in a sufficient side-lying state when the side-lying time is a constant L or more, and determines that the grown-up cattle is in an insufficient side-lying state when the side-lying time is less than the constant L. (mathematical concept)
Dependent claim 11 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
comprising creating a two-dimensional coordinate system with the beat value at the time A0 and the side-lying time as axes, and fractionating the two-dimensional coordinate system into four regions below: (mathematical concept)
Region 1: a region in which the beat value at the time A0 does not satisfy any of the magnitude relationships of the formulae (1) to (5) and the side-lying time is the constant L or more (mathematical concept)
Region 2: a region in which the beat value at the time A0 does not satisfy any of the magnitude relationships of the formulae (1) to (5) and the side-lying time is less than the constant L (mathematical concept)
Region 3: a region in which the beat value at the time A0 satisfies at least one of the magnitude relationships of the formulae (1) to (5) and the side-lying time is the constant L or more (mathematical concept)
Region 4: a region in which the beat value at the time A0 satisfies at least one of the magnitude relationships of the formulae (1) to (5) and the side-lying time is less than the constant L. (mathematical concept)
Dependent claim 12 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
wherein each of the average values of the beat intervals is an average value of RRIs each of which is an interval between an R wave and an R wave in an electrocardiographic signal. (mathematical concept)
Dependent claim 13 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
wherein each of the beat numbers is a heart rate or a pulse rate.
Dependent claim 14 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
wherein each of the variations in the beat intervals is at least one of SDNN, RMSSD, CVRR, NN50, or pNN50, provided that, the SDNN is a standard deviation of an RRI that is an interval between an R wave and an R wave in an electrocardiographic signal, the RMSSD is a square root of an average value of squares of differences between consecutive adjacent RRIs, the CVRR is a value obtained by dividing a value of the SDNN by an average value of RRIs and multiplying the obtained value by 100, the NN50 is a value indicating a total number of times in which the differences between the consecutive adjacent RRIs exceed 50 ms, and the pNN50 is a value indicating a ratio of heartbeats in which the differences between the consecutive adjacent RRIs exceed 50 ms. (mathematical concept)
Independent claim 17 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
calculating at least one (hereinafter referred to as beat values) of average values of the beat intervals, variations in the beat intervals, beat numbers, HFs, or LF/HFs based on the beat intervals (mathematical concept)
obtaining a regression formula of the beat values and the accelerations, and obtaining a beat value when an acceleration is 0 (hereinafter referred to as a time A0) using the regression formula; and (mathematical concept)
determining that the grown-up cattle is in a fasting state when a magnitude relationship of at least one of following formulae (1) to (5) is satisfied, and determining that the grown-up cattle is in a non-fasting state when none of magnitude relationships of following formulae (1) to (5) is satisfied: the average value of beat intervals at the time A 0 >A 1 (1), the variation in beat intervals at the time A 0 >A 2 (2), the beat number at the time A 0 <A 3 (3), the HF at the time A 0 >A 4 (4), the LH/HF at the time A 0 <A 5 (5) (mathematical concept)
in the formulae (1) to (5), A1 to A5 are constants, provided that, each LF is a value obtained by performing definite integration of a power spectrum from frequencies Lf1 to Lf2, the power spectrum being obtained by including a step of performing frequency spectrum conversion on beat intervals, and each HF is a value obtained by performing definite integration of the power spectrum from frequencies Hf1 to Hf2, where Hf1>Lf1 and Hf2>Lf2 are satisfied. (mathematical concept)
The abstract ideas recited in the claims are evaluated under the broadest reasonable interpretation (BRI) of the claim limitations when read in light of and consistent with the specification. As noted in the foregoing section, the claims are determined to contain limitations that can practically be performed in the human mind with the aid of a pencil and paper, and therefore recite judicial exceptions from the mental process grouping of abstract ideas. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind.
Therefore, claims 1-17 recite an abstract idea as the dependent claims will inherit the abstract ideas from the independent claims.
[Step 2A Prong One: YES]
Eligibility Step 2A Prong Two: In determining whether a claim is directed to a judicial exception, further
examination is performed that analyzes if the claim recites additional elements that when examined as a
whole integrates the judicial exception(s) into a practical application (MPEP 2106.04(d)). A claim that
integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception
in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements
are analyzed to determine if the abstract idea is integrated into a practical application (MPEP
2106.04(d)(I); MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract
idea, the claim fails to integrate the abstract idea into a practical application (MPEP 2106.04(d)(III)).
The judicial exceptions identified in Eligibility Step 2A Prong One are not integrated into a practical application because of the reasons noted below.
The additional element in independent claim 1 includes:
A method for managing a health condition of grown-up cattle, comprising:
measuring beat intervals and accelerations in a predetermined period;
The additional element in dependent claim 7 includes:
wherein the beat intervals are measured using a biological information measuring garment.
The additional element in dependent claim 8 includes:
wherein the biological information measuring garment includes: a clothing fabric; and an electrode provided on a skin-side surface side of the clothing fabric, the clothing fabric includes a first band portion on one-end portion side in a body circumferential direction and a second band portion on an other-end portion side in the body circumferential direction, and a front region ahead of a region from the first band portion to the second band portion of the clothing fabric has an area larger than a rear region behind the region from the first band portion to the second band portion of the clothing fabric.
The additional element in Independent claim 9 includes:
A system for managing a health condition of grown-up cattle, comprising:
a measurement unit that measures beat intervals and accelerations in a predetermined period;
The additional element in dependent claim 15 includes:
wherein the measurement unit is provided on a clothing fabric of a biological information measuring garment, the clothing fabric includes a first band portion on one-end portion side in a body circumferential direction and a second band portion on an other-end portion side in the body circumferential direction, and a front region ahead of a region from the first band portion to the second band portion of the clothing fabric has an area larger than a rear region behind the region from the first band portion to the second band portion of the clothing fabric.
The additional element in dependent claim 16 includes:
A garment comprising at least a part of the system for managing a health condition of grown-up cattle according to claim 9.
The additional element in independent claim 17 includes:
An apparatus for managing a health condition of grown-up cattle, comprising:
a measurement unit that measures beat intervals and accelerations in a predetermined period;
The additional elements of measuring beat intervals and accelerations in a predetermined period; (Claim 1), wherein the beat intervals are measured using a biological information measuring garment (Claim 7), wherein the biological information measuring garment includes: a clothing fabric; and an electrode provided on a skin-side surface side of the clothing fabric, the clothing fabric includes a first band portion on one-end portion side in a body circumferential direction and a second band portion on an other-end portion side in the body circumferential direction, and a front region ahead of a region from the first band portion to the second band portion of the clothing fabric has an area larger than a rear region behind the region from the first band portion to the second band portion of the clothing fabric (Claim 8), a measurement unit that measures beat intervals and accelerations in a predetermined period (Claim 9), wherein the measurement unit is provided on a clothing fabric of a biological information measuring garment, the clothing fabric includes a first band portion on one-end portion side in a body circumferential direction and a second band portion on an other-end portion side in the body circumferential direction, and a front region ahead of a region from the first band portion to the second band portion of the clothing fabric has an area larger than a rear region behind the region from the first band portion to the second band portion of the clothing fabric (Claim 15), A garment comprising at least a part of the system for managing a health condition of grown-up cattle according to claim 9 (Claim 16), a measurement unit that measures beat intervals and accelerations in a predetermined period (Claim 17) are insignificant extra-solution activity that are part of the data gathering process used in the recited judicial exceptions (see MPEP 2106.05(g)).
The additional elements of A method for managing a health condition of grown-up cattle, comprising (Claim 1), A system for managing a health condition of grown-up cattle, comprising (Claim 9), An apparatus for managing a health condition of grown-up cattle, comprising (Claim 17) fail to integrate a judicial exception into a practical application merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f).
The additionally recited elements merely invoke a computer as a tool, and/or amount to insignificant extra-solution data gathering activity, and as such, when all limitations in claims 1-17 have been considered as a whole, the claims are deemed to not recite any additional elements that would integrate a judicial exception into a practical application, and therefore claims 1-17 are directed to an abstract idea (MPEP 2106.04(d)).
[Step 2A Prong Two: NO]
Eligibility Step 2B: Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims are probed for a specific inventive concept. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). Identifying whether the additional elements beyond the abstract idea amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they amount to significantly more than the judicial exception (MPEP 2106.05A i-vi).
The claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception(s) because of the reasons noted below.
The additional elements recited in claims 1-17 are identified above, and carried over from Step 2A: Prong Two along with their conclusions for analysis at Step 2B. Any additional element or combination of elements that was considered to be insignificant extra-solution activity at Step 2A: Prong Two was re-evaluated at Step 2B, because if such re-evaluation finds that the element is unconventional or otherwise more than what is well-understood, routine, conventional activity in the field, this finding may indicate that the additional element is no longer considered to be insignificant; and all additional elements and combination of elements were evaluated to determine whether any additional elements or combination of elements are other than what is well-understood, routine, conventional activity in the field, or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, per MPEP 2106.05(d).
The additional elements of measuring beat intervals and accelerations in a predetermined period; (Claim 1), wherein the beat intervals are measured using a biological information measuring garment (Claim 7), wherein the biological information measuring garment includes: a clothing fabric; and an electrode provided on a skin-side surface side of the clothing fabric, the clothing fabric includes a first band portion on one-end portion side in a body circumferential direction and a second band portion on an other-end portion side in the body circumferential direction, and a front region ahead of a region from the first band portion to the second band portion of the clothing fabric has an area larger than a rear region behind the region from the first band portion to the second band portion of the clothing fabric (Claim 8), a measurement unit that measures beat intervals and accelerations in a predetermined period (Claim 9), wherein the measurement unit is provided on a clothing fabric of a biological information measuring garment, the clothing fabric includes a first band portion on one-end portion side in a body circumferential direction and a second band portion on an other-end portion side in the body circumferential direction, and a front region ahead of a region from the first band portion to the second band portion of the clothing fabric has an area larger than a rear region behind the region from the first band portion to the second band portion of the clothing fabric (Claim 15), A garment comprising at least a part of the system for managing a health condition of grown-up cattle according to claim 9 (Claim 16), a measurement unit that measures beat intervals and accelerations in a predetermined period (Claim 17) are conventional and part of the data gathering process used in the recited judicial exceptions (see MPEP 2106.05(g)). Evidence for conventionality is shown by Oishi et al. which monitors cows beat intervals and accelerations as well as Miwa et al. which uses a wearable device to monitor cows.
The additional elements of A method for managing a health condition of grown-up cattle, comprising (Claim 1), A system for managing a health condition of grown-up cattle, comprising (Claim 9), An apparatus for managing a health condition of grown-up cattle, comprising (Claim 17) are conventional fail to integrate a judicial exception into a practical application merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f).
Claims 1-17 do not recite any elements in addition to the judicial exception. Therefore, when taken alone, all additional elements in claims 1-17 do not amount to significantly more than the above-identified judicial exception(s). Even when evaluated as a combination, the additional elements fail to transform the exception(s) into a patent-eligible application of that exception. Thus, claims 1-17 are deemed to not contribute an inventive concept, i.e., amount to significantly more than the judicial exception(s) (MPEP 2106.05(II)).
[Step 2B: NO]
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over combine Erdmann et al. (Erdmann et al. Indices of Heart Rate Variability as Potential Early Markers of Metabolic Stress and Compromised Regulatory Capacity in Dried-Off High-Yielding Dairy Cows. animal 2018, 12 (7), 1451–1461.) in view of Miwa et al. (Miwa et al. Application of Overall Dynamic Body Acceleration as a Proxy for Estimating the Energy Expenditure of Grazing Farm Animals: Relationship with Heart Rate. PLOS ONE 2015, 10 (6), e0128042.) in view of Oishi et al. (Oishi et al. Correcting the Activity-Specific Component of Heart Rate Variability Using Dynamic Body Acceleration Under Free-Moving Conditions. Frontiers in Physiology 2018, 9.) in view of Diosdado et al. (Vázquez Diosdado, J. A.; Barker, Z. E.; Hodges, H. R.; Amory, J. R.; Croft, D. P.; Bell, N. J.; Codling, E. A. Classification of Behaviour in Housed Dairy Cows Using an Accelerometer-Based Activity Monitoring System. Animal Biotelemetry 2015, 3 (1)) in view of US8568330B2. The italicized text corresponds to the instant claim limitations.
With respect to the limitations of claims 1, 5, 9, 13, 17, Oishi et al. teaches
Simultaneous measurements of the body acceleration and cardiac inter-beat intervals of the tested animals was executed according to the method proposed (Measurements of Body Acceleration and Inter-Beat Intervals, 1st paragraph, measuring beat intervals and accelerations in a predetermined period (Claim 1) Oishi et al. also teaches for each 5-min interval, several HRV parameters were calculated using four different analyses: time domain analysis, frequency domain analysis, Poincaré measures and the recurrence quantification analysis (RQA). For the parameters in the time domain analysis, in addition to the mean HR, the root mean square of the successive inter-beat interval differences (RMSSD) was calculated. (Data Processing and Calculation, paragraph 4, calculating at least one (hereinafter referred to as beat values) of average values of the beat intervals, variations in the beat intervals, beat numbers, HFs, or LF/HFs based on the beat intervals; (Claim 1, Claim 9, Claim 17) wherein each of the beat numbers is a heart rate or a pulse rate.(Claim 5, Claim 13) Oishi et al. also teaches for each 5-min interval, several HRV parameters were calculated using four different analyses: time domain analysis, frequency domain analysis, Poincaré measures and the recurrence quantification analysis (RQA). For the parameters in the time domain analysis, in addition to the mean HR, the root mean square of the successive inter-beat interval differences (RMSSD) was calculated. In the frequency domain analysis, the normalized power of the high frequency band (HF) and the ratio of the normalized power of the low frequency band to HF (LF/HF) were calculated using the Fast Fourier Transformation of the power spectrum analysis. The LF ranges were set to 0.05–0.20 Hz for all animals, and the HF ranges were set to 0.20–0.58 Hz for cattle and 0.20–0.40 Hz for sheep (Data Processing and Calculation, 5th paragraph, in the formulae (1) to (5), A1 to A5 are constants,provided that, each LF is a value obtained by performing definite integration of a power spectrum from frequencies Lf1 to Lf2, the power spectrum being obtained by including a step of performing frequency spectrum conversion on beat intervals, and each HF is a value obtained by performing definite integration of the power spectrum from frequencies Hf1 to Hf2, where Hf1>Lf1 and Hf2>Lf2 are satisfied. (Claim 1, Claim 9, Claim 17)
Oishi et al. does not explicitly teach
determining that the grown-up cattle is in a fasting state when a magnitude relationship of at least one of following formulae (1) to (5) is satisfied, and determining that the grown-up cattle is in a non-fasting state when none of magnitude relationships of following formulae (1) to (5) is satisfied: the average value of beat intervals at the time A 0 >A 1 (1) the variation in beat intervals at the time A 0 >A 2 (2) the beat number at the time A 0 <A 3 (3) the HF at the time A 0 >A 4 (4) the LH/HF at the time A 0 <A 5 (5) (Claim 1, Claim 9, Claim 17)
hereinafter referred to as a time A0) using the regression formula (Claim 1, Claim 9, Claim 17)
wherein each of the average values of the beat intervals is an average value of RRIs each of which is an interval between an R wave and an R wave in an electrocardiographic signal. (Claim 4, Claim 12)
comprising setting, as negative acceleration, a value obtained by multiplying acceleration in a body height direction at a time of standing of the grown-up cattle by −1 when the acceleration in the body height direction is a positive value, setting a negative value as the negative acceleration when the acceleration is the negative value, and determining that the grown-up cattle is in a sufficient side-lying state when a time during which the negative acceleration is a constant T or more (hereinafter, referred to as a side-lying time) is a constant L or more, and determining that the grown-up cattle is in an insufficient side-lying state when the side-lying time is less than the constant L. (Claim 2),
wherein the calculation unit sets, as negative acceleration, a value obtained by multiplying acceleration in a body height direction at a time of standing of the grown-up cattle by −1 when the acceleration in the body height direction is a positive value, sets a negative value as the negative acceleration when the acceleration is the negative value, and calculates a time during which the negative acceleration is a constant T or more (hereinafter, referred to as a side-lying time), and the determination unit determines that the grown-up cattle is in a sufficient side-lying state when the side-lying time is a constant L or more, and determines that the grown-up cattle is in an insufficient side-lying state when the side-lying time is less than the constant L. (Claim 10)
comprising creating a two-dimensional coordinate system with the beat value at the time A0 and the side-lying time as axes, and fractionating the two-dimensional coordinate system into four regions below: Region 1: a region in which the beat value at the time A0 does not satisfy any of the magnitude relationships of the formulae (1) to (5) and the side-lying time is the constant L or more Region 2: a region in which the beat value at the time A0 does not satisfy any of the magnitude relationships of the formulae (1) to (5) and the side-lying time is less than the constant L Region 3: a region in which the beat value at the time A0 satisfies at least one of the magnitude relationships of the formulae (1) to (5) and the side-lying time is the constant L or more (Claim 3),
wherein the determination unit creates a two-dimensional coordinate system with the beat value at the time A0 and the side-lying time as axes and fractionates the two-dimensional coordinate system into four regions below: Region 1: a region in which the beat value at the time A0 does not satisfy any of the magnitude relationships of the formulae (1) to (5) and the side-lying time is the constant L or more Region 2: a region in which the beat value at the time A0 does not satisfy any of the magnitude relationships of the formulae (1) to (5) and the side-lying time is less than the constant L Region 3: a region in which the beat value at the time A0 satisfies at least one of the magnitude relationships of the formulae (1) to (5) and the side-lying time is the constant L or more Region 4: a region in which the beat value at the time A0 satisfies at least one of the magnitude relationships of the formulae (1) to (5) and the side-lying time is less than the constant L. (Claim 11)
Wherein the biological information measuring garment includes: a clothing fabric; and an electrode provided on a skin-side surface side of the clothing fabric, the clothing fabric includes a first band portion on one-end portion side in a body circumferential direction and a second band portion on an other-end portion side in the body circumferential direction, and (Claim 8) wherein the measurement unit is provided on a clothing fabric of a biological information measuring garment,
the clothing fabric includes a first band portion on a one-end portion side in a body circumferential direction and a second band portion on an other-end portion side in the body circumferential direction, and (Claim 15)
a front region ahead of a region from the first band portion to the second band portion of the clothing fabric has an area larger than a rear region behind the region from the first band portion to the second band portion of the clothing fabric. (Claim 8), a front region ahead of a region from the first band portion to the second band portion of the clothing fabric has an area larger than a rear region behind the region from the first band portion to the second band portion of the clothing fabric. (Claim 15)
wherein each of the variations in the beat intervals is at least one of SDNN, RMSSD, CVRR, NN50, or pNN50, provided that, the SDNN is a standard deviation of an RRI that is an interval between an R wave and an R wave in an electrocardiographic signal, the RMSSD is a square root of an average value of squares of differences between consecutive adjacent RRIs, the CVRR is a value obtained by dividing a value of the SDNN by an average value of RRIs and multiplying the obtained value by 100, the NN50 is a value indicating a total number of times in which the differences between the consecutive adjacent RRIs exceed 50 ms, and the pNN50 is a value indicating a ratio of heartbeats in which the differences between the consecutive adjacent RRIs exceed 50 ms. (Claim 6, 14)
With respect to the limitations of claims 1, 7 8, 15, 9, 16, 17, Miwa et al. teaches using a regression formula to obtain a heart rate which is an obvious variant and has a direct relationship with beat value. If OBDA is 0 then acceleration is 0. (The relationship between ODBA and heart rate, obtaining a regression formula of the beat values and the accelerations, and obtaining a beat value when an acceleration is 0 (hereinafter referred to as a time A0) using the regression formula (Claim 1, Claim 9, Claim 17) Fig 1. The position of the accelerometer and the electrodes for the heart rate monitor.
The position of the accelerometer is at the top of the animal’s back (behind the withers), and the positions of the two electrodes connected to a transmitter of the heart rate monitor are at the animal’s right shoulder and left anterior thorax, which are known to be the appropriate points for heart rate measurements for ruminants. (Figure 1 Caption and Image
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Figure 1, Under BRI this is a garment also additionally it is an aesthetic and obvious choice to add a jacket to it. A garment comprising at least a part of the system for managing a health condition of grown-up cattle according to claim 9. (Claim 16)
wherein the beat intervals are measured using a biological information measuring garment. (Claim 7)
Wherein the biological information measuring garment includes: a clothing fabric; and an electrode provided on a skin-side surface side of the clothing fabric, the clothing fabric includes a first band portion on one-end portion side in a body circumferential direction and a second band portion on an other-end portion side in the body circumferential direction, and (Claim 8) wherein the measurement unit is provided on a clothing fabric of a biological information measuring garment,
the clothing fabric includes a first band portion on a one-end portion side in a body circumferential direction and a second band portion on an other-end portion side in the body circumferential direction, and (Claim 15) Under MPEP § 2144.04, the USPTO treats "aesthetic design changes" as standard, routine modifications that anyone with ordinary skill in the art could make. a front region ahead of a region from the first band portion to the second band portion of the clothing fabric has an area larger than a rear region behind the region from the first band portion to the second band portion of the clothing fabric. (Claim 8), a front region ahead of a region from the first band portion to the second band portion of the clothing fabric has an area larger than a rear region behind the region from the first band portion to the second band portion of the clothing fabric. (Claim 15)
With respect to the limitations of claims 1, 4, 8, 9, 12, 15, 17, Erdmann et al. teaches high performing dairy cows experience distinct metabolic stress during periods of negative energy balance. Subclinical disorders of the cow’s energy metabolism facilitate failure of adaptational responses resulting in health problems and reduced performance. The autonomic nervous system (ANS) with its sympathetic and parasympathetic branches plays a predominant role in adaption to inadequate energy and/or fuel availability and mediation of the stress response. Therefore, we hypothesize that indices of heart rate variability (HRV) that reflect ANS activity and sympatho-vagal balance could be early markers of metabolic stress, and possibly useful to predict cows with compromised regulatory capacity. In this study we analysed the autonomic regulation and stress level of 10 pregnant dried-off German Holstein cows before, during and after a 10-h fasting period by using a wide range of HRV parameters. In addition heat production (HP), energy balance, feed intake, rumen fermentative activity, physical activity, non-esterified fatty acids, β-hydroxybutyric acid, cortisol and total ghrelin plasma concentrations, and body temperature (BT) were measured. In all cows fasting induced immediate regulatory adjustments including increased lipolysis (84%) and total ghrelin levels (179%), reduction of HP (−16%), standing time (−38%) and heart rate (−15%). However, by analysing frequency domain parameters of HRV (high-frequency (HF) and low-frequency (LF) components, ratio LF/HF) cows could be retrospectively assigned to groups reacting to food removal with increased or decreased activity of the parasympathetic branch of the ANS. Regression analysis reveals that under control conditions (feeding ad libitum) group differences were best predicted by the nonlinear domain HRV component Maxline (LMAX, R2=0.76, threshold; TS=258). Compared with cows having LMAX values above TS (>LMAX: 348±17), those with LMAX values below TS (<LMAX: 109±26) had higher basal blood cortisol levels, lower concentrations of insulin, and respond to fasting with a shift of their sympatho-vagal balance towards a much stronger dominance of the sympathetic branch of the ANS and development of stress-induced hyperthermia. The data indicate a higher stress level, reduced well-being and restricted regulatory capacity in <LMAX cows. This assumption is in accord with the lower dry matter intake and energy corrected milk yield (16.0±0.7 and 42±2 kg/day) in lactating <LMAX compared with >LMAX cows (18.5±0.4 and 47.3 kg/day). From the present study, it seems conceivable that LMAX can be used as a predictive marker to discover alterations in central autonomic regulation that might precede metabolic disturbances. (abstract)
Table 3 summarizes the effects of the 10-h feed deprivation (P2) and subsequent re-feeding (P3) on HRV indices. The mean HR and the resulting R-R interval were 72±2 beats/min and 844±19 ms, respectively, under control conditions (ad libitum feeding, P1). Heart rate and R-R intervals showed a significant reduction (15±2%) or increase (18±3%) in P2 compared with P1 and returned to baseline levels during P3 (Table 3). During all experimental periods HR was positively correlated with HP (P1: r=0.58, P=0.08; P2: r=0.78, P=0.007; P3: r=0.72, P=0.02). L MAX values were significantly higher during the re-feeding period (313±29) compared with P2 (236±17). Over all cows none of the other HRV parameters were significantly influenced by the 10-h feed deprivation. All cows also lowered physical activity (reduction of movements) Our data suggest a reduction of activity-related HP to be a main component of at least short-term behavioural adaptation to feed deprivation in dairy cows. In accordance with findings showing that the HR of dairy cows must be considered in relation to its metabolic und behavioural status. The establishment between heartrate, metabolism, and fasting was already well established any person skilled in the art would be able to use that information to determine if a cow is in a fasting state.
(Response of heart rate and heart rate variability indices to a 10-h feed deprivation and subsequent re-feeding) (determining that the grown-up cattle is in a fasting state when a magnitude relationship of at least one of following formulae (1) to (5) is satisfied, and determining that the grown-up cattle is in a non-fasting state when none of magnitude relationships of following formulae (1) to (5) is satisfied: the average value of beat intervals at the time A 0 >A 1 (1) the variation in beat intervals at the time A 0 >A 2 (2) the beat number at the time A 0 <A 3 (3) the HF at the time A 0 >A 4 (4) the LH/HF at the time A 0 <A 5 (5) (Claim 1, Claim 9, Claim 17) Erdmann et al. also teaches
The mean HR and the resulting R-R interval were 72±2 beats/min and 844±19 ms, respectively, under control conditions (ad libitum feeding, P1). Heart rate and R-R intervals showed a significant reduction (15±2%) or increase (18±3%) in P2 compared with P1 and returned to baseline levels during P3. (wherein each of the average values of the beat intervals is an average value of RRIs each of which is an interval between an R wave and an R wave in an electrocardiographic signal. (Claim 4, Claim 12)
With respect to the limitations of Claims 1, 2, 3, 9, 10, 11, 17, Diosdado et al. teaches sensor position, orientation and orientation changes when lying and standing. a Orientation and location of the neck collar mounted sensor on the neck of the cow. b Schematic figure of the coordinate frame of the sensor with X forwards, Y right and Z down according to the illustration. When a cow is wearing a neck collar with attached sensor, a change in the acceleration in the x-axis corresponds to a sidewise movement to the left or to the right. A change in the acceleration in the y-axis measures the forward and backward movements while changes in the acceleration in the z-axis measure the sidewise rotation of the neck. c Example of the orientation of the sensor when a cow is observed standing. The component in the y-axis of the gravitation acceleration varies according to
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where β is the angle in degrees of the sensor relative to the horizontal. d Example of the orientation of the sensor when a cow is observed lying. The component
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will be different from standing as the angle α for lying is bigger than β (Figure 1 Caption) They also construct a two-dimensional feature space. Observations for the k-means algorithm are given by the 2-dimensional feature characteristics. The first dimension is represented by the mean of the VeDBA values over the window size, whereas the second dimension is represented by the mean of the acceleration in the y-axis (SCAY). The k-means algorithm discriminates between the observations in one step using both feature characteristics at the same time. This represents a key difference between the decision-tree and the k-means, since the former uses one feature characteristic at each decision rule. (k-means) The four regions are inherent to the two binary tests. this expression, a preselected threshold of −0.055 g for the static component in the y-axis corresponds to an angle of β = 86.84° (where an angle of β = 90° can be interpreted as the cow having its neck aligned horizontally). A further algorithm can detect transition events between lying and standing or vice versa (95.45 % sensitivity and 87.50 % precision when transition events are not classified as lying down or standing up specifically, comprising setting, as negative acceleration, a value obtained by multiplying acceleration in a body height direction at a time of standing of the grown-up cattle by −1 when the acceleration in the body height direction is a positive value, setting a negative value as the negative acceleration when the acceleration is the negative value, and determining that the grown-up cattle is in a sufficient side-lying state when a time during which the negative acceleration is a constant T or more (hereinafter, referred to as a side-lying time) is a constant L or more, and determining that the grown-up cattle is in an insufficient side-lying state when the side-lying time is less than the constant L. (Claim 2), wherein the calculation unit sets, as negative acceleration, a value obtained by multiplying acceleration in a body height direction at a time of standing of the grown-up cattle by −1 when the acceleration in the body height direction is a positive value, sets a negative value as the negative acceleration when the acceleration is the negative value, and calculates a time during which the negative acceleration is a constant T or more (hereinafter, referred to as a side-lying time), and the determination unit determines that the grown-up cattle is in a sufficient side-lying state when the side-lying time is a constant L or more, and determines that the grown-up cattle is in an insufficient side-lying state when the side-lying time is less than the constant L. (Claim 10) comprising creating a two-dimensional coordinate system with the beat value at the time A0 and the side-lying time as axes, and fractionating the two-dimensional coordinate system into four regions below: Region 1: a region in which the beat value at the time A0 does not satisfy any of the magnitude relationships of the formulae (1) to (5) and the side-lying time is the constant L or more Region 2: a region in which the beat value at the time A0 does not satisfy any of the magnitude relationships of the formulae (1) to (5) and the side-lying time is less than the constant L
Region 3: a region in which the beat value at the time A0 satisfies at least one of the magnitude relationships of the formulae (1) to (5) and the side-lying time is the constant L or more (Claim 3), wherein the determination unit creates a two-dimensional coordinate system with the beat value at the time A0 and the side-lying time as axes and fractionates the two-dimensional coordinate system into four regions below: Region 1: a region in which the beat value at the time A0 does not satisfy any of the magnitude relationships of the formulae (1) to (5) and the side-lying time is the constant L or more
Region 2: a region in which the beat value at the time A0 does not satisfy any of the magnitude relationships of the formulae (1) to (5) and the side-lying time is less than the constant L Region 3: a region in which the beat value at the time A0 satisfies at least one of the magnitude relationships of the formulae (1) to (5) and the side-lying time is the constant L or more Region 4: a region in which the beat value at the time A0 satisfies at least one of the magnitude relationships of the formulae (1) to (5) and the side-lying time is less than the constant L. (Claim 11) A method for managing a health condition of grown-up cattle, comprising: (Claim 1) A system for managing a health condition of grown-up cattle, comprising: (Claim 9) An apparatus for managing a health condition of grown-up cattle, comprising (Claim 17)
With respect to the limitations of Claims 1, 6, 9, 14, 17, US8568330B2 teaches assuming that the block 302 heart beat data comprises or can be used to obtain a sequence of heart beat (R-R) intervals 120, block 304 may comprise any one or more of several techniques to determine HRV. The most widely used techniques for determining HRV can be grouped under time-domain and frequency-domain categories. Time-domain methods are based on measuring the duration of beat-to-beat (R-R) intervals, and then further analyzing the RR intervals to provide metrics: SDNN, the standard deviation of R-R intervals, often calculated over a 24-hour period. SDANN, the standard deviation of the average R-R intervals calculated over relatively short periods, usually 5 minutes. (SDANN is therefore a measure of changes in heart rate due to cycles longer than 5 minutes. RMSSD, the square root of the mean squared difference of successive R peaks. NN50, the number of pairs of successive RRs that differ by more than 50 ms. pNN50, the proportion of NN50 divided by total number of RRs. Any of these time-domain-based HRV metrics may comprise cardiac parameters Ci of the type determined in block (Description, measuring beat intervals in a predetermined period; (Claims 1, 9, 17) wherein each of the variations in the beat intervals is at least one of SDNN, RMSSD, CVRR, NN50, or pNN50, provided that, the SDNN is a standard deviation of an RRI that is an interval between an R wave and an R wave in an electrocardiographic signal, the RMSSD is a square root of an average value of squares of differences between consecutive adjacent RRIs, the CVRR is a value obtained by dividing a value of the SDNN by an average value of RRIs and multiplying the obtained value by 100, the NN50 is a value indicating a total number of times in which the differences between the consecutive adjacent RRIs exceed 50 ms, and the pNN50 is a value indicating a ratio of heartbeats in which the differences between the consecutive adjacent RRIs exceed 50 ms. (Claim 6, Claim 14)
A person having ordinary skill in the art would be motivated to combine Erdmann et al. in view of Miwa et al. in view of Oishi et al. in view of Diosdado et al. in view of US8568330B2 in order to create a device to monitor the heart rates and health of cattle. As each work either involves monitoring cattle or the heart rates of humans which any person of ordinary skill in the art would see how heart rate data is used in other mammals when developing their method. Erdmann et al. teaches the connection between heart rate and fasting vs non fasting states. Miwa et al. teaches the fitting of a regression model of a beat value and reading that value at acceleration being 0. Oishi et al. teaches measuring heartbeat intervals and computing values such as the RMSSD. Diosdado et al. teaches relating the use of the beat value at the time A0 and the side-lying time US8568330B2 teaches the architecture for deriving a physiological index from heart rate data, although designed in humans the same principal can easily be applied to other mammals. There is a reasonable expectation as applicant is just putting together individual components which work separated therefore, they are expected to work together when combined as the function of each individual component still works together as it did separately.
Conclusion
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/C.H.B./Examiner, Art Unit 1687
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687
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