DETAILED ACTION
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3-4, 7-10, 13-14 and 17-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 3 recites the membrane comprising “a water breakthrough pressure in the range of at least 1 psi to about 3 psi, and the breathable membrane enables airflow across the breathable membrane in the range of about 80 standard liters per minute (SLM) to about 100 SLM”. The specification fails to disclose exemplary materials for the membrane configured to provide a water breakthrough pressure in the range of at least 1 psi to about 3 psi, and the breathable membrane enables airflow across the breathable membrane in the range of about 80 standard liters per minute (SLM) to about 100 SLM. Thus, claim 3 contains subject matter that does not enable one skilled in the art to make the invention. For the purposes of compact prosecution, a membrane that is hydrophobic with a pore size in the range of about 5 micrometers to about 10 micrometers will inherently exhibit the claimed water breakthrough pressure and airflow range.
Claims 9-10 are rejected due to dependency on claim 3.
Claim 4 recites “a second layer having a breakthrough pressure in the range of 1 psi to about 3 psi, and a third layer that enables airflow across the breathable membrane in the range of about 80 standard liters per minute (SLM) to about 100 SLM”. The specification fails to disclose exemplary materials for the second and third layers that exhibit a water breakthrough pressure in the range of at least 1 psi to about 3 psi and an airflow across the breathable membrane in the range of about 80 standard liters per minute (SLM) to about 100 SLM, respectively. Thus, claim 4 contains subject matter that does not enable one skilled in the art to make the invention. For the purposes of compact prosecution, claim 4 will be interpreted as “wherein the breathable membrane comprises multiple layers, a first layer having one or more pores, where the pores size is less than about 10 micrometers but greater than about 2 micrometers”.
Claim 7 recites the subject matter recited in claim 3 and is also rejected for the above reasons.
Claim 8 recites the subject matter recited in claim 4 and is also rejected for the above reasons.
Claim 13 recites the subject matter recited in claim 3 and is also rejected for the above reasons.
Claims 19-20 are rejected due to dependency on claim 13.
Claim 14 recites the subject matter recited in claim 4 and is also rejected for the above reasons.
Claim 17 recites the subject matter recited in claim 3 and is also rejected for the above reasons.
Claim 18 recites the subject matter recited in claim 4 and is also rejected for the above reasons.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 5, 11-12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glithero et al. (Pub. No.: US 2018/0303655 A1).
Regarding claim 1, Glithero discloses (fig. 1-2B) a drainage tube assembly (vent adaptor assembly 102/202) for an external incontinence device (urinary drainage bag system 100) (¶ 0026), the drainage tube assembly comprising:
A drainage tube (distal portion 226) connected to a proximal chamber (intermediate portion 240) (¶ 0036, fig. 2A); and
An atmospheric equilibrium valve (vent 210) disposed in fluid communication with the proximal chamber (fig. 2B), the atmospheric equilibrium valve having an airway (vent wall 242) with a cross-sectional air inlet area (apertures 252), the airway connecting to the proximal chamber (¶ 0040) at an interface having a membrane area (see vent opening 228, fig. 2B); and
A hydrophobic breathable membrane (filter 232, ¶ 0045) disposed on an inside surface of the proximal chamber over the interface (fig. 2B).
Glithero fails to disclose the membrane area being in the range of about 4 to about 8 times larger than the air inlet area.
However, Glithero discloses that the membrane area is larger than the air inlet area (fig. 2B) and that the air inlet area exhibits a shape and size configured to allow air to flow therethrough while preventing the hydrophobic breathable membrane from being able to pass therethrough (¶ 0048).
Thus, Glithero discloses that the air inlet area is a result-effective variable and discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (See MPEP §2144.05). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention optimize the air inlet area of Glithero such that the membrane area is in the range of about 4 to about 8 times larger than the air inlet area in order configure the air inlet area with a shape and size that allows air to flow therethrough while preventing the hydrophobic breathable membrane from being able to pass therethrough (¶ 0048).
Absent any showing of critical or unexpected results, such limitations appear to be routine optimization within the skill of the ordinary artisan before the effective filing date of the invention are therefore prima facie obvious.
Regarding claim 2, Glithero discloses wherein the drainage tube comprises a bottom end (see distal opening 238), and the drainage tube assembly further comprises an adaptor for connecting the bottom end either to a flexible female connector or to a stepped male connector (¶ 0037, fig. 1).
Regarding claim 5, Glithero discloses an external wearable collection bag (drainage bag 104) having a drainage conduit (drainage tube 108) disposed therein (¶ 0033, fig. 1).
Regarding claim 11, Glithero discloses (fig. 1-2B) a drainage tube assembly (vent adaptor assembly 102/202) for an external incontinence device (urinary drainage bag system 100) (¶ 0026), the drainage tube assembly comprising:
A drainage tube (distal portion 226) connected to a proximal chamber (intermediate portion 240) (¶ 0036, fig. 2A); and
An atmospheric equilibrium valve (vent 210) disposed in fluid communication with the proximal chamber (fig. 2B), the atmospheric equilibrium valve having an airway (vent wall 242) with a cross-sectional air inlet area (apertures 252), the airway connecting to the proximal chamber (¶ 0040) at an interface having a membrane area (see vent opening 228, fig. 2B); and
A hydrophobic breathable membrane (filter 232, ¶ 0045) disposed on an inside surface of the proximal chamber over the interface (fig. 2B).
Glithero fails to disclose two or more atmospheric equilibrium valves.
However, a mere duplication of parts has no patentable significance unless a new and unexpected result is produced (In re Harza, 124 USPQ 70, see MPEP § 2144.04 VI. B.).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the atmospheric equilibrium valve of Glithero in order to provide additional venting.
Glithero fails to disclose the membrane area being in the range of about 4 to about 8 times larger than the air inlet area.
However, Glithero discloses that the membrane area is larger than the air inlet area (fig. 2B) and that the air inlet area exhibits a shape and size configured to allow air to flow therethrough while preventing the hydrophobic breathable membrane from being able to pass therethrough (¶ 0048).
Thus, Glithero discloses that the air inlet area is a result-effective variable and discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (See MPEP §2144.05). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention optimize the air inlet area of Glithero such that the membrane area is in the range of about 4 to about 8 times larger than the air inlet area in order configure the air inlet area with a shape and size that allows air to flow therethrough while preventing the hydrophobic breathable membrane from being able to pass therethrough (¶ 0048).
Absent any showing of critical or unexpected results, such limitations appear to be routine optimization within the skill of the ordinary artisan before the effective filing date of the invention are therefore prima facie obvious.
Regarding claim 12, Glithero discloses wherein the drainage tube comprises a bottom end (see distal opening 238), and the drainage tube assembly further comprises an adaptor for connecting the bottom end either to a flexible female connector or to a stepped male connector (¶ 0037, fig. 1).
Regarding claim 15, Glithero discloses an external wearable collection bag (drainage bag 104) having a drainage conduit (drainage tube 108) disposed therein (¶ 0033, fig. 1).
Claim(s) 3-4, 7-9, 13-14, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glithero as applied to claims 1 and 11 above, and further in view of Gobel (Pub. No.: US 2022/0354684 A1).
Regarding claim 3, Glithero discloses wherein the breathable membrane comprises pores (¶ 0045).
Glithero fails to disclose pores having a size in the range of about 5 micrometers to about 10 micrometers and a water breakthrough pressure in the range of at least 1 psi to about 3 psi, and the breathable membrane enables airflow across the breathable membrane in the range of about 80 standard liters per minute (SLM) to about 100 SLM.
Gobel teaches (fig. 1) a drainage tube assembly (stool-removing apparatus 1) and thus in the same field of endeavor, comprising a hydrophobic breathable membrane (separating layer 7 made of expanded polytetrafluorethylene, ¶ 0022), wherein the breathable membrane comprises pores having a size in the range of 10 micrometers or less (¶ 0022) which overlaps with the claimed range of about 5 micrometers to about 10 micrometers, configured to prevent the escape of waste (¶ 0078).
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pores of Glithero such that they have a size in the range of about 5 micrometers to about 10 micrometers, as taught by Gobel, in order to prevent the escape of waste (Gobel ¶ 0078).
Accordingly, the feature of the breathable membrane having a water breakthrough pressure in the range of at least 1 psi to about 3 psi, and enables airflow across the breathable membrane in the range of about 80 standard liters per minute (SLM) to about 100 SLM is inherent to the breathable membrane of Glithero in view of Gobel since such membrane is hydrophobic and has a pore size in the range of about 5 micrometers to about 10 micrometers.
Regarding claim 4, Glithero discloses the breathable membrane having a first layer having one or more pores (¶ 0045).
Glithero fails to disclose wherein the breathable membrane comprises multiple layers, a first layer having one or more pores, where the pore size is less than about 10 micrometers but greater than about 2 micrometers.
Gobel teaches (fig. 1) a drainage tube assembly (stool-removing apparatus 1) and thus in the same field of endeavor, comprising a breathable membrane (adsorbing and/or filtering module 5 and separating layer 7), wherein the breathable membrane comprises multiple layers (adsorbing and/or filtering module 5 and separating layer 7) configured to filter infectious pathogens (¶ 0030), a first layer (separating layer 7) having one or more pores less than about 10 micrometers (¶ 0022) which overlaps with the claimed range of less than about 10 micrometers but greater than about 2 micrometers, configured to prevent the escape of waste (¶ 0078).
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the breathable membrane of Gobel such that it comprises multiple layers, a first layer having one or more pores less than about 10 micrometers but greater than about 2 micrometers, as taught by Gobel, in order to provide a breathable membrane that filters infectious pathogens (Gobel ¶ 0030) and in order to prevent the escape of waste (Gobel ¶ 0078).
Regarding claim 7, Glithero discloses wherein the breathable membrane comprises pores (¶ 0045).
Glithero fails to disclose pores having a size in the range of about 5 micrometers to about 10 micrometers and a water breakthrough pressure in the range of at least 1 psi to about 3 psi, and the breathable membrane enables airflow across the breathable membrane in the range of about 80 standard liters per minute (SLM) to about 100 SLM.
Gobel teaches (fig. 1) a drainage tube assembly (stool-removing apparatus 1) and thus in the same field of endeavor, comprising a hydrophobic breathable membrane (separating layer 7 made of expanded polytetrafluorethylene, ¶ 0022), wherein the breathable membrane comprises pores having a size in the range of 10 micrometers or less (¶ 0022) which overlaps with the claimed range of 5 about 5 micrometers to about 10 micrometers, configured to prevent the escape of waste (¶ 0078).
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pores of Glithero such that they have a size in the range of about 5 micrometers to about 10 micrometers, as taught by Gobel, in order to prevent the escape of waste (Gobel ¶ 0078).
Accordingly, the feature of the breathable membrane having a water breakthrough pressure in the range of at least 1 psi to about 3 psi, and enables airflow across the breathable membrane in the range of about 80 standard liters per minute (SLM) to about 100 SLM is inherent to the breathable membrane of Glithero in view of Gobel since such membrane is hydrophobic and has a pore size in the range of about 5 micrometers to about 10 micrometers.
Regarding claim 8, Glithero discloses the breathable membrane having a first layer having one or more pores (¶ 0045).
Glithero fails to disclose wherein the breathable membrane comprises multiple layers, a first layer having one or more pores, where the pore size is less than about 10 micrometers but greater than about 2 micrometers.
Gobel teaches (fig. 1) a drainage tube assembly (stool-removing apparatus 1) and thus in the same field of endeavor, comprising a breathable membrane (adsorbing and/or filtering module 5 and separating layer 7), wherein the breathable membrane comprises multiple layers (adsorbing and/or filtering module 5 and separating layer 7) configured to filter infectious pathogens (¶ 0030), a first layer (separating layer 7) having one or more pores less than about 10 micrometers (¶ 0022) which overlaps with the claimed range of less than about 10 micrometers but greater than about 2 micrometers, configured to prevent the escape of waste (¶ 0078).
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the breathable membrane of Gobel such that it comprises multiple layers, a first layer having one or more pores less than about 10 micrometers but greater than about 2 micrometers, as taught by Gobel, in order to provide a breathable membrane that filters infectious pathogens (Gobel ¶ 0030) and in order to prevent the escape of waste (Gobel ¶ 0078).
Regarding claim 9, Glithero discloses an external wearable collection bag (drainage bag 104) having a drainage conduit (drainage tube 108) disposed therein (¶ 0033, fig. 1).
Regarding claim 13, Glithero discloses wherein the breathable membrane comprises pores (¶ 0045).
Glithero fails to disclose pores having a size in the range of about 5 micrometers to about 10 micrometers and a water breakthrough pressure in the range of at least 1 psi to about 3 psi, and the breathable membrane enables airflow across the breathable membrane in the range of about 80 standard liters per minute (SLM) to about 100 SLM.
Gobel teaches (fig. 1) a drainage tube assembly (stool-removing apparatus 1) and thus in the same field of endeavor, comprising a hydrophobic breathable membrane (separating layer 7 made of expanded polytetrafluorethylene, ¶ 0022), wherein the breathable membrane comprises pores having a size in the range of 10 micrometers or less (¶ 0022) which overlaps with the claimed range of 5 about 5 micrometers to about 10 micrometers, configured to prevent the escape of waste (¶ 0078).
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pores of Glithero such that they have a size in the range of about 5 micrometers to about 10 micrometers, as taught by Gobel, in order to prevent the escape of waste (Gobel ¶ 0078).
Accordingly, the feature of the breathable membrane having a water breakthrough pressure in the range of at least 1 psi to about 3 psi, and enables airflow across the breathable membrane in the range of about 80 standard liters per minute (SLM) to about 100 SLM is inherent to the breathable membrane of Glithero in view of Gobel since such membrane is hydrophobic and has a pore size in the range of about 5 micrometers to about 10 micrometers.
Regarding claim 14, Glithero discloses the breathable membrane having a first layer having one or more pores (¶ 0045).
Glithero fails to disclose wherein the breathable membrane comprises multiple layers, a first layer having one or more pores, where the pore size is less than about 10 micrometers but greater than about 2 micrometers.
Gobel teaches (fig. 1) a drainage tube assembly (stool-removing apparatus 1) and thus in the same field of endeavor, comprising a breathable membrane (adsorbing and/or filtering module 5 and separating layer 7), wherein the breathable membrane comprises multiple layers (adsorbing and/or filtering module 5 and separating layer 7) configured to filter infectious pathogens (¶ 0030), a first layer (separating layer 7) having one or more pores less than about 10 micrometers (¶ 0022) which overlaps with the claimed range of less than about 10 micrometers but greater than about 2 micrometers, configured to prevent the escape of waste (¶ 0078).
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the breathable membrane of Gobel such that it comprises multiple layers, a first layer having one or more pores less than about 10 micrometers but greater than about 2 micrometers, as taught by Gobel, in order to provide a breathable membrane that filters infectious pathogens (Gobel ¶ 0030) and in order to prevent the escape of waste (Gobel ¶ 0078).
Regarding claim 17, Glithero discloses wherein the breathable membrane comprises pores (¶ 0045).
Glithero fails to disclose pores having a size in the range of about 5 micrometers to about 10 micrometers and a water breakthrough pressure in the range of at least 1 psi to about 3 psi, and the breathable membrane enables airflow across the breathable membrane in the range of about 80 standard liters per minute (SLM) to about 100 SLM.
Gobel teaches (fig. 1) a drainage tube assembly (stool-removing apparatus 1) and thus in the same field of endeavor, comprising a hydrophobic breathable membrane (separating layer 7 made of expanded polytetrafluorethylene, ¶ 0022), wherein the breathable membrane comprises pores having a size in the range of 10 micrometers or less (¶ 0022) which overlaps with the claimed range of 5 about 5 micrometers to about 10 micrometers, configured to prevent the escape of waste (¶ 0078).
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pores of Glithero such that they have a size in the range of about 5 micrometers to about 10 micrometers, as taught by Gobel, in order to prevent the escape of waste (Gobel ¶ 0078).
Accordingly, the feature of the breathable membrane having a water breakthrough pressure in the range of at least 1 psi to about 3 psi, and enables airflow across the breathable membrane in the range of about 80 standard liters per minute (SLM) to about 100 SLM is inherent to the breathable membrane of Glithero in view of Gobel since such membrane is hydrophobic and has a pore size in the range of about 5 micrometers to about 10 micrometers.
Regarding claim 18, Glithero discloses the breathable membrane having a first layer having one or more pores (¶ 0045).
Glithero fails to disclose wherein the breathable membrane comprises multiple layers, a first layer having one or more pores, where the pore size is less than about 10 micrometers but greater than about 2 micrometers.
Gobel teaches (fig. 1) a drainage tube assembly (stool-removing apparatus 1) and thus in the same field of endeavor, comprising a breathable membrane (adsorbing and/or filtering module 5 and separating layer 7), wherein the breathable membrane comprises multiple layers (adsorbing and/or filtering module 5 and separating layer 7) configured to filter infectious pathogens (¶ 0030), a first layer (separating layer 7) having one or more pores less than about 10 micrometers (¶ 0022) which overlaps with the claimed range of less than about 10 micrometers but greater than about 2 micrometers, configured to prevent the escape of waste (¶ 0078).
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the breathable membrane of Gobel such that it comprises multiple layers, a first layer having one or more pores less than about 10 micrometers but greater than about 2 micrometers, as taught by Gobel, in order to provide a breathable membrane that filters infectious pathogens (Gobel ¶ 0030) and in order to prevent the escape of waste (Gobel ¶ 0078).
Regarding claim 19, Glithero discloses an external wearable collection bag (drainage bag 104) having a drainage conduit (drainage tube 108) disposed therein (¶ 0033, fig. 1).
Claim(s) 6, 10, 16 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glithero in view of Gobel.
Regarding claim 6, Glithero discloses (fig. 1-2B) a drainage tube assembly (vent adaptor assembly 102/202) for an external incontinence device (urinary drainage bag system 100) (¶ 0026), the drainage tube assembly comprising:
A drainage tube (distal portion 226) connected to a proximal chamber (intermediate portion 240) (¶ 0036, fig. 2A); and
An atmospheric equilibrium valve (vent 210) disposed in fluid communication with the proximal chamber (fig. 2B), the atmospheric equilibrium valve having an airway (vent wall 242) with a cross-sectional air inlet area (apertures 252), the airway connecting to the proximal chamber (¶ 0040) at an interface having a membrane area (see vent opening 228, fig. 2B).
Wherein the atmospheric equilibrium valve comprises one or more of a duckbill valve, an umbrella valve, a ball check valve, a push-pull valve, a twist push valve, a bridge check valve, or a sintered filter (filter 232, ¶ 0045).
Glithero fails to disclose the membrane area being in the range of about 4 to about 8 times larger than the air inlet area.
However, Glithero discloses that the membrane area is larger than the air inlet area (fig. 2B) and that the air inlet area exhibits a shape and size configured to allow air to flow therethrough while preventing the hydrophobic breathable membrane from being able to pass therethrough (¶ 0048).
Thus, Glithero discloses that the air inlet area is a result-effective variable and discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (See MPEP §2144.05). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention optimize the air inlet area of Glithero such that the membrane area is in the range of about 4 to about 8 times larger than the air inlet area in order configure the air inlet area with a shape and size that allows air to flow therethrough while preventing the hydrophobic breathable membrane from being able to pass therethrough (¶ 0048).
Absent any showing of critical or unexpected results, such limitations appear to be routine optimization within the skill of the ordinary artisan before the effective filing date of the invention are therefore prima facie obvious.
Glithero fails to disclose a hydrophobic breathable membrane disposed on an inside surface of the proximal chamber over the interface.
Gobel teaches (fig. 1a) a drainage tube assembly (stool-removing apparatus 1) and thus in the same field of endeavor, comprising a hydrophobic breathable membrane (separating layer 7 made of expanded polytetrafluorethylene, ¶ 0022) disposed on an inside surface of a proximal chamber (basic element 4) over an interface (fig. 1, ¶ 0069) configured to prevent the escape of waste (¶ 0078).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drainage tube assembly of Glithero such that it comprises a hydrophobic breathable membrane disposed on an inside surface of the proximal chamber over the interface, as taught by Gobel, in order to prevent the escape of waste (Gobel ¶ 0078).
Regarding claim 10, Glithero discloses (fig. 1-2B) a drainage tube assembly (vent adaptor assembly 102/202) for an external incontinence device (urinary drainage bag system 100) (¶ 0026), the drainage tube assembly comprising:
A drainage tube (distal portion 226) connected to a proximal chamber (intermediate portion 240) (¶ 0036, fig. 2A); and
An atmospheric equilibrium valve (vent 210) disposed in fluid communication with the proximal chamber (fig. 2B), the atmospheric equilibrium valve having an airway (vent wall 242) with a cross-sectional air inlet area (apertures 252), the airway connecting to the proximal chamber (¶ 0040) at an interface having a membrane area (see vent opening 228, fig. 2B).
Wherein the atmospheric equilibrium valve comprises one or more of a duckbill valve, an umbrella valve, a ball check valve, a push-pull valve, a twist push valve, a bridge check valve, or a sintered filter (filter 232, ¶ 0045).
Glithero fails to disclose the membrane area being in the range of about 4 to about 8 times larger than the air inlet area.
However, Glithero discloses that the membrane area is larger than the air inlet area (fig. 2B) and that the air inlet area exhibits a shape and size configured to allow air to flow therethrough while preventing the hydrophobic breathable membrane from being able to pass therethrough (¶ 0048).
Thus, Glithero discloses that the air inlet area is a result-effective variable and discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (See MPEP §2144.05). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention optimize the air inlet area of Glithero such that the membrane area is in the range of about 4 to about 8 times larger than the air inlet area in order configure the air inlet area with a shape and size that allows air to flow therethrough while preventing the hydrophobic breathable membrane from being able to pass therethrough (¶ 0048).
Absent any showing of critical or unexpected results, such limitations appear to be routine optimization within the skill of the ordinary artisan before the effective filing date of the invention are therefore prima facie obvious.
Glithero fails to disclose a hydrophobic breathable membrane disposed on an inside surface of the proximal chamber over the interface, the breathable membrane comprises pores having a size in the range of about 10 micrometers and a water breakthrough pressure in the range of at least 1 psi to about 3 psi, and the breathable membrane enables airflow across the breathable membrane in the range of about 80 standard liters per minute (SLM) to about 100 SLM.
Gobel teaches (fig. 1a) a drainage tube assembly (stool-removing apparatus 1) and thus in the same field of endeavor, comprising a hydrophobic breathable membrane (separating layer 7 made of expanded polytetrafluorethylene, ¶ 0022) disposed on an inside surface of a proximal chamber (basic element 4) over an interface (fig. 1, ¶ 0069) wherein the breathable membrane comprises pores having a size in the range of 10 micrometers or less (¶ 0022) which overlaps with the claimed range of 5 about 5 micrometers to about 10 micrometers, configured to prevent the escape of waste (¶ 0078).
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pores of Glithero such that they have a size in the range of about 5 micrometers to about 10 micrometers, as taught by Gobel, in order to prevent the escape of waste (Gobel ¶ 0078).
Accordingly, the feature of the breathable membrane having a water breakthrough pressure in the range of at least 1 psi to about 3 psi, and enables airflow across the breathable membrane in the range of about 80 standard liters per minute (SLM) to about 100 SLM is inherent to the breathable membrane of Glithero in view of Gobel since such membrane is hydrophobic and has a pore size in the range of about 5 micrometers to about 10 micrometers.
Regarding claim 16, Glithero discloses (fig. 1-2B) a drainage tube assembly (vent adaptor assembly 102/202) for an external incontinence device (urinary drainage bag system 100) (¶ 0026), the drainage tube assembly comprising:
A drainage tube (distal portion 226) connected to a proximal chamber (intermediate portion 240) (¶ 0036, fig. 2A); and
An atmospheric equilibrium valve (vent 210) disposed in fluid communication with the proximal chamber (fig. 2B), the atmospheric equilibrium valve having an airway (vent wall 242) with a cross-sectional air inlet area (apertures 252), the airway connecting to the proximal chamber (¶ 0040) at an interface having a membrane area (see vent opening 228, fig. 2B).
Wherein the atmospheric equilibrium valve comprises one or more of a duckbill valve, an umbrella valve, a ball check valve, a push-pull valve, a twist push valve, a bridge check valve, or a sintered filter (filter 232, ¶ 0045).
Glithero fails to disclose two or more atmospheric equilibrium valves.
However, a mere duplication of parts has no patentable significance unless a new and unexpected result is produced (In re Harza, 124 USPQ 70, see MPEP § 2144.04 VI. B.).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the atmospheric equilibrium valve of Glithero in order to provide additional venting.
Glithero fails to disclose the membrane area being in the range of about 4 to about 8 times larger than the air inlet area.
However, Glithero discloses that the membrane area is larger than the air inlet area (fig. 2B) and that the air inlet area exhibits a shape and size configured to allow air to flow therethrough while preventing the hydrophobic breathable membrane from being able to pass therethrough (¶ 0048).
Thus, Glithero discloses that the air inlet area is a result-effective variable and discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (See MPEP §2144.05). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention optimize the air inlet area of Glithero such that the membrane area is in the range of about 4 to about 8 times larger than the air inlet area in order configure the air inlet area with a shape and size that allows air to flow therethrough while preventing the hydrophobic breathable membrane from being able to pass therethrough (¶ 0048).
Absent any showing of critical or unexpected results, such limitations appear to be routine optimization within the skill of the ordinary artisan before the effective filing date of the invention are therefore prima facie obvious.
Glithero fails to disclose a hydrophobic breathable membrane disposed on an inside surface of the proximal chamber over the interface.
Gobel teaches (fig. 1a) a drainage tube assembly (stool-removing apparatus 1) and thus in the same field of endeavor, comprising a hydrophobic breathable membrane (separating layer 7 made of expanded polytetrafluorethylene, ¶ 0022) disposed on an inside surface of a proximal chamber (basic element 4) over an interface (fig. 1, ¶ 0069) configured to prevent the escape of waste (¶ 0078).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drainage tube assembly of Glithero such that it comprises a hydrophobic breathable membrane disposed on an inside surface of the proximal chamber over the interface, as taught by Gobel, in order to prevent the escape of waste (Gobel ¶ 0078).
Regarding claim 20, Glithero discloses (fig. 1-2B) a drainage tube assembly (vent adaptor assembly 102/202) for an external incontinence device (urinary drainage bag system 100) (¶ 0026), the drainage tube assembly comprising:
A drainage tube (distal portion 226) connected to a proximal chamber (intermediate portion 240) (¶ 0036, fig. 2A); and
An atmospheric equilibrium valve (vent 210) disposed in fluid communication with the proximal chamber (fig. 2B), the atmospheric equilibrium valve having an airway (vent wall 242) with a cross-sectional air inlet area (apertures 252), the airway connecting to the proximal chamber (¶ 0040) at an interface having a membrane area (see vent opening 228, fig. 2B).
Wherein the atmospheric equilibrium valve comprises one or more of a duckbill valve, an umbrella valve, a ball check valve, a push-pull valve, a twist push valve, a bridge check valve, or a sintered filter (filter 232, ¶ 0045).
Glithero fails to disclose two or more atmospheric equilibrium valves.
However, a mere duplication of parts has no patentable significance unless a new and unexpected result is produced (In re Harza, 124 USPQ 70, see MPEP § 2144.04 VI. B.).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the atmospheric equilibrium valve of Glithero in order to provide additional venting.
Glithero fails to disclose the membrane area being in the range of about 4 to about 8 times larger than the air inlet area.
However, Glithero discloses that the membrane area is larger than the air inlet area (fig. 2B) and that the air inlet area exhibits a shape and size configured to allow air to flow therethrough while preventing the hydrophobic breathable membrane from being able to pass therethrough (¶ 0048).
Thus, Glithero discloses that the air inlet area is a result-effective variable and discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (See MPEP §2144.05). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention optimize the air inlet area of Glithero such that the membrane area is in the range of about 4 to about 8 times larger than the air inlet area in order configure the air inlet area with a shape and size that allows air to flow therethrough while preventing the hydrophobic breathable membrane from being able to pass therethrough (¶ 0048).
Absent any showing of critical or unexpected results, such limitations appear to be routine optimization within the skill of the ordinary artisan before the effective filing date of the invention are therefore prima facie obvious.
Glithero fails to disclose a hydrophobic breathable membrane disposed on an inside surface of the proximal chamber over the interface, the breathable membrane comprises pores having a size in the range of about 10 micrometers and a water breakthrough pressure in the range of at least 1 psi to about 3 psi, and the breathable membrane enables airflow across the breathable membrane in the range of about 80 standard liters per minute (SLM) to about 100 SLM.
Gobel teaches (fig. 1a) a drainage tube assembly (stool-removing apparatus 1) and thus in the same field of endeavor, comprising a hydrophobic breathable membrane (separating layer 7 made of expanded polytetrafluorethylene, ¶ 0022) disposed on an inside surface of a proximal chamber (basic element 4) over an interface (fig. 1, ¶ 0069) wherein the breathable membrane comprises pores having a size in the range of 10 micrometers or less (¶ 0022) which overlaps with the claimed range of 5 about 5 micrometers to about 10 micrometers, configured to prevent the escape of waste (¶ 0078).
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pores of Glithero such that they have a size in the range of about 5 micrometers to about 10 micrometers, as taught by Gobel, in order to prevent the escape of waste (Gobel ¶ 0078).
Accordingly, the feature of the breathable membrane having a water breakthrough pressure in the range of at least 1 psi to about 3 psi, and enables airflow across the breathable membrane in the range of about 80 standard liters per minute (SLM) to about 100 SLM is inherent to the breathable membrane of Glithero in view of Gobel since such membrane is hydrophobic and has a pore size in the range of about 5 micrometers to about 10 micrometers.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Babb et al. (Pub. No.: US 2014/0214008 A1) discloses a drainage tube having an equilibrium valve. Moghe et al. (Pub. No.: US 2014/0039349 A1) discloses a drainage tube having an equilibrium valve.
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/MEAGAN NGO/Examiner, Art Unit 3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781