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 01/26/2026 has been entered. Claims 1-3, 13, 16, 18-21, and 26 have been amended. Claims 143-154 are newly added. Claims 119-130 and 140-142 have been cancelled. Applicant’s amendments to the claims have overcome the objections and 112(b) rejections raised in the non-final rejection mailed on 09/26/2025. Claims 1-3, 9, 13, 16, 18-20, 26, and 143-154 are pending in the instant application.
Response to Arguments
Applicant’s arguments with respect to claim 1 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
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 9, 13, 16, 18-20, 145-151 are rejected under 35 U.S.C. 103 as being unpatentable over US20110201797A1 to Voss et al. (hereinafter “Voss”) in view of US20150045704A1 to Lurie et al. (hereinafter “Lurie”).
Regarding claim 1, Voss discloses a system for providing resuscitative therapy to a patient (Figs. 5 & 11 system 500, device 1100; Paragraph 0002 discloses the system is for administering active compression decompression CPR to a patient), comprising:
a defibrillator configured to be connected with at least one electrode (Fig. 11 contact pad 1102, electrodes 1103,1104; Paragraph 0100 discloses the contact pad includes an imbedded automated external defibrillator (AED)) and a handheld compression sensor (Paragraph 0079 discloses a load or force sensor may be present in the handle (i.e. Fig. 11 handle 1101); Examiner notes the user holds the handle and if the sensor is inside the handle, then the sensor itself is handheld), the defibrillator configured to provide electrotherapy to the patient via the at least one electrode when the at least one electrode is positioned on the patient (Paragraphs 0099-0100 disclose defibrillation may be applied to the patient via the electrodes when adhered to the patient’s chest), and
the handheld compression sensor configured to be physically coupled with the at least one electrode (Examiner notes when the handle 1101 is attached to the contact pad 1102 the electrodes and sensor would be physically coupled to one another), and be physically separated from the at least one electrode without removing the at least one electrode from the patient (Fig. 9 shows the handle 702 may be separated from the contact pad 707; Paragraph 0076 discloses the handle may break away from the pad in a variety of breakaway mechanisms); and
an ACD device configured to be coupled to the patient's chest (Fig. 11 handle 1101, contact pad 1102; Paragraph 0011 discloses the system is used to apply guided active compression decompression) while the at least one electrode is positioned on the patient (Examiner notes the user would be able to apply ACD on the patient while electrodes 1103,1104 are positioned on the patient’s chest), the ACD device different from the handheld compression sensor (Examiner notes the ACD device (handle 1101, contact pad 1102) is a separate entity from the load/force sensor), the ACD device comprising:
at least one sensor configured for sensing at least one active compression decompression parameter (Paragraph 0079 discloses a load or force sensor may be present in the handle (i.e. Fig. 11 handle 1101)).
Voss does not explicitly disclose at least one processor configured to process the at least one active compression decompression parameter and generate output based at least in part on the at least one active compression decompression parameter. However, Lurie teaches a system for providing active compression decompression CPR on a patient which has at least one processor configured to process the at least one active compression decompression parameter and generate output based at least in part on the at least one active compression decompression parameter (Fig. 3B controller 25; Paragraph 0042 discloses a controller may include one or more processors and appropriate software/hardware for performing operations under direction of the processor; Paragraph 0046 discloses the system may include a way to communicate with a CPR device or defibrillator to provide feedback in terms of how to perform CPR at a proper rate of chest compressions and ventilation rates; Paragraph 0056 discloses sensor measurements may be communicated to the controller by wired or wireless connection).
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 system of Voss to further include at least one processor configured to process the at least one active compression decompression parameter and generate output based at least in part on the at least one active compression decompression parameter, as taught by Lurie, in order to provide feedback based on sensor measurements to guide the CPR administration (Paragraphs 0046 & 0056).
Regarding claim 2, Voss in view of Lurie discloses the system of claim 1, and Voss as modified by Lurie further discloses a connector for use in establishing communication from the ACD device to the defibrillator (Lurie Paragraph 0046 discloses the system may include a way to communicate with a CPR device or defibrillator (patient monitor) to provide feedback in terms of how to perform CPR such as proper rate of chest compression and ventilation rate; Paragraph 0056 discloses sensor measurements may be communicated to the controller by wired or wireless connection; Examiner notes that the wired connection between the ACD device and the patient monitor (defibrillator) would inherently have a point of connection (a connector)).
Regarding claim 3, Voss in view of Lurie discloses the system of claim 1, and Voss further discloses wherein the handheld compression sensor comprises at least one of a motion sensor, an accelerometer, and a force sensor, wherein the at least one of the motion sensor, the accelerometer, and the force sensor is configured for monitoring at least one of: motion of at least a portion of the patient's chest in response to force applied during the active compression decompression therapy, and force applied to at least a portion of the patient's chest during the active compression decompression therapy (Paragraph 0079 discloses a load or force sensor may be present to sense compressive forces in the handle (i.e. Fig. 11 handle 1101).
Regarding claim 9, Voss in view of Lurie discloses the system of claim 1, and Voss further discloses wherein the ACD device includes a pad configured to be adhered to and to cover at least a portion of the patient's chest (Fig. 11 contact pad 1102; See also Fig. 2).
Regarding claim 13, Voss in view of Lurie discloses the system of claim 9, and Voss further discloses wherein the pad includes at least one receptacle for receiving an electrode assembly comprising the at least one electrode (Fig. 11 contact pad 1102, electrodes 1103 and 1104; Col. 23 lines 4-13 disclose the electrodes are connected to an external AED machine via leads 1105 and 1106; Examiner notes that the slots the electrodes are received in are the receptacles).
Regarding claim 16, Voss in view of Lurie discloses the system of claim 1, and Voss further discloses wherein the defibrillator is connected with an electrode assembly comprising the at least one electrode (Fig. 11 contact pad 1102, electrodes 1103,1104, load/force sensor (See Paragraph0079); Paragraph 0100 discloses the contact pad includes an imbedded automated external defibrillator (AED)).
Regarding claim 18, Voss in view of Lurie discloses the system of claim 1, and Voss further discloses wherein the defibrillator comprises a patient monitor (Fig. 11 LCD display 1107; Paragraph 0100 discloses the LCD display shows information about compression forces on the patient).
Regarding claim 19, Voss in view of Lurie discloses the system of claim 16, and Voss further discloses wherein the electrode assembly comprises the handheld compression sensor (Examiner notes the electrode assembly includes the force/load sensor (See rejection of claim 16 above)).
Regarding claim 20, Voss in view of Lurie discloses the system of claim 1, and Voss further discloses wherein the handheld compression sensor is configured to transfer data related to chest compressions (Paragraph 0079 discloses a load or force sensor to measure compressive forces may be present in the handle (i.e. Fig. 11 handle 1101)).
Regarding claim 145, Voss discloses a method for providing resuscitative therapy to a patient by delivering active chest compression decompressions (Figs. 5 & 11 system 500, device 1100; Paragraph 0002 discloses the system and methods are for administering active compression decompression CPR to a patient), comprising:
applying manual chest compressions to the patient, comprising using a handheld compression sensor connected with at least one electrode of a defibrillator (Fig. 11 contact pad 1102, electrodes 1103,1104; Paragraph 0100 discloses the contact pad includes an imbedded automated external defibrillator (AED); Paragraph 0079 discloses a load or force sensor may be present in the handle (i.e. Fig. 11 handle 1101); Paragraph 0085 discloses using the handle to administer manual compressions; Examiner notes the user holds the handle and if the sensor is inside the handle, then the sensor itself is handheld);
while the at least one electrode is positioned on the patient, and without removing the at least one electrode from the patient (Fig. 11 electrodes 1103,1104): separating the handheld compression sensor from the at least one electrode; positioning an ACD device on the patient's chest for administering of active compression decompression therapy (Fig. 9 shows the handle 702 may be separated from the contact pad 707; Paragraph 0076 discloses the handle may break away from the pad in a variety of breakaway mechanisms); and
applying the active compression decompression therapy to the patient using the ACD device (Fig. 11 handle 1101, contact pad 1102; Paragraph 0011 discloses the system is used to apply guided active compression decompression).
Voss does not explicitly disclose stopping applying the manual chest compressions. However, Lurie teaches a system for providing active compression decompression CPR on a patient which discloses stopping applying the manual chest compressions (Fig. 3B controller 25; Paragraph 0042 discloses a controller may include one or more processors and appropriate software/hardware for performing operations under direction of the processor; Paragraph 0046 discloses the system may include a way to communicate with a CPR device or defibrillator to provide feedback in terms of how to perform CPR at a proper rate of chest compressions and ventilation rates; Paragraph 0056 discloses sensor measurements may be communicated to the controller by wired or wireless connection).
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 system of Voss to further include stopping applying manual chest compressions, as taught by Lurie, in order to cease therapy in case the therapy is futile (Paragraph 0052).
Regarding claim 146, Voss in view of Lurie discloses the method of claim 145, and Voss further discloses comprising using a connector in establishing communication from the ACD device to the defibrillator (Lurie; Examiner notes that the wired connection between the ACD device and the patient monitor (defibrillator) would inherently have a point of connection (a connector)).
Regarding claim 147, Voss in view of Lurie discloses the method of claim 145, and Voss further discloses comprising using the handheld compression sensor in monitoring at least one of: motion of at least a portion of the patient's chest in response to force applied during the active compression decompression therapy, and force applied to at least a portion of the patient's chest during the active compression decompression therapy (Paragraph 0079 discloses a load or force sensor may be present to sense compressive forces in the handle (i.e. Fig. 11 handle 1101).
Regarding claim 148, Voss in view of Lurie discloses the method of claim 145, and Voss further discloses wherein the ACD device includes a pad, and comprising adhering the pad to a portion of the patient's chest (Fig. 11 contact pad 1102; See also Fig. 2).
Regarding claim 149, Voss in view of Lurie discloses the method of claim 148, and Voss further discloses wherein the pad includes at least one receptacle, and comprising using the at least one receptacle for receiving an electrode assembly comprising the at least one electrode (Fig. 11 contact pad 1102, electrodes 1103 and 1104; Col. 23 lines 4-13 disclose the electrodes are connected to an external AED machine via leads 1105 and 1106; Examiner notes that the slots the electrodes are received in are the receptacles).
Regarding claim 150, Voss in view of Lurie discloses the method of claim 145, and Voss further discloses connecting the defibrillator with an electrode assembly comprising the at least one electrode (Fig. 11 contact pad 1102, electrodes 1103,1104; Paragraph 0100 discloses the contact pad includes an imbedded automated external defibrillator (AED)).
Regarding claim 151, Voss in view of Lurie discloses the method of claim 145, and Voss further discloses handheld compression sensor transferring data related to chest compressions to the defibrillator (Paragraph 0079 discloses a load or force sensor to measure compressive forces may be present in the handle (i.e. Fig. 11 handle 1101); Paragraph 0067 discloses a processor component may receive treatment parameter signals from the sensor input).
Claims 26, 144, 152, and 154 are rejected under 35 U.S.C. 103 as being unpatentable over Voss in view of Lurie as applied to claims 1 and 145 above, and further in view of US20160067141A1 to Wakabayashi (hereinafter “Waka”).
Regarding claim 26, Voss in view of Lurie discloses the system of claim 1, but does not explicitly disclose wherein the defibrillator and the ACD device are configured to mutually establish a wireless communications channel. However, Waka teaches a defibrillator (patient monitor) in wireless communication with a cpr assisting device (Fig. 1 defibrillator 10, communicating unit 11, controlling unit 12, cpr assisting device 20, communicating unit 21, controlling unit 22; Paragraph 0016 discloses the defibrillator 10 establishes a communication with the cpr device 20; Fig. 1 shows the defibrillator and cpr device share information through their communicating units; Paragraph 0021 discloses communication units 11 and 21 are connected via Bluetooth; Paragraph 0022-0023 disclose a sensor in the compression device detects compression depth and rate which is applied to the rescuee).
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 Lurie to further include a wireless communication unit configured to transfer data related to output of a compression device to a defibrillator, as taught by Waka, in order to provide a wireless means of communication such as Bluetooth (Paragraph 0016). Examiner notes the inclusion of a secondary communication circuit will allow for communication between the devices when physically connected and when they are within close proximity to one another but not directly physically connected.
Regarding claim 144, Voss in view of Lurie discloses the system of claim 1, but Voss does not disclose while the at least one electrode is positioned on the patient, when the ACD device comes within sufficient proximity with the defibrillator, the ACD device and the defibrillator wirelessly couple such that the output can be wirelessly transmitted from the ACD device to the defibrillator. However, Waka teaches a defibrillator (patient monitor) in wireless communication with a cpr assisting device (Fig. 1 defibrillator 10, communicating unit 11, controlling unit 12, cpr assisting device 20, communicating unit 21, controlling unit 22; Paragraph 0016 discloses the defibrillator 10 establishes a communication with the cpr device 20; Fig. 1 shows the defibrillator and cpr device share information through their communicating units; Paragraph 0021 discloses communication units 11 and 21 are connected via Bluetooth; Paragraph 0022-0023 disclose a sensor in the compression device detects compression depth and rate which applied to the rescuee).
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 Lurie to further include a wireless communication unit configured to transfer data related to output of a compression device to a defibrillator, as taught by Waka, in order to provide a wireless means of communication such as Bluetooth (Paragraph 0016). Examiner notes the inclusion of a secondary communication circuit will allow for communication between the devices when physically connected and when they are within close proximity to one another but not directly physically connected.
Regarding claim 152, Voss in view of Lurie discloses the method of claim 145, but Voss does not disclose wherein the defibrillator and the ACD device are configured to mutually establish a wireless communications channel. However, Waka teaches a defibrillator (patient monitor) in wireless communication with a cpr assisting device (Fig. 1 defibrillator 10, communicating unit 11, controlling unit 12, cpr assisting device 20, communicating unit 21, controlling unit 22; Paragraph 0016 discloses the defibrillator 10 establishes a communication with the cpr device 20; Fig. 1 shows the defibrillator and cpr device share information through their communicating units; Paragraph 0021 discloses communication units 11 and 21 are connected via Bluetooth; Paragraph 0022-0023 disclose a sensor in the compression device detects compression depth and rate which applied to the rescuee).
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 Lurie to further include a wireless communication unit configured to transfer data related to output of a compression device to a defibrillator, as taught by Waka, in order to provide a wireless means of communication such as Bluetooth (Paragraph 0016). Examiner notes the inclusion of a secondary communication circuit will allow for communication between the devices when physically connected and when they are within close proximity to one another but not directly physically connected.
Regarding claim 154, Voss in view of Lurie discloses the method of claim 145, but Voss does not disclose while the at least one electrode is positioned on the patient, when the ACD device comes within sufficient proximity with the defibrillator, the ACD device and the defibrillator wirelessly couple such that the output can be wirelessly transmitted from the ACD device to the defibrillator. However, Waka teaches a defibrillator (patient monitor) in wireless communication with a cpr assisting device (Fig. 1 defibrillator 10, communicating unit 11, controlling unit 12, cpr assisting device 20, communicating unit 21, controlling unit 22; Paragraph 0016 discloses the defibrillator 10 establishes a communication with the cpr device 20; Fig. 1 shows the defibrillator and cpr device share information through their communicating units; Paragraph 0021 discloses communication units 11 and 21 are connected via Bluetooth; Paragraph 0022-0023 disclose a sensor in the compression device detects compression depth and rate which applied to the rescuee).
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 Lurie to further include a wireless communication unit configured to transfer data related to output of a compression device to a defibrillator, as taught by Waka, in order to provide a wireless means of communication such as Bluetooth (Paragraph 0016). Examiner notes the inclusion of a secondary communication circuit will allow for communication between the devices when physically connected and when they are within close proximity to one another but not directly physically connected.
Allowable Subject Matter
Claims 143 and 153 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 143, Voss in view of Lurie, the closest prior art combination of record, discloses the system of claim 1, and Voss as modified by Lurie further discloses a connector connected to the defibrillator (Lurie Paragraph 0046 discloses the system may include a way to communicate with a CPR device or defibrillator (patient monitor) to provide feedback in terms of how to perform CPR such as proper rate of chest compression and ventilation rate; Paragraph 0056 discloses sensor measurements may be communicated to the controller by wired or wireless connection; Examiner notes that the wired connection between the ACD device and the patient monitor (defibrillator) would inherently have a point of connection (a connector)). Voss in view of Lurie does not disclose “connect with the handheld compression sensor to establish a communicative connection between the handheld compression sensor and the defibrillator, physically separate from the handheld compression sensor, connect with the ACD device to establish a communicative connection between the ACD device and the defibrillator.”. Nor would it have been obvious to make such modifications. The modified device of Voss has a wired connection to allow communication between the ACD device and the defibrillator, but there is no contemplation of a connector which makes a connection between a handheld compression sensor and a defibrillator which is physically separate from the handheld compression sensor that connects with the active compression decompression device to establish communication between the ACD device and the defibrillator. In order to make the required modifications, the communications systems of modified Voss would need to redesigned to accommodate the physical connector.
Absent any new prior art made of record, it would not have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make such modifications.
Regarding claim 153, Voss in view of Lurie, the closest prior art combination of record, discloses the method of claim 145, and Voss as modified by Lurie further discloses while the at least one electrode is positioned on the patient, and without removing the at least one electrode from the patient: connecting a connector, connected with the defibrillator (Lurie Paragraph 0046 discloses the system may include a way to communicate with a CPR device or defibrillator (patient monitor) to provide feedback in terms of how to perform CPR such as proper rate of chest compression and ventilation rate; Paragraph 0056 discloses sensor measurements may be communicated to the controller by wired or wireless connection; Examiner notes that the wired connection between the ACD device and the patient monitor (defibrillator) would inherently have a point of connection (a connector); Examiner notes that the connector would be connected when the handle 1101 is connected to therapy pad 1102 with the electrodes on the pad). Voss in view of Lurie does not disclose “[connecting the connector] with the handheld compression sensor to establish a communicative connection between the handheld compression sensor and the defibrillator, separating the connector from the handheld compression sensor, and connecting the connector with the ACD device to establish a communicative connection between the ACD device and the defibrillator.”. Nor would it have been obvious to make such modifications. The modified device of Voss has a wired connection to allow communication between the ACD device and the defibrillator, but there is no contemplation of a connector which makes a connection between a handheld compression sensor and a defibrillator which is physically separate from the handheld compression sensor that connects with the active compression decompression device to establish communication between the ACD device and the defibrillator. In order to make the required modifications, the communications systems of modified Voss would need to redesigned to accommodate the physical connector.
Absent any new prior art made of record, it would not have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make such modifications.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US-20120330199-A1 to Lurie; US-20050126578-A1 to Garrison; US-20050096570-A1 to Palazzolo; and US-20040230140-A1 to Steen.
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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/TYLER A RAUBENSTRAW/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799