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
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.
Claims 1-4, 6-8 and 12-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Squitieri et al. (USPGPub 2013/0255699) in view of Kloecker et al. (USPGPub 2010/0042026).
Regarding claim 1, Squitieri teaches a structural body (pump housing, [0079] necessarily having some ingress interface with the pump [0079] in order to be functional and some egress to allow filing of the pressure mitigating apparatus (Fig.2), a processor [0134] and memory [0134] that includes instructions [0134] for regulating air flow in the mitigation device using real time data [0103] that is sensed [0061], wherein the detection of connection to the mitigation apparatus would be a capability of the device of Squitieri due to the ability to sense the change in pressure or any pressure change at all from the chambers as described, wherein a pattern of controlling individual chambers may be identified and employed [0084] to allow for varying inflation and deflation in a coordinated fashion which would shift pressure and contact points in the patient [0088] and wherein durations of pressure maintenance may be programmed [0087]. Squitieri fails to teach wherein valves and transducers are used as part of the hardware employed for filling the individual chambers. However, Kloecker teaches that for pressurized medical devices similar to that of Squitieri involving the inflation of discrete chambers independently, it is known to use a combination of valves and transducers manipulated through a controller comprising a tubing manifold with each exiting air line related to an individual fluid supply line provided by the manifold in order to monitor and regulate pressure in independent chambers [0112-0118]. Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the transducer/valve configuration system including a manifold of Kloecker in the pressure mitigation device of Squitieri as an application of a known transducer/valve pressure control system including a manifold to a known pressure mitigation device ready for improvement wherein the results would be predictable. See KSR, 550 U.S. at 418, 82 USPQ2d at 1396.
Regrading claim 2, the pressures and durations of Squitieri are reasonably referred to as cycles and are employed in the manner claimed.
Regarding claim 3, Squitieri generally guides toward the use of pressures in the claimed range [0104].
Regarding claims 4, the teachings of Squitieri in view of Kloecker are as shown above. Squitieri teaches that the times between variation are used to prevent issues caused by “prolonged periods of time” that are known to cause issues with lack of movement [0070] but Squitieri is generally silent as to any specific timeframe used. However, generally one reading Squitieri would reasonably consider factors in the description of Squitieri such as the position of the patient that is being treated such as those in a prolonged period of time in the “seated” position. Reasonably the examiner would consider sitting for an entire period of 8 hours ( a common workday) to be considered “prolonged” at a minimum. Likely even half of that would be considered “prolonged”. As such, it must reasonably be determined that Squitieri is likely referring to moving patients at least every four hours or less. However, Squitieri is not otherwise limiting or even literally limited to the range discussed by the examiner. Reasonably any range that would prevent ulcers would be suited for Squitieri which would even include constant movement. Therefore logically Squitieri likely provides a range of hours down to constant movement with no provided preference. However, Squitieri does indicate in the sections cited that timeframes that are prolonged cause medical issues and as such it would logically clear that the frequency of movement directly affects patient outcomes as related to the bedridden issues of Squitieri. Therefore, in the absence of criticality of the specific timeframe of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the time between cycle (i.e., the time before the patient is moved) in order to optimize the patient health outcomes associated with provided movement.
Regarding claim 6, as described by Kloecker, the manifold and pump and controller are all part of a singular unit wherein air would enter through the pump to be compressed (see Figs 11-12).
Regarding claims 7 and 16, Squitieri teaches a structural body (pump housing, [0079] necessarily having some ingress interface with the pump [0079] in order to be functional and some egress to allow filing of the pressure mitigating apparatus (Fig.2), a processor [0134] and memory [0134] that includes instructions [0134] for regulating air flow in the mitigation device using real time data [0103] that is sensed [0061], wherein the detection of connection to the mitigation apparatus would be a capability of the device of Squitieri due to the ability to sense the change in pressure or any pressure change at all from the chambers as described, wherein a pattern of controlling individual chambers may be identified and employed [0084] to allow for varying inflation and deflation in a coordinated fashion which would shift pressure and contact points in the patient [0088] and wherein durations of pressure maintenance may be programmed [0087]. Squitieri fails to teach wherein valves and transducers are used as part of the hardware employed for filling the individual chambers. However, Kloecker teaches that for pressurized medical devices similar to that of Squitieri involving the inflation of discrete chambers independently, it is known to use a combination of valves and transducers manipulated through a controller comprising a tubing manifold with each exiting air line related to an individual fluid supply line provided by the manifold in order to monitor and regulate pressure in independent chambers [0112-0118]. Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the transducer/valve configuration system including a manifold of Kloecker in the pressure mitigation device of Squitieri as an application of a known transducer/valve pressure control system including a manifold to a known pressure mitigation device ready for improvement wherein the results would be predictable. See KSR, 550 U.S. at 418, 82 USPQ2d at 1396.
Regarding claim 8, as cited above, figures 11 and 12 of Kloecker teach that the presence of a host of valves and transducers for the controlling of fluid to a plurality of individual sections of a singular inflation device.
Regrading claim 12, because the device of Squitieri in view of Kloecker is programmable through a controller it is reasonably implicit that the device comprises circuitry that is integrated to perform the functions stated wherein the transducers are electrically operated [0090].
Regarding claims 13-14, Kloecker generally teaches the use of two way valves wherein air both enters and leaves the system through what is considered to be the manifold through a pump and vent respectively (see Figs 11 and 12).
Regarding claim 15, Kloecker further teaches wherein the system may comprise check valves (one-way valves) [0052].
Regarding claims 17-19, Squitieri teaches a structural body (pump housing, [0079] necessarily having some ingress interface with the pump [0079] in order to be functional and some egress to allow filing of the pressure mitigating apparatus (Fig.2), a processor [0134] and memory [0134] that includes instructions [0134] for regulating air flow in the mitigation device using real time data [0103] that is sensed [0061], wherein the detection of connection to the mitigation apparatus would be a capability of the device of Squitieri due to the ability to sense the change in pressure or any pressure change at all from the chambers as described, wherein a pattern of controlling individual chambers may be identified and employed [0084] to allow for varying inflation and deflation in a coordinated fashion which would shift pressure and contact points in the patient [0088] and wherein durations of pressure maintenance may be programmed [0087]. Squitieri fails to teach wherein valves and transducers are used as part of the hardware employed for filling the individual chambers. However, Kloecker teaches that for pressurized medical devices similar to that of Squitieri involving the inflation of discrete chambers independently, it is known to use a combination of valves and transducers manipulated through a controller comprising a tubing manifold with each exiting air line related to an individual fluid supply line provided by the manifold in order to monitor and regulate pressure in independent chambers [0112-0118]. Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the transducer/valve configuration system including a manifold of Kloecker in the pressure mitigation device of Squitieri as an application of a known transducer/valve pressure control system including a manifold to a known pressure mitigation device ready for improvement wherein the results would be predictable. See KSR, 550 U.S. at 418, 82 USPQ2d at 1396.
Regarding claim 20, Kloecker [0024-0025] generally teaches that a compressor is known to be used as part of the provision of air which as shown can be through a pump.
Regarding claim 21, the teachings of Squitieri in view of Kloecker are as shown above. Squitieri in view of Kloecker fails to teach the use of a plurality of compressors in the inflation system. However, the court has long held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). In this particular case, there is no new and unexpected result provided as relates to the use of a plurality of compressors versus a singular compressor.
Claims 5 and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Squitieri et al. (USPGPub 2013/0255699) in view of Kloecker et al. (USPGPub 2010/0042026) as applied to claims 1-4, 6-8 and 12-21 above and further in view of Yano et al. (USPGPub 2004/0206409).
Regarding claim 5, the teachings of Squitieri in view of Kloecker are as shown above. Squitieri in view of Kloecker fails to teach wherein the valves are necessarily piezoelectric valves. . However, Yano teaches that air control operations using valves are known to employ piezoelectric valves in particular as the valve type (abstract). Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the piezoelectric valves of Yano as the valves of Squitieri in view of Kloecker as use of a known valve type applied to an air supply/control mechanism ready for improvement and wherein the results would be predictable. See KSR, 550 U.S. at 418, 82 USPQ2d at 1396.
Regarding claim 9, the teachings of Squitieri in view of Kloecker are as shown above. Squitieri in view of Kloecker fails to teach wherein the valves are necessarily piezoelectric valves. . However, Yano teaches that air control operations using valves are known to employ piezoelectric valves in particular as the valve type (abstract). Therefore it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the piezoelectric valves of Yano as the valves of Squitieri in view of Kloecker as use of a known valve type applied to an air supply/control mechanism ready for improvement and wherein the results would be predictable. See KSR, 550 U.S. at 418, 82 USPQ2d at 1396.
Regarding claim 10, the claim describes merely describes the known functioning of a piezoelectric valve based on the definition of a piezoelectric transducer driven valve.
Regarding claim 11, the valves of Yano read upon what is considered to be a piezoelectric stack (see Fig. 9)[0054].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J BOWMAN whose telephone number is (571)270-5342. The examiner can normally be reached Mon-Sat 5:00AM-11:00AM.
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/ANDREW J BOWMAN/Examiner, Art Unit 1717