DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 11/07/2023. Claims 1-11 are pending and examined below.
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.
“A storage means” is defined as a memory in paragraph [0099] of the PGPub US 20240269511 A1
“A measurement means: is not properly defined by the Specification.
“A computation means” is defined as a CPU in paragraph [0099] of the PGPub US 20240269511 A1
“An instruction means” is not properly defined by the Specification.
For the purposes of this examination a measurement is interpreted as a spo2 or heart sensor and the instruction means in interpreted as part of a processor/CPU.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6, and claims dependent thereof, 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.
Claim limitation “a measurement means” and “an instruction means” 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. “A measurement means” and “an instruction means” is not linked to a corresponding structure. 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.
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.
For the purpose of examination measurement means is interpreted as an Spo2 sensor and the instrument means is interpreted as a processor component.
Claim Rejections - 35 USC § 112(a)
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.
Claims 6, and claims dependent thereof, 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.
Regarding claim 6, because the Specification fails to disclose sufficient structure for “a measurement means” and an “instruction means” and the claim is indefinite under 35 USC 112(b) for failure to particularly point out and distinctly claim the invention, "such a limitation also lacks an adequate written description as required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because an indefinite, unbounded functional limitation would cover all ways of performing a function” See also MPEP § 2181."
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.
Regarding claims 1-11, the claims are rejected under 35 U.S.C. 101 because the claimed invention is directed to receiving and manipulating data without significantly more.
Claim 1 recites “A method for estimating optimal exercise intensity, characterized by comprising: a step to give a ramped load to a subject so as to obtain a value of blood oxygen concentration (SpO2) at each predetermined different workload, which is measured over a range that overlaps at least a part of 96 to 100%; and a step to determine a starting point of decline at which the measured value of blood oxygen concentration starts to show a declining trend as the workload increases; wherein the workload at the starting point of decline is estimated as an optimal exercise intensity for the subject.”
This falls into a mental process grouping of abstract ideas. These limitations are either capable of being performed mentally by looking at measurements and making mental assessments thereafter or considered insignificant extra-solution activity.
The step of giving a ramped load to a subject so as to obtain a value of blood oxygen concentration (SpO2) at each predetermined different workload, which is measured over a range that overlaps at least a part of 96 to 100% is insignificant extra-solution activity (mere data gathering).
The step of determining a starting point of decline at which the measured value of blood oxygen concentration starts to show a declining trend as the workload increases, wherein the workload at the starting point of decline is estimated as an optimal exercise intensity for the subject is a mental process that can be performed in a human mind or by a pencil and paper by a skilled clinician.
Additionally the judicial exception is not integrated into a practical application because there are not additional elements.
Finally, the claims analyzed as a whole do not provides any element, or combination of elements, sufficient to amount to significantly more than the mental process as no additional elements are claimed.
Regarding dependent claims 2-3, 5-9, the claims also fail to add something more to the abstract independent claims as they merely further limit the abstract idea or provide insignificant extra solution activity.
Specifically, in regards to claim 6, the judicial exception is not integrated into a practical application because the additional element of a storage means, computation means, and instructions means, for performing the steps is, at its broadest reasonable interpretation, a generic computer structure for performing the generic computer function of data processing, which does not qualify as an integration of the abstract idea into a practical application. Likewise, the inclusion of a measurement means (a generic optical sensor) for measuring data is merely insignificant, extra-solution activity in the form of mere data gathering, which also does not qualify as an integration of the abstract idea into a practical application.
Finally, the claims analyzed as a whole do not provides any element, or combination of elements, sufficient to amount to significantly more than the mental process as only a generic computer structure and generic optical sensor for data collection are claimed. As noted previously, the addition of a generic computer structure for performing the generic computer function of data processing and the inclusion of a generic optical sensor for gathering data (merely insignificant, extra-solution activity in the form of mere data gathering), does not qualify as significantly more than the abstract idea itself. Additionally, the claimed sensors are well-understood, routine and conventional activity and thus do not amount to significantly more than the abstract idea itself.
The following examples show that the generic optical sensor is well understood, routine, and conventional activity: JPH06142086A,
Regarding claim 10, the claim is a parallel apparatus claim to that of claim 1, and is rejected for substantially the same reasons.
Regarding claims 4, the claims are rejected under 35 U.S.C. 101 because the claimed invention is directed to receiving and manipulating data without significantly more.
Claim 4 recites “A method for estimating optimal exercise intensity, characterized by comprising: a step to give a ramped load to a subject so as to obtain a value of blood oxygen concentration (SpO2) at each predetermined different workload, which is measured over a range that overlaps at least a part of 96 to 100%, and measure a pulse rate simultaneously with the SpO2; and a step to determine an inflection point at which a behavior of (SpO2/pulse rate) changes as the workload increases; wherein the workload at the inflection point is estimated as an optimal exercise intensity for the subject.”
This falls into a mental process grouping of abstract ideas. These limitations are either capable of being performed mentally by looking at measurements and making mental assessments thereafter or considered insignificant extra-solution activity.
The step of giving a ramped load to a subject so as to obtain a value of blood oxygen concentration (SpO2) at each predetermined different workload, which is measured over a range that overlaps at least a part of 96 to 100%, and measure a pulse rate simultaneously with the SpO2 is insignificant extra-solution activity (mere data gathering).
The step of determining an inflection point at which a behavior of (SpO2/pulse rate) changes as the workload increases; wherein the workload at the inflection point is estimated as an optimal exercise intensity for the subject is a mental process that can be performed in a human mind or by a pencil and paper by a skilled clinician.
Additionally the judicial exception is not integrated into a practical application because there are not additional elements.
Finally, the claims analyzed as a whole do not provides any element, or combination of elements, sufficient to amount to significantly more than the mental process as no additional elements are claimed.
Regarding claim 11, the claims are rejected under 35 U.S.C. 101 because the claimed invention is directed to receiving and manipulating data without significantly more.
Claim 11 recites “A system for estimating optimal exercise intensity, characterized by comprising: A measurement part that measures a blood oxygen concentration (SpO2) over a range that overlaps at least a part of 96 to 100%, and also simultaneously measures a pulse rate; an instruction part that indicates a workload that is used as a ramped load; and a computation part that calculates an inflection point at which a behavior of (SpO2/pulse rate) changes as the workload increases; wherein the workload at the inflection point is estimated as an optimal exercise intensity”
This falls into a mental process grouping of abstract ideas. These limitations are either capable of being performed mentally by looking at measurements and making mental assessments thereafter or considered insignificant extra-solution activity.
The step of giving a ramped load to a subject so as to obtain a value of blood oxygen concentration (SpO2) at each predetermined different workload, which is measured over a range that overlaps at least a part of 96 to 100%, and measure a pulse rate simultaneously with the SpO2 is insignificant extra-solution activity (mere data gathering).
The step of determining an inflection point at which a behavior of (SpO2/pulse rate) changes as the workload increases; wherein the workload at the inflection point is estimated as an optimal exercise intensity for the subject is a mental process that can be performed in a human mind or by a pencil and paper by a skilled clinician.
Additionally, the judicial exception is not integrated into a practical application because the additional element of instruction part and computation part for performing the steps is, at its broadest reasonable interpretation, a generic computer structure for performing the generic computer function of data processing, which does not qualify as an integration of the abstract idea into a practical application. Likewise, the inclusion of a measurement means (a generic optical sensor) for measuring data is merely insignificant, extra-solution activity in the form of mere data gathering, which also does not qualify as an integration of the abstract idea into a practical application.
Finally, the claims analyzed as a whole do not provides any element, or combination of elements, sufficient to amount to significantly more than the mental process as only a generic computer structure and generic optical sensor for data collection are claimed. As noted previously, the addition of a generic computer structure for performing the generic computer function of data processing and the inclusion of a generic optical sensor for gathering data (merely insignificant, extra-solution activity in the form of mere data gathering), does not qualify as significantly more than the abstract idea itself. Additionally, the claimed sensors are well-understood, routine and conventional activity and thus do not amount to significantly more than the abstract idea itself.
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, 5-7, 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable by JP 2021000344 A (cited in IDS; hereinafter referred to as “Yuki” (Note: used translation provided by Applicant)) in view of US 20100317933 A1 (hereinafter referred to as “Coleman”).
Regarding claims 1 and 10, Yuki, a training support system/method, teaches a method/system for estimating optimal exercise intensity (abstract), characterized by comprising:
A measurement part (measuring device 3; as shown in Figure 2), an instruction part (storage unit 43; as shown in Figure 2), and a computation part (control calculation unit 41; as shown in Figure 2) which allows for the following steps:
a step to give a ramped load to a subject so as to obtain a value of blood oxygen concentration (SpO2) at each predetermined different workload (“A first step of providing a user a first exercise action of gradually increasing a load from an initial load in the exercise to an all-out load”; abstract; claim 1),
a step to determine a starting point of decline at which the measured value of blood oxygen concentration starts to show a declining trend as the workload increases (paragraphs [0053]-[0054]);
wherein the workload at the starting point of decline is estimated as an optimal exercise intensity for the subject (“adjusting the exercise speed and oxygen concentration to carry out for safer training” (an optimal exercise intensity); paragraphs [0053]-[0054]); but does not explicitly teach the SpO2 is measured over a range that overlaps at least a part of 96 to 100%.
However, Colman, a medical monitoring apparatus, teaches a normal range of SpO2 is between 96 to 100% (paragraph [0050]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Yuki, which already is evaluating SpO2, to see if the SpO2 is in a normal range of 96 to 100%, as taught by Coleman, because doing so provides a direct indication is the user’s oxygen saturation is in an acceptable range.
Regarding claim 5, Yuki, in view of Coleman, teaches A training method characterized in that exercise is performed at the optimal exercise intensity estimated by the estimation method according to claim 1 (paragraph [0056]).
Regarding claim 6, Yuki, in view of Coleman, teaches An exercise instruction device characterized by comprising:
a storage means for storing biological information values at the optimal exercise intensity estimated by the estimation method according to claim 1 (storage unit 43; paragraphs [0041]-[0043]; as shown in Figure 2);
a measurement means capable of measuring the biological information values (measuring device 3; paragraphs [0041]-[0043]; as shown in Figure 2);
a computation means for calculating a workload by comparing the biological information values measured by the measurement means against the biological information values at the optimal exercise intensity (control calculation unit 41; paragraphs [0041]-[0043]; as shown in Figure 2); and
an instruction means for indicating the workload calculated by the computation means (control calculation unit 41; paragraphs [0041]-[0043]; as shown in Figure 2).
Regarding claim 7, Yuki, in view of Coleman teaches the measurement means is capable of measuring a blood oxygen concentration (SpO2) (paragraphs [0053]-[0054]);
the instruction means is capable of indicating the workload which is a workload used as a ramped load, based on information relating to the biological information values from the measurement means (abstract; claim 1); and
the computation means is capable of calculating a starting point of decline at which the measured value of blood oxygen concentration starts to show a declining trend as the workload increases (paragraphs [0053]-[0054]).
Regarding claim 9, The exercise instruction device according to claim 6, characterized by being a wearable terminal (paragraph [0064]).
Claim(s) 4 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable JP H06142086 A (hereinafter referred to as “Tanabe” (Note: used Google Patents translation provided)) in view of Yuki and Coleman.
Regarding claims 4 and 11, Tanabe, a training support system/method, teaches a method/system for estimating optimal exercise intensity (abstract), characterized by comprising:
A measurement part (1,2; page 2), an instruction part (memory 5; page 2), and a computation part (CPU 6; page 2) which allows for the following steps:
a step to give a ramped load to a subject so as to obtain a value of blood oxygen concentration (SpO2) at each predetermined different workload (“The ramp load sequence is a sequence in which a linearly gradually increasing ramp load (see (b) of FIG. 2) is applied to a subject and the oxygen change of blood in the tissue during the exercise is measured. Instead of the lamp load, a step load (see (a) of FIG. 2) that increases by a constant amount at regular time intervals may be used”; page 3); and
a step to determine an inflection point at which a behavior of (SpO2) changes as the workload increases (claim 1);
wherein the workload at the inflection point is estimated as an optimal exercise intensity for the subject (claim 1); but does not explicitly teach measure a pulse rate simultaneously with the SpO2 and the SpO2 is measured over a range that overlaps at least a part of 96 to 100%.
Yuki teaches measure a pulse rate simultaneously with the SpO2 (claim 3). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tanabe, to measure heart rate, as taught by Yuki, because doing so provides further information as to a user’s exhaustion point.
However, Colman, a medical monitoring apparatus, teaches a normal range of SpO2 is between 96 to 100% (paragraph [0050]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tanabe, in view of Yuki, which already is evaluating SpO2, to see if the SpO2 is in a normal range of 96 to 100%, as taught by Coleman, because doing so provides a direct indication is the user’s oxygen saturation is in an acceptable range.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yuki, in view of Coleman as applied to claim 6 above, and further in view of Tanabe.
Regarding claim 8, Yuki, in view of Coleman teaches the measurement means is capable of measuring a blood oxygen concentration (SpO2) and a pulse rate (paragraphs [0053]-[0054]);
the instruction means is capable of indicating the workload which is a workload used as a ramped load, based on information relating to the biological information values from the measurement means (paragraphs [0053]-[0054]); and measuring for pulse rate changes; but does not explicitly teach the computation means is capable of calculating an inflection point at which a behavior of SpO2/pulse rate changes as the workload increases.
However, Tanabe teaches the computation means is capable of calculating an inflection point at which a behavior of SpO2/pulse rate changes as the workload increases (claim 1). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Yuki, in view of Coleman, to detect an inflection point, as taught by Tanabe doing so shows a clear sign of fatigue and decline in performance capability.
Conclusion
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/ABID A MUSTANSIR/Examiner, Art Unit 3791