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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to U.S. Provisional App. No. 63/223,210 filed July 19, 2021.
Status of Claims
This Office Action is responsive to the claims filed on 08/06/2025. Claims 2, 19, and 22 were previously cancelled. Claims 1, 5, 11, 16, 18, 20, 21, and 23 have been amended. Claim 17 has been cancelled. Claims 1, 3-16, 18, 20, 21, and 23 are presently pending in this application.
Claim Objections
Claim 16 is objected to because of the following informalities:
Claim 16, line 4: “of the lung tissue” lacks proper antecedent basis and should be amended to read “of lung tissue”.
Claim 16, line 11: “into lung tissue of the patient” should be amended to read “into the lung tissue of the patient”, such that the lung tissue refers to “lung tissue” now recited in line 4.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “optical emitter” in claim 1, line 4, claim 16, line 7, and claim 21, line 5; “optical detector” in claim 1, line 7, claim 16, line 9, and claim 21, line 8; and “a second optical emitter” in claim 8, line 1. The corresponding structure for the optical emitters defined within the specification is “light emitting diodes (LED), vertical-cavity surface-emitting lasers (VCSELs), electroluminescent (EL) devices” (Pg. 20, Lines 21-23) and any functional equivalents. The corresponding structure for the optical detector defined within the specification is “a photodiode, a phototransistor, a charge-coupled device (CCD), a junction field effect transistor (JFET) optical sensor, a complementary metal-oxide semiconductor (CMOS) optical sensor, an integrated photo detector integrated circuit, a light to voltage converter” (Pg. 20, Lines 23-27) and any functional equivalents.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1, 3-6, 8-10, 12-16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bang (US 20220192600) in view of Nitzan (US 20130310669).
Regarding claim 1, Bang teaches a monitoring device (Paragraph [0052]; implantable cardiac monitoring device (ICM), device 100, Fig. 1) comprising:
an implantable housing (Paragraph [0052]; other implantable devices, including, but not limited to: a biocompatible housing; Paragraph [0085]; Implantable device 100 comprises one or more housings, housing 101 shown, Fig. 3) defining an interior volume (Paragraph [0085]; housing 101 can comprise a volume, Fig. 3 shows an interior volume), the implantable housing comprising:
control circuitry disposed within the interior volume (Paragraph [0091]; Implantable device 100 can further comprise a module configured to control; control assembly 160; Fig. 3);
an optical emitter (Paragraph [0093]; Functional element 190 can comprise one, two or more sensors, transducers…; consisting of: a light) coupled to the implantable housing (Paragraph [0093]; implantable device 100 further comprises one or more functional elements, functional element 190 shown) and in electrical communication with the control circuitry (Paragraph [0091]; Control assembly 160 can further comprise processor 165. Processor 165 can comprise an electronic module configured to instruct one or more components of implantable device 100 to perform one or more functions; Fig. 3), wherein the optical emitter is configured to emit light at a first wavelength (Paragraph [0042]; light energy to tissue (e.g. a transducer comprising a laser, light emitting diode and/or optical component such as a lens or prism)); and
an optical detector (Paragraph [0093]; an optical sensor, Fig. 3) coupled to the implantable housing (Paragraph [0093]; implantable device 100 further comprises one or more functional elements, functional element 190 shown, Fig. 3) and in electrical communication with the control circuitry (Paragraph [0091]; Control assembly 160 can further comprise processor 165. Processor 165 can comprise an electronic module configured to instruct one or more components of implantable device 100 to perform one or more functions), wherein the optical detector is configured to detect incident light (Paragraph [0093]; an optical sensor;); and
wherein the monitoring device is configured to be implanted in a subcutaneous tissue of a patient (Paragraph [0084]; Implantable device 100 comprises one or more devices that are configured to be implanted under the skin of a patient (e.g. implantable device 100 can be implanted into subcutaneous tissue) and collect patient data (e.g. patient physiologic data) from one or more sensors positioned under the skin of the patient).
Bang does not explicitly teach the monitoring device is an optical cardiogenic modulation monitoring device wherein the monitoring device is configured so that light emitted from the optical emitter propagates through lung tissue;
wherein the control circuitry is configured to use detected incident light to measure cardiogenic oscillations of the lung tissue.
Nitzan, however, teaches an optical cardiogenic modulation monitoring device (Paragraphs [0033] and [0055]; a method is presented for the measurement of the pulmonary PPG signal; The preferred pulse oximeter is a device) comprising:
an optical emitter (Paragraphs [0035]-[0039] and [0043]; light source; such as a laser diode or LED, Fig. 6), wherein the optical emitter is configured to emit light at a first wavelength (Paragraphs [0009] and [0042]; PPG probe consists of a light source emitting light into the tissue; infrared light which is less absorbed than visible light, is preferred… infrared light, of 700-1000 nm wavelength); and
an optical detector (Paragraphs [0035]-[0039] and [0044]; a detector are applied to the thoracic wall of a patient and the detector measures the light which was emitted from the light source; The "detector" thus defined may be an electro-optic light detecting element, such as a PIN diode or avalanche photodiode, Fig. 6), wherein the optical detector is configured to detect incident light (Paragraphs [0035]-[0039] and [0044]; light detecting element which detects the light scattered from the tissue);
wherein the monitoring device is configured so that light emitted from the optical emitter propagates through lung tissue (Paragraphs [0034]-[0039]; light emitted from a light-source reaches the lungs and that the light transmitted through the lung tissue is detected, Fig. 6);
wherein the control circuitry is configured to use detected incident light to measure cardiogenic oscillations of the lung tissue (Paragraph [0033]; a method is presented for the measurement of the pulmonary PPG signal, presenting the oscillations at the heart rate of the transmission of light through a region in the microcirculation of the pulmonary system, Figs. 2 and 3; Examiner notes the measured PPG signal is a result of cardiogenic oscillations as understood in light of the Applicant’s specification, pg. 33, ln. 7-13 and Fig. 24, and is thus considered to read on the claimed limitation of using detected incident light to measure cardiogenic oscillations of the lung tissue in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have configured the device of Bang to have further used the detected incident light to measure cardiogenic oscillations of the lung tissue and thus additionally have been an optical cardiogenic modulation monitoring device by performing the monitoring method as taught by Nitzan because it would further increase the utility of the device by measuring of parameters such as dissolved oxygen deep within the lung (Nitzan, Paragraph [0033]) and obtaining the PPG amplitude which is used to provide information on the arterial compliance of the systemic circulation (Nitzan, Paragraph [0009]) thereby giving more information about the state of the cardiopulmonary system and allowing more accurate diagnoses of lung or heart problems.
Regarding claim 3, together Bang and Nitzan teach all of the limitations of claim 1 as noted above.
Bang discloses the invention as claimed and discussed above, but fails to explicitly disclose at least one of absorption, scattering and phase of the light detected by the optical detector is used to measure cardiogenic oscillations of the lung tissue.
Nitzan, however, further teaches the at least one of absorption and scattering of the light detected by the optical detector is used to measure cardiogenic oscillations of the lung tissue (Paragraphs [0047] and [0058]; These methods derive the required parameter from spectroscopic absorption measurements; a significant quantity of the light reaching the detector have been scattered by the lung tissue and the PPG pulse will mainly represent the blood volume changes in the pulmonary circulation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the optical detector of Bang in view of Nitzan to have used the absorption and scattering of the light to measure cardiogenic oscillations of the lung tissue because it would have been a well-understood method of obtaining the PPG signal, and thus measuring oxygen saturation of blood (Nitzan, Paragraphs [0006], [0009], and [0047]) that further allows measurement of concentrations of blood analytes (Paragraph [0013]) thereby providing additional information about the cardiopulmonary system.
Regarding claim 4, together Bang and Nitzan teach all of the limitations of claim 3 as noted above.
Bang discloses the invention as claimed and discussed above, but fails to explicitly disclose the absorption is used to determine an optical density of an optical path from the optical emitter to the optical detector and the optical density is used to measure the cardiogenic oscillations of the lung tissue.
Nitzan, however, further teaches the absorption is used to determine an optical density of an optical path from the optical emitter to the optical detector and the optical density is used to measure the cardiogenic oscillations of the lung tissue (Paragraphs [0013]-[0015] and [0051]; The transmitted light intensity, through a tissue sample which includes vessels with whole blood is based on Beer-Lambert law and is given by equation (2) where l is the effective optical path-length… α is the absorption constant of the tissue; in the pulmonary pulse oximetry technique, if the difference between the pathlengths of the two wavelengths in the infrared is significant, calibration by extracted blood from the pulmonary artery is required; Examiner notes the calculation of the absorption constant is considered to read on an optical density in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have configured the device of Bang in view of Nitzan to have used the absorption to determine an optical density of an optical path from the optical emitter to the optical detector and the optical density is used to measure the cardiogenic oscillations of the lung tissue as taught by Nitzan. This would have allowed measurement of the PPG signal and further using the PPG signal to assess the oxygen saturation of the tissue (Nitzan, Paragraph [0005]).
Regarding claim 5, together Bang and Nitzan teach all of the limitations of claim 1 as noted above.
Bang discloses the invention as claimed and discussed above, but fails to explicitly disclose both an AC component and a DC component of the light detected by the optical detector are used to determine used to measure the cardiogenic oscillations of the lung tissue.
Nitzan, however, further teaches both an AC component (Paragraphs [0009] and [0013]-[0015]; The amplitude of the PPG signal, (ID-IS), is related to the maximal change in arterial blood volume during systole) and a DC component (Paragraphs [0009] and [0013]-[0015]; The minimal value of the PPG signal, IS) of the light detected by the optical detector are used to determine used to measure the cardiogenic oscillations of the lung tissue (Paragraphs [0013]-[0015] and [0051]; ln(ID/IS) can be approximated by ΔIa/IS; the ratio R, defined by equation (5); the determination of the relationship between SaO2 and the measured parameter R derived from the two PPG signals).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the device of Bang in view of Nitzan such that both an AC component and a DC component of the light are detected by the optical detector and are used to determine used to measure the cardiogenic oscillations of the lung tissue as taught by Nitzan. This would have allowed deriving the oxygen saturation of the tissue (Nitzan, Paragraph [0015]) that further could be used for pulse oximetry without needing to perform a calibration (Nitzan, Paragraph [0051]).
Regarding claim 6, together Hedberg, Nitzan, and Kuhn teach all of the limitations of claim 1 as noted above.
Bang discloses the invention as claimed and discussed above, but fails to explicitly disclose the first wavelength is from 800 nm to 1000 nm.
Nitzan, however, further teaches the first wavelength is from 800 nm to 1000 nm (Paragraph [0051]; wavelengths in the infrared are preferably used for the measurement of the pulmonary PPG signals; Paragraph [0042]; infrared light, of 700-1000 nm wavelength).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Bang in view of Nitzan such that the first wavelength is from 800 nm to 1000 nm as taught by Nitzan because it would allow the measurement of light absorption of arterial blood required for the determination of oxygen saturation by measuring the difference in absorption between the pathlengths of red and infrared PPG signals. (Paragraph [0051]).
Regarding claim 8, together Bang and Nitzan teach all of the limitations of claim 1 as noted above.
Bang discloses the invention as claimed and discussed above, but fails to explicitly disclose a second optical emitter;
wherein the second optical emitter is configured to emit light at a second wavelength.
Nitzan further teaches the device further comprises a second optical emitter (Paragraph [0041]; a second detector can be attached to the esophageal wall or the thoracic wall, where the second detector and the light source are separated by less than 8 mm); wherein the second optical emitter is configured to emit light at a second wavelength (Paragraphs [0041]-[0045]; the measurement of pulmonary PPG in two wavelengths provides information on the oxygen saturation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Bang in view of Nitzan to have included a second optical emitter; wherein the second optical emitter is configured to emit light at a second wavelength as taught by Nitzan because it would have allowed determining an approximation of the dissolved oxygen by obtaining a ratio of the absorbance between the two wavelengths of light (Nitzan, Paragraph [0052]).
Regarding claim 9, together Bang and Nitzan teach all of the limitations of claim 8 as noted above.
Bang discloses the invention as claimed and discussed above, but fails to explicitly disclose the second wavelength is a near-infrared wavelength.
Nitzan, however, further teaches the second wavelength is a near-infrared wavelength (Paragraphs [0021], [0025], and [0042]; using pulse oximetry based on two infrared light emitting diodes (peak wavelengths 767 and 811 nm); infrared light, of 700-1000 nm wavelength; FIG. 1b is a plot of the extinction coefficients… as a function of the wavelength, in the near-infrared region; Examiner notes the wavelengths of 767 and 811 fall within the NIR region shown in Fig. 1b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the second wavelength in the device of Bang in view of Nitzan to have been a near-infrared wavelength because it is preferable to use two adjacent wavelengths in the infrared because it results in a small difference between their pathlength, thus not requiring the use of calibration (Nitzan, Paragraph [0051]).
Regarding claim 10, together Bang and Nitzan teach all of the limitations of claim 8 as noted above.
Bang discloses the invention as claimed and discussed above, but fails to explicitly disclose the second wavelength is from 750 nm to 1500 nm and different than the first wavelength.
Nitzan further teaches the second wavelength is a near-infrared wavelength (Paragraphs [0021], [0025], and [0042]; using pulse oximetry based on two infrared light emitting diodes (peak wavelengths 767 and 811 nm); infrared light, of 700-1000 nm wavelength; The wavelengths of 767 and 811 nm are different).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the second wavelength in the device of Bang in view of Nitzan to have been from 750 nm to 1500 nm and different than the first wavelength as taught by Nitzan because it would have allowed determining an approximation of the dissolved oxygen by obtaining a ratio of the absorbance between the two wavelengths of light (Nitzan, Paragraph [0052]); and furthermore it is preferable to use two adjacent wavelengths in the infrared because it results in a small difference between their pathlength, thus not requiring the use of calibration (Nitzan, Paragraph [0051]).
Regarding claim 12, together Bang and Nitzan teach all of the limitations of claim 1 as noted above.
Bang discloses the invention as claimed and discussed above, but fails to explicitly disclose the optical emitter is disposed from 1 cm to 10 cm away from the optical detector.
Nitzan, however, further teaches the optical emitter is disposed from 1 cm to 10 cm away from the optical detector (Paragraph [0054]; In the pulmonary pulse oximeter the light-sources emit infrared light and the light sources-detector separation is higher than 10-20 mm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Bang in view of Nitzan such that the optical emitter is disposed from 1 cm to 10 cm away from the optical detector as further taught by Nitzan because it would have allow penetration of light to depth of 10-20 mm relative to the measurement surface, which contains pulmonary tissue in order to measure the oxygen saturation in internal tissue (Paragraph [0054]).
Regarding claim 13, together Bang and Nitzan teach all of the limitations of claim 1 as noted above.
Bang discloses the invention as claimed and discussed above, but fails to explicitly disclose the light from the optical emitter propagates a depth of 1 cm to 5 cm into the lung tissue as measured from a surface of the optical cardiogenic monitoring device.
Nitzan further teaches the light from the optical emitter propagates a depth of 1 cm to 5 cm into the lung tissue as measured from a surface of the optical cardiogenic monitoring device (Paragraph [0054]; allow penetration of light to depth of 10-20 mm relative to the measurement surface, which contains pulmonary tissue).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Bang in view of Nitzan such that the light from the optical emitter propagates a depth of 1 cm to 5 cm into the lung tissue as measured from a surface of the optical cardiogenic monitoring device as taught by Nitzan because it would have ensured the light propagated passes through pulmonary tissue, thereby ensuring the oxygen saturation is measured from the pulmonary tissue.
Regarding claim 14, together Bang and Nitzan teach all of the limitations of claim 1 as noted above.
Bang further teaches the device further comprises at least one of a posture sensor (Paragraph [0052]; an accelerometer (e.g. a three-axis accelerometer or other sensor for monitoring patient activity level, body posture and/or body position)), and heart rate sensor (Paragraph [0057]-[0059]; System 10 can be configured to determine a heart rate and activity calculation to perform a heart rate variability (HRV) assessment).
Regarding claim 15, together Bang and Nitzan teach all of the limitations of claim 14 as noted above.
Bang fails to explicitly disclose the cardiogenic oscillation measurements are interpreted in view of at least one of heart rate, respiration, circadian rhythm, and posture.
Nitzan further teaches the cardiogenic oscillation measurements are interpreted in view of at least one of heart rate (Paragraph [0034]; The light transmitted through the lung tissue oscillates at the heart rate, like the systemic PPG, and like the latter the pulmonary PPG is related to the blood volume change in the pulmonary arteries through Equation 1) and respiration (Paragraph [0063]; In another preferred embodiment the pulmonary PPG signal is obtained during specific phase of the respiration).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Bang in view of Nitzan such that the cardiogenic oscillation measurements are interpreted in view of at least one of heart rate and respiration because it would have allowed the pulmonary PPG signal to provide information on cardiovascular parameters in the cardio-pulmonary system during different parts of the cardiac and respiratory cycles (Nitzan, Paragraph [0034]).
Regarding claim 16, Bang teaches a method (Paragraph [0052]; implantable cardiac monitoring device (ICM), device 100, Fig. 1; Paragraph [0064]; Implantation of device 100) comprising:
implanting an monitoring device (Paragraph [0064]; Implantation of device 100 can be performed during a brief (e.g. between 1 and 5 minutes) procedure in an office,) in the patient subcutaneously (Paragraph [0084]; Implantable device 100 comprises one or more devices that are configured to be implanted under the skin of a patient (e.g. implantable device 100 can be implanted into subcutaneous tissue)) at or near a site of the lung tissue (Paragraph [0087]; can be positioned within housing 101, and configured to record sounds (e.g. heart or lung sounds)), the monitoring device comprising an implantable housing (Paragraph [0052]; other implantable devices, including, but not limited to: a biocompatible housing; Paragraph [0085]; Implantable device 100 comprises one or more housings, housing 101 shown, Fig. 3) defining an interior volume (Paragraph [0085]; housing 101 can comprise a volume, Fig. 3 shows an interior volume), the implantable housing comprising:
control circuitry disposed within the interior volume (Paragraph [0091]; Implantable device 100 can further comprise a module configured to control; control assembly 160; Fig. 3):
an optical emitter (Paragraph [0093]; Functional element 190 can comprise one, two or more sensors, transducers…; consisting of: a light) coupled to the implantable housing (Paragraph [0093]; implantable device 100 further comprises one or more functional elements, functional element 190 shown) and in electrical communication with the control circuitry (Paragraph [0091]; Control assembly 160 can further comprise processor 165. Processor 165 can comprise an electronic module configured to instruct one or more components of implantable device 100 to perform one or more functions; Fig. 3):
and an optical detector (Paragraph [0093]; an optical sensor, Fig. 3) coupled to the implantable housing (Paragraph [0093]; implantable device 100 further comprises one or more functional elements, functional element 190 shown, Fig. 3) and in electrical communication with the control circuitry (Paragraph [0091]; Control assembly 160 can further comprise processor 165. Processor 165 can comprise an electronic module configured to instruct one or more components of implantable device 100 to perform one or more functions);
emitting light with the optical emitter into lung tissue of the patient;
detecting incident light with the optical detector; and
measuring cardiogenic oscillations in the patient based on the light detected by the optical detector; and
wherein the emitted light is configured to propagate through the lung tissue of the patient from the optical emitter to the optical detector in an arc-shaped optical path.
Bang does not explicitly teach the monitoring device is an optical cardiogenic modulation monitoring device for measuring cardiogenic oscillations in a patient; and
emitting light with the optical emitter into lung tissue of the patient;
detecting incident light with the optical detector; and
measuring cardiogenic oscillations in the patient based on the light detected by the optical detector; and
wherein the emitted light is configured to propagate through the lung tissue of the patient from the optical emitter to the optical detector in an arc-shaped optical path.
Nitzan, however, teaches a method for measuring cardiogenic oscillations (Paragraphs [0033] and [0055]; a method is presented for the measurement of the pulmonary PPG signal) in a patient (Paragraph [0035]; applied to the thoracic wall of a patient) comprising:
using an optical cardiogenic monitoring device in a patient (Paragraph [0038]; A light source is applied to the thoracic wall of a patient and a detector is inserted into the esophagus and brought into close contact with its wall in a site where the pulmonary tissue is in tight proximity to the esophageal wall), the optical cardiogenic monitoring device comprising an optical emitter (Paragraphs [0035]-[0039] and [0043]; light source; such as a laser diode or LED, Fig. 6) and an optical detector (Paragraphs [0035]-[0039] and [0044]; a detector are applied to the thoracic wall of a patient and the detector measures the light which was emitted from the light source; The "detector" thus defined may be an electro-optic light detecting element, such as a PIN diode or avalanche photodiode, Fig. 6);
emitting light with the optical emitter into the lung tissue of the patient (Paragraphs [0009] and [0042]; PPG probe consists of a light source emitting light into the tissue; infrared light which is less absorbed than visible light, is preferred… infrared light, of 700-1000 nm wavelength);
detecting incident light with the optical detector (Paragraphs [0035]-[0039] and [0044]; light detecting element which detects the light scattered from the tissue); and
measuring cardiogenic oscillations in the patient based on the light detected by the optical detector (Paragraph [0033]; a method is presented for the measurement of the pulmonary PPG signal, presenting the oscillations at the heart rate of the transmission of light through a region in the microcirculation of the pulmonary system, Figs. 2 and 3; Examiner notes the measured PPG signal is a result of cardiogenic oscillations as understood in light of the Applicant’s specification, pg. 33, ln. 7-13 and Fig. 24, and is thus considered to read on the claimed limitation of using detected incident light to measure cardiogenic oscillations of the lung tissue in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Bang to have included measuring cardiogenic oscillations in a patient; the monitoring device being an optical cardiogenic monitoring device; and measuring cardiogenic oscillations in the patient based on the light detected by the optical detector as taught by Nitzan because it would further increase the utility of the device using the method by measuring of parameters such as dissolved oxygen deep within the lung (Nitzan, Paragraph [0033]) and obtaining the PPG amplitude which is used to provide information on the arterial compliance of the systemic circulation (Nitzan, Paragraph [0009]) thereby giving more information about the state of the cardiopulmonary system and allowing more accurate diagnoses of lung or heart problems.
Regarding claim 20, together Bang and Nitzan teach all of the limitations of claim 16 as noted above.
Bang discloses the invention as claimed and discussed above, but fails to explicitly disclose emitting light with the optical emitter into the lung tissue of the patient comprises propagating the light from 1 cm to 5 cm into the tissue of the patient relative to a surface of the optical cardiogenic monitoring device.
Nitzan further teaches the light from the optical emitter propagates a depth of 1 cm to 5 cm into the lung tissue as measured from a surface of the optical cardiogenic monitoring device (Paragraph [0054]; allow penetration of light to depth of 10-20 mm relative to the measurement surface, which contains pulmonary tissue).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Bang in view of Nitzan such that the light from the optical emitter propagates a depth of 1 cm to 5 cm into the lung tissue as measured from a surface of the optical cardiogenic monitoring device as taught by Nitzan because it would have ensured the light propagated passes through pulmonary tissue, thereby ensuring the oxygen saturation is measured from the pulmonary tissue.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bang in view of Nitzan as applied to claim 1 above, and further in view of DiLorenzo (US 20200268536).
Regarding claim 7, together Bang and Nitzan teach all of the limitations of claim 1 as noted above.
Together Bang and Nitzan fail to explicitly disclose the first wavelength is from 150 nm to 250 nm.
DiLorenzo, however, teaches a device (Paragraphs [0034] and [0426]; The apparatus for performing the stimulation are also described) comprising an optical emitter (Paragraphs [0139] and [0428]; Said modulator may take the form of … optical source; modulation comprising at least one of stimulation… optical stimulation) configured to emit light at a first wavelength, wherein the first wavelength is from 150 nm to 250 nm (Paragraph [0428]; ultraviolet C (UV-C) 280 nm-200 nm, and vacuum UV (UV-V) 200 nm-100 nm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Bang in view of Nitzan such that the optical emitter is configured to further emit light at a wavelength of 150 to 250 nm as it would have allowed stimulation of the nervous system (DiLorenzo, Paragraph [0034]) in the event of cardiac failure or other detected heart diseases and failures (DiLorenzo, Paragraph [0493]).
Claims 11 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Bang (US 20220192600) in view of Nitzan (US 20130310669) and Hedberg (US 20100106210).
Regarding claim 11, together Bang and Nitzan teach all of the limitations of claim 1 as noted above.
Together Bang and Nitzan do not explicitly teach the housing comprising a flexible member extending from the housing, wherein at least one of the optical emitter and the optical detector are disposed on the flexible member.
Hedberg, however, teaches a housing (Paragraph [0057]; pacemaker 2 has a housing, Fig. 1) comprising a flexible member extending from the housing (Paragraph [0057]; pacemaker lead 6a coupled to the pacemaker 2, Fig. 1), wherein at least one of the optical emitter and the optical detector are disposed on the flexible member (Paragraph [0057]; one lead 6a comprises a light source 4 and one light detector 9, Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the housing of Bang in view of Nitzan to have included a flexible member extending from the housing, wherein at least one of the optical emitter and the optical detector are disposed on the flexible member as taught by Hedberg because it would have allowed the optical sensor to be directed and position to specific tissue when the implantable device is implanted away from the target area (Paragraph [0057]-[0058]).
Regarding claim 21, Bang teaches a monitoring device (Paragraph [0052]; implantable cardiac monitoring device (ICM), device 100, Fig. 1) comprising:
an implantable housing (Paragraph [0052]; other implantable devices, including, but not limited to: a biocompatible housing; Paragraph [0085]; Implantable device 100 comprises one or more housings, housing 101 shown, Fig. 3) defining an interior volume (Paragraph [0085]; housing 101 can comprise a volume, Fig. 3 shows an interior volume), the implantable housing comprising:
control circuitry disposed within the interior volume (Paragraph [0091]; Implantable device 100 can further comprise a module configured to control; control assembly 160; Fig. 3);
an optical emitter (Paragraph [0093]; Functional element 190 can comprise one, two or more sensors, transducers…; consisting of: a light) coupled to the implantable housing (Paragraph [0093]; implantable device 100 further comprises one or more functional elements, functional element 190 shown) and in electrical communication with the control circuitry (Paragraph [0091]; Control assembly 160 can further comprise processor 165. Processor 165 can comprise an electronic module configured to instruct one or more components of implantable device 100 to perform one or more functions; Fig. 3), wherein the optical emitter is configured to emit light at a first wavelength (Paragraph [0042]; light energy to tissue (e.g. a transducer comprising a laser, light emitting diode and/or optical component such as a lens or prism)); and
an optical detector (Paragraph [0093]; an optical sensor, Fig. 3) coupled to the implantable housing (Paragraph [0093]; implantable device 100 further comprises one or more functional elements, functional element 190 shown, Fig. 3) and in electrical communication with the control circuitry (Paragraph [0091]; Control assembly 160 can further comprise processor 165. Processor 165 can comprise an electronic module configured to instruct one or more components of implantable device 100 to perform one or more functions), wherein the optical detector is configured to detect incident light (Paragraph [0093]; an optical sensor;); and
wherein the optical cardiogenic monitoring device is configured to be implanted in a subcutaneous tissue of a patient (Paragraph [0084]; Implantable device 100 comprises one or more devices that are configured to be implanted under the skin of a patient (e.g. implantable device 100 can be implanted into subcutaneous tissue) and collect patient data (e.g. patient physiologic data) from one or more sensors positioned under the skin of the patient).
Bang does not explicitly teach the monitoring device is an optical cardiogenic modulation monitoring device wherein the monitoring device is configured so that light emitted from the optical emitter propagates through lung tissue;
wherein the control circuitry is configured to use detected incident light to measure cardiogenic oscillations of the lung tissue; and
Nitzan, however, teaches an optical cardiogenic modulation monitoring device (Paragraphs [0033] and [0055]; a method is presented for the measurement of the pulmonary PPG signal; The preferred pulse oximeter is a device) comprising:
an optical emitter (Paragraphs [0035]-[0039] and [0043]; light source; such as a laser diode or LED, Fig. 6), wherein the optical emitter is configured to emit light at a first wavelength (Paragraphs [0009] and [0042]; PPG probe consists of a light source emitting light into the tissue; infrared light which is less absorbed than visible light, is preferred… infrared light, of 700-1000 nm wavelength); and
an optical detector (Paragraphs [0035]-[0039] and [0044]; a detector are applied to the thoracic wall of a patient and the detector measures the light which was emitted from the light source; The "detector" thus defined may be an electro-optic light detecting element, such as a PIN diode or avalanche photodiode, Fig. 6), wherein the optical detector is configured to detect incident light (Paragraphs [0035]-[0039] and [0044]; light detecting element which detects the light scattered from the tissue);
wherein the monitoring device is configured so that light emitted from the optical emitter propagates through lung tissue (Paragraphs [0034]-[0039]; light emitted from a light-source reaches the lungs and that the light transmitted through the lung tissue is detected, Fig. 6);
wherein the control circuitry is configured to use detected incident light to measure cardiogenic oscillations of the lung tissue (Paragraph [0033]; a method is presented for the measurement of the pulmonary PPG signal, presenting the oscillations at the heart rate of the transmission of light through a region in the microcirculation of the pulmonary system, Figs. 2 and 3; Examiner notes the measured PPG signal is a result of cardiogenic oscillations as understood in light of the Applicant’s specification, pg. 33, ln. 7-13 and Fig. 24, and is thus considered to read on the claimed limitation of using detected incident light to measure cardiogenic oscillations of the lung tissue in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have configured the device of Bang to have further used the detected incident light to measure cardiogenic oscillations of the lung tissue and thus additionally have been an optical cardiogenic modulation monitoring device by performing the monitoring method as taught by Nitzan because it would further increase the utility of the device by measuring of parameters such as dissolved oxygen deep within the lung (Nitzan, Paragraph [0033]) and obtaining the PPG amplitude which is used to provide information on the arterial compliance of the systemic circulation (Nitzan, Paragraph [0009]) thereby giving more information about the state of the cardiopulmonary system and allowing more accurate diagnoses of lung or heart problems.
Together Bang and Nitzan do not explicitly teach wherein the optical emitter and the optical detector are spaced along a common planar surface of the implantable housing.
Hedberg, however, teaches a monitoring device (Paragraph [0057]; a pacemaker 2 implanted in a patient) wherein the optical emitter and the optical detector are spaced along a common planar surface of the implantable housing (Paragraph [0073]; Fig. 9 shows the light source 74 and the light detector 79 are spaced along a common planar surface of the implantable housing).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Bang in view of Nitzan such that the optical emitter and the optical detector are spaced along a common planar surface of the implantable housing as taught by Hedberg because it would have allowed light to have entered the lung and further allow detection of scattered light penetrating deep into the lung tissue, thereby allowing measurement of the change of the amount blood and other fluids in the lung (Paragraph [0022]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Bang in view of Nitzan as applied to claim 16 above, and further in view of An (US 20180344252).
Regarding claim 18, together Bang and Nitzan teach all of the limitations of claim 16 as noted above.
Together Bang and Nitzan do not explicitly teach implanting the optical cardiogenic monitoring device subcutaneously comprises implanting the optical cardiogenic monitoring device in an intercostal space at or near the site of the lung tissue.
An, however, teaches a method of monitoring a patient (Paragraph [0004]; a method of treating a patient using an implantable medical device (IMD), the method comprising detecting activity of a body part of the patient using at least one oscillatory sensor of the IMD) comprising implanting a monitoring device subcutaneously (Paragraph [0074]; For example, the one or more of the electrodes 426A-426F and oscillatory sensors 428A, 428B may be positioned subcutaneously) in a patient (Paragraph [0065]; The intercostal veins #24, 26 may be a final implant location for a device or lead, or may provide an avenue for implantation of a device) in an intercostal space at or near the site of the lung tissue (Paragraphs [0063]-[0067]; The intercostal veins #24, 26 may be a final implant location for a device; The left anterior intercostal vein #68, Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Bang in view of Nitzan such that the device is implanted subcutaneously in an intercostal space at or near the site of the lung tissue. This would further enhance the IMD’s ability to detect various activity of the lungs and provide physiological parameters regarding the overall health of the patient such as respiratory interval, respiratory amplitude, respiratory sound, respiratory depth, respiratory rate, a frequency of oscillation, and/or a pattern of oscillation of the lungs may indicate that the patient may be experiencing wheezing, rales, snoring, rhonchi, a pathological asymmetrical respiratory pattern (An, Paragraph [0127]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Bang in view of Nitzan as applied to claim 1 above, and further in view of Dixon (US 20220248993).
Regarding claim 23, together Bang and Nitzan teach all of the limitations of claim 1 as noted above.
Bang teaches an accelerometer to detect posture (Paragraph [0052]; an accelerometer (e.g. a three-axis accelerometer or other sensor for monitoring patient activity level, body posture and/or body position)).
Together Bang and Nitzan do not explicitly teach the cardiogenic oscillation measurements are interpreted in view the posture.
Dixon, however, teaches a optical cardiogenic modulation monitoring device (Paragraph [0005]; apparatus for determining data indicative of blood oxygen levels of internal organs) wherein the cardiogenic oscillation measurements (Paragraph [0047]; In some embodiments, the method further comprises averaging the determined modified ratio of ratio values using the cardiac oscillations across the phase of the respiratory cycle) are interpreted in view the posture (Paragraph [0237]-[0239]; one or more signals predominantly associated with the lung, the apparatus 100 may be positioned in the vicinity of the upper region of the lungs (e.g. near the apex of the lungs) where the lungs are above heart and the subject is oriented in a semi-upright body position).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Bang in view of Nitzan such that the cardiogenic oscillation measurements are interpreted in view the posture as taught by Dixon. This is because the blood flow may be dependent on the postural position of the person. Unlike other organs of the body, oxygen levels fall during systole and increase during diastole. In addition, the changes in oxygen levels during the pulse period are very large (Paragraph [0238]).
Response to Arguments
Claim Objections
Examiner acknowledges the amendments to the claim 16. The amendments to claim 16 raises new objections which are now presented.
Claim Interpretation under – 35 U.S.C. § 112(f)
Examiner maintains all claim interpretations under 35 U.S.C. § 112(f).
Claim Rejections under – 35 U.S.C. § 112(b)
Examiner acknowledges the amendments to claim 20 and withdraws all previous rejections under 35 USC 112(b).
Claim Rejections under – 35 U.S.C. § 102 and 103
Applicant’s arguments with respect to the previous 35 U.S.C. § 103 rejections have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
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.
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/DEAN N EDUN/Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 11/19/25
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