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 Objections
The claim amendment submitted on July 11th, 2023 has been entered. Claims 1-7, 17-24, and 40-54 are herein cancelled. Claims 8-16 and 25-39 are currently pending and subject to the below restriction requirement. Applicant has provisionally selected claims 31-35 through telephonic election as detailed below.
Election/Restrictions
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) 8-16, drawn to a fluid collection device with support including wicking portion and packing portion.
Group II, claim(s) 25-30, drawn to a fluid collection device with support including first and second layers having different porosity.
Group III, claim(s) 31-35, drawn to a fluid collection device with support including a material having a density or porosity gradient along a short axis of the fluid permeable body.
Group IV, claim(s) 36-39, drawn to a fluid collection device with support including a density or porosity gradient along a long axis of the fluid permeable body.
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-IV lack unity of invention a posteriori because even though the inventions of these groups require the technical feature of a fluid collection device, comprising: a fluid impermeable barrier having an inner surface at least partially defining a chamber, a first end region defining an aperture extending therethrough and including a first outer surface portion, and a second end region distal to the first end region, the fluid impermeable barrier also defining an opening extending longitudinally along the fluid impermeable barrier and configured to be positioned adjacent to a female urethra; and a fluid permeable body positioned at least partially within the chamber to extend across at least a portion of the opening and configured to wick fluid away from the opening, wherein the fluid permeable body includes a support, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Sanchez (U.S. Publication 2017/0266031). Sanchez discloses a fluid collection device 1802, comprising: a fluid impermeable barrier 1804 having an inner surface (surface of casing that forms internal space that elements 1830, 1840, and 1821 are inserted into ¶0144) at least partially defining a chamber (internal space that elements 1830, 1840, and 1821 are inserted into ¶0144) , a first end region (region at which element 1820 is placed) defining an aperture 1820 extending therethrough (¶0143 fluid removed through tube and out of the outlet, tube inserted through outlet 1820 into chamber) and including a first outer surface portion (outer surface opposite inner surface, surface facing away from interior), and a second end region 1810 distal to the first end region, the fluid impermeable barrier 1804 also defining an opening 1804A extending longitudinally along the fluid impermeable barrier and configured to be positioned adjacent to a female urethra (¶0010 disposed with the opening adjacent to a urethral opening of a user; ¶0068 disposing in operative relationship with the urethral opening of a female user); and a fluid permeable body 1830 positioned at least partially within the chamber to extend across at least a portion of the opening (¶0144 inserted through elongated opening of the impermeable casing and the impermeable casing surrounds the permeable membrane except in the area of the elongated opening) and configured to wick fluid away from the opening (¶0143 permeable membrane can be same in structure and function to the permeable membranes described herein, ¶0073 permeable membrane configured to wick fluid away from the urethral opening, wicking away from urethral opening would also result in wicking away from opening placed in contact with urethral opening), wherein the fluid permeable body includes a support 1840.
During a telephone conversation with Marcus Simon on November 19th, 2025 a provisional election was made without traverse to prosecute the invention of Group III, claim 31-35. Affirmation of this election must be made by applicant in replying to this Office action. Claims 8-16, 25-30, and 36-39 are 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).
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) 31-33 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez (U.S. Publication 2017/0266031) in view of Yang (U.S. Patent No. 5,525,407).
Regarding claims 31-33 and 35, Sanchez discloses a fluid collection device (Fig. 34, element 1802), comprising: a fluid impermeable barrier 1804 having an inner surface (surface of casing that forms internal space that elements 1830, 1840, and 1821 are inserted into ¶0144) at least partially defining a chamber (internal space that elements 1830, 1840, and 1821 are inserted into ¶0144) , a first end region (region at which element 1820 is placed) defining an aperture 1820 extending therethrough (¶0143 fluid removed through tube and out of the outlet, tube inserted through outlet 1820 into chamber) and including a first outer surface portion (outer surface opposite inner surface, surface facing away from interior), and a second end region 1810 distal to the first end region, the fluid impermeable barrier 1804 also defining an opening 1804A extending longitudinally along the fluid impermeable barrier and configured to be positioned adjacent to a female urethra (¶0010 disposed with the opening adjacent to a urethral opening of a user; ¶0068 disposing in operative relationship with the urethral opening of a female user); and a fluid permeable body 1830 positioned at least partially within the chamber to extend across at least a portion of the opening (¶0144 inserted through elongated opening of the impermeable casing and the impermeable casing surrounds the permeable membrane except in the area of the elongated opening) and configured to wick fluid away from the opening (¶0143 permeable membrane can be same in structure and function to the permeable membranes described herein, ¶0073 permeable membrane configured to wick fluid away from the urethral opening, wicking away from urethral opening would also result in wicking away from opening placed in contact with urethral opening), wherein the fluid permeable body includes a support 1840 made of a material (¶0143 permeable support same structure and function to and of permeable supports described herein, ¶0166 material of which permeable support 2640) having a density (density inherent to a material) and porosity (¶0166 sufficient porosity and permeablility) along a short axis (axis of 1840 when installed in device of Fig. 34 that exists along cross section of device taken perpendicular to the longitudinal axis of Fig. 34) of the fluid permeable body, and the material having an outer surface and a center location (center position is location of tube 1821 which 1840 is rolled around ¶0144 rolled to a tube, see Fig. 32 for visual of placement of 1621 in center of roll of 1640).
While Sanchez describes the material of the support being sufficiently porous and/or permeable ¶0166 as well as having wicking properties ¶0167, Sanchez does not expressly disclose a porosity or density gradient present in the material of the support along the short axis (Claim 31), a greater density at a location proximate to a center of the fluid permeable body and a lower density at a location proximate to an outer surface of the fluid permeable body (Claim 32), a lower density at a location proximate to a center of the fluid permeable body and a greater density at a location proximate to an outer surface of the fluid permeable body (Claim 33), or a lower porosity at a location proximate to a center of the fluid permeable body and a greater porosity at a location proximate to an outer surface of the fluid permeable body (Claim 34).
However, Yang, in the same field of endeavor of fluid transport through layers intended to transport urine excreted by a user away from the user interface surface, teaches a material (Fig. 5) having an outer surface (surface on side of transfer layer) and an inner surface (surface opposite outer surface on side of storage layer) that has a greater density at a location proximate the inner surface (Fig. 5, 0.24 G/C.C. Density of Wicking layer) and a lower density proximate an outer surface (Fig. 5, 0.1 g/C.C. density of transfer layer) and a lower density at a location proximate to an inner surface (Fig. 5, 0.09g/c.c. density of Receiving layer) with a greater density at a location proximate an outer surface (Fig. 5, 0.1 g/C.c. density of transfer layer greater than density of receiving layer), as well as a lower porosity at a location proximate to the inner surface and a greater porosity at a location proximate to the outer surface (Col. 8 lines 31-39 the pore sizes in the receiving layer gradually reduce from top to the bottom) for the purpose of enabling the composite to quickly receive and move large amounts of fluid to the bottom of the structure to prevent wet feed and leakage (Col. 7 lines42-62), enabling the composite to quickly receive and move large amounts of fluid to the bottom of the structure to prevent leakage (Col. 8 lines 20-30).
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 support material of Sanchez that performs the function of providing transport of fluid away from an outer surface (¶0167 of Sanchez wick fluid away from urethral opening) toward an inner surface/center (¶0167 wicks away from urethral opening and transports through the layer thus toward inner surface of material) for the material of Yang since these elements perform the same function of quickly receiving and moving fluid away from a receiving surface. Simply substituting one fluid transporting material means for another would yield the predictable result of allowing a(n) fluid receiving device to transport fluid away from the user from which the fluid was received. 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 fluid wicking support of Sanchez out of the material of Yang, 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, and Yang has provided the teaching motivation to one of ordinary skill in the art to have made the substitution for the purpose of enabling the composite to quickly receive and move large amounts of fluid to the bottom of the structure to prevent wet feed and leakage (Col. 7 lines42-62 of Yang) and enabling the composite to quickly receive and move large amounts of fluid to the bottom of the structure to prevent leakage (Col. 8 lines 20-30 of Yang).
Substituting the material sheet of Sanchez with the material sheet of Yang would have resulted in the sheet being rolled as described by Sanchez (¶0144 permeable support rolled such that it shaped is changed from a sheet or tube) which would have resulting in the outer surface of Yang being presented on the urethral facing surface, and the inner surface of Yang being presented toward a center of the device surrounding the tube and as such all location proximate the inner surface would have been proximate the center of the device.
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez (U.S. Publication 2017/0266031) in view of Yang (U.S. Patent No. 5,525,407) and further in view of McDowall et al. (U.S. Patent No. 5,700,254).
Regarding claim 34 Sanchez in view of Yang suggest the fluid collection device of claim 31. Sanchez in view of Yang do not expressly disclose the material having a greater porosity at a location proximate to the center of the fluid permeable body and a lower porosity at a location proximate to an outer surface of the fluid permeable body.
However, McDowell, in the same field of endeavor of fluid transport through layers intended to transport urine excreted by a user away from the user interface surface, teaches increasing the porosity of a fluid distributing layer toward sections remote to the initial liquid intake (liquid intake at facing layer 12) which would result in a greater porosity at a location proximate an inner surface 18 and a lower porosity at a location proximate an outer surface 12 for the purpose of allowing the sections away remote to the initial liquid intake to have a faster capacity for liquid transfer than the section where the liquid distribution layer takes direct insults of incoming liquids, improving the speed of directional liquid movement (Col. 9 lines 49-58).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed inventions to have modified the receiving layer (receiving layer of Fig. 5 of Yang) as suggested by Sanchez in view of Yang to have had a greater porosity approaching the inner surface/center as defined by the rolling of the material by Sanchez for the purpose of allowing a faster capacity for liquid transfer from the outer surface taking direct insults of incoming liquids toward the sections away from the initial liquid intake and improving the speed of directional liquid movement (Col. 9 lines 49-58 of McDowell).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Meyer et al. (U.S. Patent No. 4,798,603) discloses a pore size gradient of a fluid transport layer.
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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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781