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 .
Response to Amendment
The amendment filed 11/17/2025 has been entered. Claims 1 - 12, 57, 59,61, 65, 66, 71 - 83, and 135 are pending and claims 13 - 56, 58, 60, 62 - 64, 67 - 70, and 84 - 134 are cancelled. Applicant’s amendments to the claims have overcome each and every objection in the claims. The objection to claim 1 is withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 135 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In regard to claim 135, which provides further details about “the probe” introduced in claim 57. However, as written claim 57 positively claims “a generator” and “a computing circuit”, but does not positively claim “a probe”, but rather that the system is intended to be used with or able to interface with a probe that is configured to direct electromagnetic energy into the body and collect the redirect electromagnetic energy. Thus, the limitations of claim 135 directed to “the probe” are not further limiting because the limitations are not directed towards a positively claimed element of the apparatus of claim 57.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(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 57, 59, 73, 74, & 78 – 83 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kadavy (US 20150217056 A1 – Previously cited).
In regard to claim 57, Kadavy discloses an apparatus, comprising:
generator that includes light-emitting diodes each configured to generate electromagnetic energy across approximately a same spectrum and to provide wavelengths of electromagnetic energy in an approximate range of 400nm - 900nm to a probe configurable: to direct the electromagnetic energy into a body having at least one muscle cell, and to collect a portion of the electromagnetic energy redirected by the body over a time during which the generator provides the electromagnetic energy; Kadavy specifically discloses a generator (FIG. 100) that includes a LED source (FIG. 2, components 114 & 116), a power source that powers the LEDs (FIG. 2, component 126), and a controller (FIG. 2, component 122) that controls the operation of the LEDs (paragraph [0028]). The plurality of LEDs is made up of two light sources, one of which emits visible light in the range of 540 – 620 nm and the other which emits NIR light in the range of 740 – 790 nm (paragraph [0043]). The light sources are used to illuminate a desired region of tissue of the patient (paragraph [0026]). A light detector (FIG. 2, component 118) is used to receive the light reflected from the desired region of tissue which is then transmitted to the spectrometer (FIG. 2, component 120) where the light is processed and analyzed (paragraph [0027]). Examiner notes that as written, while claim 57 positively claims “a generator” and “a computing circuit”, claim 57 does not positively claim “a probe”, but rather that the system is intended to be used with or able to interface with a probe that is configured to direct electromagnetic energy into the body and collect the redirect electromagnetic energy. Regardless, Kadavy additionally discloses that the apparatus includes a probe (FIG. 4, component 206) for use with the system of FIG. 2 that includes a visible light source comprising a plurality of LEDs that emit light in the same spectrum of visible wavelengths of 540 – 620 nm (paragraph [0043]).
and a computing circuit configured to determine, in response to the portion of redirected electromagnetic energy, a level of myoglobin-oxygen saturation of one or more of the at least one muscle cell. Kadavy specifically discloses that the tissue oxygenation detection system includes a controller made up of one or more computing devices, such as processors, application-specific integrated circuits, microprocessors, and the like, for processing the detected spectra and determining muscle oxygenation (paragraphs [0028] & [0032]). Kadavy additionally discloses that a computer system can be used to perform analyses to calculate myoglobin saturation where collected absorbance spectrum for oxymyoglobin and deoxymyoglobin are determined using multivariate curve resolution (MCR) to determine a level of myoglobin oxygen saturation (paragraph [0054]). Applicant defines “a level of oxygenation in muscle cells” as “a level of ‘myoglobin oxygen saturation’ in the muscle cells” in paragraph [0016] of the specification. Kadavy further teaches that a machine learning model using locally weighted regression (LWR) is configured to measure tissue oxygenation and more specifically myoglobin-oxygen saturation (paragraph [0059])
In regard to claim 59, Kadavy discloses the claimed invention substantially as set forth for claim 57, wherein the generator includes at least one light-emitting diode each configured for generating at least one wavelength having a first intensity and at least one wavelength having a second intensity that is less than the first intensity. Kadavy specifically discloses that the system includes a probe (FIG. 4, component 206) for use with the system of FIG. 2 (paragraph [0042]). The probe includes a NIR light source and visible light source. The NIR light source comprises a light-emitting diode that emits light in the NIR wavelength of approximately 740 – 790 nm (paragraph [0043]), and the visible light source comprises a light-emitting diode that emits light in the visible wavelength of 540 – 620 nm, which is less than the first intensity of 740 – 790 nm emitted by the NIR light source.
In regard to claims 73 & 74, Kadavy discloses the claimed invention substantially as set forth for claim 57, further comprising a spectrometer configured: for receiving, from a probe, the redirected portion of the electromagnetic energy; and for generating, for each of at least one wavelength range in the redirected portion of the electromagnetic energy, a respective electronic signal related to a value of a characteristic of the at least one wavelength range. Kadavy specifically discloses a spectrometer (FIG. 2, component 120) configured to receive signals transmitted from the light detector (FIG. 2, component 118) which receives light reflected from a desired region of tissue (paragraph [0027]). The processor uses the collected spectra to determine information about levels of oxymyoglobin, deoxymyoglobin, oxyhemoglobin, and deoxyhemoglobin (paragraphs [0050] – [0052]).
In regard to claim 78, Kadavy discloses the claimed invention substantially as set forth for claim 57, wherein the computing circuit is configured to control the generator. Kadavy specifically discloses a controller (FIG. 2, component 122) that controls the activation and power of the light-emitting diodes (FIG. 2, components 114 & 116; paragraph [0030]).
In regard to claim 79, Kadavy discloses the claimed invention substantially as set forth for claim 57, wherein the computing circuit is configured for determining a level of myoglobin-0xygen saturation of one or more of the at least one muscle cell in response to a respective value of a characteristic of each of at least one wavelength range of the portion of redirected electromagnetic energy. Kadavy specifically discloses that the computing circuit (FIG. 2, component 122) processes the detected spectra collected by the light detector (FIG. 2, component 118) and spectrometer (FIG. 2, component 120) in order to calculate muscle oxygenation levels (paragraph [0032] and myoglobin-oxygen saturation where collected absorbance spectrum for oxymyoglobin and deoxymyoglobin are determined using multivariate curve resolution (MCR) to determine a level of myoglobin oxygen saturation (paragraph [0054]). Applicant defines “a level of oxygenation in muscle cells” as “a level of ‘myoglobin oxygen saturation’ in the muscle cells” in paragraph [0016] of the specification. Kadavy further teaches that a machine learning model using locally weighted regression (LWR) is configured to measure tissue oxygenation and more specifically myoglobin-oxygen saturation (paragraph [0059]).
In regard to claim 80, Kadavy discloses the claimed invention substantially as set forth for claim 57, for implementing a machine-learning algorithm; Kadavy discloses that the computing circuit includes a processor configured to execute instructions for implementing an algorithm to process tissue oxygenation data collected from the sensor (FIG. 2, component 106). Kadavy further discloses that the computing circuit implements a locally weighted regression (LWR) model to provide real time measurement of muscle oxygenation values (paragraph [0049]).
and for determining a level of myoglobin-oxygen saturation of one or more of the at least one muscle cell by providing, as at least one input to the implemented machine-learning algorithm, a respective value of a characteristic of each of at least one wavelength range of the portion of redirected electromagnetic energy. Kadavy discloses that the system uses LWR with partial least squares techniques to calculate muscle oxygenation in real time. The LWR builds a local PLS model from spectra in the in vivo training set that are most similar to the new spectrum and then calculates muscle oxygenation and myoglobin-oxygen saturation using test set spectrum by application of the local PLS model (paragraph [0058] & [0059]).
In regard to claims 81, 82, & 83, Kadavy discloses the claimed invention substantially as set forth for claim 57, wherein the computing circuit is configured:
for implementing a mathematical algorithm, mathematical model, and locally weighted regression model; The computing circuit (FIG. 2, component 122) implements a locally weighted regression (LWR) model that includes a nonparametric learning algorithm that modifies a conventional linear or nonlinear least squares regression model by introducing a weighting scheme to give greater effect to "local" data points, and less weight to more distant data points (paragraph [0049]).
and for determining a level of myoglobin-oxygen saturation of one or more of the at least one muscle cell by providing, as at least one input to the implemented mathematical algorithm, a respective value of a characteristic of each of at least one wavelength range of the portion of redirected electromagnetic energy. Kadavy discloses that the system uses LWR with partial least squares techniques to calculate muscle oxygenation and hemoglobin-oxygen saturation. The LWR builds a local PLS model from spectra in the in vivo training set that are most similar to the new spectrum and then calculates muscle oxygenation using test set spectrum by application of the local PLS model (paragraph [0058]). Kadavy additionally discloses that a computer system can be used to perform analyses to calculate myoglobin saturation where collected absorbance spectrum for oxymyoglobin and deoxymyoglobin are determined using multivariate curve resolution (MCR) to determine a level of myoglobin oxygen saturation (paragraph [0054]). Applicant defines “a level of oxygenation in muscle cells” as “a level of ‘myoglobin oxygen saturation’ in the muscle cells” in paragraph [0016] of the specification. Kadavy further teaches that a machine learning model using locally weighted regression (LWR) is configured to measure tissue oxygenation and more specifically myoglobin-oxygen saturation (paragraph [0059]).
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.
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.
Claims 1 – 4, 6, 8, 10 – 12, and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Kadavy (US 20150217056 A1 – Previously cited) in view of Yang (US 20150131098 A1).
In regard to claim 1, Kadavy discloses a system, comprising:
a housing (FIG. 1, component 102);
an electromagnetic energy generator disposed in the housing and configured: to generate electromagnetic energy during a time; and to direct the electromagnetic energy into a body having at least one muscle cell; Kadavy specifically discloses that the system includes a tissue oxygenation measurement device (FIGs 1 & 2, component 106) that is connected to the housing of the system (FIG. 2, component 120) and controlled using the controller (FIG. 2, component 122) disposed within the housing of the system to generate different wavelengths of light using LED light sources (FIG. 2, components 114 & 116). Kadavy additionally discloses that the system includes a probe (FIG. 4, component 206) for use with the system of FIG. 2 (paragraph [0042]) where the light source may be disposed away from the probe and that light may be transmitted through fiber optic cables or the like to the probe (paragraphs [0042] & [0047]). One of ordinary skill in the art would recognize that the light source could be disposed within the housing away from the probe and carried via the disclosed fiber optic cable set up to the probe. The light sources may illuminate a desired region of tissue of a patient adjacent to the tissue oxygenation measurement device (FIG. 2, component 106; paragraph [0026]), such as the thenar muscle group in the hand, to measure the tissue oxygenation of muscle (paragraph [0032]).
an optical sensor disposed in the housing and configured to receive a portion of the electromagnetic energy redirected by the body and to convert the received portion of the electromagnetic energy into a signal; Kadavy specifically discloses an optical sensor interface connected to the housing (FIG. 2, component 118) that receives light reflected from or transmitted through the tissue of interest and transmits detected light to a spectrometer disposed in the housing unit (FIG. 2, component 120; paragraph [0027]).
And a computing circuit disposed in the housing, coupled to the electromagnetic unit and the optical sensor, and configured to determine, in response to the signal, a level of oxygenation in only one or more of the at least one muscle cell. Kadavy discloses a controller (FIG. 2, component 122) that includes one or more computing devices, such as processors and application-specific integrated circuits (paragraph [0029]). The controller controls operation of all components of the device, including the light sources (FIG. 2, components 114 & 116; paragraph [0030]), and additionally processes the measured light signals (paragraph [0028]) to calculate muscle oxygenation (paragraph [0032]).
In interpreting the amended claims which refer to “determine… a level of oxygenation in only one or more of the at least one muscle cell”, Examiner notes that Applicant defines “a level of oxygenation in muscle cells” as “a level of ‘myoglobin oxygen saturation’ in the muscle cells” in paragraph [0016] of the specification. Consistent with this understanding, Kadavy additionally discloses that a computer system can be used to perform analyses to calculate myoglobin saturation where collected absorbance spectrum for oxymyoglobin and deoxymyoglobin are determined using multivariate curve resolution (MCR) to determine a level of myoglobin oxygen saturation (paragraph [0054]). Kadavy further teaches that a machine learning model using locally weighted regression (LWR) is configured to measure tissue oxygenation and more specifically myoglobin-oxygen saturation (paragraph [0059]).
While Kadavy discloses an electromagnetic-energy generator configured to direct the electromagnetic energy into a body having at least one muscle cell using a probe (FIG. 4, component 206), they do not disclose that the electromagnetic-energy generator is configured to direct the electromagnetic energy at two or more body-illumination locations that are different distances from a body-collection location.
However, Yang teaches an optical measurement system for measuring a parameter such as tissue oxygenation (paragraph [0022]) using an arrangement of light sources (Paragraphs [0038] & [0087], FIG. 4B, components 116a and 116d) and a light detector (FIG. 4B, component 116c) where the light sources are configured to direct the electromagnetic energy at two or more body-illumination locations (FIG. 4B, components 116a and 116d) that are spaced at different distances from the body-collection location (FIG. 4B, component 116c) with one light source (FIG. 4B, component 116d) a closer distance to the body-collection location (FIG. 4B, component 116c) than the other light source (FIG. 4B, component 116a).
It would have been obvious to one of ordinary skill in the art to have modified the system disclosed by Kadavy, including the probe for delivering different wavelengths of light to a body having at least one muscle cell, with the teaching that an oxygenation measurement system can include two or more light sources positioned at two or more body-illumination locations that are different distances from a body-collection location because doing so allows the system to analyze different depths of biological tissue and remove interfering spectral influence of one or more tissues that are not of interest such that only the spectral information of a tissue of interest, such as muscle, can be measured (Yang, paragraphs [0071] - [0072]).
In regard to claim 2, Kadavy discloses the claimed invention substantially as set forth for claim 1, wherein the electromagnetic energy generator includes at least one light-emitting diode. Kadavy discloses that visible and near-infrared (NIR) light is delivered to the tissue of interest using light-emitting diodes (FIG. 2, components 114 & 116).
In regard to claim 3, Kadavy discloses the claimed invention substantially as set forth for claim 1, wherein the electromagnetic energy generator includes at least one light-emitting diode each configured for generating at least one wavelength in an approximate range of 400nm - 900nm and having a first intensity and at least one wavelength in an approximate range of 400nm - 900nm and having a second intensity that is less than the first intensity. Kadavy specifically discloses that the system includes a probe (FIG. 4, component 206) for use with the system of FIG. 2 (paragraph [0042]). The probe includes a NIR light source and visible light source. The NIR light source comprises a light-emitting diode that emits light in the NIR wavelength of approximately 740 – 790 nm (paragraph [0043]), which is substantially within the range of 400 – 900 nm. The visible light source comprises a light-emitting diode that emits light in the visible wavelength of 540 – 620 nm, which is both substantially within the range of 400 – 900 nm and less than the first intensity of 740 – 790 nm emitted by the NIR light source.
In regard to claim 4, Kadavy discloses the claimed invention substantially as set forth for claim 1, wherein the electromagnetic energy generator includes at least one light-emitting diode each configured for generating at least one wavelength in a range of 400-900 nm. Kadavy specifically discloses that the system includes a probe (FIG. 4, component 206) for use with the system of FIG. 2 (paragraph [0042]). The probe includes a NIR light source and visible light source. The NIR light source comprises a light-emitting diode that emits light in the NIR wavelength of approximately 740 – 790 nm (paragraph [0043]), which is substantially within the range of 400 – 900 nm.
In regard to claim 6, Kadavy discloses the claimed invention substantially as set forth for claim 1, wherein the energy generator: light-emitting diodes; and a drive circuit configured for activating and powering, selectively, the light-emitting diodes. Kadavy discloses a controller (FIG. 2, component 122) that controls the activation and power of the light-emitting diodes (FIG. 2, components 114 & 116). More specifically, the controller can activate each light-emitting diode such that they emit light intermittently during specific time periods. The lights can be activated at the same time or in an alternating fashion (paragraph [0030]).
In regard to claim 8, Kadavy discloses the claimed invention substantially as set forth for claim 1, wherein the optical sensor includes a spectrometer (FIG. 2, component 120) configured:
to receive the redirected portion of the electromagnetic energy; Kadavy discloses that light detector (FIG. 2, component 118) receives light reflected from the desired region of tissue and transmits the detected light to the spectrometer (paragraph [0027]).
and to generate, for each of at least one wavelength range in the redirected portion of the electromagnetic energy, a respective electronic signal related to a value of a characteristic of the at least one wavelength range. Kadavy discloses that the spectrometer receives light reflected from the desired region of tissue and transmits the detected light to the spectrometer (paragraph [0027]) which records the spectra and transmits the data to the controller (FIG. 2, component 122) for further analysis to calculate muscle oxygenation (paragraph [0032]).
In regard to claim 10, Kadavy discloses the claimed invention substantially as set forth for claim 1, wherein the computing circuit is configured for determining a level of oxygenation in only at least one muscle cell in response to a respective value of a characteristic of each of at least one wavelength range of the portion of redirected electromagnetic energy. Kadavy specifically discloses that the computing circuit (FIG. 2, component 122) processes the detected spectra collected by the light detector (FIG. 2, component 118) and spectrometer (FIG. 2, component 120) in order to calculate muscle oxygenation levels (paragraph [0032]) and more specifically myoglobin-oxygen saturation (paragraph [0059]).
In regard to claim 11, Kadavy discloses the claimed invention substantially as set forth for claim 1, wherein the computing circuit is configured:
for implementing a machine-learning algorithm; Kadavy discloses that the computing circuit includes a processor configured to execute instructions for implementing an algorithm to process tissue oxygenation data collected from the sensor (FIG. 2, component 106). Kadavy further discloses that the computing circuit implements a locally weighted regression (LWR) model to provide real time measurement of muscle oxygenation values (paragraph [0049]).
and for determining a level of oxygenation in only at least one muscle cell by providing, as at least one input to the implemented machine-learning algorithm, a respective value of a characteristic of each of at least one wavelength range of the portion of redirected electromagnetic energy. Kadavy discloses that the system uses LWR with partial least squares techniques to calculate muscle oxygenation in real time. The LWR builds a local PLS model from spectra in the in vivo training set that are most similar to the new spectrum and then calculates muscle oxygenation and myoglobin-oxygen saturation using test set spectrum by application of the local PLS model (paragraph [0058] & [0059]).
In regard to claim 12, Kadavy discloses the claimed invention substantially as set forth for claim 1, wherein the computing circuit is configured:
to implement a locally weighted regression model; Kadavy discloses that the computing circuit implements a locally weighted regression (LWR) model to provide real time measurement of muscle oxygenation values (paragraph [0049])
and to determine a level of oxygenation in only at least one muscle cell by providing, as at least one input to the implemented locally weighted regression model, a respective value of a characteristic of each of at least one wavelength range of the portion of redirected electromagnetic energy. Kadavy discloses that the computing circuit includes a processor configured to execute instructions for implementing an algorithm to process tissue oxygenation data collected from the sensor (FIG. 2, component 106). Kadavy further discloses that the computing circuit implements a locally weighted regression (LWR) model to provide real time measurement of muscle oxygenation values (paragraph [0049]). The LWR builds a local PLS model from spectra in the in vivo training set that are most similar to the new spectrum and then calculates muscle oxygenation and myoglobin-oxygen saturation using test set spectrum by application of the local PLS model (paragraph [0058] & [0059]).
In regard to claim 61, Kadavy discloses the claimed invention substantially as set forth for claim 1, wherein the generator includes light- emitting diodes each configured to generate electromagnetic energy across approximately a same spectrum. Kadavy specifically discloses that the system includes a probe (FIG. 4, component 206) for use with the system of FIG. 2 that includes a visible light source comprising a plurality of LEDs that emit light in the same spectrum of visible wavelengths of 540 – 620 nm (paragraph [0043]). Kadavy additionally discloses that the light sources of the probe (FIG. 4, component 206) may be disposed away from the probe and that light may be transmitted through fiber optic cables or the like to the probe (paragraphs [0042] & [0047]) such that the light sources are contained within the housing.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kadavy (US 20150217056 A1 – Previously cited) in view of Yang (US 20150131098 A1) as applied to claim 1 above, and further in view of Mujeeb-U-Rahman (US 20230172500 A1 – Previously cited).
In regard to claim 5, Kadavy discloses the claimed invention substantially as set forth for claim 1, wherein the electromagnetic energy generator includes multiple light-emitting diodes (FIG. 4, components 214 & 216). While Kadavy emphasizes the importance of the positioning the LEDs on one side of the probe in order to maximize the spacing between the LEDs and detectors, they do not disclose that the LEDs are in a linear arrangement.
However, Mujeeb-U-Rahman teaches non-invasive tissue oximetry device that utilizes multiple light sources (FIG. 2, components 106 & 108) in a linear arrangement.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electromagnetic unit disclosed by Kadavy that includes a probe with multiple LEDs (FIG. 4, components 214 & 216) with the configuration of light sources in a linear arrangement as taught by Mujeeb-U-Rahman because it would be considered a rearrangement of parts that would not modify the function of the device and would yield the predictable result of using the light sources to measure oxygen levels in the tissue.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kadavy (US 20150217056 A1 – Previously cited) in view of Yang (US 20150131098 A1) as applied to claim 1 above, and further in view of Margiott (US 20210212584 A1 – Previously cited).
In regard to claim 7, Kadavy discloses the claimed invention substantially as set forth for claim 1, wherein the electromagnetic energy generator includes: light-emitting diodes (FIG. 2, components 114 & 116). Kadavy does not disclose the use of a temperature-control circuit configured to maintain a respective temperature of each of the light-emitting diodes within a temperature range.
However, Margiott teaches the use of a temperature control logic circuit (FIG. 21) for increasing or decreasing a temperature of an oximeter device until the system unit is within a predetermined temperature window (FIG. 19) by controlling the power to the LEDs (paragraph [0011]). Monitoring and adjusting the temperature of the medical device increases the reliability of the electronics components and oximetry measurements (paragraph [0011] & [0098]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the measurement system disclosed by Kadavy with the temperature control circuit taught by Margiott because it would increase the reliability of the oximetry measurements taken by the system (paragraph [0098]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kadavy (US 20150217056 A1 – Previously cited) in view of Yang (US 20150131098 A1) as applied to claim 1 above, and further in view of Huang (CN 110025320 A – Previously cited).
In regard to claim 9, Kadavy discloses the claimed invention substantially as set forth for claim 1, further comprising a housing wherein the electromagnetic energy generator, the optical sensor, and the computing circuit are disposed in the housing (FIG. 2). While Kadavy discloses a use of a probe (FIG. 4, component 206) in combination with the housing elements (FIG. 2, components (120, 122, & 126), they do not disclose that the housing is configured to directly attach to a body.
However, Huang teaches a muscle oxygenation detecting device that includes an electromagnetic unit (FIG. 5, component 36), optical sensor (FIG. 5, component 37), and computing circuit (FIG. 4, component 38) within a housing configured to be placed directly on the body without wired connection.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the muscle oxygenation device disclosed by Kadavy with the wireless configuration for a muscle oxygenation detection device taught by Huang because it would be considered use of a known technique to improve similar devices in the same way with the predictable result of measuring tissue oxygenation.
Claims 65, 66, 71, 72, & 75 are rejected under 35 U.S.C. 103 as being unpatentable over Kadavy (US 20150217056 A1 – Previously cited) as applied to claim 57 above, and further in view of Quast (US 6481899 B1 – Previously cited).
In regard to claim 65, Kadavy discloses the claimed invention substantially as set forth for claim 57, wherein the generator includes light-emitting diodes and a receptacle configured for receiving a probe connector housing ends of optical fibers. Kadavy specifically discloses that the tissue oxygenation detection system includes a includes a probe (FIG. 4, component 206) for use with the system of FIG. 2 that includes a plurality of LEDs that emit and are controlled using the controller (FIG. 2, component 122) and powered by the power source (FIG. 2, component 126) to generate light stimuli. Additionally, Kadavy discloses a receptable (FIG. 1, component 102) that is coupled to the probe (FIG. 1, components 106; FIG. 4, component 206) to measure tissue oxygenation levels (paragraph [0024]). The probe is connected to the receptacle via a cable assembly (FIG. 4, components 240) that includes plastic optical fiber and conductors for the LEDs (FIG. 6, component 240). While Kadavy discloses that the probe is connected to the receptacle via cable assembly, they do not disclose further details including aligning each of the ends of the optical fibers with a respective one of the light-emitting diodes.
However, Quast teaches an optical probe connector (FIG. 2) in which the ends of each of the optical fibers (FIG. 2, components 50, 52, 54, & 56) are aligned with a respective one LED (FIG. 2, components 40, 42, 44, 46; column).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electromagnetic unit disclosed by Kadavy with the optical probe connector of Quast because Kadavy already discloses that the optical probe is connected to the receptacle via cable assembly, and modifying that connection with the teachings of Quast would be considered combining prior art elements according to known methods to yield the predictable result of optically coupling the components of the optical probe and receptacle in order to measure muscle oxygenation.
In regard to claim 66, Kadavy discloses the claimed invention substantially as set forth for claim 57, wherein the generator includes light-emitting diodes and a receptacle configured for receiving a probe connector housing ends of optical fibers. Kadavy specifically discloses that the tissue oxygenation detection system includes a includes a probe (FIG. 4, component 206) for use with the system of FIG. 2 that includes a plurality of LEDs that emit and are controlled using the controller (FIG. 2, component 122) and powered by the power source (FIG. 2, component 126) to generate light stimuli. Additionally, Kadavy discloses a receptable (FIG. 1, component 102) that is coupled to the probe (FIG. 1, components 106; FIG. 4, component 206) to measure tissue oxygenation levels (paragraph [0024]). The probe is connected to the receptacle via a cable assembly (FIG. 4, components 240) that includes plastic optical fiber and conductors for the LEDs (FIG. 6, component 240). Kadavy does not disclose a latch or a motor configured for aligning each of the ends of the optical fibers with a respective one of the light-emitting diodes by causing the latch to engage the probe connector.
However, Quast teaches an optical probe connector (FIG. 7) with a latching mechanism for spectrophotometric instruments that includes latch holes (FIG. 7, components 116 & 118) that are positioned opposite shell peg heads (FIG. 7, components 130 & 132) that are configured to receive ferrule pins (FIG. 7, components 146 & 148; column 6, lines 10 - 37). The shell peg heads (FIG. 7, components 130 & 132) and ferrule pins (FIG. 7, components 146 & 148) engage with the latch holes (FIG. 7, components 116 & 118) to optically couple the optical fibers and LEDs. Additionally, Quast teaches that a motor can be included to apply torque to the handle shaft and move the shell peg and ferrules into position (column 6, lines 51 - 59).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electromagnetic unit disclosed by Kadavy with the optical probe connector of Quast because Kadavy already discloses that the optical probe is connected to the receptacle via cable assembly, and modifying that connection with the teachings of Quast would be considered combining prior art elements according to known methods to yield the predictable result of optically coupling the components of the optical probe and receptacle in order to measure muscle oxygenation.
In regard to claim 71, Kadavy discloses the claimed invention substantially as set forth for claim 57, wherein the generator includes light-emitting diodes the apparatus further comprising: a receptacle having contact regions and configured to receive a probe connector housing ends of optical fibers. Kadavy specifically discloses that the tissue oxygenation detection system includes a includes a probe (FIG. 4, component 206) for use with the system of FIG. 2 that includes a plurality of LEDs that emit and are controlled using the controller (FIG. 2, component 122) and powered by the power source (FIG. 2, component 126) to generate light stimuli. Additionally, Kadavy discloses a receptable (FIG. 1, component 102) that is coupled to the probe (FIG. 1, components 106; FIG. 4, component 206) to measure tissue oxygenation levels (paragraph [0024]). The probe is connected to the receptacle via a cable assembly (FIG. 4, components 240) that includes plastic optical fiber and conductors for the LEDs (FIG. 6, component 240). Kadavy does not disclose that the probe connector housing includes a latch-engagement region, or the presence of a latch and a motor configured for aligning each of the ends of the optical fibers with a respective one of the light-emitting diodes by causing the latch to engage the latch- engagement region to force the probe connector against the contact regions.
However, Quast teaches an optical probe connector (FIG. 7) with a latching mechanism for spectrophotometric instruments that includes a latch-engagement region made up of latch holes (FIG. 7, components 116 & 118) that are positioned opposite shell peg heads (FIG. 7, components 130 & 132) that are configured to receive ferrule pins (FIG. 7, components 146 & 148; column 6, lines 10 - 37). The shell peg heads (FIG. 7, components 130 & 132) and ferrule pins (FIG. 7, components 146 & 148) engage with the latch holes (FIG. 7, components 116 & 118) to optically couple the optical fibers and LEDs. Additionally, Quast teaches that a motor can be included to apply torque to the handle shaft and move the shell peg and ferrules into position (column 6, lines 51 - 59).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electromagnetic unit disclosed by Kadavy with the optical probe connector of Quast because Kadavy already discloses that the optical probe is connected to the receptacle via cable assembly, and modifying that connection with the teachings of Quast would be considered combining prior art elements according to known methods to yield the predictable result of optically coupling the components of the optical probe and receptacle in order to measure muscle oxygenation.
In regard to claim 72, Kadavy as modified discloses the claimed invention substantially as set forth for claim 71, wherein the motor is further configured for releasing the probe connector for removal from the receptacle by causing the latch to disengage the latch-engagement region. Quast teaches that a motor can be used to engage with the latch-engagement region of an optical probe connector in order to optically couple optical fibers and LEDs. Additionally, Quast teaches that the probe connector (FIG. 1, component 28) can be disengaged from the receptacle (FIG. 1, component 30) latch mechanism by rotating the bearing block (FIG. X, component 170 in the opposite direction (column 9, lines 10 – 17) and that the bearing block may be replaced by a variety of actuators such as a rotary or linear motor (column 6, lines 51 – 56). It would have been obvious to one of ordinary skill in the art that the motor could apply force in the opposite direction to disengage the latch-engagement region to remove the probe from the receptacle.
In regard to claim 75, Kadavy discloses the claimed invention substantially as set forth for claim 57, wherein the generator includes light-emitting diodes, the apparatus further comprising: a spectrometer having an input configured for receiving, from a probe, the redirected portion of the electromagnetic energy, and configured for generating, for each of at least one wavelength range in the redirected portion of the electromagnetic energy, a respective electronic signal related to a value of a characteristic of the at least one wavelength range; Kadavy specifically discloses that the tissue oxygenation detection system includes a includes a probe (FIG. 4, component 206) for use with the system of FIG. 2 that includes a plurality of LEDs that emit and are controlled using the controller (FIG. 2, component 122) and powered by the power source (FIG. 2, component 126) to generate light stimuli. The probe is connected to the receptacle via a cable assembly (FIG. 4, components 240) that includes plastic optical fiber and conductors for the LEDs (FIG. 6, component 240). Additionally, Kadavy discloses a spectrometer (FIG. 2, component 120) configured to receive signals transmitted from the light detector (FIG. 2, component 118) which receives light reflected from a desired region of tissue (paragraph [0027]). The processor uses the collected spectra to determine information about levels of oxymyoglobin, deoxymyoglobin, oxyhemoglobin, and deoxyhemoglobin (paragraphs [0050] – [0052]). While Kadavy discloses that the probe is connected to the receptacle via cable assembly, they do not disclose further details including aligning each of the ends of the optical fibers with a respective one of the light-emitting diodes and aligning each of the ends of at least one other of the optical fibers with the spectrometer input.
However, Quast teaches an optical probe connector (FIG. 2) in which the ends of each of the optical fibers (FIG. 2, components 50, 52, 54, & 56) are aligned with a respective one LED (FIG. 2, components 40, 42, 44, 46; column 4, lines 25 - 28). Additionally, Quast teaches that the ends of at least one other optical fiber (FIG. 2, component 59) are aligned with the spectrometer input (FIG. 2, component 22; column 4, lines 34 - 38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electromagnetic unit disclosed by Kadavy with the optical probe connector of Quast because Kadavy already discloses that the optical probe is connected to the receptacle via cable assembly, and modifying that connection with the teachings of Quast would be considered combining prior art elements according to known methods to yield the predictable result of optically coupling the components of the optical probe and receptacle in order to measure muscle oxygenation.
Claims 76 & 77 is rejected under 35 U.S.C. 103 as being unpatentable over Kadavy (US 20150217056 A1 – Previously cited) as applied to claim 57 above, and further in view of Quast (US 6481899 B1 – Previously cited) and further in view of Hok (US 5786592 A – Previously cited).
In regard to claim 76, Kadavy discloses the claimed invention substantially as set forth for claim 57, wherein the generator includes light-emitting diodes, the apparatus further comprising; a spectrometer having an input configured for receiving, from a probe, the redirected portion of the electromagnetic energy, and configured for generating, for each of at least one wavelength range in the redirected portion of the electromagnetic energy, a respective electronic signal related to a value of a characteristic of the at least one wavelength range; and a receptacle configured for receiving a probe connector housing ends of optical fibers, Kadavy specifically discloses that the tissue oxygenation detection system includes a includes a probe (FIG. 4, component 206) for use with the system of FIG. 2 that includes a plurality of LEDs that emit and are controlled using the controller (FIG. 2, component 122) and powered by the power source (FIG. 2, component 126) to generate light stimuli. The probe is connected to the receptacle via a cable assembly (FIG. 4, components 240) that includes plastic optical fiber and conductors for the LEDs (FIG. 6, component 240). Additionally, Kadavy discloses a spectrometer (FIG. 2, component 120) configured to receive signals transmitted from the light detector (FIG. 2, component 118) which receives light reflected from a desired region of tissue (paragraph [0027]). The processor uses the collected spectra to determine information about levels of oxymyoglobin, deoxymyoglobin, oxyhemoglobin, and deoxyhemoglobin (paragraphs [0050] – [0052]). While Kadavy discloses that the probe is connected to the receptacle via cable assembly, they do not disclose further details including aligning each of the ends of the optical fibers with a respective one of the light-emitting diodes and aligning each of the ends of at least one other of the optical fibers with the spectrometer input.
However, Quast teaches an optical probe connector (FIG. 2) in which the ends of each of the optical fibers (FIG. 2, components 50, 52, 54, & 56) are aligned with a respective one LED (FIG. 2, components 40, 42, 44, 46; column 4, lines 25 - 28). Additionally, Quast teaches that the ends of at least one other optical fiber (FIG. 2, component 59) are aligned with the spectrometer input (FIG. 2, component 22; column 4, lines 34 - 38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electromagnetic unit disclosed by Kadavy with the optical probe connector of Quast because Kadavy already discloses that the optical probe is connected to the receptacle via cable assembly, and modifying that connection with the teachings of Quast would be considered combining prior art elements according to known methods to yield the predictable result of optically coupling the components of the optical probe and receptacle in order to measure muscle oxygenation.
Kadavy as modified by Quast also fails to teach an electromagnetic-radiation shield configured for disposal between the ones of the optical fibers while respective aligned with the light-emitting diodes and the at least one other of the optical fibers while aligned with the spectrometer input.
However, Hok teaches the use of an electromagnetic shield disposed between light emitting and light detecting parts made up of optical fibers within a single housing using a screen that blocks optical and electromagnetic signals (column 3, lines 58 – 65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system disclosed by Kadavy as modified by Quast with the electromagnetic shielding between light emitting and light detecting parts taught by Hok because the screen blocks optical and electromagnetic signals between the two components (column 3, lines 58 – 65).
In regard to claim 77, Kadavy discloses the claimed invention substantially as set forth for claim 57, wherein the generator includes light-emitting diodes, the apparatus further comprising: a spectrometer having an input configured for receiving, from a probe, the redirected portion of the electromagnetic energy, and configured for generating, for each of at least one wavelength range in the redirected portion of the electromagnetic energy, a respective electronic signal related to a value of a characteristic of the at least one wavelength range; and a receptacle configured for receiving a probe connector housing ends of optical fibers. Kadavy specifically discloses that the tissue oxygenation detection system includes a includes a probe (FIG. 4, component 206) for use with the system of FIG. 2 that includes a plurality of LEDs that emit and are controlled using the controller (FIG. 2, component 122) and powered by the power source (FIG. 2, component 126) to generate light stimuli. The probe is connected to the receptacle via a cable assembly (FIG. 4, components 240) that includes plastic optical fiber and conductors for the LEDs (FIG. 6, component 240). Additionally, Kadavy discloses a spectrometer (FIG. 2, component 120) configured to receive signals transmitted from the light detector (FIG. 2, component 118) which receives light reflected from a desired region of tissue (paragraph [0027]). The processor uses the collected spectra to determine information about levels of oxymyoglobin, deoxymyoglobin, oxyhemoglobin, and deoxyhemoglobin (paragraphs [0050] – [0052]). While Kadavy discloses that the probe is connected to the receptacle via cable assembly, they do not disclose further details including aligning each of the ends of the optical fibers with a respective one of the light-emitting diodes and aligning each of the ends of at least one other of the optical fibers with the spectrometer input or a slot between a first set of the optical fibers and a second set of at least one of the optical fibers, configured for aligning each of the ends of the optical fibers of the first set with a respective one of the light-emitting diodes.
However, Quast teaches an optical probe connector (FIG. 2) in which the ends of each of the optical fibers (FIG. 2, components 50, 52, 54, & 56) are aligned with a respective one LED (FIG. 2, components 40, 42, 44, 46; column 4, lines 25 - 28). Additionally, Quast teaches that the ends of at least one other optical fiber (FIG. 2, component 59) are aligned with the spectrometer input (FIG. 2, component 22; column 4, lines 34 - 38). The connector taught by Quast also includes slots between a first set of optical fibers and second set of optical fibers (FIG. 2, components 60 & 88) which carry the reference and sample signals.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electromagnetic unit disclosed by Kadavy with the optical probe connector of Quast because Kadavy already discloses that the optical probe is connected to the receptacle via cable assembly, and modifying that connection with the teachings of Quast would be considered combining prior art elements according to known methods to yield the predictable result of optically coupling the components of the optical probe and receptacle in order to measure muscle oxygenation.
Kadavy as modified by Quast also fails to teach an electromagnetic-radiation shield configured for disposal between the ones of the optical fibers while respective aligned with the light-emitting diodes and the at least one other of the optical fibers while aligned with the spectrometer input.
However, Hok teaches the use of an electromagnetic shield disposed between light emitting and light detecting parts made up of optical fibers within a single housing using a screen that blocks optical and electromagnetic signals (column 3, lines 58 – 65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system disclosed by Kadavy as modified by Quast with the electromagnetic shielding between light emitting and light detecting parts taught by Hok because the screen blocks optical and electromagnetic signals between the two components (column 3, lines 58 – 65).
Claim 135 is rejected under 35 U.S.C. 103 as being unpatentable over Kadavy (US 20150217056 A1 – Previously cited) as applied to claim 57 above, and further in view of Yang (US 20150131098 A1).
In regard to claim 135, Kadavy discloses the claimed invention as set forth for claim 57. As noted in the 102 rejection of claim 57 above, “the probe” is not positively claimed and is thus not required to meet the claim limitations of claim 135. However, Kadavy does disclose an electromagnetic-energy generator configured to direct the electromagnetic energy into a body having at least one muscle cell using a probe (FIG. 4, component 206). Kadavy does not disclose that the probe is further configurable:
to direct the electromagnetic energy into the body at two or more body-illumination locations that are different distances from a body-collection location;
and to collect the portion of the electromagnetic energy redirected by the body at the body- collection location.
However, Yang teaches an optical measurement system for measuring a parameter such as tissue oxygenation (paragraph [0022]) using an arrangement of light sources (Paragraphs [0038] & [0087], FIG. 4B, components 116a and 116d) and a light detector (FIG. 4B, component 116c) where the light sources are configured to direct the electromagnetic energy at two or more body-illumination locations (FIG. 4B, components 116a and 116d) that are spaced at different distances from the body-collection location (FIG. 4B, component 116c) with one light source (FIG. 4B, component 116d) a closer distance to the body-collection location (FIG. 4B, component 116c) than the other light source (FIG. 4B, component 116a).
It would have been obvious to one of ordinary skill in the art to have modified the system disclosed by Kadavy, including the probe for delivering different wavelengths of light to a body having at least one muscle cell, with the teaching that an oxygenation measurement system can include two or more light sources positioned at two or more body-illumination locations that are different distances from a body-collection location because doing so allows the system to analyze different depths of biological tissue and remove interfering spectral influence of one or more tissues that are not of interest such that only the spectral information of a tissue of interest, such as muscle, can be measured (Yang, paragraphs [0071] - [0072]).
Response to Arguments
Applicant’s arguments, see Remarks, filed 11/17/2025, with respect to the rejections of claims 1 - 12 under 35 USC 112(b) have been fully considered and are persuasive. The rejection of claims 1 - 12 under 35 USC 112(b) have been withdrawn.
Applicant’s arguments, see Remarks, filed 8/20/2025, with respect to the rejections of claims 1 - 4, 8, 10 - 12, 57, 59, 61, 73, 74, and 78 - 83 under 35 USC 102 and claims 5, 7, 9, 65, 66, 71, 72, 75, 76, and 77 under USC 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground of rejection is made, consistent with the amended claim scope, in view of Kadavy with respect to the rejections of independent claim 57 and dependent claims 59, 73, 74, & 78 – 83 and in view of Kadavy in further view of Yang with respect to the rejections of independent claim 1 and dependent claims 2 - 4, 8, 10 - 12, and 61; in view of Kadavy in view of Yang and further in view of Mujeeb-U-Rahman with respect to claim 5; in view of Kadavy in view of Yang and further in view of Margiott with respect to claim 7; in view of Kadavy in view of Yang and further in view of Huang with respect to claim 9; in view of Kadavy further in view of Quast with respect to claims 65, 66, 71, 72, and 75; and in view of Kadavy and further in view of Quast in view of Hok with respect to claims 76 and 77.
As Applicant notes, claim 57 has been amended to recite “a generator that includes light-emitting diodes each configured to generate electromagnetic energy across approximately a same spectrum...” and points to paragraphs [0026], [0028], [0030], [0032], [0037], [0040], [0042], [0043], and [0047] as teaching away from the generator including multiple light-emitting diodes that each generate electromagnetic energy “across approximately the same spectrum”. While Applicant correctly notes that there are two light sources disclosed by Kadavy, a visible light source (FIG. 2, component 114 or FIG. 4, component 214) and an NIR light source (FIG. 2, component 116 or FIG. 4, component 216), they fail to address that Kadavy discloses that the visible light source includes a plurality of light emitting diodes that emit light in approximately the same spectrum (540 - 620 nm). The claim as written only requires that the generator comprises or includes multiple light-emitting diodes that emit light across approximately the same spectrum which Kadavy discloses in paragraph [0043], not that all light sources emit light at similar wavelengths.
Conclusion
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/S.C.P./Examiner, Art Unit 3791