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 .
Election/Restrictions
Applicant’s election of Group 1, drawn to the process of non-contact estimation of oxygen saturation, in the reply filed on 07/13/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). In contract, Applicant’s election of Species B with traversal of the Species requirement is persuasive and the election of species requirement is withdrawn.
Claims 31-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/13/26.
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.
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 30 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 30, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 30, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 19-30 and 38-40 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 may fairly and reasonably be considered a mental process performable in the human mind and/or mathematical concepts of mathematical relationships and calculations.
For independent claim 19, the claim(s) recite(s) a process of estimating oxygen saturation by pre-processing signal data, extracting frequency and time domain features from pre-processed signal data, computing statistical parameters of the time domain features, and estimating oxygen saturation based on extracted frequency domain features and computed statistical parameters of the time domain features using a model trained therefor.
As broadly as claimed these steps may be reasonably considered as the judicial exception of (i) a mental process performable within the human mind, including by observation, evaluation, judgement and opinion forming, or by a human using pen and paper and/or (ii) mathematical concepts of mathematical relationships and calculations (see MPEP 2106.04(a)(2) subsections I and III). For example, at least, these limitations are nothing more than (i) a medical professional and/or mathematician capturing data, printing it out, and using the data with pen and paper to process, extract, compute, and estimate from the data and/or (ii) organizing and manipulating information through mathematical correlations.
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 no additional elements and/or any structure are recited. The examiner respectfully notes that although PPG signal data is input for pre-processing, the claim does not specify that the data is provided and/or obtained. Assuming arguendo this was claimed, the preliminary steps of data gathering would be well-known, routine and conventional amounting to insignificant data gathering as pre-solution activity.
Depending claims 20-30 and 38-40 inherit and do not remedy the non-statutory deficiency noted above, despite further specifying steps relating to clarifications of data manipulation including – preprocessing, filtering, extracting, or training -- that could be performed mentally and/or are merely further detailed mathematical concepts.
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) 19-30 and 38-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (US 2020/0367773 A1, hereinafter Wang).
For claim 19, Wang discloses a method for non-contact estimation of oxygen saturation, the method comprising inter alia:
pre-processing a photoplethysmography (PPG) signal of light reflected from a skin of a subject illuminated by ambient light by filtering the PPG signal to obtain a smoothed pulse signal ([0013-0046, 0067, 0074-0137]);
extracting a plurality of frequency domain and time domain features from the smoothed pulse signal by extracting time domain features from the smoothed pulse signal with respect to time and extracting frequency domain features from the smoothed pulse signal with respect to frequency ([0013-0046, 0067, 0074-0137]);
computing statistical parameters of the time domain features, wherein the statistical parameters represent measured quantities of a statistical population describing the respective time domain features ([0013-0046, 0067, 0074-0137]); and
estimating oxygen saturation for the subject based on the frequency domain features and the statistical parameters of the time domain features and an oxygen saturation estimation model trained for estimating oxygen saturation based on input frequency domain features and input statistical parameters of time domain features ([0013-0046, 0067, 0074-0137]).
For claim 20, Wang discloses the method according to claim 19, wherein pre-processing comprises filtering the PPG signal using a median average filter ([0013-0046, 0067, 0074-0137]).
For claim 28, Wang discloses the method according to claim 19, wherein computing statistical parameters comprises computing at least two of mean, median, standard deviation, mean absolute deviation, and interquartile range of the time domain features ([0013-0046, 0067, 0074-0137]).
For claim 30, Wang discloses the method according to claim 19, wherein extracting a plurality of time domain features comprises extracting at least two time domain features selected from the group consisting of difference between height of a peak of the smoothed pulse signal and average height of two valleys adjacent the peak, time duration between a peak of the smoothed pulse signal and a valley preceding the peak, time duration between two valleys of a pulse wave in the smoothed pulse signal, width at a selected percentage, peak height between a rising branch and peak point in the smoothed pulse signal, periodic energy of the smoothed pulse signal, area under a pulse cycle in the smoothed pulse signal, time between systolic peaks and a dicrotic notch in the smoothed pulse signal, distance between diastolic valleys in the smoothed pulse signal, dicrotic notch downward curve in the smoothed pulse signal, ratio of systolic peak time to peak- to-peak interval of the smoothed pulse signal, ratio of a height of a notch to a systolic peak amplitude of the smoothed pulse signal, ratio of pulse width from right at a selected percentage, time interval from a foot of the smoothed pulse signal to a time at which a first derivative of the smoothed pulse signal occurred, first maximum peak from a second derivative of the smoothed pulse signal after first maximum peak from a first derivative of the smoothed pulse signal and ratio of time interval from the foot of the smoothed signal to a time at which the first minimum peak occurred to a peak-to-peak interval of the smoothed pulse signal ([0013-0046, 0067, 0074-0137]).
For claim 38, Wang discloses the method according to claim 19, further comprising:
pre-processing a plurality of PPG signals of light reflected from skins of a plurality of subjects illuminated by ambient light by filtering the PPG signals to obtain a plurality of smoothed pulse signals ([0013-0046, 0067, 0074-0137]);
extracting, from each smoothed pulse signal of the plurality of smoothed pulse signals, the plurality of frequency domain and time domain features from the smoothed pulse signal by extracting time domain features from the smoothed pulse signal with respect to time and extracting frequency domain features from the smoothed pulse signal with respect to frequency ([0013-0046, 0067, 0074-0137]);
computing statistical parameters of the time domain features, wherein the statistical parameters represent measured quantities of a statistical population describing the respective time domain features ([0013-0046, 0067, 0074-0137]); and
training the oxygen saturation estimation model based on the frequency domain features and the statistical parameters of the time domain features and actual oxygen saturation values obtained for the plurality of subjects ([0013-0046, 0067, 0074-0137]).
For claim 39. (New) The method according to claim 38, wherein the oxygen saturation estimation model is a random forest based oxygen saturation estimation model ([0013-0046, 0067, 0074-0137]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, relating to means for processing PPG signals to estimate oxygen saturation based on (i) frequency domain features and (ii) statistical parameters of time domain features and model training therefor.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
Prosecution Insights