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 .
Response to Amendment
The amendment filed 05/22/2026 has been entered. Claims 1, 3-4, 7-8, 11, 13-14, 17-18 have been amended. Claims 1-20 remain pending in this application.
Response to Arguments
Applicant's arguments filed 05/22/2026 with respect to the rejections under 35 USC §112(a) have been fully considered but they are not persuasive.
Applicant argues that the specification identifies the material classes, structural parameters and performance properties that enable the claims.
Regarding claim 3 which recites “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 85 standard liters per minute (SLM) to about 91 SLM”, the specification fails to disclose a specific material that possesses both the claimed water breakthrough pressure and the claimed airflow. Rather, the specification recites “In an embodiment, the breathable membrane 802 comprises one or more pores, where the pore size less than about 10 micrometers but greater than about 2 micrometers. In an embodiment, the breathable membrane 802 has a water breakthrough pressure in the range of about 1 psi to about 3 psi. In an embodiment, the breathable membrane 802 enables airflow across the membrane 802 in the range of about 80 standard liters per minute (SLM) to about 100 SLM, and preferably in the range of about 85 SLM to about 91 SLM” (¶ 0087). While the specification recites that the breathable membrane is made of a hydrophobic or oleophobic material, such as a non-woven acrylic polymer and alternately, could be a hydrophobic polymer membrane (¶ 0086), such materials listed in the specification are not explicitly disclosed to have the claimed water breakthrough pressure and airflow and are not specific materials that enable a person having ordinary skill in the art to make the claimed invention.
Regarding claim 4 which recites a multi-layer configuration having “a second layer having a water 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 recite materials that exhibit such water breakthrough pressure and airflow. While the specification recites that the breathable membrane is made of a hydrophobic or oleophobic material, such as a non-woven acrylic polymer and alternately, could be a hydrophobic polymer membrane (¶ 0086), such materials are not described to have the claimed water breakthrough pressure and airflow and are not specific materials that enable a person having ordinary skill in the art to make the second and third layer.
Applicant argues that following the specification’s disclosures hydrophobic or oleophobic membrane materials combined with pore size of 2 to 10 microns enables a person having ordinary skill in the art to make and use a membrane that satisfies the claimed performance ranges without undue experimentation. However, a person having ordinary skill in the art before the effective filing date, in order to make the claimed invention, would have to perform undue experimentation in order to determine what hydrophobic or oleophobic membrane materials with the claimed pore size will have the claimed water breakthrough pressure and airflow as not all hydrophobic or oleophobic materials will exhibit the claimed water breakthrough pressure and airflow. Applicant argues that the position of the examiner regarding compact prosecution is contradictory. However, the position below is for the purposes of compact prosecution. To further reiterate, such features of the membrane having a water breakthrough pressure and an airflow relate to inherent characteristics of the membrane and such membrane being of a hydrophobic material is considered to have the claimed inherent characteristics.
Applicant's arguments filed 05/22/2026 with respect to claim 1 rejected under 35 USC §103 have been fully considered but they are not persuasive.
Applicant argues, page 13-15, that Glithero does not identify the ratio of the membrane area to air inlet area as a variable that is recognized to affect any result. However, as discussed in the rejection below and reiterated herein, Glithero discloses the air inlet area size as being a result effective variable, which is related to a ratio of the membrane area to air inlet area. Glithero also discloses the membrane area being larger than the air inlet area. Accordingly, such ratio is considered to be optimizable and obvious.
Claim 1 has been amended to recite the membrane being configured to operate under both gravitational fluid flow and hospital wall suction without the membrane restricting air flow across the interface. Applicant argues, page 15-16, that Glithero is designed for gravity-driven urinary drainage and does not disclose such limitation. However, as discussed in the rejection below, such limitation relates to a function of the breathable membrane. Accordingly, since the modified membrane of Glithero is identical to the membrane of the claimed invention, it is capable of operating under hospital wall suction without the membrane restricting air flow across the interface.
Applicant’s arguments, pages 16-17, with respect to claim(s) 11 have been considered but are moot because the new ground of rejection does not rely Glithero alone for any teaching or matter specifically challenged in the argument. A new grounds of rejection is made over Glithero in view of Jones.
Applicant argues, pages 18-19, that a person having ordinary skill in the art would not look to Gobel for guidance on membrane selection in a urinary drainage vent adaptor. Applicant argues that Gobel is for stool while Glithero is for urine. However, Gobel discloses that the device can be used for “other strongly odor-forming excretions or secretions from the human or animal body” (abstract). Gobel further discloses that the separating layer is configured to repel liquid (¶ 0008). Accordingly, Gobel is in the same field of endeavor.
Regarding applicants arguments, pages 19-20, regarding the water breakthrough pressure and airflow, such limitations remain inherent, as discussed below.
Applicant’s arguments, pages 20-22, with respect to claim(s) 4, 8, 14 and 18 have been considered but are moot because the new ground of rejection does not rely Glithero in view of Gobel for any teaching or matter specifically challenged in the argument. A new grounds of rejection is made citing Sharma which teaches a multi-layer breathable membrane.
Regarding claims 6, 10, 16 and 20, a new grounds of rejection is made citing Babb.
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 85 standard liters per minute (SLM) to about 91 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 95 standard liters per minute (SLM) to about 91 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, and an additional layer comprising a fluoropolymer surface modification”.
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.
Claims 11-20 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 11 has been amended to recite “wherein the two or more atmospheric equilibrium valves are configured to provide distinct functional roles such that a first of the two or more atmospheric equilibrium valves is configured to alleviate pressure differentials arising under gravitational fluid flow and a second of the two or more atmospheric equilibrium valves is configured to alleviate pressure differentials arising under hospital wall suction. Applicant points to figs. 18-34 for support for such limitations. However, the specification fails to describe such limitation. While figs. 18-34 illustrate two atmospheric equilibrium valves, the specification refers to figs. 18-34 in ¶ 0077-¶ 0079 which is silent regarding gravitational fluid flow and hospital wall suction. Such recitation of amended claim 11 is new matter.
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 and 5 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), the hydrophobic breathable membrane configured to operate under gravitational fluid flow without the breathable membrane restricting air flow across the interface (¶ 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 the hydrophobic breathable membrane configured to operate under hospital wall suction without the breathable membrane restricting air flow across the interface. However, such limitation relates to the function of the system. The specification discloses that such membranes having the claimed air inlet area range configures the membrane to operate under both gravitational fluid flow and hospital wall suction (¶ 0084). Since the modified membrane of Glithero is a hydrophobic breathable membrane and is identical to the device as claimed, it must necessarily function in the identical manner. Furthermore, the hydrophobic breathable membrane of Glithero is fully capable of being configured to operate under hospital wall suction without the breathable membrane restricting air flow across the interface.
Features of an apparatus may be recited either structurally or functionally. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). See also MPEP § 2173.05(g). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432.
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).
Claim(s) 3, 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glithero as applied to claims 1 and 2 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 85 standard liters per minute (SLM) to about 91 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, the breathable membrane comprising pores 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 85 standard liters per minute (SLM) to about 91 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 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 85 standard liters per minute (SLM) to about 91 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 85 standard liters per minute (SLM) to about 91 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 9, Glithero discloses an external wearable collection bag (drainage bag 104) having a drainage conduit (drainage tube 108) disposed therein (¶ 0033, fig. 1).
Claim(s) 4 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glithero, as applied to claims 1 and 2 above, and further in view of Sharma et al. (Pub. No.: US 2022/0379001 A1).
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 and an additional layer comprising a fluoropolymer surface modification.
Sharma teaches (fig. 1) a drainage tube assembly (apparatus 100, abstract) and thus in the same field of endeavor, comprising a breathable membrane comprising multiple layers, a first layer having one or more pores, where the pore size is 0.01 or more microns, which overlaps with the claimed range of less than about 10 micrometers but greater than about 2 micrometers, and an additional layer comprising a fluoropolymer surface modification (¶ 0245) such breathable membrane configured to be odor absorbing/neutralizing (¶ 0245).
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 Glithero such that it 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 and an additional layer comprising a fluoropolymer surface modification, as taught by Sharma, as such breathable membrane is suitable for odor absorbing/neutralizing (Sharma ¶ 0245).
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 and an additional layer comprising a fluoropolymer surface modification.
Sharma teaches (fig. 1) a drainage tube assembly (apparatus 100, abstract) and thus in the same field of endeavor, comprising a breathable membrane comprising multiple layers, a first layer having one or more pores, where the pore size is 0.01 or more microns, which overlaps with the claimed range of less than about 10 micrometers but greater than about 2 micrometers, and an additional layer comprising a fluoropolymer surface modification (¶ 0245) such breathable membrane configured to be odor absorbing/neutralizing (¶ 0245).
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 Glithero such that it 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 and an additional layer comprising a fluoropolymer surface modification, as taught by Sharma, as such breathable membrane is suitable for odor absorbing/neutralizing (Sharma ¶ 0245).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glithero, as applied to claim 1 above, and further in view of Babb et al. (Pub. No.: US 2014/0214008 A1).
Regarding claim 6, Glithero fails to disclose 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.
Babb teaches (fig. 1-4) a drainage tube assembly (precision venting device 26, abstract) and thus in the same field of endeavor, comprising: an atmospheric equilibrium valve (venting valve 40), wherein the atmospheric equilibrium valve comprises one or more of a duckbill valve (¶ 0023), an umbrella valve, a ball check valve, a push-pull valve, a twist push valve, a bridge check valve, or a sintered filter, such duckbill valve allowing for precise control of partial vacuum without requiring a carefully matched, costly or less desirable molded sealing surface (¶ 0008).
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 atmospheric equilibrium valve of Glithero such that it 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, as taught by Babb, in order to provide precise control of partial vacuum without requiring a carefully matched, costly or less desirable molded sealing surface (Babb ¶ 0008).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glithero in view of Gobel, as applied to claim 3 above, and further in view of Babb.
Regarding claim 10, Glithero in view of Gobel fail to disclose 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.
Babb teaches (fig. 1-4) a drainage tube assembly (precision venting device 26, abstract) and thus in the same field of endeavor, comprising: an atmospheric equilibrium valve (venting valve 40), wherein the atmospheric equilibrium valve comprises one or more of a duckbill valve (¶ 0023), an umbrella valve, a ball check valve, a push-pull valve, a twist push valve, a bridge check valve, or a sintered filter, such duckbill valve allowing for precise control of partial vacuum without requiring a carefully matched, costly or less desirable molded sealing surface (¶ 0008).
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 atmospheric equilibrium valve of Glithero in view of Gobel such that it 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, as taught by Babb, in order to provide precise control of partial vacuum without requiring a carefully matched, costly or less desirable molded sealing surface (Babb ¶ 0008).
Claim(s) 11-12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glithero in view of Jones et al. (Pub. No.: US 2023/0083906 A1).
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);
Wherein the equilibrium valve is configured to alleviate pressure differentials arising under gravitational fluid flow (¶ 0027).
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 two or more atmospheric equilibrium valves; wherein the two atmospheric equilibrium valves are configured to provide distinct functional roles such that a second of the two or more atmospheric equilibrium valves is configured to alleviate pressure differentials under hospital wall suction.
Jones teaches (fig. 1-2) a drainage tube assembly (urine collection assembly 105) for an incontinence device (abstract) and thus in the same field of endeavor, comprising: at atmospheric equilibrium valve (air vent 107) configured to alleviate pressure differentials arising under hospital wall suction (¶ 0048) in order to preventing the assembly from reaching pressures that could potentially cause harm to the patient in a system wherein the drainage tube assembly is used with an vacuum source (¶ 0048).
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 includes a second atmospheric equilibrium valve configured to alleviate pressure differentials under hospital wall suction, as taught Jones, in order to preventing the assembly from reaching pressures that could potentially cause harm to the patient in a system wherein the drainage tube assembly is used with an vacuum source (Jones ¶ 0048).
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) 13, 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glithero in view of Jones, as applied to claim 11 and 12 above, and further in view of Gobel.
Regarding claim 13, Glithero discloses wherein the breathable membrane comprises pores (¶ 0045).
Glithero in view of Jones fail 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 85 standard liters per minute (SLM) to about 91 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, the breathable membrane comprising pores 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 in view of Jones 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 85 standard liters per minute (SLM) to about 91 SLM is inherent to the breathable membrane of Glithero in view of Jones and further 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 17, Glithero discloses wherein the breathable membrane comprises pores (¶ 0045).
Glithero in view of Jones fail 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 85 standard liters per minute (SLM) to about 91 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 in view of Jones 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 85 standard liters per minute (SLM) to about 91 SLM is inherent to the breathable membrane of Glithero in view of Jones and further 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 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) 14 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glithero in view of Jones, as applied to claims 11 and 12 above, and further in view of Sharma.
Regarding claim 14, Glithero discloses the breathable membrane having a first layer having one or more pores (¶ 0045).
Glithero in view of Jones fail 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 and an additional layer comprising a fluoropolymer surface modification.
Sharma teaches (fig. 1) a drainage tube assembly (apparatus 100, abstract) and thus in the same field of endeavor, comprising a breathable membrane comprising multiple layers, a first layer having one or more pores, where the pore size is 0.01 or more microns, which overlaps with the claimed range of less than about 10 micrometers but greater than about 2 micrometers, and an additional layer comprising a fluoropolymer surface modification (¶ 0245) such breathable membrane configured to be odor absorbing/neutralizing (¶ 0245).
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 Glithero in view of Jones such that it 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 and an additional layer comprising a fluoropolymer surface modification, as taught by Sharma, as such breathable membrane is suitable for odor absorbing/neutralizing (Sharma ¶ 0245).
Regarding claim 18, Glithero discloses the breathable membrane having a first layer having one or more pores (¶ 0045).
Glithero in view of Jones fail 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 and an additional layer comprising a fluoropolymer surface modification.
Sharma teaches (fig. 1) a drainage tube assembly (apparatus 100, abstract) and thus in the same field of endeavor, comprising a breathable membrane comprising multiple layers, a first layer having one or more pores, where the pore size is 0.01 or more microns, which overlaps with the claimed range of less than about 10 micrometers but greater than about 2 micrometers, and an additional layer comprising a fluoropolymer surface modification (¶ 0245) such breathable membrane configured to be odor absorbing/neutralizing (¶ 0245).
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 Glithero in view of Jones such that it 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 and an additional layer comprising a fluoropolymer surface modification, as taught by Sharma, as such breathable membrane is suitable for odor absorbing/neutralizing (Sharma ¶ 0245).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glithero in view of Jones, as applied to claim 11 above, and further in view of Babb.
Regarding claim 16, Glithero in view of Jones fail to disclose 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.
Babb teaches (fig. 1-4) a drainage tube assembly (precision venting device 26, abstract) and thus in the same field of endeavor, comprising: an atmospheric equilibrium valve (venting valve 40), wherein the atmospheric equilibrium valve comprises one or more of a duckbill valve (¶ 0023), an umbrella valve, a ball check valve, a push-pull valve, a twist push valve, a bridge check valve, or a sintered filter, such duckbill valve allowing for precise control of partial vacuum without requiring a carefully matched, costly or less desirable molded sealing surface (¶ 0008).
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 atmospheric equilibrium valve of Glithero in view of Jones fail such that it 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, as taught by Babb, in order to provide precise control of partial vacuum without requiring a carefully matched, costly or less desirable molded sealing surface (Babb ¶ 0008).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glithero in view of Jones and further in view of Gobel, as applied to claim 13 above, and further in view of Babb.
Regarding claim 20, Glithero in view of Jones and further in view of Gobel fail to disclose 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.
Babb teaches (fig. 1-4) a drainage tube assembly (precision venting device 26, abstract) and thus in the same field of endeavor, comprising: an atmospheric equilibrium valve (venting valve 40), wherein the atmospheric equilibrium valve comprises one or more of a duckbill valve (¶ 0023), an umbrella valve, a ball check valve, a push-pull valve, a twist push valve, a bridge check valve, or a sintered filter, such duckbill valve allowing for precise control of partial vacuum without requiring a carefully matched, costly or less desirable molded sealing surface (¶ 0008).
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 atmospheric equilibrium valve of Glithero in view of Jones and further in view of Gobel fail such that it 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, as taught by Babb, in order to provide precise control of partial vacuum without requiring a carefully matched, costly or less desirable molded sealing surface (Babb ¶ 0008).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Salvadori et al. (Pub. No.: US 2007/0203463 A1) discloses an assembly having an atmospheric equilibrium valve.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MEAGAN NGO/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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