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 claim amendment submitted on June 8th, 2026 has been entered. Claims 1-7, 17-24, and 40-54 remain cancelled. Claims 8-16 and 25-39 are currently pending and subject to the below restriction requirement. Claims 8-16, 25-30, and 34-39 remain withdrawn from consideration in accordance with previously presented restriction requirement. Claims 55 and 56 have been newly added. As such claims 31-35 and 55-56 are presently under consideration.
Response to Arguments
Applicant's arguments filed June 8th, 2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument that Yang discloses a multi-layered structure and demonstrates that each of these layers exhibit different densities but does not illustrate that any single layer of Yang has “at least one of a density or a porosity gradient” let alone such a gradient “along a short axis of the fluid permeable body”, examiner respectfully disagrees in that the requirement of a single layer having a density or a porosity gradient is not currently claimed with the claim currently requiring “a single material having at lest one of a density or a porosity gradient”. The scope of “a single material” vs. a single layer is considered to be different in that a material can be formed from multiple layers and still be a single material based on being incorporated or bound together as is the case in the present interpretation of Yang below.
Examiner however, would like to point out that if the claims were to point to a scope in which a single layer has at least one of a density or a porosity gradient as argued by the applicant, Yang would still be seen to teach this as depicted by Fig. 5 and reiterated in the specification in Col.8 lines 31-39 “the pore sized in the receiving layer gradually reduces from top to the bottom and its distribution is much broader” and its disclosure of intralayer density gradients on Col. 8 line 10 “intralayer density gradients” thus teaching a density gradient within a single layer. However, as stated above, this is not currently claimed and as such is not detailed in the current rejection.
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 permeability) 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 single material (Fig. 5; Col. 6 lines 51-67, the composite of the present invention is preferably incorporated into an absorbent structure by first fusing the composited produced through an oven….layers thus fused together and comprise a single material) 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 within a single layer (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.
Regarding claim 56, Sanchez in view of Yang suggest the fluid collection device of claim 31. Sanchez in view of Yang do not expressly disclose the material being configured to equilibrate pressure along a length of the fluid permeable body.
However, the limitation of “configured to equilibrate pressure along a length of the fluid permeable body” is considered functional language (based on Paragraph 9 of Applicant' s specification indicated that equilibration of pressure is a functional characteristic related to a layer with different porosity or density). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Sanchez in view of Yang suggests all the structure as claimed, and suggests a layer with different porosity or density and as such, it is considered capable of performing the functions as claimed (i.e. it is capable of equilibration of pressure).
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).
Claim(s) 55 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 Jayakody et al. (U.S. Publication 2011/0070423).
Regarding 55, Sanchez in view of Yang suggest the fluid collection device of claim 31. Sanchez in view of Yang do not expressly disclose the material including a gradient density foam or a gradient porosity foam.
However, Jayakody, in the same field of endeavor of fluid distributing materials (¶0011 structured to provide porosity or capillarity gradients through the material by the establishment of multiple cross-sectional regions having different fiber characteristics or distributions; ¶0037 transfer of liquid exudates), teaches combining web layers with polymer foam (¶0008 dispensing the polymer foam precursor onto the web of fibers and forcing penetration of the polymer foam precursor into and through the web of fibers) to form a material having a gradient of porosity along a short axis (¶0048 the fiber matrix was distributed throughout the foam component such that there existed a predetermined variable distribution of the fibers and a gradient density through the thickness of the composite material) for the purpose of imparting properties of the foam material such as hydrophilicity (¶0006 impart it with properties of the foam material) while also allowing for gradient porosity that is characteristic of the fiber composite materials (¶0026 open cell hydrophilic foams…have a relatively homogeneous, or isotropic, pore structure, which means that they may not be configured to contain a gradient of porosity or capillarity; ¶0042 foam-fiber composite materials according to embodiments of the invention have been produced and have demonstrated improved tensile strength, tear strength, and swelling properties over unreinforced foam materials. The composite materials produced have included structure with preordained gradient porosity or capillarity, and have been shown to be manufacturable in an inexpensive and efficient manner).
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 material of Sanchez in view of Yang to have included a foam as taught by Jayakody (see above), resulting in a gradient porosity foam, as taught by Jayakody (see above) for the purpose of imparting properties of the foam material such as hydrophilicity (¶0006 of Jayakody impart it with properties of the foam material) while also allowing for gradient porosity that is characteristic of the fiber composite materials (¶0026 of Jayakody open cell hydrophilic foams…have a relatively homogeneous, or isotropic, pore structure, which means that they may not be configured to contain a gradient of porosity or capillarity; ¶0042 of Jayakody foam-fiber composite materials according to embodiments of the invention have been produced and have demonstrated improved tensile strength, tear strength, and swelling properties over unreinforced foam materials. The composite materials produced have included structure with preordained gradient porosity or capillarity, and have been shown to be manufacturable in an inexpensive and efficient manner).
Conclusion
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.
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
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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