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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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) 4-5, 7-8 10-11. 13-14, and 16-19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Levi (US 2023/0341548).
Regarding claim 4, Levi discloses (Figs. 1-8I) an external flow monitor, comprising: an
emitter (probe unit 20a) configured to output an incident beam toward a brain of an adult subject (paragraph [0043]);
a receiver (probe unit 20b) configured to detect a reflection of the incident beam from blood vessels in the brain (paragraph [0043]);
a processor (processing unit 28u) configured to:
determine, by analyzing data indicative of the reflection of the incident beam, a magnitude of blood flowing through the brain during an event (paragraphs [0080]-[0081]), the event comprising a cardiac cycle (paragraph [0082]); and
output a signal indicative of the magnitude of blood flowing in the brain (paragraphs [0016] and [0080]).
Regarding claim 5, Levi discloses the incident beam comprises ultrasound having a frequency in a range of 100 kHz to 2 MHz (paragraph [0041]).
Regarding claim 7, Levi discloses the emitter is configured to output the incident beam through an orbital cavity, a temple, or an ear canal of the subject (see Figs. 3B, 4A and 5A).
Regarding claim 8, Levi discloses the processor is configured to determine the magnitude of the blood flowing in the brain by comparing a frequency of the reflection of the incident beam to a frequency of the incident beam (paragraph [0003]).
Regarding claim 10, Levi discloses a transceiver (interface module 28n), wherein the processor is configured to output the signal by causing the transceiver to transmit the signal to a medical device or a mobile device (paragraph [0068]).
Regarding claim 11, Levi discloses an output device (display device, paragraph [0086]), wherein the processor is configured to output the signal by causing the output device to output the signal to a user (paragraph [0090]).
Regarding claim 13, Levi discloses (Figs. 1-8I) a method, comprising:
transmitting an incident beam toward a brain of a subject (via probe unit 20a, paragraph [0043]);
detecting a reflection of the incident beam from blood in blood vessels in the brain of the subject (via probe unit 20b, paragraph [0043]);
estimating a magnitude of blood flowing through the brain by analyzing data indicative of the reflection of the incident beam (paragraphs [0080]-[0081]); and
outputting a signal indicative of the magnitude of blood flowing through the brain (paragraphs [0016] and [0080]).
Regarding claim 14, Levi discloses the incident beam comprises ultrasound having a frequency in a range of 100 kHz to 2 MHz (paragraph [0041]).
Regarding claim 16, Levi discloses transmitting the incident beam toward the blood vessel in the brain of the subject comprises transmitting the incident beam through an orbital cavity, a temple, or an ear canal of the subject (see Figs. 3B, 4A and 5A).
Regarding claim 17, Levi discloses determining the magnitude of the blood flowing through the brain comprises comparing a frequency of the reflection of the incident beam to a frequency of the incident beam (paragraph [0003]).
Regarding claim 18, Levi discloses outputting the signal indicative of the magnitude of blood flowing through the brain comprises transmitting the signal to a medical device or to a mobile device (paragraph [0068]).
Regarding claim 19, Levi discloses outputting the signal indicative of the magnitude of blood flowing through the brain comprises causing an output device (display device, paragraph [0086]) to output the signal to a user (paragraph [0090]).
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.
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.
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) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lampe (US 2021/0045967, hereinafter Lampe ‘967) in view of Levi (US 2023/0341548) and Lampe (US 20230048327, hereinafter Lampe ‘327).
Regarding claim 1, Lampe discloses (Fig. 1) a resuscitation system, comprising:
an external flow monitor (patient monitoring device 108) comprising:
a housing (housing of monitor device 108 shown in Fig. 1);
an emitter (sensor 101a) disposed in the housing and configured to output an ultrasound beam toward the subject (paragraph [0033]);
a receiver (sensor 101b) disposed in the housing and configured to detect a reflection of the ultrasound beam from blood vessels in a brain of the subject (paragraph [0033]);
a transceiver (module that transmits data over network, paragraph [0041]);
a processor (“processor”, paragraph [0041]) configured to:
determine a magnitude of blood flowing in the blood vessels in the brain of the subject by analyzing the reflection of the ultrasound beam from the blood vessel in the brain of the subject (paragraph [0050]);
determine that the magnitude of blood flowing in the blood vessels in the brain is below a threshold (paragraph [0091]).
Lampe ‘967 does not disclose a strap coupled to the housing and configured to hold the external flow monitor on an external surface of a head of the subject, the emitter disposed in the housing; and the receiver disposed in the housing.
However, Levi teaches (Figs. 1-8I) an external flow monitor comprising a strap (head loop strap 13) coupled to the housing and configured to hold the external flow monitor on an external surface of a head of the subject (attaches and holds flow monitor 20 on head of subject, see Fig. 1G and paragraph [0050]), the emitter disposed in the housing (housing 21 that contains emitter 48, paragraph [0064]); and the receiver disposed in the housing (housing 21 that contains receiver 48, paragraph [0067]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Lampe ‘967 to include a strap coupled to the housing and configured to hold the external flow monitor on an external surface of a head of the subject, the emitter disposed in the housing; and the receiver disposed in the housing, as taught by Levi, for the purpose of providing a comfortable and adjustable interface for mounting the sensors to a user so that precise and on-going monitoring of user condition during an event can be performed optimally (Abstract Levi).
Modified Lampe ‘967 does not disclose the system includes a mechanical chest compression device configured to administer chest compressions to a subject; and in response to determining that the magnitude of blood flowing in the blood vessels in the brain is below the threshold, the processor causes the transceiver to transmit, to the mechanical chest compression device, a signal instructing the mechanical chest compression device to change a position, frequency, timing, or depth of the chest compressions.
However, Lampe ‘327 teaches (Fig. 1-5) a system includes a mechanical chest compression device (automated chest compression device 210) configured to administer chest compressions to a subject (paragraph [0103]); and in response to determining that a magnitude of blood flowing in the blood vessels in the brain is below the threshold, the processor causes the transceiver to transmit, to the mechanical chest compression device, a signal instructing the mechanical chest compression device to change a position, frequency, timing, or depth of the chest compressions (paragraph [0116]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Lampe ‘967 to include a mechanical chest compression device configured to administer chest compressions to a subject; and in response to determining that the magnitude of blood flowing in the blood vessels in the brain is below the threshold, the processor causes the transceiver to transmit, to the mechanical chest compression device, a signal instructing the mechanical chest compression device to change a position, frequency, timing, or depth of the chest compressions, as taught by Lampe ‘327, for the purpose of allowing for the chest compressions to be performed automatically without a trained user and to adjust the parameters of the compressions based on sensor data so that CPR of patient can be optimally performed.
Regarding claim 2, modified Lampe ‘627 discloses the emitter is configured to output the ultrasound beam through the subject to measure blood flow in the brain, but does not disclose the beam is outputted through an orbital cavity, a temple, or an ear canal of the subject, and wherein the blood vessels are located in a circle of Willis of the subject.
However, Levi teaches (Figs. 1-8I) the beam is outputted through an orbital cavity, a temple, or an ear canal of the subject (see Fig. 5A), and wherein the blood vessels are located in a circle of Willis of the subject (paragraph [0004]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Lampe ‘627 such that beam is outputted through an orbital cavity, a temple, or an ear canal of the subject, and wherein the blood vessels are located in a circle of Willis of the subject, as taught by Levi, for the purpose of providing for accurate measurement of blood volume in the brain so that therapy can be optimized.
Regarding claim 3, modified Lampe ‘627 discloses an ultrasound beam, but does not disclose the beam has a frequency in a range of 100 kHz to 2 MHz.
However, Levi teaches (Figs. 1-8I) an ultrasound beam that has a frequency in a range of 100 kHz to 2 MHz (paragraph [0041]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Lampe ‘627 such that the beam has a frequency in a range of 100 kHz to 2 MHz, as taught by Levi, for the purpose of providing a frequency sufficient for Doppler ultrasound sensing to occur so that user blood volume can be more accurately measured.
Claims 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Levi (US 2023/0341548) in view of Shapira (US 8,702,615).
Regarding claims 6 and 15, Levi discloses an incident beam,but does not disclose the incident beam comprises infrared light.
However, Shapira teaches (Fig. 2B) a system that utilizes an infrared laser to send an incident beam of infrared light to measure blood flow in the brain (Col. 18 lines 1-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify system/method of Levi such that incident beam comprises infrared light, as taught by Shapira, for the purpose of improving accuracy by decreasing likelihood of Doppler failure (Col. 1 lines 50-60 Shapira).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi (US 2023/0341548) in view of Siedenburg (US 2018/0369065).
Regarding claim 9, Levi discloses the receiver is configured to detect a reflection of the incident beam, but does not disclose the reflection of the beam from a contrast agent disposed in the blood in the blood vessel.
However, Siedenburg teaches (Fig. 1-2) a CPR system comprising a receiver (device 200) configured to detect a reflection of the incident beam from a contrast agent disposed in the blood in the blood vessel (paragraph [0042])
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Levi such that the receiver is configured to detect a reflection of the incident beam from a contrast agent disposed in the blood in the blood vessel, as taught by Siedenburg, for the purpose of increasing the accuracy and/or detectability of blood flow in areas of the patient's body in which it can otherwise be difficult to detect (paragraph [0042] Siedenburg).
Claims 12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Levi (US 2023/0341548) in view of Lampe ‘967 (US 2021/0045967).
Regarding claim 12 and 20, Levi does not the processor is further configured to: determine a volume of the blood flowing through the brain by integrating a velocity of the blood flowing in the blood vessel with respect to time; and determine that the volume of the blood flowing through the brain is below a threshold, wherein the signal indicative of the magnitude of blood flowing in the blood vessel comprises an instruction to initiate or change additional chest compressions administered to the subject.
However, Lampe ‘967 teaches (Figs. 1) a processor further configured to: determine a volume of the blood flowing through the brain by integrating a velocity of the blood flowing in the blood vessel with respect to time (paragraph [0088]); and determine that the volume of the blood flowing through the brain is below a threshold (paragraph [0088]), wherein the signal indicative of the magnitude of blood flowing in the blood vessel comprises an instruction to initiate or change additional chest compressions administered to the subject (paragraph [0092]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Levi so that it is further configured to: determine a volume of the blood flowing through the brain by integrating a velocity of the blood flowing in the blood vessel with respect to time; and determine that the volume of the blood flowing through the brain is below a threshold, wherein the signal indicative of the magnitude of blood flowing in the blood vessel comprises an instruction to initiate or change additional chest compressions administered to the subject, as taught by Lampe ‘967, for the purpose of improving user outcome by adjusting chest compressions based on blood volume data collected in real time from patient.
Regarding claim 20, Levi does not disclose the step of determining that the magnitude of the blood flowing through the brain is below a threshold, wherein the signal indicative of the magnitude of blood flowing through the brain comprises an instruction to initiate or change chest compressions administered to the subject.
However, Lampe ‘967 teaches (Fig. 1) the step of determining that the magnitude of the blood flowing through the brain is below a threshold (paragraph [0091]), wherein the signal indicative of the magnitude of blood flowing through the brain comprises an instruction to initiate or change chest compressions administered to the subject (paragraphs [0088] and [0091]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Levi to include the step of determining that the magnitude of the blood flowing through the brain is below a threshold, wherein the signal indicative of the magnitude of blood flowing through the brain comprises an instruction to initiate or change chest compressions administered to the subject, as taught by Lampe ‘967, for the purpose of optimizing chest compressions so that user can receive better treatment based on current condition.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Adedipe (US 2020/0107989) discloses a CPR device that uses blood flow measurements to adjust operation of the device.
Browning (US 2017/0196465) discloses a US system for measuring blood flow in brain.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R MOON whose telephone number is (571)272-2554. The examiner can normally be reached Monday-Thursday 7:30am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW R MOON/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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