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 .
Claim Objections
Claim 14 is objected to because of the following informalities:
In claim 14, line 5 “a humidifier” should be changed to --the humidifier-- to correct antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In the last line of claim 1 the limitation “generated sensor output signals” is confusing if these output signals are the same or additional to the output signals in line 8 of claim 1.
In claim 2, lines 2-5 the limitation “a device parameter group consisting of … and an ambient parameter group consisting of…” is unclear if the ambient parameter group is part of the device parameter group choices or additional parameters required with a parameter of the group.
In claim 3, line 3 the limitation “a quasi-steady state can be described” is unclear if the steady state is or is not described by the limitation that follows.
In claim 14, line 3 the limitations “a blower assembly” and “a blower” is confusing if these are the same as the blower section and blower in claim 1, line 2 or if these are additional structures.
In claim 15, lines 10-13 the limitation “one or more device parameters selected from the group consisting of … and other parameters that comprise…” is unclear if the other parameters are part of the group or additional parameters required in addition to a parameter of the group.
In the last line of claim 15 the limitation “generated sensor output signals” is confusing if these output signals are the same or additional to the output signals in line 9 of claim 15.
Claim 16, lines 2-3 recite the limitation "heater plate temperature, a pressure generated by the blower, and a flow rate generated by the blower" which is unclear if these are the same output signals as in claim 15, lines 10-12 or additional output signals.
Claim 16, lines 4-5 recite the limitation "ambient temperature, ambient relative humidity, and ambient pressure" which is unclear if these are the same output signals as in claim 15, lines 12-13 or additional output signals.
In line 4 of claim 17 the limitation “generated sensor output signals” is confusing if these output signals are the same or additional to the output signals in line 9 of claim 15.
All remaining claims are rejected based on their dependency of a rejected base claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 16 is a repeat of the claim limitation in lines 10-13 of claim 15. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 7-10, 14-17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bath (2020/0114098) in view of Bowman (2015/0165146).
With respect to claim 1, Bath discloses a humidifier of a heated pass-over type (5000, fig 1) for use in a sleep or respiratory therapy device (see [0003] and 4000, (fig 1) that includes a blower section having a blower (4142, fig 4A) for supplying a pressurized flow of breathable gas ([0140]), comprising a heater plate (5240, fig 5B); a water reservoir (5110, fig 5B) structured to house a volume of water ([0284]), the water reservoir having a breathable gas inlet (5002, fig 5A) and a humidified breathable gas outlet (5004, fig 5A), wherein the water reservoir includes at least one surface for contacting the heater plate (5120, fig 5B; [0289]); and one or more sensors (5210, fig 5C) configured to generate output signals conveying information about an operating status of the humidifier and ambient conditions ([0292]); a controller (5250, fig 5C) configured to control an evaporation rate of the volume of water housed in the water reservoir (see [0300]) for humidifying the flow of breathable gas received at the breathable gas inlet of the water reservoir into a flow of humidified breathable gas at the humidified breathable gas outlet of the water reservoir ([0296]) with a power control according to a power control algorithm for humidifying ([0330-331]), but is silent regarding the power control algorithm includes a transfer function in which a required power input to the heater plate is a function of a desired evaporation rate based upon generated sensor output signals.
However, Bowman teaches a humidification system (100, fig 6) comprising a controller (200/303, fig 6) configured to control an evaporation rate of the volume of water housed in the water reservoir with a power control according to a power control algorithm for humidifying (see 636-642, fig 16) the flow of breathable gas received at a breathable gas inlet of the water reservoir (416, fig 12) into a flow of humidified breathable gas at a humidified breathable gas outlet of the water reservoir (408, fig 12 and [0084]), wherein the power control algorithm includes a transfer function in which a required power input to the heater plate is a function of a desired evaporation rate (see [0081 and 135]) based upon generated sensor output signals (see ‘based on one or more of:” in [0081]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the power control of Bath to include the transfer function requiring power input to the heater plate as a function of a desired evaporation rate based upon generated sensor output signals as taught by Bowman so as to provide a modulated control to ensure delivery of a generally continuous level of humidity (see [0080] of Bowman).
With respect to claim 2, the modified Bath shows the generated sensor output signal is heater plate temperature (see [0295] of Bath) and an ambient parameter is ambient temperature (see [0295] of Bath).
With respect to claim 3, the modified Bath shows the transfer function is specific to a given humidifier design and where the required power input to the heater plate during a quasi- steady state can be described as a function of (i) a desired quasi-steady state evaporation rate and (ii) generated sensor output signals (note the continuous monitoring of the power and additional parameters will allow for specific transfer functions and therefore during a quasi-steady state).
With respect to claim 4, the modified Bath shows the generated sensor output signal is heater plate temperature (see [0295] of Bath) and an ambient parameter is ambient temperature (see [0295] of Bath).
With respect to claim 7, the modified Bath shows the water reservoir includes a plate (conductive portion; 5120, fig 5B of Bath) disposed on or integral with the at least one surface of the water reservoir and configured for being placed in contact with the heater plate (see [0289] of Bath).
With respect to claim 8, the modified Bath shows the required power input comprises an electric power input to the heater plate that is operable as a control parameter to regulate the evaporation rate (see figs 5D-5E of Bath where the power supply provides power to control the controller and the heater plate thus the evaporation/humidification of the humidifier).
With respect to claim 9, the modified Bath shows the required electrical power input to the heater plate comprises an electrical power controlled by pulse width modulation (see [0324] of Bath).
With respect to claim 10, the modified Bath shows the evaporation rate is continuously adapted to changes in the operating status of the humidifier and the ambient conditions (note the continual sensing and feedback to the humidifier controller of Bath provides changes to the heating power based on the sensing; see fig 5M and adaptive power management [0340] of Bath).
With respect to claim 14, the modified Bath shows a gas delivery system (3000/4000/5000, fig 1 of Bath) for delivering a pressurized flow of humidified breathable gas to a patient (see [0090] of Bath) via a patient circuit (3000, fig 1 of Bath), comprising a blower assembly having a blower (4142, fig 4A of Bath) adapted to generate the pressurized flow of breathable gas ([0140] of Bath), and a gas flow path including an inlet (5002, fig 5A of Bath) and an outlet (5004, fig 5A of Bath); and a humidifier according to claim 1 (see rejection of claim 1 above), wherein there is a fluidic coupling between the blower, the humidifier, and the patient circuit (see connections in fig 4B of Bath).
With respect to claim 15, the modified Bath shows a method of humidifying (see figs 5E and 5M) a flow of breathable gas in a sleep or respiratory therapy device (5000, fig 1) that includes a blower section having a blower (4142, fig 4A) for supplying a pressurized flow of breathable gas ([0140]) using a humidifier of a heated pass-over type (5000, fig 1), the method comprising providing a heater plate (5240, fig 5B); providing a water reservoir (5110, fig 5B) structured to house a volume of water ([0284]), the water reservoir having a breathable gas inlet (5002, fig 5A) and a humidified breathable gas outlet (5004, fig 5A), wherein the water reservoir includes at least one surface for contacting the heater plate (5120, fig 5B; [0289]); and providing one or more sensors (5210, fig 5C) configured to generate output signals conveying information that indicates one or more device parameter of heater plate temperature (5216; fig 5C and [0295]); controlling, via a controller (5250, fig 5C), an evaporation rate of the volume of water housed in the water reservoir (see [0300]) for humidifying the flow of breathable gas received at the breathable gas inlet of the water reservoir into a flow of humidified breathable gas at the humidified breathable gas outlet of the water reservoir ([0296]) with a power control according to a power control algorithm for humidifying ([0330-331]), but is silent regarding the power control algorithm includes a transfer function in which a required power input to the heater plate is a function of a desired evaporation rate based upon generated sensor output signals.
However, Bowman teaches a humidification system (100, fig 6) comprising a controller (200/303, fig 6) configured to control an evaporation rate of the volume of water housed in the water reservoir with a power control according to a power control algorithm for humidifying (see 636-642, fig 16) the flow of breathable gas received at a breathable gas inlet of the water reservoir (416, fig 12) into a flow of humidified breathable gas at a humidified breathable gas outlet of the water reservoir (408, fig 12 and [0084]), wherein the power control algorithm includes a transfer function in which a required power input to the heater plate is a function of a desired evaporation rate (see [0081 and 135]) based upon generated sensor output signals (see ‘based on one or more of:” in [0081]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the power control of Bath to include the transfer function requiring power input to the heater plate as a function of a desired evaporation rate based upon generated sensor output signals as taught by Bowman so as to provide a modulated control to ensure delivery of a generally continuous level of humidity (see [0080] of Bowman).
With respect to claim 16, the modified Bath shows the generated sensor output signal is heater plate temperature (see [0295] of Bath) and an ambient parameter is ambient temperature (see [0295] of Bath).
With respect to claim 17, the modified Bath shows the transfer function is specific to a given humidifier design and where the required power input to the heater plate during a quasi- steady state can be described as a function of (i) a desired quasi-steady state evaporation rate and (ii) generated sensor output signals (note the continuous monitoring of the power and additional parameters will allow for specific transfer functions and therefore during a quasi-steady state).
With respect to claim 20, the modified Bath shows the water reservoir includes a heat conductive plate (conductive portion; 5120, fig 5B of Bath) disposed on or integral with the at least one surface of the water reservoir and configured for being placed in contact with the heater plate (see [0289] of Bath).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bath and Bowman as applied to claim 1 above, and further in view of McRae (2003/0033055).
With respect to claim 11, the modified Bath shows all the elements as claimed above but lacks a shunt resistance in series with the heater plate, wherein the controller is further configured to obtain a measurement of electrical power delivered to the heater plate via measuring a voltage drop across the shunt resistance, determining electrical current to the heater plate using the measured voltage drop across the shunt resistance and voltage, Vhp, across the heater plate.
However, McRae teaches an aerosol generator (300, fig 3) comprising a shunt resistance (see [0053]) in series with a heater plate (310, fig 3), wherein a controller (350, fig 3) is configured to obtain a measurement of electrical power delivered to the heater plate via measuring a voltage drop across the shunt resistance (see [0053-54]), determining electrical current to the heater plate using the measured voltage drop across the shunt resistance and voltage across the heater plate (see [0053]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the humidifier of the modified Bath to include a shunt resistance as taught by McRae so as to continuously regulate the temperature (see [0053] of McRae).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bath and Bowman as applied to claim 1 above, and further in view of Barker (2013/0104886).
With respect to claim 13, the modified Bath shows all the elements as claimed above but is silent regarding the controller is further configured, responsive to a detection of an increase in heater plate temperature above a threshold amount, to reduce the power input to the heater plate.
However, Barker teaches a humidifier (1, fig 2a) comprising a controller (8b, fig 2a) configured responsive to a detection of an increase in heater plate temperature above a threshold amount, to reduce the power input to the heater plate (see [0027] and [0091] and fig 1 and 8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of the modified Bath to control temperature based on feedback as taught by Barker so as to allow for continuous monitoring of an at home device (see [0012] of Barker).
Allowable Subject Matter
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Claims 5-6, 12, and 18-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. McAuley (2010/0043791), Winski (2015/0306335), Novkov (2019/0344038), and Higashiyama (2021/0178108) are cited to show additional humidification devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY E BALLER whose telephone number is (571)272-8153. The examiner can normally be reached Monday - Friday 8 AM - 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KELSEY E BALLER/ Examiner, Art Unit 3785
/TU A VO/ Primary Examiner, Art Unit 3785
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