DETAILED ACTION
This office action is in response to the amendment dated 11/26/2025. As directed by the amendment, claims 2 and 15 have been amended, claims 1, 3, and 16 have been cancelled, and claims 26-28 have been newly added. Thus, claims 2, 4-15, and 18-28 are presently pending in this application.
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 2, 5, 7, 11-15, 19, and 23-25 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Biondi et al (2003/0037786) in view of Sherman (9,180,266) and Banner et al (2007/0000494).
Regarding claim 2, Biondi discloses a ventilation system for providing ventilation to a patient, the system comprising: a patient port (21) (flexible tubing) configured to fluidly communicate with the patient (flexible tubing is capable of attachment to a patient, and therefore, includes a port to deliver a gas to the patient) (para [0030]); at least one valve configured for controlling gas flow through the patient port (21) to the patient (20) during administration of a positive pressure ventilation procedure (pneumatic system (41) controls gas flow and pressure in the patient’s airway, and includes a high speed pneumatically driven proportional valve (not shown)) (para [0032]); and a user interface (12) (display controller) configured to allow a user to choose between operating modes (display controller (12) collects input information from a clinician and creates a therapy control structure from the input information) (para [0034]) wherein, in a second operating mode, respiratory rate and tidal volume are determined based at least in part on input of a patient-specific parameter value (clinician can select control buttons to display control slider (106) to change control settings (para [0059]), and control settings can include (tidal volume and breathing rate) (para [0060], Table, page 6).
Biondi does not disclose that, wherein, in the first operating mode, respiratory rate and tidal volume are automatically set based at least in part on a user selection corresponding to an adult patient or a pediatric patient.
However, Sherman teaches a ventilation system for providing ventilation treatment to a patient, the system comprising: a patient port (480) (patient connection) adapted to be in fluid communication with the patient's airway (fig 2, col 8, ln 45-52); and a user interface (operating controls) configured to receive a user input for assisting a user in operating the ventilator mechanism (user interface allows operator to make and enter operating modes and function settings) (col 9, ln 42-52), wherein, in a first operating mode, respiratory rate and tidal volume are automatically set based at least in part on a user selection corresponding to an adult patient or a pediatric patient (operator enters data representing a patient’s individual weight so that default related values of tidal volume and breath rate are used (fig 5, col 9, ln 61-67), and based on the weight, the device determines whether the patient is an adult or child when the operator enters the patient’s approximate weight (col 12, ln 50-52) such that patients greater than 24 kg are treated using adult default settings and patients under 24 kg are treated using pediatric default settings (col 15, ln 43-49).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of Biondi so that the user interface is configured to allow a user to choose a first operating mode, wherein, in the first operating mode, respiratory rate and tidal volume are automatically set based at least in part on a user selection corresponding to a patient weight (which corresponds to an adult patient or a pediatric patient) as taught by Sherman in order to allow the device to deliver tidal volume and other parameters to match a patient based in an estimate of a patient’s individual characteristic (Sherman, abstract) to allow low skill personnel to easily use and deploy the device (Sherman, col 2, ln 36-52).
The now-modified Biondi’s device discloses the device operating in a first operating mode (Sherman, fig 5, col 9, ln 61-67), and a second operating mode (Biondi, para [0060], Table, page 6) and a user interface (Biondi, para [0034]); however, modified Biondi does not disclose the user interface is configured for a user to select between the first operating mode and the second operating mode via at least one selection.
However, Sherman teaches a ventilation system for providing ventilation treatment to a patient, the system comprising a user interface (600, 610) (power pushbutton switch, rotary encoder switch), and as shown in fig 7, the user interface (610) is configured to select an operating mode via a selection by the user interface (610) (col 9, ln 43-53; col 11, ln 15-24).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of modified Biondi by configuring the user interface to select between the first operating mode and the second operating mode via at least one selection as taught by Sherman in order to allow a user to make and enter operating mode settings (Sherman, col 9, ln 49-53) and to set a new operating mode if desired by a user (Sherman, col 17, ln 37-45).
The now-modified Biondi’s device discloses the user selection corresponds to a patient weight; however modified Biondi does not disclose the user selection corresponds to a patient height.
However, Banner in fig 3 teaches a ventilator for providing ventilation to a patient including a control unit (34), wherein input parameters such as patient height are used to provide customized values for ventilator settings (input parameters, such as patient height, are useful in establishing and monitoring desired ventilator control settings and/or ventilation parameters) (para [0044]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of modified Biondi so that the user selection used to provide a customized treatment protocol corresponds with a patient height taught by Banner in order to provide a treatment protocol using an ideal body weight based on height, as it is known in the art that the size of the patient's lungs are a function of the patient's height since overweight patients have the same lung size as normal or underweight patients (Banner, para [0044)). The now-modified Biondi’s device discloses that the user selection corresponds to a patient height, as Banner discloses that a patient height input parameter is used to determine an ideal body weight based on the height to provide customized values for ventilator settings (para [0044])
Regarding claim 5, the modified Biondi’s references disclose one or more selectable display items associated with patient height (as shown in fig 5 of Sherman, the user interface includes one or more selectable display items associated with patient weight (Sherman, fig 5, col 9, ln 35-col 10, ln 3), and because a selection of height is used to determine an ideal body weight (Banner, para [0046]), the user interface would include a display item for a user to select the height of the patient to correspond with the ideal body weight.
Regarding claim 7, the modified Biondi’s references discloses that in the first operating mode, respiratory rate and tidal volume are automatically set based at least in part on a calculated bodyweight (user selection corresponding to patient height is used to determine an ideal body weight (Banner, para [0044]), and body weight is used to determine a respiratory rate and tidal volume (Sherman, fig 5, col 9, ln 61-67)).
Regarding claim 11, Biondi discloses the patient-specific parameter value comprises a treatment system parameter value (control settings can include tidal volume and breathing rate) (para [0060], Table, page 6).
Regarding claim 12, Biondi discloses the treatment system parameter value comprises respiratory rate or tidal volume (control settings can include tidal volume and breathing rate) (para [0060], Table, page 6).
Regarding claim 13, modified Biondi discloses a user interface.
Modified Biondi does not disclose the user interface comprises a user- selectable display item that is selectable to start ventilation of the patient.
However, Sherman discloses a ventilation device including a user interface, wherein the user interface includes a confirm setting including a user-selectable display item (“YES”) that is selectable to confirm ventilator settings (8), wherein once the user has confirmed the selected settings, the ventilator immediately begins operation (9) (fig 7, col 11, ln 30-36)
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the user interface of modified Biondi by providing a confirm setting including a user- selectable display item that is selectable to start ventilation of the patient once the user has confirmed the selected settings as taught by Sherman in order to allow the user to confirm settings before starting ventilation (Sherman, col 11, ln 30-36)
Regarding claim 14, Biondi discloses the user interface (26) comprises a touchscreen of a display (para [0034]).
Regarding claim 15, Biondi discloses a ventilation system for providing ventilation to a patient, the system comprising: a patient port (21) (flexible tubing) configured to fluidly communicate with the patient (flexible tubing is capable of attachment to a patient, and therefore, includes a port to deliver a gas to the patient) (para [0030]); at least one valve configured for controlling gas flow through the patient port (21) to the patient (20) during administration of a positive pressure ventilation procedure (pneumatic system (41) controls gas flow and pressure in the patient’s airway, and includes a high speed pneumatically driven proportional valve (not shown)) (para [0032]); and a user interface (12) (display controller) configured to allow a user to choose between operating modes (display controller (12) collects input information from a clinician and creates a therapy control structure from the input information) (para [0034 wherein, in a second operating mode, respiratory rate and tidal volume are determined based at least in part on input of a patient-specific parameter value (clinician can select control buttons to display control slider (106) to change control settings (para [0059]), and control settings can include (tidal volume and breathing rate) (para [0060], Table, page 6).
Biondi does not disclose that, wherein, in the first operating mode, respiratory rate and tidal volume are automatically set based at least in part on a user selection corresponding to an adult patient or a pediatric patient.
However, Sherman teaches a ventilation system for providing ventilation treatment to a patient, the system comprising: a patient port (480) (patient connection) adapted to be in fluid communication with the patient's airway (fig 2, col 8, ln 45-52); and a user interface (operating controls) configured to receive a user input for assisting a user in operating the ventilator mechanism (user interface allows operator to make and enter operating modes and function settings) (col 9, ln 42-52), wherein, in a first operating mode, respiratory rate and tidal volume are automatically set based at least in part on a user selection corresponding to an adult patient or a pediatric patient (operator enters data representing a patient’s individual weight so that default related values of tidal volume and breath rate are used (fig 5, col 9, ln 61-67), and based on the weight, the device determines whether the patient is an adult or child when the operator enters the patient’s approximate weight (col 12, ln 50-52) such that patients greater than 24 kg are treated using adult default settings and patients under 24 kg are treated using pediatric default settings (col 15, ln 43-49).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of Biondi so that the user interface is configured to allow a user to choose a first operating mode, wherein, in the first operating mode, respiratory rate and tidal volume are automatically set based at least in part on a user selection corresponding to a patient weight (which corresponds to an adult patient or a pediatric patient) as taught by Sherman in order to allow the device to deliver tidal volume and other parameters to match a patient based in an estimate of a patient’s individual characteristic (Sherman, abstract) to allow low skill personnel to easily use and deploy the device (Sherman, col 2, ln 36-52).
The now-modified Biondi’s device discloses the user selection corresponds to a patient weight; however modified Biondi does not disclose the user selection corresponds to a patient height.
However, Banner in fig 3 teaches a ventilator for providing ventilation to a patient including a control unit (34), wherein input parameters such as patient height are used to provide customized values for ventilator settings (input parameters, such as patient height, are useful in establishing and monitoring desired ventilator control settings and/or ventilation parameters) (para [0044]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the patient weight parameter used to provide a customized treatment protocol with a patient height parameter to provide a customized treatment protocol as taught by Banner in order to provide a treatment protocol using an ideal body weight based on height, as it is known in the art that the size of the patient's lungs are a function of the patient's height since overweight patients have the same lung size as normal or underweight patients (Banner, para [0044)). The now-modified Biondi’s device discloses that the user selection corresponds to a patient height, as Banner discloses that a patient height input parameter is used to determine an ideal body weight based on the height to provide customized values for ventilator settings (para [0044])
Regarding claim 19, the modified Biondi’s references discloses that in the first operating mode, respiratory rate and tidal volume are automatically set based at least in part on a calculated bodyweight (user selection corresponding to patient height is used to determine an ideal body weight (Banner, para [0044]), and body weight is used to determine a respiratory rate and tidal volume (Sherman, fig 5, col 9, ln 61-67)).
Regarding claim 23, Biondi discloses the patient-specific parameter value comprises a treatment system parameter value (control settings can include tidal volume and breathing rate) (para [0060], Table, page 6).
Regarding claim 24, Biondi discloses the treatment system parameter value comprises respiratory rate or tidal volume (control settings can include tidal volume and breathing rate) (para [0060], Table, page 6).
Regarding claim 25, modified Biondi discloses a user interface.
Modified Biondi does not disclose the user interface comprises a user-selectable display item that is selectable to start ventilation of the patient.
However, Sherman discloses a ventilation device including a user interface, wherein the user interface includes a confirm setting including a user-selectable display item (“YES”) that is selectable to confirm ventilator settings (8), wherein once the user has confirmed the selected settings, the ventilator immediately begins operation (9) (fig 7, col 11, ln 30-36)
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the user interface of modified Biondi by providing a confirm setting including a user- selectable display item that is selectable to start ventilation of the patient once the user has confirmed the selected settings as taught by Sherman in order to allow the user to confirm settings before starting ventilation (Sherman, col 11, ln 30-36)
Claims 4, 6 and 17-18 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Biondi et al, Sherman and Banner et al as applied to claims 2 and 15 above, and further in view of NHLBI (NHLBI ARDS Network, Tools: Predicted body weight calculator, http://www.ardsnet.org/files/pbwtables_2005-02-02.pdf, dated 2/2/2005).
Regarding claims 4 and 17, modified Biondi discloses that, in the first operating mode, respiratory rate and tidal volume are automatically set based at least in part on patient weight (Sherman, fig 5, col 9, ln 61-67).
Modified Biondi does not disclose that respiratory rate and tidal volume are automatically set based at least in part on patient height.
However, Banner in fig 3 teaches a ventilator for providing ventilation to a patient including a control unit (34), wherein input parameters such as patient height are used to provide customized values for ventilator settings (input parameters, such as patient height, are useful in establishing and monitoring desired ventilator control settings and/or ventilation parameters) (para [0044]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the patient weight parameter used to provide a customized treatment protocol with a patient height parameter to provide a customized treatment protocol as taught by Banner in order to provide a treatment protocol using an ideal body weight based on height, as it is known in the art that the size of the patient's lungs are a function of the patient's height since overweight patients have the same lung size as normal or underweight patients (Banner, para [0044)).
The now-modified Biondi’s device does not disclose the respiratory rate and tidal volume are automatically set based at least in part on a height chart.
However, NHLBI teaches a predicted body weight calculator, wherein tidal volumes for an ARMA study were based on a predicted body weight using a height chart.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of modified Biondi so that the respiratory rate and tidal volume are automatically set based at least in part on a height chart as taught by NHLBI, as the use of a height chart to predict body weight for calculating tidal volumes is known in the art, and it appears that the device of Biondi would perform equally well to provide appropriate respiratory parameters using the height chart disclosed in NHLBI. See MPEP 2143(I)(A).
Regarding claim 18, the modified Biondi’s references disclose one or more selectable display items associated with patient height (as shown in fig 5 of Sherman, the user interface includes one or more selectable display items associated with patient weight (Sherman, fig 5, col 9, ln 35-col 10, ln 3), and because a selection of height is used to determine an ideal body weight (Banner, para [0046]), the user interface would include a display item for a user to select the height of the patient to correspond with the ideal body weight.
Regarding claim 6, modified Biondi discloses that, in the first operating mode, respiratory rate and tidal volume are automatically set based at least in part on patient height (Banner, para [0044]).
Modified Biondi device does not disclose the one or more selectable display items associated with patient height are associated with a specific height range.
However, NHLBI teaches a predicted body weight calculator, wherein tidal volumes for an ARMA study were based on a predicted body weight using a height chart with the ranges of heights shown in the chart.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of modified Biondi so that the respiratory rate and tidal volume are automatically set based at least in part on a height chart as taught by NHLBI, as the use of a height chart to predict body weight for calculating tidal volumes is known in the art, and it appears that the device of Biondi would perform equally well to provide appropriate respiratory parameters using the height chart disclosed in NHLBI. See MPEP 2143(I)(A). The now-modified Biondi’s device is considered to disclose the one or more selectable display items associated with patient height are associated with a specific height range, as the height chart shown in NHLBI discloses a specific height range shown at the bottom and top of the height chart.
Claims 8-10 and 20-22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Biondi et al, Sherman, and Banner et al as applied to claims 2 and 15 above, and further in view of Bertinetti et al (2010/0229867).
Regarding claims 8 and 20, modified Biondi discloses the user interface comprising one display item associated with the user selection (Sherman, fig 5), wherein the user selection corresponds to a patient height which is used to determine an ideal body weight as a function of a patient height (Banner, para [0044]), wherein a patient is ventilated according to an adult or pediatric patient according the weight (Sherman, col 9, ln 61-67).
Modified Biondi does not disclose the user interface comprises at least one display item associated with the user selection corresponding to an adult or pediatric patient.
However, Bertinetti teaches a ventilator system including a user interface (50), wherein the user interface in fig 4b includes at least one display item associated with the user selection corresponding to an adult or pediatric patient (provides a display item corresponding to “Adult” or “Child” that is selected by a user) (para [0046]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the user interface of modified Biondi so that the user interface includes at least one display item associated with the user selection corresponding to an adult or pediatric patient as taught by Bertinetti in order to provide an indication that a selection of a given weight under 24 kg would operate the ventilator according to a pediatric mode and that a selection of a given weight above 24 kg would operate the ventilator according to an adult mode (Bertinetti, para [0046]).
Regarding claims 9 and 21, the modified Biondi’s reference discloses the user interface comprises at least one display item associated with an adult patient (adult) (Bertinetti, fig 4b, para [0046]).
Regarding claims 10 and 22, the modified Biondi’s reference discloses the user interface comprises at least one display item associated with a non-adult patient (child) (Bertinetti, fig 4b, para [0046]).
Claims 26-28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Biondi et al, Sherman, and Banner et al as applied to claim 2 above, and further in view of Woodring et al (6,543,449).
Regarding claim 26, modified Biondi discloses a user interface.
Modified Biondi does not disclose the user interface comprises a first portion relating to the first operating mode and a second portion relating to the second operating mode.
However, Woodring in figs 23-35 teaches a medical ventilator device, wherein the device can operate in multiple operating modes (volume ventilation, pressure ventilation, non-invasive ventilation), and wherein the device includes a user interface (31) (graphical user interface), wherein the user interface comprises a first portion (160) (volume ventilation button) relating to the first operating mode (user interface includes a volume ventilation button (160) for selecting a ventilation settings associated with the first operating mode (pressing volume ventilation button (160) at first portion of user interface allows user to select the desired mode of operation (col 9, ln 37-47), and opens screen shown in fig 23 to allow user to change ventilator settings (col 9, ln 49-54) and to activate the device according to the ventilator settings (col 10, ln 42-44)) and a second portion (162) (pressure ventilation button) for selecting a ventilation settings associated with the second operating mode (pressing pressure ventilation button (162) at a second portion of user interface allows user to select the desired mode of operation (col 9, ln 37-47), and opens screen shown in fig 27 to allow user to change ventilator settings and includes an active button to activate the device (col 11, ln 47-56).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Biondi by modifying the user interface to comprise a graphical user interface including a first portion comprising a first button to allow a user to select the first operating mode and to select ventilation settings associated with the first operating mode, and a second portion comprising a second button to allow a user to select the second operating mode and to select ventilation settings associated with the second operating mode as taught by Woodring in order to provide a graphical user interface that enables an operator to select the desired mode of operation wherein only those parameters related to that specific mode of operation are presented (Woodring, abstract).
Regarding claim 27, the modified Biondi’s reference discloses the first portion (160 of Woodring) comprises at least one first user-selectable feature relating to the first operating mode and wherein the second portion (162 of Woodring) comprises at least one second user-selectable feature relating to the second operating mode (buttons (160, 162 of Woodring) are used to select a desired mode of operation and allows the operator to select and display the ventilator settings related to the desired mode of operation) (Woodring, col 9, ln 37-49)
Regarding claim 28, the modified Biondi’s reference discloses the at least one selection comprises a selection of the first user-selectable feature or the second user-selectable feature (buttons (160, 162 of Woodring) are used to select a desired mode of operation) (Woodring, col 9, ln 37-42).
Terminal Disclaimer
The terminal disclaimer filed on 4/14/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent 11,583,645 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant's arguments filed 11/26/2025 have been fully considered but they are not persuasive.
Applicant argues on page 9, first full paragraph-page 11, first full paragraph of applicant’s remarks, that one of ordinary skill would not be motivated to modify Biondi’s user interface to provide an additional operating mode because Biondi is designed to be operated based on input of selected operating parameters such as tidal volume and breathing rate by a clinician and therefore would defeat the purpose of Biondi for complete control for weaning a person off of a ventilator. However, providing an additional operating mode would not defeat the purpose of Biondi, as Biondi can be operated in an operating mode where respiratory rate and tidal volume are determined based in part on an input of a patient-specific parameter value, and Sherman teaches that the benefit of providing an additional operating mode wherein respiratory rate and tidal volume are automatically set based at least in part on a user selection of patient size such as weight would provide a benefit of allowing device to deliver tidal volume and other parameters to match a patient based in an estimate of a patient’s individual characteristic (Sherman, abstract) to allow the device to be quickly and easily deployed (Sherman, col 2, ln 36-42). Therefore, the rejection is maintained.
Applicant argues on page 11, first full paragraph of applicant’s remarks, that Sherman does not disclose height as a patient characteristic. However, applicant’s argument is moot in view of the new grounds of rejection further in view of Banner, which in fig 3 teaches a ventilator for providing ventilation to a patient including a control unit (34), wherein input parameters such as patient height are used to provide customized values for ventilator settings (input parameters, such as patient height, are useful in establishing and monitoring desired ventilator control settings and/or ventilation parameters) (para [0044]). Therefore, it would have been obvious to the skilled artisan, upon seeing Banner’s disclosure, to modify the device of modified Biondi by substitute the patient weight parameter used to provide a customized treatment protocol with a patient height parameter to provide a customized treatment protocol as taught by Banner in order to provide a treatment protocol using an ideal body weight based on height, as it is known in the art that the size of the patient's lungs are a function of the patient's height since overweight patients have the same lung size as normal or underweight patients (Banner, para [0044)). Therefore, the rejection is maintained.
Applicant argues on page 11, second full paragraph of applicant’s remarks, that Sherman discloses that the ventilator determines whether the patient is an adult or a child. However, a selection of a user selection of a weight (or, as modified by Banner, a user selection of a height that corresponds to an ideal body weight) is considered to read on a user selection of “a user selection corresponding to an adult patient or a pediatric patient”, as a user selection of weight (and therefore, of a height corresponding to in ideal bodyweight) greater than 24 kg would correspond to an adult patient, and a user selection of weight greater than 24 kg would correspond to a child patient (Sherman, col 16, ln 35-41). Therefore, the rejection is maintained.
Applicant argues on page 11, third and fourth full paragraphs of applicant’s remarks, that Sherman does not disclose or suggest a user interface configured for a user to select between a first operating mode and a second operating mode via at least one selection (claim 1) or a user interface configured for at least one selection relating to a first operating mode and configured for at least one selection relating to a second operating mode (claim 15), wherein, in the first operating mode, respiratory rate and tidal volume are automatically set or established based at least in part on a user selection corresponding to an adult patient or a pediatric patient, the user selection further corresponding to patient height, or wherein, in the second operating mode, respiratory rate and tidal volume are determined based at least in part on input of a patient-specific parameter value, as specified in independent claims 1 and 15, respectively. However, the modified Sherman’s device is considered to disclose the limitations of claims 1 and 15, as the device includes a patient interface (12 of Biondi) (Biondi, para [0034]), which, as modified by Sherman, is configured for a user to select between a first operating mode and a second operating mode via at least one selection (as shown in fig 7 of Sherman, user interface (610 of Sherman) is configured to select an operating mode via a selection by the user interface (610 of Sherman) (Sherman, col 9, ln 43-53; col 11, ln 15-24), wherein, in the first operating mode, respiratory rate and tidal volume are automatically set or established based at least in part on a user selection corresponding to an adult patient or a pediatric patient (operator enters data representing a patient’s individual weight so that default related values of tidal volume and breath rate are used (Sherman, fig 5, col 9, ln 61-67), and based on the weight, the device determines whether the patient is an adult or child when the operator enters the patient’s approximate weight (Sherman, col 12, ln 50-52) such that patients greater than 24 kg are treated using adult default settings and patients under 24 kg are treated using pediatric default settings (Sherman, col 15, ln 43-49), the user selection further corresponding to patient height (a patient height parameter is entered instead in order to provide a treatment protocol using an ideal body weight based on height, as the size of the patient's lungs are a function of the patient's height since overweight patients have the same lung size as normal or underweight patients (Banner, para [0044)), and further configured to operate in a second operating mode, wherein respiratory rate and tidal volume are determined based at least in part on input of a patient-specific parameter value (in an operating mode, clinician can select control buttons to display control slider (106 of Biondi) to change control settings (Biondi, para [0059]), and control settings can include (tidal volume and breathing rate) (Biondi, para [0060], Table, page 6). Therefore, because modified Biondi discloses the limitations of claim 1, the rejection is maintained.
Applicant argues on page 11, fifth full paragraph-page 13 first paragraph of applicant’s remarks, that Banner does not disclose a user interface configured for a user to select between a first operating mode and a second operating mode, as Banner does not disclose two separate operating modes, and does not provide a choice or selection between either an adult patient, the user selection corresponding to patient height. However, as discussed above, the Biondi and Sherman disclose the feature of provide a user interface configured for a user to select between a first operating mode and a second operating mode, and the teaching of Banner discloses that the user selection corresponds to a patient height (Banner, para [0044]). Therefore, the rejection is maintained.
Applicant argues on page 13, first full paragraph of applicant’s remarks, that a person would not be motivated to enter height since height is not a respiratory control setting as specified in para [0060]). However, Biondi’s disclosed operating mode is considered to read on the claimed second operating mode, and Sherman teaches that in a first operating mode, a user selection of a weight (which can correspond to an adult patient or pediatric patient) (Sherman, col 12, ln 50-52) can be used to automatically set patient parameters and tidal volume (Sherman, fig 5, col 9, ln 61-67), and Banner teaches using a user selection of a height corresponding to an ideal bodyweight of a patient is more beneficial than a user input of weight because the size of the patient's lungs are a function of the patient's height since overweight patients have the same lung size as normal or underweight patients (Banner, para [0044)). Therefore, the modified Biondi’s device discloses the limitations of claims 2 and 15 and the rejection is maintained.
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.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785