DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a signal quality classification component” in claim 1;
“an oxygen saturation estimation component” in claim 1;
“a photoelectric conversion device” in claim 1;
“a sensor selection component” in claims 1 and 6;
“an oxygen saturation index calculation component” in claim 3; and
“a light source control component” in claims 4 and 9.
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.
Claims 1-10 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.
For claims 1, 4, 6, and 9, the claims positively recited at least the following:
“a signal quality classification component” in claim 1;
“an oxygen saturation estimation component” in claim 1;
“a photoelectric conversion device” in claim 1;
“a sensor selection component” in claims 1 and 6;
“an oxygen saturation index calculation component” in claim 3; and
“a light source control component” in claims 4 and 9.
However, the instant Specification fails to disclose or link any corresponding structure(s) to the “components” above such that the written description of each “component” is a black box as to what structure(s) and/or software may comprise the “component”. Given the lack of sufficiently corresponding detail in the instant disclosure to each of the “components”, one of ordinary skill would not reasonably be apprised of possession of the invention, such that written description is lacking. Depending claims inherit and do not remedy the lack of written description issue.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 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.
For claims 1, 4, 6, and 9, the claims positively recited at least the following:
“a signal quality classification component” in claim 1;
“an oxygen saturation estimation component” in claim 1;
“a photoelectric conversion device” in claim 1;
“a sensor selection component” in claims 1 and 6;
“an oxygen saturation index calculation component” in claim 3; and
“a light source control component” in claims 4 and 9.
However, the instant Specification fails to disclose or link any corresponding structure(s) to the “components” above such that the written description of each “component” is a black box as to what structure(s) and/or software may comprise the “component”. Given the lack of sufficiently corresponding detail in the instant disclosure to each of the “components”, one of ordinary skill would not reasonably be apprised of the metes and bounds of the scope of the claimed invention, such that it is indeterminate and the claims are indefinite. Depending claims inherit and do not remedy the indefiniteness.
For independent claims 1 and 6, the term “good or bad” is a relative term which renders the claim(s) indefinite. The term “good or bad” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate with respect to what signals are explicitly, implicitly, inherently, or inferentially is required or excluded to be considered “good” and/or “bad” and/or the degree of “goodness” and/or “badness” required for the signal to be considered either. One of ordinary skill in the art given the Specification would not be apprised at the scope of the claimed invention. Depending claims 2-5 and 7-10 inherit and do not remedy the indefiniteness.
For independent claims 1 and 6, the term “highest signal quality” is a relative term which renders the claim(s) indefinite. The term “highest signal quality” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate with respect to what signal quality is/are explicitly, implicitly, inherently, or inferentially is required or excluded to be considered “high” and/or “low” and/or the degree of “high quality” required or excluded. One of ordinary skill in the art given the Specification would not be apprised at the scope of the claimed invention. Depending claims 2-5 and 7-10 inherit and do not remedy the indefiniteness.
Independent claims 1 and 6 positively recite the limitation "a sensor" in lines 16 and 17. The scope of the claimed invention is indeterminate with respect to if the two “a sensor” are the same and/or different structure(s). Further the scope of the claimed invention is indeterminate with respect to the required or excluded relationship(s) between the multipole “a sensor” recitations and the “plurality of sensors” introduced in line 10. Depending claims 2-5 and 7-10 inherit and do not remedy the indefiniteness.
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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more, wherein the abstract idea is a mental process of selecting signals for estimating oxygen saturation.
For independent claims 1 and 6, the claim(s) recite(s) a system and method of receiving and classifying PPG signals and estimating oxygen saturation from selected signals.
As broadly as claimed these steps may be reasonably considered as the judicial exception of a mental process performable within the human mind, including by observation, evaluation, judgement and opinion forming, or by a human using pen and paper (see MPEP 2106.04(a)(2) subsection III). For example, at least, these limitations are nothing more than a medical professional capturing data, printing it out, and using the data to mentally extract, classify or learn from data features to estimate oxygen saturation from selected PPG signals.
This judicial exception is not integrated into a practical application because the process steps as broadly as claimed are not tied to nor required to be performed, executed, or programmed on a special purpose computer. Further, the judicial exception is not even required to be performed on or tied to a mere generic processing device, controller, or the like.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the preliminary steps of gathering sensor data are well-known, routine and conventional amounting to insignificant data gathering as pre-solution activity. Although a server and/or plurality of sensor is inferentially required at most, assuming arguendo they would be required, a server and/or plurality of sensors are well known, routine and conventional in the art and would be considered insignificant pre-solution data gathering activity.
Depending claims 2-5 and 7-10 inherit and do not remedy the non-statutory deficiency noted above. Despite further specifying steps relating signal quality, signal indexing, and signal selection, the claims remain an abstract idea of a mental process, are not integrated into a practical application, and do not amount to significantly more than the abstract idea.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ferber et al. (US 2018/00854040 A1, hereinafter Ferber), particularly as best understood in light of the Specification and in view of the 101 and 112 issues raised above.
For claim 1, Ferber discloses a system for estimating oxygen saturation by using a photoplethysmography (PPG) signal sensing ring (Figs 16-33 and [0316-0459]), the system comprising a server (Figs 16-33 and [0316-0459]), wherein the server comprises inter alia:
a signal quality classification component (Figs 16-33 and [0316-0459]) configured to classify qualities of a first wavelength PPG signal and a second wavelength PPG signal as good or bad (Figs 16-33 and [0316-0459]); and
an oxygen saturation estimation component (Figs 16-33 and [0316-0459]) configured to estimate oxygen saturation from the first wavelength PPG signal and the second wavelength PPG signal (Figs 16-33 and [0316-0459]),
the first wavelength PPG signal and the second wavelength PPG signal are measured by using the PPG signal sensing ring, the server receives the first wavelength PPG signal (Figs 16-33 and [0316-0459]) and the second wavelength PPG signal from the PPG signal sensing ring through a terminal (Figs 16-33 and [0316-0459]),
the PPG signal sensing ring comprises a plurality of sensors at different locations (Figs 16-33 and [0316-0459]),
each of the plurality of sensors is configured to measure the first wavelength PPG signal and the second wavelength PPG signal (Figs 16-33 and [0316-0459]),
each of the plurality of sensors comprises a first wavelength light source, a second wavelength light source, and a photoelectric conversion device (Figs 16-33 and [0316-0459]), and
the terminal comprises a sensor selection component (Figs 16-33 and [0316-0459]) configured to select, from among the plurality of sensors, as a sensor for measuring the first wavelength PPG signal and the second wavelength PPG signal, a sensor that measured a combination of a first wavelength test PPG signal and a second wavelength test PPG signal, which has a highest signal quality from among a plurality of first wavelength test PPG signals and a plurality of second wavelength test PPG signals (Figs 16-33 and [0316-0459]).
For claim 2, Ferber discloses the system of claim 1, wherein signal qualities of the plurality of first wavelength test PPG signals and the plurality of second wavelength test PPG signals are evaluated by at least one of a magnitude of an acceleration signal, a signal-to-noise ratio, and a ratio of a direct current (DC) component size to an alternating current (AC) component size (Figs 16-33 and [0316-0459]).
For claim 3, Ferber discloses the system of claim 1, wherein the server further comprises an oxygen saturation index calculation component (Figs 16-33 and [0316-0459]) configured to calculate an oxygen saturation index, wherein the oxygen saturation index is defined by a ratio of a time when the qualities of the first wavelength PPG signal and the second wavelength PPG signal are classified as good by the signal quality classification component to a time when the qualities of the first wavelength PPG signal and the second wavelength PPG signal are classified as good and the oxygen saturation is outside a normal range (Figs 16-33 and [0316-0459]).
For claim 4, Ferber discloses the system of claim 1, wherein the terminal further comprises a light source control component (Figs 16-33 and [0316-0459]) configured to control the first wavelength light source and the second wavelength light source of each of the plurality of sensors such that a DC component of each of the plurality of first wavelength test PPG signals measured respectively by using the plurality of sensors is within a first predetermined range and a DC component of each of the plurality of second wavelength test PPG signals measured respectively by using the plurality of sensors is within a second predetermined range (Figs 16-33 and [0316-0459]).
For claim 5, Ferber discloses the system of claim 4, wherein the controlling of the first wavelength light source and the second wavelength light source by the light source control component and the selecting of the sensor by the sensor selection component are sequentially performed (Figs 16-33 and [0316-0459]), and the controlling of the first wavelength light source and the second wavelength light source by the light source control component and the selecting of the sensor by the sensor selection component are periodically performed (Figs 16-33 and [0316-0459]).
For claim 6, Ferber discloses a method of estimating oxygen saturation by using a photoplethysmography (PPG) signal sensing ring (Figs 16-33 and [0316-0459]), the method comprising inter alia:
receiving a first wavelength PPG signal and a second wavelength PPG signal from the PPG signal sensing ring through a terminal (Figs 16-33 and [0316-0459]);
classifying qualities of the first wavelength PPG signal and the second wavelength PPG signal as good or bad (Figs 16-33 and [0316-0459]); and
estimating oxygen saturation from the first wavelength PPG signal and the second wavelength PPG signal (Figs 16-33 and [0316-0459]),
wherein the PPG signal sensing ring comprises a plurality of sensors at different locations (Figs 16-33 and [0316-0459]),
each of the plurality of sensors is configured to measure the first wavelength PPG signal and the second wavelength PPG signal (Figs 16-33 and [0316-0459]),
each of the plurality of sensors comprises a first wavelength light source, a second wavelength light source, and a photoelectric conversion device (Figs 16-33 and [0316-0459]), and
the terminal comprises a sensor selection component configured to select, from among the plurality of sensors, as a sensor for measuring the first wavelength PPG signal and the second wavelength PPG signal, a sensor that measured a combination of a first wavelength test PPG signal and a second wavelength test PPG signal, which has a highest signal quality from among a plurality of first wavelength test PPG signals and a plurality of second wavelength test PPG signals (Figs 16-33 and [0316-0459]).
For claim 7, Ferber discloses the method of claim 6, wherein signal qualities of the plurality of first wavelength test PPG signals and the plurality of second wavelength test PPG signals are evaluated by at least one of a magnitude of an acceleration signal, a signal-to-noise ratio, and a ratio of a direct current (DC) component size to an alternating current (AC) component size (Figs 16-33 and [0316-0459]).
For claim 8, Ferber discloses the method of claim 6, further comprising calculating an oxygen saturation index (Figs 16-33 and [0316-0459]), wherein the oxygen saturation index is defined by a ratio of a time when the qualities of the first wavelength PPG signal and the second wavelength PPG signal are classified as good by the signal quality classification component to a time when the qualities of the first wavelength PPG signal and the second wavelength PPG signal are classified as good and the oxygen saturation is outside a normal range (Figs 16-33 and [0316-0459]).
For claim 9, Ferber discloses the method of claim 6, wherein the terminal further comprises a light source control component (Figs 16-33 and [0316-0459]) configured to control the first wavelength light source and the second wavelength light source of each of the plurality of sensors such that a DC component of each of the plurality of first wavelength test PPG signals measured respectively by using the plurality of sensors is within a first predetermined range and a DC component of each of the plurality of second wavelength test PPG signals measured respectively by using the plurality of sensors is within a second predetermined range (Figs 16-33 and [0316-0459]).
For claim 10, Ferber discloses the method of claim 9, wherein the controlling of the first wavelength light source and the second wavelength light source by the light source control component and the selecting of the sensor by the sensor selection component are sequentially performed (Figs 16-33 and [0316-0459]), and the controlling of the first wavelength light source and the second wavelength light source by the light source control component and the selecting of the sensor by the sensor selection component are periodically performed (Figs 16-33 and [0316-0459]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791