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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Invention I: Claims 1-7 in the reply filed on March 19 2026 is acknowledged.
Claims 8-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 19 2026.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Darty et al.( US 20170224260) hereinafter Darty et al.
Darty et al. teaches a system and method for measuring tissue oxygenation. Specifically, the present disclosure provides a method and system for determining tissue oxygenation including an electronic device for obtaining a data set comprising a plurality of images of a tissue of interest where each image is resolved at different spectral bands. The spectrum analysis includes determining an approximate value of oxygenated hemoglobin levels and deoxygenated hemoglobin.
Regarding claim 1, Darty et al. teaches a plurality of light sources configured to emit a plurality of incident light beams of different dominant lightening wavelengths;
a light sensor configured to sense a plurality of reflected light beams that are the plurality of incident light beams reflected from a skin surface; and
a processor electrically coupled to the light sensor and configured to generate a blood characteristic value based on a reconstructed spectrum, generated according to the plurality of reflected light beams, and a material absorption coefficient spectrum of the skin surface. Note Fig. 4A, 4B, Paragraph [0047] the imaging device 100 illuminates an area of the body of a subject 22 (e.g., a location on an upper extremity 24 or location on a lower extremity 26 of the subject 22) and generates imaging data of the area. In some implementations, the imaging device 100 illuminates the area of the body of the subject using one or more light sources (120). Such light sources emit light 28 that is reflected by area 24 to form reflected light 30 that is received by sensor module 110. Sensor module 100 includes photo-sensors 112 and filters 114. Paragraph [0060] In some implementations, the programs or software modules identified above correspond to sets of instructions for performing a function described above. The sets of instructions can be executed by one or more processors, e.g., a CPU(s) 210.
Paragraph [0195] Accordingly, different wavelengths of light may be used to examine different depths of a subject's skin tissue. Generally, high frequency, short-wavelength visible light is useful for investigating elements present in the epidermis, while lower frequency, long-wavelength visible light is useful for investigating both the epidermis and dermis. Furthermore, certain infra-red wavelengths are useful for investigating the epidermis, dermis, and subcutaneous tissues.
[0196] In the visible and near-infrared (VNIR) spectral range and at low intensity irradiance, and when thermal effects are negligible, major light-tissue interactions include reflection, refraction, scattering and absorption.
Regarding claim 2, Darty et al. teaches wherein the plurality of light sources include a first light source, a second light source, and a third light source, wherein a dominant lightening wavelength band of the first light source, a dominant lightening wavelength of the second light source, and a dominant lightening wavelength of the third light source are different from each other.
Note Figs. 4A, 4B and Paragraph [0195] Accordingly, different wavelengths of light may be used to examine different depths of a subject's skin tissue. Generally, high frequency, short-wavelength visible light is useful for investigating elements present in the epidermis, while lower frequency, long-wavelength visible light is useful for investigating both the epidermis and dermis. Furthermore, certain infra-red wavelengths are useful for investigating the epidermis, dermis, and subcutaneous tissues.
[0196] In the visible and near-infrared (VNIR) spectral range and at low intensity irradiance, and when thermal effects are negligible, major light-tissue interactions include reflection, refraction, scattering and absorption.
Regarding claim 3, Darty et al. teaches wherein the dominant lightening wavelength of the first light source, the dominant lightening wavelength of the second light source, and the dominant lightening wavelength of the third light source are a short-wavelength band of visible light, a long-wavelength band of visible light, and a near-infrared band respectively.
Note Figs. 4A, 4B and Paragraph [0195] Accordingly, different wavelengths of light may be used to examine different depths of a subject's skin tissue. Generally, high frequency, short-wavelength visible light is useful for investigating elements present in the epidermis, while lower frequency, long-wavelength visible light is useful for investigating both the epidermis and dermis. Furthermore, certain infra-red wavelengths are useful for investigating the epidermis, dermis, and subcutaneous tissues.
[0196] In the visible and near-infrared (VNIR) spectral range and at low intensity irradiance, and when thermal effects are negligible, major light-tissue interactions include reflection, refraction, scattering and absorption.
Regarding claim 4, Darty et al. teaches wherein the first light source, the second light source, and the third light source are configured to emit corresponding one of the plurality of incident light beams to the skin surface at different time points separately.
Note Figs. 4A, 4B and Paragraph [0084] In some implementations, hyperspectral imaging system captures (408) a first subset of the plurality of images concurrently at a first time point, and captures a second subset of the plurality of images at a second time point other than the first time point. For example, a concurrent capture imaging system (e.g., system 800 in FIG. 8) concurrently captures four images, one each at photo-sensors 112-1 to 112-4, each image at a different spectral band in the predetermined set of eight to ten spectral bands, in a first capture event. The concurrent capture imaging system then concurrently captures four more images, one each at photo-sensors 112-1 to 112-4, each image at a different spectral band in the predetermined set of eight to ten spectral bands, in a second capture event. As such, the concurrent capture imaging system captures images at eight of the predetermined set of eight to ten spectral bands between the first and second capture events. In some implementations, more than three capture events (e.g., three, four, or five capture events) can be used to capture images at all the predetermined set of eight to twelve spectral bands.
Regarding claim 6, Darty et al. teaches wherein the blood characteristic value is a blood oxygen concentration value. Note Figs. 4A, 4B and Paragraph [0067] In some implementations, the spectral analyzer analyzes a particular spectra derived from hyperspectral data cube data, the spectra having pre-defined spectral ranges (e.g., spectral ranges specific for a particular physiologic arterial parameter and/or medical condition), by comparing the spectral characteristics of a pre-determined physiologic arterial parameter and/or medical condition to the subject's spectra within the defined spectral ranges. In some implementations, the pre-defined spectral ranges correspond to values of one or more of deoxyhemoglobin levels, oxyhemoglobin levels, total hemoglobin levels, oxygen saturation, oxygen perfusion, hydration levels, total hematocrit levels, melanin levels, and collagen levels of a tissue on a patient (e.g., an area 24 or 26 of the body of a subject 22). Performing such a comparison only within defined spectral ranges can both improve the accuracy of the characterization and reduce the computational power needed to perform such a characterization.
Regarding claim 7, Darty et al. teaches wherein the processor is further configured to calibrate, based on a plurality of physiological parameters, the blood characteristic value to generate a calibrated blood characteristic value.
Note Figs. 4A, 4B and Paragraph [0065] In some implementations, the system memory 220 includes a spectral library and a spectral analyzer for comparing hyperspectral data generated by the image device 100 to known spectral patterns associated with various physiologic parameters and/or medical conditions. In some implementations, analysis of the acquired hyperspectral data is performed on an external device such as a handheld device, tablet computer, laptop computer, desktop computer, an external server, for example in a cloud computing environment or processing and/or storage center 50. Paragraph [0066] In some implementations, a spectral library includes profiles for a plurality of physiologic arterial parameters and/or medical conditions, each of which contains a set of spectral characteristics unique to the medical condition. A spectral analyzer uses the spectral characteristics to determine the probability that a region of the subject corresponding to a measured hyperspectral data cube is afflicted with a physiologic parameter and/or medical condition. In some implementations, each profile includes additional information about the physiological parameter and/or condition, e.g., information about whether the condition is malignant or benign, options for treatment, etc. In some implementations, each profile includes biological information, e.g., information that is used to modify the detection conditions for subjects of different skin types (interpreted as a calibration or adjustment of the measurement based on the physiologic parameters) . In some implementations, the spectral library is stored in a single database. In other implementations, such data is instead stored in a plurality of databases that may or may not all be hosted by the same computer, e.g., on two or more computers addressable by wide area network. In some implementations, the spectral library is electronically stored in the storage unit 220 and recalled using the controller 208 when needed during analysis of hyperspectral data cube data.
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Darty et al.( US 20170224260) hereinafter Darty et al. in view of Wong(WO 2019184812) hereinafter Wong.
Darty et al. teaches the claimed invention as set forth above including in paragraph [0067] In some implementations, the spectral analyzer analyzes a particular spectra derived from hyperspectral data cube data, the spectra having pre-defined spectral ranges (e.g., spectral ranges specific for a particular physiologic arterial parameter and/or medical condition), by comparing the spectral characteristics of a pre-determined physiologic arterial parameter and/or medical condition to the subject's spectra within the defined spectral ranges. In some implementations, the pre-defined spectral ranges correspond to values of one or more of deoxyhemoglobin levels, oxyhemoglobin levels, total hemoglobin levels, oxygen saturation, oxygen perfusion, hydration levels, total hematocrit levels, melanin levels, and collagen levels of a tissue on a patient (e.g., an area 24 or 26 of the body of a subject 22). Performing such a comparison only within defined spectral ranges can both improve the accuracy of the characterization and reduce the computational power needed to perform such a characterization. Paragraph [0195] Accordingly, different wavelengths of light may be used to examine different depths of a subject's skin tissue. Generally, high frequency, short-wavelength visible light is useful for investigating elements present in the epidermis, while lower frequency, long-wavelength visible light is useful for investigating both the epidermis and dermis. Furthermore, certain infra-red wavelengths are useful for investigating the epidermis, dermis, and subcutaneous tissues. [0196] In the visible and near-infrared (VNIR) spectral range and at low intensity irradiance, and when thermal effects are negligible, major light-tissue interactions include reflection, refraction, scattering and absorption.
Darty et al. does not specifically teach wherein the blood characteristic value is a glycated hemoglobin concentration value.
Wong teaches method of monitoring an analyte in blood, particularly glycated-hemoglobin (HbA1c or HgbA1c) uses two photoplethysmography(PPG) sensors (101, 103, 201, 203, 205, 207), which are worn on the body of a subject. Each photoplethysmography sensor (101, 103, 201, 203, 205, 207) observes the blood of the subject in a different wavelength. One of the wavelengths monitors glycated-hemoglobin. The other one of the wavelengths monitors the body of blood in general. The shapes of the pulses obtained by each of the PPG sensors from the subject are used to adjust the intensity of the light emitted by the PPG sensors into the subject. If on adjustment of the light intensity, the shapes of the pulses become similar, the size of the pulses can be used to provide quasi-quantification of the analyte. the analyte in the blood in an artery of a life subject is glycated hemoglobin; and the first wavelength is selected from 1) about 275nm, 2) about 340nm to 350nm, 3) about 415nm to 420nm, 4) about 540nm; or 5) about 580nm; and the second wavelength being in the red or infrared range. Typically, infrared wavelength from 700nm to 1000nm or beyond can be used for most organic compounds. Preferably, the second wavelength is about 940nm or 840nm for monitoring blood content in the artery. Nevertheless, the second wavelength is not restricted to the infrared range and can be selected from any suitable ultraviolet or visible wavelength in 400nm to 700nm. Optionally, the method comprises the further steps of: providing a third light source, the third light source emitting light in a third wavelength into the tissue of the subject to obtain a second-analyte-pulse; adjusting the intensity of the light emitted by the light source, the intensity of the light emitted by the second light source and/or the intensity of the light emitted by the third light source until the shape of the analyte-pulse, the shape of the second-analyte-pulse and the shape of the blood-pulse are similar, i.e. above a pre-determined similarity threshold.
Therefore It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Darty et al. a measurement of glycated hemoglobin as taught by Wong as one of the many tissue parameters measured to allow for improved detection of Diabetic and prediabetic conditions.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
BECHTEL(KR 20180128063) teaches The probe tip 110 is configured to contact tissue (e.g., a patient's skin) from which tissue oxygen is to be measured. The probe tip 110 includes first and second source structures 120a and 120b (generally a source structure 120), and the first, second, third, fourth, fifth, Sixth, seventh, and eighth detector structures 125a through 125h (generally detector structure 125). In alternative embodiments, the oxygen meter probe includes more or fewer source structures, more or fewer detector structures, or both. Each source structure 120 is configured to emit light (e.g., infrared light) and includes one or more light sources, e.g., four light sources that generate emitted light. Each light source may emit one or more light wavelengths. Each light source may include a light emitting diode (LED), a laser diode, an organic light emitting diode (OLED), a Quantum dot LED (QMLED), or other types of light sources. The probe tip 110 is configured to contact tissue (e.g., a patient's skin) from which tissue oxygen is to be measured. The probe tip 110 includes first and second source structures 120a and 120b (generally a source structure 120), and the first, second, third, fourth, fifth, Sixth, seventh, and eighth detector structures 125a through 125h (generally detector structure 125). In alternative embodiments, the oxygen meter probe includes more or fewer source structures, more or fewer detector structures, or both. Each source structure 120 is configured to emit light (e.g., infrared light) and includes one or more light sources, e.g., four light sources that generate emitted light. Each light source may emit one or more light wavelengths. Each light source may include a light emitting diode (LED), a laser diode, an organic light emitting diode (OLED), a Quantum dot LED (QMLED), or other types of light sources. Measurement information for substantially all wavelengths of light (e.g., visible light, IR, or both) is transmitted from the source into the tissue and detected by the detector.
CAFFERTY (RU 2730438) teaches a sensor system for oximeter to be used in a whole blood oxygen analyzer. Sensor system includes a light-emitting module, a light source housing, a light detector and a cuvette unit. Light-emitting module includes a group of light sources comprising at least two light-emitting diodes (LED) of visible light and an infrared LED having a wavelength range in the near infrared wavelength range. The light emitting module comprises a group of light sources comprising a plurality of light emitting diodes (LEDs) comprising at least a first visible light LED (short wavelength range), a second visible light LED (long wavelength range), and infrared LED.
EOM et al.( 4360538) teaches an apparatus for estimating a concentration of a component includes a sensor including a plurality of light sources having different central wavelengths and at least one detector configured to detect light, and a processor configured to determine a first reflectance of skin using a first light source of the plurality of light sources, set an operating condition of the sensor based on the determined first reflectance, drive the plurality of light sources according to the operating condition, and estimate a concentration of an analyte component based on a plurality of light quantities detected from skin by the at least one detector.
XAYSANASY(US 20190104975) teaches a glycated hemoglobin measurement device which creates calibration data through patient sampling to determine an average voltage value from the detector that is assigned to value. The device reduces calibration data size to reduce diagnostic capabilities across broad range of patient types. The device reduces patient specific device accuracy and accuracy of entire groups or classifications of patients.
SHAW(US 4114604) teaches an improved catheter oximeter operates on radiation at three or more different wavelengths applied to and scattered back from blood under test to provide an indication of oxygen saturation and is considerably less sensitive to accuracy-degrading variations in the blood and its environment and in the oximeter measuring system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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, Charles Marmor can be reached at (571)272-4730. 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.
/BRIAN L CASLER/Primary Examiner, Art Unit 3791
Prosecution Insights