DETAILED ACTION
Primary Examiner acknowledges Claims 21-40 are pending in this application, with Claims 21-40 having been newly added, and Claims 1-20 having been cancelled by preliminary amendment on November 12, 2024.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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 21-40 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 21, Line 9 recites “the vents”; however, this term lacks antecedent basis in the claims. It appears perhaps this limitation should be changed to “the plurality of vents” for consistency with the former recitation in Claim 21, Line 8. Dependent claims, Claims 22-30, incorporate the indefinite subject matter from which they depend. Explicitly, Primary Examiner notes Claim 26, Line 1 and Claim 27, Line 1 propagate the lack of antecedent basis by the recitation of “the vents”. It appears perhaps these limitations should be changed to “the plurality of vents” for consistency. Appropriate correction and clarification is required.
Specifically, Claim 31, Line 8 recites “the holes”; however, this term lacks antecedent basis in the claims. It appears perhaps this limitation should be changed to “the plurality of holes” for consistency with the former recitation in Claim 31, Line 7. Dependent claims, Claims 32-40, incorporate the indefinite subject matter from which they depend. Explicitly, Primary Examiner notes Claim 36, Line 1 and Claim 37, Line 2 propagate the lack of antecedent basis by the recitation of “the holes”. It appears perhaps these limitations should be changed to “the plurality of holes” for consistency. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 31, 33, 34, 37, and 39 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Artemenko et al. (4,771,770).
As to Claim 31, Artemenko discloses a heat and moisture exchanger (HMX) (Figure 2) for use with a patient interface (1, “An oxygen self-contained breathing apparatus, based on pendulum air circulation comprises a facepiece 1 (FIG. 1) for application to be face so as to cover the respiratory organs of a human being, which includes a mouthpiece 2 with a nose clamp 3, the facepiece being connected to a moisture and heat exchange device 4, a regenerating cartridge 5 containing an oxygen generating chemical such as potassium superoxide KO.sub.2 connected to a breathing bag 6.” Column 3, Lines 10-25) to humidify a flow of pressurized air (oxygen via 5 and 6, “a regenerating cartridge 5 containing an oxygen generating chemical such as potassium superoxide KO.sub.2 connected to a breathing bag 6.” Column 3, Lines 10-25) supplied to the patient by the patient interface (1), the HMX (Figure 2) comprising: a frame (4, “The moisture and heat exchange device 4 is connected to the facepiece 1 of the apparatus by means of a flexible pipe 7.” Column 3, Lines 10-25) configured to be connected to the patient interface (1); and an HMX material (at least one of 14, “The hydrophilic washers 13 and the hydrophobic washers 14 are made of fiberous polymer materials featuring a very low heat conductivity … The hydrophobic washers 14 are made of a non-woven (jet-spun) web made of Lavsan fibers. … Use of the hydrophobic washers 14 made of non-woven web manufactured from a polymer fibrous material exhibiting a low heat conductance ensures good heat exchange between air passing by in a matter of fractions of a second and fibers of the hydrophobic washer 14 having a large surface area.” Column 3, Lines 35-65; NOTE: Lavsan is a synthetic material made from petroleum products, one of the types of thermoplastic. Belongs to the group of polyester fibers. The chemical name of the fiber is polyethylene terephthalate. https://tonirsurgut.ru/en/vidy-tkanej/lavsan-eto.html) connected to the frame (4) and comprising a non-woven web of fibers (“non-woven (jet-spun) web made of Lavsan fibers” Column 3, Lines 35-65), the HMX material (at least one of 14) comprising a first side (defined by the side of the at least one of 14 proximate 11, wherein 11 – “The pipe 11 connects to the regenerating cartridge 5 (FIG. 1) and is designed for supplying dry and heated regenerated air.” Column 3, Lines 25-40) and a second side (defined by the side of the at least one of 14 proximate 10, wherein 10 – “The pipe 10 connects to the facepiece 1 of the apparatus and is designed for supplying exhaled air.” Column 3, Lines 25-40) opposite the first side (defined by the side of the at least one of 14 proximate 11), and the HMX material (at least one of 14) comprising a plurality of holes (16 of 15, best seen Figure 3, “At least one of the air-distribution pressure screens 15 is preferably made in the form of a perforated disc (FIG. 3) having its meshes (orifices) 16 increasing in size in the direction from the center towaard the periphery.” Column 4, Lines 1-25; “One of the air-distribution pressure screens 15 was made of a wire net having 16 meshes of 3.times.3 mm. The other air-distribution pressure screen 15 was arranged in coaxial rows in the form of a disc having orifices 16 of a diameter increasing from 1.5 mm in the central zone to 6 mm at the periphery of the disc.” Column 4, Lines 20-40) extending from the first side (defined by the side of the at least one of 14 proximate 11) to the second side (defined by the side of the at least one of 14 proximate 10) to allow air to flow through the plurality of holes (16 of 15) in a linear direction between the first side (defined by the side of the at least one of 14 proximate 11) to the second side (defined by the side of the at least one of 14 proximate 10).
As to Claim 33, Artemenko discloses the fibers (“non-woven (jet-spun) web made of Lavsan fibers” Column 3, Lines 35-65) comprise synthetic polymer fibers (“polymer”, “The hydrophilic washers 13 and the hydrophobic washers 14 are made of fiberous polymer materials featuring a very low heat conductivity … The hydrophobic washers 14 are made of a non-woven (jet-spun) web made of Lavsan fibers. … Use of the hydrophobic washers 14 made of non-woven web manufactured from a polymer fibrous material exhibiting a low heat conductance ensures good heat exchange between air passing by in a matter of fractions of a second and fibers of the hydrophobic washer 14 having a large surface area.” Column 3, Lines 35-65; NOTE: Lavsan is a synthetic material made from petroleum products, one of the types of thermoplastic. Belongs to the group of polyester fibers. The chemical name of the fiber is polyethylene terephthalate. https://tonirsurgut.ru/en/vidy-tkanej/lavsan-eto.html).
As to Claim 34, Artemenko discloses the HMX material (at least one of 14) can be joined to an additional HMX material (another of at least one of 14). As best seen in Figure 2, there appears to be at least five (5) layers of non-woven composite material (at least one of 14).
As to Claim 37, Artemenko discloses the HMX material (at least one of 14) has a first impedance as a function of the porosity achieved through the linear density (“The web of the hydrophobic washers 14 has a linear density of from 0.7 to 2 tex, i.e. this web is much more porous as compared with the material of the hydrophilic washers 13.” Column 3, Lines 35-50) to the flow of air and each of the plurality of holes (16 of 15) has a second impedance as a function of the porosity achieve by the diameters (“One of the air-distribution pressure screens 15 was made of a wire net having 16 meshes of 3.times.3 mm. The other air-distribution pressure screen 15 was arranged in coaxial rows in the form of a disc having orifices 16 of a diameter increasing from 1.5 mm in the central zone to 6 mm at the periphery of the disc.” Column 4, Lines 20-40) to the flow of pressurized air. The nature of the plurality of holes (16 of 15) being for the purpose of “air-distribution” imparts the second impedance to be less than the first impedance in order to permit proper flow and treatment (through heat and moisture exchange) along the pathway, whereby the impedance or resistance to flow “decreases in the direction from the center of the disc toward the periphery” (Column 4, Lines 1-25: See: “With such a construction of the air-distribution pressure screen 15, the aerodynamic resistance of the meshes decreases in the direction from the center of the disc toward the periphery. The most optimal embodiment is one in which the law of change in the aerodynamic resistance of the air-distribution pressure screen 15 in the direction from the center toward the periphery corresponds to the parabolic law of distribution of velocities of the air flow. This makes it possible to ensure uniform distribution of air flow among all zones of the multiple-layer package 12 thereby improving conditions for the flow of air around fibers of the hydrophilic and hydrophobic washers 13, 14 and to enhance efficiency of heat exchange.“ Column 4, Lines 1-25). Consequently, the porosity of the plurality of holes located on the periphery has a impedance that is less than the porosity of the HMX material.
As to Claim 39, Artemenko discloses the HMX material (at least one of 14) has a uniform thickness. As best seen in Figure 2, there appears to be at least five (5) HMX materials (at least one of 14) which are the same thickness.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21, 23, 24, 27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Artemenko et al. (4,771,770) in view of Waldo, Jr. et al. (7,069,928).
As to Claim 21, Artemenko discloses a heat and moisture exchanger (HMX) (Figure 2) for use with a patient interface (1, “An oxygen self-contained breathing apparatus, based on pendulum air circulation comprises a facepiece 1 (FIG. 1) for application to be face so as to cover the respiratory organs of a human being, which includes a mouthpiece 2 with a nose clamp 3, the facepiece being connected to a moisture and heat exchange device 4, a regenerating cartridge 5 containing an oxygen generating chemical such as potassium superoxide KO.sub.2 connected to a breathing bag 6.” Column 3, Lines 10-25) to humidify a flow of pressurized air (oxygen via 5 and 6, “a regenerating cartridge 5 containing an oxygen generating chemical such as potassium superoxide KO.sub.2 connected to a breathing bag 6.” Column 3, Lines 10-25) supplied to the patient by the patient interface (1), the HMX (Figure 2) comprising: an outer body (4, “The moisture and heat exchange device 4 is connected to the facepiece 1 of the apparatus by means of a flexible pipe 7.” Column 3, Lines 10-25) configured to be connected to the patient interface (1); and a layer of non-woven composite material (at least one of 14, “The hydrophilic washers 13 and the hydrophobic washers 14 are made of fiberous polymer materials featuring a very low heat conductivity … The hydrophobic washers 14 are made of a non-woven (jet-spun) web made of Lavsan fibers. … Use of the hydrophobic washers 14 made of non-woven web manufactured from a polymer fibrous material exhibiting a low heat conductance ensures good heat exchange between air passing by in a matter of fractions of a second and fibers of the hydrophobic washer 14 having a large surface area.” Column 3, Lines 35-65; NOTE: Lavsan is a synthetic material made from petroleum products, one of the types of thermoplastic. Belongs to the group of polyester fibers. The chemical name of the fiber is polyethylene terephthalate. https://tonirsurgut.ru/en/vidy-tkanej/lavsan-eto.html) connected to the outer body (4) and constructed from a web of fibers (“non-woven (jet-spun) web made of Lavsan fibers” Column 3, Lines 35-65), the layer of non-woven composite material (at least one of 14) comprising a first surface (defined by the surface of the at least one of 14 proximate 11, wherein 11 – “The pipe 11 connects to the regenerating cartridge 5 (FIG. 1) and is designed for supplying dry and heated regenerated air.” Column 3, Lines 25-40) and a second surface (defined by the surface of the at least one of 14 proximate 10, wherein 10 – “The pipe 10 connects to the facepiece 1 of the apparatus and is designed for supplying exhaled air.” Column 3, Lines 25-40) opposite the first surface (defined by the surface of the at least one of 14 proximate 11), and the layer of non-woven composite material (at least one of 14) comprising a plurality of vents (16 of 15, best seen Figure 3, “At least one of the air-distribution pressure screens 15 is preferably made in the form of a perforated disc (FIG. 3) having its meshes (orifices) 16 increasing in size in the direction from the center towaard the periphery.” Column 4, Lines 1-25; “One of the air-distribution pressure screens 15 was made of a wire net having 16 meshes of 3.times.3 mm. The other air-distribution pressure screen 15 was arranged in coaxial rows in the form of a disc having orifices 16 of a diameter increasing from 1.5 mm in the central zone to 6 mm at the periphery of the disc.” Column 4, Lines 20-40) extending from the first surface (defined by the surface of the at least one of 14 proximate 11) to the second surface (defined by the surface of the at least one of 14 proximate 10) to allow air to flow through the plurality of vents (16 of 15) between the first surface (defined by the surface of the at least one of 14 proximate 11) to the second surface (defined by the surface of the at least one of 14 proximate 10).
Yet, Artemenko does not expressly disclose the configuration whereby the operation of the flow occurs “without passing through the layer of non-woven composite material”.
Waldo teaches the construction of a heat and moisture exchanger (HMX) (Figure 4) for use with a patient interface (via “circuit”, “The device 10 maintains the continuity of a closed ventilator circuit without interruption of the ventilation circuit to a patient.” Column 2, Lines 50-65; “This invention relates to a patient heat-moisture exchanger attached to a nebulizer circuit. More particularly, it refers to a heat-moisture exchanger attached to a patient ventilator circuit, which includes a metered dose inhaler, the exchanger permitting medicament to pass through the heat moisture exchanger without passing through internally mounted filters and without disconnection from the ventilator circuit.” Column 1, Lines 1-15) to humidify a flow of pressurized air supplied to a patient by the patient interface (via “circuit”), the HMX (Figure 4) comprising: an outer body (10 via 12 and 18, “Referring to FIG. 1, the apparatus 10 of this invention has a first housing 12 with an integral conduit 14 passing though exterior side 16 of housing 12. Likewise, a second housing 18 has an integral conduit 20 passing though an exterior side 22.” Column 2, Lines 1-20) configured to be connected to the patient interface (via “circuit”); and a layer of composite material (38 via 28, “A cylindrical rotatable middle housing 28 is interposed between the first and second housing. … A heat-moisture exchange material 38 (HMEM) is mounted within middle housing 28. … The HMEM 38 is obtained from polyurethane foam coated in a sodium chloride solution.” Column 2, Lines 5-60) connected to the outer body (10 via 12 and 18), wherein the HMX (Figure 4) has a first surface (defined by the surface 38 proximate 14) and second surface (defined by the surface of 38 proximate 20) which permits the passage of air to flow from the first surface (defined by the surface 38 proximate 14) to the second surface (defined by the surface of 38 proximate 20).
Regarding the remaining limitations of the claims, Waldo teaches the configuration in Figure 4, whereby the air is passed from the first surface (defined by the surface 38 proximate 14) to the second surface (defined by the surface of 38 proximate 20) “without passing through the layer of non-woven composite material” by the placement of the bypass tube (46) within the flow path of gas from the first surface (defined by the surface 38 proximate 14) to the second surface (defined by the surface of 38 proximate 20). Waldo teaches the operation of this configuration provides “no obstruction to the flow of air or liquids through the apparatus” (Column 2, Lines 30-45) and further permits “medicament to pass through the heat moisture exchanger without passing through internally mounted filters and without disconnection from the ventilator circuit.” (Column 1, Lines 1-15). The resultant effect of this functionality permits for engagement and disengagement of the heat and moisture exchanger as desired, without disconnection from the patient.
In the modification of Artemenko in view of Waldo, the location of the plurality of vents (16 of 15) as related to the layer of non-woven composite material (at least one of 14) of Artemenko is simply defined to be “between two air-distribution pressure screens 15 engaging the hydrophobic washers 14” (Column 3, Lines 25-40). There is no structure that would preclude, prevent, or hinder, the placement of the plurality of vents (16 of 15) to be moved further laterally so that one of the plurality of vents (one of 16 of 15) is oriented on the air inlet (11) of the HMX (Figure 2) proximate the first surface (defined by the surface of the at least one of 14 proximate 11) and the other of the plurality of vents (other of 16 of 15) is oriented on the air outlet (10) of the HMX (Figure 2) proximate the second surface (defined by the surface of the at least one of 14 proximate 10). By this modification to include the operations of Waldo as seen in Figure 4, when the bypass tube (46) of Waldo is activated, the inline flow through the modified HMX would permit air flow to pass through the plurality of vents along the flow path of the first surface and the second surface without passing through the layer of the non-woven composite material. This configuration 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 of the gas to flow from the first surface to the second surface.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the HMX of Artemenko to include the operation of the flow occurs “without passing through the layer of non-woven composite material”, as taught by Waldo and a known result effective variable, to permit for engagement and disengagement of the heat and moisture exchanger as desired, without disconnection from the patient.
As to Claim 23, the modified Artemenko, specifically Artemenko discloses the fibers (“non-woven (jet-spun) web made of Lavsan fibers” Column 3, Lines 35-65) comprise synthetic polymer fibers (“polymer”, “The hydrophilic washers 13 and the hydrophobic washers 14 are made of fiberous polymer materials featuring a very low heat conductivity … The hydrophobic washers 14 are made of a non-woven (jet-spun) web made of Lavsan fibers. … Use of the hydrophobic washers 14 made of non-woven web manufactured from a polymer fibrous material exhibiting a low heat conductance ensures good heat exchange between air passing by in a matter of fractions of a second and fibers of the hydrophobic washer 14 having a large surface area.” Column 3, Lines 35-65; NOTE: Lavsan is a synthetic material made from petroleum products, one of the types of thermoplastic. Belongs to the group of polyester fibers. The chemical name of the fiber is polyethylene terephthalate. https://tonirsurgut.ru/en/vidy-tkanej/lavsan-eto.html).
As to Claim 24, the modified Artemenko, specifically Artemenko discloses the layer of non-woven composite material (at least one of 14) can be joined to an additional layer of non-woven composite material (another of at least one of 14). As best seen in Figure 2, there appears to be at least five (5) layers of non-woven composite material (at least one of 14).
As to Claim 27, the modified Artemenko, specifically Artemenko discloses the layer of non-woven composite material (at least one of 14) has a first impedance as a function of the porosity achieved through the linear density (“The web of the hydrophobic washers 14 has a linear density of from 0.7 to 2 tex, i.e. this web is much more porous as compared with the material of the hydrophilic washers 13.” Column 3, Lines 35-50) to the flow of air and each of the plurality of vents (16 of 15) has a second impedance as a function of the porosity achieve by the diameters (“One of the air-distribution pressure screens 15 was made of a wire net having 16 meshes of 3.times.3 mm. The other air-distribution pressure screen 15 was arranged in coaxial rows in the form of a disc having orifices 16 of a diameter increasing from 1.5 mm in the central zone to 6 mm at the periphery of the disc.” Column 4, Lines 20-40) to the flow of pressurized air. The nature of the plurality of vents (16 of 15) being for the purpose of “air-distribution” imparts the second impedance to be less than the first impedance in order to permit proper flow and treatment (through heat and moisture exchange) along the pathway, whereby the impedance or resistance to flow “decreases in the direction from the center of the disc toward the periphery” (Column 4, Lines 1-25: See: “With such a construction of the air-distribution pressure screen 15, the aerodynamic resistance of the meshes decreases in the direction from the center of the disc toward the periphery. The most optimal embodiment is one in which the law of change in the aerodynamic resistance of the air-distribution pressure screen 15 in the direction from the center toward the periphery corresponds to the parabolic law of distribution of velocities of the air flow. This makes it possible to ensure uniform distribution of air flow among all zones of the multiple-layer package 12 thereby improving conditions for the flow of air around fibers of the hydrophilic and hydrophobic washers 13, 14 and to enhance efficiency of heat exchange.“ Column 4, Lines 1-25). Consequently, the porosity of the plurality of vents located on the periphery has a impedance that is less than the porosity of the layer of non-woven composite material.
As to Claim 29, the modified Artemenko, specifically Artemenko discloses the layer of non-woven composite material (at least one of 14) has a uniform thickness. As best seen in Figure 2, there appears to be at least five (5) layers of non-woven composite material (at least one of 14) which are the same thickness.
Claims 22 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Artemenko et al. (4,771,770) alone OR Artemenko et al. (4,771,770) in view of Waldo, Jr. et al. (7,069,928), as applied to Claims 31 and 21, respectively, and further in view of Lin (8,079,574).
As to Claim 22, Artemenko OR the modified Artemenko, specifically Artemenko discloses the fibers (“non-woven (jet-spun) web made of Lavsan fibers” Column 3, Lines 35-65) of the HMX are constructed of polymer fibers (“polymer” Column 3, Lines 35-65); yet, does not expressly disclose the use of “regenerated cellulose fibers”.
Lin teaches a HMX for imparting heat and moisture exchange to a patient (“The apparatus may be used to humidify and heat air for respiratory tract therapies, gas absorption, selective transfer of specific components from a gas to a liquid or a liquid to a gas, liquid-liquid extractions, membrane distillation processes, immobilized liquid membrane systems and/or moving or flowing liquid membrane systems.” Column 2, Lines 15-25) constructed from both hydrophobic and hydrophilic membranes, whereby “regenerated cellulose” (Column 7, Line 60-70 for hydrophobic membranes and Column 8, Lines 10-20 for hydrophilic membranes) is a known material composition suitable to allow “controlled vaporization of water into air, or humidification of air” (Column 8, Line 15-20).
In the modification of Artemenko alone OR in combination with Waldo, the layer of non-woven composite material (at least one of 14) having hydrophobic properties is made of “non-woven web manufactured from a polymer fibrous material” (Column 3, Lines 35-65). Hence, the further modification of the known polymer having hydrophobic properties to consider “regenerated cellulose” as taught by Lin is an additional material suitable for imparting hydrophobic properties (Column 7, Line 60-70) and further providing the functionality of controlled vaporization of water into air, or humidification of air” (Column 8, Line 15-20).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the polymer of the layer of non-woven composite material of Artemenko OR the modified Artemenko, to include “regenerated cellulose”, as taught by Lin to be known functionality equivalent material suitable for imparting HMX properties.
As to Claim 32, Artemenko OR the modified Artemenko, specifically Artemenko discloses the fibers (“non-woven (jet-spun) web made of Lavsan fibers” Column 3, Lines 35-65) of the HMX are constructed of polymer fibers (“polymer” Column 3, Lines 35-65); yet, does not expressly disclose the use of “regenerated cellulose fibers”.
Lin teaches a HMX for imparting heat and moisture exchange to a patient (“The apparatus may be used to humidify and heat air for respiratory tract therapies, gas absorption, selective transfer of specific components from a gas to a liquid or a liquid to a gas, liquid-liquid extractions, membrane distillation processes, immobilized liquid membrane systems and/or moving or flowing liquid membrane systems.” Column 2, Lines 15-25) constructed from both hydrophobic and hydrophilic membranes, whereby “regenerated cellulose” (Column 7, Line 60-70 for hydrophobic membranes and Column 8, Lines 10-20 for hydrophilic membranes) is a known material composition suitable to allow “controlled vaporization of water into air, or humidification of air” (Column 8, Line 15-20).
In the modification of Artemenko alone OR in combination with Waldo, the HMX material (at least one of 14) having hydrophobic properties is made of “non-woven web manufactured from a polymer fibrous material” (Column 3, Lines 35-65). Hence, the further modification of the known polymer having hydrophobic properties to consider “regenerated cellulose” as taught by Lin is an additional material suitable for imparting hydrophobic properties (Column 7, Line 60-70) and further providing the functionality of controlled vaporization of water into air, or humidification of air” (Column 8, Line 15-20).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the polymer of HMX material of Artemenko OR the modified Artemenko, to include “regenerated cellulose”, as taught by Lin to be known functionality equivalent material suitable for imparting HMX properties.
Claims 25 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Artemenko et al. (4,771,770) alone OR Artemenko et al. (4,771,770) in view of Waldo, Jr. et al. (7,069,928), as applied to Claims 31 and 21, respectively, and further in view of Groenke (5,701,891).
As to Claim 25, Artemenko OR the modified Artemenko, specifically Artemenko discloses the layer of non-woven composite material (at least one of 14) having hydrophobic properties is made of “non-woven web manufactured from a polymer fibrous material” (Column 3, Lines 35-65); yet, does not expressly disclose the use of an additional coating.
Groenke teaches a HMX for imparting heat and moisture exchange to a patient (Abstract) having a HMX material medium (19, “a heat exchanger medium including an elongated spunbonded olefin sheet 19.” Column 3, Lines 5-20), whereby the HMX material medium (19) is coated with a hydrophilic coating (“The desiccant can be deposited directly on sheet 19, however, sheet 19 is preferably first coated with a hydrophilic substance such as polyvinylpyrrolidone, polyvinyl alcohol or polyacrylic acid. Then sheet 19 can be dipped into a solution containing the desiccant such that the hydrophilic coating absorbs the solution including the desiccant.” Column 3, Lines 15-30; NOTE: The coatings of “polyvinyl alcohol” and “polyacrylic acid” would also meet the limitations of the claimed “functional coating” as the “polyvinyl alcohol” is a hydroxy group, and “polyacrylic acid” is a carboxylic acid) to enhance the heat and moisture exchange properties.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the HMX of Artemenko OR the modified Artemenko, to include the use of a coating as taught by Groenke to enhance the heat and moisture exchange properties.
As to Claim 35, Artemenko OR the modified Artemenko, specifically Artemenko discloses the HMX material (at least one of 14) having hydrophobic properties is made of “non-woven web manufactured from a polymer fibrous material” (Column 3, Lines 35-65); yet, does not expressly disclose the use of an additional coating.
Groenke teaches a HMX for imparting heat and moisture exchange to a patient (Abstract) having a HMX material medium (19, “a heat exchanger medium including an elongated spunbonded olefin sheet 19.” Column 3, Lines 5-20), whereby the HMX material medium (19) is coated with a hydrophilic coating (“The desiccant can be deposited directly on sheet 19, however, sheet 19 is preferably first coated with a hydrophilic substance such as polyvinylpyrrolidone, polyvinyl alcohol or polyacrylic acid. Then sheet 19 can be dipped into a solution containing the desiccant such that the hydrophilic coating absorbs the solution including the desiccant.” Column 3, Lines 15-30; NOTE: The coatings of “polyvinyl alcohol” and “polyacrylic acid” would also meet the limitations of the claimed “functional coating” as the “polyvinyl alcohol” is a hydroxy group, and “polyacrylic acid” is a carboxylic acid) to enhance the heat and moisture exchange properties.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the HMX of Artemenko OR the modified Artemenko, to include the use of a coating as taught by Groenke to enhance the heat and moisture exchange properties.
Claims 26 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Artemenko et al. (4,771,770) alone OR Artemenko et al. (4,771,770) in view of Waldo, Jr. et al. (7,069,928), as applied to Claims 31 and 21, respectively, and further in view of Kuehn et al. (4,201,206).
As to Claim 26, Artemenko OR the modified Artemenko, specifically Artemenko discloses the plurality of vents (16 of 15) on the layer of non-woven composite material (at least one of 14); yet, does not expressly disclose the plurality of vents are oriented in a “uniform pattern”.
Kuehn teaches a HMX for heat and moisture exchange to the patient (Figures 3 and 4) having a plurality of vents (44, best seen Figure 4, “The mass of the element can be increased without increasing the thickness of the element by forming a solid perimeter 42 to receiver heat conducted by the central perforated portion 44.” Column 5, Lines 15-25) to impart heat and moisture exchange.
In light of the teachings of Kuehn, the modification of the plurality of vents (16 of 15) of Artemenko OR the modified Artemenko as seen in Figure 3, to be in the shape of a uniform pattern as taught by Kuehn would be a known shape suitable for imparting heat and moisture exchange. Thus, the change in shape of the plurality of vents 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 impart heat and moisture exchange.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the shape of the plurality of vents of Artemenko OR the modified Artemenko, to include a uniform pattern as taught by Kuehn to be a known result effective variable in order to impart heat and moisture exchange.
As to Claim 36, Artemenko OR the modified Artemenko, specifically Artemenko discloses the plurality of holes (16 of 15) on the HMX material (at least one of 14); yet, does not expressly disclose the plurality of vents are oriented in a “uniform pattern”.
Kuehn teaches a HMX for heat and moisture exchange to the patient (Figures 3 and 4) having a plurality of holes (44, best seen Figure 4, “The mass of the element can be increased without increasing the thickness of the element by forming a solid perimeter 42 to receiver heat conducted by the central perforated portion 44.” Column 5, Lines 15-25) to impart heat and moisture exchange.
In light of the teachings of Kuehn, the modification of the plurality of holes (16 of 15) of Artemenko OR the modified Artemenko as seen in Figure 3, to be in the shape of a uniform pattern as taught by Kuehn would be a known shape suitable for imparting heat and moisture exchange. Thus, the change in shape of the plurality of vents 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 impart heat and moisture exchange.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the shape of the plurality of holes of Artemenko OR the modified Artemenko, to include a uniform pattern as taught by Kuehn to be a known result effective variable in order to impart heat and moisture exchange.
Claims 28 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Artemenko et al. (4,771,770) alone OR Artemenko et al. (4,771,770) in view of Waldo, Jr. et al. (7,069,928), as applied to Claims 31 and 21, respectively, and further in view of Duveen et al. (2011/0297152).
As to Claim 28, Artemenko OR the modified Artemenko, specifically Artemenko discloses the fibers (“non-woven (jet-spun) web made of Lavsan fibers” Column 3, Lines 35-65) and the layer of non-woven composite material (at least one of 14) is configured to transfer the absorbed water to incoming pressurized air to increase humidity of the incoming pressurized air before inhalation by the patient.
Yet, does not expressly disclose the origin of the water vapor nor the ability of the fibers to “absorb water vapor from exhaled air from the patient”
Duveen teaches a HMX for heat and moisture exchange to the patient, whereby the origin of the water to be exchanged initially is a result of pre-saturation of the HMX prior to use by the patient. Explicitly, Duveen teaches the HMX has a “moisturizing pad that is typically saturated with water before use such that in use the air adjacent to the pad is moisturized to provide a humidifying effect to the air inhaled through the facemask” (Para 0005). Further, Duvven teaches the configuration of the HMX to “extract moisture from exhaled air” and release “some of this moisture by evaporation into inhaled air” (Para 0009).
In light of the teachings of Duveen the bidirectional flow of gas through the HMX was known to enable initial humidification in the inhalation direction, as well as re-humidification in the exhalation direction, in order to permit continuous heat and moisture exchange throughout the patient’s breathing cycle.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the HMX of Artemenko OR the modified Artemenko to include the use of bidirectional flow through the HMX as taught by Duveen to permit continuous heat and moisture exchange throughout the patient’s breathing cycle.
As to Claim 38, Artemenko OR the modified Artemenko, specifically Artemenko discloses the fibers (“non-woven (jet-spun) web made of Lavsan fibers” Column 3, Lines 35-65) and the HMX material (at least one of 14) is configured to transfer the absorbed water to incoming pressurized air to increase humidity of the incoming pressurized air before inhalation by the patient.
Yet, does not expressly disclose the origin of the water vapor nor the ability of the fibers to “absorb water vapor from exhaled air from the patient”
Duveen teaches a HMX for heat and moisture exchange to the patient, whereby the origin of the water to be exchanged initially is a result of pre-saturation of the HMX prior to use by the patient. Explicitly, Duveen teaches the HMX has a “moisturizing pad that is typically saturated with water before use such that in use the air adjacent to the pad is moisturized to provide a humidifying effect to the air inhaled through the facemask” (Para 0005). Further, Duvven teaches the configuration of the HMX to “extract moisture from exhaled air” and release “some of this moisture by evaporation into inhaled air” (Para 0009).
In light of the teachings of Duveen the bidirectional flow of gas through the HMX was known to enable initial humidification in the inhalation direction, as well as re-humidification in the exhalation direction, in order to permit continuous heat and moisture exchange throughout the patient’s breathing cycle.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the HMX of Artemenko OR the modified Artemenko to include the use of bidirectional flow through the HMX as taught by Duveen to permit continuous heat and moisture exchange throughout the patient’s breathing cycle.
Claims 30 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Artemenko et al. (4,771,770) alone OR Artemenko et al. (4,771,770) in view of Waldo, Jr. et al. (7,069,928), as applied to Claims 31 and 21, respectively, and further in view of Ward (4,458,679).
As to Claims 30 and 40, Artemenko OR the modified Artemenko, specifically Artemenko disclose the HMX (Figures 1 and 2) oriented with respect to the patient interface (1); yet does not expressly disclose the particulars of the patient interface.
Ward discloses a patient interface (Figures 1-3 and 6), comprising: a plenum chamber (1, “With continuing attention to the drawings wherein applied reference numerals indicate components similarly hereinafter identified, the reference numeral 1 indicates a first shell of the mask which overlies the lower portion of the face and includes a nose portion 2 and a chin portion 3.” Column 3, Lines 1-10) pressurizable to a therapeutic pressure of at least 4 cm of water above ambient air pressure (“ A portable source of compressed air or oxygen is at 40 which supplies the mask via a demand type regulator at R and branched hoses at 41-42.” Column 4, Lines 25-45), said plenum chamber (1) including a plenum chamber inlet port (20/21, “A supplemental countercurrent medium may be provided by the provision of tubular inserts at 20 and 21 which function as housings for said supplemental medium as typically indicated at 23 within an insert best shown in FIG. 4.” Column 4, Lines 10-25) sized and structured to receive a flow of the pressurized air at therapeutic pressure (via 40) for breathing by the patient; a HMX (10, “Inwardly of the insert is a mass of a countercurrent medium at 10 formed with a convex outer contour with the opposite side, i.e., the face side, being concave. The mass may be of a non-absorbent fibrous nature such as stainless steel sponge or a mass of synthetic fibres which maintain a given shape while other suitable medium material such as discrete aluminum in minute ball shape may be encapsulated in a net or mesh holder. In a mask for adult use the volume of countercurrent medium used will range between 100-300 cc's.,. The countercurrent medium is removably confined inwardly of the mask shell and exteriorly of a later described shaped member.” Column 3, Lines 45-65; also see: “A mask for use in severe arid climates which includes a countercurrent exchange medium, confined within a mask shell, which salvages heat and moisture given off during exhalation for subsequent transfer to inhalation air. ” Abstract); a seal forming structure (14, “Face piece 14 is of a soft, non-absorbent, highly porous fabric which may loosely adapt to the facial contour to prevent hinderance of jaw movement and air passage to and from the mouth and nose. Folds at 14A permit the face piece to move relative to other mask components during movement of facial features.” Column 3, Line 60 thru Column 4, Line 5; also see: “A shaped mask member forms the mask to fit snugly over the lower face and nose.” Abstract; and “Straps at 16 and 17 are stitched at their mask ends to shaping member 11 and extend about the wearer's head respectively above and below the ears to urge the peripheral margin of the mask into lightly biased contact with the nose, cheeks and chin to virtually exclude airflow therepast.” Column 4, Lines 1-10) constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways, said seal forming structure (14) having a hole therein (best seen Figure 3) such that the flow of pressurized air at said therapeutic pressure (via 40) is delivered to at least the entrance of the patient’s nares (“the reference numeral 1 indicates a first shell of the mask which overlies the lower portion of the face and includes a nose portion 2 and a chin portion 3.” Column 3, Lines 1-10), the seal forming structure (14) constructed and arranged to maintain the therapeutic pressure (via 40) in the plenum chamber (1) through the patient’s respiratory cycle; and a positioning and stabilizing structure (16/17, “Straps at 16 and 17 are stitched at their mask ends to shaping member 11 and extend about the wearer's head respectively above and below the ears to urge the peripheral margin of the mask into lightly biased contact with the nose, cheeks and chin to virtually exclude airflow therepast.” Column 4, Lines 1-10) comprising at least one tie (one of 16/17) to hold the seal forming structure (14) in a therapeutically effective position on the patient’s head.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the patient interface of the Artemenko OR the modified Artemenko to include a plenum chamber, seal forming structure, and positioning and stabilizing structure, as taught by Ward to retain the placement of the heat and moisture exchanger on the face of the user to ensure consistent HME during inhalation and exhalation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jadhav (11,998,696) and Eberl et al. (2024/0238551) share a common assignee/inventor with the instant application; however, at this time there does not appear to be a double patenting requirement. The aforementioned do not appear to recite the features of “web of fibers” (INDP Claims 21 and 31); a “plurality of holes” (INDP Claim 21) or “plurality of vents” (INDP Claim 31); the “layer” language (INDP Claim 21); the orientation “without passing through the layer of non-woven composite material” (INDP Claim 21); nor “linear direction” (INDP Claim 31).
Smith (5,666,950) discloses an HME constructed of regenerated cellulose.
Torii et al. (5,746,269) discloses a HME with a uniform pattern.
Nesbitt et al. (3,692,099) discloses a HME with concerns as how to effect impedance through the plurality of vent/holes. (Column 6, Lines 25-50).
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
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