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 12/04/2024 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)(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.
(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.
Claim(s) 7—12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S Patent Application 2008/0098527 A1 to Weedling (Weedling hereafter).
As per claim 7, Weedling teaches:
A system comprising: a pressure-mitigation device (10—Fig.1; para [0029]) that is situated between a living body and an underlying surface (106—Fig.4; para [0029]) and that includes multiple chambers that are independently inflatable (para [0039]); a controller that is configured to regulate, for each of the multiple chambers (246—Fig.14; para [0072]), a corresponding one of multiple flows of air to controllably pressurize the multiple chambers to varying degrees over time, such that force applied by the underlying surface to the living body is moved across a surface of the living body (para [0071]); and a communication module that is configured to wirelessly communicate with an electronic device that provides treatment to the living body (262—Fig.14; para [0076]).
As per claim 8, Weedling teaches:
The system of claim 7, wherein the controller is configured to regulate the multiple flows of air in accordance with a programmed pattern (para [0071]) that is selected or altered to account for information that is related to the treatment and that is obtained from the electronic device(para [0071]).
As per claim 9, Weedling teaches:
The system of claim 7, wherein the communication module is housed in the controller (262—Fig.14; para [0076]).
As per claim 10, Weedling teaches:
The system of claim 9, wherein the controller is further configured to: receive, via the communication module, input that is indicative of an indication from the electronic device that the treatment has been halted (examiner note); and cause the multiple chambers of the pressure-mitigation device to be pressurized (para [0071]; examiner note).
Note:
The examiner notes that controller 260 may be programmed to control the inflation of one or more chambers based on the rate at which gas is being delivered between the patient and the ventilator of the communication module 248. The examiner notes that halted treatment may be interpreted as a rate of zero units of treatment being delivered to the patient. The examiner defines said rate as an indication from the electronic device that treatment has been halted.
As per claim 11, Weedling teaches:
The system of claim 9, wherein the controller is further configured to: receive, via the communication module, input (Note: The examiner considers the operation state of the communication module as input) that is indicative of an indication from the electronic device that the treatment has been halted(para [0071]; examiner note above); and cause the multiple chambers of the pressure-mitigation device to be depressurized (para [0071]; examiner note above).
As per claim 12, Weedling teaches:
The system of claim 7, wherein the controller includes a manifold with multiple valves (para [0064]), each of which is actuated to regulate the corresponding one of the multiple flows of air (258—Fig.14; para [0064] & [0072]).
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.
Claim(s) 1, 5, 6, 13—15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S Patent Application 2008/0098527 A1 to Weedling (Weedling) in view of U.S Patent Application 2014/0048081 A1 to Squitieri (Squitieri hereafter).
As per claim 1, Weedling teaches:
A system for alleviating force applied by an underlying surface to a living body (10—Fig.1; para [0029]) that is undergoing treatment with a medical device (246 & 248—Fig.14; para [0069]), the system comprising: a pressure-mitigation device that is situated between the living body and the underlying surface (12 & 46—Fig.1; para [0039]) and that includes chambers that are independently inflatable (para [0039]); and a controller (210—Fig.11; para [0063]) that includes – a communication module that is configured to establish a channel over which to wireless communicate with the medical device (262—Fig.14; para [0076]), and cause the chambers of the pressure-mitigation device to be inflated to varying degrees in accordance with the programmed pattern, so as to shift the force that is applied to the living body by the underlying surface (para [0071]).
Weedling does not teach, and a processor that is configured to: receive, via the channel, information regarding the treatment from the medical device, identify, based on the information, a programmed pattern that specifies, for each of the chambers, (a) pressures to which that chamber is to be inflated and (b) durations for which the pressures are to be maintained.
Squitieri teaches, and a processor (para [0140]) that is configured to: receive, via the channel, information regarding the treatment from the medical device, identify, based on the information, a programmed pattern that specifies, for each of the chambers, (a) pressures to which that chamber is to be inflated (para [0109]) and (b) durations for which the pressures are to be maintained(para [0109]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Weedling (directed to a system for alleviating force applied by an underlying surface to a living body) and Squitieri (directed to a pressure mitigation system provided with a processor configured to inflate the support chambers for a specific time and duration based on received information of the system) and arrived at a support provided with a pressure mitigation system including a processor configured to inflate the support chambers for a specific time and duration based on received information of the system. One of ordinary skill in the art would have been motivated to make such a combination to optimize the pressure-relieving capabilities of the system as taught in Squitieri (para [0109]).
As per claim 5, Weedling (as modified) teaches:
The system of claim 1, wherein said causing is performed in response to receiving input that is representative of an acknowledgement that the living body is connected to the medical device (para [0071]: regulator receives signal that body is connected to medical device).
As per claim 6, Weedling (as modified) teaches:
The system of claim 1 wherein said causing is performed in response to receiving input that is representative of an acknowledgement that the treatment has been initiated (para [0071]: regulator receives signal that body is connected to medical device).
As per claim 13, Weedling (as modified)teaches: The system of claim 7.
Weedling does not teach, wherein the multiple chambers are intertwined around an epicenter above which a given anatomical region of the living body is to be positioned.
Squitieri teaches, wherein the multiple chambers are intertwined around an epicenter above which a given anatomical region of the living body is to be positioned (200—Fig.2; para [0091]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Weedling (directed to a system for alleviating force applied by an underlying surface to a living body) and Squitieri (directed to a pressure mitigation system provided with a multiple chambers are intertwined around an epicenter) and arrived at a support provided with a pressure mitigation system including a processor configured to inflate the support chambers for a specific time and duration based on received information of the system. One of ordinary skill in the art would have been motivated to make such a combination to provide a portion of the device that is specifically designed to match up with an epicenter of the specific anatomic region of the patient's body as taught in Squitieri (para [0091]).
As per claim 14, Weedling teaches:
The system of claim 7, wherein upon deployment of the pressure-mitigation device, the controller causes the multiple chambers to be in a naturally deflated state (para [0073]), and wherein the controller mitigates the force that is applied by the underlying surface to an anatomical region of the living body by causing inflation of at least chamber that is positioned adjacent to the anatomical region (para [0073]).
As per claim 15, Weedling teaches:
The system of claim 7, wherein upon deployment of the pressure-mitigation device, the controller causes the multiple chambers to be in a naturally inflated state (para [0073]), and wherein the controller mitigates the force that is applied by the underlying surface to an anatomical region of the living body by causing deflation of at least one chamber that is positioned beneath the anatomical region (para [0073]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S Patent Application 2008/0098527 A1 to Weedling in view of U.S Patent Application 2014/0048081 A1 to Squitieri (Squitieri hereafter) in further view of U.S Patent Application 2014/0059781 A1 to Lafleche et. al (Lafleche hereafter).
As per claim 4, Weedling (as modified) teaches: The system of claim 1.
Weedling does not teach, wherein said causing is performed in response to receiving input that is representative of an acknowledgement that the living body is positioned on the pressure-mitigation device.
Lafleche teaches, wherein said causing is performed in response to receiving input that is representative of an acknowledgement that the living body is positioned on the pressure-mitigation device (para [0065]: inflation begins once patient is acknowledged on the support system).
Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Weedling (directed to a system for alleviating force applied by an underlying surface to a living body) and Squitieri (directed to a pressure mitigation system provided with a processor configured to inflate the support chambers for a specific time and duration based on received information of the system) and arrived at a support provided with a pressure mitigation system a controller configured to detect that a living body is positioned on the pressure-mitigation device. One of ordinary skill in the art would have been motivated to make such a combination to ensure a patient is positioned thereon prior to initiating the start command as taught in Lafleche (para [0065]).
Claim(s) 16—20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S Patent Application 2008/0098527 A1 to Weedling in view of U.S Patent Application 2014/0059781 A1 to Lafleche.
As per claim 16, Weedling teaches:
A non-transitory medium with instructions stored thereon that (252—Fig.14; para [0069]), when executed by a processor housed in a controller (246—Fig.14; para [0069]),; receiving second input that specifies a characteristic of treatment that is provided by an electronic device to a living body that is situated on the pressure-mitigation device (254—Fig.14 ; para[0074]); and regulating multiple flows of air, each of which is destined for a corresponding one of the multiple chambers, in accordance with a programmed pattern that is selected or altered to account for the characteristic of the treatment (para [0074]).
Weedling does not teach: cause the controller to perform operations comprising: receiving first input that indicates a pressure-mitigation device with multiple chambers has been fluidly coupled thereto.
Lafleche teaches: cause the controller (116—Fig.7; para [0064]) to perform operations comprising: receiving first input that indicates a pressure-mitigation device with multiple chambers has been fluidly coupled thereto (116—Fig.7; para [0064]: Controller 116 is therefore able to monitor the pressure inside each of the zones 54 as they are being inflated toward the threshold pressure).
Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Weedling (directed to a system for alleviating force applied by an underlying surface to a living body) and Lafleche (directed to a pressure mitigation system provided with a controller configured to controller to perform operations comprising: receiving first input that indicates a pressure-mitigation device with multiple chambers) and arrived at a support provided with a pressure mitigation system a controller configured to controller to perform operations comprising: receiving first input that indicates a pressure-mitigation device with multiple chambers. One of ordinary skill in the art would have been motivated to make such a combination to ensure a patient is positioned thereon prior to initiating the start command as taught in Lafleche (para [0064]).
As per claim 17, Weedling (as modified) teaches:
The non-transitory medium of claim 16, wherein the characteristic is a type of the electronic device that provides the treatment to the living body (246 & 248—Fig.14; para [0069]).
As per claim 18, Weedling (as modified) teaches:
The non-transitory medium of claim 16, wherein the characteristic is a duration of the treatment that is provided by the electronic device (para [0071]: to receive a signal from the regulator representing the rate at which the ventilating gas is being delivered to the patient from the ventilator).
As per claim 19, Weedling (as modified) teaches: The non-transitory medium of claim 16.
Weedling does not teach, wherein the operations further comprise: receiving third input that indicates the living body has been situated on the pressure-mitigation device; wherein said regulating is performed in response to receiving the third input.
Lafleche teaches, wherein the operations further comprise: receiving third input that indicates the living body has been situated on the pressure-mitigation device; wherein said regulating is performed in response to receiving the third input (para [0065]: inflation begins once patient is acknowledged on the support system).
Accordingly, it would have been obvious to one of ordinary skill in the art before the invention was effectively filed to have combined Weedling (directed to a system for alleviating force applied by an underlying surface to a living body) and Lafleche (directed to a pressure mitigation system provided with a controller configured to detect that a living body is positioned on the pressure-mitigation device) and arrived at a support provided with a pressure mitigation system a controller configured to detect that a living body is positioned on the pressure-mitigation device. One of ordinary skill in the art would have been motivated to make such a combination to ensure a patient is positioned thereon prior to initiating the start command as taught in Lafleche (para [0065]).
As per claim 20, Weedling (as modified) teaches:
The non-transitory medium of claim 16, wherein the programmed pattern is associated with (i) an anatomical region of the living body across which force applied by an underlying surface is shifted over time and (ii) the electronic device (para [0071]: to receive a signal from the regulator representing the rate at which the ventilating gas is being delivered to the patient from the ventilator).
Allowable Subject Matter
Claim 2 & 3 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:
Regarding dependent claims 2 & 3, the closest prior art of record U.S Patent Application 2008/0098527 A1 to Weedling teaches a pressure mitigation system provided with a patient ventilator. The combination of structure present in claim 2 and 3 was not found in U.S. Patent Application 2008/0098527 A1. Specifically, the limitation with respect to:
wherein the medical device is an extracorporeal membrane oxygenation (ECMO) machine that includes at least two tubes through which blood is obtained from, and then returned to, the living body for oxygenation, and wherein the information specifies locations at which the at least two tubes are connected to the living body.
wherein the medical device is a mechanical ventilator that pushes air into the lungs of the living body, and wherein the information specifies a frequency at which the mechanical ventilator pushes air into the lungs of the living body.
While Weedling discloses a medical device that pushes air into the lungs, including a controller adapted to receive a signal from the regulator representing the rate at which the ventilating gas is being delivered to the patient from the ventilator based on the monitored breathing rate of the patient Weedling does not disclose identify based on the information a program pattern based on a frequency at which the mechanical ventilator pushes air into the living body.
The teachings of U.S. Patent 9826956 B2 to Freeman et. al. teaches a processor configured to: receive input that specifies locations at which the at least two tubes are connected to the living body. However, teachings were silent with respect to:
‘wherein the medical device is an extracorporeal membrane oxygenation (ECMO) machine that includes at least two tubes through which blood is obtained from, and then returned to, the living body for oxygenation, and wherein the information specifies locations at which the at least two tubes are connected to the living body.
wherein the medical device is a mechanical ventilator that pushes air into the lungs of the living body, and wherein the information specifies a frequency at which the mechanical ventilator pushes air into the lungs of the living body.
The teachings of DE 212014000239 U1 to Hunsicker disclose a vent support system including an inflatable support and a signal which indicates a patients breathing. The reference fell silent with respect to, the medical device is a mechanical ventilator that pushes air into the lungs of the living body, and wherein the information specifies a frequency at which the mechanical ventilator pushes air into the lungs of the living body. Therefor upon exhausting the art, it is concluded by the examiner for those reasons stated above that inconsideration with deficiencies of the prior art, that applicant' s invention would be considered non-obvious in light of the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S Patent 9,826,956 B2 discloses a system for determining positioning of an intubation tube in a patient.
DE 212014000239 U1 to Hunsicker disclose a vent support system including an inflatable support and a signal which indicates a patients breathing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Deborah T Gedeon whose telephone number is (571)272-8863. The examiner can normally be reached Mon - Fri 8:30am to 4:30pm 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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/D.T.G./Examiner, Art Unit 3673 02/06/2026
/JUSTIN C MIKOWSKI/Supervisory Patent Examiner, Art Unit 3673