Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/23/26 has been entered.
Response to Arguments
Applicant’s arguments, see Remarks, filed 6/23/26, with respect to the rejection(s) of claim(s) 21-26, 28-35 and 37-40 under Addision have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection are made in view of DiMaio et al. (U.S. Pub. 2009/0275808) and Ayati et al. (U.S. Pub. 2010/0022886).
Claim Interpretation
It is noted that claim 21 states that the treatment device is configured to administer chest compressions and position of the chest compressions is altered in response to receiving the CPR feedback. The Specification is silent as to the treatment device automatically altering positions but provides enough support for the device to be repositioned by a user. In this case the limitation is being analyzed as being repositioned by a user.
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) 21 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Addison et al. (U.S. Pub. 2017/0065484 hereinafter “Addison”) in view of Ayati et al. (U.S. Pub. 2010/0022886) and DiMaio et al. (U.S. Pub. 2009/0275808).
Regarding claim 21, Addison discloses a system, comprising: a medical device (e.g. 10) comprising: an emitter (e.g. 18) configured to generate a signal comprising an electromagnetic wave or a mechanical wave; a detector (e.g. 20) configured to detect a reflection of the signal from a blood vessel of a patient; an electrocardiogram (ECG) sensor (e.g. 16) configured to detect an ECG of the patient; a transmitter (e.g. 28); and a processor (e.g. 50) configured to: determine a metric indicative of blood movement or blood pressure by analyzing the reflection of the signal from the blood vessel of the patient (e.g. ¶¶37-38; [blood flow]); receive the ECG of the patient from the ECG sensor (e.g. ¶47; [ECG sensor]); identify a pulseless electrical activity (PEA) by correlating the metric with the ECG of the patient (e.g. ¶47; [pulseless data]); generate cardiopulmonary resuscitation (CPR) feedback by analyzing the metric and the PEA (e.g. ¶¶47-48; [CPR instructions]); and cause the transmitter to output the CPR feedback (e.g. ¶¶23, 48; [transmitting data]); and a treatment device configured to: administer chest compressions to the patient (e.g. ¶63; [chest compressions]), wherein a position of the chest compressions is altered in response to receiving the CPR feedback (e.g. ¶27; [change position]). Addison discloses the claimed invention except for disclosing the that the emitter and detector are for ultrasound. However, Ayati in the same field of invention clearly discloses using an ultrasound emitter and detector as set forth in paragraphs 9, 11, 22 and 40 to provide analysis to determine if there is a pulse for determining if defibrillation is appropriate for the patient (i.e., whether or not there is a pulse) or whether another form of treatment such as CPR is appropriate. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Addison, with an ultrasound system for determining blood flow as taught by Ayati, since such a modification would provide the predictable results of a non-invasive way of analyzing pulse data and providing CPR feedback. Addision in view of Ayati discloses the claimed invention including the emitter and detector, but fails to teach the emitter and transmitter being an ultrasound system that is configured to be underneath the patient in a cot. However, DiMaio teaches that it is known to use an ultrasound system for sensing data that is embedded in a bed/cot for analyzing and sensing the patient when they are supine in a non-ambulatory position while giving CPR support as set forth in Paragraphs 35, 63, 77, 94 and 121 to provide a means for sensing the patient without having to move or shift the patient. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Addison in view of Ayati, with an ultrasound system embedded in a bed/cot as taught by DiMaio, since such a modification would provide the predictable results of analyzing CPR feedback by sensing data with an ultrasound embedded within a bed/cot for providing a means for sensing the patient without having to move or shift the patient.
Regarding claims 23, Addison further discloses an output device configured to output an instruction to administer a treatment to the patient, the treatment comprising defibrillation, administration of a medication, ventilation, or intubation, wherein the processor is further configured to generate the instruction by analyzing the CPR feedback (e.g. ¶¶47-48).
Claim(s) 24, 28, 30-33, 38-40 and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Addison et al. (U.S. Pub. 2017/0065484 hereinafter “Addison”) in view of Ayati et al. (U.S. Pub. 2010/0022886).
Regarding claims 24, 33 and 43, Addison discloses a system, comprising: a medical device (e.g. 10) comprising: an emitter (e.g. 18) configured to generate a signal comprising an electromagnetic wave or a mechanical wave; a detector (e.g. 20) configured to detect a reflection of the signal from a blood vessel of a patient; an electrocardiogram (ECG) sensor (e.g. 16) configured to detect an ECG of the patient; a transmitter (e.g. 28); and a processor (e.g. 50) configured to: determine a metric indicative of blood movement or blood pressure by analyzing the reflection of the signal from the blood vessel of the patient (e.g. ¶¶37-38; [blood flow]); receive the ECG of the patient from the ECG sensor (e.g. ¶47; [ECG sensor]); identify a pulseless electrical activity (PEA) by correlating the metric with the ECG of the patient (e.g. ¶47; [pulseless data]); generate cardiopulmonary resuscitation (CPR) feedback by analyzing the metric and the PEA (e.g. ¶¶47-48; [CPR instructions]); and cause the transmitter to output the CPR feedback (e.g. ¶¶23, 48; [transmitting data]); and a treatment device configured to: administer chest compressions to the patient (e.g. ¶63; [chest compressions]), wherein a position of the chest compressions is altered in response to receiving the CPR feedback (e.g. ¶27; [change position]). Addison discloses the claimed invention except for disclosing the that the emitter and detector are for ultrasound. However, Ayati in the same field of invention clearly discloses using an ultrasound emitter and detector as set forth in paragraphs 9, 11, 22 and 40 to provide analysis to determine if there is a pulse for determining if defibrillation is appropriate for the patient (i.e., whether or not there is a pulse) or whether another form of treatment such as CPR is appropriate. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Addison, with an ultrasound system for determining blood flow as taught by Ayati, since such a modification would provide the predictable results of a non-invasive way of analyzing pulse data and providing CPR feedback.
Regarding claim 28, Addison further discloses an output device configured to output an instruction to administer a treatment to the patient, the treatment comprising defibrillation, administration of a medication, ventilation, or intubation, wherein the processor is further configured to generate the instruction by analyzing the CPR feedback (e.g. ¶¶47-48).
Regarding claims 30 and 38, Addison further discloses wherein outputting the CPR feedback comprises transmitting the CPR feedback to an external device (e.g. ¶¶32, 47-48).
Regarding claims 31 and 39, Addison further discloses wherein the external device comprises a mechanical chest compression device administering the chest compressions to the patient (e.g. ¶63), and wherein outputting the CPR feedback comprises causing the mechanical chest compression device to alter a rate, depth, or position of the chest compressions (e.g. ¶¶47-48).
Regarding claims 32 and 40, Addison further discloses detecting an ECG of the patient; and detecting a blood oxygenation of the patient (e.g. ¶22), wherein generating the CPR feedback further comprises analyzing the ECG of the patient and the blood oxygenation of the patient (e.g. ¶¶47-48).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Addison in view of Ayati and DiMaio as applied to claims 21 and 23 above, and further in view of Kaufman et al. (U.S. Pub. 2017/0000688 hereinafter “Kaufman”).
Regarding claim 22, Addison in view of Ayati and DiMaio teach the claimed invention as disclosed in detail above, but fails to explicitly state that the system determines a pulse wave velocity and velocity of the blood in the vessel. However, Kaufman discloses wherein the processor is configured to determine the metric indicative of blood movement or blood pressure by analyzing the reflection of the signal from the blood vessel of the patient by: determining, by analyzing the reflection (e.g. ¶¶20-22): a pulse wave velocity of the blood vessel; and a velocity of blood in the blood vessel (e.g. ¶¶20-22); and a geometry of the blood vessel (e.g. ¶¶20-22); and determining a product of the pulse wave velocity of the blood vessel, the velocity of the blood in the blood vessel, and a density of the blood in the blood vessel (e.g. ¶¶20-22). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Addison in view of Ayati and DiMaio, with the velocity and pulse wave velocity as taught by Kaufman, since such a modification would provide the predictable results of analyzing the reflection of the signal to determine pulse wave velocity and velocity to determine blood pressure (e.g. ¶¶20-22).
Claim(s) 25-26 and 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Addison in view of Ayati as applied to claims 24, 28, 30-33, 38-40 and 43 above, and further in view of Kaufman et al. (U.S. Pub. 2017/0000688 hereinafter “Kaufman”).
Regarding claim 25-26 and 34-35, Addison in view of Ayati discloses the claimed invention as disclosed in detail above, but fails to explicitly state that the system determines a pulse wave velocity and velocity of the blood in the vessel. However, Kaufman discloses wherein the processor is configured to determine the metric indicative of blood movement or blood pressure by analyzing the reflection of the signal from the blood vessel of the patient by: determining, by analyzing the reflection (e.g. ¶¶20-22): a pulse wave velocity of the blood vessel; and a velocity of blood in the blood vessel (e.g. ¶¶20-22); and a geometry of the blood vessel (e.g. ¶¶20-22); and determining a product of the pulse wave velocity of the blood vessel, the velocity of the blood in the blood vessel, and a density of the blood in the blood vessel (e.g. ¶¶20-22). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Addison in view of Ayati, with the velocity and pulse wave velocity as taught by Kaufman, since such a modification would provide the predictable results of analyzing the reflection of the signal to determine pulse wave velocity and velocity to determine blood pressure (e.g. ¶¶20-22).
Claims 29 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Addison in view of Ayati as applied to claims 24, 28, 30-33, 38-40 and 43 above, and further in view of Packer et al. (U.S. Pub. 2016/0133160 hereinafter “Packer”).
Regarding claims 29 and 37, Addison in view of Ayati discloses the claimed invention except for the medical device outputting feedback for a treatment that includes defibrillation, administration of a medication, ventilation or intubation. However, Packer teaches that it is known to use a similar non-invasive medical device configured to sense blood pressure and output treatment feedback to the user as taught in paragraphs 81, 98 and 103 in order to output feedback to the user to enhance CPR performance. Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the medical device of Addison in view of Ayati combined with the treatment feedback device as taught by Packer in order to provide the predictable results of outputting feedback to the user to enhance CPR performance.
Claim 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Addison in view of Ayati as applied to claims 24, 28, 30-33, 38-40 and 43 above, and further in view of Mason (U.S. Pub. 2008/0306354).
Regarding claim 41, Addison in view of Ayati discloses the claimed invention except for the medical device being a wrist-wearable device. However, Mason teaches that it is known to use a similar non-invasive medical device configured to sense blood pressure using a wrist mounted device as taught in Figure 5 and paragraphs 33-37 in order to comfortably and accurately measure blood pressure non-invasively. Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the medical device of Addison in view of Ayati combined with the wrist wearable device as taught by Mason in order to comfortably and accurately measure blood pressure non-invasively.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached on Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/Primary Examiner, Art Unit 3792
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