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 .
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.
Claim Rejections - 35 USC § 103
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.
Claims 1-3, 5, 7-8, 12-14, 16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Keller et. al.'275 (U.S. Patent Publication 20040249275 - cited by applicant) in view of Newberry et. al.'317 (U.S. Patent Publication 20200237317 – previously cited), and further in view of Sutin et. al.'831 (U.S. Patent Publication 20180070831 – previously cited).
Regarding Claim 1, Keller et. al.'275 discloses a method for determining absolute concentration values of components and at least one of a blood flow or a blood volume in tissue of an organ (Paragraph [0024] - The indicator concentration with reference to the cerebral tissue depends on the indicator concentration in the blood that flows through the tissue, as well as on the amount of the blood that flows through the tissue), the method comprising:
emitting radiation having at least one wavelength in a near-infrared spectrum into the tissue of the organ and generating, by near-infrared spectroscopy, measurement signals responsive to detected intensities of radiation emerging from the tissue of the organ (Paragraph [0023] - A radiation source (not shown) for emitting near infrared radiation into the cerebral tissue of the patient…The wavelength of the emitted radiation and the indicator used must be coordinated with one another…The intensity of the proportion of the infrared radiation that exits from the cerebral tissue at the location of second optode 3 is detected by second optode 3 and passed to the evaluation unit 4);
converting, using an evaluation algorithm executed on an evaluation unit, a temporal change of the detected intensities of the radiation emerging from the tissue of the organ into absolute concentration values of components (Paragraph [0023] - The intensity of the proportion of the infrared radiation that exits from the cerebral tissue at the location of second optode 3 is detected by second optode 3 and passed to the evaluation unit 4; Paragraph [0026] - Evaluation unit 4 is set up, in terms of program technology; Paragraph [0028] - The (time-dependent) optical density, which is essentially proportional to the indicator concentration in the tissue);
introducing an indicator comprising a dye having an absorption maximum in the near-infrared spectrum and determining a time course of concentration values of the indicator in the tissue of the organ (Paragraph [0023] - the near infrared radiation is passed by means of a light guide to first optode 2, where the radiation is emitted. The wavelength of the emitted radiation and the indicator used must be coordinated with one another; Paragraph [0028] - The (time-dependent) optical density, which is essentially proportional to the indicator concentration in the tissue, is divided up into its pulsatile component and its non-pulsatile component; Paragraph [0031] - the outflow function o(t) describes the proportion of the change in the concentration of the indicator in the cerebral tissue that comes from the amount of outflowing blood. The time immediately after the injection of indicator is t=0);
deriving a mean transit time (mtt) from the time course of concentration values of the indicator and using at least one transport function g(t) that characterizes blood flow in the tissue of the organ (Paragraph [0029] - The mean transit time mtt is sometimes also referred to as the "pass-through" time, and is a characteristic dwell time that corresponds to the time that a volume element needs, on the average, in order to pass through the system being considered; Paragraph [0032] - the transport function g(t) is calculated with the mtt iteration step (let m be the counting variable)); and
calculating at least one of blood flow or blood volume from at least one of the time course of concentration values of the indicator or from parameters derived therefrom (Paragraph [0023] - The device according to the invention shown schematically in FIG. 1 serves to determine the cerebral blood flow of a patient, for example an intensive-care patient in neurosurgery; Paragraph [0049] - The cerebral blood volume CBV is calculated as the quotient of an indicator concentration in the blood, C.sub.blood),
wherein the evaluation algorithm (Paragraph [0032] - In a computing step, the value of the inflow function for the time t is calculated according to the balance equation) is programmed to:
accept the measurement signals that transmitted to the evaluation unit, the measurement signals based on an emitted and detected portion of the emitted radiation with at least one wavelength in the near-infrared spectrum (Paragraph [0011] - using an injected indicator which includes a radiation source for emitting near infrared radiation into tissue of the organ at a first location, a sensor for detecting a proportion of the emitted near infrared radiation that exits from the organ at a second location, and an evaluation unit that detects the proportion of emitted near infrared radiation that exits from the tissue of the organ as an input signal);
determine absolute concentration values of components in the tissue of the organ of at least hemoglobin, deoxyhemoglobin, background, or water (Paragraph [0048] - In this equation, .alpha.ICG is the absorption coefficient of the indicator, .alpha..sub.Hb is the absorption coefficient of the hemoglobin, and C.sub.Hb is the hemoglobin concentration in the blood);
determine the time course of concentration values of the indicator in the tissue of the organ from the measurement signals (Paragraph [0025] - The indicator concentration in the blood that flows through the tissue changes over time, because the blood that flows out of the cerebral tissue has a different concentration from the blood that is flowing in; Paragraph [0028] - The (time-dependent) optical density, which is essentially proportional to the indicator concentration in the tissue);
iteratively determine an inflow function i(t) and an outflow function o(t) indicative of blood flow in the tissue of the organ using the at least one of transport function g(t) with a determinable mean transit time (mtt) until a termination criterion is reached (Paragraph [0032] Each iteration step includes a step-by-step calculation of an approximation of the inflow function i(t) and an approximation of the outflow function o(t), as well as the calculation of an approximation of the transport function g(t), so that the mtt approximation of the inflow function i(t), the outflow function o(t), and the transport function g(t) is calculated with the mtt iteration step (let m be the counting variable));
fit the iteratively determined inflow function i(t) and the iteratively determined outflow function o(t) using a lognormal function or another function representing tissue transit system (Paragraph [0027] - The optical density OD is formed from the intensity signal as a negative decadic logarithm of the transmission; Paragraph [0035] - In the next step, the convolution integral o(t)=i(t)*g(t) with the transport function g(t) is used for calculating the value of the outflow function at the time t; see g(t) Equation below);
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g(t) Equation
calculate the blood volume in the tissue of the organ using the time course of the concentration of the indicator in the tissue as determined in step c) or one of the functions determined in step e) (Paragraph [0047] - The indicator concentration in the blood, C.sub.blood, required for calculating the cerebral blood volume CBV is calculated according to the following formula, wherein A.sub.OD(t>0) corresponds to the value of the amplitude of the optical density for t approaching 0 that was obtained from the function extrapolated back (which is less dependent on the sharpness of the first signal peak after administration of the indicator, as compared with a value determined by direct measurement)); and
calculate the blood flow in the tissue of the organ as a quotient of the blood volume calculated in step f) and the mean transit time (mtt) determined in step d) (Paragraph [0050] - The cerebral blood flow CBF is determined as a quotient of the cerebral blood volume CBV and the mean transit time mtt).
Keller et. al.'275 discloses a program technology but fails to disclose a system matrix. Newberry et. al.'317 teaches a neural network used to store and adjust equations/functions (Paragraph [0186] - Sometimes the various machine learning techniques are intimately associated with a particular learning rule. The function ƒ may be a definition of a class of functions (where members of the class are obtained by varying parameters, connection weights, thresholds, etc.). The neural network learns by adjusting its parameters, weights and thresholds iteratively to yield desired output). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Keller et. al.’275 to include program technology containing a neural network capable storing and adjusting functions in order to adjust parameters and yield desired outputs as seen in Newberry et. al.’317.
Keller et. al.'275 further fails to disclose wherein in step f) the blood volume in the tissue of the organ is determined from an area under the inflow function i(t) and the outflow function o(t). Sutin et. al.’831 teaches determining phase differences between integral values of blood inflow and blood outflow corresponding to blood volume (Paragraph [0053] - In some aspects, the controller 110 may be programmed to determine a phase difference between various computed quantities, including an index of blood flow, a blood volume, a blood inflow, a blood outflow, a derivative of blood volume, an integral of blood volume, a derivative of the index of blood flow, an integral of the index of blood flow, or combinations thereof; Paragraph [0054] - The controller 110 may be further configured to determine a condition of the subject based on determined quantities, such as absolute blood flow, and others; Paragraph [0059] - Absolute cerebral blood flow, referred to hereafter as CBF, and CBV are related to blood inflow and blood outflow of a vascular network or vascular cerebral region through complementary ways). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Keller et. al.’275 in view of Newberry et. al.’317 to include determining blood volume based on calculated areas of inflow and outflow within a tissue of an organ in order to account for and analyze how cerebral blood volume is related to inflow and outflow as seen in Sutin et. al.’831.
Regarding Claim 12, the sections of Keller et. al.'275 in view of Newberry et. al.’317 and further in view of Sutin et. al.’831 cited above for Claim 1 disclose an apparatus comprising the elements set forth in the claim.
Regarding Claim 2, Keller et. al.'275 in view of Newberry et. al.’317 and further in view of Sutin et. al.’831 discloses the method outlined in Claim 1 above but fails to disclose the system matrix is calibratable using known concentration values of components in the tissue of the organ, measurable concentration values of components in reference tissue or definable boundary conditions for limiting concentration values of components in the tissue of the organ. Newberry et. al.'317 teaches a calibratable neural network (Paragraph [0159] - To determine a concentration level of the substance, a calibration table or database is used that associates the obtained R value to a concentration level of the substance at 720. The calibration database correlates the R value with a concentration level. The calibration database may be generated for a specific user or may be generated from clinical data of a large sample population. For example, it is determined that the R values should correlate to similar NO concentration levels across a large sample population. Thus, the calibration database may be generated from testing of a large sample of a general population to associate R values and NO concentration levels). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Keller et. al.'275 in view of Newberry et. al.’317 and further in view of Sutin et. al.’831 to include program technology containing a calibratable neural network capable storing and adjusting functions in order to provide correlated and desirable values to specific users as seen in Newberry et. al.’317. It is to be noted that the method does not positively recite calibrating a system matrix based on the limitations recited in the claims. A neural network contains a system matrix and system matrices are capable of being calibrated using the recited limitations.
Regarding Claim 13, the sections of Keller et. al.'275 in view of Newberry et. al.’317 and further in view of Sutin et. al.’831 cited above for Claim 2 disclose an apparatus comprising the elements set forth in the claim.
Regarding Claim 3, Keller et. al.'275 in view of Newberry et. al.’317 and further in view of Sutin et. al.’831 discloses the method outlined in Claim 1 above. Keller et. al.'275 further discloses the measurement signals correspond to absolute concentration values of one or more of hemoglobin, deoxyhemoglobin, water, background, or the indicator, and enable determination of the blood volume or the blood flow in the tissue of the organ (Paragraph [0031] - The inflow function i(t) describes the proportion of the change in the concentration of the indicator in the cerebral tissue that comes from the amount of inflowing blood; the outflow function o(t) describes the proportion of the change in the concentration of the indicator in the cerebral tissue that comes from the amount of outflowing blood). It is to be noted that the method does not positively recite determining a blood volume or blood flow in the tissue of the organ based on the limitations recited in the claims. Measurement signals of the recited limitations are capable of determining blood volume or blood flow using the recited limitations.
Regarding Claim 14, the sections of Keller et. al.'275 in view of Newberry et. al.’317 and further in view of Sutin et. al.’831 cited above for Claim 3 disclose an apparatus comprising the elements set forth in the claim.
Regarding Claim 5, Keller et. al.'275 in view of Newberry et. al.’317 and further in view of Sutin et. al.’831 discloses the method outlined in Claim 1 above. Keller et. al.'275 further discloses wherein in step f) the blood volume in the tissue is further determinable using an exponential regression analysis of the time course of concentration values of the indicator (Paragraph [0041] - For this purpose, the non-pulsatile component of the time progression of the optical density OD is simulated in an interval t.sub.1>0 to t.sub.2, by regression by means of an exponential function). It is to be noted that the method does not positively recite determining a blood volume based on the limitations recited in the claims. A blood volume in the tissue of an organ is capable of being determined using the recited limitations.
Regarding Claim 16, the sections of Keller et. al.'275 in view of Newberry et. al.’317 and further in view of Sutin et. al.’831 cited above for Claim 5 disclose an apparatus comprising the elements set forth in the claim.
Regarding Claim 7, Keller et. al.'275 in view of Newberry et. al.’317 and further in view of Sutin et. al.’831 discloses the method outlined in Claim 1 above. Keller et. al.'275 further discloses wherein iterative determination of the inflow function i(t) comprises several steps, wherein in each step an approximation to the inflow function i(t) is calculated according to the formula (Paragraph [0031] - The inflow function i(t) describes the proportion of the change in the concentration of the indicator in the cerebral tissue that comes from the amount of inflowing blood; Paragraph [0032] - In a computing step, the value of the inflow function for the time t is calculated according to the balance equation: i(t)=d/dt (C.sub.tissue(t))+o(t-t.sub.k); see i(t) Equation below);
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where d/dt(cICG(t)) is a determinable temporal change in concentration values of the indicator in the tissue of the organ, and o(t) is an outflow function determinable from deconvolution of a convolution integral of the inflow function i(t) and the at least one transport function g(t) (Paragraph [0033] - In this equation, t.sub.k is a constant small time interval, so that the value of the outflow function at the time t-t.sub.k is to be inserted for o(t-t.sub.k). The term d/dt (C.sub.tissue(t)) expresses the change in the indicator concentration with reference to the cerebral tissue; Paragraph [0035] - In the next step, the convolution integral o(t)=i(t)*g(t) with the transport function g(t) is used for calculating the value of the outflow function at the time t).
It is to be noted that the method does not positively recite determining d/dt(cICG(t)) as a temporal change in concentration of the indicator in the tissue of the organ or determining o(t) from deconvolution of a convolution integral of the inflow function i(t) and the at least one transport function. The recited functions d/dt(cICG(t)) and o(t) are capable of being determined using the recited limitations.
Regarding Claim 18, the sections Keller et. al.'275 in view of Newberry et. al.’317 and further in view of Sutin et. al.’831 cited above for Claim 7 disclose an apparatus comprising the elements set forth in the claim.
Regarding Claim 8, Keller et. al.'275 in view of Newberry et. al.’317 and further in view of Sutin et. al.’831 discloses the method outlined in Claim 4 above. Keller et. al.'275 further discloses wherein a termination criterion reached when determining the mean transit time (mtt) is defined by a plausibility criterion for the inflow function i(t) and the outflow function o(t) (Paragraph [0029] - The mean transit time mtt is sometimes also referred to as the "pass-through" time, and is a characteristic dwell time that corresponds to the time that a volume element needs, on the average, in order to pass through the system being considered; Paragraph [0032] - Each iteration step includes a step-by-step calculation of an approximation of the inflow function i(t) and an approximation of the outflow function o(t), as well as the calculation of an approximation of the transport function g(t), so that the mtt approximation of the inflow function i(t), the outflow function o(t), and the transport function g(t) is calculated with the mtt iteration step (let m be the counting variable); Paragraph [0038] - If, on the other hand, the end value has exceeded t.sub.2, a check is performed in the next step to see whether the function progressions of the inflow function i(t) and the outflow function o(t) are plausible. A plausibility criterion (i.e. a stop criterion of the iteration) may be that neither the inflow function i(t) nor the outflow function o(t) have values below a threshold value).
Regarding Claim 19, the sections of Keller et. al.'275 in view of Newberry et. al.’317 and further in view of Sutin et. al.’831 cited above for Claim 8 disclose an apparatus comprising the elements set forth in the claim.
Claims 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Keller et. al.'275 (U.S. Patent Publication 20040249275 - cited by applicant) in view of Newberry et. al.'317 (U.S. Patent Publication 20200237317 – previously cited), further in view of Sutin et. al.'831 (U.S. Patent Publication 20180070831 – previously cited), as applied to Claim 8 above, and further in view of Goyal et. al.'652 (U.S. Patent Publication 20190274652 – previously cited).
Regarding Claim 9, Keller et. al.'275 in view of Newberry et. al.’317 and further in view of Sutin et. al.’831 discloses the method outlined in Claim 8 above. Keller et. al.’275 further discloses a plausibility criterion containing a mean transit time (mtt) corresponding to the time that a volume of indicator takes to pass through the system (Paragraph [0029] - The mean transit time mtt is sometimes also referred to as the "pass-through" time, and is a characteristic dwell time that corresponds to the time that a volume element needs, on the average, in order to pass through the system being considered) but fails to disclose plausibility criterion is definable as a distance between a centroid of the inflow function i(t) and a centroid of the outflow function o(t) and corresponds to a determinable mean transit time (mtt). Goyal et. al.'652 teaches configuring a dwell time based on arterial peak - inflow centroid - and venous peak – outflow centroid (Paragraph [0059] - When a second (P2) and third (P3) set of CT images are obtained, ideally they are timed to generally correspond to particular phases of contrast moving through the brain. Generally, the first set (P1) of images is timed to coincide with peak dye flow through the arterial side of the brain (i.e. the normal side), the second set timed to coincide with peak dye flow to the venous side of the brain (i.e. the normal side) and peak flow through affected tissue and the third set to coincide with clearance of dye through the normal side but towards the tail end of dye moving through affected tissue). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Keller et. al.'275 in view of Newberry et. al.’317 and further in view of Sutin et. al.’831 to include a plausibility criterion accounting for time between an inflow and outflow peak in order to understand how an indicator moves in the brain as seen in Goyal et. al.’652.
It is to be noted that the method does not positively recite defining a plausibility criterion based on the recited limitations. The plausibility criterion is capable of being defined using the recited limitations.
Regarding Claim 20, the sections of Keller et. al.'275, in view of Newberry et. al.’317, further in view of Sutin et. al.’831, and further in view of Goyal et. al.’652 cited above for Claim 9 disclose an apparatus comprising the elements set forth in the claim.
Claims 10-11 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Keller et. al.'275 (U.S. Patent Publication 20040249275 - cited by applicant) in view of Newberry et. al.'317 (U.S. Patent Publication 20200237317 – previously cited), further in view of Sutin et. al.'831 (U.S. Patent Publication 20180070831 – previously cited), as applied to Claim 8 above, further in view of Keller et. al.'276 (EP Patent Application 1464276 – previously cited), and further in view of Fantini et. al.'2016 (Cerebral blood flow and autoregulation: current measurement techniques and prospects for noninvasive optical methods – previously cited).
Regarding Claim 10, Keller et. al.'275 in view of Newberry et. al.’317 and further in view of Sutin et. al.’831 discloses the method outlined in Claim 8 above but fails to disclose wherein the plausibility criterion is definable as a ratio of an area under the inflow function i(t) and an area under the outflow function o(t). Keller et. al.’276 – same device as Keller et. al.’275 – teaches a plausibility criterion corresponding to values obtained from inflow and outflow functions (Page 4 Paragraph 6 - t has exceeded the end value t .sub.2 , the next step is to check whether the function curves obtained for the inflow function i(t) and the outflow function o(t) are plausible. The plausibility criterion (i.e. termination criterion of the iteration) can be that neither the inflow function i(t) nor the outflow function o(t) have values less than a threshold value. This threshold value should suitably be chosen to be greater than or equal to 0). Fantini et. al.'2016 teaches using arterial - inflow - and venous – outflow - functions to obtain a concentrative equilibrium corresponding to area under a curve (Page 9 Figure 3 description - Three basic approaches to the measurement of cerebral blood flow. (a) The Fick principle, (b) the central volume principle, and (c) the Doppler effect or autocorrelation methods. (a) A global CBF measurement is based on recording time traces of the arterial and venous blood concentrations ([𝑥]𝑎 and [𝑥]𝑣, respectively) of a diffusible and physiologically inert intravascular tracer 𝑥 over a time Δ𝑡 that is sufficiently long to achieve equilibrium - ratio- in the blood–brain tracer diffusion; see Figure 3(a) below). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Keller et. al.'275 in view of Newberry et. al.’317 and further in view of Sutin et. al.’831 to include obtaining a plausibility criterion based on the inflow and outflow functions as seen in Keller et. al.’276 in order to obtain a concentrative equilibrium state – ratio - indicative of an inverse flow time related to cerebral blood flow in order to better understand cerebral blood flow as seen in Fantini et. al.’2016 (Page 10 Section 3.2.1 - at which time a steady state was reached, such that [N2O]𝑎=[N2O]𝑣. This steady state carries no information about CBF, but the time required to reach it is inversely related to CBF).
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Figure 3(a)
It is to be noted that the method does not positively recite defining a plausibility criterion based on the recited limitations. The plausibility criterion is capable of being defined using the recited limitations.
Regarding Claim 21, the sections of Keller et. al.'275, in view of Newberry et. al.’317, further in view of Sutin et. al.’831, further in view of Keller et. al.’276, and further in view of Fantini et. al.’2016 cited above for Claim 10 disclose an apparatus comprising the elements set forth in the claim.
Regarding Claim 11, Keller et. al.'275, in view of Newberry et. al.’317, further in view of Sutin et. al.’831, further in view of Keller et. al.’276, and further in view of Fantini et. al.’2016 discloses the method outlined in Claim 10 above. Keller et. al.’275 fails to disclose wherein the ratio is 1:1. Fantini et. al.'2016 teaches an equal concentrated area under a function – 1:1 ratio (Page 10 Section 3.2.1 - The dynamic measurements were performed over a time interval Δ𝑡=10 min following the beginning of N2O inhalation, at which time a steady state was reached, such that [N2O]𝑎=[N2O]𝑣. This steady state carries no information about CBF, but the time required to reach it is inversely related to CBF). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Keller et. al.'275, in view of Newberry et. al.’317, further in view of Sutin et. al.’831, further in view of Keller et. al.’276, and further in view of Fantini et. al.’2016 to include a plausibility criterion that represents a 1:1 ratio of inflow and outflow concentrations in order to understand cerebral blood flow corresponding to the steady state of indicator concentrations in a subjects tissue of an organ as seen in Fantini et. al.’2106.
Response to Arguments
Applicant's arguments filed 02 July 2026 have been fully considered and they are not entirely persuasive.
Applicant’s amendments have overcome the prior 35 U.S.C. 112b rejections.
Application’s amendments have overcome the prior 35 U.S.C. 101 rejections. The examiner makes note that the steps of determining absolute concentrations, determining the time course of the concentration values, iteratively determining an inflow function and outflow function, fitting the iteratively determined inflow function and outflow function, calculating the blood volume, and calculating the blood flow are all mathematical concepts being performed by an "evaluation algorithm" which is part of an "evaluation unit". An "evaluation unit" is written in the instant application’s specification as "one or more processors, which programmatically execute the evaluation algorithm". This means that the “evaluation unit” is solving the mathematical concepts by using a processor which is a generic computing device that would not overcome 101. However, all of these elements considered together are incorporated into a practical application and/or provides technological improvement, and would overcome the 101 as provided evidence by the applicant.
Claims 1-3, 5, 7-14, 16 and 18-21 are rejected under 35 U.S.C. 103 as necessitated by amendments, as discussed in Paragraphs 3-5 above.
Applicant argues that only claims 1-5, 7-8, 12-16, and 18-19 were rejected in the previous Office action with citation to allegedly pertinent prior art documents. The Examiner respectfully disagrees. Claims 6 and 17 were rejected in Paragraph 6 of the previous Office Action, Claims 9 and 20 were rejected in Paragraph 7 of the previous Office Action, and Claims 10, 11, and 21 were rejected in Paragraph 8 of the previous Office Action. As Applicant has failed to point out the errors of the previous rejections of Claims 6 and 17, Applicant's argument that the incorporation of Claims 6 and 17 into Claims 1 and 12, respectively, renders the claims patentable over the cited prior art documents is not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nakaji et. al.'251 (EP Patent Application 3094251) discloses measuring NIRS to determine blood-related concentration. Hobbs et. al.'823 (U.S. Patent 11284823) discloses determining blood concentration based on dye elimination. Islam'312 (U.S. Patent Publication 2020033312) discloses measuring NIR to determine blood-related concentration. Elliott et. al.'436 (U.S. Patent Publication 20150066436) discloses using optical measurement methods and mean transit time to determine blood-related parameters. Andrijauskas'232 (U.S. Patent Publication 20140058232) discloses using discloses measuring wavelength to determine blood-related concentration. Huiku’942 (U.S. Patent Publication 20100081942) teaches using a system matrix to filter data.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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