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 Amendment
The amendment filed on 01/09/2026 has been entered. Claims 1-3, 6, 9, 23, and 26 have been amended. Claims 24-25 have been cancelled. Claims 110-111 have been newly added. Applicant’s amendments to the claims have overcome the 112(b) rejection in the non-final rejection mailed on 09/09/2025. Claims 1-23, 26-28, and 110-111 remain pending in the instant application.
Response to Arguments
Regarding claim 1, Applicant argues that Itnati does not disclose a first compression at a predetermined initial depth and a predetermined final target depth greater in magnitude than the initial depth (Remarks Page 10 last paragraph – Page 11 2nd paragraph). Examiner respectfully disagrees. The device of Itnati discloses the compression device may apply compressions at predetermined depths that can be varied dynamically as they proceed to a final target depth (Paragraph 0134 discloses the CMD may apply compressions at a predetermined force or depth through control unit commands; Paragraph 0225 discloses the plunger may be controlled to increase depth of compressions over a number of compressions in a pre-set [predetermined] pattern; Paragraphs 0167 & 0268 discloses the system may change the plunger depth automatically to provide an optimal CPR parameter [depth] based on patient information; Examiner notes that Itnati’s device is capable of allowing for a first pre-set compression at an initial depth and then increasing the depth from that first compression over time to a final target depth). Thus it is examiner’s position the device of Itnati is capable of providing a pre-determined first compression depth and a pre-determined final target compression depth. Therefore, Applicant’s argument is found to be unpersuasive.
Applicant’s arguments with respect to claim 1 regarding a patient-specific second portion have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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.
Claims 1-8, 11-15, 20-21, 23, 26-28, and 110-111 are rejected under 35 U.S.C. 103 as being unpatentable over US20100198118A1 to Itnati (hereinafter “Itnati”) in view of US20200155862A1 to Paradis (hereinafter “Paradis 1”).
Regarding claim 1, Itnati discloses a system for administering patient-specific chest compressions to a patient (Fig. 7A device 700a), the system comprising:
an automated chest compressor configured to be applied to the chest of the patient to administer chest compressions to the patient (Fig. 7A plunger 710; Paragraph 0119 discloses the CMD device delivers automatic compressions to the patient);
at least one force sensor configured to sense force information for force exerted on the patient by the chest compressor from the applied chest compressions (Fig. 5 load sensor 62; Paragraph 0152 discloses the plunger has a load sensor which may measure and transmit data of the load of the plunger against the patient’s thorax); and
at least one processor and memory communicatively coupled with the chest compressor and the at least one force sensor (Fig. 5 control unit 20 contains a processor, memory 90; Paragraph 0025 disclose the device may contain a processor which processes input signal from the measuring devices (sensors); Paragraph 0152 discloses the load sensor 62 sends sensor data to control unit 20), wherein the at least one processor and memory are configured to:
control the chest compressor to administer the chest compressions over an initial compression period according to an initial compression protocol (Paragraph 0128 discloses the control unit controls the motions of the plunger; Paragraph 0168 discloses the plunger may be initially on the CPR patient in a slow and delicate motion to obtain information regarding the optimal compression distance and force), the initial compression protocol comprising a plurality of chest compressions of with at least a first compression at a predetermined initial depth and a final compression at a predetermined final target depth greater in magnitude than the initial depth,
wherein the depths of the chest compressions are prescheduled for a first portion of the plurality of chest compressions (Paragraph 0134 discloses the CMD may apply compressions at a predetermined force or depth; Paragraph 0225 discloses the plunger may be controlled to increase depth of compressions over a number of compressions in a pre-set [predetermined] pattern; Paragraphs 0167 & 0268 discloses the system may change the plunger depth automatically to provide an optimal CPR parameter [depth] based on patient information; Examiner notes that Itnati’s device is capable of allowing for a first pre-set compression at an initial depth and then increasing the depth from that first compression over time to a final target depth),
receive and process the sensed force information to estimate force applied to the chest during the chest compressions (Paragraph 0152 discloses the plunger has a load sensor which may measure and transmit data of the load of the plunger against the patient’s thorax; Paragraph 0025 disclose the device may contain a processor which processes input signal from the measuring devices (sensors)), and adjust a magnitude of the scheduled depths to patient-specific depths for one or more remaining chest compressions of the plurality of chest compressions of the initial compression protocol based on the estimated force applied to the chest during one or more preceding chest compressions of the plurality of chest compressions (Paragraph 0167 discloses the plunger-motor feedback mechanism enables the fine tuning of the compression of the plunger to be adjusted to the anatomical build of the treated patient; Paragraph 0169 discloses adjustment of the travel of the plunger to the elasticity of the patient’s thorax may be obtained by deriving information regarding the elasticity from load on the motor 14; Paragraphs 0216, 0225, & 0225 disclose the device may alter position of the plunger in response to sensor signals during the procedure after a pre-set pattern was selected).
Itnati does not explicitly disclose a patient-specific second portion of the plurality of chest compressions. However, Paradis 1 teaches an automated cardiopulmonary resuscitation system which has a patient-specific second portion of a plurality of chest compressions (Fig. 7 step 702, primary optimization sequence 710; Paragraph 0078 discloses CPR is started with standard sternal compression at standard force-depth parameters; Paragraph 0078 also discloses that after the first compression, the processor can initiate an optimization sequence to provide ideal compression/decompressions to the patient; Paragraph 0080 discloses optimizing force and depth; Paragraph 0093 discloses the optimized CPR (second portion) is then applied until a stable myocardial state).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the controller logic of Itnati to have a patient-specific second portion of a plurality of chest compressions, as taught by Paradis 1, in order to provide patient-specific optimization of the CPR machine (Paragraphs 0080 and 0093).
Regarding claim 2, Itnati in view of Paradis 1 discloses the system of claim 1, and Itnati further discloses wherein during the scheduled first portion of the plurality of chest compressions in which the scheduled depth of the chest compressions increases at a first rate (Paragraph 0046 discloses the pressure may be increased over time during the first half of a cycle; Examiner notes that increasing pressure upon the thorax of the patient will inherently result in increased depth due to a higher pushing force from the plunger).
Regarding claim 3, Itnati in view of Paradis 1 discloses the system of claim 2, and Itnati as modified by Paradis 1 further discloses wherein during the patient-specific second portion of the plurality of chest compressions in which the scheduled depths of the chest compressions increase at a second rate, the second rate being different from the first rate (Paragraph 0225 discloses the depth of the compressions may be increased dynamically over the duration of the ECM procedure; Paradis 1 discloses a secondary optimization sequence 730 which can further adjust the rate of compression at step 732 (See Fig. 7); Examiner notes the modified device is thus capable of increasing depth at a first rate which would be different from a second rate during a patient-specific portion).
Regarding claim 4, Itnati discloses the system of claim 3, and Itnati further discloses wherein the second rate is greater than the first rate (Paragraph 0225 discloses the depth of the compressions may be increased or decreased dynamically over the duration of the ECM procedure; Examiner notes the device is thus capable of increasing depth at a first rate which may be greater than a second rate).
Regarding claim 5, Itnati discloses the system of claim 1, and Itnati further discloses wherein the adjustment of the magnitude of the scheduled depths to the patient-specific depths for the one or more remaining chest compressions occurs at regular intervals (Paragraphs 0183 & 0228 discloses the speed of the compressions may be varied; Examiner notes that the device is also capable then of keeping the speed the same for the compression rate).
Regarding claim 6, Itnati in view of Paradis 1 discloses the system of claim 1, and Itnati further discloses wherein the initial compression protocol comprises a continuous linear increase in the scheduled depths over the scheduled first portion of the plurality of chest compressions (Paragraph 0225 discloses the depth of the compressions may be increased dynamically over the duration of the ECM procedure; Examiner notes the device is thus capable of increasing depth at a linear first rate).
Regarding claim 7, Itnati in view of Paradis 1 discloses the system of claim 1, and Itnati further discloses wherein the adjustment in the magnitude of the scheduled depths to the patient-specific depths of the one or more remaining chest compressions comprises a decrease of the scheduled depths for at least one of the one or more remaining chest compressions (Paragraph 0225 discloses the depth of the compressions may be decreased dynamically over the duration of the ECM procedure).
Regarding claim 8, Itnati in view of Paradis 1 discloses the system of claim 1, and Itnati further discloses wherein the adjustment of the magnitude of the scheduled depths to the patient-specific depths for the one or more remaining chest compressions is further based, at least in part, on a number of the preceding chest compressions already provided to the patient (Paragraph 0221 discloses the device may use history of the compressions to control the depth of the plunger).
Regarding claim 11, Itnati in view of Paradis 1 discloses the system of claim 1, and Itnati further discloses wherein the initial compression period comprises a period of time of about 1 minute to about 2 minutes (Paragraph 0221 discloses the ECM procedure may last minutes; Examiner notes the machine may thus conduct a procedure anywhere from 1-5 minutes).
Regarding claim 12, Itnati in view of Paradis 1 discloses the system of claim 1, and Itnati further discloses wherein the adjustment in the magnitude of the scheduled depths to the patient-specific depths is based on whether the estimated force falls outside of an expected range (Paragraph 0170 discloses that when reaching a threshold load value on the patient’s thorax, a safety mechanism may halt operation of the motor to decrease an overload on the patient’s thorax).
Regarding claim 13, Itnati in view of Paradis 1 discloses the system of claim 12, and Itnati further discloses wherein determination of whether the estimated force falls outside of the expected range comprises determination of whether the estimated force exceeds a predetermined force threshold (Paragraph 0170 discloses that when reaching a threshold load value on the patient’s thorax, a safety mechanism may halt operation of the motor to decrease an overload on the patient’s thorax).
Regarding claim 14, Itnati in view of Paradis 1 discloses the system of claim 1, and Itnati further discloses wherein the at least one processor and memory are further configured to control the chest compressor to administer the chest compressions according to one or more additional patient-specific compression parameters over the initial compression period (Paragraph 0128-0129 disclose the device may have “life-signs” sensors and compression indication sensors to control the driving mechanism).
Regarding claim 15, Itnati in view of Paradis 1 discloses the system of claim 14, and Itnati further discloses wherein the one or more patient-specific compression parameters comprise at least one of: compression force (Paragraph 0152 discloses the load sensor 62 represents load of the plunger on the thorax), compression hold time, release velocity, downstroke acceleration, downstroke velocity, lift displacement, lift force, upstroke acceleration, and upstroke velocity.
Regarding claim 20, Itnati in view of Paradis 1 discloses the system of claim 1, and Itnati further discloses wherein the adjustment in the magnitude of the scheduled depths to the patient-specific depths for the one or more remaining chest compressions of the plurality of chest compressions comprises a non-linear increase in compression depths for the one or more remaining chest compressions based on an increase or decrease in an estimated chest compliance over the one or more preceding chest compressions (Paragraph 0225 discloses the depth of the compressions may be increased dynamically over the duration of the pre-set ECM procedure; Examiner notes the device is thus capable of increasing depth at a non-linear rate after compressions have been delivered; Paragraph 0170 discloses the sensor is used to monitor load on the patient’s chest (chest compliance) and base operation of the motor and compressions off of the load detected).
Regarding claim 21, Itnati in view of Paradis 1 discloses the system of claim 1, and Itnati further discloses wherein the adjustment in the magnitude of the scheduled depths to the patient-specific depths for the one or more remaining chest compressions of the plurality of chest compressions comprises a substantially linear increase in compression depths for the one or more remaining chest compressions (Paragraph 0225 discloses the depth of the compressions may be increased dynamically over the duration of the pre-set ECM procedure; Examiner notes the device is thus capable of increasing depth at a linear rate after compressions have been delivered).
Regarding claim 23, Itnati in view of Paradis 1 discloses the system of claim 1, and Itnati further discloses wherein the predetermined target final depth comprises a depth of about 2.0 inches to about 2.4 inches (Paragraph 0042 discloses the compressions may be from 3cm (1.18 inches) to 8cm (3.14 inches)).
Regarding claim 26, Itnati in view of Paradis 1 discloses the system of claim 1, and Itnati further discloses wherein the chest compressor is configured to provide active compression and active decompression treatment to the chest of the patient (Paragraph 0066 discloses the device improves/optimizes force delivery to the patient’s thorax; Examiner notes active compressions are being delivered).
Regarding claim 27, Itnati in view of Paradis 1 discloses the system of claim 1, and Itnati further discloses wherein the chest compressor comprises a compression belt and a belt tensioner configured to tighten the compression belt around the chest of the patient in order to compress the chest of the patient (Fig. 7B belts 742L and 742R, mechanism 743L and 743R; Paragraph 0252 discloses the belts 742 may be tensioned by mechanism 743 to provide tension on the patient’s chest).
Regarding claim 28, Itnati in view of Paradis 1 discloses the system of claim 1, and Itnati further discloses wherein the chest compressor is a piston- based system that comprises: a piston (Fig. 7A linkage 709; Paragraph 0192 discloses the linkage 609 may be a piston; Paragraph 0302 discloses linkage 709 is the same as linkage 609), a piston driver (Fig. 7A mechanism 708; Paragraph 0193 discloses mechanism 608 may be an electric motor; Paragraph 0302 discloses mechanism 708 is the same as 608), support structures for supporting the piston and the piston driver (Fig. 7A structural housing element 706; Examiner notes the structural housing element support mechanism 708 and linkage 709 by serving as their base), and a compression pad affixed to the piston (Fig. 7A plunger 710).
Regarding claim 110, Itnati in view of Paradis 1 discloses the system of claim 1, and Itnati further discloses wherein a duration of the scheduled first portion of the plurality of chest compressions is predetermined (Paragraph 0134 discloses the CMD may apply compressions at a predetermined force or depth; Paragraph 0225 discloses the plunger may be controlled to increase depth of compressions over a number of compressions in a pre-set [predetermined] pattern; Paragraphs 0167 & 0268 discloses the system may change the plunger depth automatically to provide an optimal CPR parameter [depth] based on patient information; Paragraph 0231 discloses the duty cycle of compressions may be varied dynamically by the controller; Examiner notes that Itnati’s device is capable of allowing for a first pre-set compression at an initial depth and then increasing the depth from that first compression over time [varied duty cycle] to a final target depth).
Regarding claim 111, Itnati in view of Paradis 1 discloses the system of claim 1, and Itnati further discloses wherein the plurality of chest compressions of the initial compression protocol are configured to acclimate the patient's chest to receiving chest compressions at the predetermined final target depth (Paragraphs 0277-0280 disclose storing patient data [i.e. optimized compression depth] in a memory 90 between CPR sessions; Examiner notes that Itnati’s pre-set compressions increasing in depth over time (See Paragraphs 0167 & 0268) will naturally acclimate the patient’s chest to receiving chest compressions at a predetermined final depth; Examiner further notes that the end of the pre-set initial compression depth would be the predetermined final depth; Itnati as modified by Paradis 1 would have an optimization of the initial compression depths to achieve a final target depth).
Claims 9, 16-19, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Itnati in view of Paradis 1 as applied to claim 1 above, and further in view of US20170035650A1 to Taylor et al. (hereinafter “Taylor”).
Regarding claim 9, Itnati discloses in view of Paradis 1 the system of claim 1, but does not disclose wherein the at least one processor and memory are further configured to control the chest compressor to repeatedly administer chest compressions at the predetermined final target depth, once the adjusted patient-specific depths reaches the predetermined final target depth or following the plurality of chest compressions of the initial compression protocol. However, Taylor teaches an active compression decompression CPR compression feedback system wherein the at least one processor and memory are further configured to control the chest compressor to repeatedly administer chest compressions at the final target depth, once the adjusted patient-specific depths reaches the final target depth or following the plurality of chest compressions of the initial compression protocol (Fig. 29 steps 2910 perform test compressions at different depths, 2940 determine optimal depth from test values, 2950 perform additional cpr compressions at optimal depth; See also Fig. 28 for graphical testing of different depths and then delivering at D_OPT; Paragraph 0157 discloses processor 2842 and memory 2841 for controlling cpr system 2800).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the controller of Itnati to include repeated optimal depth chest compressions following an initial protocol, as taught by Taylor, in order to provide optimal compressions to the patient (Paragraph 0163).
Regarding claim 16, Itnati in view of Paradis 1 discloses the system of claim 1, but Itnati does not disclose at least one displacement sensor configured to sense displacement signals corresponding to displacement of the patient's chest during the applied chest compressions, wherein the at least one processor and memory are configured to receive and process the displacement signals to estimate displacement of the chest during the chest compressions. However, Taylor teaches an automatic compression system which has at least one displacement sensor configured to sense displacement signals corresponding to displacement of the patient's chest during the applied chest compressions, wherein the at least one processor and memory are configured to receive and process the displacement signals to estimate displacement of the chest during the chest compressions (Fig. 17 sensor 1746, patient 1782; Paragraph 0227 discloses the sensor may include a motion detect that is configured to detect motion of patient 1782; Paragraph 0234 discloses the processor can be configured to control operation of the compression mechanism according to the sensed parameter).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Itnati to further include a displacement sensor and apply chest compressions based on the displacement signals, as taught by Taylor, in order to provide an additional means of providing properly controlled compressions (Paragraph 0234). Examiner notes that Itnati already controls compression depth according to load sensor 62, and the modification would allow for an additional check on the safety of the depth for the patient.
Regarding claim 17, Itnati in view of Paradis 1 and Taylor discloses the system of claim 16, and Itnati as modified by Taylor further discloses wherein the adjustment of the magnitude of the scheduled depths to the patient-specific depths for one or more remaining chest compressions of the plurality of chest compressions is based, at least in part, on the estimated displacement (Examiner notes modified Itnati would perform it’s ECM procedure according to both the measurements of the load sensor and the incorporated displacement sensor of Taylor).
Regarding claim 18, Itnati in view of Paradis 1 and Taylor discloses the system of claim 16, and Itnati as modified by Taylor further discloses wherein the adjustment in the magnitude of the scheduled depths to the patient-specific depths for the one or more remaining chest compressions of the plurality of chest compressions is based, at least in part, on estimated chest compliance over the one or more preceding chest compressions (Taylor Fig. 17 sensor 1746, patient 1782; Paragraph 0227 discloses the sensor may include a motion detect that is configured to detect motion of patient 1782; Paragraph 0234 discloses the processor can be configured to control operation of the compression mechanism according to the sensed parameter; Examiner notes modified Itnati would perform it’s dynamically adjusted ECM procedure according to both the measurements of the load sensor and the incorporated displacement sensor of Taylor; Examiner further notes that chest compliance is being interpreted to be the same as chest displacement).
Regarding claim 19, Itnati in view of Paradis 1 and Taylor discloses the system of claim 18, and Itnati as modified by Taylor further discloses wherein the estimated chest compliance is based on the estimated force and the estimated displacement (Taylor Fig. 17 sensor 1746, patient 1782; Paragraph 0227 discloses the sensor may include a motion detect that is configured to detect motion of patient 1782; Paragraph 0234 discloses the processor can be configured to control operation of the compression mechanism according to the sensed parameter; Examiner notes modified Itnati would perform it’s dynamically adjusted ECM procedure according to both the measurements of the load sensor and the incorporated displacement sensor of Taylor; Taylor Paragraph 0152 discloses the load sensor senses force of the plunger against the patient’s thorax).
Regarding claim 22, Itnati and Paradis 1 discloses the system of claim 1, but does not disclose wherein the initial depth comprises a depth of about 0.1 inch to about 1.0 inch. However, Taylor teaches an automatic chest compression system wherein the initial depth comprises a depth of about 0.1 inches to about 1.0 inches (Taylor discloses Paragraphs 0160-0161 disclose the depth waveforms may be any shape; Examiner notes that the depth D1 is thus capable of being between 0.1 inches and 1.0 inches).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the compression procedure of Itnati to further include an initial depth at 0.1 inches to 1.0 inches, as taught by Taylor, in order to provide underperformance on the compressions (Paragraph 0160). Examiner notes this modification would ensure the initial depth is not uncomfortable for the patient receiving treatment.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Itnati in view of Paradis 1 as applied to claim 1 above, and further in view of US20190209428A1 to Paradis (hereinafter “Paradis”).
Regarding claim 10, Itnati discloses the system of claim 1, and Itnati further discloses wherein the initial compression period comprises a period of time of about 1 minute to about 5 minutes (Paragraph 0221 discloses the ECM procedure may last minutes; Examiner notes the machine may thus conduct a procedure anywhere from 1-5 minutes). Itnati does not disclose wherein the initial compression period comprises a period of time of about 30 seconds. However, Paradis teaches a device to improve efficacy of mechanical cpr which has an initial compression period of about 30 seconds (Paragraph 0045 discloses the system initially may administer compressions for 30 seconds – 1 minute at a time).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the ECM procedure of Itnati to give compressions initially for 30 seconds, as taught by Paradis, in order to efficiently determine the most efficacious compressions protocol (Paragraph 0045). Examiner notes this modification would streamline the process for assessing the optimal compression protocol, and thus render proper assistance to the patient more quickly.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US-20200269060-A1 to Donaghy; US-4928674-A to Halperin; US-20120016179-A1 to Paradis; US-7429250-B2 to Halperin; US-7108665-B2 to Halperin; and US-6390996-B1 to Halperin.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TYLER RAUBENSTRAW whose telephone number is (571)272-0662. The examiner can normally be reached Monday-Friday 7:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BRANDY LEE can be reached at 571-270-3525. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TYLER A RAUBENSTRAW/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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