DETAILED ACTION
This Office Action is in response to the amendment, filed on July 21, 2026, and the interview, conducted on July 15, 2026. Primary Examiner acknowledges Claims 21-28 and 30-42 are pending in this application, with Claim 21 having been currently amended, Claims 40-42 having been newly added, and Claims 1-20 and 29 having been cancelled.
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 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.
Claims 21, 25, 27, 28, and 30-38 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by McComb (5,349,946).
As to Claim 21, McComb discloses a device (Figure 1) for humidifying a flow of air pressurized by a blower (16, “The ventilator circuit 14 includes a ventilator 16 which delivers breathable dry gas at a temperature approximately equal to body temperature or about 37.degree. C. An inspiratory limb or inhalation tubing 18 connects the ventilator 16 to the mouth of a patient 12 through a suitable mask or other adapter and allows the gas from the ventilator to flow to the patient's mouth.” Column 3, Lines 5-25), the device (Figure 1) comprising: a humidification chamber (24, defined by the engagement of both 48 and 58 to form 24, wherein 48 – “Humidifier 24 comprises an outer housing 48 which is preferably constructed from plastic.” Column 4, Lines 25-50 and wherein 58 – “A threaded removable end cap 58 is provided on the inlet side of humidifier 24 providing access to the inside of humidifier 24. The bat of blotting paper 50 is easily removed from humidifier 24 and replaced by simply unscrewing cap 58 and slipping the sleeve 52 out of the housing 48.” Column 4, Lines 50-65) having a first end (18A of 58, “As indicated in FIG. 2, tubing 18A which is connected to ventilator 16 is coupled to humidifier 24.” Column 4, Lines 50-65) configured to receive the flow of air from the blower (16) and a second end (18B of 48, “Tubing 18B which is connected to provide breathable gas to the patient is coupled into the opposite (outlet) end of humidifier 24.” Column 4, Lines 50-65) opposite the first end (18A of 58) configured to direct the flow of air to a patient interface (“a suitable mask or other adapter”, “An inspiratory limb or inhalation tubing 18 connects the ventilator 16 to the mouth of a patient 12 through a suitable mask or other adapter and allows the gas from the ventilator to flow to the patient's mouth.” Column 3, Lines 5-25); a water-absorbent material (50, “A bat of blotting paper 50 or similar water absorbing material is disposed inside of housing 48. The bat 50 comprises an outer layer or sleeve of blotting paper 52. … Bat 50 is also comprised of circular discs of blotting paper 54 layered inside of and on a plane perpendicular to outer layer 52.” Column 4, Lines 25-50; also see: “From this contact region, blotting paper 50 wicks the water to the entire sleeve 52 and to the discs 54 permitting all of the blotting paper to become substantially saturated with water.” Column 5, Lines 1-25; and “As a result, the gas flowing through humidifier 24 only comes in contract with the substantially saturated blotting paper 50 which is unlike conventional humidifiers that allow gas to come in contact with a pool of water in a reservoir. Therefore, in the present invention, the humidifier delivers only molecular humidity which is substantially free of water droplets or water vapor because the gas does not come in contact with a pool of water. The desired humidity level is still reached because the appropriate amount of water is delivered to the substantially saturated blotting paper 50 via microprocessor control. Because substantially all of the water delivered to the humidifier is converted into molecular humidity, an increase in the rate at which the water is delivered directly increases the humidity of the gas.” Column 5, Lines 20-50) positioned inside of the humidification chamber (24) and shaped to substantially surround (best seen Figures 2 and 3) and at least partly form a path for the flow of air (via the passage of air from 18A through 56 to 18B, wherein 56 – “As indicated in FIG. 3, circular blotting paper rings 54 include holes 56 to allow gas to more freely flow through the humidifier.” Column 4, Lines 25-50) though the humidification chamber (24) such that the water absorbent material (50) is directly exposed (“As a result, the gas flowing through humidifier 24 only comes in contract with the substantially saturated blotting paper 50 which is unlike conventional humidifiers that allow gas to come in contact with a pool of water in a reservoir.” Column 5, Lines 20-50) to the flow of air flowing along the flow path (via the passage of air from 18A through 56 to 18B); a heating element (45, “Therefore, an optional heater 45 is added to humidification system 10 in a preferred embodiment of the present invention for heating humidifier 24 so that the temperature of the gas can be increased as the gas flows through the humidifier. Heater 45 can be turned on and off in response to a control signal from microprocessor 36 received via a line 47. The heater 45 provides added flexibility by allowing humidification system 10 to control both the relative humidity and the temperature of the gas being delivered to the patient.” Column 4, Lines 15-30) configured to heat the water absorbent material (50) to evaporate absorbed water into the flow of air; and a reservoir (26, “A reservoir 26 is filled with water and is separated from humidifier 24. Piping 28 connects reservoir 26 to humidifier 24 and carries water from the reservoir to the humidifier. Typically, water flows from reservoir 26 to humidifier 24 because the reservoir is pressurized. A valve 30 which can be turned on and off in pulses is disposed in the piping 28 between reservoir 26 and humidifier 24. Pulsing valve 30 is controlled for limiting the amount of water delivered to humidifier 24 from reservoir 26.” Column 3, Lines 25-40) positioned outside of the humidification chamber (24), the reservoir (26) configured to retain a water supply, and the reservoir (26) being in fluid communication (“As illustrated in FIG. 3, a contact region 66 indicates where water from reservoir 26 coming into housing 60 and through opening 61 actually makes contact with blotting paper 50.” Column 5, Lines 1-25) with the water absorbent material (50) to direct the water supply to the water absorbent material (50).
As to Claim 25, McComb discloses a housing (defined by the engagement of both 48 and 58 to form 24, wherein 48 – “Humidifier 24 comprises an outer housing 48 which is preferably constructed from plastic.” Column 4, Lines 25-50 and wherein 58 – “A threaded removable end cap 58 is provided on the inlet side of humidifier 24 providing access to the inside of humidifier 24. The bat of blotting paper 50 is easily removed from humidifier 24 and replaced by simply unscrewing cap 58 and slipping the sleeve 52 out of the housing 48.” Column 4, Lines 50-65) that at least partly forms the humidification chamber (24).
As to Claim 27, McComb discloses the water absorbent material (50) is removable (“A threaded removable end cap 58 is provided on the inlet side of humidifier 24 providing access to the inside of humidifier 24. The bat of blotting paper 50 is easily removed from humidifier 24 and replaced by simply unscrewing cap 58 and slipping the sleeve 52 out of the housing 48.” Column 4, Lines 50-65) from the housing (defined by the engagement of both 48 and 58 to form 24).
As to Claim 28, McComb discloses the reservoir (26) is positioned outside (best seen Figure 1) of the housing (defined by the engagement of both 48 and 58 to form 24).
As to Claim 30, McComb discloses the water absorbent material (50) is in a tubular shape (best seen Figure 3).
As to Claim 31, McComb discloses the water absorbent material (50) comprises paper (“A bat of blotting paper 50 or similar water absorbing material is disposed inside of housing 48. The bat 50 comprises an outer layer or sleeve of blotting paper 52. … Bat 50 is also comprised of circular discs of blotting paper 54 layered inside of and on a plane perpendicular to outer layer 52.” Column 4, Lines 25-50).
As to Claim 32, McComb discloses the water absorbent material (50) comprises a corrugated inner surface (via series of 54, “circular discs of blotting paper 54” Column 4, Lines 25-50).
As to Claim 33, McComb discloses an inner surface (via series of 54, “circular discs of blotting paper 54” Column 4, Lines 25-50) of the water absorbent material (50) is porous (via 56, “As indicated in FIG. 3, circular blotting paper rings 54 include holes 56 to allow gas to more freely flow through the humidifier.” Column 4, Lines 25-50).
As to Claim 34, McComb discloses the water absorbent material (50) consists of a single piece of water absorbent material (best seen Figure 3, as the unitary structure of 50).
As to Claim 35, McComb discloses a conduit (28, “Piping 28 connects reservoir 26 to humidifier 24 and carries water from the reservoir to the humidifier. Typically, water flows from reservoir 26 to humidifier 24 because the reservoir is pressurized. A valve 30 which can be turned on and off in pulses is disposed in the piping 28 between reservoir 26 and humidifier 24.” Column 3, Lines 25-35) fluidly connecting the reservoir (26) to the water absorbent material (50).
As to Claim 36, McComb discloses a valve (30, “A valve 30 which can be turned on and off in pulses is disposed in the piping 28 between reservoir 26 and humidifier 24. Pulsing valve 30 is controlled for limiting the amount of water delivered to humidifier 24 from reservoir 26.” Column 3, Lines 25-35) configured to control a flow of water through the conduit (28).
As to Claim 37, McComb discloses a pump (defined by the “pulses” energizing and deenergizing the valve, “A valve 30 which can be turned on and off in pulses is disposed in the piping 28 between reservoir 26 and humidifier 24. Pulsing valve 30 is controlled for limiting the amount of water delivered to humidifier 24 from reservoir 26.” Column 3, Lines 25-35) configured to direct a flow of water from the reservoir (26) through the conduit (28) and to the water absorbent material (50).
As to Claim 38, McComb discloses capillary channels (defined by the series of 54 within 50 which draw the water therethrough, “From this contact region, blotting paper 50 wicks the water to the entire sleeve 52 and to the discs 54 permitting all of the blotting paper to become substantially saturated with water. As respiratory gas flows through the discs 54 and adjacent the sleeve 52, the gas picks up moisture or is humidified.” Column 5, Lines 1-25).
Claims 21, 23- 26, 28, 30, 31, 33-36, 41 and 42 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Milewicz (6,010,118).
As to Claim 21, Milewicz discloses a device (Figure 1) for humidifying a flow of air pressurized by a blower (3, “Now looking more closely at the drawings and in particular FIG. 1, it will be seen that gas can be supplied from a gas supply tank 1 by a gas supply tube 2 to supply controller or insufflator 3. The insufflator 3 has controllers to control gas flow rate and pressure and heating of the gas supply.” Column 3, Lines 25-45), the device comprising: a humidification chamber (10, “The humidification chamber 10 of the present invention is placed in the first gas supply tube 5 and includes a liquid entry port 11 at an exit end of the humidification chamber 10. The humidification chamber 10 will be discussed in more detail in relation to FIG. 2.” Column 3, Lines 40-55) having a first end (16, “Now looking at the humidification chamber shown in detail in FIG. 2 and FIG. 3, it will be seen that the humidification chamber comprises an elongate chamber defined by an outer wall 15 which extends from an inlet end 16 to an outlet end 17.” Column 3, Lines 50-65) configured to receive the flow of air from the blower (3) and a second end (17, “Now looking at the humidification chamber shown in detail in FIG. 2 and FIG. 3, it will be seen that the humidification chamber comprises an elongate chamber defined by an outer wall 15 which extends from an inlet end 16 to an outlet end 17.” Column 3, Lines 50-65) opposite the first end (16) configured to direct the flow of air to a patient interface (“suitable equipment such as a port”, “The second gas supply tube 12 extending beyond the humidification chamber extends to suitable equipment such as a port for enabling the heated and humidified gas to be supplied to a patient.” Column 3, Lines 40-55); a water absorbent material (23, “A layer of water absorbent and gas permeable gauze 23 is wound over the perforated metal tube core 21 and then a winding of wire 24 is wound around the layer of gauze 23.” Column 4, Lines 5-20) positioned inside of the humidification chamber (10) and shaped to substantially surround (best seen Figure 3) and at least partly form a path for the flow of air (via the passage of air from 16 to the lumen of 23 to 17) through the humidification chamber (10) such that the water absorbent material (23) is directly exposed (via the “perforated metal tube core 21”) to the flow of air flowing along the path; a heating element (24, “A layer of water absorbent and gas permeable gauze 23 is wound over the perforated metal tube core 21 and then a winding of wire 24 is wound around the layer of gauze 23. The electrical heating wire 24 is a continuation of the heating wire 7 as shown in FIG. 1.” Column 4, Lines 5-20) configured to heat the water absorbent material (23) to evaporate absorbed water into the flow of air (via the passage of air from 16 to the lumen of 23 to 17); and a reservoir (“a hypodermic needle” via 20, “A side port 20 is provided at the end 17 for the addition of water to the humidifier as required. The side port 20 has an elastomeric seal through which a hypodermic needle may be inserted to enable extra water to be added if required.” Column 3, Lines 50-70) positioned outside of the humidification chamber (10), the reservoir (“a hypodermic needle” via 20) configured to retain a water supply, the reservoir (“a hypodermic needle” via 20) being in fluid communication with the water absorbent material (23) to direct the water supply to the water absorbent material (23).
As to Claim 23, Milewicz discloses the heating element (24) is an electrical resistance heater (“The heating element may comprise a resistance heating wire which extends along the length of the gas supply tube from a gas supply and heater control box, through the chamber and continuing on in the tube to the outlet end.” Column 2, Lines 25-35; “The heating element may comprise a resistance heating wire which extends along the length of the first gas supply tube from the controller through the humidification chamber and continuing on in the second gas supply tube to the outlet end.” Column 2, Lines 55-65; “An electrical current is passed through the wire 7 and by resistance heating the gas in the tube 5 is heated.” Column 3, Lines 25-45).
As to Claim 24, Milewicz discloses the heating element (24) is positioned on an opposite side (more external, as shown in Figure 3) of the water absorbent material (23) from the flow of air (via the passage of air from 16 to the lumen of 23 to 17 – as located interior as shown in Figure 3).
As to Claim 25, Milewicz discloses a housing (34, “Around the elongate humidification chamber is an insulation layer 35 to prevent loss of heat from the humidification chamber. The insulation layer 35 is held in place by a shrink-wrap sleeve 34 over the insulation layer. The insulation layer is preferably a continuous band of a foil-backed, felted fabric wound around the chamber so that there are at least three layers.” Column 3, Line 65 thru Column 4, Line 5) that at least partly forms the humidification chamber (10).
As to Claim 26, Milewicz discloses the heating element (24) is positioned inside the housing (34).
As to Claim 28, Milewicz discloses the reservoir (“a hypodermic needle” via 20) is positioned outside of the housing (34).
As to Claim 30, Milewicz discloses the water absorbent material (23) is tubular in shape (best seen Figure 3).
As to Claim 31, Milewicz discloses the water absorbent material (23) is a hydrophilic fiber (“The gas permeable gauze is preferably a high absorbency cotton swab wound onto the core 21 to give a radial thickness of gauze of approximately 5 mm.” Column 4, Lines 15-25).
As to Claim 33, Milewicz discloses the water absorbent material (23) is porous (“a high absorbency cotton” Column 4, Lines 15-25, to permit the absorbency of water).
As to Claim 34, Milewicz discloses the water absorbent material (23) consists of a single piece (“A layer”, “A layer of water absorbent and gas permeable gauze 23 is wound over the perforated metal tube core 21 and then a winding of wire 24 is wound around the layer of gauze 23.” Column 4, Lines 5-20) of the water absorbent material (23).
As to Claim 35, Milewicz discloses a conduit (20, “A side port 20 is provided at the end 17 for the addition of water to the humidifier as required. The side port 20 has an elastomeric seal through which a hypodermic needle may be inserted to enable extra water to be added if required.” Column 3, Lines 50-70) fluidly connecting the reservoir (“a hypodermic needle” via 20) to the water absorbent material (23).
As to Claim 36, Milewicz discloses a valve (“an elastomeric seal” Column 3, Lines 50-70) configured to control a flow of water through the conduit (20).
As to Claim 41, Milewicz discloses a frame (21, “A perforated metal tube core 21 extends from the inlet baffle 30 to the outlet baffle 32 and is supported on projections on the respective baffles. The aperture 31 allows gas to pass through the inlet baffle into the tube core 21. A layer of water absorbent and gas permeable gauze 23 is wound over the perforated metal tube core 21 and then a winding of wire 24 is wound around the layer of gauze 23.” Column 4, Lines 5-20) positioned in the path for the flow of air (via the passage of air from 16 to the lumen of 23 to 17) through the humidification chamber (10) and configured to support the water absorbent material (23), and the frame (21) being shaped and dimensioned to span the diameter (best seen Figure 3) of the path for the flow of air through the humidification chamber (10).
As to Claim 42, Milewicz discloses a frame (21) comprises a baffle (via 30/32 as extending from 21, “The internal construction of this embodiment of the humidifier comprises an inlet baffle 30 with an aperture 31. The inlet baffle 30 fits tightly against the outer wall 15 to prevent gas flow around the outside of the inlet baffle. An outlet baffle 32 does not fit tightly against the wall 15 so that gas can flow past the outlet baffle 32. A perforated metal tube core 21 extends from the inlet baffle 30 to the outlet baffle 32 and is supported on projections on the respective baffles. The aperture 31 allows gas to pass through the inlet baffle into the tube core 21.” Column 4, Lines 5-20), the baffle (via 30/32 as extending from 21) comprising one or more baffle elements (30/32), each one of the one or more baffle elements (30/32) to lengthen the path for the flow air through the humidification chamber (10).
Claims 21, 23-26, 28, 30, and 33-35 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Sata (2012/0012108).
As to Claim 21, Sata ‘108 discloses a device (Figure 2) for humidifying a flow of air pressurized by a blower (22, “The artificial airway 2 with a configuration as described above has, as shown in FIG. 2, one end connected to an inspiratory gas supply source 22 configuring a breathing circuit 20, and a predetermined flow rate of an inspiratory gas flows in the aeration region 12 of the artificial airway 2 to be supplied to a user.” Para 0058; “The breathing circuit 20 of the present embodiment is provided mainly with the artificial airway 2, the inspiratory gas supply source 22 connected to the artificial airway 2, the water supply means 30 to supply water to the water retention region 10 of the artificial airway 2, measurement means 40 and 42, and control means 28.” Para 0101; “By the breathing circuit 20 with a configuration as mentioned above, the inspiratory gas supplied from the inspiratory gas supply source 22 is supplied to a user through the artificial airway 2 and the expiratory gas of the user is discharged to the atmosphere through an expiratory tube 32.” Para 0103), the device comprising: a humidification chamber (2, best seen Figure 4A, “An artificial airway 2 is provided with a tubular outer shell 4 having air tightness and water tightness, a moisture permeable and water resistant film 6 having moisture permeability and water resistance disposed on the entire circumference of the internal surface of the outer shell 4, and a heater 8 disposed outside the outer shell 4.” Para 0055) having a first end (the end of 2 proximate 22) configured to receive the flow of air from the blower (22) and a second end (the end of 2 proximate 42) opposite the first end (the end of 2 proximate 22) configured to direct the flow of air to the patient interface (“Normally, an artificial nose has one end in communication with an inspiratory tube (equivalent to the artificial airway 2 shown in FIGS. 1(a) and 1(b)) and with an expiratory tube via a Y shaped connector and has the other end used by being connected to an intratracheal tube of the user. This intratracheal tube is inserted to a patient from the nose (in a case of nasal intubation), the mouth (in a case of oral intubation), or the trachea (in a case of tracheal intubation).” Para 0137); a water absorbent material (10, “Thus, a water retention region 10 is formed between the internal surface of the outer shell 4 and an outer surface of the moisture permeable and water resistant film 6, and an aeration region 12 is formed on the internal surface side of the moisture permeable and water resistant film 6. That is, the water retention region 10 and the aeration region 12 are partitioned by the moisture permeable and water resistant film 6.” Para 0055, “As shown in FIG. 1(a), water supplied from a water container 24 is led into the water retention region 10 from a feed water inlet 14 through a water supply tube 16. In this case, at the feed water inlet 14, water is supplied to the water retention region 10 with a static pressure of a head of water H. The outer shell 4 has air tightness and water tightness, and the moisture permeable and water resistant film 6 has moisture permeability and water resistance which is permeable to a gas, like water vapor, but not permeable to water, which is a liquid, so that the water supplied from the feed water inlet 14 is retained in the water retention region 10 formed between the outer shell 4 and the moisture permeable and water resistant film 6.” Para 0056) positioned inside the humidification chamber (2) and shaped to substantially surround (best seen Figure 4B) and at least partly form a path for the flow of air (defined by the entrance of air via the end of 2 along 12 to the opposite end of 2) through the humidification chamber (2) such that the water absorbent material (10) is directly exposed (via 6, which permits the passage of water vapor) to the flow of air along the path; a heating element (8, “An artificial airway 2 is provided with a tubular outer shell 4 having air tightness and water tightness, a moisture permeable and water resistant film 6 having moisture permeability and water resistance disposed on the entire circumference of the internal surface of the outer shell 4, and a heater 8 disposed outside the outer shell 4.” Para 0055) configured to heat the water absorbent material (10) to evaporate absorbed water into the flow of air; and a reservoir (24, “As shown in FIG. 1(a), water supplied from a water container 24 is led into the water retention region 10 from a feed water inlet 14 through a water supply tube 16. In this case, at the feed water inlet 14, water is supplied to the water retention region 10 with a static pressure of a head of water H.” Para 0056) positioned outside of the humidification chamber (2), the reservoir (24) configured to retain a water supply, and the reservoir (24) being in fluid communication (via 16) with the water absorbent material (10) to direct the water supply to the water absorbent material (10).
As to Claim 23, Sata ‘108 discloses the heating element (8) is an electrical resistance heater (“The heater 8 of the present embodiment is a resistive heating linear heater (so-called ribbon heater) and is wound helically on an outer surface of the outer shell 4 in the entire region where the water retention region 10 is formed.” Para 0057).
As to Claim 24, Sata ‘108 discloses the heating element (8) is positioned on an opposite side (external as best seen in Figure 4B) of the water absorbent material (10) from the flow of air (defined by the entrance of air via the end of 2 along 12 to the opposite end of 2 – as located interior as shown in Figure 4B).
As to Claim 25, Sata ‘108 discloses a housing (4, “An artificial airway 2 is provided with a tubular outer shell 4 having air tightness and water tightness, a moisture permeable and water resistant film 6 having moisture permeability and water resistance disposed on the entire circumference of the internal surface of the outer shell 4, and a heater 8 disposed outside the outer shell 4.” Para 0055) that at least partly forms the humidification chamber (2).
As to Claim 26, Sata ‘108 discloses the heating element (8) is positioned inside (best seen Figure 4B) of the housing (4).
As to Claim 28, Sata ‘108 discloses the reservoir (24) is positioned outside (best seen Figure 2) of the housing (4).
As to Claim 30, Sata ‘108 discloses the water absorbent material (10) is tubular in shape (Figure 4B, the exterior shape as abutting the housing 4 is circular and thus has a tube shape).
As to Claim 33, Sata ‘108 discloses an inner surface (6, “a moisture permeable and water resistant film 6” Para 0055) of the water absorbent material (10) is porous (to permit the passage of water vapor).
As to Claim 34, Sata ‘108 discloses the water absorbent material (10) consists of a single piece (best seen Figure 4B) of water absorbent material (10).
As to Claim 35, Sata ‘108 discloses a conduit (16, “As shown in FIG. 1(a), water supplied from a water container 24 is led into the water retention region 10 from a feed water inlet 14 through a water supply tube 16.” Para 0056; “The water stored in the water container 24 is led into the water retention region 10 from the feed water inlet 14 through the water supply tube 16.” Para 0074; “The feed water inlet 14 to supply water to the water retention region 10 can be formed by making a hole, in the outer shell 4, having a diameter approximately identical to an outer diameter of that of the water supply tube 16, by inserting the water supply tube 16 into this hole, and by seal bonding the outer circumference of the water supply tube 16 and the outer shell 4 using an adhesive. For the water supply tube 16, a resin material same as that of the outer shell 4 can be used and any other resin material can also be used.” Para 0097; “The water supply means 30 is provided with the water container 24 and a dropping chamber 26 having an upper portion in communication with the water container 24 and a lower portion in communication with the water supply tube 16. The upper portion of the dropping chamber 26 is provided with a pipe 26a in communication with the water container 24 and the water in the water container 24 is dropped from this pipe 26a and thus the water can be supplied to the water supply tube 16 connected to the water retention region 10 of the artificial airway 2. As already described using FIGS. 1(a) and 1(b), the water supplied to the water supply tube 16 is supplied to the water retention region 10 through the feed water inlet 14.” Para 0105; “For the water supply tube 16 from the water container 24 to the artificial airway 2, it is preferred to use, for example, a thin tube like one used for transfusion.” Para 0108; “As described above, the level fluctuation of the water surface in the dropping chamber 26 is extremely small compared to the difference H in height with the artificial airway 2 and there is also the flow resistance of the water supply tube 16, so that the water supply means 30 can supply water to the water retention region 10 of the artificial airway 2 at a basically constant static pressure (head of water H).” Para 0111; “The outer shell 4 is also provided with the feed water inlet 16 to supply water to the water retention region 10.” Para 0139; “Outside the outer shell 4, a heater 8 is disposed (not shown) and the water stored in the water container 24 is led into the water retention region 10 from the feed water inlet 14 through the water supply tube 16.” Para 0145; “Outside the outer shell 4, a heater 8 is disposed (not shown), and water stored in the water container 24 is led into the water retention region 10 from the feed water inlet 14 through the water supply tube 16.” Para 0151) fluidly connecting the reservoir (24) to the water absorbent material (10).
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 22 is rejected under 35 U.S.C. 103 as being unpatentable over McComb (5,349,946) in view of Fuller et al. (2008/0160500).
As to Claim 22, McComb discloses the heating element (45); yet, does not expressly disclose the configuration of the “the heating element comprises carbon ink printed on the water-absorbent material”.
Fuller teaches a medical device for heating a fluid, wherein the medical device includes a heating element (42) to impart heat to the fluid. Specifically, Fuller teaches “The heating element 42 may comprise a resistive coil which generates heat when a current is passed therethrough. The heating element may comprise a ceramic plate with resistive carbon ink printed on top. Such a heating element may have a resistance of 18 ohms. The heating element 42 may alternatively comprise a Peltier device. The Peltier device functions as a heat pump and is preferably connected to a heat sink.” (Para 0136).
In light of the teachings of Fuller, the construction of a heating element with “carbon ink printed” is a known method of imparting resistive heating to generate heat to the fluid.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the heating element of McComb to include the use of a “carbon ink printed on the water absorbent material” as taught by Fuller to impart resistive heating to generate heat to the fluid.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Milewicz (6,010,118) in view of Fuller et al. (2008/0160500).
As to Claim 22, Milewicz discloses the heating element (24); yet, does not expressly disclose the configuration of the “the heating element comprises carbon ink printed on the water-absorbent material”.
Fuller teaches a medical device for heating a fluid, wherein the medical device includes a heating element (42) to impart heat to the fluid. Specifically, Fuller teaches “The heating element 42 may comprise a resistive coil which generates heat when a current is passed therethrough. The heating element may comprise a ceramic plate with resistive carbon ink printed on top. Such a heating element may have a resistance of 18 ohms. The heating element 42 may alternatively comprise a Peltier device. The Peltier device functions as a heat pump and is preferably connected to a heat sink.” (Para 0136).
In light of the teachings of Fuller, the construction of a heating element with “carbon ink printed” is a known method of imparting resistive heating to generate heat to the fluid.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the heating element of Milewicz to include the use of a “carbon ink printed on the water absorbent material” as taught by Fuller to impart resistive heating to generate heat to the fluid.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Sata (2012/0012108) in view of Fuller et al. (2008/0160500).
As to Claim 22, Sata ‘108 discloses the heating element (8); yet, does not expressly disclose the configuration of the “the heating element comprises carbon ink printed on the water-absorbent material”.
Fuller teaches a medical device for heating a fluid, wherein the medical device includes a heating element (42) to impart heat to the fluid. Specifically, Fuller teaches “The heating element 42 may comprise a resistive coil which generates heat when a current is passed therethrough. The heating element may comprise a ceramic plate with resistive carbon ink printed on top. Such a heating element may have a resistance of 18 ohms. The heating element 42 may alternatively comprise a Peltier device. The Peltier device functions as a heat pump and is preferably connected to a heat sink.” (Para 0136).
In light of the teachings of Fuller, the construction of a heating element with “carbon ink printed” is a known method of imparting resistive heating to generate heat to the fluid.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the heating element of Sata ‘108 to include the use of a “carbon ink printed on the water absorbent material” as taught by Fuller to impart resistive heating to generate heat to the fluid.
Claims 23 is rejected under 35 U.S.C. 103 as being unpatentable over McComb (5,349,946) in view of Anthony (2006/0012057).
As to Claim 23, McComb discloses the heating element (45); yet, does not expressly disclose the heating element is an electrical resistance heater.
Anthony discloses a device (Figure 3) for humidifying a flow of air (via 13, “In another embodiment shown on FIG. 3, said device comprises a housing 1 having a bottom 2, and a cover 4, wherein said housing 1 is provided with an inlet opening 5 for the supply of medical gas as illustrated with arrow 13, and an outlet opening 6 for the treated medical gas as illustrated with arrow 14, further comprising conditioning means for the humidification and warming of said gas.” Para 0033), the device (Figure 3) comprising: a humidification chamber (1, “In another embodiment shown on FIG. 3, said device comprises a housing 1 having a bottom 2, and a cover 4, wherein said housing 1 is provided with an inlet opening 5 for the supply of medical gas as illustrated with arrow 13, and an outlet opening 6 for the treated medical gas as illustrated with arrow 14, further comprising conditioning means for the humidification and warming of said gas.” Para 0033) having a first end (5, “In another embodiment shown on FIG. 3, said device comprises a housing 1 having a bottom 2, and a cover 4, wherein said housing 1 is provided with an inlet opening 5 for the supply of medical gas as illustrated with arrow 13, and an outlet opening 6 for the treated medical gas as illustrated with arrow 14, further comprising conditioning means for the humidification and warming of said gas.” Para 0033) configured to receive the flow of air and a second end (6, “In another embodiment shown on FIG. 3, said device comprises a housing 1 having a bottom 2, and a cover 4, wherein said housing 1 is provided with an inlet opening 5 for the supply of medical gas as illustrated with arrow 13, and an outlet opening 6 for the treated medical gas as illustrated with arrow 14, further comprising conditioning means for the humidification and warming of said gas.” Para 0033) opposite the first end (5) configured to direct the flow of air to a patient interface (via “delivered via nose or mouth to the lungs”, e.g. “However, when a patient is undergoing artificial respiration the nose is shunted by a flexible tube, whose distal end is inserted into the trachea.” Para 0002, and “According to an embodiment, the inlet 5 and outlet 6 have connection pipes, illustrated respectively as 5a and 6a on FIGS. 2 and 4, planned for attaching a tube. … The connecting pipe 6a on the outlet can be connected to tube, which supplies gas to a patient.” Para 0040, also see: “It also relates to any gas to be delivered to body cavities or organs of an individual in need thereof, such as for example such as normal air to be delivered via nose or mouth to the lungs, or O.sub.2/CO.sub.2 gas mixtures to be provided during laparoscopic surgery.” Para 0028); a water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3, “The space between the heating device and the rigid evaporating body may also be larger than 0.1 cm, and may be in such case further provided therein with a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like. For example, the space between the heating device and the rigid evaporating body may be provided with a second rigid evaporating body with water absorbing properties. The thin layer of water would be inserted in said second water absorbing properties.” Para 0011, wherein 7 – “a rigid evaporating body 7 arranged in said housing 1 between said inlet 5 and outlet 6, a heating device 8, and a water inlet 9, characterized in that said rigid evaporating body 7 and said heating device 8 are arranged in a concentric way forming a space 11 between them and wherein said water inlet 9 is connected to the housing such that a thin layer of water is able to be inserted between the heating device 8 and the rigid evaporating body 7. As illustrated FIG. 3, said rigid evaporating body 7 is surrounded by said heating device 8 in a concentric way forming a space 11 between them.” Para 0033 and wherein 8 – “a rigid evaporating body 7 arranged in said housing 1 between said inlet 5 and outlet 6, a heating device 8, and a water inlet 9, characterized in that said rigid evaporating body 7 and said heating device 8 are arranged in a concentric way forming a space 11 between them and wherein said water inlet 9 is connected to the housing such that a thin layer of water is able to be inserted between the heating device 8 and the rigid evaporating body 7. As illustrated FIG. 3, said rigid evaporating body 7 is surrounded by said heating device 8 in a concentric way forming a space 11 between them.” Para 0033) positioned inside of the humidification chamber (1) and shaped to substantially surround a path for the flow of air (via 13) through the humidification chamber (1); a heating element (8, “a rigid evaporating body 7 arranged in said housing 1 between said inlet 5 and outlet 6, a heating device 8, and a water inlet 9, characterized in that said rigid evaporating body 7 and said heating device 8 are arranged in a concentric way forming a space 11 between them and wherein said water inlet 9 is connected to the housing such that a thin layer of water is able to be inserted between the heating device 8 and the rigid evaporating body 7. As illustrated FIG. 3, said rigid evaporating body 7 is surrounded by said heating device 8 in a concentric way forming a space 11 between them.” Para 0033) configured to heat the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3) to evaporate (via 7 - “a rigid evaporating body 7” Para 0033) absorbed water into the flow of air (via 13); and a reservoir (“a water reservoir” via 9, “The water inlet 9 is connected to said space 11. The water to be supplied is preferably held in a water reservoir that is connected to said inlet 9. Said water reaches the interior of the space 11 via the water supply inlet 9.” Para 0044; also see: “a water inlet 9, characterized in that said rigid evaporating body 7 and said heating device 8 are arranged in a concentric way forming a space 11 between them and wherein said water inlet 9 is connected to the housing such that a thin layer of water is able to be inserted between the heating device 8 and the rigid evaporating body 7.” Para 0033) positioned outside of the humidification chamber (1), the reservoir (“a water reservoir” via 9) configured to retain a water supply (“The water to be supplied is preferably held in a water reservoir that is connected to said inlet 9.” Para 0044), and the reservoir (“a water reservoir” via 9) being in fluid communication with the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3) to direct the water supply (“water to be supplied” Para 0044) to the water absorbent material (“a water absorbing product such as blotting paper, sponge, ceramic, synthetic water absorbing material and the like” oriented between 7 and 8 as shown in Figure 3).
Regarding the remaining limitations of the claims, Anthony discloses the heating element (8) is an electrical resistance heater (“Said heating device 8 can be a self-adjusting resistance of the PTC-type. It can comprise a heating component 10, which may be cylindrical as shown FIG. 3, which surround a metallic element cylinder, such as an anodized aluminum cylinder.” Para 0033).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the heating element of McComb to be a resistance heater as taught by Anthony to permit self adjusting.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over McComb (5,349,946) in view of Gradon et al. (2002/0005201).
As to Claim 39, McComb discloses a device (Figure 1) for humidifying a flow of air pressurized by a blower (16, “The ventilator circuit 14 includes a ventilator 16 which delivers breathable dry gas at a temperature approximately equal to body temperature or about 37.degree. C. An inspiratory limb or inhalation tubing 18 connects the ventilator 16 to the mouth of a patient 12 through a suitable mask or other adapter and allows the gas from the ventilator to flow to the patient's mouth.” Column 3, Lines 5-25), the device (Figure 1) comprising: a humidification chamber (24, defined by the engagement of both 48 and 58 to form 24, wherein 48 – “Humidifier 24 comprises an outer housing 48 which is preferably constructed from plastic.” Column 4, Lines 25-50 and wherein 58 – “A threaded removable end cap 58 is provided on the inlet side of humidifier 24 providing access to the inside of humidifier 24. The bat of blotting paper 50 is easily removed from humidifier 24 and replaced by simply unscrewing cap 58 and slipping the sleeve 52 out of the housing 48.” Column 4, Lines 50-65) having a first end (18A of 58, “As indicated in FIG. 2, tubing 18A which is connected to ventilator 16 is coupled to humidifier 24.” Column 4, Lines 50-65) configured to receive the flow of air from the blower (16) and a second end (18B of 48, “Tubing 18B which is connected to provide breathable gas to the patient is coupled into the opposite (outlet) end of humidifier 24.” Column 4, Lines 50-65) opposite the first end (18A of 58) configured to direct the flow of air to a patient interface (“a suitable mask or other adapter”, “An inspiratory limb or inhalation tubing 18 connects the ventilator 16 to the mouth of a patient 12 through a suitable mask or other adapter and allows the gas from the ventilator to flow to the patient's mouth.” Column 3, Lines 5-25); a water-absorbent material (50, “A bat of blotting paper 50 or similar water absorbing material is disposed inside of housing 48. The bat 50 comprises an outer layer or sleeve of blotting paper 52. … Bat 50 is also comprised of circular discs of blotting paper 54 layered inside of and on a plane perpendicular to outer layer 52.” Column 4, Lines 25-50; also see: “From this contact region, blotting paper 50 wicks the water to the entire sleeve 52 and to the discs 54 permitting all of the blotting paper to become substantially saturated with water.” Column 5, Lines 1-25; and “As a result, the gas flowing through humidifier 24 only comes in contract with the substantially saturated blotting paper 50 which is unlike conventional humidifiers that allow gas to come in contact with a pool of water in a reservoir. Therefore, in the present invention, the humidifier delivers only molecular humidity which is substantially free of water droplets or water vapor because the gas does not come in contact with a pool of water. The desired humidity level is still reached because the appropriate amount of water is delivered to the substantially saturated blotting paper 50 via microprocessor control. Because substantially all of the water delivered to the humidifier is converted into molecular humidity, an increase in the rate at which the water is delivered directly increases the humidity of the gas.” Column 5, Lines 20-50) positioned inside of the humidification chamber (24) and shaped to substantially surround (best seen Figures 2 and 3) and at least partly form a path for the flow of air (via the passage of air from 18A through 56 to 18B, wherein 56 – “As indicated in FIG. 3, circular blotting paper rings 54 include holes 56 to allow gas to more freely flow through the humidifier.” Column 4, Lines 25-50) though the humidification chamber (24) such that the water absorbent material (50) is directly exposed (“As a result, the gas flowing through humidifier 24 only comes in contract with the substantially saturated blotting paper 50 which is unlike conventional humidifiers that allow gas to come in contact with a pool of water in a reservoir.” Column 5, Lines 20-50) to the flow of air flowing along the flow path (via the passage of air from 18A through 56 to 18B); a heating element (45, “Therefore, an optional heater 45 is added to humidification system 10 in a preferred embodiment of the present invention for heating humidifier 24 so that the temperature of the gas can be increased as the gas flows through the humidifier. Heater 45 can be turned on and off in response to a control signal from microprocessor 36 received via a line 47. The heater 45 provides added flexibility by allowing humidification system 10 to control both the relative humidity and the temperature of the gas being delivered to the patient.” Column 4, Lines 15-30) configured to heat the water absorbent material (50) to evaporate absorbed water into the flow of air; and a reservoir (26, “A reservoir 26 is filled with water and is separated from humidifier 24. Piping 28 connects reservoir 26 to humidifier 24 and carries water from the reservoir to the humidifier. Typically, water flows from reservoir 26 to humidifier 24 because the reservoir is pressurized. A valve 30 which can be turned on and off in pulses is disposed in the piping 28 between reservoir 26 and humidifier 24. Pulsing valve 30 is controlled for limiting the amount of water delivered to humidifier 24 from reservoir 26.” Column 3, Lines 25-40) positioned outside of the humidification chamber (24), the reservoir (26) configured to retain a water supply, and the reservoir (26) being in fluid communication (“As illustrated in FIG. 3, a contact region 66 indicates where water from reservoir 26 coming into housing 60 and through opening 61 actually makes contact with blotting paper 50.” Column 5, Lines 1-25) with the water absorbent material (50) to direct the water supply to the water absorbent material (50).
Yet, McComb does not expressly disclose the “blower configured to pressurize air above ambient pressure for breathing by the patient during therapy”, the patient interface in the form of “a seal-forming structure configured to contact and seal against the patient's face; a connection port configured to receive air pressurized by the blower; and a positioning and stabling structure comprising at least one strap and configured to hold the seal-forming structure in sealing contact with the patient's face during therapy”, nor “an air circuit connected to the blower and the device and configured to direct pressurized air from the blower to the device, wherein the device is fluidly connected to the connection port of the patient interface.”
Gradon teaches a humidification device (defined by the combination of 6, 7, and 8 as shown in Figure 3, “Humidification chamber 6 is preferably formed from a plastics material and may have a highly heat conductive base (for example an aluminium base) which is in direct contact with a heater plate 7 of humidifier 8.” Para 0030) having a blower (15, “Blower 15 is provided with variable pressure regulating means or variable speed fan 21 which draws air or other gases through blower inlet 17. The speed of variable speed fan 21 is controlled by electronic controller 18 (or alternatively the function of controller 18 could carried out by controller 9) in response to inputs from controller 9 and a user set predetermined required value (preset value) of pressure or fan speed via dial 19.” Para 0032) configured to provide pressurized air above ambient pressure for breathing by a patient during therapy (CPAP, Abstract), a patient interface (2, “With reference to FIG. 3 a humidified Continuous Positive Airway Pressure (CPAP) system is shown in which a patient 1 is receiving humidified and pressurised gases through a nasal mask 2 connected to a humidified gases transportation pathway or inspiratory conduit 3.” Para 0030; also see: “Referring to FIG. 4 the nasal mask, according to the preferred embodiment of the present invention, is shown in detail. The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3. The mask 2 is positioned around the nose of the user 1 with the headgear 108 secured around the back of the head of the patient 1. The restraining force from the headgear 108 on the hollow body 102 and the forehead rest 106 ensures enough compressive force on the mask cushion 104, to provide an effective seal against the patient's face.” Para 0033) in the form of a nasal mask having a seal forming structure (104, best seen Figure 4, “The restraining force from the headgear 108 on the hollow body 102 and the forehead rest 106 ensures enough compressive force on the mask cushion 104, to provide an effective seal against the patient's face.” Para 0033; and “To further ensure user comfort and effective pressure on the mask cushion 104, the headgear 108 may be constructed either using two straps running around the back of the user's head as shown in FIG. 4 or with a partial skull cap or any other configurations as are known in the art.” Para 0038) configured to contact and seal against the patient’s face; a connection port (103 via 3, best seen Figure 4, “The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3.” Para 0033) configured to receive air pressurized by the blower (15); and a positioning and stabilizing structure (106/108, best seen Figure 4, “The mask 2 is positioned around the nose of the user 1 with the headgear 108 secured around the back of the head of the patient 1. The restraining force from the headgear 108 on the hollow body 102 and the forehead rest 106 ensures enough compressive force on the mask cushion 104, to provide an effective seal against the patient's face.” Para 0033; also see: “Referring now to FIGS. 4 and 5 the headgear 108 is shown connected to the hollow body 102. Rather than traditional fixed or adjustable attachments the present invention utilises a sliding engagement between the headgear 108 and the hollow body 102. This is achieved with a loop 120, running through harnessing clips 122, 124 on either side of the headgear 108 and over the top of the hollow body 102. The loop 120 is reciprocally engaged with guides 126, 128 mounted on the top surface of the hollow body 102. The guides constrain the loop 120 but allow it to slide in and out, meaning the headgear 108 can move laterally, independently of the hollow body 102.” Para 0035; “To further ensure user comfort and effective pressure on the mask cushion 104, the headgear 108 may be constructed either using two straps running around the back of the user's head as shown in FIG. 4 or with a partial skull cap or any other configurations as are known in the art.” Para 0038) comprising at least one strap (“two straps” Para 0038) and configured to hold the seal forming structure (104) in sealing contact with the patient’s face during therapy; and an air circuit (defined by the conduit between 21 and 16, as shown in Figure 3, “As the volume of water 6 within humidification chamber 5 is heated, water vapour begins to fill the volume of the chamber above the water's surface and is passed out of the humidification chamber 5 outlet 4 with the flow of gases (for example air) provided from a gases supply means or blower 15 which enters the chamber through inlet 16. Exhaled gases from the patient's mouth are passed directly to ambient surroundings in FIG. 3.” Para 0031) connected to the blower (15) and the device (defined by the combination of 6, 7, and 8 as shown in Figure 3) and configured to direct pressurized air from the blower (15) to the device (defined by the combination of 6, 7, and 8 as shown in Figure 3), wherein the device (defined by the combination of 6, 7, and 8 as shown in Figure 3) is fluidly connected to the connection port (103 via 3) of the patient interface (2). Gradon teaches the functionality of the system (Figure 3) for treating a respiratory disorder (“This invention relates to nasal masks particularly though not solely for use in providing CPAP therapy to patients suffering from obstructive sleep apnoea (OSA).” Para 0001) of the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the humidifier device of the McComb, to be utilized with a blower suitable for imparting pressure above ambient pressure, a specific patient interface having a seal forming structure, connection port, and positioning and stabilizing structure, and the connection of an air circuit between the blower and the device so that the device is fluidly connected to the patient interface, as taught by Gradon to treat “patients suffering from obstructive sleep apnoea (OSA).” (Para 0001).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Milewicz (6,010,118) in view of Gradon et al. (2002/0005201).
As to Claim 39, Milewicz discloses a device (Figure 1) for humidifying a flow of air pressurized by a blower (3, “Now looking more closely at the drawings and in particular FIG. 1, it will be seen that gas can be supplied from a gas supply tank 1 by a gas supply tube 2 to supply controller or insufflator 3. The insufflator 3 has controllers to control gas flow rate and pressure and heating of the gas supply.” Column 3, Lines 25-45), the device comprising: a humidification chamber (10, “The humidification chamber 10 of the present invention is placed in the first gas supply tube 5 and includes a liquid entry port 11 at an exit end of the humidification chamber 10. The humidification chamber 10 will be discussed in more detail in relation to FIG. 2.” Column 3, Lines 40-55) having a first end (16, “Now looking at the humidification chamber shown in detail in FIG. 2 and FIG. 3, it will be seen that the humidification chamber comprises an elongate chamber defined by an outer wall 15 which extends from an inlet end 16 to an outlet end 17.” Column 3, Lines 50-65) configured to receive the flow of air from the blower (3) and a second end (17, “Now looking at the humidification chamber shown in detail in FIG. 2 and FIG. 3, it will be seen that the humidification chamber comprises an elongate chamber defined by an outer wall 15 which extends from an inlet end 16 to an outlet end 17.” Column 3, Lines 50-65) opposite the first end (16) configured to direct the flow of air to a patient interface (“suitable equipment such as a port”, “The second gas supply tube 12 extending beyond the humidification chamber extends to suitable equipment such as a port for enabling the heated and humidified gas to be supplied to a patient.” Column 3, Lines 40-55); a water absorbent material (23, “A layer of water absorbent and gas permeable gauze 23 is wound over the perforated metal tube core 21 and then a winding of wire 24 is wound around the layer of gauze 23.” Column 4, Lines 5-20) positioned inside of the humidification chamber (10) and shaped to substantially surround (best seen Figure 3) and at least partly form a path for the flow of air (via the passage of air from 16 to the lumen of 23 to 17) through the humidification chamber (10) such that the water absorbent material (23) is directly exposed (via the “perforated metal tube core 21”) to the flow of air flowing along the path; a heating element (24, “A layer of water absorbent and gas permeable gauze 23 is wound over the perforated metal tube core 21 and then a winding of wire 24 is wound around the layer of gauze 23. The electrical heating wire 24 is a continuation of the heating wire 7 as shown in FIG. 1.” Column 4, Lines 5-20) configured to heat the water absorbent material (23) to evaporate absorbed water into the flow of air (via the passage of air from 16 to the lumen of 23 to 17); and a reservoir (“a hypodermic needle” via 20, “A side port 20 is provided at the end 17 for the addition of water to the humidifier as required. The side port 20 has an elastomeric seal through which a hypodermic needle may be inserted to enable extra water to be added if required.” Column 3, Lines 50-70) positioned outside of the humidification chamber (10), the reservoir (“a hypodermic needle” via 20) configured to retain a water supply, the reservoir (“a hypodermic needle” via 20) being in fluid communication with the water absorbent material (23) to direct the water supply to the water absorbent material (23).
Yet, Milewicz does not expressly disclose the “blower configured to pressurize air above ambient pressure for breathing by the patient during therapy”, the patient interface in the form of “a seal-forming structure configured to contact and seal against the patient's face; a connection port configured to receive air pressurized by the blower; and a positioning and stabling structure comprising at least one strap and configured to hold the seal-forming structure in sealing contact with the patient's face during therapy”, nor “an air circuit connected to the blower and the device and configured to direct pressurized air from the blower to the device, wherein the device is fluidly connected to the connection port of the patient interface.”
Gradon teaches a humidification device (defined by the combination of 6, 7, and 8 as shown in Figure 3, “Humidification chamber 6 is preferably formed from a plastics material and may have a highly heat conductive base (for example an aluminium base) which is in direct contact with a heater plate 7 of humidifier 8.” Para 0030) having a blower (15, “Blower 15 is provided with variable pressure regulating means or variable speed fan 21 which draws air or other gases through blower inlet 17. The speed of variable speed fan 21 is controlled by electronic controller 18 (or alternatively the function of controller 18 could carried out by controller 9) in response to inputs from controller 9 and a user set predetermined required value (preset value) of pressure or fan speed via dial 19.” Para 0032) configured to provide pressurized air above ambient pressure for breathing by a patient during therapy (CPAP, Abstract), a patient interface (2, “With reference to FIG. 3 a humidified Continuous Positive Airway Pressure (CPAP) system is shown in which a patient 1 is receiving humidified and pressurised gases through a nasal mask 2 connected to a humidified gases transportation pathway or inspiratory conduit 3.” Para 0030; also see: “Referring to FIG. 4 the nasal mask, according to the preferred embodiment of the present invention, is shown in detail. The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3. The mask 2 is positioned around the nose of the user 1 with the headgear 108 secured around the back of the head of the patient 1. The restraining force from the headgear 108 on the hollow body 102 and the forehead rest 106 ensures enough compressive force on the mask cushion 104, to provide an effective seal against the patient's face.” Para 0033) in the form of a nasal mask having a seal forming structure (104, best seen Figure 4, “The restraining force from the headgear 108 on the hollow body 102 and the forehead rest 106 ensures enough compressive force on the mask cushion 104, to provide an effective seal against the patient's face.” Para 0033; and “To further ensure user comfort and effective pressure on the mask cushion 104, the headgear 108 may be constructed either using two straps running around the back of the user's head as shown in FIG. 4 or with a partial skull cap or any other configurations as are known in the art.” Para 0038) configured to contact and seal against the patient’s face; a connection port (103 via 3, best seen Figure 4, “The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3.” Para 0033) configured to receive air pressurized by the blower (15); and a positioning and stabilizing structure (106/108, best seen Figure 4, “The mask 2 is positioned around the nose of the user 1 with the headgear 108 secured around the back of the head of the patient 1. The restraining force from the headgear 108 on the hollow body 102 and the forehead rest 106 ensures enough compressive force on the mask cushion 104, to provide an effective seal against the patient's face.” Para 0033; also see: “Referring now to FIGS. 4 and 5 the headgear 108 is shown connected to the hollow body 102. Rather than traditional fixed or adjustable attachments the present invention utilises a sliding engagement between the headgear 108 and the hollow body 102. This is achieved with a loop 120, running through harnessing clips 122, 124 on either side of the headgear 108 and over the top of the hollow body 102. The loop 120 is reciprocally engaged with guides 126, 128 mounted on the top surface of the hollow body 102. The guides constrain the loop 120 but allow it to slide in and out, meaning the headgear 108 can move laterally, independently of the hollow body 102.” Para 0035; “To further ensure user comfort and effective pressure on the mask cushion 104, the headgear 108 may be constructed either using two straps running around the back of the user's head as shown in FIG. 4 or with a partial skull cap or any other configurations as are known in the art.” Para 0038) comprising at least one strap (“two straps” Para 0038) and configured to hold the seal forming structure (104) in sealing contact with the patient’s face during therapy; and an air circuit (defined by the conduit between 21 and 16, as shown in Figure 3, “As the volume of water 6 within humidification chamber 5 is heated, water vapour begins to fill the volume of the chamber above the water's surface and is passed out of the humidification chamber 5 outlet 4 with the flow of gases (for example air) provided from a gases supply means or blower 15 which enters the chamber through inlet 16. Exhaled gases from the patient's mouth are passed directly to ambient surroundings in FIG. 3.” Para 0031) connected to the blower (15) and the device (defined by the combination of 6, 7, and 8 as shown in Figure 3) and configured to direct pressurized air from the blower (15) to the device (defined by the combination of 6, 7, and 8 as shown in Figure 3), wherein the device (defined by the combination of 6, 7, and 8 as shown in Figure 3) is fluidly connected to the connection port (103 via 3) of the patient interface (2). Gradon teaches the functionality of the system (Figure 3) for treating a respiratory disorder (“This invention relates to nasal masks particularly though not solely for use in providing CPAP therapy to patients suffering from obstructive sleep apnoea (OSA).” Para 0001) of the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the humidifier device of the Milewicz, to be utilized with a blower suitable for imparting pressure above ambient pressure, a specific patient interface having a seal forming structure, connection port, and positioning and stabilizing structure, and the connection of an air circuit between the blower and the device so that the device is fluidly connected to the patient interface, as taught by Gradon to treat “patients suffering from obstructive sleep apnoea (OSA).” (Para 0001).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Sata (2012/0012108) in view of Gradon et al. (2002/0005201).
As to Claim 39, Sata ‘108 discloses a device (Figure 2) for humidifying a flow of air pressurized by a blower (22, “The artificial airway 2 with a configuration as described above has, as shown in FIG. 2, one end connected to an inspiratory gas supply source 22 configuring a breathing circuit 20, and a predetermined flow rate of an inspiratory gas flows in the aeration region 12 of the artificial airway 2 to be supplied to a user.” Para 0058; “The breathing circuit 20 of the present embodiment is provided mainly with the artificial airway 2, the inspiratory gas supply source 22 connected to the artificial airway 2, the water supply means 30 to supply water to the water retention region 10 of the artificial airway 2, measurement means 40 and 42, and control means 28.” Para 0101; “By the breathing circuit 20 with a configuration as mentioned above, the inspiratory gas supplied from the inspiratory gas supply source 22 is supplied to a user through the artificial airway 2 and the expiratory gas of the user is discharged to the atmosphere through an expiratory tube 32.” Para 0103), the device comprising: a humidification chamber (2, best seen Figure 4A, “An artificial airway 2 is provided with a tubular outer shell 4 having air tightness and water tightness, a moisture permeable and water resistant film 6 having moisture permeability and water resistance disposed on the entire circumference of the internal surface of the outer shell 4, and a heater 8 disposed outside the outer shell 4.” Para 0055) having a first end (the end of 2 proximate 22) configured to receive the flow of air from the blower (22) and a second end (the end of 2 proximate 42) opposite the first end (the end of 2 proximate 22) configured to direct the flow of air to the patient interface (“Normally, an artificial nose has one end in communication with an inspiratory tube (equivalent to the artificial airway 2 shown in FIGS. 1(a) and 1(b)) and with an expiratory tube via a Y shaped connector and has the other end used by being connected to an intratracheal tube of the user. This intratracheal tube is inserted to a patient from the nose (in a case of nasal intubation), the mouth (in a case of oral intubation), or the trachea (in a case of tracheal intubation).” Para 0137); a water absorbent material (10, “Thus, a water retention region 10 is formed between the internal surface of the outer shell 4 and an outer surface of the moisture permeable and water resistant film 6, and an aeration region 12 is formed on the internal surface side of the moisture permeable and water resistant film 6. That is, the water retention region 10 and the aeration region 12 are partitioned by the moisture permeable and water resistant film 6.” Para 0055, “As shown in FIG. 1(a), water supplied from a water container 24 is led into the water retention region 10 from a feed water inlet 14 through a water supply tube 16. In this case, at the feed water inlet 14, water is supplied to the water retention region 10 with a static pressure of a head of water H. The outer shell 4 has air tightness and water tightness, and the moisture permeable and water resistant film 6 has moisture permeability and water resistance which is permeable to a gas, like water vapor, but not permeable to water, which is a liquid, so that the water supplied from the feed water inlet 14 is retained in the water retention region 10 formed between the outer shell 4 and the moisture permeable and water resistant film 6.” Para 0056) positioned inside the humidification chamber (2) and shaped to substantially surround (best seen Figure 4B) and at least partly form a path for the flow of air (defined by the entrance of air via the end of 2 along 12 to the opposite end of 2) through the humidification chamber (2) such that the water absorbent material (10) is directly exposed (via 6, which permits the passage of water vapor) to the flow of air along the path; a heating element (8, “An artificial airway 2 is provided with a tubular outer shell 4 having air tightness and water tightness, a moisture permeable and water resistant film 6 having moisture permeability and water resistance disposed on the entire circumference of the internal surface of the outer shell 4, and a heater 8 disposed outside the outer shell 4.” Para 0055) configured to heat the water absorbent material (10) to evaporate absorbed water into the flow of air; and a reservoir (24, “As shown in FIG. 1(a), water supplied from a water container 24 is led into the water retention region 10 from a feed water inlet 14 through a water supply tube 16. In this case, at the feed water inlet 14, water is supplied to the water retention region 10 with a static pressure of a head of water H.” Para 0056) positioned outside of the humidification chamber (2), the reservoir (24) configured to retain a water supply, and the reservoir (24) being in fluid communication (via 16) with the water absorbent material (10) to direct the water supply to the water absorbent material (10).
Yet, Sata ‘108 does not expressly disclose the “blower configured to pressurize air above ambient pressure for breathing by the patient during therapy”, the patient interface in the form of “a seal-forming structure configured to contact and seal against the patient's face; a connection port configured to receive air pressurized by the blower; and a positioning and stabling structure comprising at least one strap and configured to hold the seal-forming structure in sealing contact with the patient's face during therapy”, nor “an air circuit connected to the blower and the device and configured to direct pressurized air from the blower to the device, wherein the device is fluidly connected to the connection port of the patient interface.”
Gradon teaches a humidification device (defined by the combination of 6, 7, and 8 as shown in Figure 3, “Humidification chamber 6 is preferably formed from a plastics material and may have a highly heat conductive base (for example an aluminium base) which is in direct contact with a heater plate 7 of humidifier 8.” Para 0030) having a blower (15, “Blower 15 is provided with variable pressure regulating means or variable speed fan 21 which draws air or other gases through blower inlet 17. The speed of variable speed fan 21 is controlled by electronic controller 18 (or alternatively the function of controller 18 could carried out by controller 9) in response to inputs from controller 9 and a user set predetermined required value (preset value) of pressure or fan speed via dial 19.” Para 0032) configured to provide pressurized air above ambient pressure for breathing by a patient during therapy (CPAP, Abstract), a patient interface (2, “With reference to FIG. 3 a humidified Continuous Positive Airway Pressure (CPAP) system is shown in which a patient 1 is receiving humidified and pressurised gases through a nasal mask 2 connected to a humidified gases transportation pathway or inspiratory conduit 3.” Para 0030; also see: “Referring to FIG. 4 the nasal mask, according to the preferred embodiment of the present invention, is shown in detail. The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3. The mask 2 is positioned around the nose of the user 1 with the headgear 108 secured around the back of the head of the patient 1. The restraining force from the headgear 108 on the hollow body 102 and the forehead rest 106 ensures enough compressive force on the mask cushion 104, to provide an effective seal against the patient's face.” Para 0033) in the form of a nasal mask having a seal forming structure (104, best seen Figure 4, “The restraining force from the headgear 108 on the hollow body 102 and the forehead rest 106 ensures enough compressive force on the mask cushion 104, to provide an effective seal against the patient's face.” Para 0033; and “To further ensure user comfort and effective pressure on the mask cushion 104, the headgear 108 may be constructed either using two straps running around the back of the user's head as shown in FIG. 4 or with a partial skull cap or any other configurations as are known in the art.” Para 0038) configured to contact and seal against the patient’s face; a connection port (103 via 3, best seen Figure 4, “The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3.” Para 0033) configured to receive air pressurized by the blower (15); and a positioning and stabilizing structure (106/108, best seen Figure 4, “The mask 2 is positioned around the nose of the user 1 with the headgear 108 secured around the back of the head of the patient 1. The restraining force from the headgear 108 on the hollow body 102 and the forehead rest 106 ensures enough compressive force on the mask cushion 104, to provide an effective seal against the patient's face.” Para 0033; also see: “Referring now to FIGS. 4 and 5 the headgear 108 is shown connected to the hollow body 102. Rather than traditional fixed or adjustable attachments the present invention utilises a sliding engagement between the headgear 108 and the hollow body 102. This is achieved with a loop 120, running through harnessing clips 122, 124 on either side of the headgear 108 and over the top of the hollow body 102. The loop 120 is reciprocally engaged with guides 126, 128 mounted on the top surface of the hollow body 102. The guides constrain the loop 120 but allow it to slide in and out, meaning the headgear 108 can move laterally, independently of the hollow body 102.” Para 0035; “To further ensure user comfort and effective pressure on the mask cushion 104, the headgear 108 may be constructed either using two straps running around the back of the user's head as shown in FIG. 4 or with a partial skull cap or any other configurations as are known in the art.” Para 0038) comprising at least one strap (“two straps” Para 0038) and configured to hold the seal forming structure (104) in sealing contact with the patient’s face during therapy; and an air circuit (defined by the conduit between 21 and 16, as shown in Figure 3, “As the volume of water 6 within humidification chamber 5 is heated, water vapour begins to fill the volume of the chamber above the water's surface and is passed out of the humidification chamber 5 outlet 4 with the flow of gases (for example air) provided from a gases supply means or blower 15 which enters the chamber through inlet 16. Exhaled gases from the patient's mouth are passed directly to ambient surroundings in FIG. 3.” Para 0031) connected to the blower (15) and the device (defined by the combination of 6, 7, and 8 as shown in Figure 3) and configured to direct pressurized air from the blower (15) to the device (defined by the combination of 6, 7, and 8 as shown in Figure 3), wherein the device (defined by the combination of 6, 7, and 8 as shown in Figure 3) is fluidly connected to the connection port (103 via 3) of the patient interface (2). Gradon teaches the functionality of the system (Figure 3) for treating a respiratory disorder (“This invention relates to nasal masks particularly though not solely for use in providing CPAP therapy to patients suffering from obstructive sleep apnoea (OSA).” Para 0001) of the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the humidifier device of the Sata ‘108, to be utilized with a blower suitable for imparting pressure above ambient pressure, a specific patient interface having a seal forming structure, connection port, and positioning and stabilizing structure, and the connection of an air circuit between the blower and the device so that the device is fluidly connected to the patient interface, as taught by Gradon to treat “patients suffering from obstructive sleep apnoea (OSA).” (Para 0001).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21, 23, 25, 27, 29-33, 35, 38, 40, and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, 10, 12, and 18 of U.S. Patent No. 10,518,061.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant independent claim, Claim 21, is merely broader than the patent claim, Claim 1. It is clear all of the elements of the instant claims are found in the patent claims. The difference lies in the fact that the patent claims include many more elements and are thus much more specific. Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the instant claims. It has been held that the “generic” invention is “anticipated” by the “species”. In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Instant Claims – 18484554
Differences Underlined
Similarities Italicized
Patent Claims – 10,518,061
Differences Underlined
Similarities Italicized
21. (New) A device for humidifying a flow of air pressurized by a blower, the device comprising:
a humidification chamber having
a first end configured to receive the flow of air from the blower and
a second end opposite the first end configured to direct the flow of air to a patient interface;
a water-absorbent material positioned inside of the humidification chamber and shaped to substantially surround and at least partly form a path for the flow of air through the humidification chamber such that the water absorbent material is directly exposed to the flow of air flowing along the path;
a heating element configured to heat the water-absorbent material to evaporate absorbed water into the flow of air; and a reservoir positioned outside of the humidification chamber, the reservoir configured to retain a water supply, and the reservoir being in fluid communication with the water-absorbent material to direct the water supply to the water-absorbent material.
1. A humidifier for increasing absolute humidity of a flow of air to be delivered to a patient's airways by a respiratory therapy device, the humidifier comprising: a humidifier housing forming
a humidification chamber, the humidifier housing comprising:
an air inlet configured to receive the flow of air from a pressure device;
an air outlet configured to deliver the flow of air to a patient interface from the humidifier with added humidity; and a flow path for the flow of air from the air inlet, through the humidification chamber, and to the air outlet;
a reservoir configured to retain a first volume of water; a humidifier wick positioned within the humidification chamber and configured to retain a second volume of water, and the humidifier wick having a profiled shape to substantially enclose, in a radial direction, at least a portion of the flow path; a delivery mechanism configured to deliver a flow of water from the reservoir to the humidifier wick;
a heating element positioned in thermal communication with the humidifier wick to heat the humidifier wick to vaporise the second volume of water to add absolute humidity to the flow of air; an air flow baffle configured to lengthen at least a portion of the flow path through the humidification chamber; and a wick frame positioned within the portion of the flow path enclosed by the humidifier wick and in contact with the humidifier wick to maintain thermal communication between the humidifier wick and the heating element to promote heat transfer from the heating element to the humidifier wick; wherein the humidifier wick is removable from the humidification chamber, and wherein the humidifier wick is anisotropically constructed such that the humidifier wick has a rate of wicking that is greater in a first direction than in a second direction.
22. (New) The device of claim 21, wherein the heating element comprises carbon ink printed on the water-absorbent material.
23. (New) The device of claim 21, wherein the heating element is an electrical resistance heater.
10. The humidifier as claimed in claim 1, wherein the heating element comprises a resistive electrical track disposed on a circuit board.
24. (New) The device of claim 21, wherein the heating element is positioned on an opposite side of the water-absorbent material from the flow of air.
25. (New) The device of claim 21, further comprising a housing that at least partly forms the humidification chamber.
1. A humidifier for increasing absolute humidity of a flow of air to be delivered to a patient's airways by a respiratory therapy device, the humidifier comprising: a humidifier housing forming
a humidification chamber, the humidifier housing comprising:
an air inlet configured to receive the flow of air from a pressure device …
26. (New) The device of claim 25, wherein the heating element is positioned inside of the housing.
27. (New) The device of claim 25, wherein the water-absorbent material is removable from the housing.
1. A humidifier for increasing absolute humidity of a flow of air to be delivered to a patient's airways by a respiratory therapy device, the humidifier comprising: … wherein the humidifier wick is removable from the humidification chamber …
28. (New) The device of claim 25, wherein the reservoir is positioned outside of the housing.
29. (New) The device of claim 21, wherein the water-absorbent material is shaped to surround the path for the flow of air.
1. A humidifier for increasing absolute humidity of a flow of air to be delivered to a patient's airways by a respiratory therapy device, the humidifier comprising: … the humidifier wick having a profiled shape to substantially enclose, in a radial direction, at least a portion of the flow path …
30. (New) The device of claim 21, wherein the water-absorbent material is tubular in shape.
3. The humidifier as claimed in claim 1, wherein the flow path enclosed by the humidifier wick is substantially cylindrical.
31. (New) The device of claim 21, wherein the water-absorbent material comprises one or more of paper, hydrophilic fibres, and cellulose fibres.
5. The humidifier as claimed in claim 1, wherein the humidifier wick comprises one or more of: paper, hydrophilic fibres, and cellulose fibres.
32. (New) The device of claim 21, wherein the water-absorbent material comprises a corrugated inner surface.
4. The humidifier as claimed in claim 1, wherein the humidifier wick comprises one or more of: a corrugated, a dimpled, a perforated, a porous, a woven, a knitted, a textured, and a sintered surface.
33. (New) The device of claim 21, wherein an inner surface of the water-absorbent material is one or more of: dimpled, perforated, porous, woven, knitted, textured, and sintered.
4. The humidifier as claimed in claim 1, wherein the humidifier wick comprises one or more of: a corrugated, a dimpled, a perforated, a porous, a woven, a knitted, a textured, and a sintered surface.
34. (New) The device of claim 21, wherein the water-absorbent material consists of a single piece of the water-absorbent material.
35. (New) The device of claim 21, further comprising a conduit fluidly connecting the reservoir to the water-absorbent material.
1. A humidifier for increasing absolute humidity of a flow of air to be delivered to a patient's airways by a respiratory therapy device, the humidifier comprising: …a delivery mechanism configured to deliver a flow of water from the reservoir to the humidifier wick
36. (New) The device of claim 35, further comprising a valve configured to control a flow of water through the conduit.
37. (New) The device of claim 35, further comprising a pump configured to direct a flow of water from the reservoir, through the conduit, and to the water-absorbent material.
38. (New) The device of claim 21, further comprising capillary channels fluidly connecting the reservoir to the water-absorbent material.
12. The humidifier as claimed in claim 1, wherein the delivery mechanism is configured to deliver the flow of water to the humidifier wick through a plurality of fluid connections.
39. (New) A system for treating a respiratory disorder of a patient, the system comprising: a blower configured to pressurize air above ambient pressure for breathing by the patient during therapy; a patient interface comprising: a seal-forming structure configured to contact and seal against the patient's face; a connection port configured to receive air pressurized by the blower; and a positioning and stabling structure comprising at least one strap and configured to hold the seal-forming structure in sealing contact with the patient's face during therapy; the device of claim 21; and an air circuit connected to the blower and the device and configured to direct pressurized air from the blower to the device, wherein the device is fluidly connected to the connection port of the patient interface.
40. (New) The device of claim 21, wherein the heating element is shorter than the water- absorbent material such that a portion of the water-absorbent material is not heated by the heating element during use.
6. The humidifier as claimed in claim 1, wherein the humidifier wick comprises a heated region and an unheated region.
41. (New) The device of claim 21, further comprising a frame positioned in the path for the flow of air through the humidification chamber and configured to support the water-absorbent material, and the frame being shaped and dimensioned to span the diameter of the path for the flow of air through the humidification chamber.
18. The humidifier as claimed in claim 1, wherein the wick frame comprises a wick locator configured to contact the humidifier wick and maintain the wick frame in position relative to the humidifier wick.
42. (New) The device of claim 41, wherein the frame comprises a baffle, the baffle comprising one or more baffle elements, each of the one or more baffle elements being one or more of helical, inclined, or curved to increase turbulence and/or to lengthen the path for the flow of air through the humidification chamber.
Regarding the instant claim limitation of “shaped to substantially surround and at least partly form a path for the flow of air through the humidification chamber such that the water absorbent material is directly exposed to the flow of air flowing along the path” as compared to the patent claim limitation of “and the humidifier wick having a profiled shape to substantially enclose, in a radial direction, at least a portion of the flow path”, these limitations appear to be commensurate in scope as the “surround” feature of the instant claims is met by the “enclosed” feature of the patent, both limitations consider the “flow path”, and the ability to produce the humidification is a function of the exposure of the water within the water absorbent material to be heated to form a vapor that is entrained and directed to the patient.
Regarding the instant claim limitation of “heating element is shorter than the water- absorbent material such that a portion of the water-absorbent material” as compared to the patent claim “a heated region and an unheated region”, these limitations appear to be commensurate in scope despite the absence of the language “shorter”, the nature of a “unheated region” is the absence of the heating element, whilst, the nature of a “heated region” is the presence of the heating element.
Regarding the instant claim limitation of “configured to support the water-absorbent material, and the frame being shaped and dimensioned to span the diameter of the path for the flow of air through the humidification chamber” as compared to the patent claim limitation of “configured to contact the humidifier wick and maintain the wick frame in position relative to the humidifier wick”, it appears these limitations are commensurate in scope. Although the explicit language of “diameter” is not expressly recited the nature to “contact” and “maintain the wick frame in position” requires a commensurate dimensional features.
Thus, it appears the instant claims are not patentably distinct from the patent claims.
Claims 21, 25-27, 29, 35, and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, 24, and 26 of U.S. Patent No. 10,864,346.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant independent claim, Claim 21, is merely broader than the patent claim, Claim 24. It is clear all of the elements of the instant claims are found in the patent claims. The difference lies in the fact that the patent claims include many more elements and are thus much more specific. Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the instant claims. It has been held that the “generic” invention is “anticipated” by the “species”. In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Instant Claims – 18484554
Differences Underlined
Similarities Italicized
Patent Claims – 10,864,346
Differences Underlined
Similarities Italicized
21. (New) A device for humidifying a flow of air pressurized by a blower, the device comprising:
a humidification chamber having a first end configured to receive the flow of air from the blower and a second end opposite the first end configured to direct the flow of air to a patient interface;
a water-absorbent material positioned inside of the humidification chamber and shaped to substantially surround and at least partly form a path for the flow of air through the humidification chamber such that the water absorbent material is directly exposed to the flow of air flowing along the path;
a heating element configured to heat the water-absorbent material to evaporate absorbed water into the flow of air; and a reservoir positioned outside of the humidification chamber, the reservoir configured to retain a water supply, and the reservoir being in fluid communication with the water-absorbent material to direct the water supply to the water-absorbent material.
24. A respiratory therapy system configured to supply air at positive pressure to a patient for respiratory therapy, the respiratory therapy system comprising: a respiratory pressure therapy device configured to supply air at positive pressure; and the humidifier as claimed in claim 1, the humidifier being configured and positioned to humidify the air supplied by respiratory pressure therapy device.
Including
1. A humidifier for increasing an absolute humidity of a flow of air to be delivered to a patient's airways, the humidifier comprising:
a reservoir configured to retain a first volume of water;
a humidifier chamber comprising: an outer housing including: a water feed inlet; an inlet portion forming an air inlet configured to receive the flow of air; and an outlet portion forming an air outlet for delivering the flow of air with increased absolute humidity;
a humidifier wick positioned inside of the outer housing, the humidifier wick being configured to retain a second volume of water, the humidifier wick forming a path for the flow of air through the humidifier chamber, and the humidifier wick being removable from the humidifier chamber; a frame positioned inside of the outer housing and comprising: a wick remover engaged with the humidifier wick, the frame being removable from the humidifier chamber such that engagement of the wick remover with the humidifier wick removes the humidifier wick from the humidifier chamber when the frame is removed from the humidifier chamber; and an air flow baffle positioned within the path formed by the humidifier wick to lengthen a distance travelled by the flow of air along the path;
a heating element positioned and configured to heat the humidifier wick to vaporise the second volume of water to add absolute humidity to the flow of air travelling along the path formed by the humidifier wick; and a delivery mechanism configured to deliver water from the reservoir to the humidifier wick via the water feed inlet.
22. (New) The device of claim 21, wherein the heating element comprises carbon ink printed on the water-absorbent material.
23. (New) The device of claim 21, wherein the heating element is an electrical resistance heater.
24. (New) The device of claim 21, wherein the heating element is positioned on an opposite side of the water-absorbent material from the flow of air.
25. (New) The device of claim 21, further comprising a housing that at least partly forms the humidification chamber.
1. A humidifier for increasing an absolute humidity of a flow of air to be delivered to a patient's airways, the humidifier comprising: a reservoir configured to retain a first volume of water; a humidifier chamber comprising: an outer housing including: …
26. (New) The device of claim 25, wherein the heating element is positioned inside of the housing.
16. The humidifier as claimed in claim 1, wherein the heating element is removable from the humidifier chamber.
27. (New) The device of claim 25, wherein the water-absorbent material is removable from the housing.
1. A humidifier for increasing an absolute humidity of a flow of air to be delivered to a patient's airways, the humidifier comprising: a reservoir configured to retain a first volume of water; a humidifier chamber comprising: an outer housing including: …the humidifier wick being removable from the humidifier chamber …
28. (New) The device of claim 25, wherein the reservoir is positioned outside of the housing.
29. (New) The device of claim 21, wherein the water-absorbent material is shaped to surround the path for the flow of air.
1. A humidifier for increasing an absolute humidity of a flow of air to be delivered to a patient's airways, the humidifier comprising: a reservoir configured to retain a first volume of water; a humidifier chamber comprising: an outer housing including: … the humidifier wick forming a path for the flow of air through the humidifier chamber …
30. (New) The device of claim 21, wherein the water-absorbent material is tubular in shape.
31. (New) The device of claim 21, wherein the water-absorbent material comprises one or more of paper, hydrophilic fibres, and cellulose fibres.
32. (New) The device of claim 21, wherein the water-absorbent material comprises a corrugated inner surface.
33. (New) The device of claim 21, wherein an inner surface of the water-absorbent material is one or more of: dimpled, perforated, porous, woven, knitted, textured, and sintered.
34. (New) The device of claim 21, wherein the water-absorbent material consists of a single piece of the water-absorbent material.
35. (New) The device of claim 21, further comprising a conduit fluidly connecting the reservoir to the water-absorbent material.
1. A humidifier for increasing an absolute humidity of a flow of air to be delivered to a patient's airways, the humidifier comprising: a reservoir configured to retain a first volume of water; a humidifier chamber comprising: an outer housing including: …a delivery mechanism configured to deliver water from the reservoir to the humidifier wick via the water feed inlet.
36. (New) The device of claim 35, further comprising a valve configured to control a flow of water through the conduit.
37. (New) The device of claim 35, further comprising a pump configured to direct a flow of water from the reservoir, through the conduit, and to the water-absorbent material.
26. The humidifier as claimed in claim 1, wherein the delivery mechanism further comprises a water pump.
38. (New) The device of claim 21, further comprising capillary channels fluidly connecting the reservoir to the water-absorbent material.
39. (New) A system for treating a respiratory disorder of a patient, the system comprising: a blower configured to pressurize air above ambient pressure for breathing by the patient during therapy; a patient interface comprising: a seal-forming structure configured to contact and seal against the patient's face; a connection port configured to receive air pressurized by the blower; and a positioning and stabling structure comprising at least one strap and configured to hold the seal-forming structure in sealing contact with the patient's face during therapy; the device of claim 21; and an air circuit connected to the blower and the device and configured to direct pressurized air from the blower to the device, wherein the device is fluidly connected to the connection port of the patient interface.
40. (New) The device of claim 21, wherein the heating element is shorter than the water- absorbent material such that a portion of the water-absorbent material is not heated by the heating element during use.
41. (New) The device of claim 21, further comprising
a frame positioned in the path for the flow of air through the humidification chamber and configured to support the water-absorbent material, and the frame being shaped and dimensioned to span the diameter of the path for the flow of air through the humidification chamber.
42. (New) The device of claim 41, wherein the frame comprises a baffle, the baffle comprising one or more baffle elements, each of the one or more baffle elements being one or more of helical, inclined, or curved to increase turbulence and/or to lengthen the path for the flow of air through the humidification chamber.
Regarding the instant claim limitation of “shaped to substantially surround and at least partly form a path for the flow of air through the humidification chamber such that the water absorbent material is directly exposed to the flow of air flowing along the path” as compared to the patent claim limitation of “the humidifier wick forming a path for the flow of air through the humidifier chamber”, these limitations appear to be commensurate in scope as the “surround” feature of the instant claims is met by the “though” feature of the patent, both limitations consider the “flow path”, and the ability to produce the humidification is a function of the exposure of the water within the water absorbent material to be heated to form a vapor that is entrained and directed to the patient. Thus, it appears the instant claims are not patentably distinct from the patent claims.
Claims 21, 29, 31, 35, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 8 of U.S. Patent No. 11,491,297.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant independent claim, Claim 21, is merely broader than the patent claim, Claim 1. It is clear all of the elements of the instant claims are found in the patent claims. The difference lies in the fact that the patent claims include many more elements and are thus much more specific. Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the instant claims. It has been held that the “generic” invention is “anticipated” by the “species”. In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Instant Claims – 18484554
Differences Underlined
Similarities Italicized
Patent Claims – 11,491,297
Differences Underlined
Similarities Italicized
21. (New) A device for humidifying a flow of air pressurized by a blower, the device comprising:
a humidification chamber having a first end configured to receive the flow of air from the blower and a second end opposite the first end configured to direct the flow of air to a patient interface;
a water-absorbent material positioned inside of the humidification chamber and shaped to substantially surround and at least partly form a path for the flow of air through the humidification chamber such that the water absorbent material is directly exposed to the flow of air flowing along the path;
a heating element configured to heat the water-absorbent material to evaporate absorbed water into the flow of air; and a reservoir positioned outside of the humidification chamber, the reservoir configured to retain a water supply, and the reservoir being in fluid communication with the water-absorbent material to direct the water supply to the water-absorbent material.
1. A humidifier for use with a respiratory pressure therapy (RPT) device that is configured to pressurize and direct a flow of air to an entrance to the airways of a patient for treatment of a respiratory disorder, the humidifier being configured to increase the absolute humidity of the pressurized flow of air, the increase being compared to the absolute humidity of ambient air, the humidifier comprising:
a reservoir configured to hold a first volume of liquid; and
a humidifier chamber comprising: a humidifier inlet configured to receive the pressurized flow of air; a humidifier outlet configured to direct the pressurized flow of air out of the humidifier chamber;
a humidifier wick configured to retain a second volume of liquid and at least partly form a flow path for the pressurized flow of air that flows from the humidifier inlet to the humidifier outlet during use; and
a heating element configured to heat the humidifier wick to vapourise the second volume of liquid to add absolute humidity to the pressurized flow of air that flows along the flow path during use; and wherein the humidifier wick comprises a fibrous sheet material, the fibrous sheet material comprising a fabric woven of fibres, wherein the fabric woven of fibres comprises a first plurality of fibres and a second plurality of fibres, the first plurality of fibres being different from the second plurality of fibres in at least one aspect, wherein the first plurality of fibres are each greater in thickness than each of the second plurality of fibres, and wherein the first plurality of fibres are positioned closer to the heating element than the second plurality of fibres, and the second plurality of fibres are positioned closer to the pressurized flow of air than the first plurality of fibres.
22. (New) The device of claim 21, wherein the heating element comprises carbon ink printed on the water-absorbent material.
23. (New) The device of claim 21, wherein the heating element is an electrical resistance heater.
24. (New) The device of claim 21, wherein the heating element is positioned on an opposite side of the water-absorbent material from the flow of air.
25. (New) The device of claim 21, further comprising a housing that at least partly forms the humidification chamber.
26. (New) The device of claim 25, wherein the heating element is positioned inside of the housing.
27. (New) The device of claim 25, wherein the water-absorbent material is removable from the housing.
28. (New) The device of claim 25, wherein the reservoir is positioned outside of the housing.
29. (New) The device of claim 21, wherein the water-absorbent material is shaped to surround the path for the flow of air.
1. A humidifier for use with a respiratory pressure therapy (RPT) device … a humidifier wick configured to retain a second volume of liquid and at least partly form a flow path for the pressurized flow of air that flows from the humidifier inlet to the humidifier outlet during use; …
30. (New) The device of claim 21, wherein the water-absorbent material is tubular in shape.
31. (New) The device of claim 21, wherein the water-absorbent material comprises one or more of paper, hydrophilic fibres, and cellulose fibres.
1. A humidifier for use with a respiratory pressure therapy (RPT) device … the humidifier wick comprises a fibrous sheet material, the fibrous sheet material comprising a fabric woven of fibres, wherein the fabric woven of fibres comprises a first plurality of fibres and a second plurality of fibres, the first plurality of fibres being different from the second plurality of fibres in at least one aspect, wherein the first plurality of fibres are each greater in thickness than each of the second plurality of fibres, and wherein the first plurality of fibres are positioned closer to the heating element than the second plurality of fibres, and the second plurality of fibres are positioned closer to the pressurized flow of air than the first plurality of fibres.
32. (New) The device of claim 21, wherein the water-absorbent material comprises a corrugated inner surface.
33. (New) The device of claim 21, wherein an inner surface of the water-absorbent material is one or more of: dimpled, perforated, porous, woven, knitted, textured, and sintered.
34. (New) The device of claim 21, wherein the water-absorbent material consists of a single piece of the water-absorbent material.
35. (New) The device of claim 21, further comprising a conduit fluidly connecting the reservoir to the water-absorbent material.
8. The humidifier of claim 1, further comprising: a water feed inlet configured to direct the first volume of liquid to the humidifier wick; and a deioniser positioned upstream of the water feed inlet and configured to deionise the first volume of liquid prior to vapourisation in the humidifier wick.
36. (New) The device of claim 35, further comprising a valve configured to control a flow of water through the conduit.
37. (New) The device of claim 35, further comprising a pump configured to direct a flow of water from the reservoir, through the conduit, and to the water-absorbent material.
38. (New) The device of claim 21, further comprising capillary channels fluidly connecting the reservoir to the water-absorbent material.
2. The humidifier of claim 1, wherein the fibrous sheet material is configured to distribute water through the humidifier wick via capillary action and retain it therein.
39. (New) A system for treating a respiratory disorder of a patient, the system comprising: a blower configured to pressurize air above ambient pressure for breathing by the patient during therapy; a patient interface comprising: a seal-forming structure configured to contact and seal against the patient's face; a connection port configured to receive air pressurized by the blower; and a positioning and stabling structure comprising at least one strap and configured to hold the seal-forming structure in sealing contact with the patient's face during therapy; the device of claim 21; and an air circuit connected to the blower and the device and configured to direct pressurized air from the blower to the device, wherein the device is fluidly connected to the connection port of the patient interface.
40. (New) The device of claim 21, wherein the heating element is shorter than the water- absorbent material such that a portion of the water-absorbent material is not heated by the heating element during use.
41. (New) The device of claim 21, further comprising a frame positioned in the path for the flow of air through the humidification chamber and configured to support the water-absorbent material, and the frame being shaped and dimensioned to span the diameter of the path for the flow of air through the humidification chamber.
42. (New) The device of claim 41, wherein the frame comprises a baffle, the baffle comprising one or more baffle elements, each of the one or more baffle elements being one or more of helical, inclined, or curved to increase turbulence and/or to lengthen the path for the flow of air through the humidification chamber.
Regarding the instant claim limitation of “shaped to substantially surround and at least partly form a path for the flow of air through the humidification chamber such that the water absorbent material is directly exposed to the flow of air flowing along the path” as compared to the patent claim limitation of “at least partly form a flow path for the pressurized flow of air that flows from the humidifier inlet to the humidifier outlet during use”, these limitations appear to be commensurate in scope as the “surround” feature of the instant claims is met by the “flows from the humidifier inlet to the humidifier outlet during use” feature of the patent, both limitations consider the “flow path”, and the ability to produce the humidification is a function of the exposure of the water within the water absorbent material to be heated to form a vapor that is entrained and directed to the patient. Thus, it appears the instant claims are not patentably distinct from the patent claims.
Allowable Subject Matter
Claim 40 is 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 AND overcoming the double patenting rejection to 10,518,061.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Although Primary Examiner appreciates Applicant’s consideration of the subject matter as discussed in the interview summary to aide in advancing prosecution of this case, and the further amendments beyond the claims that were presented in the interview, the currently amended claims ARE NOT allowable over several prior art refences which were listed in Paragraph 17 of the non-final Office Action, mailed on April 20, 2026.
To aide Applicant in a further understanding of the prior art made of record, herewith Primary Examiner includes three (3) prior art rejections of the claims incorporating each of McComb, Milewicz, and Sata ‘108 to emphasize the absence of a chasm between the claimed invention and the prior art made of record. It appears Applicant should further amend the claims commensurate with the features of the disclosed invention to overcome each of McComb, Milewicz, and Sata ‘108.
It is noted the subject matter of new claim 40 as mused by the Primary Examiner during the interview appears to be allowable upon being rewritten in independent form including all of the limitations of the base claim and any intervening claims. Yet, a terminal disclaimer is still required to 10,518,061 to overcome the double patenting rejection.
In light of the aforementioned reasoning, the non-final rejection of the claims has been maintained and made FINAL.
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 ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra D Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
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