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 without traverse of Group I (claims 1-15) in the reply filed on 06/26/26 is acknowledged.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/14/24 has been acknowledged and considered. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is rejected because it recites an abstract idea as indicated in bold and underlined below:
a method for quantitatively determining at least one optical or physiological parameter in a medium using an optical sensor, the method comprising the following steps:
irradiating the medium with a primary radiation comprising at least two distinct measurement wavelengths which are emitted by at least one primary light source;
measuring primary intensities of the primary radiation for each of said at least two measurement wavelengths after said primary radiation has propagated through said medium along a respective primary optical path;
determining for each of the at least two measurement wavelengths and a wavelength specific correction factor, and
calculating an estimate of the at least one optical or physiological parameter based on said measured primary intensities and based on said at least two wavelength specific correction factors.
Step 1: Claim 1 is directed toward the abstract idea (bold and underlined above) falls in the category of mental processes.
Step 2a: While claim 1 is directed toward a statutory category of invention, the claim appears to be directed toward a judicial exception, namely the abstract idea of: irradiating the medium with a primary radiation comprising at least two distinct measurement wavelengths which are emitted by at least one primary light source; measuring primary intensities of the primary radiation for each of said at least two measurement wavelengths after said primary radiation has propagated through said medium along a respective primary optical path; determining for each of the at least two measurement wavelengths and a wavelength specific correction factor, and calculating an estimate of the at least one optical or physiological parameter based on said measured primary intensities and based on said at least two wavelength specific correction factors. For the above stated reasons, the bold and underlined parts of claim 1 shown above have been considered as mental processes. Such limitations are considered to set forth the abstract idea, because the claims are directed toward an idea in and of itself.
The claims only recite and describe gathering and combining data by reciting steps of organizing information through mathematical relationships and/or algorithms. The gathering and combining steps merely employ mathematical relationships to manipulate existing information to generate additional information in the form of "irradiating the medium with a primary radiation; measuring primary intensities of the primary radiation; determining for each of the at least two measurement wavelengths, and calculating an estimate of the at least one optical or physiological parameter ".
This idea is similar to the basic concept of manipulating information using mathematical relationships found to be an abstract idea by the courts (e.g. Benson, Flook, Diehr, Grams).
The courts have indicated that comparing new and stored information and using rules to identify options (SmartGene) and ideas in and of themselves (Bilski and Alice) are all examples of judicial exceptions, particularly abstract ideas.
The courts have indicated that, a mathematical procedure for converting one form of numerical representation to another was found to be a judicial exception, particularly abstract ideas (Benson) as were an algorithm for calculating parameters indicating an abnormal condition in Grams.
Thus, the claims are drawn to an abstract idea.
The above judicial exception is not integrated into a practical application for the following reasons:
Step 2b: Claims recites additional elements that includes: "electric unit", "optical sensor", “sensor head”, "LEDs", "photodiodes", and "printed circuit-board PCB" therefore the claims recite the abstract ideas. Viewing these limitations individually, the limitations are recited at a high level of generality and only perform generic functions of receiving, manipulating or calculating and transmitting information. Generic computers performing generic functions or components which are merely used as tools to perform the abstract idea (see MPEP § 2106.05(f)). Looking at the elements as combination does not add anything more than the elements analyzed individually. Therefore, the claims do not amount to significantly more than the abstract idea itself. The claims are not patent eligible.
There is no particular machine (discounting the generic computer components) applying the abstract idea (see MPEP § 2106.05(b)), and there is no real-world transformation in the claim (see MPEP § 2106.05(c)).
The remaining consideration is whether the claim constitutes an improvement to a particular technology (see MPEP § 2106.05(a)) or whether it just generally links the abstract idea to a particular technological environment or field-of-use (see MPEP § 2106.05(h)). The claim is generally in the field of a method for quantitatively determining at least one optical or physiological parameter. However, no evidence is provided to show that a particular technological process is being improved.
The claim doesn't recite any details of what calculation or determination results are being considered, how evaluation for comparing results, and how initiating results are obtained or an indication of them, or what is being done with the results at the end.
The underlying process that is supposed to be improved is not stated in this claim. It is not clear what the purpose of the claim is what is expected to be achieved.
For reasons stated above, it has been determined that claim 1 is directed to an abstract idea/ judicial exception with additional generic computer elements, and the genomically recited additional computer elements do not add a meaningful limitation to the abstract idea/judicial exception because they amount to simply implementing the abstract idea/judicial exception on a computer.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered separately and in combination, do not add significantly more (also known as an "Inventive concept") to the exception. The rationale detailed in the above paragraphs apply mutatis mutandis. Irradiating, measuring, determining, and calculating are all well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP § 2106.05(d).
Dependent claims 2-15 are dependent on their respective base claim 1, and include all the limitations of their respective base claims. Therefore, claims 2-15 recite the same abstract idea. The additional limitations recited in claims 2-15 are each functional generic/conventional processing steps performed by computer components comprise data gathering and processing steps which correspond to concepts identified as an abstract idea, or ideas, in the form of a mental process or mathematical formula are similar to those found to be non-patent eligible in, e.g., Alice Corp., FairWarning, and Parker V Flook. Claims 2-15 are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. Therefore, claims 2-15 are rejected under 101 U.S.C. 101 as being directed to non- statutory subject matter.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-3, 8, 12, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berneuter (US 2008/0015424).
Regarding claim 1; Berneuter discloses a method for quantitatively determining at least one optical or physiological parameter in a medium (46 @ figures 3 and 13) using an optical sensor (31S @ figure 3), the method comprising the following steps:
irradiating the medium (46 @ figures 3 and 13) with a primary radiation (31E @ figures 3 and 13) comprising at least two distinct measurement wavelengths (W0, W1, W2 @ figure 3 and paragraph [0056]: e.g., For each of the emitters 31E and 32E, three wavelengths are defined. Initially, two measurement wavelengths w0=940 nm and w2=660 nm are selected. Using equation (4) the third wavelengths w1 is about 788 nm) which are emitted by at least one primary light source (31E @ figures 3 and 13);
measuring primary intensities (paragraphs [0004] and [0056]-[0057]) of the primary radiation for each of said at least two measurement wavelengths (W0, W1, W2 @ figure 3 and paragraph [0056]) by detectors (31D, 32D @ figures 3 and 13) after said primary radiation (31E @ figures 3 and 13) has propagated through said medium (46 @ figure 3) along a respective primary optical path (A2, A3 @ figure 3 “first/primary light path A2, A3 is large than secondary light path A1, A4);
determining for each of the at least two measurement wavelengths (paragraphs [0056]-[0058] and Equations (20 and (5)-(7)) by a wavelength specific correction factor (Q in equation (2) and paragraph [0058]: e.g., Rw2,w1 and Rw1,w0 are calculated according to equation (1). As a resykt R' can be determined using equation (2) with Q as a correction factor which can be dependant on Rw2,w1 or Rw1,w0. The measured arterial oxygenation which is dependant on R' has minimized influence of scattering, blood content or other optical absorbing constituents in tissue), and
calculating an estimate of the at least one optical or physiological parameter (paragraph [0047] and [0074]-[0075]: e.g., a brain oximetry sensor was described which is able to determine arterial and mixed venous oxygenation of tissue. These two parameters can be used to calculate the oxygen extraction of tissue. A measure therefore can be the difference of arterial and mixed venous oxygenation) based on said measured primary intensities (paragraphs [0004] and [0056]-[0058]) and based on said at least two wavelength specific correction factors (paragraphs [0056]-[0058] and Equations (20 and (5)-(7): e.g., Rw2,w1 and Rw1,w0 “wavelengths” are calculated according to equation (1). As a resykt R' can be determined using equation (2) with Q as a correction factor which can be dependant on Rw2, w1 or Rw1, w0. The measured arterial oxygenation which is dependant on R' has minimized influence of scattering, blood content or other optical absorbing constituents in tissue). See figures 1-19
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Regarding claim 2; Bernreuter discloses irradiating the medium (46 @ figure 3) with a secondary radiation (32E @ figures 3 and 14) comprising at least two distinct auxiliary wavelengths (paragraph [0035]: e.g., A2 is light emitted in emitter 32E and detected in detector 31D. A3 is light emitted in 31E and received in 32D and A4 is light emitted in emitter 32E and detected in detector 32D) which are emitted by at least one auxiliary light source (32E @ figures 3 and 14); measuring secondary intensities (paragraphs [0004] and [0056]-[0057]) of the secondary radiation for each of said at least two auxiliary wavelengths (A1, A4 @ figure 3 and paragraph [0035]) after said secondary radiation (32E @ figures 3 and 14) has propagated through said medium (46 @ figure 3) along a respective secondary optical path (A2, A4 @ figure 3); and determining the wavelength specific correction factors (Q inequation (2) and paragraph [0058]: e.g., Rw2,w1 and Rw1,w0 are calculated according to equation (1). As a resykt R' can be determined using equation (2) with Q as a correction factor which can be dependant on Rw2,w1 or Rw1,w0. The measured arterial oxygenation which is dependant on R' has minimized influence of scattering, blood content or other optical absorbing constituents in tissue) based on said secondary intensities (paragraphs [0004] and [0056]-[0057]), which result from the auxiliary wavelengths (A2, A4 @ figure 3 and paragraph [0035]) emitted by the at least one auxiliary light source (32E @figure 3).
Regarding claim 3; Bernreuter discloses further comprises the following steps: detecting a secondary radiation (32E @ figure 3) comprising the at least two measurement wavelengths (W0, W1, W2 @ figure 3 and paragraph [0056]: e.g., For each of the emitters 31E and 32E, three wavelengths are defined. Initially, two measurement wavelengths w0=940 nm and w2=660 nm are selected. Using equation (4) the third wavelengths w1 is about 788 nm) with at least one auxiliary detector (31D, 32D @ figure 3), wherein the secondary radiation (32E @ figure 3) has traveled along a secondary optical path (A1, A4 @ figure 3) that is, at least partially, different from the primary optical path (A2, A3 @ figure 3) along which said primary radiation has traveled (figures 3 and 13-14); measuring secondary intensities (paragraphs [0056] and [0052]: e.g., LAwx corresponds to the logarithm of the ratio of light intensity Iwxo which is the emitted and light intensity Iwx the received light passing through tissue at wavelength wx) of the secondary radiation (32E @ figure 3) using the at least one auxiliary detector (31D, 321 @ figure 3) for each of said at least two measurement wavelengths (W0, W1, W2 @ figure 3 and paragraph [0056]) after said secondary radiation has propagated through said medium (46 @ figure 3) along the secondary optical path (A2, A4 @ figure 3); and determining the wavelength specific correction factors (paragraphs [0049], [0055], [0058] and equations (2)-(10)) based on said secondary intensities (paragraphs [0056] and [0052]) measured with the at least one auxiliary detector (31D, 32D @figure 3).
Regarding claim 8; Bernreuter discloses further comprising using the at least two wavelength specific correction factors (paragraphs [0049], [0058], and equations (1)-(2)) for correcting the calculated estimate with respect to an absorption or scattering spectrum (figures 3, 13-14 and paragraph [0056]: e.g., For each of the emitters 31E and 32E, three wavelengths are defined. Initially, two measurement wavelengths w0=940 nm and w2=660 nm are selected. Using equation (4) the third wavelengths w1 is about 788 nm. Wavelength w1=805 nm is chosen because it is close to the calculated third wavelength and is additionally at an isosbestic point of the blood absorption spectrum. The next step is to determine the resulting light attenuation LA for each of the three wavelengths w0, w1 and w3) inside the medium (46 @ figure 3) which is wavelength dependent.
It is noted that the term “OR” is alternative. Therefore, the limitation “further comprising using the at least two wavelength specific correction factors for correcting the calculated estimate with respect to at least one of: a wavelength dependent coupling factor, an absorption or scattering spectrum inside the medium which is wavelength dependent, or an optical obstruction which shows a wavelength dependent transmission or scattering spectrum” is considered to be “further comprising using the at least two wavelength specific correction factors for correcting the calculated estimate with respect to an absorption or scattering spectrum inside the medium which is wavelength dependent”
Regarding claim 12; Bernreuter discloses further comprising using at least one primary detector (31D @ figure 13B) for measuring said primary intensities (paragraphs [0004] and [0056]-[0057]) and wherein said at least one auxiliary light source (31E @ figure 13B) is located closer to said at least one primary detector (31D @ figure 13B) than to said at least one primary light source (32E @ figure 13B).
Regarding claim 15; Bernreuter discloses an optical sensor (240 @ figure 17) for measuring an optical or physiological parameter in a medium (46 @ figure 3) such as tissue, the sensor (240 @ figure 17) comprising:
at least one primary light source (31E @ figure 3 and 17) for emitting a primary radiation comprising at least two distinct measurement wavelengths (W0, W1, W2 @ figure 3 and paragraph [0056]: e.g., For each of the emitters 31E and 32E, three wavelengths are defined. Initially, two measurement wavelengths w0=940 nm and w2=660 nm are selected. Using equation (4) the third wavelengths w1 is about 788 nm),
at least one primary detector (31D @ figures 3 and 17) for detecting primary intensities (paragraphs [0004] , [0052], and [0056]-[0057]) of the primary radiation after said primary radiation has propagated through said medium (46 @ figure 3) along a respective primary optical path (A2, A3 @ figure 3), and
an electronic unit (228 @ figure 17) configured for computing an estimate of the at least one optical or physiological parameter (paragraph [0006]: e.g., a fetus has a physiological lower oxygenation than adult human beings and measurement error of SaO2 increases at low oxygenations) based on said measured primary intensities (paragraphs [0004], [0052], and [0056]-[0057]),
- at least one auxiliary light source (31D @ figures 3 and 17) for emitting a secondary radiation comprising at least two distinct auxiliary wavelengths (paragraph [0035]: e.g., A2 is light emitted in emitter 32E and detected in detector 31D. A3 is light emitted in 31E and received in 32D and A4 is light emitted in emitter 32E and detected in detector 32D) and/or at least one auxiliary detector (32D @ figures 3 and 17) capable of measuring secondary intensities (paragraphs [0004] and [0056]-[0057]) of a secondary radiation comprising the at least two distinct measurement wavelengths (A1, A4 @ figure 3 and paragraph [0035]) after said secondary radiation has propagated through said medium (46 @ figure 3) along a respective secondary optical path (A1, A4 @ figure 3) which is different from said primary optical path (A2, A3 @ figure 3), and the electronic unit (228 @ figure 17) is further configured to implement.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 5 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Berneuter (US 2008/0015424) in view of Benni (US 2011/0028812 submitted by IDS).
Regarding claim 5; Bernreuter discloses all of feature of claimed invention except for interpolating at least one of the wavelength specific correction factors mathematically, based on the measured secondary intensities. However, Benni teaches that it is known in the art to provide interpolating (figure 5 and paragraph [0044]: e.g., The graph also contains data 34 representing the differences between calculated oxyhemoglobin values (HbO2) values and empirically derived oxyhemoglobin values (the differences referred to in FIG. 5 as "Hb02-offset2 data"), and another best-fit curve “interpolating math” 36 applied to a portion of that data 34. In the example shown in FIG. 5, a statistically significant number of the data 30, 34 for each curve lies within the sloped portion 32a, 36a (i.e., the portion that does not have a constant calibration constant value). At each end of the sloped portion 32a, 36a, the curves 32, 36 are depicted as having constant calibration values 32b, 32c, 36b, 36c for convenience sake.) at least one of the wavelength specific correction factors (paragraphs [0043] and [0047]: e.g., the cerebral blood oxygen saturation level being calculated, the subject-specific calibration constants ZHb and ZHbO2 can be incorporated as corrective factors into the three wavelength algorithm (e.g., incorporated into Eqn. 13)) mathematically, based on the measured secondary intensities (paragraphs [0028]-[0032]). It would have been obvious to one having ordinary skill in the art before the effective filling date of claimed invention to combine method of Bernreuter with limitation above as taught by Benni for the purpose of improving the accuracy of the NIRS sensor for the age of the pediatric subject.
Regarding claim 13; Bernreuter discloses all of feature of claimed invention except for each time an updated value is determined for said estimate, performing a calibration measurement beforehand using the secondary radiation to determine updated values of the at least two correction factors. However, Benni teaches that it is known in the art to provide each time an updated value is determined for said estimate (figures 5 and 7), performing a calibration measurement (paragraphs [0041], [0043], [0047]: e.g., process for determining the subject-specific calibration constants can be performed one or more times in the initial period of sensing the subject to calibrate the sensor to that particular subject, preferably right after the sensor is attached to the subject. The subject-dependent calibration constants can then be used with an algorithm for measurement of a subject's blood oxygen saturation level using the same or different signal data) beforehand using the secondary radiation to determine updated values of the at least two correction factors (paragraphs [-0041], [0043] and [0047]: e.g., the cerebral blood oxygen saturation level being calculated, the subject-specific calibration constants ZHb and ZHbO2 can be incorporated as corrective factors into the three wavelength algorithm (e.g., incorporated into Eqn. 13). As a result, a more accurate determination of the subject's tissue oxygen saturation level is possible). It would have been obvious to one having ordinary skill in the art before the effective filling date of claimed invention to combine method of Bernreuter with limitation above as taught by Benni for the purpose of improving the accuracy of the NIRS sensor for the age of the pediatric subject.
Regarding claim 14; Bernreuter discloses all of feature of claimed invention except for the calibration measurement is performed using the secondary radiation to calculate updated values of the at least two correction factors as soon as a movement of the optical sensor, which is used for determining said estimate, is detected. However, Benni teaches that it is known in the art to provide the calibration measurement (paragraphs [0043] and [0047]: e.g., process for determining the subject-specific calibration constants can be performed one or more times in the initial period of sensing the subject to calibrate the sensor to that particular subject, preferably right after the sensor is attached to the subject. The subject-dependent calibration constants can then be used with an algorithm for measurement of a subject's blood oxygen saturation level using the same or different signal data) is performed using the secondary radiation (Lx, Lb @ figure 2) to calculate updated values of the at least two correction factors (paragraphs [0043 and [0047]: e.g., the cerebral blood oxygen saturation level being calculated, the subject-specific calibration constants ZHb and ZHbO2 can be incorporated as corrective factors into the three wavelength algorithm (e.g., incorporated into Eqn. 13). As a result, a more accurate determination of the subject's tissue oxygen saturation level is possible) as soon as a movement of the optical sensor (10 @ figure 2), which is used for determining said estimate (figures 5-6), is detected. It would have been obvious to one having ordinary skill in the art before the effective filling date of claimed invention to combine method of Bernreuter with limitation above as taught by Benni for the purpose of improving the accuracy of the NIRS sensor for the age of the pediatric subject.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Berneuter (US 2008/0015424) in view of Stefan et al (WO 2020239922 A1 hereinafter “Stefan”).
Regarding claim 9; Bernreuter discloses all of feature of claimed invention except for each of the at least two measurement wavelengths, measuring at least two different primary intensities using two different source-detector-separations, respectively. However, Stefan teaches that it is known in the art to provide each of the at least two measurement wavelengths (page 23 in lines 5-10:e.g., the source set of the apparatus may emit not only two substantially equal wavelengths but at least two, preferably four, most preferably eight different measurement wavelengths), measuring at least two different primary intensities (page 2 lines 4-17 and page 32 lines 1-12: e.g., variations in the light intensities emitted by the sources SI and S2 or variations in the sensitivity of the detectors D2 and D3) using two different source-detector-separations (figures 4 and 6 and page 1 lines 2-19: e.g., at least two light sources and said at least two detectors are arranged on a measurement surface such that a first optical measurement set (0MS1) is formed, featuring two first source-detector- separations (SDS1a, SDS1b) substantially equal in size along with two second source-detector-separations (SDS2a, SDS2b) substantially equal in size and each larger than each of said first source-detector-separations (SDS2a or SDS2b > SDS1a or SDS1b)), respectively. It would have been obvious to one having ordinary skill in the art before the effective filling date of claimed invention to combine method of Bernreuter with limitation above as taught by Stefan for the purpose of improving the accuracy and precision of measurements of optical or physiological parameters in a scattering medium such as human tissue.
Regarding claim 10; Bernreuter discloses all of feature of claimed invention except for using the same two different source-detector-separations are used for measuring said at least two different primary intensities for each of the at least two measurement wavelengths, using at least two of the primary light sources located at a common emission location and two primary detectors located at two distinct source-detector-separations from said common emission location. However, Stefan teaches that it is known in the art to provide using the same two different source-detector-separations (figures 4 and 6 and page 1 lines 2-19: e.g., at least two light sources and said at least two detectors are arranged on a measurement surface such that a first optical measurement set (0MS1) is formed, featuring two first source-detector- separations (SDS1a, SDS1b) substantially equal in size along with two second source-detector-separations (SDS2a, SDS2b) substantially equal in size and each larger than each of said first source-detector-separations (SDS2a or SDS2b > SDS1a or SDS1b)) are used for measuring said at least two different primary intensities (page 2 lines 4-17 and page 32 lines 1-12: e.g., variations in the light intensities emitted by the sources SI and S2 or variations in the sensitivity of the detectors D2 and D3) for each of the at least two measurement wavelengths (page 23 in lines 5-10:e.g., the source set of the apparatus may emit not only two substantially equal wavelengths but at least two, preferably four, most preferably eight different measurement wavelengths), using at least two of the primary light sources (7 @ figure 4) located at a common emission location (25 @ figure 4) and two primary detectors (8 @ figure 4) located at two distinct source-detector- separations (figures 4, 6, and page 1 lines 2-19) from said common emission location (25 @ figure 4). It would have been obvious to one having ordinary skill in the art before the effective filling date of claimed invention to combine method of Bernreuter with limitation above as taught by Stefan for the purpose of improving the accuracy and precision of measurements of optical or physiological parameters in a scattering medium such as human tissue.
Regarding claim 11; Bernreuter discloses all of feature of claimed invention except for one of the at least one auxiliary light sources is located equidistant from two primary detectors. However, Stefan teaches that it is known in the art to provide one of the at least one auxiliary light sources (21 @ figure 4 and claim 5: e.g., a source sub-set (21) consisting of at least two light sources (7) spaced from each other) is located equidistant from two primary detectors (8 @ figure 4). It would have been obvious to one having ordinary skill in the art before the effective filling date of claimed invention to combine method of Bernreuter with limitation above as taught by Stefan for the purpose of improving the accuracy and precision of measurements of optical or physiological parameters in a scattering medium such as human tissue.
Allowable Subject Matter
Claims 4 and 6-7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art of record, taken alone or in combination, fails discloses or render obvious a method for quantitatively determining at least one optical or physiological parameter in a medium comprising all the specific elements with the specific combination including at least one of the at least two distinct auxiliary wavelengths is identical to (λa1= λm1 and/or λa2 = λm2) or distinct from (λa1 ǂ λm1 and/or λa2 ǂ λm2), a respective one of the at least two measurement wavelengths (λm1, λm2), and each of said at least two auxiliary wavelengths (λa1, λa2) varies by less than 30% from a corresponding one of the at least two measurement wavelengths (λm1, λm2) in set forth of claim 4.
The prior art of record, taken alone or in combination, fails discloses or render obvious a method for quantitatively determining at least one optical or physiological parameter in a medium comprising all the specific elements with the specific combination including based on the at least two different secondary intensities, each measured for one of said two distinct auxiliary wavelengths (λa1, λa2), respectively, adapting a model C(λ) describing a wavelength dependence of at least one of the correction factors c(λ) which affects said measured primary intensities (Im1,Im2) is adapted and using the adapted model c(λ) to determine a secondary estimate, and said at least two wavelength specific correction factors (C1(λm1), C2(λm2)) are calculated from said adapted model C(λ) for each of said at least two measurement wavelengths (λm1, λm2) in set forth of claim 6.
The prior art of record, taken alone or in combination, fails discloses or render obvious a method for quantitatively determining at least one optical or physiological parameter in a medium comprising all the specific elements with the specific combination including the at least two wavelength specific correction factors (C1, C2) define a respective wavelength specific correction C1(λm1), C2(λm2) that is to be applied to the primary intensities (Im1, Im2) measured for each of said at least two measurement wavelengths (λm1), the respective correction factor is a ratio of two secondary intensities (IS1,SDS1(λa1)/Is1,SDS2(λa1)) which have been measured using the same auxiliary wavelength (λa1) in set forth of claim 7.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
1) Bechtel et al (US 2021/0045695) discloses an oximeter probe that takes into account tissue color (e.g., skin color or melanin content) to improve accuracy when determining oxygen saturation of tissue.
2) Cheng (US 2015/0351675) discloses a device for non-invasively measuring at least one parameter of a cardiac blood vessel in a patient comprises at least one light source that directs light at a tissue site on the patient.
3) Roberts (US 2007/0060811) discloses the method includes determining tissue overgrowth correction factor that includes optical properties of the tissue that cause scattering of the emitted light to a detector and relative amplitudes of the emitted light wavelengths.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANG H NGUYEN whose telephone number is (571)272-2425. The examiner can normally be reached M-F.
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/SN/
August 03, 2026
/SANG H NGUYEN/ Primary Examiner, Art Unit 2877
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