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 .
Status of the Application
Claims 1-20 have been examined in this application. This communication is the first action on merits. The Information Disclosure Statement (IDS) filed on 07/24/2024 has been acknowledged by the Office.
Claim Rejections - 35 USC § 102
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.
Claims 1-6, 8-13, and 15-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Freeman (US 20170079876 A1).
In regards to Claim 1, Freeman teaches: A system for assisting a rescuer in providing chest compressions to a patient in need of acute care (100, 102, 104 – Fig. 1; [0028]-[0029]), the system comprising: a chest compression device (100 – Figs. 1-2) comprising: at least one motion sensor configured to generate motion signals signifying chest compressions administered to the patient (216b, 216c – Fig. 2; 404a, 404b – Fig. 4; [0045]-[0047], [0051]), at least one force sensor configured to generate force signals signifying chest compressions administered to the patient (216a – Fig. 2; 402 – Fig. 4; [0045], [0051]), and a housing supporting the at least one motion sensor and the at least one force sensor (218 – Fig. 2; [0045]-[0046]); at least one processor operatively connected to the at least one motion sensor and the at least one force sensor (400 – Fig. 4; [0051]) and configured to: receive and process signals from the at least one motion sensor and the at least one force sensor ([0051]), determine a chest compliance relationship based on the signals from the at least one motion sensor and the at least one force sensor (414 – Fig. 4; 502 – Fig. 5; [0031]-[0032], [0039]-[0045], [0056], [0062]-[0063]), detect a compressible transition layer at an anterior location of the patient based on the chest compliance relationship (504, 508, 506 – Fig. 5, showing changes in compliance over time corresponding to transitions in compressibility; [0062]-[0063]), and generate an output signal based on the compressible transition layer (406 – Fig. 4; [0052], [0059]); and an output device configured to provide feedback to a user based on the compressible transition layer (408 – Fig. 4; [0052]-[0054], [0057]-[0059]).
In regards to Claim 2, Freeman teaches: The system of claim 1, wherein the at least one processor is configured to estimate a chest compression depth based on signals from at least one of the at least one motion sensor or the at least one force sensor (Fig. 3; [0048]-[0049], showing displacement during chest compressions C1-C5 and teaching that compression depth is measured from compression onset to peak displacement, e.g., d1-d0; further see [0058], [0078], teaching determination of chest compression depth utilizing accelerometer and/or force sensor information).
In regards to Claim 3, Freeman teaches: The system of claim 2, wherein the at least one processor is configured to estimate the chest compression depth based on a change in the chest compliance relationship (Figs. 5 and 6A-6B; [0062]-[0067], showing changes in the chest compliance relationship during compression and using changes in compliance, including changes in slope and inflection points, to determine characteristics of the compression and whether compression depth should be increased or decreased).
In regards to Claim 4, Freeman teaches: The system of claim 1, wherein the at least one processor is configured to detect the compressible transition layer based on determining whether the chest compliance relationship satisfies a threshold criterion (502 – Fig. 5; Figs. 6A-6B; [0063]-[0067], teaching detection of changes in chest compliance, including changes in slope and comparison of compliance with predetermined threshold values).
In regards to Claim 5, Freeman teaches: The system of claim 4, wherein the threshold criterion is satisfied when an absolute value of a rate of change of chest compliance is less than a threshold rate of change of compliance (Fig. 5, showing compliance as a function of time and relatively flat compliance regions 504, 508, and 506, from which the rate of change of compliance is directly calculable; [0062]-[0067], further teaching detection and threshold analysis based on changes in compliance and slope).
In regards to Claim 6, Freeman teaches: The system of claim 4, wherein the at least one processor is configured to estimate the chest compression depth by calculating a displacement from signals from the at least one motion sensor when the threshold criterion is satisfied (Fig. 3, showing acceleration and corresponding displacement during chest compressions; [0045], [0048]-[0049], teaching that the accelerometer senses chest motion, the accelerometer signal is integrated to determine displacement, and compression depth is measured from compression onset to peak displacement, e.g., d1-d0; further see [0063]-[0067] regarding the compliance threshold determination).
In regards to Claim 8, Freeman teaches: The system of claim 1, wherein the output device is configured to provide an indication to a user based on detecting the compressible transition layer (406, 408 – Fig. 4; [0052]-[0054], [0057]-[0059], teaching that processor 400 generates output information based on the determined chest compliance and provides the information to user interface module 408 for providing visual, textual, graphical, audio, tactile, and/or other feedback to the rescuer).
In regards to Claim 9, Freeman teaches: The system of claim 1, wherein the at least one motion sensor comprises an accelerometer (216b, 216c – Fig. 2; 404a, 404b – Fig. 4; [0045], [0047], [0051], teaching accelerometers configured to sense motion during administration of CPR).
In regards to Claim 10, Freeman teaches: The system of claim 1, wherein the at least one processor is configured to identify an occurrence of active decompression applied to the patient based on signals from at least one of the at least one motion sensor or the at least one force sensor (Figs. 3 and 9; [0048]-[0049], [0078]-[0079], teaching identification of compression and decompression phases based upon sensed movement, displacement, force, direction of movement, and the determined neutral position).
In regards to Claim 11, Freeman teaches: The system of claim 10, wherein the output device is configured to provide feedback to the user based on identifying the occurrence of active decompression applied to the patient (406, 408 – Fig. 4; Fig. 8; [0052]-[0054], [0078]-[0083], teaching output information and feedback concerning decompression, including DE height and prompting the rescuer regarding the administration of compression/decompression).
In regards to Claim 12, Freeman teaches: The system of claim 1, wherein the at least one processor is configured to determine whether a chest compression has started or stopped based on signals from at least one of the at least one motion sensor or the at least one force sensor (Fig. 3; [0048]-[0049], teaching detection of individual chest compressions C1-C5 from the displacement signal and determination of compression onset and peak displacement; further see Fig. 9 and [0079], teaching determination of compression-cycle phases based upon sensed movement and neutral position).
In regards to Claim 13, Freeman teaches: The system of claim 1, wherein the at least one processor is configured to determine a neutral position of chest compression based at least in part on a feature of the chest compliance relationship (416 – Fig. 4; Figs. 5, 6A-6B and 7; [0058], [0069]-[0075], teaching determination of the neutral position based upon features of the compliance relationship, including compliance peaks 504/506, intersection point 604, midpoint 612 between peaks 614/616, and midpoint 606).
In regards to Claim 15, Freeman teaches: The system of claim 1, wherein the at least one processor is configured to determine a state of the patient based on signals from the at least one motion sensor and the at least one force sensor (400, 402, 404a, 404b – Fig. 4; [0051], [0056]-[0058], [0063]-[0068], teaching determination of the patient’s chest compliance and changes in the condition of the patient’s chest from force and motion information obtained during CPR).
In regards to Claim 16, Freeman teaches: The system of claim 15, wherein the output device is configured to alert a user based on the determined state of the patient, and wherein the state of the patient is representative of a likelihood of injury to the patient during the course of resuscitation (Fig. 8; [0063]-[0068], teaching monitoring changes in chest compliance associated with excessive compression and an increased risk of rib fracture or other injury and providing a warning to the rescuer based upon the determined condition).
In regards to Claim 17, Freeman teaches: The system of claim 16, wherein the alert comprises a notification that the patient is at risk of suffering from injury during the course of resuscitation ([0063]-[0068], teaching providing an audio, visual, and/or tactile warning to the rescuer based upon a change in compliance indicative of excessive compression and an increased likelihood of rib fracture or other injury during CPR).
Allowable Subject Matter
Claim(s) 7, 14, and 19-20 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:
In regards to Claim 7, Freeman teaches the system of claim 1, including detecting changes in a chest compliance relationship associated with compression of the patient; however, Freeman does not teach, disclose, or render obvious, either alone or in combination with the prior art of record, wherein, when detecting the compressible transition layer, the at least one processor is configured to detect at least one of an adipose layer, a clothing, and/or a gauze at the anterior location of the patient. While Freeman detects changes in chest compliance, including the transitions illustrated by 504, 508, and 506 of Fig. 5, Freeman does not identify or distinguish the detected compressible transition layer as an adipose layer, clothing, and/or gauze positioned at the anterior location of the patient.
In regards to Claim 14, Freeman teaches the system of claim 1 including at least one force sensor configured to generate force signals during administration of chest compressions; however, Freeman does not teach, disclose, or render obvious, either alone or in combination with the prior art of record, wherein the at least one force sensor has a first resolution with a first least significant measurement (LSM) of less than 1.0 lb over a first force range, and a second resolution with a second LSM over a second force range, wherein the second LSM is at least 2 times greater than the first LSM. Particularly, Freeman does not disclose a force sensor having the claimed different resolutions and corresponding least significant measurements over respective first and second force ranges.
In regards to Claim 19, Freeman teaches the system of claim 15 including determining a state of the patient and estimating chest compression depth using motion and/or force information; however, Freeman does not teach, disclose, or render obvious, either alone or in combination with the prior art of record, wherein the state of the patient comprises having a compressible surface underneath the patient, and wherein the at least one processor is configured to estimate a chest compression depth based on detecting the compressible surface underneath the patient. Particularly, Freeman’s compliance determinations concern the patient’s chest and the interaction occurring at the anterior chest location and do not detect a compressible supporting surface underneath the patient or estimate chest compression depth based upon detection of such an underlying compressible surface.
In regards to Claim 20, Freeman teaches the system of claim 1 including a chest compression device configured to be positioned at an anterior location of the patient; however, Freeman does not teach, disclose, or render obvious, either alone or in combination with the prior art of record, an additional chest compression device configured to be placed at a posterior location of the patient. Particularly, Freeman does not disclose a second chest compression device positioned posteriorly relative to the patient in addition to the anterior chest compression device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Nysaether (US 20080300517 A) teaches: A method for monitoring chest compressions using a compression member includes measuring a force exerted by the compression member, measuring a displacement of the compression member, providing a chest stiffness function representing the relationship between force and displacement based on values derived from the measured force and the measured displacement, and analyzing linearity of the chest stiffness function. Embodiments of the invention also include devices for performing the method.
Voss et al. (US 20110201979 A1) teaches: Systems and methods for applying guided active compression decompression cardiopulmonary resuscitation are provided. Exemplary systems include a load cell, a handle, an adhesive pad. The handle and the adhesive pad are configured for magnetic coupling.
Halperin et al. (US 6390996 B1) teaches: Chest compressions are measured and prompted to facilitate the effective administration of CPR. A displacement detector produces a displacement indicative signal indicative of the displacement of the CPR recipient's chest toward the recipient's spine. A signaling mechanism provides chest compression indication signals directing a chest compression force being applied to the chest and a frequency of such compressions. An automated controller and an automated constricting device may be provided for applying CPR to the recipient in an automated fashion. The automated controller receives the chest compression indication signals from the signaling mechanism, and, in accordance with the chest compression indication signals, controls the force and frequency of constrictions. The system may be provided with a tilt compensator comprising a tilt sensor mechanism outputting a tilt compensation signal indicative of the extent of tilt of the device, and may be further provided with an adjuster for adjusting the distance value in accordance with the tilt compensation signal. An ECG signal processor may be provided which removes the CPR-induced artifact from a measured ECG signal obtained during the administration of CPR.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADISON MATTHEWS whose telephone number is (571)272-8473. The examiner can normally be reached M-F 7:30-4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justin Mikowski can be reached at (571)-272-8525. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MADISON MATTHEWS
Primary Examiner
Art Unit 3673
/MADISON MATTHEWS/Primary Examiner, Art Unit 3673
08/09/2026
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