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 .
Status of Claims
Claims 1-2, 4-5, 9, 12, 14, 21-25, 27, 34, and 36 are pending.
Claims 27, 34, and 36 are withdrawn from prosecution.
Claims 1-2, 4-5, 9, 12, 14, 21-25 are rejected.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Withdrawn Objections
The objections made to claim 14 has been withdrawn pursuant of Applicant’s amendments filed 11/26/2025.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-5, 9, 12, 14, and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Cinbis, et al., US 20100318146 A1 in view of Wiese, et al., US 20190099116 A1.
Regarding claim 1, Cinbis teaches a device ([0019] and fig. 1 disclose a system 2) for estimating tissue metabolic rate of oxygen consumption (tMRO2) in a subject ([0064] states that “an activity sensor is included to provide a signal corresponding to activity of the patient as an indicator of metabolic demand. An activity sensor signal can be used to compute a sensor-indicated rate (SIR) for use in rate-responsive pacing. An activity sensor signal may be used in combination with tissue oxygenation measurements to determine if a heart failure therapy, such as CRT, needs to be adjusted for improving tissue oxygen availability during periods of exercise”), comprising:
an optical detector (100) (sensor 100 of [0040]) configured for blood flow measurements, and oxygenation measurements ([0014] discloses measurements of tissue volume in the optical path of the sensor indicative of blood flow measurements and measurement of tissue oxygenation), coupled with a plurality of light sources (200) without implementing fiber optics ([0040] discloses the sensors with light sources 106, and without implementing fiber optics),
wherein the optical detector (100) comprises an aperture (150) comprising a single slit ([0022] states that “Housing 14 includes at least one opening or window through which light is emitted from a light emitting portion of the optical sensor 12 and at least one additional window through which light is detected by a light detecting portion of optical sensor 12”);
wherein the srDRS measurements, the blood flow measurements, and the oxygenation measurements are combined to estimate the tMRO2 ([0064] states that “an activity sensor is included to provide a signal corresponding to activity of the patient as an indicator of metabolic demand. An activity sensor signal can be used to compute a sensor-indicated rate (SIR) for use in rate-responsive pacing. An activity sensor signal may be used in combination with tissue oxygenation measurements to determine if a heart failure therapy, such as CRT, needs to be adjusted for improving tissue oxygen availability during periods of exercise”).
Cinbis does not teach an optical detector configured for spatially resolved diffuse reflectance spectroscopy (srDRS) measurements.
However, within the same field of endeavor, Wiese teaches a wearable optical device is described for optically detecting parameters of interest within muscle, such as during physical activity or when at rest. The parameters of interest include oxygenation level and/or hemoglobin concentrations in some situations. The detected parameters, such as oxygenation level, may be used to assess physical performance, such as the extent to which the muscle is utilizing aerobic or anaerobic processes. Methods for determining the parameters of interest, such as oxygenation level, from the detected optical signals are also described, and feedback may be provided to a user (see abstract). The optical device includes an optical detector (optical sensor of [0031]) configured for spatially resolved ([0049] discloses that “detectors may be provided with different spacing on both sides of the LEDs. According to a further alternative, multiple linear detector arrays may be provided in different spatial directions. This may allow for mapping of the spatial distribution of the muscle oxygenation and/or hemoglobin concentration over the muscle to examine a larger portion of the tissue”) diffuse ([0040]) reflectance spectroscopy (srDRS) measurements ([0092]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Cinbis wherein the optical detector is configured for spatially resolved diffuse reflectance spectroscopy (srDRS) measurements, as taught by Wiese, as such modification would improve the quality of the acquired signal ([0092]).
Regarding claim 4, Cinbis in view of Wiese teaches all the limitations of claim 1.
Cinbis further teaches wherein the optical detector (100) comprises a lens that enables a wider field of view but does not require an image to be in focus ([0040] states that “Light emitting portion 102 includes one or more light sources 106 positioned to emit light through a lens 103 sealed in an opening in hermetically-sealed housing 101”).
Regarding claim 5, Cinbis in view of Wiese teaches all the limitations of claim 1.
Cinbis further teaches wherein the plurality of light sources (200) comprise coherent light sources, chip-based light sources, vertical-cavity surface-emitting lasers (VCSELs), light-emitting diodes (LEDs), or a combination thereof (“Light emitting portion 102 includes one or more light sources 106 positioned to emit light through a lens 103 sealed in an opening in hermetically-sealed housing 101. Light source(s) 106 may be embodied as single white light source or multiple light sources emitting light at separate spaced-apart wavelengths. Suitable light sources include, without limitation, optoelectronic devices such as light emitting diodes (LEDs), lasers such as vertical cavity surface emitting lasers (VCSELs), luminescent or phosphorescent and incandescent light sources” [0040]).
Regarding claim 9, Cinbis in view of Wiese teaches all the limitations of claim 1.
Cinbis further teaches wherein the plurality of light sources (200) are at different wavelengths ([0040] states that “Light source(s) 106 may be embodied as single white light source or multiple light sources emitting light at separate spaced-apart wavelengths”).
Regarding claim 12, Cinbis in view of Wiese teaches all the limitations of claim 1.
Cinbis further teaches wherein the aperture (150) is located in the front of the optical detector (100) (“Housing 14 includes at least one opening or window through which light is emitted from a light emitting portion of the optical sensor 12 and at least one additional window through which light is detected by a light detecting portion of optical sensor 12” [0022]).
Regarding claim 21, Cinbis in view of Wiese teaches all the limitations of claim 1.
Cinbis further teaches wherein the optical detector (100) is further configured for examination of one or more clinical markers, measurements of metabolism, or a combination thereof (“Computer 130 includes an intensity ratio calculation unit 131, an oxygen saturation calculation unit 132, and a CPU 133” and “According to this patent, tissue metabolic rate of oxygen consumption (TMRO.sub.2) may be calculated by combining the blood flow data and oxygen saturation data…” [0046]).
Regarding claim 22, Cinbis in view of Wiese teaches all the limitations of claim 1.
Cinbis further teaches wherein the optical detector (100) is further configured for measurements of deoxyhemoglobin, oxyhemoglobin, and/or metabolism ([0064] states that “an activity sensor is included to provide a signal corresponding to activity of the patient as an indicator of metabolic demand. An activity sensor signal can be used to compute a sensor-indicated rate (SIR) for use in rate-responsive pacing. An activity sensor signal may be used in combination with tissue oxygenation measurements to determine if a heart failure therapy, such as CRT, needs to be adjusted for improving tissue oxygen availability during periods of exercise”).
Regarding claim 23, Cinbis in view of Wiese teaches all the limitations of claim 1.
Cinbis fails to teach wherein the device is a wearable.
However, Wiese further teaches wherein the device is a wearable (see abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Cinbis wherein the device is a wearable, as taught by Wiese, as such modification provides optimal efficiency in presenting information to the user ([0032]).
Regarding claim 24, Cinbis in view of Wiese teaches all the limitations of claim 1.
Cinbis fails to teach wherein the device is miniaturized.
However, Wiese further teaches wherein the device is miniaturized (see abstract indicating that the device is wearable. The wearability of the device implies its miniaturization).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Cinbis wherein the device is miniaturized, as taught by Wiese, as such modification provides optimal efficiency in presenting information to the user ([0032]).
Regarding claim 25, Cinbis in view of Wiese teaches all the limitations of claim 1.
Cinbis fails to teach wherein the device is configured for mobile use.
However, Wiese further teaches wherein the device is miniaturized (see abstract indicating that the device is wearable. The wearability of the device implies that it is configured for mobile use. Also see fig. 4 for a patient wearing the device on a thigh).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Cinbis wherein the device is configured for mobile use, as taught by Wiese, as such modification provides optimal efficiency in presenting information to the user ([0032]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Cinbis in view of Wiese, as applied to claim 1 above, and further in view of Liang, et al., CN 102914270 A.
Regarding claim 2, Cinbis in view of Wiese teaches all the limitations of claim 1.
Cinbis in view of Wiese fails to teach wherein the aperture (150) provides point estimation of optical properties for the device.
However, Liang teaches “a method based on support vector machine regression crystal diameter measuring method, firstly using CCD camera collects the aperture image of the single crystal silicon growing process in the aperture image pre-processing to obtain the estimated sampling point, and then the standard model of the ellipse derived from one for support vector machine regression model, using the -SVR model of weight w and offset b in the model so as to determine the parameter of ellipse fitting”, see abstract, stating in [0006] “A crystal diameter measuring method based on support vector machine regression, firstly using CCD camera collected by the aperture image in single crystal silicon growing process, the aperture image pre-processing to obtain the sampling point estimation, then, a standard model of elliptical derived one epsilon-epsilon-SVR model for support vector machine regression”.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Cinbis as modified by Wiese, wherein the aperture (150) provides point estimation of optical properties for the device, to provide an accurate measure of the region of interest (see abstract) with a reasonable expectation of success as Nakaji also directs to improving optical based oxygenation measurements ([0014]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Cinbis in view of Wiese, as applied to claim 1 above, and further in view of Lo, et al., US 20170227466 A1.
Regarding claim 14, Cinbis in view of Wiese teaches all the limitations of claims 1 above.
Cinbis in view of Wiese fails to teach wherein the single slit comprises dimensions of 2 to 12 mm long and .2 to 2.75 mm wide.
However, Lo teaches “a method of imaging a particle in a flow cytometer includes transmitting a light beam at a fluidic channel to illuminate a fluid sample containing particles to affect the light (e.g., scatter or emit) to be received by a pattern of apertures spatially arranged about the fluidic channel, in which the pattern of apertures includes a substrate structured to form a plurality of slits arranged on the substrate such that different portions of a particle flowing across the pattern of apertures will pass different slits at different times” [0032]. Lo further teaches wherein the aperture (150) is a slit with dimensions of about 2 to 12 mm long and .2 to 2.75 mm wide (“The illustration of the spatial filter depicts an engineered spatial filter design that has ten 100 ?m by 1 mm slits positioned apart in the way of one is immediately after another in both x-direction (transverse to the flow direction) and y-direction (longitudinal to the flow direction).” [0036]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Cinbis as modified by Wiese wherein the aperture (150) is a slit with dimensions of about 2 to 12 mm long and .2 to 2.75 mm wide, as taught by Schenkman, as such modification would allow for improved spatial resolution ([0028]) with a reasonable expectation of success as Nakaji also directs to improving optical based oxygenation measurements ([0014]).
Conclusion
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 Farouk A Bruce whose telephone number is (408)918-7603. The examiner can normally be reached Mon-Fri 8-5pm PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached on (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/FAROUK A BRUCE/ Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797