DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Species B, drawn to Claims 3-5 and 19-20 in the reply filed on 1/29/2026 is acknowledged. The traversal is acknowledged and persuasive. Therefore, the Requirement for Restriction is withdrawn and all claims have been examined on the merits.
Claim Objections
Claim 11 is objected to because of the following informalities: “comprises is at least” should read “comprises at least”. Appropriate correction is required.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 7-11, 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20140163334 A1 to Volpe et al. (hereinafter, Volpe).
Regarding Claims 1 and 17, Volpe discloses an article of personal protective equipment and method of using (PPE) ([0029] “FIG. 1 shows a patient 1 with a wearable defibrillator. Typically the devices shown would be worn as a vest, belt and/or other clothing.”), comprising inter alia:
at least one sensor (accelerometer, [0030]) configured to generate motion signals indicative of a motion of a user of the article of PPE ([0030] “Any motion sensor can be used. In the present preferred embodiment accelerometers are used. Such sensors indicate accelerating movements.”); and
a controller (computer 47) communicably coupled to the at least one sensor, wherein the controller ([0068] “The computer 47 controls various system parameters such as accelerometer sensitivity, multiplexer (MUX) 45 channel select, the analog to digital converter (ADC) 46, and serial communications.”) is configured to:
determine a plurality of motions of the user over a plurality of time periods based on the motion signals received from the at least one sensor ([0013] “The invention can detect a patient condition based upon the level of activity of a patient over a period of time based upon said stored output of said accelerometer, and can be used to detect conditions such as, for example, congestive heart failure or sleep disorders.”), wherein each motion from the plurality of motions occurs over a corresponding time period from the plurality of time periods, and wherein each motion comprises a corresponding magnitude and a corresponding direction over the corresponding time period ([0007] “Accelerometers are able to measure x, y, and z positions.”) ([0032] “Accelerometers 21, 31, indicate change in velocity. Patients will normally have an activity level when conscious that includes changes in both velocity and direction… Outputs from sensors may be integrated, compared or differentiated to best predict patient activity, and reduce interference or error signals.”);
determine a motion pattern based on the plurality of motions, such that the motion pattern comprises at least one motion from the plurality of motions that has a non-zero value for the corresponding magnitude ([0015] “Embodiments can detect vertical and prone positions and determine a patient activity and a patient body orientation.”) [0016] “The following is a list of the functionality, information that can be provided by the motion detection or accelerometers: [0017] Patient body state: Patient is vertical, Patient is horizontal (On left side, On right side). [0018] Patient is moving in repetitive pattern: Vibrating (environmental), Convulsing. [0019] Patient is accelerating: Patient is falling. [0020] Equipment (belt and monitor) state: x/y/z position. [0021] Equipment acceleration. [0022] Equipment mechanical shock (high force impact, acceleration). [0023] Verification of tactile motor operation in belt node.”) ([0035] “Generally, cardiac treatment is not required if the patient is conscious. By using accelerometers the patient body state can be monitored. If there has been no change in patient body state for a period of time as detected by the accelerometer(s) then there will be an increased confidence of the algorithm that the patient is unconscious. If a change in patient body state has been detected by the accelerometer(s) then there will be a decreased confidence of the algorithm that the patient is unconscious.”) ([0035] “The wearable defibrillator can hasten its decision to apply treatment if a high level of confidence exists that the patient is unconscious.”);
determine an emergency event at least based on the motion pattern ([0018] “Patient is moving in repetitive pattern: Vibrating (environmental), Convulsing.”) ([0019] “Patient is accelerating: Patient is falling.”) ([0073] “If the patient becomes motionless coinciding with the arrhythmia detection, there is an increased confidence that the arrhythmia diagnosis is accurate…”); and
generate an alert signal upon determination of the emergency event ([0036] “The tactile stimulator may be turned on or the audio volume may be increased to notify the patient reference 1.”) ([0039] “In this case special alarms or voice messages could be generated to inform the bystander of the equipment and treatment status. Additional shocks could be delayed or cancelled to prevent a shock to the bystanders or rescue personnel.”) ([0053] “… the monitor will provide either an audio or visual (display) indication to the patient that the event has occurred…”) ([0054] “If continuous vibration above a certain predefined acceptable threshold is detected for a period of time then the monitor on 15 may also provide a warning to the patient.”).
Regarding Claim 7, Volpe discloses the article of PPE of claim 1, further comprising a personal alert safety system (PASS) device (microcontroller 22) communicably coupled to the at least one sensor, wherein the PASS comprises the controller ([0032] “Processing of accelerometer data can be performed by the microcontroller 22 in the belt/vest node 20 or a system computer 32 located in the monitor 30 or at both processing locations.”).
Regarding Claim 8, Volpe discloses the article of PPE of claim 1, wherein the at least one sensor comprises an accelerometer (accelerometer, [0030]).
Regarding Claim 9, Volpe discloses the article of PPE of claim 1, further comprising an alarm circuit communicably coupled to the controller, wherein the alarm circuit is configured to generate an alert upon receiving the alert signal from the controller ([0036] “The tactile stimulator may be turned on or the audio volume may be increased to notify the patient reference 1.”) ([0039] “In this case special alarms or voice messages could be generated to inform the bystander of the equipment and treatment status. Additional shocks could be delayed or cancelled to prevent a shock to the bystanders or rescue personnel.”) ([0053] “… the monitor will provide either an audio or visual (display) indication to the patient that the event has occurred…”) ([0054] “If continuous vibration above a certain predefined acceptable threshold is detected for a period of time then the monitor on 15 may also provide a warning to the patient.”).
Regarding Claim 10, Volpe discloses the article of PPE of claim 9, wherein the alert comprises an information indicative of at least one of an identification of the user of the article of PPE and a type of the emergency event ([0015] “Embodiments can detect vertical and prone positions and determine a patient activity and a patient body orientation.”) [0016] “The following is a list of the functionality, information that can be provided by the motion detection or accelerometers: [0017] Patient body state: Patient is vertical, Patient is horizontal (On left side, On right side). [0018] Patient is moving in repetitive pattern: Vibrating (environmental), Convulsing. [0019] Patient is accelerating: Patient is falling. [0020] Equipment (belt and monitor) state: x/y/z position. [0021] Equipment acceleration. [0022] Equipment mechanical shock (high force impact, acceleration). [0023] Verification of tactile motor operation in belt node.”) ([0035] “Generally, cardiac treatment is not required if the patient is conscious. By using accelerometers the patient body state can be monitored. If there has been no change in patient body state for a period of time as detected by the accelerometer(s) then there will be an increased confidence of the algorithm that the patient is unconscious. If a change in patient body state has been detected by the accelerometer(s) then there will be a decreased confidence of the algorithm that the patient is unconscious.”) ([0035] “The wearable defibrillator can hasten its decision to apply treatment if a high level of confidence exists that the patient is unconscious.”).
Regarding Claim 11, Volpe discloses the article of PPE of claim 9, wherein the alert comprises is at least one of an audio alert, a visual alert, a haptic alert, and a notification ([0036] “The tactile stimulator may be turned on or the audio volume may be increased to notify the patient reference 1.”) ([0039] “In this case special alarms or voice messages could be generated to inform the bystander of the equipment and treatment status. Additional shocks could be delayed or cancelled to prevent a shock to the bystanders or rescue personnel.”) ([0053] “… the monitor will provide either an audio or visual (display) indication to the patient that the event has occurred…”) ([0054] “If continuous vibration above a certain predefined acceptable threshold is detected for a period of time then the monitor on 15 may also provide a warning to the patient.”).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 2 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Volpe in view of US 20090062696 A1 to Nathan et al. (hereinafter, Nathan).
Volpe discloses the article of PPE of claim 1, wherein the controller is further configured to determine that the motion pattern comprises a plurality of successive repeated motions with respect to the corresponding magnitudes and corresponding directions ([0018] “Patient is moving in repetitive pattern: Vibrating (environmental), Convulsing.”) and determine that the emergency event is an emergency medical event upon determining the plurality of successive repeated motions ([0015]-[0023]).
Volpe does not expressly disclose where the plurality of successive repeated motions are equal to each other with respect to the corresponding magnitudes and corresponding directions.
However, Nathan teaches a seizure monitoring that is wearable and uses an accelerometer to gather motion sensor data from the user (Abstract). Nathan teaches [0052] “If a preset number of peaks in the amplitude of the acceleration are obtained within a certain time interval, then it is considered to be a seizure” and explains that repeated peaks ([0097]) (e.g., equal magnitude) and corresponding peaks on the same axis ([0098]) (e.g., equal direction), result in seizure determination ([0052]).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the emergency event determination of Vople to include the plurality of successive repeated motions that are equal to each other with respect to the corresponding magnitudes and corresponding directions of Nathan, as Nathan teaches at [0003]-[0004] that their instant invention would have been an improvement in the art over convention EEG devices for detection of seizures.
Claim(s) 6 s/are rejected under 35 U.S.C. 103 as being unpatentable over Volpe in view of US 20200380840 A1 to Galarneau et al. (hereinafter, Galarneau).
Volpe discloses the claimed invention except for expressly disclosing wherein the controller is further configured to: determine that the motion pattern comprises a first motion and a second motion succeeding the first motion, such that a ratio of the magnitude of the first motion to the magnitude of the second motion is greater than or equal to 100; and determine that the emergency event is at least one of a fall event, and a collapse event upon determining that the motion pattern comprises the first motion and the second motion.
However, Galarneau teaches a device that uses an accelerometer signal to detect a fall (Abstract). Galarneau teaches at [0035]-[0036] that a fall is detected upon a spike in acceleration (e.g., a second motion greater than a first motion), where a ratio is used, being the magnitude of the output vector at 1.0g. While Galarneau does not expressly disclose that this ratio is expressly 100, one having an ordinary skill in the art would have chosen an output ration of 100 to determine a fall, as this is any one of a plurality of rations of acceleration data that can be used to determine a fall, and is nothing more than routine optimization of a ration to determine a fall.
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the motion sensing of Volpe with the ratio of magnitude performed by Galarneau, as Galarneau teaches at [0036] that this method would have allowed for fall detection.
Claim(s) 12 s/are rejected under 35 U.S.C. 103 as being unpatentable over Volpe in view of US 20100245078 A1 to Nadkarni et al. (hereinafter, Nadkarni).
Volpe discloses the claimed invention except for expressly disclosing further comprising a memory communicably coupled to the controller, wherein the memory stores a plurality of motion signatures, and wherein the controller is configured to determine the emergency event further based on a comparison between the motion pattern and the plurality of motion signatures.
However, Nadkarni teaches a wearable motion sensor device (Abstract). Nadkarni teaches at [0037] a memory storing a plurality of motion signatures, where the collected motion signatures are comparted to the stored motion signatures to determine a motion event.
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the device of Volpe to include the memory and motion sensing matching to determine a motion signature event of Nadkarni, as Nadkarni teaches at [0005] that this would have more accurately allowed monitoring of motion of a human being.
Allowable Subject Matter
Claims 3-5, 13-16 and 19-21 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791
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