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.
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 13-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more, wherein the claimed invention includes determining skin tone which may be considered a mental process as an abstract idea.
For independent claim 13, the claim(s) recite(s) determining a skin tone of a subject from a signal. 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 determine a skin tone. The examiner notes that a mere layperson in society determines skin tones mentally on a routine basis when interacting with other individuals.
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 illuminating with a light source of an optical vital signs monitor and receiving a resultant signal with spectral sensor of the optical vital signs monitor are well-known, routine and conventional amounting to insignificant data gathering as pre-solution activity.
Depending claims 14-22 inherit and do not remedy the non-statutory deficiency noted above, despite further specifying steps relating to stimulus application, feature extraction, and/or relaxation technique training treatment that could merely be provided verbally.
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) 1-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dietiker (US 2019/0261859 A1).
For claim 1, Dietiker discloses an optical vital signs monitor (100), comprising inter alia: a light source (110) ([0026]); a spectral sensor (120); a processor (125); and a non-transitory computer readable medium comprising instructions executable by the processor to perform or control performance of operations(130, 135) comprising: illuminating (510), via the light source, a body of a subject (145) (Fig 5); receiving (515), via the spectral sensor, a resultant signal from the body of the subject; (Fig 5) and determining a skin tone of the subject from the received resultant signal (520, 525, 530) (Fig 5) ([0036-0040, 0060-0061]).
For claim 2, Dietiker discloses the optical vital signs monitor of claim 1, wherein the resultant signal comprises illumination radiation transmitted through the subject or reflected from the subject (Fig 5) ([0036]).
For claim 3, Dietiker discloses the optical vital signs monitor of claim 1, wherein the light source is configured to emit light in a broad spectral range ([0026, 0064-0065]).
For claim 4, Dietiker discloses the optical vital signs monitor of claim 3, wherein the broad spectral range spans at least 100 nanometers in the visible spectrum ([0026, 0036, 0065]).
For claim 5, Dietiker discloses the optical vital signs monitor of claim 3, further comprising a second light source ([0026, 0036, 0065]) and a third light source ([0026, 0036, 0065]), the second light source configured to emit radiation in the red spectral range and the third light source configured to emit radiation in the infrared spectral range ([0026, 0036, 0065]).
For claim 6, Dietiker discloses the optical vital signs monitor of claim 1, wherein the light source: is located adjacent to and facing a same direction as the spectral sensor; or is located spaced apart from and facing the spectral sensor (Figs 1-2).
For claim 7, Dietiker discloses the optical vital signs monitor of claim 1, wherein the spectral sensor comprises two or more detectors with different spectral response properties ([0036)].
For claim 8, Dietiker discloses the optical vital signs monitor of claim 7, wherein: receiving the resultant signal from the body of the subject includes receiving the resultant signal at a first detector of the two or more detectors and at a second detector of the two or more detectors ([0036-0040]); and determining the skin tone of the subject from the received resultant signal comprises determining the skin tone of the subject from a first signal generated by the first detector responsive to receiving the resultant signal at the first detector and from a second signal generated by the second detector responsive to receiving the resultant signal at the second detector (520, 525, 530) (Fig 5) ([0036-0040]).
For claim 9, Dietiker discloses the optical vital signs monitor of claim 8, wherein determining the skin tone of the subject from the first and second signals comprises performing signal processing on the first and second signals to accurately determine signal levels of the first and second signals (520, 525, 530) (Fig 5) ([0036-0040]).
For claim 10, Dietiker discloses the optical vital signs monitor of claim 9, further comprising a lookup table (400) (Fig 4) stored in the non-transitory computer readable medium, wherein determining the skin tone of the subject further comprises comparing the signal levels to correlation data stored in the lookup table, the correlation data correlating signal levels to skin tone (520, 525, 530) (Fig 5) ([0040, 0060-0061]).
For claim 11, Dietiker discloses the optical vital signs monitor of claim 10, the operations further comprising: generating a physiological measurement of the subject based on the received resultant signal; and correcting the physiological measurement based on the determined skin tone (520, 525, 530) (Fig 5) ([0040, 0060-0061]).
For claim 12, Dietiker discloses the optical vital signs monitor of claim 11, wherein the physiological measurement comprises peripheral oxygen saturation (SpO2) of the subject (520, 525, 530) (Fig 5) ([0040, 0060-0061]).
For claim 13, Dietiker discloses a method, comprising inter alia: illuminating (510), via a light source (110) ([0026]) of an optical vital signs monitor (100), a body of a subject (145) (Figs 1, 5); receiving (515), via a spectral sensor (120) of the optical vital signs monitor, a resultant signal from the body of the subject (Figs 1, 5); and determining a skin tone of the subject from the received resultant signal (520, 525, 530) (Fig 5) ([0036-0040, 0060-0061]).
For claim 14, Dietiker discloses the method of claim 13, wherein receiving the resultant signal comprises receiving illumination radiation transmitted through the subject or reflected from the subject (Fig 5) ([0036]).
For claim 15, Dietiker discloses the method of claim 13, wherein illuminating the body of the subject comprises illuminating the body of the subject with light in a broad spectral range ([0026, 0064-0065]).
For claim 16, Dietiker discloses the method of claim 15, wherein the broad spectral range spans at least 100 nanometers in the visible spectrum ([0026, 0036, 0065]).
For claim 17, Dietiker discloses the method of claim 15, further comprising separately illuminating the body of the subject with red light and infrared light ([0026, 0036, 0065]).
For claim 18, Dietiker discloses the method of claim 13, wherein: the spectral sensor comprises two or more detectors ([0036]) with different spectral response properties ([0036-0040]); receiving the resultant signal from the body of the subject includes receiving the resultant signal at a first detector of the two or more detectors and at a second detector of the two or more detectors ([0036-0040]); and determining the skin tone of the subject from the received resultant signal comprises determining the skin tone of the subject from a first signal generated by the first detector responsive to receiving the resultant signal at the first detector and from a second signal generated by the second detector responsive to receiving the resultant signal at the second detector (520, 525, 530) (Fig 5) ([0040, 0060-0061]).
For claim 19, Dietiker discloses the method of claim 18, wherein determining the skin tone of the subject from the first and second signals comprises performing signal processing on the first and second signals to accurately determine signal levels of the first and second signals (520, 525, 530) (Fig 5) ([0040, 0060-0061]).
For claim 20, Dietiker discloses the method of claim 19, wherein determining the skin tone of the subject further comprises comparing the signal levels to correlation data stored in a lookup table (400) (Fig 4) on the optical vital signs monitor, the correlation data correlating signal levels to skin tone (520, 525, 530) (Fig 5) ([0040, 0060-0061]).
For claim 21, Dietiker discloses the method of claim 10, further comprising: generating a physiological measurement of the subject based on the received resultant signal; and correcting the physiological measurement based on the determined skin tone (520, 525, 530) (Fig 5) ([0040, 0060-0061]).
For claim 22, Dietiker discloses the method of claim 21, wherein the physiological measurement comprises peripheral oxygen saturation (SpO2) of the subject (520, 525, 530) (Fig 5) ([0040, 0060-0061]).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means and methods for evaluating pulse oximetry in view of skin tone.
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.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791