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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims, 12-19 in the reply filed on 11/01/2023 is acknowledged.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-13 & 16-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Derchak et al. (US 2011/0054271) in view of Lynn et al. (US 2013/0338459) and further in view of Wondka et al. (US 2010/0083968).
Claim 12.
Derchak et al. teaches:
A wearable apparatus
E.G. via the disclosed wearable monitoring garment adapted to monitor physiological characteristics of a subject {[0040], [0046], [0070] & (Figs 3-6)}.
…for measuring ventilation rate and activity level in a subject…
E.G. via the disclosed respiratory monitoring during physical activity ([0038], [0046], [0066]-[0068]).
…comprising a ventilation rate sensor, and an activity sensor and a processor…
E.G. via the disclosed magnetometer system configured to monitor thoracic movement associated with respiration, an accelerometer of other movement monitoring sensor; and processor subsystem {[0038]-[0040], [0043]-[0046], [0076]-[0080] & (Figs. 2-6)}.
…wherein the ventilation rate sensor and the activity sensor are in electrical communication with the processor…
E.G. via the disclosed physiological measurements received from the sensors are processed by the processor subsystem ([0043]-[0045] & [0079]-[0080]).
However, Derchak et al. does not explicitly disclose:
…wherein the processor is configured to process the data received from the ventilation rate sensor and activity sensor to determine a ventilation rate above predicted (VRAP).
Lynn et al. teaches:
A processor analysis of physiological parameters having known predictable physiological linkages [0204];
Using minute ventilation as a monitored physiological parameter ([0204]-[0205]);
Comparing measured physiological behavior with expected or predicted physiological behavior to determine whether physiological parameters follow or diverge from expected trends [0204];
Processor identification of expected physiological relationships between ventilation and other physiological parameters to evaluate respiratory status [0204].
Wondka et al. further teaches;
Processing measurements obtained from both a breath sensor and an activity sensor [0012];
A control unit configured to process respiration and patient activity measurements together [0013];
Adjusting ventilation based upon the processed respiration and activity measurement ([0012]-[0013]);
Storing measured ventilation parameters and performing processor-executed predictive analysis of respiratory information [0013]
Under the broadest reasonable interpretation (BRI) consistent with the specification, the recitation of “determine a ventilation rate above predicted (VRAP)” reasonably encompasses processing measured ventilation data together with activity data to determine whether the measured ventilation corresponds to, exceeds, or otherwise differs from an expected or predicted ventilation value or physiological relationship. The claims does not positively recite any particular mathematical equation, algorithm, or proprietary calculation for determining VRAP. Accordingly, the limitation reasonably reads on processor-based analysis of measured ventilation using known predictive physiological relationships as taught by Lynn et al., together with the combined processing of respiration and activity measurements as taught by Wondka et al.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Derchak’s wearable physiological monitoring system to incorporate Lynn’s processor-based evaluation of measured ventilation using expected physiological relationships, as further evidenced by Wondka’s teaching of jointly processing respiration and activity measurements, in order to improve respiratory assessment by analyzing measured ventilation in view of expected physiological behavior, thereby more accurate respiratory monitoring and earlier identification of physiological changes.
The modification merely applies known processor-based predictive respiratory analysis techniques to Derchak’s known respiratory monitoring system for their established purpose of improving respiratory assessment, yielding the predictable results of enhanced physiological monitoring. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
Claim 13.
…further comprising a support structure wherein the support structure is a thoracic strap.
E.G. Derchak et al. teaches a wearable monitoring garment adapted to cover at least a portion of the subject’s torso and configured to support the respiratory monitoring components.
Claim 16.
…further comprising an output device….in wireless communication with the processor.
E.G. Derchak et al. teaches an output subsystem 60 and a wireless communication link for transmitting processed physiological information {[0045], [0081]-[0082] & (Fig 1)}.
Claim 17.
…wherein the ventilation sensor comprises a magnet and a magnetic field sensor.
E.G. Derchak et al. teaches paired magnetometers configured to generate and receive magnetic fields for determining respiratory movement {[0038], [0040], [0077]-[0078] & (Figs. 2-6)}.
Claim 18.
…wherein the activity sensor is an accelerometer, optionally a tri-axial accelerometer.
E.G. Derchak et al. teaches accelerometers for detecting subject movement and activity.
Claim 19.
…comprising more than one ventilation sensors and/or more than one activity sensor.
E.G. Derchak et al. teaches paired magnetometers and additional physiological sensors carried by the wearable monitoring garment {[0039], [0041], [0046], [0077]-[0078] & (Figs. 2-6)}.
Claim 20.
Derchak et al., as modified by Lynn et al. and Wondka et al. as discussed above with respect to claim 12, teaches or suggests the limitation of claim 20 for substantially the same reasons. Specifically:
The wearable apparatus of claim 12 corresponds to the recited system comprising a thoracic strap, ventilation rate sensor, and processor (see mapping for claim 12 and claim 13).
The ventilation rate sensor, activity sensor, and processor attached to the thoracic strap (see claim 13 mapping and Derchak; [0038], [0040], [0070], [0092] & (Figs. 3 & 6).
The ventilation sensor comprising a magnet and magnetic field sensor (see claim 17 mapping; Derchak [0038], [0077]-[0078].
The ventilation rate sensor and activity sensor being in electrical communication with the processor (see claim 12 mapping; Derchak [0043]-[0045], [0079]-[0080].
It would have been obvious to one having ordinary skill to configure the apparatus of Derchak et al. as an equivalent system including the recited components because no patentable distinction exists between the claimed apparatus and system with respect to the recited structural limitations, yielding the predictable result of the same physiological monitoring functionality. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
Claim 21.
Claim 21 is rejected over Derchak et al. in view of Lynn et al. and Wondka et al. for the reasons discussed with respect to claim 20 and further for the reasons set forth in the rejection of claim 12 regarding the processor configured to determine a ventilation rate above predicted (VRAP), which are incorporated by reference.
Claim 22.
…wherein the activity sensor is an accelerometer.
E.G. Derchak et al. teaches accelerometers for detecting subject movement and activity.
Response to Arguments
Applicant's arguments filed July 22, 2024 have been fully considered but they are not persuasive.
The applicant amendment independent claim 12 to further recite the processor is configured to process data received from the ventilation rate sensor and the activity sensor to determine a ventilation rate above predicted (VRAP). While Derchak et al. may not expressly disclose determining a ventilation rate above predicted, Lynn et al. teaches processor-based evaluation of measured ventilation using known predictable physiological relationships and expected ventilation behavior ([0204]-[0205]), and Wondka et al. teaches processing respiration and activity measurements together using a processor to evaluate respiratory status ([0012]-[0013]).
Therefore, it would have been obvious to one of ordinary skill in the art to incorporate these known processor-based predictive respiratory analysis techniques into Derchak’s wearable monitoring system to improve respiratory assessment using measured ventilation and activity information, yielding the predictable results of improved physiological monitoring.
Applicant has not presented persuasive evidence that the amended limitations, either individually or in combination, distinguish over the combined teachings of Derchak et al., Lynn et al., and Wondka et al. Accordingly, the rejections of claims 12-13 and 16-22 are maintained.
Applicant’s arguments, filed July 22, 2024, with respect to the objections of the drawings and the 35 U.S.C §112(b), second paragraph claim rejections have been fully considered and are persuasive and have been withdrawn.
Conclusion
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 NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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