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 Status
The amendment submitted on December 20th, 2024 has been entered. Claims 1-5,7-18 and 20 are currently pending and under consideration. Claims 6 and 19 have been cancelled. Claims 15-18 and 20 are herein withdrawn in accordance with the below Unity of Invention Requirement.
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-5 and 7-14, drawn to a fluid collection device.
Group II, claim(s) 15-18 and 20, drawn to a method to manufacture a fluid collection device.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a fluid collection device comprising, a fluid impermeable barrier, the fluid impermeable barrier at least partially defining a chamber and an opening extending there through, the opening configured to be positioned adjacent to a urethra of a user, the fluid impermeable barrier including at least one foaming agent incorporated therein, the at least one foaming agent being composed to increase a flexibility of the fluid impermeable barrier and maintain a selected geometric configuration; the fluid collection device further including a permeable material disposed in the chamber and a conduit including an inlet and an outlet, the inlet being positioned in the chamber and the outlet extending through an aperture in the fluid impermeable barrier, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Davis et al. (U.S. Publication 2018/0228642) in view of Park et al. (U.S. Patent No. 5,340,840) as is detailed in the below rejection of claim 1.
During a telephone conversation with Johnathan Rowe on August 5th, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-5 and 7-14. Affirmation of this election must be made by applicant in replying to this Office action. Claims 15-18 and 20 are herein withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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.
Claim(s) 1-5, 6-11 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (U.S. Publication 2018/0228642) in view of Park et al. (U.S. Patent No. 5,340,840).
Regarding claim 1-3, Davis discloses a fluid collection device (Fig. 1) comprising:
A fluid impermeable barrier 20 at least partially defining a chamber (internal space of barrier), the fluid impermeable barrier also defining an opening 30 extending therethrough (extends from outer surface through to chamber), the opening configured to be positioned adjacent to a urethra of a user (Abstract, assembly configured to be disposed against the body of the user, with the at least one fenestration in operative relation with a urethral opening of the user), the fluid impermeable barrier being foamed (¶0053 fin the form of a foam) to increase a flexibility of the fluid impermeable barrier and maintain a selected geometric configuration (¶0053);
A permeable material disposed in the chamber; and
A conduit including an inlet and an outlet, the inlet being positioned in the chamber and the outlet extending through an aperture in the fluid impermeable barrier (see Fig. 1, 32 and ¶0060).
Davis does not expressly disclose at least one foaming agent incorporated therein, wherein the fluid impermeable barrier exhibits a specific gravity less than 0.85 or the foaming agent is composed to increase a flexibility of the fluid impermeable barrier and maintain a selected geometric configuration (Claim 1), the fluid impermeable barrier including a thermoplastic elastomer (Claim 2), the thermoplastic elastomer including at least one of polyethylene, polypropylene, polyamide, and polyvinylchloride (Claim 3).
However, Park, in the same field of endeavor of foamed materials, teaches a foamed material (Example 2 Col. 18 lines 25-43) comprising at least one foaming agent (HCFC-142b blowing agent) incorporated therein, wherein the foamed material exhibits a specific gravity less than 0.85 (Col. 18 lines 40-43; 45 kg/m3, density of water ranges from 1000.0 kg/m3 to 958.40 kg/m3 depending on temperature, making the 45 kg/m3 equal to a specific gravity range of 0.045-0.0469), the at least one foaming agent is composed to increase a flexibility of the foam material (Col. 1 lines 14-16 enhanced elasticity) and maintain a selected geometric configuration (Col. 1 lines 14-16 enhanced toughness; Col. 18m lines 40-43 dimensionally stable, and resilient) (Claim 1), the foamed material including a thermoplastic elastomer (Claim 2) and wherein the thermoplastic elastomer includes polyethylene (Claim 3) (Col. 18 lines 25-26 prepared using CG3; Col. 16 lines 33-40 linear low density polyethylene resins (CGCT resins)…CGCT resins are indicated by “CG”; linear low density polyethylene is a thermoplastic elastomer) for the purpose of enhancing toughness and elasticity of the foam (Col. 1 lines 14-16 of Park).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the foam material of the fluid impermeable barrier of Davis that performs the function of providing a flexible (soft) foam for the foam material of Park since these elements perform the same function of providing a soft material, i.e. cushioned with reference to Park. Simply substituting one cushioning foam material means for another would yield the predictable result of allowing a(n) foamed component to provide a soft/cushioned feel. See MPEP 2143.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the foamed material of Davis out of the foamed material of Park since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed the above material substitution for the purpose of enhancing the toughness and elasticity of the foam as taught by Park (Col. 1 lines 14-16 of Park).
Regarding claims 4, 5, and 7, Davis in view of Park suggest the fluid collection device of claim 1. Davis in view of Park in the present embodiment do not expressly disclose the foaming agent including a sodium bicarbonate (Claim 7). However, Park, in the same field of endeavor of foamed materials, further teaches incorporating various additive such as nucleating agents, such as sodium bicarbonate, in an amount from about 0.01 to about 5 parts by weight per hundred parts by weight of a polymer resin, for the purpose of controlling the size of foam cells (Col. 15 lines 62-68 and Col. 16 lines 1-2).
Regarding the foaming agent including sodium bicarbonate, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the foaming agent suggested by Davis in view of Park to have further included a nucleating agent of sodium bicarbonate, as taught by Park, for the purpose of controlling the size of foam cells.
Furthermore, Park discloses the density of the linear polymers being from about 0.85 g/cm3 to about 0.97 g/cm3 (Col. 2 lines 51-55). This coupled with the teaching of Parks to include sodium bicarbonate mixture in an amount from about 0.01 to about 5 parts by weight per hundred parts by weight and the would stipulate a by volume percentage somewhere in the range between greater than 1.7% and less than 12.9% (based on the inherent densities of sodium bicarbonate of 2.2 g/cm3 and citric acid of 1.67 g/cm3 and an inherent density of without knowing the percentage of citric acid to sodium bicarbonate present in the mixture would result in a range based on a minimum volume percent calculated based with the minimum density of the sodium bicarbonate citric acid mixture of greater than 1.67 g/cm3 multiplied by the minimum percentage by weight of 0.01 percent divided by the maximum density of the polymer resulting in a minimum volume percentage of [(0.01%)*(1.67 g/cm3)]/0.97 g/cm3 = 1.7% and the maximum volume percent calculated based with the maximum density of the sodium bicarbonate citric acid mixture of less than 2.2 g/cm3 multiplied by the maximum percentage by weight of 5 percent divided by the minimum density of the polymer resulting in a maximum volume percentage of [(5%)*(2.2g/cm3)]/0.85g/cm3 = 12.9%).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the percentage by volume of the sodium bicarbonate to be in the range of less than 10 percent (claim 4) or between 0.04 and about 5% (Claim 5) as applicant appears to have placed no criticality on the claimed range (¶0030 fluid impermeable barrier may include less than 10% by volume of the at least one foaming agent. In some embodiments, the fluid impermeable barrier may include between about 0.4% and about 5% of the at least one foaming agent) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Davis in view of Park would not operate differently still being presented with a foamed outer material with the claimed range. Further, applicant places no criticality on the ranged claimed, indicating simply that the fluid impermeable barrier may include less than 10% by volume of the at least one foaming agent. In some embodiments, the fluid impermeable barrier may include between about 0.4% and about 5% of the at least one foaming agent (¶0030 of applicants’ specification).
Regarding claim 8, Davis in view of Park in the present embodiment do not expressly disclose the foaming agent including an azide compound. However, Park, in the same field of endeavor of foamed materials, further teaches utilizing a number of different foaming agents including different azide compounds (Col. 14 lines 63-68 and Col. 15 lines 1-35 Blowing agents useful in making the present foam structure include…benzenesulfonhydrazide, 4,4-oxybenzene sulfonyl-semicarbazide, p-toluene sulfonyl semi-carbazide).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the blowing agent of Davis in view of Park as detailed above in claim 1 that performs the function of foaming a polymer for the azide blowing agent of the additional embodiment of Park since these elements perform the same function of providing a blowing agent to create cells and foam the polymer. Simply substituting one blowing agent means for another would yield the predictable result of allowing a(n) polymer to be foamed. See MPEP 2143.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have utilized the azide blowing agent, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claims 9 and 10, Davis discloses a fluid collection system (Fig. 32 utilized with Fig. 1), comprising:
A fluid storage container 204 configured to hold a fluid (Fig. 32 shows fluid);
A fluid collection device 10 fluidly coupled to the fluid storage container (Coupled through 202), the fluid collection device including:
A fluid impermeable barrier 20 at least partially defining a chamber (internal space of barrier), the fluid impermeable barrier also defining an opening 30 extending therethrough (extends from outer surface through to chamber), the opening configured to be positioned adjacent to a urethra of a user (Abstract, assembly configured to be disposed against the body of the user, with the at least one fenestration in operative relation with a urethral opening of the user), the fluid impermeable barrier being foamed (¶0053 fin the form of a foam) to increase a flexibility of the fluid impermeable barrier and maintain a selected geometric configuration (¶0053);
A permeable material disposed in the chamber;
A conduit 32 including an inlet 34 and an outlet 33, the inlet being positioned in the chamber and the outlet extending through an aperture in the fluid impermeable barrier (see Fig. 1, 32 and ¶0060); and
A vacuum source 210 fluidly coupled to the fluid collection device via the conduit (¶0060 suction is applied to the tube).
Davis does not expressly disclose at least one foaming agent incorporated therein, wherein the fluid impermeable barrier exhibits a specific gravity less than 0.85 or the foaming agent is composed to increase a flexibility of the fluid impermeable barrier and maintain a selected geometric configuration (Claim 1), the fluid impermeable barrier including a thermoplastic elastomer (Claim 10).
However, Park, in the same field of endeavor of foamed materials, teaches a foamed material (Example 2 Col. 18 lines 25-43) comprising at least one foaming agent (HCFC-142b blowing agent) incorporated therein, wherein the foamed material exhibits a specific gravity less than 0.85 (Col. 18 lines 40-43; 45 kg/m3, density of water ranges from 1000.0 kg/m3 to 958.40 kg/m3 depending on temperature, making the 45 kg/m3 equal to a specific gravity range of 0.045-0.0469), the at least one foaming agent is composed to increase a flexibility of the foam material (Col. 1 lines 14-16 enhanced elasticity) and maintain a selected geometric configuration (Col. 1 lines 14-16 enhanced toughness; Col. 18m lines 40-43 dimensionally stable, and resilient) (Claim 9), the foamed material including a thermoplastic elastomer (Claim 10) (Col. 18 lines 25-26 prepared using CG3; Col. 16 lines 33-40 linear low density polyethylene resins (CGCT resins)…CGCT resins are indicated by “CG”; linear low density polyethylene is a thermoplastic elastomer) for the purpose of enhancing toughness and elasticity of the foam (Col. 1 lines 14-16 of Park).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the foam material of the fluid impermeable barrier of Davis that performs the function of providing a flexible (soft) foam for the foam material of Park since these elements perform the same function of providing a soft material, i.e. cushioned with reference to Park. Simply substituting one cushioning foam material means for another would yield the predictable result of allowing a(n) foamed component to provide a soft/cushioned feel. See MPEP 2143.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the foamed material of Davis out of the foamed material of Park since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed the above material substitution for the purpose of enhancing the toughness and elasticity of the foam as taught by Park (Col. 1 lines 14-16 of Park).
Regarding claim 11, Davis in view of Park suggest the fluid collection device of claim 9. Davis in view of Park do not expressly disclose or suggest the fluid impermeable barrier including less than 10% foaming agent by volume in the embodiment presented in the above rejection of claim 9. However, Park, in the same field of endeavor of foamed materials, further teaches incorporating various additive such as nucleating agents, such as sodium bicarbonate, in an amount from about 0.01 to about 5 parts by weight per hundred parts by weight of a polymer resin, for the purpose of controlling the size of foam cells (Col. 15 lines 62-68 and Col. 16 lines 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the foaming agent suggested by Davis in view of Park to have further included a nucleating agent of sodium bicarbonate, as taught by Park, for the purpose of controlling the size of foam cells.
Furthermore, Park discloses the density of the linear polymers being from about 0.85 g/cm3 to about 0.97 g/cm3 (Col. 2 lines 51-55). This coupled with the teaching of Parks to include sodium bicarbonate mixture in an amount from about 0.01 to about 5 parts by weight per hundred parts by weight and the would stipulate a by volume percentage somewhere in the range between greater than 1.7% and less than 12.9% (based on the inherent densities of sodium bicarbonate of 2.2 g/cm3 and citric acid of 1.67 g/cm3 and an inherent density of without knowing the percentage of citric acid to sodium bicarbonate present in the mixture would result in a range based on a minimum volume percent calculated based with the minimum density of the sodium bicarbonate citric acid mixture of greater than 1.67 g/cm3 multiplied by the minimum percentage by weight of 0.01 percent divided by the maximum density of the polymer resulting in a minimum volume percentage of [(0.01%)*(1.67 g/cm3)]/0.97 g/cm3 = 1.7% and the maximum volume percent calculated based with the maximum density of the sodium bicarbonate citric acid mixture of less than 2.2 g/cm3 multiplied by the maximum percentage by weight of 5 percent divided by the minimum density of the polymer resulting in a maximum volume percentage of [(5%)*(2.2g/cm3)]/0.85g/cm3 = 12.9%).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the percentage by volume of the sodium bicarbonate to be in the range of less than 10 percent as applicant appears to have placed no criticality on the claimed range (¶0030 fluid impermeable barrier may include less than 10% by volume of the at least one foaming agent. In some embodiments, the fluid impermeable barrier may include between about 0.4% and about 5% of the at least one foaming agent) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Davis in view of Park would not operate differently still being presented with a foamed outer material with the claimed range. Further, applicant places no criticality on the ranged claimed, indicating simply that the fluid impermeable barrier may include less than 10% by volume of the at least one foaming agent (¶0030 of applicants’ specification).
Regarding claim 14, Davis in view of Park suggest the fluid collection device of claim 9. Davis further discloses the fluid impermeable barrier defining a cylindrical shape with a longitudinally extending opening therein (see Fig. 1 element 20, cylindrical and opening extends along longitudinal length).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (U.S. Publication 2018/0228642) in view of Park et al. (U.S. Patent No. 5,340,840), as applied to claim 9 above, and further in view of Kharkar et al. (U.S. Publication 2022/0265461).
Regarding claims 12 and 13, Davis in view of Park disclose the fluid collection device of claim 9. Davis does not expressly disclose or suggest a connector disposed within the chamber, the inlet of the conduit being coupled to the connector, wherein the connector includes a shore hardness greater than the fluid impermeable barrier.
However, Kharkar, in the same field of endeavor of fluid collection devices, teaches providing a connector 1515 disposed within a chamber 1538 formed by a fluid impermeable barrier (collection member 1512; ¶0147 liquid impermeable) wherein an inlet of a conduit is coupled to the connector (Fig. 15 shows conduit coupled to port at 1578), wherein the connector includes a hardness greater than the fluid impermeable barrier (¶0059 the port support structure can be formed from a material having a rigidity that is greater than a rigidity of the collection member) for the purpose of reducing or preventing collapse of the collection member due to vacuum pressure, kinking at the interface between the collection member and the drain tube, and/or closing of the fluid flow path due to external pressure applied to interface between the collection member and the drain tube (¶0059).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Davis to have included a connector within the chamber formed by the fluid impermeable barrier that couples to an inlet of the conduit, as taught by Kharkar, for the purpose of reducing or preventing collapse of the collection member due to vacuum pressure, kinking at the interface between the collection member and the drain tube, and/or closing of the fluid flow path due to external pressure applied to interface between the collection member and the drain tube (¶0059).
Kharkar does not expressly teach the hardness being a “shore” hardness (claim 12), or the fluid impermeable barrier being over molded onto the connector (Claim 13).
Regarding the limitation of shore, the limitation of “shore” simply describes the method utilized to determine hardness, i.e. the shore hardness scale. The teaching of Kharkar that the material has a rigidity that is greater than a rigidity of the collection member would have resulted in it having a greater shore hardness as these both described a greater rigidity of the material.
Regarding the limitation of being over molded, the claimed phrase “the fluid impermeable barrier is over molded onto the connector” is being treated as a product by process limitation as a material that results from the over molding process. As set forth in MPEP 2113, “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product in the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695,698,227 USPQ 964,966 (Fed. Cir. 1985). Examiner notes since there was no evidence provided by the applicant that the process of being over molded imparts structural difference onto the end product of the claimed invention that is not present in the prior art, the limitation “over molded onto the connector” is being given very little patentable weight.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Feys et al. (U.S. Patent No. 11,499,321) discloses the use of blowing agents in the forming of coverings.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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