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 .
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) 2-4, 9-12, 14-17, and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Debreczeny et al. (U.S. Patent Application Publication No. 2011/0046464) hereinafter referred to as Debreczeny; in view of Lusted et al. (U.S. Patent No. 9,711,060) hereinafter referred to as Lusted.
Regarding claim 2, Debreczeny teaches a wearable device (Fig. 7) comprising:
a band (Fig. 7, element 110 inflatable cuff) configured to be secured to an appendage of a user (Fig. 7, user’s finger ¶[0029]), the band defining an inside surface and an external surface of the wearable device (Fig. 7, interior and exterior surface of the band);
an actuator configured to expand and retract to change a shape of the inside surface (Fig. 7, pressure device ¶[0043], inflation tube, element 111 and pressure device element 32);
a sensor system (Fig. 7, element 108 photoplethymographic sensor, ¶[0047]) comprising:
an optical emitter positioned along the inside surface and configured to emit light towards the appendage of the user (¶[0047] emitter sewn into the inflatable cuff); and
an optical detector positioned along the inside surface and configured to detect light reflected from the appendage of the user (¶[0047] detector sewn into the inflatable cuff); and
a processor (¶[0032] microprocessor) communicatively coupled to the sensor system (¶[0032]) and to the plurality of actuators (¶[0036]), the processor configured to receive a physiological signal from the user and actuate the plurality of actuators based on the physiological signal (¶[0047] adjusted automatically via patient monitor, Fig. 4 pressure is changed based on PPG signal results).
Debreczeny does not teach a plurality of actuators.
Attention is brought to the Lusted reference, which teaches additional fit adjustment actuators (Fig. 14A-B, col. 9 lines 31-47, col. 19, lines 63-67 one or more).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the pressure controlled finger sensor of Debreczeny to include additional actuators for fit adjustment, as taught by Lusted, because creating variable ring geometry accommodates different sized fingers while offering a comfortable fit for the user (Lusted col. 8, lines 49-51, in col. 9 lines 31-47 also referencing a benefit to this particular embodiment for additional appendages such as wrist, ankle, etc.).
Regarding claim 3, Debreczeny as modified teaches the wearable device of claim 2.
Debreczeny further teaches wherein: the plurality of actuators comprise a bladder; and the bladder is configured to expand relative to the inside surface to compress the appendage of the user (Fig. 7, ¶[0047]).
Regarding claim 4, Debreczeny as modified teaches the wearable device of claim 3.
Debreczeny further teaches wherein the bladder expands via a fluid that fills the bladder (Fig. 7, ¶[0047] liquid or gas from an inflation tube).
Regarding claim 9, the claim is directed to a device comprising substantially the same subject matter as claim 3, and is rejected under substantially the same sections of Debreczeny and Lusted.
Regarding claim 10, Debreczeny as modified teaches the monitoring device of claim 9.
Debreczeny further teaches a bladder spaced circumferentially along an inside surface of the band (Fig. 7).
Debreczeny as modified teaches all of the elements of the claimed invention except for a third bladder.
It nevertheless would have been prima facie obvious to one of ordinary skill in the art at the time of filing to modify the pressure controlled sensing system of Debreczeny as modified to include three bladders, because the courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In the instant application, no criticality or new/unexpected result is disclosed as a result of arranging specifically three bladders circumferentially along a band and therefore this limitation is considered an obvious modification.
Regarding claim 11, Debreczeny as modified teaches the monitoring device of claim 9.
Debreczeny further teaches wherein: the monitoring device comprises a pump; and the pump is configured to expand and retract the plurality of bladders (¶[0046]).
Regarding claim 12, Debreczeny as modified teaches the monitoring device of claim 9.
Lusted further teaches wherein the band is configured to be worn around an arm of a user (col. 9 lines 31-47).
Regarding claim 14, Debreczeny as modified teaches the monitoring device of claim 9.
Debreczeny further teaches wherein the plurality of bladders comprise a material configured to undergo a phase change in response to a change in temperature (all materials undergo a phase change in response to a change in temperature, such as air comprising a plurality of elements that phase change in response to a change in temperature).
Regarding claim 15, Debreczeny as modified teaches the monitoring device of claim 9.
Debreczeny further teaches where at least a portion of the band is formed from a reshapeable material configured to expand and retract with the plurality of bladders (¶[0047] the fit of the band is responsive to the inflation and deflation therefore reshapable according to the bladder expansion).
Regarding claim 16, the claim is directed to a device comprising substantially the same subject matter as claims 2-3, and is rejected under substantially the same sections of Debreczeny and Lusted.
With respect to the difference between the claims, Debreczeny teaches a pressure sensor configured to detect a pressure of at least one actuator of the plurality of actuators against the appendage of the user (¶[0047] element 32, pressure sensor); and a processor communicatively coupled to the plurality of actuators and configured to actuate the plurality of actuators based on one of the pressure or a physiological signal detected from the sensor system (Fig. 4).
Regarding claim 17, Debreczeny as modified teaches the monitoring device of claim 16.
Debreczeny further teaches wherein the processor is configured to actuate the plurality of actuators to measure a physiological signal requiring tighter coupling of the band with respect to the appendage of the user (Fig. 4, device tightens the pressure at step 84 to begin diagnostic measurement at step 90).
Regarding claim 20, Debreczeny as modified teaches the monitoring device of claim 16.
Debreczeny further teaches wherein: the plurality of actuators further comprise: a bladder (Fig. 7, ¶[0047]); an air inlet (Fig. 7, ¶[0047] inflation tube); and an air outlet (¶[0047] deflating in response to supply from inflation tube); the plurality of bladders are configured to expand using air pumped via the air inlet (¶[0047] supplied gas); and the plurality of bladders are configured to retract by releasing air via the air outlet (¶[0047] deflating).
Lusted further teaches a plurality of bladders, comprising an air inlet and outlet (col. 9, lines 40-47).
Regarding claim 21, Debreczeny as modified teaches the monitoring device of claim 16.
Lusted further teaches wherein in an extended configuration, the plurality of actuators define a rounded surface protruding from the inside surface (Fig. 14A-B, the pneumatic balloon is concave and rounded, protruding from the inside surface).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Debreczeny and Lusted as applied to claim 2 above, and further in view of Muehlsteff et al. (U.S. Patent Application Publication No. 2008/0194917) hereinafter referred to as Muehlsteff.
Regarding claims 7-8, Debreczeny as modified teaches the wearable device of claim 2.
Debreczeny as modified teaches the plurality of actuators and the device worn on an appendage of a user, above.
Debreczeny as modified does not teach wherein: the processor is configured to determine an increase in user activity based on one or more signals from the sensor system; and in response to detecting the change in user activity, the plurality of actuators are configured to expand.
Attention is drawn to the Muehlsteff reference, which teaches a processor (¶[0030] control unit) configured to determine an increase in user activity based on one or more signals from the sensor system (¶[0030], ¶[0032]); and in response to detecting the change in user activity (¶[0030]), the plurality of actuators are configured to expand (¶[0034]) and the plurality of actuators are configured adjust a stability of the wearable device with respect to the user (¶[0032], ¶[0034]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the pressure controlled device of Debreczeny as modified to include adjustment of pressure actuators and device stability in response to a change in user activity, as taught by Muehlsteff, because Muehlsteff teaches a system that is reliable and accommodatable to different activity levels of the individual (Muehlsteff ¶[0032]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Debreczeny and Lusted as applied to claim 9 above, and further in view of Alberth et al. (U.S. Patent Application Publication No. 2013/0053661) hereinafter referred to as Alberth.
Regarding claim 13, Debreczeny as modified teaches the monitoring device of claim 9.
Debreczeny as modified teaches the processor is configured to cause at least one bladder of the plurality of bladders to change a volume, thereby adjusting a tightness of the band in response to data detected from the sensor system, above.
Debreczeny as modified does not teach the sensor system is configured to detect a change in an environmental condition.
Attention is drawn to the Alberth reference, which teaches a sensor system configured to detect a change in an environmental condition (¶[0014] two thermocouples configured to sense skin or ambient temperatures).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the pressure controlled device of Debreczeny as modified to include environmental sensing for band tightness sensing, as taught by Alberth, because the thermocouple sensing method ensures reliable physiological information from the subject during the subject’s wearing of the wearable device (Alberth ¶[0011]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Debreczeny and Lusted as applied to claim 16 above, and further in view of Moon et al. (U.S. Patent Application Publication No. 2014/0088386) hereinafter referred to as Moon.
Regarding claim 18, Debreczeny as modified teaches the monitoring device of claim 16.
Debreczeny as modified does not teach wherein the pressure sensor is an oscillometric sensor.
Attention is drawn to the Moon reference, which teaches wherein a pressure sensor in an inflatable cuff is an oscillometric sensor (¶¶[0129-0130]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the pressure controlled device of Debreczeny as modified to include oscillometric sensing, as taught by Moon, because calibration of PPG based measurement using a pressure-based calibration of oscillometric blood pressure improves the accuracy of a PPG system (Moon ¶[0068]).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Debreczeny and Lusted as applied to claim 16 above, and further in view of Naghavi et al. (U.S. Patent Application Publication No. 2007/0225614) hereinafter referred to as Naghavi.
Regarding claim 19, Debreczeny as modified teaches the monitoring device of claim 16.
Debreczeny as modified further teaches the plurality of actuators comprising a bladder, which expands and contracts, above
Debreczeny as modified does not teach the plurality of actuators comprise a mesh expansion sleeve; in response to expansion, the mesh expansion sleeve is a first length; in response to retraction, the mesh expansion sleeve is a second length; and the first length is less than the second length.
Attention is drawn to the Naghavi reference, which teaches a mesh expansion sleeve (Fig. 16, element 1304 coupler); in response to expansion, the mesh expansion sleeve is a first length; in response to retraction, the mesh expansion sleeve is a second length; and the first length is less than the second length (this describes the Poisson effect of a material stretching in a particular direction/circumferentially).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the pressure controlled device of Debreczeny as modified to include a mesh expansion sleeve, as taught by Naghavi, because it ensures skin contact without contributing temperature or pressure change (Naghavi, ¶[0192]).
Allowable Subject Matter
Claims 5-6 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:
The closest prior art of record does not teach or make obvious wherein the fluid comprises a metal alloy; wherein the fluid is configured to change a shape of the inside surface in response to a change in voltage.
U.S. Patent No. 6,230,501 to Bailey et al. teaches adjustable contour surfaces for medical devices including a fluid-filled bladder (col. 51, peristaltic pump embodiment, lines 16-24), but does not go so far as to teach the fluid comprises a metal alloy; or wherein the fluid is configured to change a shape of the inside surface in response to a change in voltage.
U.S. Patent Application Publication No. 2014/0343599 to Smith et al. teaches an adjustable collar comprising a shape memory alloy polymer configured to change the fit of the collar due to the material’s response to a change in voltage, but does not teach a fluid comprising a metal alloy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent No. 11,478,158 to Connor teaches an adjustable wearable band, including inflatable bladders.
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/AMANDA L STEINBERG/Examiner, Art Unit 3792