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 .
Response to Amendment
Examiner acknowledges the reply filed on 03/11/2026 in which claims 47, 60, 67, 73, and 78-79 have been amended. Currently, claims 47-80 are pending for examination in this application, of which claims 47-59 are withdrawn from consideration.
Response to Arguments
Applicant has resolved the objections to the claims; therefore, those objections have been withdrawn.
Applicant has resolved the rejections under 35 U.S.C. § 112; therefore those rejections are withdrawn.
Applicant's arguments, see Remarks pg. 7-9, filed 03/11/2026 have been fully considered but they are not persuasive. Applicant states that Burgess does not teach controlling “during the high-temperature mode and immediately after termination of the high-temperature mode”, “the respiratory support apparatus to restrict a characteristic of the gases flow to maintain an enthalpy or a dew-point of the gases flow below a predetermined level” because Burgess does not teach a cool-down mode or other safety measures for transitioning between temperature modes. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a cool-down mode) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Burgess teaches a first and second target temperature modes comprising a lower temperature mode and a higher temperature mode respectively. In this situation, as there are only two modes, once the high temperature mode is switched to the low temperature mode the temperature characteristic of the gas flow is restricted to be in the predetermined range of the low temperature mode, which restricts the enthalpy as enthalpy is directly proportional to temperature, Alternatively, the device is turned off which achieves the same effect of lowering the temperature eventually and thereby restricting the enthalpy.
Applicant's arguments, see Remarks pg. 9-10, filed 03/11/2026 have been fully considered but they are not persuasive. Applicant states that Peiris does not teach controlling “during the high-temperature mode and immediately after termination of the high-temperature mode”, “the respiratory support apparatus to restrict a characteristic of the gases flow to maintain an enthalpy or a dew-point of the gases flow below a predetermined level”. Peiris teaches an open/high flow therapy CPAP mode and a closed/traditional CPAP mode (see [0059]) where [0034] the temperature for an open CPAP mode is higher than the temperature for a closed CPAP mode. During the open/high flow therapy CPAP mode the gas flow rate and temperature are restricted, when the open/high follow therapy CPAP mode switches to a closed/traditional CPAP mode the temperature and flow rate is restricted with a lower temperature range and lower flow rate range. In this situation, as there are only two modes, once the high temperature and flow rate mode is switched to the low temperature and flow rate mode, the temperature and flow rate characteristic of the gas flow is restricted to be in the predetermined range of the lower temperature and lower flow rate mode, which restricts the enthalpy as enthalpy is directly proportional to temperature. Alternatively, the device is turned off which achieves the same effect of lowering the temperature and flow rate eventually and thereby restricting the enthalpy.
Election/Restrictions
Claims 47-59 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/10/2025.
Applicant’s election without traverse of claims 60-66 in the reply filed on 12/10/2025 is acknowledged.
Claim Objections
Claim 67 is objected to because of the following informalities:
Claim 67, line 9, “immediate” should be “immediately”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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) 60-61, 63-64, and 66 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burgess et al. (WO 2018052320 A2).
Regarding claim 60, Burgess discloses a respiratory support apparatus configured to provide a gases flow to a patient ([0092] flow therapy apparatus 10; figure 1A), the respiratory support apparatus comprising:
a flow generator configured to generate the gases flow ([0092] flow generator 11; figure 1A);
a humidifier configured to humidify the gases flow ([0092] humidifier 12; figure 1A);
a controller ([0092] controller 13; figure 1A) configured to control the respiratory support apparatus to function in at least two modes ([0028] The system may further comprise a controller coupled to the temperature sensor and the thermistor circuit, wherein the controller is configured to adjust the thermistor circuit to change between the at least first and second target temperature modes, in response to changes in the measured gases flow temperature. Also see [0052-0053]), the at least two modes including a normal mode ([0052] The first and second target temperature modes may comprise a lower temperature mode and a higher temperature mode) and a high-temperature mode ([0052] The first and second target temperature modes may comprise a lower temperature mode and a higher temperature mode), wherein a temperature of gas delivered to the patient when in the high-temperature mode is higher than when in the normal mode ([0057] The first and second target temperature modes may be associated with gases flow temperature ranges of between about 0°C to about 60°C, and between about 20°C to about 100°C respectively. also see [0121]);
wherein during the high-temperature mode (Examiner notes that the temperature of the gas flow is restricted to predetermined ranges associated with the second target temperature mode in the second target temperature mode as supported by [0057]) and immediately after termination of the high-temperature mode (Examiner notes that the temperature of the gas flow is restricted to predetermined ranges associated with the first target temperature mode after termination of the high-temperature mode and switching to the first target temperature mode, as supported by [0053] and [0057]), the controller controls the respiratory support apparatus to restrict a characteristic of the gases flow to maintain an enthalpy or a dew-point of the gases flow below a predetermined level (this is a functional limitation: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Examiner notes enthalpy is directly proportional to temperature and since gas flow temperature is controlled to be below a predetermined level that results in enthalpy being controlled to be below a predetermined level).
Regarding claim 61, Burgess discloses the respiratory support apparatus of claim 60, wherein when in the high-temperature mode, the gases flow to the patient comprises a temperature range of 41 C to 50 C ([0057] The first and second target temperature modes may be associated with gases flow temperature ranges of about 0°C to about 40°C and about 30°C to about 70°C respectively. Examiner notes about 30°C to about 70°C encompasses the entirety of the range 41 C to 50 C; therefore, the limitation is met).
Regarding claim 63, Burgess discloses the respiratory support apparatus of claim 60, wherein the controller returns the respiratory support apparatus to the normal mode in dependence upon the temperature of the gases flow ([0053] The controller may be configured to switch the thermistor circuit from operating in the higher temperature mode to the lower temperature mode when the measured gases flow temperature is lower than a second threshold value).
Regarding claim 64, Burgess discloses the respiratory support apparatus of claim 60, wherein the controller returns the respiratory support apparatus to the normal mode in dependence upon the temperature of the gases flow being less than a predetermined temperature ([0053] The controller may be configured to switch the thermistor circuit from operating in the higher temperature mode to the lower temperature mode when the measured gases flow temperature is lower than a second threshold value).
Regarding claim 66, Burgess discloses the respiratory support apparatus of claim 60, wherein the controller returns the respiratory support apparatus to the normal mode in dependence upon the enthalpy of the gases flow (Examiner notes enthalpy is directly proportional to temperature and since switching of the temperature modes is dependent on gas flow temperature, that results in switching of the temperature modes also being dependent on enthalpy).
Claim(s) 67-72 and 78-80 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peiris (US 20120291783 A1).
Regarding claim 67, Peiris discloses a respiratory support apparatus configured to provide a gases flow to a patient ([0046] breathing assistance apparatus; figure 1a-1b), the respiratory support apparatus comprising:
a flow generator configured to generate the gases flow ([0047] blower unit 2; figure 1a-1b);
a humidifier configured to humidify the gases flow ([0047] humidifier unit 3; figure 1a-1b);
a controller ([0052] control unit/controller 13; figure 1a-1b) configured to control the respiratory support apparatus to function in at least two modes ([0062] Subsequent to this detection the controller may adjust the operating parameters or automatically switch between [closed] CPAP and open CPAP delivery modes depending on the interface detected at the end of the breathing circuit. Examiner notes that closed CPAP delivery mode is also referred to as traditional CPAP delivery mode and open CPAP delivery mode is also referred to as high flow therapy, as supported by [0059]), the at least two modes including a normal mode (see [0034, closed CPAP mode) and a high-temperature mode ([0034] the temperature for an open CPAP mode is higher than the temperature for a closed CPAP mode), wherein a temperature of gas delivered to the patient when in the high-temperature mode is higher than when in the normal mode ([0034] a further aspect said operating parameter includes the temperature of gases delivered to the patient; the temperature for an open CPAP mode is higher than the temperature for a closed CPAP mode. [0082] The controller is preferably configured to increase the supplied humidity, for example by commanding an increase in power to the humidifier heater plate, when switching from closed CPAP to open CPAP mode);
wherein during the high-temperature mode ([0079] the controller will typically be configured to set the operating mode for open CPAP therapy to deliver flow rates of 20 to 40 L/minute, which will typically require a pressure range of approximately 4-6 cmH.sub.2O) and immediate after termination of the high-temperature mode ([0079] the controller will typically set the operating mode for closed CPAP therapy to deliver a pressure range of 4 to 20 cmH.sub.2O, which will typically see flow rates of up to or exceeding 40 L/minute. Examiner notes that the flow rates is restricted to predetermined ranges of up to or exceeding 40 L/minute after termination of the open CPAP mode and switching to the closed CPAP mode, as supported by [0064] and [0079]), the controller controls the respiratory support apparatus to restrict a flow rate of the gases flow to maintain an enthalpy or a dew-point of the gases flow below a predetermined level (this is a functional limitation: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Examiner notes during the open/high flow therapy CPAP mode the gas flow rate and temperature are restricted, when the open/high follow therapy CPAP mode switches to a closed/traditional CPAP mode the temperature and flow rate is restricted with a lower temperature range and lower flow rate range. In this situation, as there are only two modes, once the high temperature and flow rate mode (open CPAP) is switched to the low temperature and flow rate mode (closed CPAP), the temperature and flow rate characteristic of the gas flow is restricted to be in the predetermined range of the lower temperature and lower flow rate mode, which restricts the enthalpy as enthalpy is directly proportional to temperature. Since the temperature of gases is controlled to be below a predetermined level when the controller is in open CPAP mode and when it is switched from being in open CPAP mode to closed CPAP mode, that results in enthalpy being controlled to be below a maximum predetermined level. See [0059] for temperatures).
Regarding claim 68, Peiris discloses the respiratory support apparatus of claim 67, wherein the flow rate generated in the high-temperature mode ([0079] the controller will typically be configured to set the operating mode for open CPAP therapy to deliver flow rates of 20 to 40 L/minute, which will typically require a pressure range of approximately 4-6 cmH.sub.2O) is restricted compared to a flow rate range used in the normal mode ([0079] the controller will typically set the operating mode for closed CPAP therapy to deliver a pressure range of 4 to 20 cmH.sub.2O, which will typically see flow rates of up to or exceeding 40 L/minute. Examiner notes that the range of 20-40 L/min is more restrictive numerically than the range up to or exceeding 40 L/min).
Regarding claim 69, Peiris discloses the respiratory support apparatus of claim 67, wherein in the normal mode the controller controls the flow generator to generate the gases flow at a flow rate within a first flow rate range that is limited by a first peak flow rate ([0079] the controller will typically set the operating mode for closed CPAP therapy to deliver a pressure range of 4 to 20 cmH.sub.2O, which will typically see flow rates of up to or exceeding 40 L/minute); and
wherein in the high-temperature mode, the controller controls the flow generator to generate the gases flow at a flow rate within a second flow rate range that is limited by a second peak flow rate ([0079] the controller will typically be configured to set the operating mode for open CPAP therapy to deliver flow rates of 20 to 40 L/minute, which will typically require a pressure range of approximately 4-6 cmH.sub.2O).
Regarding claim 70, Peiris discloses the respiratory support apparatus of claim 69, wherein the second peak flow rate is lower than the first peak flow rate (Examiner notes the second peak flow rate is 40 L/min and the first peak flow rate may exceed 40 L/min).
Regarding claim 71, Peiris discloses the respiratory support apparatus of claim 69, wherein the second peak flow rate (open CPAP: 40 L/min) is higher than the first peak flow rate (Examiner notes Burgess teaches for closed CPAP therapy “flow rates of up to” 40 L/min, which also means the first peak flow rate may be below 40 L/min as “up to” defines a maximum value. In such an embodiment, the second peak flow rate of the open CPAP mode is higher than the first peak flow rate of the closed CPAP mode).
Regarding claim 72, Peiris discloses the respiratory support apparatus of claim 69, wherein the first flow rate range is limited by a first minimum flow rate ([0079] the controller will typically set the operating mode for closed CPAP therapy to deliver a pressure range of 4 to 20 cmH.sub.2O, which will typically see flow rates of up to or exceeding 40 L/minute. Examiner notes that since no minimum value is explicitly disclosed the minimum flow rate would be 0 L/min) and the second flow rate range is limited by a second minimum flow rate ([0079] the controller will typically be configured to set the operating mode for open CPAP therapy to deliver flow rates of 20 to 40 L/minute, which will typically require a pressure range of approximately 4-6 cmH.sub.2O), the second minimum flow rate being higher than the first minimum flow rate (20 L/min is higher than 0 L/min).
Regarding claim 78, Peiris discloses the respiratory support apparatus of claim 67, wherein the flow rate of the gases flow immediately after termination of the high-temperature mode is maintained within a predetermined threshold ([0079] the controller will typically set the operating mode for closed CPAP therapy to deliver a pressure range of 4 to 20 cmH.sub.2O, which will typically see flow rates of up to or exceeding 40 L/minute. Examiner notes that the flow rates is restricted to predetermined ranges of up to or exceeding 40 L/minute after termination of the open CPAP mode and switching to the closed CPAP mode, as supported by [0064] and [0079]).
Regarding claim 79, Peiris discloses the respiratory support apparatus of claim 67, wherein the flow rate of the gases flow immediately after termination of the high-temperature mode is maintained within a threshold determined by a function of the flow rate that was used during the high-temperature mode ([0079] the controller will typically set the operating mode for closed CPAP therapy to deliver a pressure range of 4 to 20 cmH.sub.2O, which will typically see flow rates of up to or exceeding 40 L/minute. Examiner notes that the flow rates is restricted to predetermined ranges of up to or exceeding 40 L/minute after termination of the open/high flow therapy CPAP mode and switching to the closed/traditional CPAP mode, as supported by [0059] [0064] and [0079]. The flow rate in the closed/traditional CPAP mode is a function of the flow rate in the open/high flow therapy CPAP mode as the flow rate in traditional CPAP mode is known to be lower than the flow rate in high flow therapy CPAP mode).
Regarding claim 80, Peiris discloses the respiratory support apparatus of claim 67, wherein the flow rate of the gases flow immediately after termination of the high-temperature mode may be a threshold that represents a highest flow rate that the respiratory support apparatus can quickly transition to (this is a functional limitation: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). [0079] the controller will typically set the operating mode for closed CPAP therapy to deliver a pressure range of 4 to 20 cmH.sub.2O, which will typically see flow rates of up to or exceeding 40 L/minute. Examiner notes that the flow rates is restricted to predetermined ranges of up to or exceeding 40 L/minute, which represents a maximal flow rate, after termination of the open CPAP mode and switching to the closed CPAP mode, as supported by [0064] and [0079]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burgess et al. (WO 2018052320 A2), as applied to claim 60 above, and further in view of Jackson et al. (US 20160228671 A1).
Regarding claim 62, Burgess discloses the respiratory support apparatus of claim 60, but is silent as to wherein the controller returns the respiratory support apparatus to the normal mode after a predetermined period of time following an end of the high-temperature mode, wherein the predetermined period of time comprises a range of 15 to 60 minutes.
Burgess teaches [0027] The gases flow rate sensing system may be configured to operate in more than two different temperature modes.
Additionally, Jackson teaches a humidifier system with an intermediate cooldown mode between a first and second mode ([0258] FIG. 30B illustrates a flow chart of the second mode 3020, which may be referred to as a cooldown mode or a heater-off testing mode. While operating in the second mode 3020, the humidification system can deactivate one or more or all of the heaters to allow the system to cool down and to stabilize the temperature of the gases. The humidification system can be configured to monitor parameters of the flow of gases during the second mode 3020 to determine when and/or whether to exit the second mode 3020 and/or which mode of operation to perform upon exiting the second mode. [0259] In block 3022, the humidification system is configured to turn off the heaters in the system (for example, heater plate, heater wires, etc.). In block 3023, the humidification system is configured to start a timer that determines a maximum amount of time to remain in the second mode of operation 3020 before exiting to another operation mode. The timer can be set to run for at least about 1 min., at least about 1.5 min., at least about 2 min., or at least about 4 min. In block 3024, the humidification system tests whether a reverse-flow flag or a no-flow flag has been set. The respective flags may be set in the third mode 3030, described herein. If no flags have been set, the humidification system cools down for a prescribed amount of time before entering the third mode 3030. This may be useful when temperatures have increased to levels that have been deemed undesirable, as described herein, such as when the gas temperature is high enough that it may injure a user; see figure 30A-30C).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Burgess to implement an intermediate cooldown mode in between the two modes, lasting at least about 4 min, in order to allow the system to cool down stabilize the temperature of the gases, as taught by Jackson [0259].
Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify duration of the cooldown mode of modified Burgess from at least about 4 minutes to a range of 15 to 60 minutes as applicant appears to have placed no criticality on the claimed range (see [0057]) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burgess et al. (WO 2018052320 A2), as applied to claim 60 above, and further in view of Soysa et al. (US 20160256642 A1).
Regarding claim 65, Burgess discloses the respiratory support apparatus of claim 60, but is silent as to wherein the controller returns the respiratory support apparatus to the normal mode in dependence upon the dew-point of the gases flow.
However, Soysa teaches a respiratory support apparatus configured to be controlled based upon the dew-point of the gases flow ([0018] In some embodiments, the breathing assistance apparatus displays an estimated dewpoint on a display instead of or in addition to a measured gases temperature. The estimated dewpoint displayed can indicate an estimate of the dewpoint of gases being provided and/or that is being targeted by the breathing assistance apparatus. It is to be understood that, although the dewpoint may be expressed as a temperature, the dewpoint is correlated with the humidity of gases and can be different from the gases temperature. The breathing assistance apparatus can be configured to measure parameters of gases (e.g., the temperature, flow rate, etc.) at one or more locations within the apparatus in the gases flow path to estimate the dewpoint. In some embodiments, the breathing assistance apparatus may display a dewpoint set point on a display instead of or in addition to a temperature (e.g., gases temperature) set point. In some embodiments, the breathing assistance apparatus may provide a dewpoint set point adjustment control instead of or in addition to a temperature (e.g., gases temperature) set point adjustment control. Also see [0012] and [0075-0077]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the controller of Burgess to implement controlling the respiratory support apparatus, specifically the switching of the temperature modes, in dependence on the dewpoint of the delivered gases in addition to dependence on gases temperature, in order to consider the humidity of the gases delivered to the user as supported by Soysa [0018].
Claim(s) 73-77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peiris et al. (US 20120291783 A1).
Regarding claim 73, Peiris discloses the respiratory support apparatus of claim 69, wherein the first flow rate range is limited by a first minimum flow rate ([0079] the controller will typically set the operating mode for closed CPAP therapy to deliver a pressure range of 4 to 20 cmH.sub.2O, which will typically see flow rates of up to or exceeding 40 L/minute. Examiner notes that since no minimum value is explicitly disclosed the minimum flow rate would be 0 L/min) and the second flow rate range is limited by a second minimum flow rate ([0079] the controller will typically be configured to set the operating mode for open CPAP therapy to deliver flow rates of 20 to 40 L/minute, which will typically require a pressure range of approximately 4-6 cmH.sub.2O), but is silent as to the second minimum flow rate of the second flow rate range, is equal to or less than the first minimum flow rate of the first flow rate range.
However, Peiris teaches an open CPAP treatment mode wherein the minimum flow rate of the flow rate range is equal to 0 L/min ([0061] Open CPAP treatment or treatment with nasal insufflation or `trans nasal insufflation` (TNI) is based on the principles of HFT where an open nasal cannula system is used to deliver high flow rates to the nares of a patient to alleviate the symptoms of obstructive sleep apnoea-hypopnea syndrome (OSAHS) or upper airway resistance syndrome (UARS). It has been shown in the art that a linear increase in expiratory pharyngeal pressures (EPP) is possible with increasing flow rates. For example, EPP increased from 0.8-7.4 cmH2O during mouth closed and from 0.3-2.7 cmH2O during mouth open, for flow rates from 0-60 L/min).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to teach wherein the second minimum flow rate of the second flow rate range is equal to 0 L/min for an open CPAP treatment mode.
Regarding claim 74, Peiris discloses the respiratory support apparatus of claim 68, but is silent as to wherein the flow rate range in the normal mode is 10 to 70 L/min.
Peiris teaches [0079] the controller will typically set the operating mode for closed CPAP therapy to deliver a pressure range of 4 to 20 cmH.sub.2O, which will typically see flow rates of up to or exceeding 40 L/minute.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the flow rate range of the normal mode of Peiris from up to or exceeding 40 L/minute to 10 to 70 L/min as applicant appears to have placed no criticality on the claimed range (see [0027-0029] wherein multiple ranges are disclosed) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 75, Peiris discloses the respiratory support apparatus of claim 69, but is silent as to wherein the second flow rate range in high temperature mode is 30 to 40 L/min.
Peiris teaches [0079] the controller will typically be configured to set the operating mode for open CPAP therapy to deliver flow rates of 20 to 40 L/minute, which will typically require a pressure range of approximately 4-6 cmH.sub.2O. E
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second flow rate range of the high temperature mode of Peiris from 20 to 40 L/minute to 30 to 40 L/min as applicant appears to have placed no criticality on the claimed range (see [0027-0029] wherein multiple ranges are disclosed) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 76, Peiris discloses the respiratory support apparatus of claim 69, but is silent as to wherein the second flow rate range in high temperature mode is 30 to 70 L/min.
Peiris teaches [0079] the controller will typically be configured to set the operating mode for open CPAP therapy to deliver flow rates of 20 to 40 L/minute, which will typically require a pressure range of approximately 4-6 cmH.sub.2O. E
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second flow rate range of the high temperature mode of Peiris from 20 to 40 L/minute to 30 to 70 L/min as applicant appears to have placed no criticality on the claimed range (see [0027-0029] wherein multiple ranges are disclosed), and as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The motivation for doing so would to be able to provide a flow of gases at a wider flow rate range depending on a user’s condition.
Regarding claim 77, Peiris discloses the respiratory support apparatus of claim 69, but is silent as to wherein the second flow rate range in high temperature is 10 to 40 L/min.
Peiris teaches [0079] the controller will typically be configured to set the operating mode for open CPAP therapy to deliver flow rates of 20 to 40 L/minute, which will typically require a pressure range of approximately 4-6 cmH.sub.2O. E
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second flow rate range of the high temperature mode of Peiris from 20 to 40 L/minute to 10 to 40 L/min as applicant appears to have placed no criticality on the claimed range (see [0027-0029] wherein multiple ranges are disclosed), and as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The motivation for doing so would to be able to provide a flow of gases at a wider flow rate range depending on a user’s condition.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mautin I Ashimiu whose telephone number is (571)272-0760. The examiner can normally be reached Monday - Friday, 7:30 a.m. - 4:30 p.m. ET.
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/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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