DETAILED ACTION
Primary Examiner acknowledges Claims 1-20 are pending in this application as originally filed on July 18, 2023.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11, 12, 17, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, Claim 11, Line 1 recites the limitation “the metal”; however, this limitation appears to lack antecedent basis in the claims. The parentage of Claim 11 includes Claim 10 which recites the term “an open pore metal foam”. Primary Examiner is unsure of the breadth and scope upon which Applicant is seeking patent protection. Should the recitation of Claim 11, Line 1 include “the open pore metal foam is comprised of a metal foam and a polymer foam, wherein the metal foam is constructed of a metal component comprising …” or alternatively if some other aspect is desired for patent protection. As the breadth and scope of the claimed invention is unclear, the recitation of Claim 11 is indefinite. Appropriate correction and clarification is required.
Specifically, Claim 12, Line 1 recites “the metal foam”; however, this limitation appears to lack antecedent basis in the claims. The parentage of Claim 12 includes claim 10 which recites the term “an open pore metal foam”. Primary Examiner is unsure of the breadth and scope upon which Applicant is seeking patent protection. Should the recitation of Claim 12, Line 1 include “the open pore metal foam…” or alternatively if some other aspect is desired for patent protection. As the breadth and scope of the claimed invention is unclear, the recitation of Claim 12 is indefinite. Appropriate correction and clarification is required.
Specifically, Claim 12, Line 2 recites “a polymer foam”; however, the breadth and scope of this limitation is unclear how it relates back to the parentage of the Claim 12 having Claim 10 which recites the term “an open pore metal foam”. Is the “polymer foam” of Claim 12 manufactured with the “metal foam” of Claim 10 to make the claimed “an open pore metal foam”. Primary Examiner is unsure of the breadth and scope of Claim 12. It is unclear if Claim 12 should read “the open pore metal foam is comprised of a metal foam and a polymer foam, wherein …” or some other limitation. Hence, Claim 12 is indefinite. Appropriate correction and clarification is required.
Specifically, Claim 12, Line 2 recites “such as an open cell polyurethane foam”, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction and clarification is required.
Specifically, Claim 17, Line 2 recites “such as silicon carbide…”, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction and clarification is required.
Specifically, Claim 20, Line 2 recites “such as heat shrink…”, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 3-5, 7, 8, 13, 14, and 19 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Turnbull (5,769,071).
As to Claim 1, Turnbull discloses a humidifier (Figure 1), comprising: a heating element (25, “On the patient side of the exchange element 24, within the housing 23, there is an electrical heater 25 covered by an absorbent wick 26. … The control unit 20 controls the speed of the pump 30 and also provides power output to the heater 25 via a lead 32.” Column 2, Lines 5-25; “The heat and moisture of the inhaled gas, after passing through the exchange element 24 is supplemented by heat from the heater 25 and moisture evaporated from the wick 26.” Column 2, Lines 20-40; and “ fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 35-50) including a porous structure (26, “On the patient side of the exchange element 24, within the housing 23, there is an electrical heater 25 covered by an absorbent wick 26. A water inlet 27 is located close to the wick 26 and is connected via tubing 28 to a water reservoir in the form of a suspended bag 29 of sterile water. … The control unit 20 controls the speed of the pump 30 and also provides power output to the heater 25 via a lead 32.” Column 2, Lines 5-25; “The heat and moisture of the inhaled gas, after passing through the exchange element 24 is supplemented by heat from the heater 25 and moisture evaporated from the wick 26.” Column 2, Lines 20-40; and “ fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 35-50) 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”/ “moisture”, “The heat and moisture of the inhaled gas, after passing through the exchange element 24 is supplemented by heat from the heater 25 and moisture evaporated from the wick 26.” Column 2, Lines 20-40; and “ fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 35-50) that is passed through the porous structure (26), the porous structure (26) having a water inlet (27, “A water inlet 27 is located close to the wick 26 and is connected via tubing 28 to a water reservoir in the form of a suspended bag 29 of sterile water.” Column 2, Lines 5-25) and a vapor outlet (via 25 proximate 23/16); an outer housing (22 – which includes 23 and 24, “The flexible tubing 16 extends to a heat and moisture exchange (HME) device 22 forming a part of the humidifier apparatus 2. The device 22 has an outer housing 23 and an exchange element 24 made of paper or foam plastics treated to be hygroscopic.” Column 2, Lines 5-25) surrounding (as bounded by 23 and 24) at least a portion of the porous structure (26) for containing the liquid and vapor within the porous structure (26); and wherein the porous structure (26) includes a first electrical connector (via one of 32, “The control unit 20 controls the speed of the pump 30 and also provides power output to the heater 25 via a lead 32.” Column 2, Lines 5-25) and a second electrical connector (via other of 32, “The control unit 20 controls the speed of the pump 30 and also provides power output to the heater 25 via a lead 32.” Column 2, Lines 5-25), the first and second connectors (32/32) being configured for receiving electrical power and applying voltage (“The control unit 20 controls the speed of the pump 30 and also provides power output to the heater 25 via a lead 32.” Column 2, Lines 5-25)” across the porous structure (26) to generate heat.
As to Claim 3, Turnbull discloses a connector fitting (defined by the engagement of 27 and 28, “A water inlet 27 is located close to the wick 26 and is connected via tubing 28 to a water reservoir in the form of a suspended bag 29 of sterile water.” Column 2, Lines 5-25) configured to deliver liquid (“sterile water”) from a supply of liquid (via 29) to the liquid inlet (27).
As to Claim 4, Turnbull discloses a connector fitting (defined by the engagement of 27 and 28) comprises a connection spigot (via 30, “The tubing 28 passes through a peristaltic pump 30 contained within the same housing 31 as the control unit 20.” Column 2, Lines 5-25), and the humidifier (Figure 1) further comprises a sealing tube (via 28) configured to form a sealed connection between the connection spigot (via 30) and the outer housing (22).
As to Claim 5, Turnbull discloses a connector fitting (defined by the engagement of 27 and 28) comprises a liquid inlet spigot (via 30, “The tubing 28 passes through a peristaltic pump 30 contained within the same housing 31 as the control unit 20.” Column 2, Lines 5-25) configured to receive liquid (“sterile water”) from a supply of liquid (via 29), and wherein the humidifier (Figure 1) further comprises a liquid supply tube (28) connected to the liquid inlet spigot (via 30).
As to Claim 7, Turnbull discloses the porous structure (26) and the outer housing (22) are each elongate, and the vapor outlet (via 25 proximate 23/16) of the porous structure (26) is configured to be exposed to a flow of breathable gas (via 4, “In operation, the ventilator 4 supplies gas to the patient via the HME device 22 and gas supply means comprising the tubing 16, connector 15 and the tracheal tube 1. Exhaled gas flows from the patient towards the ventilator 4 through the exchange element 24 to which it gives up a large part of its heat and moisture.” Column 2, Lines 20-40) to be humidified through an open end (via connection of 4 to 22) of the outer housing (22).
Regarding the elongate limitation, the porous structure (26) has a greater length across the diameter outer housing (22) than coaxially within the outer housing (22), and thus is elongated across the length of the diameter of the outer housing (22); whilst, the outer housing (22) has a greater length transverse to the diameter porous structure (26) than coaxially within the porous structure (26), and thus is elongated transverse to the diameter of the porous structure (26). Primary Examiner notes the claims do not require the elongation configuration to be coplanar/coaxial for each of the porous structure as compared to the outer housing.
As to Claim 8, Turnbull discloses the vapor outlet (via 25 proximate 23/16) of the porous structure (26) extends beyond the outer housing (22) to enable the humidified gas to be imparted to the patient.
As to Claim 13, Turnbull discloses the porous structure (26) is a wick, whereby by conventional practice, wicks are formed by the weaving/braiding/twisting/knitting of a body of fibers.
As to Claim 14, Turnbull discloses the porous structure (26) is a wick, whereby by conventional practice, wicks are formed by the weaving/braiding/twisting/knitting of a body of fibers. The common manner of bundling the wick structure includes the claimed actions of weaving/braiding/twisting/knitting.
As to Claim 19, Turnbull discloses the outer housing (22) is formed of an electrically and thermally insulating material (to ensure the operational humidification control without causing shock or harm to the user by the water and electrical heating interaction).
Claims 1, 3-5, 7, 8, 13, 14, 17, and 19 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Fodor (4,038,980).
As to Claim 1, Fodor discloses 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.
As to Claim 3, Fodor discloses a connector fitting (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) configured to deliver a liquid (“water”) from a supply of liquid (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) to the liquid inlet (32).
As to Claim 4, Fodor discloses a connector fitting (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) comprises a connection spigot (defined by the operational control of 58), and the humidifier (Figures 1 and 2) further comprising a sealing tube (60, “inspection chamber 60” Column 3, Lines 55-70) configured to form a sealed connection between the connection spigot (defined by the operational control of 58) and the outer housing (2).
As to Claim 5, Fodor discloses a connector fitting (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) comprises a liquid inlet spigot (defined by the operational control of 58) configured to receive a liquid (“water”) from a supply of liquid (50), and wherein the humidifier (Figures 1 and 2) further comprising a liquid supply tube (60, “inspection chamber 60” Column 3, Lines 55-70) configured to form a sealed connection to the liquid inlet spigot (defined by the operational control of 58).
As to Claim 7, Fodor discloses the porous structure (22) and the outer housing (2) are each elongate (in the same directionality), and the vapor outlet (via 22 proximate 18) of the porous structure (22) is configured to be exposed to a flow of breathable gas to be humidified (via 9, “Port 4 is threaded to receive a locking ring 6 for securing an inlet pipe 8. Pipe 8 is connected to a source of air 9 e.g. a breathing machine.” Column 3, Lines 30-40) through an open end (4, “Referred to FIG. 1, the air humidifier has a tubular body 2 having in its side adjacent one end on air inlet port 4. Port 4 is threaded to receive a locking ring 6 for securing an inlet pipe 8. Pipe 8 is connected to a source of air 9 e.g. a breathing machine.” Column 3, Lines 30-40) of the outer housing (2).
As to Claim 8, Fodor discloses the vapor outlet (via 22 proximate 18) of the porous structure (22) extends beyond the outer housing (2) towards the patient interface at 21.
As to Claim 13, Fodor discloses the porous structure (22) is constructed from a body of fibers (“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; 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).
As to Claim 14, Fodor discloses the manner of manufacturing the body of fibers of the porous structure (22) includes weaving (“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; 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).
As to Claim 17, Fodor discloses the porous structure (22) is formed of a ceramic material (“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).
As to Claim 19, Fodor discloses the outer housing (2) is formed of an electrically and thermally insulating material (to ensure the operational humidification control without causing shock or harm to the user by the water and electrical heating interaction).
Claims 1, 3-9, 13, 14, 18, and 19 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Nitta (6,394,084).
As to Claim 1, Nitta discloses a humidifier (Figures 1-3), comprising: a heating element (16, “Exothermic member 13 comprises a heating wire 16 (a heater wire) and an electrically insulating member 17 enclosing the periphery of heating wire 16. Heating wire 16 is disposed in the inside of electrically insulating member 17 and has the function of generating heat upon receiving an electric current. A connection cord 18 is connected to heating wire 16 and extends from one end of exothermic member 13. An end portion of connection cord 18 is provided with a connector 19 for supplying electric current to the heating wire.” Column 5, Lines 40-70) including a porous structure (14, “As shown in FIG. 3, humidifying element 7 comprises exothermic member 13, multiple hollow fibers 14 held at the outer surface of exothermic member 13, and a mesh cover tube 15 covering, exothermic member 13 and multiple hollow fibers 14.” Column 5, Lines 40-70; also see: “Each hollow fiber constituting the multiple hollow fibers 14 has a peripheral wall with minute openings (for example a porosity rate of approximately 57.8%) which allows a as, such as water vapor, to permeate therethrough, yet prevents a liquid, such as water, from passing therethrough.” Column 5, Line 65 thru Column 6, Line 20; “this configuration allows water to be supplied to multiple hollow fibers 14 from both ends of the multiple hollow fibers 14, for example, thereby allowing each of multiple hollow fibers 14 to be filled with water at a high speed and with a high degree of precision.” Column 7, Lines 40-55; “By connecting connectors 19 and 28, electric current is allowed to be supplied to heating wire 16, thereby generating heat and warming each of the multiple hollow fibers 14 to cause them to discharge water vapor into the flow to breathing gas 3 from multiple hollow fibers 14. The amount of the water vapor discharged may be adjusted automatically on the basis of the difference between the pressure of the water vapor in multiple hollow fibers 14 and the pressure of the water vapor in patient circuit 1.”Column 8, Lines 20-35) 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 (“generating heat and warming each of the multiple hollow fibers 14 to cause them to discharge water vapor into the flow to breathing gas 3 from multiple hollow fibers 14”) that is passed through the porous structure (14), the porous structure (14) having a liquid inlet (via 21, “Water supply tube 25 has one end portion connected (for example, held by engagement) to water outlet 24a of water bag 24 and another end portion formed with a connector 26 (schematically shown) as the counterpart of connector 21, as shown in FIG. 1 and 4. Connector 26 is formed so as to engage connector 21 in an airtight manner by a one-touch operation.” Column 8, Lines 1-15) and a vapor outlet (via 7 proximate 31); an outer housing (4 – which includes 5 and 6, “In the embodiment shown in FIGS. 1 and 2, patient circuit 1 is mounted detachably to a humidification unit 4 that is provided with a short connection tube 5 as a support member, a mounting flange 6, and a humidifying element 7.” Column 4, Lines 50-70) surrounding at least a portion of the porous structure (14) for containing the liquid and vapor within the porous structure (14); and wherein the porous structure (14) includes a first electrical connector (one of the positive or negative wire as contained in 18, “A connection cord 18 is connected to heating wire 16 and extends from one end of exothermic member 13. An end portion of connection cord 18 is provided with a connector 19 for supplying electric current to the heating wire.” Column 5, Lines 40-70) and a second electrical connector (other of the positive or negative wire as contained in 18, “A connection cord 18 is connected to heating wire 16 and extends from one end of exothermic member 13. An end portion of connection cord 18 is provided with a connector 19 for supplying electric current to the heating wire.” Column 5, Lines 40-70), the first and second electrical connectors (wires as contained in 18, “A connection cord 18 is connected to heating wire 16 and extends from one end of exothermic member 13. An end portion of connection cord 18 is provided with a connector 19 for supplying electric current to the heating wire.” Column 5, Lines 40-70) being configured for receiving electrical power and applying voltage across the porous structure (14) to generate heat.
As to Claim 3, Nitta discloses a connector fitting (26, “Water supply tube 25 has one end portion connected (for example, held by engagement) to water outlet 24a of water bag 24 and another end portion formed with a connector 26 (schematically shown) as the counterpart of connector 21, as shown in FIG. 1 and 4. Connector 26 is formed so as to engage connector 21 in an airtight manner by a one-touch operation.” Column 8, Lines 1-15) configured to deliver a liquid (“water”) from a supply of liquid (24) to the liquid inlet (via 21).
As to Claim 4, Nitta discloses a connector fitting (26) comprises a connection spigot (via operation of 27, “Further, as shown in FIG. 1 water supply tube 25 is provided with a water drop counting device 27 as a flow meter for measuring the flow of water therethrough. The water drop counting device 27 is arranged so as to allow a flow of water to multiple hollow fibers 14 after the water has been dropped from water bag 24 into the water drop counting device 27. Further, water drop counting device 27 is arranged so as to visually confirm the state in which the water drops.” Column 8, Lines 10-20), and the humidifier (Figures 1-3) further comprising a sealing tube (via tube from 27 to 26, as shown in Figure 1) configured to form a sealed connection between the connection spigot (via the operation of 27) and the outer housing (4 as connected to 21).
As to Claim 5, Nitta discloses a connector fitting (26) comprises a liquid inlet spigot (via operation of 27, “Further, as shown in FIG. 1 water supply tube 25 is provided with a water drop counting device 27 as a flow meter for measuring the flow of water therethrough. The water drop counting device 27 is arranged so as to allow a flow of water to multiple hollow fibers 14 after the water has been dropped from water bag 24 into the water drop counting device 27. Further, water drop counting device 27 is arranged so as to visually confirm the state in which the water drops.” Column 8, Lines 10-20) configured to receive liquid (“water”) from a supply of liquid (24), and the humidifier (Figures 1-3) further comprising a liquid supply tube (via tube from 27 to 26, as shown in Figure 1) configured to form a sealed connection to the liquid inlet spigot (via the operation of 27).
As to Claim 6, Nitta discloses the first and second electrical connectors (wires as contained in 18, “A connection cord 18 is connected to heating wire 16 and extends from one end of exothermic member 13. An end portion of connection cord 18 is provided with a connector 19 for supplying electric current to the heating wire.” Column 5, Lines 40-70) are crimped together and thus a crimp connector.
As to Claim 7, Nitta discloses the porous structure (14) and the outer housing (4) are each elongate in the same directionality, and the vapor outlet (via 7 proximate 31) of the porous structure (14) is configured to be exposed to a flow of breathable gas (via 3, “The flow of breathing gas ill patient circuit 1 is indicated by arrow 3.” Column 4, Lines 35-55) to be humidified through an open end (1a) of the outer housing (4).
As to Claim 8, Nitta discloses the vapor outlet (via 7 proximate 31) of the porous structure (14) extends beyond the outer housing (4) towards the patient.
As to Claim 9, Nitta discloses the porous structure (14) has a cylindrical shape (best seen Figure 3 – at the connection 21 and vapor outlet (via 7 proximate 31)) and a tapered shape (proximate reference character 14 of Figure 3).
As to Claim 13, Nitta discloses the porous structure (14) is comprised of a body of fibers (“As shown in FIG. 3, humidifying element 7 comprises exothermic member 13, multiple hollow fibers 14 held at the outer surface of exothermic member 13, and a mesh cover tube 15 covering, exothermic member 13 and multiple hollow fibers 14.” Column 5, Lines 40-70).
As to Claim 14, Nitta discloses the porous structure (14) is comprised of a body of fibers (“As shown in FIG. 3, humidifying element 7 comprises exothermic member 13, multiple hollow fibers 14 held at the outer surface of exothermic member 13, and a mesh cover tube 15 covering, exothermic member 13 and multiple hollow fibers 14.” Column 5, Lines 40-70) arranged in a tape structure (as shown in Figure 3 the elements are wounded like a tape – “Furthermore, multiple hollow fibers 14 are wound around exothermic member 13 in such a manner that the axis of each of hollow fiber is arranged so as to be generally parallel to the axis of exothermic member 13, thereby ensuring a secure contact of each hollow fiber with the outer surface of exothermic member 13, thereby improving the transmission of heat to each hollow fiber from exothermic member 13. In addition, the amount of multiple hollow fibers 14 wound around exothermic member 13 can be readily adjusted, thereby allowing a ready increase or a decrease of the humidifying ability of the humidification unit according to the present invention.” Column 9, Lines 35-50).
As to Claim 18, Nitta discloses the porous structure (14) has a substantially uniform porosity (“Each hollow fiber constituting the multiple hollow fibers 14 has a peripheral wall with minute openings (for example a porosity rate of approximately 57.8%) which allows a as, such as water vapor, to permeate therethrough, yet prevents a liquid, such as water, from passing therethrough.” Column 5, Line 65 thru Column 6, Line 20).
As to Claim 19, Nitta discloses the outer housing (4) is formed of an electrically and thermally insulating material (to ensure the operational humidification control without causing shock or harm to the user by the water and electrical heating interaction).
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1, 3-9, 13, 14, 19, and 20 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Sata et al. (WO 2010116847 A1 also known as PCT/JP2010/054136 having a publication date of October 14, 2010 - for purposes of rejection as the WIPO/PCT document is not in English, Primary Examiner is utilizing the 371 National Stage publication of the WIPO/PCT document – US 2012/0017905 A1 – for reference in the rejection analysis).
As to Claim 1, Sata discloses a humidifier (Figure 2A), comprising: a heating element (8, “An artificial nose main body 2a is provided with a cylindrically shaped 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, a heat and moisture exchanger element 14 mounted inside the moisture permeable and water resistant film 6, and a wire heater 8 wrapped around outside the outer shell 4.” Para 0057) including a porous structure (14, “a heat and moisture exchanger element 14” Para 0057; also see: “the heat and moisture exchanger element 14 is loaded in this aeration region 12. Here, the heat and moisture exchanger element 14 is a material that captures and retains heat and moisture and further is capable of discharging the captured and retained heat and the moisture. Although the heat and moisture exchanger element 14 of the present embodiment is configured with a resin made foam, it may also be configured with a resin fiber tangled like cotton wool (for example, like nylon wool). The heat and moisture exchanger element 14 using such a resin material is excellent in reliability and durability. In addition, it may also be configured with, for example, hygroscopic paper, and in this case, the heat and moisture exchanger element 14 can be provided at low costs. As described above, it is preferred to use an optimal material in accordance with a status of use.” Para 0057) 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” – “As shown in FIG. 2(a), water supplied from a water container 24 is led into the water retention region 10 from a feed water inlet 16 through a dropping chamber 26 and the water supply tube 38 (the dropping chamber 26 is described later in detail using FIG. 5).” Para 0058) that is passed through the porous structure (14), the porous structure (14) having a liquid inlet (via 16, “As shown in FIG. 2(a), water supplied from a water container 24 is led into the water retention region 10 from a feed water inlet 16 through a dropping chamber 26 and the water supply tube 38 (the dropping chamber 26 is described later in detail using FIG. 5).” Para 0058) and a vapor outlet (via 14 proximate 2b); an outer housing (4, “a cylindrically shaped outer shell 4” Para 0057) surrounding at least a portion of the porous structure (14) for containing the liquid and vapor within the porous structure (14); and wherein the porous structure (14) includes a first electrical connector (8a/8b, “In the embodiment shown in FIGS. 2(a) and 2(b), the wire heater 8 is connected to a heater cable 8a, and at the other end of the heater cable 8a, a heater power connector 8b is connected for termination. In the water retention region 10, a thermistor 18 is arranged, and this thermistor 18 is connected to a thermistor cable 18a, and at the other end of the thermistor cable 18a, a thermistor connector 18b is connected for termination. Then, as shown in FIG. 5, the heater power connector 8b and the thermistor connector 18b are connected to heater output adjustment means 42, respectively.” Para 0101) and a second electrical connector (18a/18b, “In the embodiment shown in FIGS. 2(a) and 2(b), the wire heater 8 is connected to a heater cable 8a, and at the other end of the heater cable 8a, a heater power connector 8b is connected for termination. In the water retention region 10, a thermistor 18 is arranged, and this thermistor 18 is connected to a thermistor cable 18a, and at the other end of the thermistor cable 18a, a thermistor connector 18b is connected for termination. Then, as shown in FIG. 5, the heater power connector 8b and the thermistor connector 18b are connected to heater output adjustment means 42, respectively.” Para 0101), the first and second connectors (8a/8b and 18a/18b) being configured for receiving electrical power and applying a voltage across the porous structure (14) to generate heat.
As to Claim 3, Sata discloses a connector fitting (26, “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 38. 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 38 connected to the water retention region 10 of the artificial nose 2. As already described using FIGS. 2(a) and 2(b), the water supplied to the water supply tube 38 is supplied to the water retention region 10 through the feed water inlet 16.” Para 0129) configured to deliver liquid (“water”) from a supply of liquid (24, “water container 24” Para 0129) to the liquid inlet (16).
As to Claim 4, Sata discloses the connector fitting (26) comprises a connector spigot (defined by the operation of 26), and the humidifier (Figure 2A) further comprises a sealing tube (38, “water supply tube 38” Para 0129) configured to form a sealed connection between the connector spigot (defined by the operation of 26) and the outer housing (4).
As to Claim 5, Sata discloses the connector fitting (26) comprises a liquid inlet spigot (defined by the operation of 26) configured to receive liquid (“water”) from a supply of liquid (24, “water container 24” Para 0129), and wherein the humidifier (Figure 2A) further comprises a liquid supply tube (38, “water supply tube 38” Para 0129) connected to the liquid inlet spigot (defined by the operation of 26).
As to Claim 6, Sata discloses the first and second connectors (8a/8b and 18a/18b) is a crimp connector as the cables (8a/18a) are crimped and secured within (8b/18b).
As to Claim 7, Sata discloses the porous structure (14) and the outer housing (4) are each elongate in the same directionality, and the vapor outlet (via 14 proximate 2b) of the porous structure (14) is configured to be exposed to a flow of breathable gas (via 2c, “FIG. 1 is a full view (photograph) of a first embodiment of an artificial nose according to the present invention. An artificial nose 2 of the present embodiment is configured with an artificial nose main body 2a, and a user side end 2b and an inspiratory gas supply source side end 2c that are integrally formed with both ends thereof.” Para 0055; “In addition, with the outer shell 4, the artificial nose main body 2a, and the user side end 2b and the inspiratory gas supply source side end 2c are integrally formed with both ends thereof.” Para 0070) through an open end (2c) of the outer housing (4).
As to Claim 8, Sata discloses the vapor outlet (via 14 proximate 2b) of the porous structure (14) extends beyond the outer housing (4) towards the patient at 2b.
As to Claim 9, Sata discloses the porous structure (14) has a cylindrical shape (best shown in cross section in 2B as circular).
As to Claim 13, Sata discloses the porous structure (14) is constructed with a body of fibers (“Although the heat and moisture exchanger element 14 of the present embodiment is configured with a resin made foam, it may also be configured with a resin fiber tangled like cotton wool (for example, like nylon wool).” Para 0057).
As to Claim 14, Sata discloses the porous structure (14) is constructed with a body of fibers (“Although the heat and moisture exchanger element 14 of the present embodiment is configured with a resin made foam, it may also be configured with a resin fiber tangled like cotton wool (for example, like nylon wool).” Para 0057) wherein the method of manufacturing includes the formation of twists which result in a “tangled” construction.
As to Claim 19, Sata discloses the outer housing (4) is formed of an electrically and thermally insulating material (to ensure the operational humidification control without causing shock or harm to the user by the water and electrical heating interaction). Explicitly, Sata discloses “The outer shell 4 is configured with a resin material having air tightness and water tightness and also flexibility, and in the present embodiment, it is configured with vinyl chloride. It should be noted that it is not limited thereto and any other resin material, including polypropylene, polyethylene, polyethylene and ethylene vinyl acetate, and polyvinyl chloride, can be used.” Para 0069).
As to Claim 20, Sata discloses the outer housing (4) is can be formed from various polymers to include “polypropylene, polyethylene, polyethylene and ethylene vinyl acetate, and polyvinyl chloride” (Para 0069).
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.
Claim 15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fodor (4,038,980) in view of Aulgur (5,803,062).
As to Claim 15, Fodor discloses the manner of manufacturing the body of fibers of the porous structure (22) includes mineral fibers (“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; 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).
Yet, does not expressly disclose the use of carbon fiber.
Aulgur teaches known mineral fibers include the claimed carbon fiber. Explicitly, Aulgur teaches “Other reinforcement materials that can be used include metal fibers, silicon carbide fibers, mineral fibers such as boron, graphite, carbon fibers, aramid fibers, glass spheres and flakes, natural fibers such as cotton or jute, synthetic fibers such as acrylic and rayon, and the like.” (Column 8, Lines 5-55). As carbon fiber is considered as a species of under the generic disclosure of mineral fibers, the use of carbon fiber is obvious.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the mineral fiber of Fodor to utilize carbon fiber, a known type of mineral fiber, as taught by Aulgur.
Claim 16 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fodor (4,038,980) in view of Aulgur (5,803,062), as applied to Claim 15 and further in view of Counts et al. (5,369,723)
As to Claim 16, the modified Fodor, specifically Aulgur teaches the use of carbon fiber, a known type of mineral fiber.
Yet, does not expressly disclose “carbon fibres have precursors of Poly Acyrlic Nitrile, rayon and/or pitch.”
Counts teaches the construction of carbon fibers includes the claimed precursors. Explicitly, Counts teaches “The carbon mat includes carbon fibers that are made from a precursor selected from the group consisting of rayon, pitch and polyacrylonitrile.” (Abstract and Column 3, Lines 1-5). Further, Counts teaches the manner of manufacturing of carbon fiber is “made by carbonizing a carbon fiber precursor material selected from the group consisting of rayon, pitch and, more preferably, polyacrylonitrile (PAN). The carbonization of such precursors results in a carbon fiber that is either rayon-based, pitch-based, or polyacrylonitrile-based, depending upon the precursor material used to produce the fiber.” (Column 4, Lines 40-60). In light of the teachings of Count the manner of manufacturing carbon fiber includes the claimed precursors.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the manner of manufacturing of carbon fiber of the modified Fodor to include the claimed precursors as taught by Counts to construct a carbon fiber component.
Claim 10 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sata et al. (WO 2010116847 A1 also known as PCT/JP2010/054136 having a publication date of October 14, 2010 - for purposes of rejection as the WIPO/PCT document is not in English, Primary Examiner is utilizing the 371 National Stage publication of the WIPO/PCT document – US 2012/0017905 A1 – for reference in the rejection analysis) 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, Sata discloses the porous structure (14) can be formed of foam (“Although the heat and moisture exchanger element 14 of the present embodiment is configured with a resin made foam, it may also be configured with a resin fiber tangled like cotton wool (for example, like nylon wool).” Para 0057).
Yet, does not expressly disclose the use of “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 foam structure of Sata 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”.
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sata et al. (WO 2010116847 A1 also known as PCT/JP2010/054136 having a publication date of October 14, 2010 - for purposes of rejection as the WIPO/PCT document is not in English, Primary Examiner is utilizing the 371 National Stage publication of the WIPO/PCT document – US 2012/0017905 A1 – for reference in the rejection analysis) 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 applied to Claim 10, and further in view of Sprinkel et al. (5,649,554).
As to Claim 11, the modified Sata, specifically Fernandez Pernia teaches the use of the claimed “an open pore metal foam” to provide “better thermal conductivity from the heat source to the heat exchanger”.
Yet, does not expressly disclose the material composition of the metal component of the claimed “an open pore metal foam”.
Sprinkel teaches the construction of the cooperative arrangement of the heater and the porous structure combined together to enable the “appropriate electrical resistivity to generate the desired temperature” (Column 6, Line 65 thru Column 7, Line 25). Explicitly, Sprinkel teaches “As shown in FIGS. 3A-3E, the heater 32 is preferably mounted on a PEEK and ceramic substrate, as discussed below. A preferred material for heater 32 is a nickel-chromium-aluminum-iron-yttrium alloy such as an alloy comprising about 75% nickel, about 16% chromium, about 4.5% aluminum, about 3% iron, and traces of yttrium such as that sold by Haynes International, of Kokomo, Ind., under the trademark HASTELLOY.RTM. or the trademark HAYNES 214.RTM.” Column 6, Line 65 thru Column 7, Line 25). The configuration of Sprinkel meets the limitation of the claims as M is “at least 50% by weight” including 75% nickel and about 3% iron to yield 78% by weight; Cr is “between 8% and 35% by weight” by 16% chromium; Al is “greater than 0% but less than 8% by weight” by about 4.5% aluminum; and X is “less than 25% by weight” by traces of yttrium.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the material composition of the metal component of the claimed “an open pore metal foam” of the modified Sata to include the specifically claimed composition as taught by Sprinkel to ensure “appropriate electrical resistivity to generate the desired temperature”.
Claim 12 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sata et al. (WO 2010116847 A1 also known as PCT/JP2010/054136 having a publication date of October 14, 2010 - for purposes of rejection as the WIPO/PCT document is not in English, Primary Examiner is utilizing the 371 National Stage publication of the WIPO/PCT document – US 2012/0017905 A1 – for reference in the rejection analysis) 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 applied to Claim 10, and further in view of Vinton et al. (5,649,554).
As to Claim 11, the modified Sata, specifically Fernandez Pernia teaches the use of the claimed “an open pore metal foam” to provide “better thermal conductivity from the heat source to the heat exchanger”.
Yet, does not expressly disclose the manner of manufacturing to include the formation “by pyrolysis and/or metallisation of a polymer foam”.
Vinton teaches “A rapid method for forming vitreous carbon foams from flexible polyurethane foams having membranes dividing contiguous cells, which faithfully reproduces the geometry of the uncarbonized polyurethane foams, by infusing the polyurethane foams with substantially unresinified or unpolymerized furfuryl alcohol which is capable of resinification at temperatures above room temperature is described.” (Abstract), whereby “In Step 4, as shown in FIG. 5, the vitreous carbon foam 20 is produced by carbonizing the thermoset furan resin and polyurethane foam combination 17 in a neutral or reducing atmosphere or in a vacuum at elevated temperatures. In one method the impregnated foam 17 is placed in a container 21 on a support 22 with a loose fitting cover 23 and carbonized. The pyrolysis products of the infused foam function to eliminate oxygen and to maintain reducing or neutral conditions during carbonization. However, other gaseous neutral or inert atmospheres such as nitrogen or argon or gaseous reducing agents or reducing gaseous atmospheres such as hydrogen, or a vacuum, can be provided in the container 21 with sealing by the cover 23 to prevent the oxidation of the carbon foam 20 by excluding reaction with oxidizing gases during carbonization and during cooling.” (Column 4, Lines 35-55). The resultant effect of the reduced oxidation is the ability to manufacture the foam in less time without cracking/failure (“The present invention relates to a method for forming vitreous carbon foams which comprises; infusing flexible polyurethane foams with substantially unresinified but resinifiable furfuryl alcohol so as to cause the foams to swell by infusion of the furfuryl alcohol into the polymer comprising the foams, removing substantially all of the non-infused furfuryl alcohol from within the cells and from the surfaces of the infused foams, resinifying the furfuryl alcohol in the foams to form a thermoset resin, and carbonizing the infused foams under vacuum, neutral, non-oxidizing or reducing conditions thereby allowing crack-free carbonization to be achieved in less than about five hours at a rate of temperature change which causes cracking of the foam when substantial resinified furfuryl alcohol remains on the surfaces.” Column 2, Lines 35-70).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the claimed “an open pore metal foam” of the modified Sata to be made from the methodology of pyrolysis, as taught by Vinton to be a known method reducing time in the formation of foam materials.
Claim 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Turnbull (5,769,071) in view of Milewicz (6,101,118).
As to Claim 2, Turnbull discloses a humidifier having first and second connectors (32/32) being configured for receiving electrical power and applying voltage (“The control unit 20 controls the speed of the pump 30 and also provides power output to the heater 25 via a lead 32.” Column 2, Lines 5-25) across the porous structure (26) to generate heat, wherein the first and second connectors (32/32) appear to be attached at the same location.
Yet, does not expressly disclose the configuration whereby “the first electrical connector is located at or near the liquid inlet and the second electrical connector is located at or near the vapour outlet.”
Milewicz teaches an alternative construction of a humidifier having a first electrical connector (7 proximate 11) located proximate the liquid inlet (via 11, “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) and a second electrical connector (7 proximate 5) located proximate the source of the flow of breathable gas to be humidified (via 5, “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), wherein the electrical connector extend along the entire length of the humidifier to achieve the desired rate of heating (“The amount of heating supplied to the gas tubes and the humidifier is calculated from the amount of gas flowing and the period it has been flowing. Within the insufflation 3, the controller for the electricity supplied to the heater wire may act upon gas flow rate to switch on and off the electricity. This switching on and off may be termed the duty cycle with continuously on being 100% duty cycle. Approximately 30% of the heating occurs in the first tube, 65% in the humidification chamber, and 5% in the second tube.” Column 4, Line 55-70) thereby assuring the proper humidification of the liquid along the length of the humidifier.
Although Milewicz does not teach the explicit location of the second electrical connector as claimed to be “located at or near the vapor outlet”, the decision to modify the location of the second electrical connector of Turnbull to be “located at or near the vapor outlet” would be obvious to try choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, whereby success would be defined by the ability to achieve the desired humidification of for administration of humidified gases to the patient.
In light of the teachings of Milewicz the orientation of the second electrical connector of Turnbull to be located opposite the liquid inlet would yield the predictable results of ensuring the gas to be delivered to the patient achieves the desired humidification for administration to the patient. Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the Turnbull as modified by Milewicz in order to achieve the desired humidification for administration to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify Turnbull to include the orientation of the second electrical connector opposite the liquid inlet and proximate the vapor outlet, a known result effective variable, in order to achieve the desired humidification for administration to the patient.
Claim 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fodor (4,038,980) in view of Milewicz (6,101,118).
As to Claim 2, Fodor discloses a humidifier having 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, wherein the first and second connectors (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) appear to be attached at the same location.
Yet, does not expressly disclose the configuration whereby “the first electrical connector is located at or near the liquid inlet and the second electrical connector is located at or near the vapour outlet.”
Milewicz teaches an alternative construction of a humidifier having a first electrical connector (7 proximate 11) located proximate the liquid inlet (via 11, “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) and a second electrical connector (7 proximate 5) located proximate the source of the flow of breathable gas to be humidified (via 5, “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), wherein the electrical connector extend along the entire length of the humidifier to achieve the desired rate of heating (“The amount of heating supplied to the gas tubes and the humidifier is calculated from the amount of gas flowing and the period it has been flowing. Within the insufflation 3, the controller for the electricity supplied to the heater wire may act upon gas flow rate to switch on and off the electricity. This switching on and off may be termed the duty cycle with continuously on being 100% duty cycle. Approximately 30% of the heating occurs in the first tube, 65% in the humidification chamber, and 5% in the second tube.” Column 4, Line 55-70) thereby assuring the proper humidification of the liquid along the length of the humidifier.
Although Milewicz does not teach the explicit location of the second electrical connector as claimed to be “located at or near the vapor outlet”, the decision to modify the location of the second electrical connector of Fodor to be “located at or near the vapor outlet” would be obvious to try choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, whereby success would be defined by the ability to achieve the desired humidification of for administration of humidified gases to the patient.
In light of the teachings of Milewicz the orientation of the second electrical connector of Fodor to be located opposite the liquid inlet would yield the predictable results of ensuring the gas to be delivered to the patient achieves the desired humidification for administration to the patient. Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the Fodor as modified by Milewicz in order to achieve the desired humidification for administration to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify Fodor to include the orientation of the second electrical connector opposite the liquid inlet and proximate the vapor outlet, a known result effective variable, in order to achieve the desired humidification for administration to the patient.
Claim 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nitta (6,394,084) in view of Milewicz (6,101,118).
As to Claim 2, Nitta discloses a humidifier having first and second electrical connectors (wires as contained in 18, “A connection cord 18 is connected to heating wire 16 and extends from one end of exothermic member 13. An end portion of connection cord 18 is provided with a connector 19 for supplying electric current to the heating wire.” Column 5, Lines 40-70) being configured for receiving electrical power and applying voltage across the porous structure (14) to generate heat, wherein the first and second connectors (32/32) appear to be attached at the same location.
Yet, does not expressly disclose the configuration whereby “the first electrical connector is located at or near the liquid inlet and the second electrical connector is located at or near the vapour outlet.”
Milewicz teaches an alternative construction of a humidifier having a first electrical connector (7 proximate 11) located proximate the liquid inlet (via 11, “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) and a second electrical connector (7 proximate 5) located proximate the source of the flow of breathable gas to be humidified (via 5, “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), wherein the electrical connector extend along the entire length of the humidifier to achieve the desired rate of heating (“The amount of heating supplied to the gas tubes and the humidifier is calculated from the amount of gas flowing and the period it has been flowing. Within the insufflation 3, the controller for the electricity supplied to the heater wire may act upon gas flow rate to switch on and off the electricity. This switching on and off may be termed the duty cycle with continuously on being 100% duty cycle. Approximately 30% of the heating occurs in the first tube, 65% in the humidification chamber, and 5% in the second tube.” Column 4, Line 55-70) thereby assuring the proper humidification of the liquid along the length of the humidifier.
Although Milewicz does not teach the explicit location of the second electrical connector as claimed to be “located at or near the vapor outlet”, the decision to modify the location of the second electrical connector of Nitta to be “located at or near the vapor outlet” would be obvious to try choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, whereby success would be defined by the ability to achieve the desired humidification of for administration of humidified gases to the patient.
In light of the teachings of Milewicz the orientation of the second electrical connector of Nitta to be located opposite the liquid inlet would yield the predictable results of ensuring the gas to be delivered to the patient achieves the desired humidification for administration to the patient. Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the Nitta as modified by Milewicz in order to achieve the desired humidification for administration to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify Nitta to include the orientation of the second electrical connector opposite the liquid inlet and proximate the vapor outlet, a known result effective variable, in order to achieve the desired humidification for administration to the patient.
Claim 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sata et al. (WO 2010116847 A1 also known as PCT/JP2010/054136 having a publication date of October 14, 2010 - for purposes of rejection as the WIPO/PCT document is not in English, Primary Examiner is utilizing the 371 National Stage publication of the WIPO/PCT document – US 2012/0017905 A1 – for reference in the rejection analysis) in view of Milewicz (6,101,118).
As to Claim 2, Sata discloses a humidifier having the first and second connectors (8a/8b and 18a/18b) being configured for receiving electrical power and applying a voltage across the porous structure (14) to generate heat, wherein the first and second connectors (8a/8b and 18a/18b) appear to be attached at the same location.
Yet, does not expressly disclose the configuration whereby “the first electrical connector is located at or near the liquid inlet and the second electrical connector is located at or near the vapour outlet.”
Milewicz teaches an alternative construction of a humidifier having a first electrical connector (7 proximate 11) located proximate the liquid inlet (via 11, “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) and a second electrical connector (7 proximate 5) located proximate the source of the flow of breathable gas to be humidified (via 5, “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), wherein the electrical connector extend along the entire length of the humidifier to achieve the desired rate of heating (“The amount of heating supplied to the gas tubes and the humidifier is calculated from the amount of gas flowing and the period it has been flowing. Within the insufflation 3, the controller for the electricity supplied to the heater wire may act upon gas flow rate to switch on and off the electricity. This switching on and off may be termed the duty cycle with continuously on being 100% duty cycle. Approximately 30% of the heating occurs in the first tube, 65% in the humidification chamber, and 5% in the second tube.” Column 4, Line 55-70) thereby assuring the proper humidification of the liquid along the length of the humidifier.
Although Milewicz does not teach the explicit location of the second electrical connector as claimed to be “located at or near the vapor outlet”, the decision to modify the location of the second electrical connector of Sata to be “located at or near the vapor outlet” would be obvious to try choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, whereby success would be defined by the ability to achieve the desired humidification of for administration of humidified gases to the patient.
In light of the teachings of Milewicz the orientation of the second electrical connector of Sata to be located opposite the liquid inlet would yield the predictable results of ensuring the gas to be delivered to the patient achieves the desired humidification for administration to the patient. Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the Sata as modified by Milewicz in order to achieve the desired humidification for administration to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify Sata to include the orientation of the second electrical connector opposite the liquid inlet and proximate the vapor outlet, a known result effective variable, in order to achieve the desired humidification for administration to the patient.
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 1-5, and 7-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,307,559.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant independent claim, Claim 1, is merely broader than patent 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 is thus much more specific. Thus, the invention of the patent claim is in effect a “species” of the “generic” invention of the instant claim. It has been held that the “generic” invention is “anticipated” by the ”species”. See 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 Claim – 18/353,965
Italics are minor differences which are rejected under 112(2/b).
Patent Claim - 10,307,559
Differences Underlined
1. A humidifier, comprising: a heating element including a porous structure of electrically resistive and thermally conductive material configured to substantially vaporise liquid that is passed through the porous structure, the porous structure having a liquid inlet and a vapour outlet; an outer housing surrounding at least a portion of the porous structure for containing the liquid and vapour within the porous structure; and wherein the porous structure includes a first electrical connector and a second electrical connector, the first and second connectors being configured for receiving electrical power and applying a voltage across the porous structure to generate heat.
1. A humidifier for increasing a humidity of a supply of air, the humidifier comprising: an enclosed gas flow path for the supply of air; a heating element including a porous structure of electrically resistive and thermally conductive material configured to substantially vaporise liquid that is passed through the porous structure, the porous structure having a liquid inlet and a vapour outlet; and an outer housing surrounding at least a portion of the porous structure for containing the liquid and vapour within the porous structure, an enclosure of the enclosed gas flow path surrounding the outer housing so that the enclosed gas flow path is between the outer housing and the enclosure of the enclosed gas flow path and the heating element and the outer housing are immersed within the supply of air in the enclosed gas flow path; wherein the porous structure includes a first electrical connector and a second electrical connector, the first
electrical connector and the second electrical connector being configured for receiving electrical power and applying a voltage across the porous structure so that the porous structure generates heat; and the vapour outlet is arranged to expel heated vapour for delivery into the enclosed gas flow path to increase the humidity of the supply of air.
2. The humidifier according to claim 1, wherein the first electrical connector is located at or near the liquid inlet and the second electrical connector is located at or near the vapour outlet.
2. The humidifier according to claim 1, wherein the first electrical connector is located at or near the liquid inlet and the second electrical connector is located at or near the vapour outlet.
3. The humidifier according to claim 1, further comprising a connector fitting configured to deliver liquid from a supply of liquid to the liquid inlet.
3. The humidifier according to claim 1, further comprising a connector fitting configured to deliver liquid from a supply of liquid to the liquid inlet.
4. The humidifier according to claim 3, wherein the connector fitting comprises a connection spigot, and the humidifier further comprises a sealing tube configured to form a sealed connection between the connection spigot and the outer housing.
4. The humidifier according to claim 3, wherein the connector fitting comprises a connection spigot, and the humidifier further comprises a sealing tube configured to form a sealed connection between the connection spigot and the outer housing.
5. The humidifier according to claim 3, wherein the connector fitting comprises a liquid inlet spigot configured to receive liquid from the supply of liquid, and wherein the humidifier further comprises a liquid supply tube connected to the liquid inlet spigot.
5. The humidifier according to claim 3, wherein the connector fitting comprises a liquid inlet spigot configured to receive liquid from the supply of liquid, and wherein the humidifier further comprises a liquid supply tube connected to the liquid inlet spigot.
6. The humidifier according to claim 1, wherein the first electrical connector and/or the second electrical connector is a crimp connector.
7. The humidifier according to claim 1, wherein the porous structure and the outer housing are each elongate, and the vapour outlet of the porous structure is configured to be exposed to a flow of breathable gas to be humidified through an open end of the outer housing.
6. The humidifier according to claim 1, wherein the porous structure and the outer housing are each elongate, and the vapour outlet of the porous structure extends beyond the outer housing and is configured to be exposed to a flow of breathable gas to be humidified through an open end of the outer housing.
8. The humidifier according to claim 7, wherein the vapour outlet of the porous structure extends beyond the outer housing.
6. The humidifier according to claim 1, wherein the porous structure and the outer housing are each elongate, and the vapour outlet of the porous structure extends beyond the outer housing and is configured to be exposed to a flow of breathable gas to be humidified through an open end of the outer housing.
9. The humidifier according to claim 1, wherein the porous structure has a cylindrical shape or a tapered shape.
7. The humidifier according to claim 1, wherein the porous structure has a cylindrical shape or a tapered shape.
10. The humidifier according to claim 1, wherein the porous structure is formed of an open pore metal foam.
8. The humidifier according to claim 1, wherein the porous structure is formed of an open pore metal foam and the open pore metal foam comprises a chromium alloy, the chromium alloy comprising MCrAlX, where M is one or more of Nickel (Ni), Cobalt (Co) or Iron (Fe) contributing at least 50% by weight, Chromium (Cr) contributing between 8% and 35% by weight, Aluminium (Al) contributing greater than 0% but less than 8% by weight, and X contributing less than 25% by weight, with X including zero or more other elements, including Molybdenum (Mo), Rhenium (Re), Ruthenium (Ru), Titanium (Ti), Tantalum (Ta), Vanadium (V), Tungsten (W), Niobium (Nb), Zirconium (Zr), Boron (B), Carbon (C), Silicon (Si), Yttrium (Y) and Hafnium (Hf).
11. The humidifier according to claim 10, wherein the metal comprises a chromium alloy, the chromium alloy comprising MCrAlX, where M is one or more of Nickel (Ni), Cobalt (Co) or Iron (Fe) contributing at least 50% by weight, Chromium (Cr) contributing between 8% and 35% by weight, Aluminium (Al) contributing greater than 0% but less than 8% by weight, and X contributing less than 25% by weight, with X including zero or more other elements, including to Molybdenum (Mo), Rhenium (Re), Ruthenium (Ru), Titanium (Ti), Tantalum (Ta), Vanadium (V), Tungsten (W), Niobium (Nb), Zirconium (Zr), Boron (B), Carbon (C), Silicon (Si), Yttrium (Y) and Hafnium (Hf).
8. The humidifier according to claim 1, wherein the porous structure is formed of an open pore metal foam and the open pore metal foam comprises a chromium alloy, the chromium alloy comprising MCrAlX, where M is one or more of Nickel (Ni), Cobalt (Co) or Iron (Fe) contributing at least 50% by weight, Chromium (Cr) contributing between 8% and 35% by weight, Aluminium (Al) contributing greater than 0% but less than 8% by weight, and X contributing less than 25% by weight, with X including zero or more other elements, including Molybdenum (Mo), Rhenium (Re), Ruthenium (Ru), Titanium (Ti), Tantalum (Ta), Vanadium (V), Tungsten (W), Niobium (Nb), Zirconium (Zr), Boron (B), Carbon (C), Silicon (Si), Yttrium (Y) and Hafnium (Hf).
12. The humidifier according to claim 10, wherein the metal foam is formed by pyrolysis and/or metallisation of a polymer foam such as an open cell polyurethane foam.
9. The humidifier according to claim 8, wherein the open pore metal foam is formed by pyrolysis and/or metallisation of a polymer foam.
13. The humidifier according to claim 1, wherein the porous structure comprises a body of fibres.
10. The humidifier according to claim 1, wherein the porous structure comprises a body of carbon fibres bundled in a form of tow-, twist-, knit-, braid-, felt-, woven fabric or tape- structures, the body of carbon fibres having precursors of Poly Acyrlic Nitrile, rayon and/or pitch.
14. The humidifier according to claim 13, wherein the body of fibres is bundled in a form of tow-, twist-, knit-, braid-, felt-, woven fabric- or tape- structures.
10. The humidifier according to claim 1, wherein the porous structure comprises a body of carbon fibres bundled in a form of tow-, twist-, knit-, braid-, felt-, woven fabric or tape- structures, the body of carbon fibres having precursors of Poly Acyrlic Nitrile, rayon and/or pitch.
15. The humidifier according to claim 13, wherein the body of fibres comprises carbon fibres.
10. The humidifier according to claim 1, wherein the porous structure comprises a body of carbon fibres bundled in a form of tow-, twist-, knit-, braid-, felt-, woven fabric or tape- structures, the body of carbon fibres having precursors of Poly Acyrlic Nitrile, rayon and/or pitch.
16. The humidifier according to claim 15, wherein the carbon fibres have precursors of Poly Acyrlic Nitrile, rayon and/or pitch.
10. The humidifier according to claim 1, wherein the porous structure comprises a body of carbon fibres bundled in a form of tow-, twist-, knit-, braid-, felt-, woven fabric or tape- structures, the body of carbon fibres having precursors of Poly Acyrlic Nitrile, rayon and/or pitch.
17. The humidifier according to claim 1, wherein the porous structure is formed of ceramic material such as silicon carbide, titanium nitride or pyrolytic carbon.
11. The humidifier according to claim 1, wherein the porous structure is formed of ceramic material.
18. The humidifier according to claim 1, wherein the porous structure has a substantially uniform porosity or has a porosity that varies along its length and/or diameter.
12. The humidifier according to claim 1, wherein the porous structure has a substantially uniform porosity or has a porosity that varies along its length and/or diameter.
19. The humidifier according to claim 1, wherein the outer housing is formed of electrically and thermally insulating material.
13. The humidifier according to claim 1, wherein the outer housing is formed of electrically and thermally insulating material.
20. The humidifier according to claim 19, wherein the outer housing is formed of alumina, fused quartz, or a polymer such as heat shrink or silicone rubber.
14. The humidifier according to claim 13, wherein the outer housing is formed of alumina, fused quartz, or a polymer.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,307,559 in view of Brooks et al. (4,922,901).
As to Claim 6, 10,307,559 discloses “the porous structure includes a first electrical connector and a second electrical connector, the first electrical connector and the second electrical connector being configured for receiving electrical power and applying a voltage across the porous structure so that the porous structure generates heat” (Patent Claim 1); yet, does not expressly disclose “wherein the first electrical connector and/or the second electrical connector is a crimp connector.”
Books teaches the use of crimp connectors was known as the terminal points of a heating element suitable for imparting a gripping surface upon which the heating element can be introduced and/or removed safely without harm to the user. Explicitly, as shown in Figures 1 and 2, Brooks teaches “Two 15 mm long crimp connectors 40, 41, including pins 38, 39, are obtained from Black Box Corp., Pittsburgh, PA. under Catalog No GH-FA810. Crimp connectors 40, 41 are attached to each end of the heating element 18. Pin 38 of the first connector 40 is inserted through one of the smaller passageways in the plug 16. The heating element then is folded over a 20 mm long, 5 mm wide strip of Kapton polyimide film 36, to keep the heating element from contacting itself, and pin 39 of the second connector 41 then is inserted through the second small passageway of the plug 16.” (Column 15, Lines 45-60; also see: “The plug 16 includes two electrical connector pins or prongs 38, 39 connected to the ends of heating element 18 via connectors 40, 41.” Column 7, Lines 20-35). The resultant effect of the configuration of utilizing a crimp connector enables the heating element to be readily introduced and/or removed from the additional components of the medical device without the user gripping the hot wire of the heating element.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the electrical connections of the heating element of 10,307,559 to include the use of crimp connectors, as a known termination structure suitable for imparting introduction and/or removal of the components of the medical device as desired without harm to the user.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Foote et al. (11,744,979) shares a common assignee/inventor with the instant application; however, at this time there does not appear to be a double patenting rejection applicable – as the instantly claimed porous structure of the heating element is not recited within the conflicting claim listing to be constructed of a “thermally conductive material”; the instantly claimed outer housing is not recited within the conflicting claims to be “outer”; nor the instantly claimed configuration of the first and second electrical connectors being configured for applying a voltage across the porous structure to generate heat” is not recited withing the conflicting claims to include a positive recitation of “voltage”.
Du et al. (7,428,902) recites an additional humidifier system having a heater (34), porous structure (24), a water inlet (26) and a vapor outlet (21), an outer housing (35) and electrical connections (45); yet, does not expressly disclose the claimed “first and second electrical connectors”.
Anthony (2006/0012057) recites an additional humidifier system having a heater (10), a porous structure (7), a water inlet (via 9), a vapor outlet (via 14), an outer housing (3) and electrical connections (12); yet, does not expressly disclose the claimed “first and second electrical connectors”.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785