Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
2. This office action is in response to the filing of the application on 08/31/2023. Claims 1-20 are pending in the application.
Claim Interpretation
3. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
At this time no claims are being interpreted under 112(f).
Claim Rejections - 35 USC § 112
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 3 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim(s) 3 and 18 are rejected due to use of an indefinite limitation. Claim limitation “wherein the therapy comprises pacing.” (claim 3, ln. 1; claim 18, ln. 1). It is unclear what type of therapy “pacing” is meant to be. For purposes of this examination, it is being interpreted to mean pacing of defibrillation shocks in line with compression data.
Claim Rejections - 35 USC § 102
5. 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.
6. Claim(s) 1-4, 6, 8-11, 13-16, and 18-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tan et al. (US 20180256446 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).
Regarding claim 2, Tan discloses a method for delivering defibrillation and chest compression (para. 96), wherein the therapy comprises defibrillation (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, Tan discloses a method for delivering defibrillation and chest compression (para. 96), wherein the therapy comprises pacing (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, Tan discloses a method for delivering defibrillation and chest compression (para. 96), further comprising: determining, by the external defibrillator analyzing the data, a time of an upcoming pause that will follow one of the chest compressions 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. (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, Tan discloses a method for delivering defibrillation and chest compression (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. (para. 115, the chest compression assembly may transmit CPR parameters to the defibrillator, 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), 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., 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, Tan discloses a method for delivering defibrillation and chest compression (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. (para. 118, the defibrillator 1210 may include the dashboard 1499, 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, 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 ((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).
Regarding claim 10, an external defibrillator (para. 96), wherein the electrical shock comprises a defibrillation shock. (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, an external defibrillator (para. 96), further comprising an output device configured to output information (see 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 (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 fig. 14, dashboard 1499 depicts ECG waveform 1410).
Regarding claim 13, an external defibrillator (para. 96), further comprising an output device configured to output information (see 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 (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 fig. 14, dashboard 1499).
Regarding claim 14, an external defibrillator (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 (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, para. 128, The defibrillator 1500 may include a user interface 1599, para. 128, the user interface 1599 may display the CPR dashboard 1545, para. 160, the CPR dashboard 1545 may include the chest release indicator 1526, 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); 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. (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 16, Tan discloses a method for administering compressions and defibrillation (para. 96), wherein the therapy comprises defibrillation. (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, Tan discloses a method for administering compressions and defibrillation (para. 96), wherein the therapy comprises pacing (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, Tan discloses a method for administering compressions and defibrillation (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. (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, Tan discloses a method for administering compressions and defibrillation (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. (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).
Claim Rejections - 35 USC § 103
7. 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.
8. Claim(s) 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Tan et al. (US 20180256446 A1) in view of Chapman et al. (US 20060229680 A1).
Regarding claim 5, Tan discloses a method for administering compressions and defibrillation (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 (para. 7), as well as, provide optimal timing for medication injection based on CPR data (para. 37). (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, (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, Tan discloses a method for administering compressions and defibrillation (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 (para. 7), as well as, provide optimal timing for medication injection based on CPR data (para. 37). (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, (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).
9. Claim(s) 7 is 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 7, Tan discloses a method for administering compressions and defibrillation (para. 96), but is silent on determining, by the external defibrillator analyzing the data, a position with respect to 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 (abs.), which includes a (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, (para. 153, the compression of a mattress below a patient during chest compressions ensuring proper position information).
10. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Tan et al. (US 20180256446 A1) in view of Freeman et al. (US 10893812 B2).
Regarding claim 17, Tan discloses a method for administering compressions and defibrillation (para. 96), wherein the control parameter is a shock parameter (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 (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.
Conclusion
11. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure are Sullivan et. al (US 20150265845 A1) and Myklebust et al. (US 20080097534 A1). These prior art are various Defibrillation and compression apparatuses.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEC ROBERT WAHL whose telephone number is (571)272-9880. The examiner can normally be reached Monday - Friday 8:30 a.m. to 6:00 p.m..
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/A.R.W./Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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