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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 2 and 11-12 are objected to because of the following informalities:
Claim 2 “the light from the first optical emitter” should be “light from the first optical emitter”.
Claim 2 “the light from the second optical emitter” should be “light from the second optical emitter”.
Claim 11 “the light from the first optical emitter” should be “light from the first optical emitter”.
Claim 11 “the light from the second optical emitter” should be “light from the second optical emitter”.
Claim 12, “in pulsed mode” should be “in a pulsed mode” or similar.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5, 7-8, 10-12, 14, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Zielinski (US 20180055386 A1).
Regarding claim 1, 10, and 18, Zielinski teaches a system (system 5) comprising:
a medical device (device 10) including:
at least one optical emitter configured to output light to tissue of a patient (Paragraph 0071-- the first and second sensors 12, 14 may include, or use, other sensing apparatus other than electrodes such as optical sensors; paragraph 0076-- an optical sensor including a light emitter 21 and a light detector 22 for measuring an arterial pulse waveform); and
a first optical detector and a second optical detector configured to receive the light reflected from the tissue of the patient (Paragraph 0071, 0076); and processing circuitry (Paragraph 0057, 0061, 0073-- exemplary implantable devices 10 may generally include an operating system that may employ microprocessor 54 to control device functions) configured to:
receive an indication from the first optical detector of a pressure wave from a cardiac contraction passing the first optical detector (Paragraph 0071-- Regardless of the sensing modality, the first and second sensors 12, 14 may sense and generate a first and second signal, respectively, that includes a natural pulse originating from the heart or an artificial pulse originating from a pulse generator than traverses the patient's tissue, blood vessel structure, etc. Further, as shown, the second sensor 14 measures the second electrical signal in a location further along a circulatory path from the patient's heart than the where the first sensor 12 measures the first electrical signal.);
receive an indication from the second optical detector of the pressure wave from the cardiac contraction passing the second optical detector (Paragraph 0071);
determine a pulse transit time of the pressure wave between the first optical detector and the second optical detector based on: the received indication from the first optical detector, and the received indication from the second optical detector (Paragraph 0073-0076-- A pulse transit time calculation may be derived from the difference in time between fiducial points in the two signals 16, 17 and/or two time stamps/markers. Additionally, in one or more embodiments, single device calculations, such as pulse transit time calculations, can also be used in place of transmitting data representative of the first and second signals 16, 17 to the external monitoring device 20, and subsequently, the pulse transit times can be transmitted to the external monitoring device 20); and
output an electronic signal comprising a health indication for the patient based on the determined pulse transit time (Paragraph 0072-0073, 0076-- the signals 16, 17 could be displayed on the display 76 of the external monitoring device 20 is a user desired to do so …the pulse transit times can be transmitted to the external monitoring device 20).
Regarding claim 2, 11, and 19, Zielinski teaches the system of claim 1, 10, and 18. Zielinski additionally teaches wherein the at least one optical emitter comprises a first optical emitter and a second optical emitter ((Paragraph 0071-- the first and second sensors 12, 14 may include, or use, other sensing apparatus other than electrodes such as optical sensors; paragraph 0076-- an optical sensor including a light emitter 21 and a light detector 22 for measuring an arterial pulse waveform; it is noted that with sensors 12, 14 being configured as optical sensors including a light emitter 21 and 22 as described in paragraph 0076, each sensor would thus include an emitter and a detector)),
wherein the first optical detector is configured to receive the light from the first optical emitter reflected from the tissue of the patient (Paragraph 0073--A first signal 16 may be sensed from the first sensor 12), and
wherein the second optical detector is configured to receive the light from the second optical emitter reflected from the tissue of the patient (Paragraph 0073--The second signal 17 may be sensed by, or from, the second sensor 14 on the same device 10).
Regarding claim 5, Zielinski teaches the system of claim 1. Zielinski additionally teaches wherein the medical device is configured to be implanted in the patient (Paragraph 0070—implantable device 10).
Regarding claim 7, Zielinski teaches the system of claim 1. Zielinski additionally teaches wherein the medical device comprises the processing circuitry (Paragraph 0057, 0061, 0073-- exemplary implantable devices 10 may generally include an operating system that may employ microprocessor 54 to control device functions).
Regarding claim 8, 14, and 20, Zielinski teaches the system of claim 1, 10, and 18. Zielinski additionally teaches wherein the first optical detector and the second optical detector define a vector between the first optical detector and the second optical detector (Fig. 5A-5B shows vector between sensors 12 and 14, which may include optical detectors), and
wherein the medical device is arranged relative to a blood vessel carrying the pressure wave (Fig. 5A-5B, positioned relative to artery 3):
wherein the blood vessel is located within a field of the light output by the optical emitter (See Fig. 5B which demonstrates light field of an optical emitter of sensors 12/14 in the artery 3), and
wherein the vector is other than perpendicular to a longitudinal axis of the blood vessel (Figs. 5A-5B, vector is not perpendicular).
Regarding claim 12, Zielinski teaches the device of claim 10. Zielinski additionally teaches wherein the processing circuitry is configured to operate the medical device in pulsed mode (Paragraph 0045-0046, 0049, 0084--… the device or plurality of devices may compare a sensed or pulsed signal of a first period or a referenced time point to a sensed signal of a subsequent period).
Claim(s) 1-2, 4-5, 7, 9-11, 13, and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Kuhn (US 20200397355 A1).
Regarding claim 1, 10, and 18, Kuhn teaches a medical system (Medical device system 2; paragraph 0033), the system comprising:
a medical device (implantable device 10) including:
at least one optical emitter configured to output light to tissue of a patient (light emitter(s) 38; paragraph 0076--Light emitter(s) 38 include a light source, such as an LED, that may emit light at one or more wavelengths within the visible (VIS) and/or near-infrared (NIR) spectra);
a first optical detector and a second optical detector configured to receive the light reflected from the tissue of the patient (proximal and distal light detectors 40A and 40B; paragraph 0076, 0080--Light detectors 40A, 40B each may receive light from light emitter(s) 38 that is reflected by the tissue);
processing circuitry (processing circuitry 14/50; paragraph 0033-0034, 0080--Processing circuitry of IMD 10 then may evaluate the electrical signals from light detectors 40A, 40B) configured to:
receive an indication from the first optical detector of a pressure wave from a cardiac contraction passing the first optical detector (Paragraph 0076, 0080--generate electrical signals indicating the intensities of the light detected by light detectors 40A, 40B);
receive an indication from the second optical detector of the pressure wave from the cardiac contraction passing the second optical detector (Paragraph 0076, 0080);
determine a pulse transit time of the pressure wave between the first optical detector and the second optical detector based on: the received indication from the first optical detector, and the received indication from the second optical detector (paragraph 0034, 0064, 0071-- medical device system 2 may be configured to monitor one or more parameters in addition to or instead of any of, StO.sub.2, SpO.sub.2, patient motion level, patient posture, ambient light level, optical signal quality, impedance, heart rate, heart rate variability, respiration rate, pulse transit time… sensors on IMD 10 or one or more other implanted or external devices may be configured to sense signals associated with such parameters…Processing circuitry 14 may determine a pulse transit time value); and
output an electronic signal comprising a health indication for the patient based on the determined pulse transit time (paragraph 0034, 0036, 0053, 0064, 0071, 0108-- processing circuitry 14 may output an alert).
Regarding claim 2, 11, and 19, Kuhn teaches the system of claim 1, 10, and 18. Kuhn additionally teaches wherein the at least one optical emitter comprises a first optical emitter and a second optical emitter, wherein the first optical detector is configured to receive the light from the first optical emitter reflected from the tissue of the patient, and wherein the second optical detector is configured to receive the light from the second optical emitter reflected from the tissue of the patient (light emitter(s) 38 and light detectors 40A and 40B; paragraph 0025-0026, 0035, 0076-0081—two or more light emitters…IMD 10 may include only one of light detectors 40A, 40B, or may include additional light emitters and/or additional light detectors…Light detectors 40A, 40B each may receive light from light emitter(s) 38 that is reflected by the tissue…).
Regarding claim 4 and 13, Kuhn teaches the system of claim 1 and 10. Kuhn additionally teaches wherein a distance between the first optical detector and the second optical detector is less than or equal to fifty millimeters (mm) (paragraph 0068-- a spacing between proximal electrode 16A and distal electrode 16B may range from about 30-55 millimeters (mm), about 35-55 mm, or about 40-55 mm, or more generally from about 25-60 mm. Overall, IMD 10 may have a length L of about 20-30 mm, about 40-60 mm, or about 45-60 mm. NOTE: per Fig. 2, the distance between the detectors 40A and 40B must be less than the distance “L” and the spacing between the electrodes 16A and 16B such that is must be less than or equal to fifty millimeters).
Regarding claim 5, Kuhn teaches the system of claim 1. Kuhn additionally teaches wherein the medical device is configured to be implanted in the patient(IMD 10; paragraph 0033, 0056, 0067-0074—IMD 10 is implanted…).
Regarding claim 7, Kuhn teaches the system of claim 1. Kuhn additionally teaches wherein the medical device comprises the processing circuitry (processing circuitry 14/50 is part of the IMD 10, Figs. 2-3).
Regarding claim 9, Kuhn teaches the system of claim 1. Kuhn additionally teaches wherein the medical device comprises an energy storage component configured to provide power to components of the medical device, and wherein the energy storage component is a battery (Power source 68; paragraph 0026, 0090-- the IMD may be powered by a power source (e.g., a battery)… Power source 68 may include a battery and a power generation circuit to produce the operating power).
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) 3, 6, 16, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zielinski in view of Hilgers (US 20200345246 A1).
Regarding claim 3 and 17, Zielinski teaches the system of claim 1 and 10. However, Zielinski fails to explicitly disclose wherein the medical device is configured to determine a change in pulse transit time of less than or equal to 100 microseconds (µsec).
Hilgers, in the same field of endeavor of a device utilizing an optical sensor for determining pulse transit time, teaches wherein the medical device is configured to determine a change in pulse transit time of less than or equal to 100 microseconds (µsec) (Paragraph 0057-- a sample time interval of 100 microseconds).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Zielinski to include the sampling time of Hilgers in order to predictably improve the accuracy of the device by enabling measurement of very small changes in the pulse transit time which would allow for more precise and accurate monitoring for changes in hemodynamic status (see Hilgers, paragraph 0058-- higher sample rate will increase the accuracy of measurement).
Regarding claim 6 and 16, Zielinski teaches the system of claim 1 and 10. Zielinski additionally teaches that pulse wave velocity and pulse transit time are similar parameters which may be calculated using the device (Paragraph 0041-0042—pulse wave velocity…). However, Zielinski fails to explicitly disclose wherein the processing circuitry is further configured to calculate a pulse wave velocity for the pressure wave based on the pulse transit time.
Hilgers, in the same field of endeavor of a device utilizing an optical sensor for determining pulse transit time, teaches processing circuitry of the device is further configured to calculate a pulse wave velocity for the pressure wave based on the pulse transit time (Paragraph 0011-0012, 0055-0057-- PWV is derived from the pulse transit time (PTT)… PWV is obtained by: PWV=D/PTT, where D refers to the pulse travel distance…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Zielinski to include the pulse wave velocity calculation of Hilgers in order to predictably improve the device by enabling the determination of additional hemodynamic parameters which may indicate a health state of the user.
Claim(s) 4, 9, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zielinski in view of Kuhn (US 20200397355 A1).
Regarding claim 4 and 13, Zielinski teaches the system of claim 1 and 10. However, Zielinski fails to explicitly disclose wherein a distance between the first optical detector and the second optical detector is less than or equal to fifty millimeters (mm).
Kuhn, in the same field of endeavor of a device utilizing an optical sensor for determining pulse transit time, teaches wherein a distance between the first optical detector and the second optical detector is less than or equal to fifty millimeters (mm) (paragraph 0068-- a spacing between proximal electrode 16A and distal electrode 16B may range from about 30-55 millimeters (mm), about 35-55 mm, or about 40-55 mm, or more generally from about 25-60 mm. Overall, IMD 10 may have a length L of about 20-30 mm, about 40-60 mm, or about 45-60 mm. NOTE: per Fig. 2, the distance between the detectors 40A and 40B must be less than the distance “L” and the spacing between the electrodes 16A and 16B such that is must be less than or equal to fifty millimeters).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the distance between optical detectors to less than or equal to 50 millimeters in order to predictably improve the ability of the device to be placed in small vessels of the body by having an overall small size.
Regarding claim 9, Zielinski teaches the system of claim 1. However, Zielinski fails to explicitly disclose wherein the medical device comprises an energy storage component configured to provide power to components of the medical device, and wherein the energy storage component is a battery.
Kuhn, in the same field of endeavor of a device utilizing an optical sensor for determining pulse transit time, teaches wherein the medical device comprises an energy storage component configured to provide power to components of the medical device, and wherein the energy storage component is a battery (Power source 68; paragraph 0026, 0090-- the IMD may be powered by a power source (e.g., a battery)… Power source 68 may include a battery and a power generation circuit to produce the operating power).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Zielinski to include a battery as described by Kuhn in order to predictably improve the ability of the device to be used for long term monitoring of a user without explanting the device by enabling the device to remain powered without requiring removal.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zielinski in view of Ferber (US 20170245767 A1).
Regarding claim 15, Zielinski teaches the device of claim 10. However, Zielinski fails to explicitly disclose wherein the processing circuitry is configured to determine the pulse transit time of the pressure wave between the first optical detector and the second optical detector based on: a derivative of the received indication from the first optical detector, and a derivative of the received indication from the second optical detector.
Ferber, in the same field of endeavor of a device utilizing an optical sensor for determining pulse transit time, teaches wherein the processing circuitry is configured to determine the pulse transit time of the pressure wave between the first optical detector and the second optical detector based on: a derivative of the received indication from the first optical detector, and a derivative of the received indication from the second optical detector (Paragraph 0179—pulse transit time (PTT) features… the transit time may be measured as… (2) the distance between the peaks in first derivatives between the two LED-PD systems).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Zielinski to additionally calculate the pulse transit time based on derivatives as disclosed by Ferber in order to predictably improve the accuracy of the device by enabling the PTT to be calculated in two different ways such that a second calculation may be used to confirm or average with the first calculation to allow a user to ignore measurements likely to be erroneous or outliers and/or to reduce error through averaging multiple determined values.
Claim(s) 3, 6, 8, 14, 16-17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuhn in view of in view of Hilgers (US 20200345246 A1).
Regarding claim 3 and 17, Kuhn teaches the system of claim 1 and 10. However, Kuhn fails to explicitly disclose wherein the medical device is configured to determine a change in pulse transit time of less than or equal to 100 microseconds (µsec).
Hilgers, in the same field of endeavor of a device utilizing an optical sensor for determining pulse transit time, teaches wherein the medical device is configured to determine a change in pulse transit time of less than or equal to 100 microseconds (µsec) (Paragraph 0057-- a sample time interval of 100 microseconds).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Kuhn to include the sampling time of Hilgers in order to predictably improve the accuracy of the device by enabling measurement of very small changes in the pulse transit time which would allow for more precise and accurate monitoring for changes in hemodynamic status (see Hilgers, paragraph 0058-- higher sample rate will increase the accuracy of measurement).
Regarding claim 6 and 16, Kuhn teaches the system of claim 1 and 10. However, Kuhn fails to explicitly disclose wherein the processing circuitry is further configured to calculate a pulse wave velocity for the pressure wave based on the pulse transit time.
Hilgers, in the same field of endeavor of a device utilizing an optical sensor for determining pulse transit time, teaches processing circuitry of the device is further configured to calculate a pulse wave velocity for the pressure wave based on the pulse transit time (Paragraph 0011-0012, 0055-0057-- PWV is derived from the pulse transit time (PTT)… PWV is obtained by: PWV=D/PTT, where D refers to the pulse travel distance…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Kuhn to include the pulse wave velocity calculation of Hilgers in order to predictably improve the device by enabling the determination of additional hemodynamic parameters which may indicate a health state of the user.
Regarding claim 8, 14, and 20, Kuhn teaches the system of claim 1, 10, and 18. Kuhn generally teaches that wherein the first optical detector and the second optical detector define a vector between the first optical detector and the second optical detector (Fig. 2, a vector between detector 40A and detector 40B), and wherein the medical device is arranged relative to a blood vessel carrying the pressure wave (Fig. 1, paragraph 0033, wherein being positioned near the sternum near or just below the level of the heart is relative to a blood vessel carrying the pressure wave): wherein the blood vessel is located within a field of the light output by the optical emitter (Paragraph 0005, 0034, 0055, 0064, 0080-0081-- sensors including one or more optical sensors (not illustrated in FIG. 1), which collectively detect signals…oxygen saturation level of the patient's tissue may affect the amount of light that is absorbed by blood within the tissue adjacent IMD 10).
However, Kuhn fails to explicitly disclose wherein the vector is other than perpendicular to a longitudinal axis of the blood vessel.
Hilgers, in the same field of endeavor of a device utilizing an optical sensor for determining pulse transit time, teaches wherein the first optical detector and the second optical detector define a vector between the first optical detector and the second optical detector, and wherein the medical device is arranged relative to a blood vessel carrying the pressure wave: wherein the blood vessel is located within a field of the light output by the optical emitter, and wherein the vector is other than perpendicular to a longitudinal axis of the blood vessel (Fig. 5—the device 10a is arranged relative to a blood vessel carrying the pressure wave wherein the blood vessel is located within a field of light output by actuator 12, 12’, where the position of sensors 18 and 18’ forms a vector other than perpendicular to the longitudinal axis of the blood vessel 16 (shown in Fig. 1); paragraph 0092-0096 ).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Kuhn to include the spatial arrangement of Hilgers in order to predictably improve the device by allowing a detection of a natural pulse wave and blood flow velocity in the vessel (see Hilgers, paragraph 0095-0096).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuhn in view of Zielinski.
Regarding claim 12, Kuhn teaches the medical device of claim 10. However, Kuhn fails to explicitly disclose wherein the processing circuitry is configured to operate the medical device in pulsed mode.
Zielinski, in the same field of endeavor of an implantable device for assessing pulse transit time, discloses wherein the processing circuitry is configured to operate the medical device in pulsed mode (Paragraph 0045-0046, 0049, 0084--… the device or plurality of devices may compare a sensed or pulsed signal of a first period or a referenced time point to a sensed signal of a subsequent period).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Kuhn to include a pulsed mode as described by Zielinski in order to predictably improve the device by allowing for monitoring not just the PTT but also a change in PTT over different periods of time and/or relative to other signals such as respiratory or cardiac events.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuhn in view of Ferber (US 20170245767 A1).
Regarding claim 15, Kuhn teaches the device of claim 10. However, Kuhn fails to explicitly disclose wherein the processing circuitry is configured to determine the pulse transit time of the pressure wave between the first optical detector and the second optical detector based on: a derivative of the received indication from the first optical detector, and a derivative of the received indication from the second optical detector.
Ferber, in the same field of endeavor of a device utilizing an optical sensor for determining pulse transit time, teaches wherein the processing circuitry is configured to determine the pulse transit time of the pressure wave between the first optical detector and the second optical detector based on: a derivative of the received indication from the first optical detector, and a derivative of the received indication from the second optical detector (Paragraph 0179—pulse transit time (PTT) features… the transit time may be measured as… (2) the distance between the peaks in first derivatives between the two LED-PD systems).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Kuhn to additionally calculate the pulse transit time based on derivatives as disclosed by Ferber in order to predictably improve the accuracy of the device by enabling the PTT to be calculated in two different ways such that a second calculation may be used to confirm or average with the first calculation to allow a user to ignore measurements likely to be erroneous or outliers and/or to reduce error through averaging multiple determined values.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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, Alexander Valvis can be reached at (571) 272-4233. 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.
/ANNA ROBERTS/Examiner, Art Unit 3791
Prosecution Insights