DETAILED ACTION
This Office Action is in response to the amendment, filed on May 22, 2026. Primary Examiner acknowledges Claims 1, 2, 4, 5, 7, 9, 10, and 18-28 are pending in this application, with Claims 1, 2, 4, 5, 7, and 20 having been currently amended, Claims 21-28 having been newly added, and Claims 3, 6, 8, and 11-17 having been cancelled.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 1, 7, 21, and 27 are objected to because of the following informalities:
Claim 1, Line 9 recites the limitation “first and second connector”; however, it appears this recitation should read “first and second electrical connectors” to provide consistency with the former recitation of the “first electrical connector” and the “second electrical connector” as introduced in Lines 8 and 9. Appropriate correction is required.
Claim 7, Line 3 recites “exposed to the respiratory flow an open end of the outer housing”; however, this phrase appears to be grammatically incorrect. Perhaps the word “through” should be inserted between “flow” and “an open end”? Appropriate correction is required.
Claim 21, Lines 9-10 recites the limitation “first and second connector”; however, it appears this recitation should read “first and second electrical connectors” to provide consistency with the former recitation of the “first electrical connector” and the “second electrical connector” as introduced in Lines 8 and 9, respectively. Appropriate correction is required.
Claim 27, Line 2 recites “the gas flow path”; however, it appears this recitation should read “the respiratory gas flow path” to provide consistency with the former recitation of “a respiratory gas flow path” introduced in Claim 21, Lines 16 and 17. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 4, 5, 7, 9, and 18-28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Milewicz (6,010,118) in view of Bauer et al. (4,266,166) and Fodor (4,038,980).
As to Claim 1, Milewicz discloses a humidifier (“Medical Humidifier” Title, best seen Figures 1-4), comprising: a heating element (defined by the combination of 10 and 11, best seen Figure 1 as an exterior view, and Figures 2-4 as interior views, “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.” Column 3, Lines 40-55) including a porous structure (interior of 10 as defined by the combination of 21 and 23, “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) of electrically resistive and thermally conductive material (“metal tube core 21”) configured to substantially convert liquid (via 20 of 11, “a liquid entry port 11 at an exit end of the humidification chamber 10 … 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 40-65) that is passed through the porous structure (interior of 10 as defined by the combination of 21 and 23) into vapor (“Preferably, the heated gas line with humidification chamber delivers gas from the chamber at approximately 40.degree. C. and 98% humidity.” Column 4, Lines 35-40), the porous structure (interior of 10 as defined by the combination of 21 and 23) having a liquid inlet (20 of 11, “a liquid entry port 11 … 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 40-65) and a vapor outlet (19, “The first gas supply tube 5 connects to a socket 18 at the inlet end and the second gas supply tube 12 connects to a fitting 19 at the end 17 for delivery of warmed, humidified gas to a patient.” Column 3, Lines 50-65); and an outer housing (34, “The insulation layer 35 is held in place by a shrink-wrap sleeve 34 over the insulation layer.” Column 3, Line 65 thru Column 4, Line 5) surrounding at least a portion of the porous structure (interior of 10 as defined by the combination of 21 and 23) to contain the liquid and steam within the porous structure (interior of 10 as defined by the combination of 21 and 23), wherein the porous structure (interior of 10 as defined by the combination of 21 and 23) includes a first electrical connector (one of 7/41/43, “… the electrical heating wires 7, 41, and 43 are continuous.” Column 4, Lines 35-50) and a second electrical connector (other of 7/41/43, “… the electrical heating wires 7, 41, and 43 are continuous.” Column 4, Lines 35-50), the first and second electrical connectors (7/41/43) being configured to receive electrical power and apply a voltage (“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) across the porous structure (interior of 10 as defined by the combination of 21 and 23) to generate heat, wherein the vapor outlet (19) is positioned to discharge the vapor into a respiratory gas flow path (12, “The first gas supply tube 5 connects to a socket 18 at the inlet end and the second gas supply tube 12 connects to a fitting 19 at the end 17 for delivery of warmed, humidified gas to a patient.” Column 3, Lines 50-65) to a patient.
Yet, Milewicz does not expressly disclose the configuration of the first and second electrical connectors to “receive electrical power and apply a voltage” nor the vapor to be in the form of steam, whereby “the temperature of the steam is 100 degrees C or greater”.
Regarding the configuration of the first and second electrical connectors to “receive electrical power and apply a voltage”, in the field of electrical engineering it is well known that current and voltage are intimately related variable utilized to measure resistance. Explicitly, Ohm’s Law expresses the proportionality of electrical current as compared to voltage, whereby the current in an electrical circuit depends on the applied voltage and the resistance of the conductor.
Clearly, Milewicz explicitly states the application of “electrical current” conducted through the first and second electrical connectors (7/41/43) for the formation of vapor within the humidifier; but, remains silent to the instantly claimed “voltage”.
Nevertheless, Bauer teaches an additional humidifier device having first and second electrical connectors (4/5 via A/B, “At the interior of envelope 1, and connected to terminals A, B of a source of electrical energy, are two electrodes 4 and 5” Column 3, Lines 35-45) which are energized through a power supply to produce steam (“With an alternating supply voltage of 220 volts and a supply current intensity of 0.5 amps, one obtains upon injection of 0.2 cc of distilled water, an instantaneous power of 110 watts and the production of superheated steam.” Column 4, Lines 15-25; also see: “For a volume of distilled water of 1 cc contained in the porous material disposed between the electrodes, one obtains under a supply voltage of 220 volts and a current intensity of 1 amp, an instantaneous power of 220 watts and the production of superheated steam.” Column 5, Lines 30-40). Furthermore, it is noted the vapor of Bauer in the form of “superheated steam” has an operational temperature of “greater than 105.degree. C.”. (Column 1, Lines 30-35).
By the teachings of Bauer, it is unequivocally clear the relationship of the energizing of the electrical connectors with a specific current and a specific voltage results in the production of vapor within the humidifier as function of the electrical resistance of the electrical connectors producing heat which vaporizes the liquid within the humidifier.
Thus, the modification of Milewicz to meet the claim functionality of “voltage” is intrinsic to the energizing operation of first and second electrical connectors, as taught by Bauer to produce vapor.
Regarding the temperature of the vapor produced by the humidifier to be in the form of steam, whereby “the temperature of the steam is 100 degrees C or greater”, Fodor teaches a humidifier (Figures 1 and 2), comprising: a heating element (24, "A heating element 24 (not shown in FIG. 1 but see FIG. 2) of low thermal mass, about 20 g Cu, is inserted into sheath 22." Column 3, Lines 40-50) including a porous structure (22, "Chamber 10 contains a centrally disposed sheath 22 of stainless steel woven wire. A heating element 24 (not shown in FIG. 1 but see FIG. 2) of low thermal mass, about 20 g Cu, is inserted into sheath 22." Column 3, Lines 40-50; "At the end of sheath 22 adjacent outlet port 18 is disposed a water drip feed unit inlet comprising a tubular insert 32 having internal elements 34 with bores of predetermined diameter to regulate the rate of feed of water drops onto sheath 22." Column 3, Lines 45-55; "In operation of the humidifier, the air flowing through the inlet 4 of the humidifier is first warmed by direct heat transfer from sheath 22. The air then flows into the region adjacent the outlet where water is evaporating on sheath 22." Column 4, Lines 15-30; also see: "The surface of the heater is therefore covered by porous sheath 22. Whilst sheath 22 is preferably formed of steel wire, it may alternatively be formed of mineral fibre or porous ceramic." Column 4, Lines 25-40) of electrically resistive and thermally conductive material (so as to ensure the operational humidification control by the water and electrical heating interaction) configured to substantially vaporize liquid ("water is evaporating on sheath 22" Column 4, Lines 15-30) that is passed through the porous structure (22), the porous structure (22) having a liquid inlet (via 32, "At the end of sheath 22 adjacent outlet port 18 is disposed a water drip feed unit inlet comprising a tubular insert 32 having internal elements 34 with bores of predetermined diameter to regulate the rate of feed of water drops onto sheath 22." Column 3, Lines 45-55) and a vapor outlet (via 22 proximate 18); an outer housing (2, "Referred to FIG. 1, the air humidifier has a tubular body 2 having in its side adjacent one end on air inlet port 4." Column 3, Lines 30-35) surrounding at least a portion of the porous structure (22) for containing the liquid and vapor within the porous structure (22); and wherein the porous structure (22) includes a first electrical connector (via one of wire leading from 66 to 24, as shown in Figure 2) and a second electrical connector (via other wire leading from 24 to 68 and back to 66, as shown in Figure 2), the first and second electrical connector (via one of wire leading from 66 to 24, as shown in Figure 2; via other wire leading from 24 to 68 and back to 66, as shown in Figure 2) being configured for receiving electrical power and applying voltage across the porous structure (22) to generate heat.
Clearly, Milewicz explicitly states the formation of vapor (“Preferably, the heated gas line with humidification chamber delivers gas from the chamber at approximately 40.degree. C. and 98% humidity.” Column 4, Lines 35-40); but, remains silent to the instantly claimed temperature of “100 degrees C or greater”.
Nevertheless, Fodor teaches the configuration of the humidifier to impart the claimed operational temperature of “100 degrees C or greater” in a medical device was known. Explicitly, Fodor states “The surface of the sheath 22 is kept considerably above the boiling point of water typically 200.degree.-300.degree. C. so that a drop of water falling on to it will be vaporised substantially instantaneously and completely in the manner of a flash boiler.” (Column 4, Lines 25-40).
By scientific convention, water boils at 100 degrees C (212 degrees F) at sea level, resulting in the formation of steam. Consequently, the operational of Fodor to “vaporised substantially instantaneously and completely” when functioning at temperature more than twice of the water boiling temperature, also results in the formation of steam.
In light of the teachings of Fodor, it would have been obvious to modify the operational temperature of Milewicz to operate at the claimed “100 degrees C or greater” as taught by Fodor to be a known operational temperature suitable for providing humidified gas to a patient.
Therefore, it would have been obvious to modify the electrical connectors of Milewicz to provide “electrical power and voltage” as taught by Bauer to be a known electrical circuity configuration to provide humidified gas, and to modify the operational temperature of Milewicz to include “steam … 100 degrees C or greater” as taught by Fodor to be a known temperature suitable for imparting humidified gas to a patient.
As to Claim 2, the modified Milewicz, specifically Milewicz discloses the first electrical connector (one of 7/41/43) is located at or near the liquid inlet (20 of 11) and the second electrical connector (other of 7/41/43) is located at or near the steam outlet (19).
As to Claim 4, the modified Milewicz, specifically Milewicz discloses a connector fitting (17, “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 40-65) configured to deliver liquid from a supply of liquid to the liquid inlet (20 of 11), wherein the connector fitting (17) comprises a connection spigot (via insertion of “a hypodermic needle” into 20, “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 40-65), and the humidifier (“Medical Humidifier” Title, best seen Figures 1-4) comprises a sealing tube (“an elastomeric seal” in 20 of 11, “a liquid entry port 11 at an exit end of the humidification chamber 10 … 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 40-65) configured to form a sealed connection between the connection spigot (via insertion of “a hypodermic needle” into 20) and the outer housing (34).
As to Claim 5, the modified Milewicz, specifically Milewicz discloses a connector fitting (17, “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 40-65) configured to deliver liquid from a supply of liquid to the liquid inlet (20 of 11), wherein the connector fitting (17) comprises a liquid inlet spigot (via insertion of “a hypodermic needle” into 20, “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 40-65) configured to receive liquid from the supply of liquid (water retained in the barrel of the hypodermic needle), and wherein the humidifier (“Medical Humidifier” Title, best seen Figures 1-4) comprises a liquid supply tube (“an elastomeric seal” in 20 of 11, “a liquid entry port 11 at an exit end of the humidification chamber 10 … 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 40-65) connected to the liquid inlet spigot (via insertion of “a hypodermic needle” into 20).
As to Claim 7, the modified Milewicz, specifically Milewicz discloses the porous structure (interior of 10 as defined by the combination of 21 and 23) and the outer housing (34) are each elongate (best seen Figures 2-4), and the steam outlet (19) of the porous structure (interior of 10 as defined by the combination of 21 and 23) is configured to be exposed to the respiratory gas flow (via 12) through an open end of the outer housing (34), and wherein the steam outlet (19) of the porous structure (interior of 10 as defined by the combination of 21 and 23) extends beyond the outer housing (34).
As to Claim 9, the modified Milewicz, specifically Milewicz discloses the porous structure (interior of 10 as defined by the combination of 21 and 23) has a cylindrical shape.
As to Claim 18, the modified Milewicz, specifically Milewicz discloses the porous structure (interior of 10 as defined by the combination of 21 and 23) has a substantially unform porosity (best seen Figures 2 and 4).
As to Claim 19, the modified Milewicz, specifically Milewicz discloses the outer housing (34) is formed of electrically and thermally insulating material (“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).
As to Claim 20, the modified Milewicz, specifically Milewicz discloses the outer housing (34) is formed of a polymer. By convention, Shrink Wrap is a heat sensitive polymer for encasement of an open, whereby when heated contracts and seals the object contained therewith.
As to Claim 25, the modified Milewicz, specifically Milewicz discloses the steam is delivered only during an inspiration phase of the patient’s breathing cycle – “delivery of warmed, humidified gas to a patient” (Column 3, Lines 50-65).
As to Claim 21, Milewicz discloses a humidifier (“Medical Humidifier” Title, best seen Figures 1-4), comprising: a water supply (water retained in the barrel of the hypodermic needle, “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 40-65); and a steam generator (defined by the combination of 10 and 11, best seen Figure 1 as an exterior view, and Figures 2-4 as interior views, “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.” Column 3, Lines 40-55) configured to receive the a volume of water from the water supply (water retained in the barrel of the hypodermic needle), the steam generator (defined by the combination of 10 and 11) comprising: a porous material (interior of 10 as defined by the combination of 21 and 23, “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) of electrically resistive and thermally conductive material (“metal tube core 21”) configured to substantially convert liquid (via 20 of 11, “a liquid entry port 11 at an exit end of the humidification chamber 10 … 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 40-65) that is passed through the porous material (interior of 10 as defined by the combination of 21 and 23) into vapor (“Preferably, the heated gas line with humidification chamber delivers gas from the chamber at approximately 40.degree. C. and 98% humidity.” Column 4, Lines 35-40), the porous material (interior of 10 as defined by the combination of 21 and 23) having a liquid inlet (20 of 11, “a liquid entry port 11 … 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 40-65) and a vapor outlet (19, “The first gas supply tube 5 connects to a socket 18 at the inlet end and the second gas supply tube 12 connects to a fitting 19 at the end 17 for delivery of warmed, humidified gas to a patient.” Column 3, Lines 50-65); a first electrical connector (one of 7/41/43, “… the electrical heating wires 7, 41, and 43 are continuous.” Column 4, Lines 35-50) attached to the porous material (interior of 10 as defined by the combination of 21 and 23); and a second electrical connector (other of 7/41/43, “… the electrical heating wires 7, 41, and 43 are continuous.” Column 4, Lines 35-50), the first and second electrical connectors (7/41/43) being configured to receive electrical power and apply a voltage (“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) across the porous material (interior of 10 as defined by the combination of 21 and 23) to generate heat, wherein the water supply (water retained in the barrel of the hypodermic needle) is configured to supply the volume of water at a rate corresponding to a vapor outlet (19) of the steam generator (defined by the combination of 10 and 11), wherein the vapor outlet (19) is positioned to discharge the vapor into a respiratory gas flow path (12, “The first gas supply tube 5 connects to a socket 18 at the inlet end and the second gas supply tube 12 connects to a fitting 19 at the end 17 for delivery of warmed, humidified gas to a patient.” Column 3, Lines 50-65) to a patient.
Yet, Milewicz does not expressly disclose the configuration of the first and second electrical connectors to “receive electrical power and apply a voltage” nor the vapor to be in the form of steam, whereby “the temperature of the steam is 100 degrees C or greater” and is configured to “substantially convert the volume of water into steam”.
Regarding the configuration of the first and second electrical connectors to “receive electrical power and apply a voltage”, in the field of electrical engineering it is well known that current and voltage are intimately related variable utilized to measure resistance. Explicitly, Ohm’s Law expresses the proportionality of electrical current as compared to voltage, whereby the current in an electrical circuit depends on the applied voltage and the resistance of the conductor.
Clearly, Milewicz explicitly states the application of “electrical current” conducted through the first and second electrical connectors (7/41/43) for the formation of vapor within the humidifier; but, remains silent to the instantly claimed “voltage”.
Nevertheless, Bauer teaches an additional humidifier device having first and second electrical connectors (4/5 via A/B, “At the interior of envelope 1, and connected to terminals A, B of a source of electrical energy, are two electrodes 4 and 5” Column 3, Lines 35-45) which are energized through a power supply to produce steam (“With an alternating supply voltage of 220 volts and a supply current intensity of 0.5 amps, one obtains upon injection of 0.2 cc of distilled water, an instantaneous power of 110 watts and the production of superheated steam.” Column 4, Lines 15-25; also see: “For a volume of distilled water of 1 cc contained in the porous material disposed between the electrodes, one obtains under a supply voltage of 220 volts and a current intensity of 1 amp, an instantaneous power of 220 watts and the production of superheated steam.” Column 5, Lines 30-40). Furthermore, it is noted the vapor of Bauer in the form of “superheated steam” has an operational temperature of “greater than 105.degree. C.”. (Column 1, Lines 30-35).
By the teachings of Bauer, it is unequivocally clear the relationship of the energizing of the electrical connectors with a specific current and a specific voltage results in the production of vapor within the humidifier as function of the electrical resistance of the electrical connectors producing heat which vaporizes the liquid within the humidifier.
Thus, the modification of Milewicz to meet the claim functionality of “voltage” is intrinsic to the energizing operation of first and second electrical connectors, as taught by Bauer to produce vapor.
Regarding the temperature of the vapor produced by the humidifier to be in the form of steam, whereby “the temperature of the steam is 100 degrees C or greater” and is configured to “substantially convert the volume of water into steam”, Fodor teaches a humidifier (Figures 1 and 2), comprising: a heating element (24, "A heating element 24 (not shown in FIG. 1 but see FIG. 2) of low thermal mass, about 20 g Cu, is inserted into sheath 22." Column 3, Lines 40-50) including a porous structure (22, "Chamber 10 contains a centrally disposed sheath 22 of stainless steel woven wire. A heating element 24 (not shown in FIG. 1 but see FIG. 2) of low thermal mass, about 20 g Cu, is inserted into sheath 22." Column 3, Lines 40-50; "At the end of sheath 22 adjacent outlet port 18 is disposed a water drip feed unit inlet comprising a tubular insert 32 having internal elements 34 with bores of predetermined diameter to regulate the rate of feed of water drops onto sheath 22." Column 3, Lines 45-55; "In operation of the humidifier, the air flowing through the inlet 4 of the humidifier is first warmed by direct heat transfer from sheath 22. The air then flows into the region adjacent the outlet where water is evaporating on sheath 22." Column 4, Lines 15-30; also see: "The surface of the heater is therefore covered by porous sheath 22. Whilst sheath 22 is preferably formed of steel wire, it may alternatively be formed of mineral fibre or porous ceramic." Column 4, Lines 25-40) of electrically resistive and thermally conductive material (so as to ensure the operational humidification control by the water and electrical heating interaction) configured to substantially vaporize liquid ("water is evaporating on sheath 22" Column 4, Lines 15-30) that is passed through the porous structure (22), the porous structure (22) having a liquid inlet (via 32, "At the end of sheath 22 adjacent outlet port 18 is disposed a water drip feed unit inlet comprising a tubular insert 32 having internal elements 34 with bores of predetermined diameter to regulate the rate of feed of water drops onto sheath 22." Column 3, Lines 45-55) and a vapor outlet (via 22 proximate 18); an outer housing (2, "Referred to FIG. 1, the air humidifier has a tubular body 2 having in its side adjacent one end on air inlet port 4." Column 3, Lines 30-35) surrounding at least a portion of the porous structure (22) for containing the liquid and vapor within the porous structure (22); and wherein the porous structure (22) includes a first electrical connector (via one of wire leading from 66 to 24, as shown in Figure 2) and a second electrical connector (via other wire leading from 24 to 68 and back to 66, as shown in Figure 2), the first and second electrical connector (via one of wire leading from 66 to 24, as shown in Figure 2; via other wire leading from 24 to 68 and back to 66, as shown in Figure 2) being configured for receiving electrical power and applying voltage across the porous structure (22) to generate heat.
Clearly, Milewicz explicitly states the formation of vapor (“Preferably, the heated gas line with humidification chamber delivers gas from the chamber at approximately 40.degree. C. and 98% humidity.” Column 4, Lines 35-40); but, remains silent to the instantly claimed temperature of “100 degrees C or greater”.
Nevertheless, Fodor teaches the configuration of the humidifier to impart the claimed operational temperature of “100 degrees C or greater” in a medical device was known. Explicitly, Fodor states “The surface of the sheath 22 is kept considerably above the boiling point of water typically 200.degree.-300.degree. C. so that a drop of water falling on to it will be vaporised substantially instantaneously and completely in the manner of a flash boiler.” (Column 4, Lines 25-40).
By scientific convention, water boils at 100 degrees C (212 degrees F) at sea level, resulting in the formation of steam. Consequently, the operational of Fodor to “vaporised substantially instantaneously and completely” when functioning at temperature more than twice of the water boiling temperature, also results in the formation of steam.
In light of the teachings of Fodor, it would have been obvious to modify the operational temperature of Milewicz to operate at the claimed “100 degrees C or greater” as taught by Fodor to be a known operational temperature suitable for providing humidified gas to a patient.
Therefore, it would have been obvious to modify the electrical connectors of Milewicz to provide “electrical power and voltage” as taught by Bauer to be a known electrical circuity configuration to provide humidified gas, and to modify the operational temperature of Milewicz to include “steam … 100 degrees C or greater” as taught by Fodor to be a known temperature suitable for imparting humidified gas to a patient.
As to Claim 22, the modified Milewicz, specifically Milewicz discloses the steam generator (defined by the combination of 10 and 11) comprises a fibrous structure (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. … 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 5-25) of thermally conductive material through which the volume of water is passed through (“water absorbent”).
As to Claim 23, the modified Milewicz, specifically Milewicz discloses the respiratory gas flow path (12) is preheated (as best seen in Figure 1, the respiratory gas flow path is includes preheating within tube 5 prior to the entry into the steam generator (defined by the combination of 10 and 11) and final disposition at the patient via 12).
As to Claim 24, the modified Milewicz, specifically Fodor teaches a water supply (50, "Referring now to the control circuit of FIG. 2 the water supply for the drip feed comprises a reservoir 50 having an outlet pipe 52 through which water is forced by pressurising the reservoir from a compressed air supply." Column 3, Lines 55-70) in the form of a pump (via energizing/deenergizing of 58, "Water from valve 58 gathers in the bottom of an inspection chamber 60 before passing into evaporating chamber 10 via insert 32." Column 3, Lines 55-70) to provide a metered volume of water to the steam generator (defined by the combination of 10 and 11). The benefit of the construction of Fodor is the ability to continuously supply volumes of water as necessitated through the energizing and deenergizing of the valve 58, as compared to the additional functionalities of Milewicz utilizing a closed and specific volume as retained it the barrel of the hypodermic needle which must be redrawn from the source of water and reinserted for delivery into the steam generator. Thus, the construction of Fodor’s modification provides greater efficiency and automizing of the volume of liquid.
As to Claim 26, Milewicz discloses a respiratory apparatus (Figure 1) for delivering a flow of breathable gas to a patient, comprising: a flow generator (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) configured to generate the flow of breathable gas; and a humidifier (“Medical Humidifier” Title, best seen Figures 1-4), comprising: a water supply (water retained in the barrel of the hypodermic needle, “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 40-65); and a steam generator (defined by the combination of 10 and 11, best seen Figure 1 as an exterior view, and Figures 2-4 as interior views, “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.” Column 3, Lines 40-55) configured to receive the a volume of water from the water supply (water retained in the barrel of the hypodermic needle), the steam generator (defined by the combination of 10 and 11) comprising: a porous material (interior of 10 as defined by the combination of 21 and 23, “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) of electrically resistive and thermally conductive material (“metal tube core 21”) configured to substantially convert liquid (via 20 of 11, “a liquid entry port 11 at an exit end of the humidification chamber 10 … 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 40-65) that is passed through the porous material (interior of 10 as defined by the combination of 21 and 23) into vapor (“Preferably, the heated gas line with humidification chamber delivers gas from the chamber at approximately 40.degree. C. and 98% humidity.” Column 4, Lines 35-40), the porous material (interior of 10 as defined by the combination of 21 and 23) having a liquid inlet (20 of 11, “a liquid entry port 11 … 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 40-65) and a vapor outlet (19, “The first gas supply tube 5 connects to a socket 18 at the inlet end and the second gas supply tube 12 connects to a fitting 19 at the end 17 for delivery of warmed, humidified gas to a patient.” Column 3, Lines 50-65); a first electrical connector (one of 7/41/43, “… the electrical heating wires 7, 41, and 43 are continuous.” Column 4, Lines 35-50) attached to the porous material (interior of 10 as defined by the combination of 21 and 23); and a second electrical connector (other of 7/41/43, “… the electrical heating wires 7, 41, and 43 are continuous.” Column 4, Lines 35-50), the first and second electrical connectors (7/41/43) being configured to receive electrical power and apply a voltage (“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) across the porous material (interior of 10 as defined by the combination of 21 and 23) to generate heat, wherein the water supply (water retained in the barrel of the hypodermic needle) is configured to supply the volume of water at a rate corresponding to a vapor outlet (19) of the steam generator (defined by the combination of 10 and 11), wherein the vapor outlet (19) is positioned to discharge the vapor into a respiratory gas flow path (12, “The first gas supply tube 5 connects to a socket 18 at the inlet end and the second gas supply tube 12 connects to a fitting 19 at the end 17 for delivery of warmed, humidified gas to a patient.” Column 3, Lines 50-65) to a patient.
Yet, Milewicz does not expressly disclose the configuration of the first and second electrical connectors to “receive electrical power and apply a voltage” nor the vapor to be in the form of steam, whereby “the temperature of the steam is 100 degrees C or greater” and is configured to “substantially convert the volume of water into steam”.
Regarding the configuration of the first and second electrical connectors to “receive electrical power and apply a voltage”, in the field of electrical engineering it is well known that current and voltage are intimately related variable utilized to measure resistance. Explicitly, Ohm’s Law expresses the proportionality of electrical current as compared to voltage, whereby the current in an electrical circuit depends on the applied voltage and the resistance of the conductor.
Clearly, Milewicz explicitly states the application of “electrical current” conducted through the first and second electrical connectors (7/41/43) for the formation of vapor within the humidifier; but, remains silent to the instantly claimed “voltage”.
Nevertheless, Bauer teaches an additional humidifier device having first and second electrical connectors (4/5 via A/B, “At the interior of envelope 1, and connected to terminals A, B of a source of electrical energy, are two electrodes 4 and 5” Column 3, Lines 35-45) which are energized through a power supply to produce steam (“With an alternating supply voltage of 220 volts and a supply current intensity of 0.5 amps, one obtains upon injection of 0.2 cc of distilled water, an instantaneous power of 110 watts and the production of superheated steam.” Column 4, Lines 15-25; also see: “For a volume of distilled water of 1 cc contained in the porous material disposed between the electrodes, one obtains under a supply voltage of 220 volts and a current intensity of 1 amp, an instantaneous power of 220 watts and the production of superheated steam.” Column 5, Lines 30-40). Furthermore, it is noted the vapor of Bauer in the form of “superheated steam” has an operational temperature of “greater than 105.degree. C.”. (Column 1, Lines 30-35).
By the teachings of Bauer, it is unequivocally clear the relationship of the energizing of the electrical connectors with a specific current and a specific voltage results in the production of vapor within the humidifier as function of the electrical resistance of the electrical connectors producing heat which vaporizes the liquid within the humidifier.
Thus, the modification of Milewicz to meet the claim functionality of “voltage” is intrinsic to the energizing operation of first and second electrical connectors, as taught by Bauer to produce vapor.
Regarding the temperature of the vapor produced by the humidifier to be in the form of steam, whereby “the temperature of the steam is 100 degrees C or greater” and is configured to “substantially convert the volume of water into steam”, Fodor teaches a humidifier (Figures 1 and 2), comprising: a heating element (24, "A heating element 24 (not shown in FIG. 1 but see FIG. 2) of low thermal mass, about 20 g Cu, is inserted into sheath 22." Column 3, Lines 40-50) including a porous structure (22, "Chamber 10 contains a centrally disposed sheath 22 of stainless steel woven wire. A heating element 24 (not shown in FIG. 1 but see FIG. 2) of low thermal mass, about 20 g Cu, is inserted into sheath 22." Column 3, Lines 40-50; "At the end of sheath 22 adjacent outlet port 18 is disposed a water drip feed unit inlet comprising a tubular insert 32 having internal elements 34 with bores of predetermined diameter to regulate the rate of feed of water drops onto sheath 22." Column 3, Lines 45-55; "In operation of the humidifier, the air flowing through the inlet 4 of the humidifier is first warmed by direct heat transfer from sheath 22. The air then flows into the region adjacent the outlet where water is evaporating on sheath 22." Column 4, Lines 15-30; also see: "The surface of the heater is therefore covered by porous sheath 22. Whilst sheath 22 is preferably formed of steel wire, it may alternatively be formed of mineral fibre or porous ceramic." Column 4, Lines 25-40) of electrically resistive and thermally conductive material (so as to ensure the operational humidification control by the water and electrical heating interaction) configured to substantially vaporize liquid ("water is evaporating on sheath 22" Column 4, Lines 15-30) that is passed through the porous structure (22), the porous structure (22) having a liquid inlet (via 32, "At the end of sheath 22 adjacent outlet port 18 is disposed a water drip feed unit inlet comprising a tubular insert 32 having internal elements 34 with bores of predetermined diameter to regulate the rate of feed of water drops onto sheath 22." Column 3, Lines 45-55) and a vapor outlet (via 22 proximate 18); an outer housing (2, "Referred to FIG. 1, the air humidifier has a tubular body 2 having in its side adjacent one end on air inlet port 4." Column 3, Lines 30-35) surrounding at least a portion of the porous structure (22) for containing the liquid and vapor within the porous structure (22); and wherein the porous structure (22) includes a first electrical connector (via one of wire leading from 66 to 24, as shown in Figure 2) and a second electrical connector (via other wire leading from 24 to 68 and back to 66, as shown in Figure 2), the first and second electrical connector (via one of wire leading from 66 to 24, as shown in Figure 2; via other wire leading from 24 to 68 and back to 66, as shown in Figure 2) being configured for receiving electrical power and applying voltage across the porous structure (22) to generate heat.
Clearly, Milewicz explicitly states the formation of vapor (“Preferably, the heated gas line with humidification chamber delivers gas from the chamber at approximately 40.degree. C. and 98% humidity.” Column 4, Lines 35-40); but, remains silent to the instantly claimed temperature of “100 degrees C or greater”.
Nevertheless, Fodor teaches the configuration of the humidifier to impart the claimed operational temperature of “100 degrees C or greater” in a medical device was known. Explicitly, Fodor states “The surface of the sheath 22 is kept considerably above the boiling point of water typically 200.degree.-300.degree. C. so that a drop of water falling on to it will be vaporised substantially instantaneously and completely in the manner of a flash boiler.” (Column 4, Lines 25-40).
By scientific convention, water boils at 100 degrees C (212 degrees F) at sea level, resulting in the formation of steam. Consequently, the operational of Fodor to “vaporised substantially instantaneously and completely” when functioning at temperature more than twice of the water boiling temperature, also results in the formation of steam.
Should Applicant respectfully assert the “flow generator” of Milewicz is not the same as the claimed invention, it should be noted Fodor expressly teaches a flow generator (9) in the form of a “breathing machine”. (Column 3, Lines 30-35).
In light of the teachings of Fodor, it would have been obvious to modify the operational temperature of Milewicz to operate at the claimed “100 degrees C or greater” as taught by Fodor to be a known operational temperature suitable for providing humidified gas to a patient.
Therefore, it would have been obvious to modify the electrical connectors of Milewicz to provide “electrical power and voltage” as taught by Bauer to be a known electrical circuity configuration to provide humidified gas, and to modify the operational temperature of Milewicz to include “steam … 100 degrees C or greater” as taught by Fodor to be a known temperature suitable for imparting humidified gas to a patient.
As to Claim 27, the modified Milewicz, specifically Milewicz discloses an air delivery tube (5, “Gas is provided through port 4 in the insufflator to a first gas supply tube 5, which passes through an optional filter 6 so that the supplied gas is clean before it enters a patient. … 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. 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 4, Lines 25-55) containing the respiratory gas flow path (12).
As to Claim 28, the modified Milewicz, specifically Milewicz discloses the humidifier (“Medical Humidifier” Title, best seen Figures 1-4) is supported within the air delivery tube (5) by means of one or more mounting structures (attachments at 12 and 18 as best seen in Figure 2) such that the major axis of the humidifier (“Medical Humidifier” Title, best seen Figures 1-4) is generally parallel to an axis of the air delivery tube (5).
Claim 10 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Milewicz (6,010,118) in view of Bauer et al. (4,266,166) and Fodor (4,038,980), as applied to Claim 1 and further in view of Fernandez Pernia (2011/0126831, which is 371 National Stage publication of PCT/ES08/70167 having a 371 publication date of February 26, 2010).
As to Claim 10, the modified Milewicz, specifically Milewicz discloses the porous structure (interior of 10 as defined by the combination of 21 and 23) is formed of an open pore metal; yet, does not expressly disclose the construction to be “an open pore metal foam”.
Fernandez Pernia teaches the construction of a "heat exchanger comprising an open cell foam structure" (Abstract), wherein the construction of "The open cell foam structure can be metallic whereas the metallic structure offers better thermal conductivity from the heat source to the heat exchanger." (Para 0020). Therefore, it would have been obvious to modify the open pore metal structure of the modified Milewicz to be constructed of the claimed "an open pore metal foam", as taught by Fernandez Pernia to provide "better thermal conductivity from the heat source to the heat exchanger".
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection.
Applicant’s amendments incorporating the language of “the temperature of the steam is 100 degrees C or greater” appears to overcome the former double patenting rejection to the instant claim listing.
However, an updated search with the newly added limitations appears to yield an obviousness rejection to the instant claim listing whereby Milewicz (6,010,118) appears to disclose the general structure of the humidifier as claimed, with the teachings of Bauer et al. (4,266,166) for the explicit functionality of “the first and second electrical connectors being configured to receive electrical power and apply voltage across the porous structure to generate heat” for the formation of vapor was known and the teachings of Fodor (4,038,980) for the explicit operational temperature of the vapor, in the form of steam having a temperature of “100 degrees C or greater” to “substantially convert liquid … passed through the porous structure/material into steam in medical devices was known.
In light of this new rejection combination, 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.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
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