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 12/03/2024 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) 1, 6 & 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S Patent Application 2008/0098527 A1 to Weedling et al. (Weedling hereafter).
As per claim 1, Weedling teaches:
A method comprising: identifying a patient who is a candidate for treatment with a mechanical ventilator (248—Fig.14; para [0069]) ; obtaining a portable system that includes – a pressure-mitigation device (10—Fig.1; para [0029]) that includes chambers that are independently inflatable (88—Fig.4; para [0062]), and a controller that is configured to controllably inflate each of the chambers by regulating one or more flows of air (para [0039]); deploying the pressure-mitigation device on a surface on which the patient is to be immobilized (88—Fig.4; para [0062]); orienting the patient such that an anatomical region is located adjacent the pressure-mitigation device (134—Fig.8; para [0062]); determining that the patient has been connected to the mechanical ventilator (para [0071]: controller adapted to receive signal from regulator); and causing the portable system to shift pressure that is applied by the surface to the anatomical region by inflating the chambers to varying degrees over time in accordance with a programmed pattern (para [0071]).
As per claim 6, Weedling teaches:
The method of claim 1, wherein the pressure-mitigation device is designed to alleviate pressure along a posterior side of the patient while in a supine position (para [0073]: device alleviates pressure in a fully supine position).
As per claim 7, Weedling teaches:
The method of claim 1, wherein the portable system is communicatively connected to the mechanical ventilator, and wherein the controller is configured to regulate the one or more flows of air to inflate the chambers based on a frequency at which the mechanical ventilator pushes air into the lungs of the patient (para [0071]: controller receives rate at which air is delivered to lungs and adjust air flow in chambers).
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) 2, 3 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 2004/0116898 A1 to Hawk (Hawk).
As per claim 2, Weedling teaches: The method of claim 1.
Weedling does not teach, further comprising: anesthetizing the patient so as to induce a loss of consciousness.
Hawk teaches: further comprising: anesthetizing the patient so as to induce a loss of consciousness (para [0032]).
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 patient positioning system including a controller in communication with a mechanical ventilation device) and Hawk (directed to a method for intubation provided with anesthetizing a patient following orientation and followed by causing a controller to perform an action) and arrived at a patient positioning system including a method for intubation provided with anesthetizing a patient following orientation and followed by causing a controller to perform an action. One of ordinary skill in the art would have been motivated to make such a combination for preventing the patient from experiencing physiological reactions such as coughing, pain or discomfort from the indwelling tracheal tube as taught in Hawk (abstract).
As per claim 3, Weedling (as modified) teaches:
The method of claim 2, further comprising: intubating the patient by inserting a tube connected to the mechanical ventilator into the trachea (para [0003]).
As per claim 4, Weedling teaches: The method of claim 3.
Weedling does not teach, wherein said anesthetizing is performed following said orienting, wherein said intubating is performed following said anesthetizing, and wherein said causing is performed following said intubating.
Hawk teaches: wherein said anesthetizing is performed following said orienting (para [0037]), wherein said intubating is performed following said anesthetizing (para [0037]), and wherein said causing is performed following said intubating (para [0037]).
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 patient positioning system including a controller in communication with a mechanical ventilation device) and Hawk (directed to a method for intubation provided with anesthetizing a patient following orientation and followed by causing a controller to perform an action) and arrived at a patient positioning system including a method for intubation provided with anesthetizing a patient following orientation and followed by causing a controller to perform an action. One of ordinary skill in the art would have been motivated to make such a combination for preventing the patient from experiencing physiological reactions such as coughing, pain or discomfort from the indwelling tracheal tube as taught in Hawk (abstract).
Claim(s) 5 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 2008/0142022 A1 to Biondo et al. (Biondo hereafter).
As per claim 5, Weedling teaches: The method of claim 1.
Weedling does not teach, wherein the pressure-mitigation device is designed to alleviate pressure along an anterior side of the patient while in a prone position.
Biondo teaches, wherein the pressure-mitigation device is designed to alleviate pressure along an anterior side of the patient while in a prone position (132—Fig.11; para [0113]).
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 patient positioning system including a controller in communication with a mechanical ventilation device) and Biondo (directed to a patient positioning system designed to alleviate pressure along an anterior side of the patient while in a prone position) and arrived at a patient positioning system including a controller in communication with a constraining the patient with a structural feature that is located adjacent the surface. One of ordinary skill in the art would have been motivated to make such a combination to facilitate rotation of the patient 23 to and from the prone position as taught in Biondo (para [0113]).
Claim(s) 8—14 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 2016/0278663 A1 to Freeman et al. (Freeman hereafter).
As per claim 8, Weedling teaches:
A method for treating a patient who is a candidate for treatment with a mechanical ventilator (248—Fig.14; para [0069]), the method comprising: deploying a pressure-mitigation device that includes multiple chambers that are independently inflatable on a surface on which the patient is to be immobilized (10—Fig.1; para [0029]); connecting the pressure-mitigation device to a controller (210—Fig.11; para [0063]) that is configured to controllably inflate the multiple chambers over time by regulating one or more flows of air (para [0063]); orienting the patient such that a given anatomical region is located above the pressure-mitigation device (para [0073]), and in response to a determination that an intubation operation in which a tube connected to the mechanical ventilator causing the controller to shift a pressure that is applied by the surface to the given anatomical region through varied inflation of the multiple chambers over time (para [0073]).
Weedling does not teach: and in response to a determination that an intubation operation in which a tube connected to the mechanical ventilator is inserted into the trachea has been completed.
Freeman teaches and in response to a determination that an intubation operation in which a tube connected to the mechanical ventilator is inserted into the trachea has been completed causing the controller (114—Fig.1A; para [0035]).
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 patient positioning system including a controller in communication with a mechanical ventilation device) and Freeman (directed to a method for positioning an intubation tube in a patient) and arrived at a patient positioning system including a controller in communication with a mechanical ventilation device with a method for positioning an intubation tube in a patient and causing a controller to perform an action in response to determining the tube connected to the trachea has been properly inserted into the patient. One of ordinary skill in the art would have been motivated to make such a combination to convey notice of proper placement of the intubation tube or convey an alert when the intubation tube has been improperly placed as taught in Freeman (para [0035]).
As per claim 9, Weedling teaches:
The method of claim 8, wherein said connecting comprises attaching tubing between one or more fluid egress interfaces of the controller and one or more fluid ingress interfaces of the pressure-mitigation device (100, 102 & 104—Fig.4 & 202 204, 206 & 208—Fig.11;para [0062]) .
As per claim 10, Weedling teaches:
The method of claim 8, wherein the controller inflates the multiple chambers in accordance with a programmed pattern that is associated with the given anatomical region (para [0072-73]).
As per claim 11, Weedling teaches:
The method of claim 8, further comprising: indicating a frequency at which the mechanical ventilator pushes air into the lungs of the patient (para [0071]), such that the controller inflates the multiple chambers only while air is being pushed into the lungs by the mechanical ventilator (para [0071]), only while carbon dioxide is being removed from the lungs by the mechanical ventilator, or only while the mechanical ventilator is not taking any action.
As per claim 12, Weedling teaches:
The method of claim 8, wherein the multiple chambers of the pressure-mitigation device are inflated over time in accordance with a programmed pattern (para [0074]).
As per claim 13, Weedling teaches:
The method of claim 12, further comprising: determining that treatment with the pressure-mitigation device is appropriate based on a characteristic of the treatment provided by the mechanical ventilator(para [0074]); and inputting, via an interface that is presented by the controller, the characteristic of the treatment(para [0074]), so as to allow the controller to select or adjust the programmed pattern to account for the characteristic of the treatment(para [0074]).
As per claim 14, Weedling teaches:
The method of claim 12, further comprising: determining that treatment with the pressure-mitigation device is appropriate based on a characteristic of the patient (para [0071]); and inputting, via an interface that is presented by the controller (para [0071]), the characteristic of the patient, so as to allow the controller to select or adjust the programmed pattern to account for the characteristic of the patient (para [0071]).
Claim(s) 15, 16 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 2016/0278663 A1 to Freeman in view of U.S Patent Application 2008/0142022 A1 to Biondo et al. (Biondo hereafter).
As per claim 15, Weedling teaches: The method of claim 8.
Weedling does not, wherein said orienting comprises constraining the patient with a structural feature that is located adjacent the surface.
Biondo teaches, wherein said orienting comprises constraining the patient with a structural feature that is located adjacent the surface (26 & 28—Fig.1; para [0106]).
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 patient positioning system including a controller in communication with a mechanical ventilation device) and Freeman (directed to a method for positioning an intubation tube in a patient) and Biondo (directed to a patient positioning system provided with a constraining the patient with a structural feature that is located adjacent the surface) and arrived at a patient positioning system including a controller in communication with a constraining the patient with a structural feature that is located adjacent the surface. One of ordinary skill in the art would have been motivated to make such a combination for engaging and securing portions of the patient's body as taught in Biondo (para [0106]).
As per claim 16, Weedling teaches: The method of claim 15.
Weedling does not teach, wherein the structural feature is part of a same structure as the surface.
Biondo teaches, wherein the structural feature is part of a same structure as the surface (para [0106]).
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 patient positioning system including a controller in communication with a mechanical ventilation device) and Freeman (directed to a method for positioning an intubation tube in a patient) and Biondo (directed to a patient positioning system provided with a constraining the patient with a structural feature that is located adjacent the surface) and arrived at a patient positioning system including a controller in communication with a constraining the patient with a structural feature that is located adjacent the surface. One of ordinary skill in the art would have been motivated to make such a combination for engaging and securing portions of the patient's body as taught in Biondo (para [0106]).
Claim(s) 17—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 (Lafleche hereafter).
As per claim 17, Weedling teaches:
A non-transitory medium (252—Fig.14; para [0069]) with instructions stored thereon that, when executed by a processor housed in a controller(246—Fig.14; para [0069]), cause the controller to perform operations comprising: ; and regulating multiple flows of air, each of which is destined for a corresponding one of the multiple chambers (para [0074]), in accordance with a programmed pattern that is selected or altered to account for the patient receiving the treatment from the mechanical ventilator (para [0074]).
Weedling does not teach: receiving first input that indicates a pressure-mitigation device with multiple chambers has been fluidly coupled to the controller; receiving second input that indicates a patient has been situated on the pressure-mitigation device such that a given anatomical region is located above the pressure-mitigation device
Lafleche teaches: receiving first input that indicates a pressure-mitigation device with multiple chambers has been fluidly coupled to the controller (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) ; receiving second input that indicates a patient has been situated on the pressure-mitigation device such that a given anatomical region is located above the pressure-mitigation device (para [0065]).
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 18, Weedling teaches:
The non-transitory medium of claim 17, wherein the operations further comprise: establishing a channel over which the controller is able to wirelessly communicate with the mechanical ventilator (262—Fig.14; para [0076]); receiving, via the channel, fourth input that specifies a frequency at which the mechanical ventilator pushes air into the lungs of the patient (para [0071]: controller receives rate at which air is delivered to lungs and adjust air flow in chambers); and identifying the programmed pattern for inflating the multiple chambers by either: selecting the programmed pattern from among multiple programmed patterns based on the frequency, or adjusting a default programmed pattern to account for the frequency (para [0071]).
As per claim 19, Weedling teaches:
The non-transitory medium of claim 17, wherein the operations further comprise: establishing a channel over which the controller is able to wirelessly communicate with the mechanical ventilator; and receiving, via the channel (para [0071]), fourth input that specifies a frequency at which the mechanical ventilator pushes air into the lungs of the patient (para [0071]: controller receives rate at which air is delivered to lungs and adjust air flow in chambers).
As per claim 20, Weedling teaches:
The non-transitory medium of claim 19, wherein said regulating is based on the frequency, such that the controller inflates the multiple chambers only while air is being pushed into the lungs by the mechanical ventilator (para [0071]), only while carbon dioxide is being removed from the lungs by the mechanical ventilator, or only while the mechanical ventilator is not taking any action.
Conclusion
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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/D.T.G./Examiner, Art Unit 3673 2/11/2026
/JUSTIN C MIKOWSKI/Supervisory Patent Examiner, Art Unit 3673