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 04/30/2026 has been entered. Claims 1 - 12, 57, 59,61, 65, 66, 71 - 83, and 135 are pending.
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 § 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.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: Claim 57 has been amended to include the limitation “a generator that includes first light-emitting diodes each configured to generate electromagnetic energy across approximately a same spectrum and that includes no other light-emitting diode configured to generate electromagnetic energy across a different spectrum”. While the cited reference Kadavy discloses a method for determining a level of myoglobin-oxygen saturation of at least one muscle cell, the method includes the use of visible and NIR light (paragraph [0050]). Kadavy does not suggest or indicate that the determination of a level of myoglobin-oxygen saturation of at least one muscle cell could be carried out using light emitting diodes of only one light spectrum. The modification of Kadavy with Yang further does not suggest the use of “first light-emitting diodes each configured to generate electromagnetic energy across approximately a same spectrum and that includes no other light-emitting diode configured to generate electromagnetic energy across a different spectrum”.
For these reasons, independent claim 57 and dependent claims 59, 65, 66, and 71 - 83 are allowed.
Response to Arguments
Applicant’s arguments, see Remarks, filed 4/30/2026, with respect to the rejections of claims 135 under 35 USC 112(d) have been fully considered and are not persuasive. Claim 135 is directed towards details of a probe. However, claim 135 depends from claim 57 which is directed towards “an apparatus” comprising “a generator” and “a computing circuit”. While claim 57 includes the limitation, “a generator that includes first light-emitting diodes each configured to generate electromagnetic energy… to a probe”, as written, claim 57 only positively claims the generator and light-emitting diodes, not the probe. Being “configured” to provide light to a probe only encompasses that the generator is able to provide the light to a probe, not the probe itself. As such, claim 135 which only includes details of the probe that do not materially affect any positively claimed element of the base claim, is not further limiting of the apparatus because no details of positively claimed elements are included in the dependent claim. As such, the rejection of claim 135 under 35 U.S.C. 112(d) is maintained. Examiner suggests either positively claiming the probe as a part of the apparatus claim of claim 57 or cancelling claim 135.
Applicant’s arguments, see Remarks, filed 4/30/2026, with respect to the rejections of claims 1 - 12 & 61 under 35 U.S.C. 103 have been fully considered and are not persuasive.
In regard to claim 1, Applicant argues that Kadavy cannot measure myoglobin saturation separately from hemoglobin saturation. While Kadavy discloses that a level of muscle oxygenation or Mox is determined by the concentration of oxyMbHb divided by the sum of the concentration of oxyMbHb and deoxyMbHb multiplied by 100, they additionally state that myoglobin saturation alone can be calculated using multivariate curve resolution (MCR) as defined by the equation Mbsat={[oxyMb]/([oxyMb]+[deoxyMb])}*100 (paragraphs [0054] - [0056]). Kadavy further discloses that “Mb sat may be measured from spectra in the training set and used to build an LWR model that will measure Mb sat from patient spectra.” 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 discloses that their computer system can be used to perform analyses to calculate myoglobin saturation or level of oxygenation in only at least one muscle cell. Additionally, Examiner notes that the claim limitation recites “a computing circuit… configured to determine in response to the signal, a level of oxygenation in only at least one muscle cell” and does not disqualify the consideration of hemoglobin saturation when determining myoglobin saturation.
Applicant additionally argues that Kadavy teaches that his two LEDs (FIG. 5, components 214 and 216) “are all the same distance”. While Kadavy does indicate that “the visible light LEDs 214 and NIR LED 216 may all be disposed along a circular arc centered on the detector 232 such that the LEDs 214, 216 are all the same distance from the detector 232,” Kadavy does not teach away from other configurations. Examiner maintains that Yang teaches that the spectral information of a tissue of interest, such as the muscle tissue, can be isolated and obtained by having two or more body-illumination locations in order to improve the measured spectral information of a tissue of interest by excluding the spectral influence of other tissues that are not of interest.
Applicant argues that there is no motivation to combine Kadavy and Yang because Kadavy does not specifically disclose that there is a problem or flaw in the disclosed system for measuring myoglobin saturation and that Yang merely teaches that “correcting spectra recorded with a long source-detector spacing against spectra recorded with a short source-detector spacing can remove the spectral features of the overlying features from the spectra of the internal, deeper lying features” in paragraph [0013]. While Applicant is correct that Kadavy does not disclose that there is a problem or flaw in the disclosed system for measuring myoglobin saturation, Examiner notes that Kadavy is interested in measuring spectral data specifically in one type of tissue, the muscle, where the distance from the LEDs (FIG. 5, components 214 & 216) may be selected to optimize light collection depending on characteristics of the tissue and the spectral information being collected (paragraph [0044]) and that Yang teaches a system and method for processing spectral information specific to the muscle based on the distance between the light sources and the light detector (paragraph [0116]) such that modifying Kadavy with Yang improves data collection from specifically the muscle. Applicant further argues that Yang merely teaches that “correcting spectra recorded with a long source-detector spacing against spectra recorded with a short source-detector spacing can remove the spectral features of the overlying features from the spectra of the internal, deeper lying features” in paragraph [0013], but Yang is specifically interested in improving spectroscopy techniques for the noninvasive measurements of tissue chemistry in muscle where Yang teaches that spectroscopy techniques used for noninvasive measurements of blood and tissue chemistry in human and animal subjects are impacted by variations in the tissue structures being measured such that the variations in muscle and other organs cause spectral interference that are irrelevant to the measurements (paragraph [0006]) and that by collecting spectral information using two body-illumination locations that are different distances from the body-collection location (FIG. 5A, see distances (SD)1 and (SD)2), the system can be configured to isolate spectral information about the muscle tissue (FIG. 5A, component 102m) from spectral information about the skin layer and fat layer (FIG. 5A, components 102s and 102f) that contributes to unwanted noise in spectral measurements (paragraph [0116]). Applicant additionally argues that Yang does not allow or improve measurement of myoglobin saturation, but it would be obvious to one of ordinary skill in the art that optimizing the measurement of spectral data from the muscle by eliminating spectral interference from other tissues to determine a tissue chemistry parameter, such as myoglobin saturation, would be within the scope of the teachings of Yang.
Applicant further cites the paper “Noninvasively Determined Muscle Oxygenation Saturation as an Early Indicator of Central Hypovolemia in Humans” Soller et al., J. App. Physiol. to show that “NIRS cannot distinguish myoglobin absorbance from hemoglobin absorbance,” but the reference Yang is merely teaching that an electromagnetic-energy generator can be configured “to direct electromagnetic energy into a body… at two or more body-illumination locations that are different distances from a body-collection location”, not the determination of myoglobin saturation which Kadavy already discloses using a combination of visible and near-infrared light (paragraph [0050]) to measure spectral information about the concentrations of oxymyoglobin and deoxymyoglobin respectively which are then used to determine a value of myoglobin saturation as discussed above (paragraph [0054]). The modifying reference of Yang is not required to re-teach a limitation that is disclosed by the primary reference of Kadavy and instead focuses on improving signal collection for spectral imaging of muscle which is still relevant to the system disclosed by Kadavy without being focused on the particular processing to determine a level of oxygenation in only at least one muscle cell. Additionally, Examiner notes that while Yang discusses spectral interference in relation to near infrared spectroscopy (paragraph [0007]), one of ordinary skill in the art would recognize that the same method and system configuration can be applied to different spectral collection methods including visible light spectroscopy. Yang additionally discusses that their system is configured to produce light from the light sources (FIG. 4B, components 116a & 116d) in the near-infrared region, visible region, and other regions of the electromagnetic spectrum (paragraph [0112]) and Kadavy indicates the use of both visible and near-infrared light in determining myoglobin saturation (paragraph [0054]). Notably, claim 1 does not specify the spectrum or wavelength of light that is generated by the “electromagnetic-energy generator”. As such, the rejection of claims 1 - 12 & 61 under 35 U.S.C. 103 are maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/S.C.P./Examiner, Art Unit 3791
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