DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is responsive to a preliminary amendment filed on 1/25/2024. As directed by the amendment, claims 1-30 were cancelled and new claims 31-49 were added. Thus, claims 31-49 are presently pending in this application.
Claim Objections
Claim 32 is objected to because of the following informalities:
In claim 32, lines 1-2, the term “wherein mixing the foaming agent into the polymeric base material comprises injecting an inert gas into the polymeric base material” is suggested to be changed to --wherein the foaming agent is an inert gas, and the mixing of the foaming agent into the polymeric base material comprises injecting the inert gas into the polymeric base material-- in order to clarify the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 37, 39-41 and 45- 49 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 pre-AIA the applicant regards as the invention.
Regarding claim 37, the limitation “voids” (line 1) is unclear if the voids are the same as or different from “voids” being claimed in claim 31, line 12. If the voids are different, then it is unclear as to which voids is being referred to by the limitation “the voids” in claim 37, line 2.
Regarding claim 39, the limitation “a tube shape” (line 2) is unclear if the limitation is trying to claim a structure having a mass or a shape, if the tube shape is a structure, it is unclear if the tube shape is referring to the medical circuit component or not.
Regarding claim 45, the limitation “quickly” (line 1) is unclear as to how to determine the metes and bounds of the limitation, the term “quickly” is too relative.
Regarding claim 47, the limitation “than those of the second plurality of voids” (lines 3-4) is unclear as to what structure is being referred to by the term “those”.
Regarding claim 47, the limitation “a first plurality of voids…a second plurality of voids” (lines 1-2) is unclear if the first plurality of voids and the second plurality of voids are the same as, a part of or different from “voids” being claimed in claim 31, line 12.
Regarding claim 49, the limitation “cells” (line 1) is unclear if cells is the same as or different from the term “voids” being claimed in claim 31, line 12.
Any remaining claims are rejected for their dependency on a rejected base claim.
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 of this title, 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 the subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 31-32, 34-38 and 43-49 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Veliss (2010/0018534) in view of Albrecht (7,083,849).
Regarding claim 31, Veliss discloses a method of manufacturing a medical circuit component (80 and associated tubing shown in figs. 12-1 to 12-3, figs. 13-1 to 13-7c, see paragraphs 0236-0239 and 0254-0257, and see paragraphs 0297 and 0330-0334) for use with humidified gas (see paragraphs 00240 and 0332, Veliss discloses that the foam interface has the ability to retain moisture, therefore, the gas would be humidified gas due to the user’s exhalation containing moisture, alternatively, the medical circuit is capable of being used with humidified gas), the method comprising: making a wall of the medical circuit component, at least a part of the wall being permeable to water-vapor and substantially impermeable to liquid water and bulk flow of gas (see paragraphs 0264 and 0297-0298, Veliss discloses that the foam interface has an internal cell structure that is permeable, having the foam permeable has the advantage of allowing transport of air and moisture through the foam, therefore, is permeable to water-vapor and would be able to be substantially impermeable to liquid water and bulk flow of gas, since the purpose of the patient interface is to provide gas to the user, furthermore, due to the size of the cell/voids, it would be substantially impermeable to liquid water, see figs. 13-1 to 13-7c), the medical circuit is made from a base polymeric material (see paragraphs 0267-0270, Veliss discloses that the foam interface can be made from polyurethane, which is a polymeric material), and the medical circuit component comprising a solid polymer and voids distributed throughout the solid polymer (see paragraphs 0267-0270, Veliss discloses that the foam interface can be made from polyurethane, which is a polymeric material, foam polymeric material would have a solid polymeric material and would have voids distributed throughout, see cells and figs. 13-1 to 13-7c), but fails to disclose the step of mixing a foaming agent into a polymeric base material to form a mixture; allowing the foaming agent to release gas bubbles into the polymeric base material of the mixture; processing the mixture to form at least a part of a wall of the medical circuit component, the at least a part of the wall; and arresting the release of gas bubbles to form a foamed material, wherein the foaming agent and polymeric base material are selected and the mixture is processed to form the at least a part of the wall of the medical circuit component.
However, Albrecht teaches a method of manufacturing a component comprising a wall that is permeable to water-vapor and substantially impermeable to liquid water and bulk flow of gas (Col 1, lines 1-19, Col 3, lines 6-10, Albrecht discloses a breathable polymer foam material that is permeable to water vapor), the component is a foamed polymer component that is substantially impermeable to liquid water and bulk flow of gas (Col 1, lines 1-19, Col 3, lines 6-10, Albrecht discloses a breathable polymer foam material that is permeable to water vapor, therefore, depending on how much water the foamed material is exposed to and how fast the water is traveling, the foamed material would be impermeable to liquid water to a certain degree), the component comprises solid polymer and voids distributed throughout the solid polymer (Col 1, lines 64-67, Col 2, lines 1-6, Col 11, lines 3-15, Albrecht discloses the foamed material having cell voids), the method comprising mixing a foaming agent into a polymeric base material to form a mixture; allowing the foaming agent to release gas bubbles into the polymeric base material of the mixture; processing the mixture to form at least a part of a wall of the component, the at least a part of the wall; and arresting the release of gas bubbles to form a foamed material, wherein the foaming agent and polymeric base material are selected and the mixture is processed (see col 3, line 56 to col 4, line 58 and col 8, line 56 to col 9, line 30 and full disclosure, Albrecht discloses that blowing agent (foaming agent) can be either inert gas which includes nitrogen or nitrogen and oxygen blend or can be a chemical blowing agent, the chemical blowing agent is mixed into the polymeric material, and bubbles are allowed to be released and formed, and then arrested in order to create the foamed material, see col 7, lines 14-27 regarding the cooling of the foamed material).
Therefore, it would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the method of manufacturing and the medical circuit component of Veliss to be made by the method of manufacturing as taught by Albrecht for the purpose of providing a well-known method of manufacturing a breathable foamed component that would provide the predictable result of allowing the foamed medical circuit component of Veliss to be manufactured (see col 1, lines 1-19, col 3, lines 6-10 and see col 3, line 56 to col 4, line 58 and col 8, line 56 to col 9, line 30 of Albrecht).
It is noted that after the modification with Albrecht, the foaming agent can be either the physical foaming agent or chemical foaming agent as taught by Albrecht.
Regarding claim 32, the modified Veliss discloses that mixing the foaming agent into the polymeric base material comprises injecting an inert gas into the polymeric base material (see col 8, line 56 to col 9, line 16 of Albrecht, Albrecht discloses that the physical foaming agent (blowing agent) can be nitrogen or nitrogen and oxygen blend, nitrogen is an inert gas).
Regarding claim 34, the modified Veliss discloses mixing the foaming agent into the polymeric base material comprises adding a chemical to the polymeric base material, the chemical configured to induce a chemical decomposition reaction when heated (see col 9, lines 16-31 of Albrecht, Albrecht discloses a foaming agent utilizing a chemical foaming agent, Albrecht further discloses in col 3, line 56 to col 4, line 37 that the chemical foaming agent are introduced into the polymeric material and when melted and then when exiting the die, the foaming agent decomposed to produce a gas).
Regarding claim 35, the modified Veliss discloses that at least a part of the wall has a thickness of between 0.1 mm and 3.0 mm (see paragraphs 0320-0322 of Veliss, Veliss discloses that the foam has a thickness of about 5-20 mm, see figs. 13-1 and 13-2, with a thickness of 5-20mm, the sharp corner or edge would have a portion that would be between 0.1mm to 3.00 mm depending on where the “part” is measured or sectioned off, alternatively, Veliss discloses a skin contacting layer of the foam may be very soft and thin having a thickness of 1-3 mm).
Regarding claim 36, the modified Veliss discloses a void fraction (see paragraph 0258 of Veliss and figs. 13-1 to 13-7c, Veliss discloses that there are cells distributed throughout, therefore, there would be a void fraction), but fails to disclose that the foamed material has a void fraction greater than 25%. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have constructed the foamed material of the modified Veliss to have a void fraction greater than 25%, since where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Regarding claim 36, the modified Veliss discloses a void fraction (see paragraph 0258 of Veliss and figs. 13-1 to 13-7c, Veliss discloses that there are cells distributed throughout, therefore, there would be a void fraction), but fails to disclose that the foamed material has void fraction greater than 25%.
However, Albrecht teaches foamed-polymer material (title, Col 1, lines 10-19) that is permeable to water vapor (Col 1, lines 1-19, Col 3, lines 6-10, Albrecht discloses a breathable polymer foam material that is permeable to water vapor), wherein the foamed-polymer material is substantially impermeable to liquid water and bulk flow of gas (Col 1, lines 1-19, Col 3, lines 6-10, Albrecht discloses a breathable polymer foam material that is permeable to water vapor, therefore, depending on how much water the foamed material is exposed to and how fast the water is traveling, the material would be impermeable to liquid water to a certain degree), the foamed material comprises void fraction greater than 25% (Albrecht, Col 11, lines 3-15, Albrecht discloses porosity is at least 90%).
Therefore, it would have been obvious to one of the ordinary skill in the art at the time the invention was made to substitute the water vapor permeable foamed material of the modified Veliss with the water vapor permeable foamed material as taught by Albrecht for the purpose of substituting one well-known water vapor permeable material with another well-known water vapor permeable material that provides the predictable result of allowing the wall of the medical circuit component to be permeable to water vapor.
Regarding claim 37, the modified Veliss discloses that the foamed material comprises voids and at least 10% of the voids are interconnected (see paragraph 0258 of Veliss, Veliss discloses that there are cells distributed throughout, see figs. 13-1 to 13-7c of Veliss, the cells are part of foamed interface 80, therefore, the cells are interconnected, the claim does not claim how the voids are interconnected, furthermore, Veliss discloses in paragraphs 0270-0271 that the foamed material can have a varying degrees of open and closed cell content, depending on the air and moisture permeability needed, and further discloses that in an embodiment 10% of the cells can be open cells). However, if there is any doubt that the modified Veliss discloses that the foamed material comprises voids and at least 10% of the voids are interconnected.
Albrecht teaches foamed-polymer material (title, Col 1, lines 10-19) that is permeable to water vapor (Col 1, lines 1-19, Col 3, lines 6-10, Albrecht discloses a breathable polymer foam material that is permeable to water vapor), wherein the foamed-polymer material is substantially impermeable to liquid water and bulk flow of gas (Col 1, lines 1-19, Col 3, lines 6-10, Albrecht discloses a breathable polymer foam material that is permeable to water vapor, therefore, depending on how much water the foamed material is exposed to and how fast the water is traveling, the material would be impermeable to liquid water to a certain degree), wherein at least 10% of the cell voids are interconnected (Albrecht, Col 1, lines 64-67, Col 2, lines 1-6, Col 11, lines 3-15, Albrecht discloses cell voids being cell and pores) (Albrecht, Col 1, lines 64-67, Col 2, lines 1-10, Albrecht discloses that the term porous means having at least one open channel from an outer major surface through the material to another outer major surface through which air can pass, which means the cell voids are open cell and are interconnected with one another, further Albrecht discloses that the disclosed process can yield highly porous foams, therefore, it is well known within the art that a highly porous foams in addition to the definition given by Albrecht is when cell voids are interconnected to form an open channel that is greater than 20%).
Therefore, it would have been obvious to one of the ordinary skill in the art at the time the invention was made to substitute the water vapor permeable foamed material of the modified Veliss with the water vapor permeable foamed material as taught by Albrecht for the purpose of substituting one well-known water vapor permeable material with another well-known water vapor permeable material that provides the predictable result of allowing the wall of the medical circuit component to be permeable to water vapor.
Regarding claim 38, the modified Veliss fails to discloses that the foamed material comprises a copolyester thermoplastic elastomer with a polyether soft segment.
However, Albrecht teaches foamed-polymer material (title, Col 1, lines 10-19) that is permeable to water vapor (Col 1, lines 1-19, Col 3, lines 6-10, Albrecht discloses a breathable polymer foam material that is permeable to water vapor), wherein the foamed-polymer material is substantially impermeable to liquid water and bulk flow of gas (Col 1, lines 1-19, Col 3, lines 6-10, Albrecht discloses a breathable polymer foam material that is permeable to water vapor, therefore, depending on how much water the foamed material is exposed to and how fast the water is traveling, the material would be impermeable to liquid water to a certain degree), the foamed material comprises a copolyester thermoplastic elastomer with a polyether soft segment (see col 7, line 40 to col 8, line 36, Albrecht discloses that the thermoplastic elastomer being used to make the foamed material can comprise polyetheresters, polyetheresters is a copolyester thermoplastic elastomer with a polyether soft segment).
Therefore, it would have been obvious to one of the ordinary skill in the art at the time the invention was made to substitute the water vapor permeable foamed material of the modified Veliss with the water vapor permeable foamed material as taught by Albrecht for the purpose of substituting one well-known water vapor permeable material with another well-known water vapor permeable material that provides the predictable result of allowing the wall of the medical circuit component to be permeable to water vapor.
Regarding claim 43, the modified Veliss discloses that the medical circuit component is a mask (the medical circuit component is redefined to be the foamed interface 80 and 20, see figs. 1-1 to 1-8 of Veliss, which is a mask).
Regarding claim 44, the modified Veliss discloses that arresting the release of gas bubbles comprises cooling the mixture (see col 7, lines 14-27 of Albrecht regarding the cooling of the foamed material).
Regarding claim 45, the modified Veliss discloses that cooling the mixture comprises quickly cooling the mixture to form a first zone and a second zone through a thickness of the at least a part of the wall (see col 7, lines 14-27 of Albrecht regarding the cooling of the foamed material, the cooling would be relatively quickly, the claim does not define how quickly is “quickly”, furthermore, the foamed material formed by 80 of Veliss can be sectioned to multiple zones, see figs. 13-1 to 13-7c, furthermore, Veliss discloses in paragraphs 0270-0271 that the foam can have varying degrees of closed cell content and open cell content, therefore, the zone having open cell can be one zone and the zone having closed cell can be another zone).
Regarding claim 46, the modified Veliss discloses that the first zone is an outer skin (see paragraphs 0270-0271 of Veliss, the foam material can have an outer skin (permeable or impermeable skin)).
Regarding claim 47, the modified Veliss discloses that the first zone comprises a first plurality of voids and the second zone comprises a second plurality of voids, the first plurality of voids having an average void size and a maximum void size smaller than those of the second plurality of voids (see paragraphs 0257-0258, 0276, 0299 of Veliss, Veliss discloses that the cells/voids can be heterogenous cell structure, which can be layered, which would have small voids and large voids, see figs. 13-3 to 13-7c of Veliss, the second plurality of voids can be the largest, while the first plurality of voids can be the smallest).
Regarding claim 48, the modified Veliss discloses that the first plurality of voids is less likely to form a leak path through the at least a part of the wall than the second plurality of voids (see paragraph 0270 and figs. 13-3 to 13-7c and paragraphs 0257-0258, 0276, 0299 of Veliss, Veliss discloses that the foamed material can be made of open cells and further discloses that the cells can be large and small, the small cells forming the first plurality of voids would less likely to form a leak path versus the larger voids, furthermore, even in the embodiment where the cells are closed and opened, depending on the wear and tear of the device overtime, the smaller voids would be less likely to form a leak path than the larger voids).
Regarding claim 49, the modified Veliss discloses that the second zone comprises open cells (see paragraph 0270-0271 of Veliss, Veliss discloses open cellular structure and further discloses that there can be open cell and closed cell, therefore, the open cells are interpreted as the second zone).
Claim 33 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Veliss (2010/0018534) in view of Albrecht (7,083,849) as applied to claim 32 above, and further in view of Radwanski (2006/0148917).
Regarding claim 33, the modified Veliss fails to specifically disclose introducing a nucleating agent into the polymeric base material.
However, Radwanski teaches that the foaming agent can include both a gas and a nucleating agent (see paragraph 0078, Radwanski discloses that chemical blowing agents can be used with physical blowing agent and that gases such as nitrogen can be combined with chemical blowing agents to enhance the foaming, here, the chemical agent is the nucleating agent).
Therefore, it would have been obvious to one of the ordinary skill in the art at the time the invention was made to modify the method of manufacturing of the modified Veliss to include both a blowing agent and a nucleating agent as taught by Radwanski for the purpose of providing an alternative method of manufacturing a foamed article that would enhance the foaming process (see paragraph 0078 of Radwanski).
Allowable Subject Matter
Claims 39-42 are allowable over the prior art.
Claims 39-41 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 42 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for indicating allowable subject matter: The closest prior art of record Veliss (2010/0018534), Albrecht (7,083,849) and Smith (7,140,366) do not specifically disclose the claimed method as presented in the claims 39-42.
Regarding claim 39, Veliss discloses a method of manufacturing a medical circuit component (80 and associated tubing shown in figs. 12-1 to 12-3, figs. 13-1 to 13-7c, see paragraphs 0236-0239 and 0254-0257, and see paragraphs 0297 and 0330-0334) for use with humidified gas (see paragraphs 00240 and 0332, Veliss discloses that the foam interface has the ability to retain moisture, therefore, the gas would be humidified gas due to the user’s exhalation containing moisture, alternatively, the medical circuit is capable of being used with humidified gas), the method comprising: making a wall of the medical circuit component, at least a part of the wall being permeable to water-vapor and substantially impermeable to liquid water and bulk flow of gas (see paragraphs 0264 and 0297-0298, Veliss discloses that the foam interface has an internal cell structure that is permeable, having the foam permeable has the advantage of allowing transport of air and moisture through the foam, therefore, is permeable to water-vapor and would be able to be substantially impermeable to liquid water and bulk flow of gas, since the purpose of the patient interface is to provide gas to the user, furthermore, due to the size of the cell/voids, it would be substantially impermeable to liquid water, see figs. 13-1 to 13-7c), the medical circuit is made from a base polymeric material (see paragraphs 0267-0270, Veliss discloses that the foam interface can be made from polyurethane, which is a polymeric material), and the medical circuit component comprising a solid polymer and voids distributed throughout the solid polymer (see paragraphs 0267-0270, Veliss discloses that the foam interface can be made from polyurethane, which is a polymeric material, foam polymeric material would have a solid polymeric material and would have voids distributed throughout, see cells and figs. 13-1 to 13-7c).
Albrecht teaches a method of manufacturing a component comprising a wall that is permeable to water-vapor and substantially impermeable to liquid water and bulk flow of gas (Col 1, lines 1-19, Col 3, lines 6-10, Albrecht discloses a breathable polymer foam material that is permeable to water vapor), the component is a foamed polymer component that is substantially impermeable to liquid water and bulk flow of gas (Col 1, lines 1-19, Col 3, lines 6-10, Albrecht discloses a breathable polymer foam material that is permeable to water vapor, therefore, depending on how much water the foamed material is exposed to and how fast the water is traveling, the foamed material would be impermeable to liquid water to a certain degree), the component comprises solid polymer and voids distributed throughout the solid polymer (Col 1, lines 64-67, Col 2, lines 1-6, Col 11, lines 3-15, Albrecht discloses the foamed material having cell voids), the method comprising mixing a foaming agent into a polymeric base material to form a mixture; allowing the foaming agent to release gas bubbles into the polymeric base material of the mixture; processing the mixture to form at least a part of a wall of the component, the at least a part of the wall; and arresting the release of gas bubbles to form a foamed material, wherein the foaming agent and polymeric base material are selected and the mixture is processed (see col 3, line 56 to col 4, line 58 and col 8, line 56 to col 9, line 30 and full disclosure, Albrecht discloses that blowing agent (foaming agent) can be either inert gas which includes nitrogen or nitrogen and oxygen blend or can be a chemical blowing agent, the chemical blowing agent is mixed into the polymeric material, and bubbles are allowed to be released and formed, and then arrested in order to create the foamed material, see col 7, lines 14-27 regarding the cooling of the foamed material).
Smith discloses an expiratory limb (fig. 13) for a breathing circuit for carrying humidified gases exhaled by a patient (Col 1, lines 37-45, Smith discloses the expiratory limb allows the passage of water vapour without allowing the passage of liquid water or respiratory gases, and a water vapour flow path from said exhalation flow passage to ambient air through said material), the expiratory limb comprising: a conduit/tube (456, Col 11, lines 39-51) that is permeable to water vapor and substantially impermeable to liquid water and bulk flow of gas (Col 11, lines 52-67 to Col 12, lines 1-7, Col 1, lines 37-45).
However, Veliss, Albrecht, and Smith fail to disclose the combination of the method as claimed and processing the mixture comprises extruding the mixture into a tube shape. The modify Veliss, Albrecht and Smith to have an extruded tube shape that is made of a foamed material that is permeable to water-vapor and substantially impermeable to liquid water and bulk flow of gas would not have been obvious and would be based upon improper hindsight reasoning.
Regarding claim 42, Veliss discloses a method of manufacturing a medical circuit component (80 and associated tubing shown in figs. 12-1 to 12-3, figs. 13-1 to 13-7c, see paragraphs 0236-0239 and 0254-0257, and see paragraphs 0297 and 0330-0334) for use with humidified gas (see paragraphs 00240 and 0332, Veliss discloses that the foam interface has the ability to retain moisture, therefore, the gas would be humidified gas due to the user’s exhalation containing moisture, alternatively, the medical circuit is capable of being used with humidified gas), the method comprising: making a wall of the medical circuit component, at least a part of the wall being permeable to water-vapor and substantially impermeable to liquid water and bulk flow of gas (see paragraphs 0264 and 0297-0298, Veliss discloses that the foam interface has an internal cell structure that is permeable, having the foam permeable has the advantage of allowing transport of air and moisture through the foam, therefore, is permeable to water-vapor and would be able to be substantially impermeable to liquid water and bulk flow of gas, since the purpose of the patient interface is to provide gas to the user, furthermore, due to the size of the cell/voids, it would be substantially impermeable to liquid water, see figs. 13-1 to 13-7c), the medical circuit is made from a base polymeric material (see paragraphs 0267-0270, Veliss discloses that the foam interface can be made from polyurethane, which is a polymeric material), and the medical circuit component comprising a solid polymer and voids distributed throughout the solid polymer (see paragraphs 0267-0270, Veliss discloses that the foam interface can be made from polyurethane, which is a polymeric material, foam polymeric material would have a solid polymeric material and would have voids distributed throughout, see cells and figs. 13-1 to 13-7c).
Albrecht teaches a method of manufacturing a component comprising a wall that is permeable to water-vapor and substantially impermeable to liquid water and bulk flow of gas (Col 1, lines 1-19, Col 3, lines 6-10, Albrecht discloses a breathable polymer foam material that is permeable to water vapor), the component is a foamed polymer component that is substantially impermeable to liquid water and bulk flow of gas (Col 1, lines 1-19, Col 3, lines 6-10, Albrecht discloses a breathable polymer foam material that is permeable to water vapor, therefore, depending on how much water the foamed material is exposed to and how fast the water is traveling, the foamed material would be impermeable to liquid water to a certain degree), the component comprises solid polymer and voids distributed throughout the solid polymer (Col 1, lines 64-67, Col 2, lines 1-6, Col 11, lines 3-15, Albrecht discloses the foamed material having cell voids), the method comprising mixing a foaming agent into a polymeric base material to form a mixture; allowing the foaming agent to release gas bubbles into the polymeric base material of the mixture; processing the mixture to form at least a part of a wall of the component, the at least a part of the wall; and arresting the release of gas bubbles to form a foamed material, wherein the foaming agent and polymeric base material are selected and the mixture is processed (see col 3, line 56 to col 4, line 58 and col 8, line 56 to col 9, line 30 and full disclosure, Albrecht discloses that blowing agent (foaming agent) can be either inert gas which includes nitrogen or nitrogen and oxygen blend or can be a chemical blowing agent, the chemical blowing agent is mixed into the polymeric material, and bubbles are allowed to be released and formed, and then arrested in order to create the foamed material, see col 7, lines 14-27 regarding the cooling of the foamed material).
Smith discloses an expiratory limb (fig. 13) for a breathing circuit for carrying humidified gases exhaled by a patient (Col 1, lines 37-45, Smith discloses the expiratory limb allows the passage of water vapour without allowing the passage of liquid water or respiratory gases, and a water vapour flow path from said exhalation flow passage to ambient air through said material), the expiratory limb comprising: a conduit/tube (456, Col 11, lines 39-51) that is permeable to water vapor and substantially impermeable to liquid water and bulk flow of gas (Col 11, lines 52-67 to Col 12, lines 1-7, Col 1, lines 37-45).
However, Veliss, Albrecht, and Smith fail to disclose the combination of the method as claimed and the medical circuit component is an expiratory tube that is made of a foamed material that is permeable to water-vapor and substantially impermeable to liquid water and bulk flow of gas. The modify Veliss, Albrecht and Smith to have the medical circuit component being an expiratory tube that is made of a foamed material that is permeable to water-vapor and substantially impermeable to liquid water and bulk flow of gas would not have been obvious and would be based upon improper hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Veliss (WO 2008070929) is cited to show an interface comprising a foamed material.
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/TU A VO/ Primary Examiner, Art Unit 3785