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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/19/2026 has been entered.
Response to Amendment
The amendment filed 02/19/2026 has been entered. Amendments to claims 1, 6, 8, 9, 11, 16 and 17, cancellation of claims 3, 7, 10, 18 and 19, and new claims 21-24 are acknowledged. Claims 1, 2, 4-6, 8, 9, 11-17 and 20-24 remain pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “about” in claim 21 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. “About” renders the wavelengths indefinite as it is unclear what wavelength constitutes “about 605”.
Claim Rejections - 35 USC § 103
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 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.
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.
Claim(s) 1-2, 4-6, 8-9, 11-12, 14, 16-17, 21, and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cinbis (US 20120108923) in view of Pesach et al. (US 20060251146 A1).
Regarding claim 1, Cinbis discloses an optical monitoring device (title) comprising: an implantable housing defining an interior volume ([0008]: “An exemplary implantable medical device described herein may include a hermetically sealed housing”), the implantable housing comprising: control circuitry disposed within the interior volume ([0010]: “a control module”); a first optical emitter coupled to the implantable housing and in electrical communication with the control circuitry, wherein the first optical emitter is configured to emit light at a first wavelength ([0021]: “a first optical sensor portion 14 including at least one light emitting device 26 and at least one light detecting device”, [0029]: “The two light emitting devices 26 and 48 emit light corresponding to two different wavelengths.”); wherein the first wavelength is from 100 nm to 2000 nm ([0029]: “may emit red light and the other emit infrared light.” [0039]: “The intensity of infrared light scattered by the body fluid or tissue can be made independent of the concentration of oxygenated hemoglobin by proper choice of wavelength (e.g., 800 nm).”); a second optical emitter coupled to the implantable housing and in electrical communication with the control circuitry, wherein the second optical emitter is configured to emit light at a second wavelength, an optical detector, coupled to the implantable housing and in electrical communication with the control circuitry ([0026]: “the second optical sensor portion 16 may include a light emitting device 48 (e.g., a light source embodied as an LED) and a light detecting device 46 (e.g., a light detector embodied as a silicon photodiode) co-located with the light emitting device 48”), wherein the optical detector is configured to detect incident light ([0040]: “be coupled to light detecting devices to receive the current or voltage generated by light detecting devices in response to scattered light incident”); wherein the optical temperature monitoring device is configured so that the light from the first optical emitter and the second optical emitter propagates at a depth of at least 1 cm through tissue as measured from a surface of the optical temperature monitoring device and back to the optical detector ([0029]: “may emit red light and the other emit infrared light.”, [0039]: “The intensity of infrared light scattered by the body fluid or tissue can be made independent of the concentration of oxygenated hemoglobin by proper choice of wavelength (e.g., 800 nm).”, wherein NIR may penetrate up to 3 cm depth, see Henderson et al. “Near-infrared photonic energy penetration: can infrared phototherapy effectively reach the human brain?”); wherein a first optical density temperature coefficient of the first wavelength has a lower dependence on blood oxygenation than a second optical density temperature coefficient of the second wavelength ([0039]: “The intensity of infrared light scattered by the body fluid or tissue can be made independent of the concentration of oxygenated hemoglobin by proper choice of wavelength (e.g., 800 nm).”, [0029]: “one of light emitting devices 26 and 48 may emit red light and the other emit infrared light.”, wherein per applicant’s specification page 31: “Compared to the optical density temperature coefficients for blood below 700 nm, the optical density temperature coefficient for blood from 800 nm to 1100 nm is more dependent on oxygen saturation.”, thus choosing a wavelength below 700 nm and above 800 nm sufficiently meets the limitation); and wherein the optical temperature monitoring device is configured to be implanted in a tissue of a patient ([0008]: “implantable medical device”).
Cinbis fails to disclose wherein a ratio of a parameter of the incident light on the detector originating from the light emitted at the first wavelength and a parameter of the incident light on the detector originating from the light emitted at the second wavelength is used to determine a temperature of the tissue.
Pesach discloses a temperature sensor (title) wherein the temperature of the tissue is determined from a ratio of a parameter of the incident light on the detector originating from the light emitted at the first wavelength and a parameter of the incident light on the detector originating from the light emitted at the second wavelength ([0063]: “Similarly, a ratio between real and/or imaginary parts of εmat(ω,T) at different frequencies determines a ratio between corresponding real and/or imaginary parts of ε*(ω,T) at the frequencies and can be used, in accordance with an embodiment of the present invention, to determine temperature of the material.”).
As Cinbis discloses the detected light parameters may correlated to a physiological parameter (Cinbis [0046]: “such detected light being used for one or more various purposes (e.g., including sensing of one or more physiological parameters.”) it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to use the determined light parameters disclosed by Cinbis by with the method of using a ratio of light parameters disclosed by Pesach in order to enable non-invasive determination of temperature of an internal region (Pesach [0003]).
Regarding claim 2, Cinbis discloses the light emitted may be red or infrared and further a wavelength of 800 nm ([0029]: “one of light emitting devices 26 and 48 may emit red light and the other emit infrared light.”, [0039]: “(e.g., 800 nm)”). However, Cinbis does not explicitly disclose wherein the first wavelength is from 590 nm to 650 nm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first wavelength to be between 590 nm to 650 nm as applicant appears to have placed no criticality on the claimed range (applicant’s specification page 15 line 26 to page 16 line 5) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 4, Pesach further discloses wherein at least one of absorption, scattering and phase of the incident light detected by the optical detector is used to determine the temperature of the tissue ([0074]: “The absorption length d(ω) for the wave may be estimated by the expression d(ω)=λo(ω)/[2πIm(ε*(ω,T)0.5)] where λo(ω) is the free space wavelength of incident wave 36.”).
Regarding claim 5, Pesach further discloses wherein the absorption is used to determine an optical density of the tissue and the optical density is used to determine the temperature of the tissue ([0020]: “The amount of deposited energy, density and specific heat of the material are used to estimate heating of the material during the measurement and to correct a temperature of the material determined from the permittivity.”).
Regarding claim 6, Cinbis further discloses an applied voltage or current, including, for example, light emitting diodes (LEDs).
Regarding claim 8, Cinbis further discloses wherein the second wavelength is from 750 nm to 1500 nm ([0039]: “(e.g., 800 nm)”).
Regarding claim 9, Cinbis further disclose wherein the second wavelength has an optical density temperature coefficient that is less than the first wavelength ([0039]: “The intensity of infrared light scattered by the body fluid or tissue can be made independent of the concentration of oxygenated hemoglobin by proper choice of wavelength (e.g., 800 nm).”, [0029]: “one of light emitting devices 26 and 48 may emit red light and the other emit infrared light.”).
Regarding claim 11, Cinbis further discloses a flexible member; wherein at least one of the optical emitter and the optical detector are disposed on the flexible member extending from the implantable housing ([0051]: “Lead 300 includes an elongated body 302 extending between a proximal end 312 and a distal end 310. The optical sensor 304 may be positioned along lead body 302, typically near distal end 310.”); and wherein the flexible member extends outward from the implantable housing (Fig 3).
Regarding claim 12, Cinbis further discloses wherein the optical emitter and the optical detector are disposed on a substantially planar surface (Fig 2A elements 26 and 28).
Regarding claim 14, Cinbis further discloses at least one of a pulse oximetry sensor, chemical sensor, posture sensor, and heart rate sensor ([0061]: “include an activity sensor, ECG sensing electrodes, pressure sensors, or other physiological sensors”).
Regarding claim 16, Cinbis discloses wherein the first optical emitter is spaced a distance away from the second optical emitter (Fig 2A elements 26 and 48).
Regarding claim 17, Cinbis discloses a method of measuring physiological parameters of a patient ([0001]: “sense physiological conditions.”) comprising: implanting the optical monitoring device in the tissue ([0052]: “Connector assembly 314 may be coupled to an implantable medical device to thereby couple the optical sensor 304 to associated sensor driver/signal processing circuitry (not shown in FIG. 3) included in, for example, a medical device (e.g., an implantable medical device).”), the optical monitoring device comprising a first optical emitter, a second optical emitter and an optical detector ([0021]: “a first optical sensor portion 14 including at least one light emitting device 26 and at least one light detecting device)”, [0029]: “The two light emitting devices 26 and 48 emit light corresponding to two different wavelengths.”); and orienting the optical temperature monitoring device such that the first optical emitter, the second optical emitter, and the optical detector face internally relative to the skin of the patient (Fig 2A), emitting light with the first optical emitter into the tissue of the patient at a first wavelength ([0029]: “The two light emitting devices 26 and 48 emit light corresponding to two different wavelengths.”); emitting light with the second optical emitter into the tissue of the patient at a second wavelength, wherein a first optical density temperature coefficient of the first wavelength has a lower dependence on blood oxygenation than a second optical density temperature coefficient of the second wavelength ([0039]: “The intensity of infrared light scattered by the body fluid or tissue can be made independent of the concentration of oxygenated hemoglobin by proper choice of wavelength (e.g., 800 nm).”, [0029]: “one of light emitting devices 26 and 48 may emit red light and the other emit infrared light.”, wherein per applicant’s specification page 31: “Compared to the optical density temperature coefficients for blood below 700 nm, the optical density temperature coefficient for blood from 800 nm to 1100 nm is more dependent on oxygen saturation.”, thus choosing a wavelength below 700 nm and above 800 nm sufficiently meets the limitation); wherein the light from the first optical emitter and the second optical emitter propagates at a depth of 1 cm to 5 cm into the tissue as measured from a surface of the optical temperature monitoring device ([0029]: “may emit red light and the other emit infrared light.”, [0039]: “The intensity of infrared light scattered by the body fluid or tissue can be made independent of the concentration of oxygenated hemoglobin by proper choice of wavelength (e.g., 800 nm).”, wherein NIR may penetrate up to 3 cm depth, see Henderson et al. “Near-infrared photonic energy penetration: can infrared phototherapy effectively reach the human brain?”); detecting incident light with the optical detector([0040]: “be coupled to light detecting devices to receive the current or voltage generated by light detecting devices in response to scattered light incident”).
Cinbis discloses the light emitted may be red or infrared and further a wavelength of 800 nm ([0029]: “one of light emitting devices 26 and 48 may emit red light and the other emit infrared light.”, [0039]: “(e.g., 800 nm)”). However, Cinbis does not explicitly disclose wherein the first wavelength is from 590 nm to 650 nm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first wavelength to be between 590 nm to 650 nm as applicant appears to have placed no criticality on the claimed range (applicant’s specification page 15 line 26 to page 16 line 5) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Cinbis fails to disclose using a ratio of a parameter of the incident light on the detector originating from the light emitted at the first wavelength and a parameter of the incident light on the detector originating from the light emitted at the second wavelength.
Pesach discloses a temperature sensor (title) using a ratio of a parameter of the incident light on the detector originating from the light emitted at the first wavelength and a parameter of the incident light on the detector originating from the light emitted at the second wavelength ([0063]: “Similarly, a ratio between real and/or imaginary parts of εmat(ω,T) at different frequencies determines a ratio between corresponding real and/or imaginary parts of ε*(ω,T) at the frequencies and can be used, in accordance with an embodiment of the present invention, to determine temperature of the material.”).
As Cinbis discloses the detected light parameters may correlated to a physiological parameter (Cinbis [0046]: “such detected light being used for one or more various purposes (e.g., including sensing of one or more physiological parameters.”) it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to use the determined light parameters disclosed by Cinbis by with the method of using a ratio of light parameters disclosed by Pesach in order to enable non-invasive determination of temperature of an internal region (Pesach [0003]).
Regarding claim 21, Cinbis discloses wherein the second wavelength is about 850 nm ([0039]). Cinbis discloses the light emitted may be red or infrared ([0029]: “one of light emitting devices 26 and 48 may emit red light and the other emit infrared light.”). However, Cinbis does not explicitly disclose wherein the first wavelength is from 590 nm to 650 nm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first wavelength to 605 nm as applicant appears to have placed no criticality on the claimed range (applicant’s specification page 15 line 26 to page 16 line 5) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 23, Pesach further discloses wherein the temperature of the tissue is calibrated with a second temperature measurement ([0075]: “The amount of heating is used to correct the temperature determined for surface 30 from ε*mat(ω, T).”).
Regarding claim 24 Cinbis discloses wherein at least 50 percent of the light incident upon the optical detector and used to determine the temperature of the tissue has propagated through a tissue at a depth of at least 1 cm as measured from a surface of the device ([0029]: “may emit red light and the other emit infrared light.”, [0039]: “The intensity of infrared light scattered by the body fluid or tissue can be made independent of the concentration of oxygenated hemoglobin by proper choice of wavelength (e.g., 800 nm).”, wherein NIR may penetrate up to 3 cm depth, see Henderson et al. “Near-infrared photonic energy penetration: can infrared phototherapy effectively reach the human brain?”);.
Claim(s) 13 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cinbis in view of Pesach in further view of Bernreuter (US 7865223 B1).
Regarding claim 13, Cinbis as modified by Pesach discloses the optical temperature monitoring device of claim 1 but fails to disclose the optical emitter is disposed from 1 cm to 10 cm away from the optical detector.
Bernreuter discloses an optical sensor wherein the optical emitter is disposed from 1 cm to 10 cm away from the optical detector (col 9 lines 42-44: “the emitter-detector distance is either about 4 cm, at least 4 cm, about 2 cm, or less than 2 cm.”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the distance between the optical temperature monitoring device as disclosed by Cinbis to a distance of 1cm to 10cm as disclosed by Bernreuter in order to enhance penetration depth (Bernreuter col 9 lines 36-42).
Regarding claim 20, Cinbis as modified by Pesach discloses the method of claim 17, but fails to disclose the optical emitter is disposed from 1 cm to 10 cm away from the optical detector.
Bernreuter discloses an optical sensor wherein the optical emitter is disposed from 1 cm to 10 cm away from the optical detector (col 9 lines 42-44: “the emitter-detector distance is either about 4 cm, at least 4 cm, about 2 cm, or less than 2 cm.”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the distance between the optical temperature monitoring device as disclosed by Cinbis to a distance of 1cm to 10cm as disclosed by Bernreuter in order to enhance penetration depth (Bernreuter col 9 lines 36-42).
Claim(s) 15 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cinbis in view of Pesach in further view of Pompei et al. (US 20140149065 A1).
Regarding claim 15, Cinbis as modified by Pesach discloses the optical temperature monitoring device of claim 14 but fails to disclose the temperature of the tissue is interpreted in view at least one of heart rate and circadian rhythm.
Pompei discloses a temperature sensor ([0006]) wherein the temperature of the tissue is interpreted in view of at least one of heart rate and circadian rhythm ([0020]: “the processor may adjust the temperature measurement using an asymmetric correction of temperature relative to the circadian cycle.”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the optical temperature monitoring device disclosed by Cinbis in view of Pesach to include the interpretation of the temperature in view of circadian rhythm as disclosed by Pompei in order to improve the accuracy of the temperature measurement (Pompei [0031]: “adjusted temperature measurement that may be used in more accurate determination of body temperature”).
Regarding claim 22, Cinbis as modified by Pesach discloses the device of claim 1 but fails to disclose wherein the temperature measured is a core temperature of the patient.
Pompei discloses wherein the temperature measured is a core temperature of the patient ([0030]: “correspond to core, oral or rectal temperature.”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date prior to the effective filing date to modify the temperature disclosed by Cinbis as modified by Pesach to include core body temperature as disclosed by Pompei in order to obtain a more robust data set.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 2, 4-6, 8, 9, 11-17 and 20-24 under 35 U.S.C. § 103 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAVYA SHOBANA BALAJI whose telephone number is (703)756-5368. The examiner can normally be reached Monday - Friday 2:00 - 6:00 ET.
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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