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 .
Response to Amendments
The Amendment filed 7/30/2026 has been entered. Claims 1, 3-4, 9, 15-16, and 18-20 were amended, claim 7 was canceled, and claim 21 was new. Thus, claims 1-6 and 8-21 are pending in the application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 6, 8-11, 13-16, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Tan et al. (US 20180256446 A1) in view of Oppenheimer (US 20200000679 A1).
Regarding claim 1, Tan discloses a method for delivering defibrillation and chest compression (para. 96) comprising: receiving, by an external defibrillator, data from a mechanical chest compression device that is administering chest compressions to a subject (para. 100, the defibrillator 1210 may communicate, via a wired and/or wireless connection 1215 with an automated chest compression device 1220, para. 96, The defibrillator processor 1262 may analyze the motion sensor signal to detect various phases and timing points in the compression cycle); determining, by the external defibrillator analyzing the data, a timing for administering a therapy to the subject in coordination with the chest compressions; and administering, by the external defibrillator, the therapy to the subject in accordance with the timing. (para. 100, The defibrillator processor 1262 may control the defibrillator 1210 to deliver the defibrillation shock at a particular point during the CPR chest compression cycle to synchronize the defibrillation shock with the chest compressions. The synchronization may increase the efficacy of the defibrillation shock. As an example, the defibrillator 1210 may deliver the shock at or near the deepest point of compression).
Tan does not disclose determining, by the external defibrillator analyzing the data, a position on a chest of the subject at which the chest compressions are being administered; outputting, by the external defibrillator, an indication of the position.
However, Oppenheimer teaches a combined defibrillating and chest compressing device (Oppenheimer abs.), which includes a (Oppenheimer para. 153, position sensor or accelerometer to determine the depth of a compression when applied to a patient) and a (second accelerometer to provide a second compression depth. This second compression depth represents the movement of the entire patient's body in response to the application of force).
Therefore, it would be obvious to one ordinary skill in the art to combine the position system taught by Oppenheimer with to the treatment apparatus of Tan, to account for as taught by Oppenheimer, (Oppenheimer para. 153, the compression of a mattress below a patient during chest compressions ensuring proper position information).
Regarding claim 2, the modified Tan teaches a method for delivering defibrillation and chest compression (Tan para. 96), wherein the therapy comprises defibrillation (Tan para. 100, The defibrillator processor 1262 may control the defibrillator 1210 to deliver the defibrillation shock at a particular point during the CPR chest compression cycle to synchronize the defibrillation shock with the chest compressions. The synchronization may increase the efficacy of the defibrillation shock. As an example, the defibrillator 1210 may deliver the shock at or near the deepest point of compression).
Regarding claim 3, the modified Tan teaches a method for delivering defibrillation and chest compression (Tan para. 96), wherein the therapy comprises outputting electrical pacing pulses (Tan para. 100, the defibrillator processor 1262 may control the defibrillator 1210 to deliver the defibrillation shock at a particular point during the CPR chest compression cycle to synchronize the defibrillation shock with the chest compressions. The synchronization may increase the efficacy of the defibrillation shock. As an example, the defibrillator 1210 may deliver the shock at or near the deepest point of compression. Device paces pulses for defibrillator shocks at certain points during chest compression cycle to increase therapy efficacy).
Regarding claim 4, the modified Tan teaches a method for delivering defibrillation and chest compression (Tan para. 96), further comprising: determining, by the external defibrillator analyzing the data, a time of a pause that will follow one of the chest compressions administered to the subject by the mechanical chest compression device; and selectively detecting, by the external defibrillator, a physiological parameter of the subject during the pause. (Tan para. 103, the defibrillator processor 1262 is configured to send a signal to a controller of the automated compression device (e.g., the controller 225 of the automated belt-based device or the control unit 286 of the automated piston-based device) to stop compressions prior to and/or during the ECG analysis. Stopping the compressions during the ECG analysis may reduce or eliminate signal artifacts from the chest compressions in the ECG signal).
Regarding claim 6, the modified Tan teaches a method for delivering defibrillation and chest compression (Tan para. 96), further comprising: determining, by the external defibrillator analyzing the data, a frequency of the chest compressions; identifying, by the external defibrillator, a filter characterized by the frequency; and removing a chest compression artifact from physiological data representing a physiological parameter of the subject by applying the filter to the physiological data. (Tan para. 115, the chest compression assembly may transmit CPR parameters to the defibrillator, Tan para. 121, defibrillator processor (e.g., 162, 1262) may control the dashboard 1499 to provide CPR parameters in box 1414 automatically in response to detecting chest compressions. For example, the CPR parameters may include the chest compression rate 1418 (e.g., number of compression cycles per minute), Tan para. 103, The defibrillator processor 1262 may filter the ECG signal from the patient in order to reduce compression signal artifacts in the ECG signal to improve the accuracy of the ECG signal., Tan para. 120, During chest compressions and decompressions, the defibrillator processor (e.g., 162, 1262) may generate the filtered ECG waveform by gathering ECG data points and motion sensor readings and filtering motion-induced (e.g., CPR-induced) noise out of the ECG waveform. The filtered ECG waveform may reduce interruptions in CPR as compared to a non-filtered ECG waveform. The non-filtered ECG waveform may include artifacts from chest compressions and decompressions that may make it difficult for the rescuer to discern the presence of an organized heart rhythm unless compressions and decompressions are halted. Filter deigned to filter ECG upon identification of artifacts indicative of chest compression such as chest compression rate).
Regarding claim 8, the modified Tan teaches a method for delivering defibrillation and chest compression (Tan para. 96), further comprising: determining, by the external defibrillator analyzing the data, an alarm associated with the mechanical chest compression device; and outputting, by the external defibrillator, an indication of the alarm. (Tan para. 118, the defibrillator 1210 may include the dashboard 1499, Tan para. 124, As another feedback example a reminder 1421 regarding “release” in performing chest compression is shown in FIG. 14. Specifically, a fatigued rescuer may lean forward on the chest of a patient and not sufficiently release pressure on the sternum of the patient at the top of each decompression stroke. This may reduce the perfusion and circulation accomplished by the chest compressions. The defibrillator processor (e.g., 162, 1262) may control the dashboard 1499 to provide the reminder 1421 when the defibrillator processor (e.g., 162, 1262) determines that the rescuer is not sufficiently releasing. For example, signals from the motion sensor 118 may exhibit an “end” to the compression cycle that is flat and thus indicates that the rescuer is maintaining pressure on the sternum to an unnecessary degree).
Regarding claim 9, Tan discloses an external defibrillator (para. 96), comprising: a transceiver (para. 100, the defibrillator 1210 may communicate via an analog signal, a serial Universal Serial Bus (USB) interface, or via a low-latency wireless protocol such as the IEEE 802.15.4 protocol standard (e.g., ZigBee®)).; a discharge circuit configured to output an electrical shock to a subject (para. 109, The rescuer may place the first electrode 1324 and the second electrode 1326 in an anterior-anterior position or an anterior-posterior position such that a therapeutic current may travel through the patient's heart); and a processor configured to: receive, via the transceiver, data from a mechanical chest compression device (Tan para. 100, the defibrillator 1210 may communicate, via a wired and/or wireless connection 1215 with an automated chest compression device 1220, para. 96, The defibrillator processor 1262 may analyze the motion sensor signal to detect various phases and timing points in the compression cycle); determine, by analyzing the data, a timing for outputting an electrical shock to the subject in coordination with chest compressions that are being administered to the subject by the mechanical chest compression device; and cause the discharge circuit to output the electrical shock to the subject in accordance with the timing. (para. 100, The defibrillator processor 1262 may control the defibrillator 1210 to deliver the defibrillation shock at a particular point during the CPR chest compression cycle to synchronize the defibrillation shock with the chest compressions. The synchronization may increase the efficacy of the defibrillation shock. As an example, the defibrillator 1210 may deliver the shock at or near the deepest point of compression).
Tan does not disclose the processor is configured to determine a position on a chest of the subject at which the chest compressions are being administered; output, by the external defibrillator, an indication of the position.
However, Oppenheimer teaches a combined defibrillating and chest compressing device (Oppenheimer abs.), which includes a (Oppenheimer para. 153, position sensor or accelerometer to determine the depth of a compression when applied to a patient) and a (second accelerometer to provide a second compression depth. This second compression depth represents the movement of the entire patient's body in response to the application of force).
Therefore, it would be obvious to one ordinary skill in the art to combine the position system taught by Oppenheimer with to the treatment apparatus of Tan, to account for as taught by Oppenheimer, (Oppenheimer para. 153, the compression of a mattress below a patient during chest compressions ensuring proper position information).
Regarding claim 10, the modified Tan teaches an external defibrillator (Tan para. 96), wherein the electrical shock comprises a defibrillation shock. (Tan para. 100, The defibrillator processor 1262 may control the defibrillator 1210 to deliver the defibrillation shock at a particular point during the CPR chest compression cycle to synchronize the defibrillation shock with the chest compressions. The synchronization may increase the efficacy of the defibrillation shock. As an example, the defibrillator 1210 may deliver the shock at or near the deepest point of compression).
Regarding claim 11, the modified Tan teaches an external defibrillator (Tan para. 96), further comprising an output device configured to output information (see Tan Fig. 14, dashboard 1499), wherein the processor is further configured to: determine, by analyzing the data, a time of an upcoming pause that will follow a chest compression administered to the subject by the mechanical chest compression device; detect a physiological parameter of the subject during the time (Tan para. 103, the defibrillator processor 1262 is configured to send a signal to a controller of the automated compression device (e.g., the controller 225 of the automated belt-based device or the control unit 286 of the automated piston-based device) to stop compressions prior to and/or during the ECG analysis. Stopping the compressions during the ECG analysis may reduce or eliminate signal artifacts from the chest compressions in the ECG signal); and cause the output device to output the physiological parameter. (see Tan Fig. 14, dashboard 1499 depicts ECG waveform 1410).
Regarding claim 13, the modified Tan teaches an external defibrillator (Tan para. 96), further comprising an output device configured to output information (see Tan Fig. 14, dashboard 1499), wherein the processor is further configured to: determine, by analyzing the data, a depth to which the chest compressions are being administered; and cause the output device to output an indication of the depth (Tan para. 121, The defibrillator processor (e.g., 162, 1262) may control the dashboard 1499 to provide CPR parameters in box 1414 automatically in response to detecting chest compressions. For example, the CPR parameters may include the chest compression rate 1418 (e.g., number of compression cycles per minute) and the chest compression depth 1416 (e.g., depth of compressions in inches or millimeters)., see Tan Fig. 14, dashboard 1499).
Regarding claim 14, the modified Tan teaches an external defibrillator (Tan para. 96), further comprising an output device configured to output information, wherein the processor is further configured to: determine, by analyzing the data, a force with which the chest compressions are being administered (Tan para. 78, the processor 162 may be configured to dynamically determine the compression neutral point 920 to account for changes in the compression neutral point 920 over the course of chest compressions. To this end, the waveform analysis algorithm may need additional information such as compression force information (e.g., as provided by the one or more force sensors 362 in the ACD device)); and cause the output device to output an indication of the force, Tan para. 128, The defibrillator 1500 may include a user interface 1599, Tan para. 128, the user interface 1599 may display the CPR dashboard 1545, Tan para. 160, the CPR dashboard 1545 may include the chest release indicator 1526, Tan para. 161, The chest release indicator 1526 may include graphics for which a colored area changes size within a frame to indicate a quality of chest release. For example, if the caregiver fully releases the chest of the patient at the end of a chest decompression during a compression/decompression cycle of a single chest compression, then the release indicator 1526 may fill completely. 1526 that is full may be based on a chest compression parameter indicative of chest release (force). At bottom of press the indicator will be empty this is when device is analyzing maximal force).
Regarding claim 15, Tan discloses a method for administering compressions and defibrillation (para. 96) comprising: receiving, by an external defibrillator, data from a mechanical chest compression device that is administering chest compressions to a subject; (para. 100, the defibrillator 1210 may communicate, via a wired and/or wireless connection 1215 with an automated chest compression device 1220, para. 96, The defibrillator processor 1262 may analyze the motion sensor signal to detect various phases and timing points in the compression cycle).
Tan does not disclose determining, by the external defibrillator analyzing the data, a position on a chest of the subject at which the chest compressions are being administered; and outputting, by the external defibrillator, an indication of the position.
However, Oppenheimer teaches a combined defibrillating and chest compressing device (Oppenheimer abs.), which includes a (Oppenheimer para. 153, position sensor or accelerometer to determine the depth of a compression when applied to a patient) and a (second accelerometer to provide a second compression depth. This second compression depth represents the movement of the entire patient's body in response to the application of force).
Therefore, it would be obvious to one ordinary skill in the art to combine the position system taught by Oppenheimer with to the treatment apparatus of Tan, to account for as taught by Oppenheimer, (Oppenheimer para. 153, the compression of a mattress below a patient during chest compressions ensuring proper position information).
Regarding claim 16, the modified Tan teaches a method for administering compressions and defibrillation (Tan para. 96), wherein the therapy comprises defibrillation. (Tan para. 100, The defibrillator processor 1262 may control the defibrillator 1210 to deliver the defibrillation shock at a particular point during the CPR chest compression cycle to synchronize the defibrillation shock with the chest compressions. The synchronization may increase the efficacy of the defibrillation shock. As an example, the defibrillator 1210 may deliver the shock at or near the deepest point of compression).
Regarding claim 18, the modified Tan teaches a method for administering compressions and defibrillation (Tan para. 96), wherein the therapy comprises outputting electrical pacing pulses (Tan para. 100, The defibrillator processor 1262 may control the defibrillator 1210 to deliver the defibrillation shock at a particular point during the CPR chest compression cycle to synchronize the defibrillation shock with the chest compressions. The synchronization may increase the efficacy of the defibrillation shock. As an example, the defibrillator 1210 may deliver the shock at or near the deepest point of compression. Device paces pulses for defibrillator shocks at certain points during chest compression cycle to increase therapy efficacy).
Regarding claim 19, the modified Tan teaches a method for administering compressions and defibrillation (Tan para. 96), wherein the control parameter is indicative of a timing with which the therapy is to be administered to the subject by the external defibrillator in coordination with the chest compressions. (Tan para. 100, The defibrillator processor 1262 may control the defibrillator 1210 to deliver the defibrillation shock at a particular point during the CPR chest compression cycle to synchronize the defibrillation shock with the chest compressions. The synchronization may increase the efficacy of the defibrillation shock. As an example, the defibrillator 1210 may deliver the shock at or near the deepest point of compression).
Regarding claim 20, the modified Tan teaches a method for administering compressions and defibrillation (Tan para. 96), further comprising: determining, by the external defibrillator analyzing the data, a time of an upcoming pause that will follow a chest compression administered to the subject by the mechanical chest compression device; and detecting, by the external defibrillator, a physiological parameter of the subject during the time. (Tan para. 103, the defibrillator processor 1262 is configured to send a signal to a controller of the automated compression device (e.g., the controller 225 of the automated belt-based device or the control unit 286 of the automated piston-based device) to stop compressions prior to and/or during the ECG analysis. Stopping the compressions during the ECG analysis may reduce or eliminate signal artifacts from the chest compressions in the ECG signal).
Regarding claim 21, the modified Tan teaches a method for administering compressions and defibrillation (Tan para. 96) further comprising: determining, by the external defibrillator analyzing the data, a control parameter for controlling administration of a therapy to the subject by the external defibrillator; and administering, by the external defibrillator, the therapy to the subject in accordance with the control parameter. (Tan para. 100, The defibrillator processor 1262 may control the defibrillator 1210 to deliver the defibrillation shock at a particular point during the CPR chest compression cycle to synchronize the defibrillation shock with the chest compressions. The synchronization may increase the efficacy of the defibrillation shock. As an example, the defibrillator 1210 may deliver the shock at or near the deepest point of compression).
Claims 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Tan and Oppenheimer as applied to claims 1 and 9 above, and further in view of Chapman et al. (US 20060229680 A1).
Regarding claim 5, the modified Tan teaches a method for administering compressions and defibrillation (Tan para. 96), but is silent on further comprising: determining, by the external defibrillator analyzing the data, a medication to administer the subject; and outputting, by the external defibrillator, an indication of the medication.
However, Chapman teaches a defibrillator which analyzes physical parameters to output accurate CPR compression count and shock timing (Chapman para. 7), as well as, provide optimal timing for medication injection based on CPR data (Chapman para. 37). (Chapman para. 38, The AED compression count may also be combined with "viability index" information provided by a ventricular fibrillation (VF) analysis algorithm. If the chest compression rate is good and yet the viability index continues to worsen, it would be clear that CPR treatment is not effective. This could indicate the need to improve the CPR chest compressions, such as instruction the user to alter the CPR treatment protocol, for example to administer a peripheral vasoconstrictor drug, such as epinephrine).
Therefore, it would be obvious to one of ordinary skill in the art to add the medication delivery analysis/timing component of the Chapman system to the treatment apparatus of Tan, in order to create a device which applies treatment in the “sweet spot”, as taught by Chapman, (Chapman para. 37, The coronary perfusion pressure elevating effects of epinephrine during CPR is rather short-lived and there is a "sweet spot" amount of chest compressions that should be delivered between injection of the epinephrine and defibrillation. Often, defibrillation pulse treatments are administered too early or too late. Too early and the heart has not received the boost in circulation; too late and the effects of circulation have worn off. So the CPR treatment protocol selected could optimize the effectiveness of an injection by instructing and counting compressions after injection, and then shocking after an appropriate amount of circulation).
Regarding claim 12, the modified Tan teaches a method for administering compressions and defibrillation (Tan para. 96), but is silent on further comprising an output device configured to output information, wherein the processor is further configured to: determine, by analyzing the data, a medication for the subject; and cause the output device to output an indication of the medication.
However, Chapman teaches a defibrillator which analyzes physical parameters to output accurate CPR compression count and shock timing (Chapman para. 7), as well as, provide optimal timing for medication injection based on CPR data (Chapman para. 37). (Chapman para. 38, The AED compression count may also be combined with "viability index" information provided by a ventricular fibrillation (VF) analysis algorithm. If the chest compression rate is good and yet the viability index continues to worsen, it would be clear that CPR treatment is not effective. This could indicate the need to improve the CPR chest compressions, such as instruction the user to alter the CPR treatment protocol, for example to administer a peripheral vasoconstrictor drug, such as epinephrine).
Therefore, it would be obvious to one of ordinary skill in the art to add the medication delivery analysis/timing component of the Chapman system to the treatment apparatus of Tan, in order to create a device which applies treatment in the “sweet spot”, as taught by Chapman, (Chapman para. 37, The coronary perfusion pressure elevating effects of epinephrine during CPR is rather short-lived and there is a "sweet spot" amount of chest compressions that should be delivered between injection of the epinephrine and defibrillation. Often, defibrillation pulse treatments are administered too early or too late. Too early and the heart has not received the boost in circulation; too late and the effects of circulation have worn off. So the CPR treatment protocol selected could optimize the effectiveness of an injection by instructing and counting compressions after injection, and then shocking after an appropriate amount of circulation).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Tan and Oppenheimer as applied to claim 16 above, and further in view of Freeman et al. (US 10893812 B2).
Regarding claim 17, the modified Tan teaches a method for administering compressions and defibrillation (Tan para. 96), wherein the control parameter is a shock parameter (Tan para. 100, The defibrillator processor 1262 may control the defibrillator 1210 to deliver the defibrillation shock at a particular point during the CPR chest compression cycle to synchronize the defibrillation shock with the chest compressions), but is silent on the shock parameter having an indicative of a level at which an electrical shock is to be delivered to the subject by the external defibrillator.
However, Freeman teaches a system for delivering defibrillation therapy in combination with analyzing data for chest compressions based on one or more sensor (abs.), wherein the defibrillator (Freeman col. 17 ln. 25-27, adaptively charges a defibrillation device to level (e.g., a desired total voltage or charge) selected based on ECG analysis).
Therefore, it would be obvious to one of ordinary skill in the art to modify the defibrillator system of Tan to adjust shock delivery level as taught by Freeman in order to allow for treatment for a range of different heart issues requiring different levels of shock for proper treatment.
Response to Arguments
Applicant's arguments filed 7/30/2026 have been fully considered but they are not persuasive.
On page 6 in section I of the Applicant’s remarks, the Applicant argues that the claims do not invoke a 35 U.S.C. 112(f) interpretation. However, no 35 U.S.C. 112(f) interpretation has been made by the Examiner, and thus this argument is moot.
On pages 6-7 in section II of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the 35 U.S.C. 102(a)(1) rejections of the previous office action. The Examiner agrees, and has thus withdrawn those 35 U.S.C. 102(a)(1) rejections. However, the claims remain rejected under 35 U.S.C. 103 as detailed above.
On pages 7-8 in section III of the Applicant’s remarks, the Applicant argues that the current prior art of record, specifically the Oppenheimer reference, does not teach the claim limitation of determining a position on a chest of the subject the chest compressions being administered, as Oppenheimer determines depth of compressions. However, the Examiner respectfully disagrees. The depth of the chest compressions into a chest is a specific type of position on the chest, and thus Oppenheimer does teach this limitation. To clarify, the position of a compression on the chest can change in at least one of three directions: left-to-right, up-and-down, and front-to-back. A change in compression depth fits the front-to-back direction. Oppenheimer uses position sensors or accelerometers to determine the depth of compressions into the patient’s chest when, in the cycle of compressions during CPR, the compression force moves from a resting position on a chest down into an active position deeper into the chest and then back to the resting position. The measured depth into the chest of the compression is the position on the chest of the compression. (Oppenheimer para. 153). Thus, the current prior art of record can still be used to teach the Applicant’s claimed invention.
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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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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