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 .
Election/Restrictions
Applicant’s election without traverse of Group 1 in the reply filed on 02/05/2026 is acknowledged.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1,6,14,26,28-29,31,34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johannes, as provided in the Restriction Requirement, and as provided in the IDS.
Regarding Claim 1, Johannes discloses a fluid collection device (Fig. 1B), comprising: a sheath (102) at least partially defining a chamber (138) sized and dimensioned to receive at least a portion of a penis of a user therein (abstract) and including: a proximal end region defining an opening configured to receive at least a urethral opening of a penis (para. 0004); a distal end region opposite to the proximal end region (para. 0004); a first layer including at least a nonwoven fabric extending at least partially between the proximal end region and the distal end region (142, where said layer may be nonwoven per para. 0041. The examiner notes that impermeable barrier (134) comprising silicone, polypropylene, polyethylene, polyethylene terephthalate, a polycarbonate, etc.), a metal film, natural rubber, another suitable material per para. 0036, is interpreted to be a portion of the first layer.); and a second layer including a fluid permeable fabric at least partially positioned between the first layer and the chamber and extending at least partially between the proximal end region and the distal end region (141, seen between first layer (142) and chamber disclosed to be fluid permeable per para. 0040), and a head (145) positioned at the distal end region of the sheath, the head defining an aperture proximate to the distal end region configured to be fluidly coupled to a tube (see coupling with tube 112 through 143) effective to provide fluid communication between the chamber and the tube (para. 0043).
The examiner notes that as detailed above under the same rejection layer 134 (any suitable fluid impermeable material per para. 0036) and layer 142 (may be made from various materials including polyester, polyurethane, polyethylene, and more per paragraph 0041) are interpreted to be the first outer portion and first inner portion of the first layer, respectively. The second layer (141) may be made from natural material (para. 0041). The examiner notes however, that there is no disclosure that either the second layer is a multilayer and thus fails to disclose the second layer including a fluid permeable multilayer fabric including a second inner portion, a second outer portion, and an intermediate portion connecting the second inner portion and the second outer portion.
Per MPEP section 2144.04 VI B In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.) Therefore modifying the first and second layers to be a multilayer composition (including an inner and outer (For first layer) and an inner, outer, and intermediate (for second layer) would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention, as adding a multiple layers of suitable material to the first and second layer would still allow said layers intended function of support and leakage prevention (for first layer) and wicking fluid (for the second layer).
Regarding Claim 14, Johannes teaches the fluid collection device of claim 1,wherein the fluid collection device includes the first layer is configured to provide venting to the chamber when a vacuum of about 0 mmHg to about 20 mmHg is pulled on the chamber through the aperture. The examiner notes that per the MPEP section 2114 section II “"[A]pparatus 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) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as the prior art reference teaches all of the structural limitations of claim 1, and the application of pressure and venting as a result of the pressure is functional language, it is interpreted that the prior art reads to the claimed limitation.
Regarding Claim 26, Johannes teaches the fluid collection device of claim 1, but fails to disclose wherein the second layer has a thickness of about 1.0 mm to about 6.0 mm. Per MPEP Section 2144.04 IV A In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. The examiner notes that both devices are sheaths for attaching to a penis comprising a second layer that touches the penis. The examiner notes that modifying the device of Johannes to have the second layer be between 1 and 6mm would not inhibit the function of the device as said layer would still serve as s fluid permeable layer adjacent to the penis. Further the claimed range is found by the examiner to not be critical as the range is “about” 1 to “about 6” mm. As such it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the second layer of Johannes to be between 1-6mm in thickness.
Regarding Claim 28, Johannes teaches the fluid collection device of claim 1, wherein the second inner portion of the second layer at least partially defines the chamber. The examiner notes that as seen in figure 2A, the defined second layer forms the chamber. Thus the inner portion of said layer would form the chamber.
Regarding Claim 29, Johannes teaches the fluid collection device of any of claim 1, wherein the first outer portion of the first layer at least partially defines an outer surface of the sheath. The examiner notes that as seen in figure 2a, the defined first layer (including the impermeable barrier 134) forms an outer portion of the sheath. Should applicant argue that the first layer can only be interpreted as the support layer 142, the examiner notes that said layer can be seen comprising of at least a portion of the outer surface at the opening for the penis (see bottom of figure).
Regarding Claim 31, Johannes teaches the fluid collection device of claim 1, wherein the head includes a fluid impermeable barrier (where sump (145) is impermeable per para. 0043) secured to the distal end region of the sheath (see figure 2b), the head tapers between the sheath and the aperture (where the width of the sump gets smaller toward the opening with tubing, thus tapers), and the second layer extends at least partially into the head (where the defined second layer is seen to form the barrier between chamber [138 of the sheath] and chamber [152 of the “head”] and is thus interpreted to extend at least partially into the head.
Regarding Claim 34, Johannes teaches the fluid collection device of claim 1, further comprising a base skirt (skirt 106 attached to base 104) secured to the proximal end region of the sheath (see figure 2a), the base skirt including an adhesive configured to adhere to skin of the user around the penis (para. 0018).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johannes in view of Butler US 2004/0102753, hereafter Butler.
Regarding Claim 2, Johannes teaches the fluid collection device of claim 1. While Johannes teaches that polyethylene and polypropylene are suitable materials for the first layer and thus is would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use both polyethylene and polypropylene for the layers as a prima facie case of obviousness per "Obvious to try" choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, Johannes does not specifically disclose that the layers include a spunbonded fabric or have a density of 20-100gsm.
Butler teaches an absorbent article and is thus considered analogous to the claimed invention. Butler teaches that the device comprises a cover made from any suitable material, which may include nonwovens, films, or composites of nonwovens and films (para. 0041). Per said citation, the cover may include an inner liner layer and an outer film layer, where the film layer may be a polyethylene film, and nonwoven, including spunbonded polypropylenes are suitable materials for the construction. In an example, a material including spunbonded polypropylene is taught to have a basis weight of 1.2osy which converts to 40.7 gsm. Therefore, as Butler teaches that composite cover layers including polyethylene films and spunbonded nonwoven polypropylenes may be used for absorbent articles to prevent fluid leakage, and Johannes teaches that polyethylene and polypropylene are suitable materials for the outer layer (per rejection of claim 1), it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use the construction taught in Butler as the first layer of Johannes. Doing so would merely involve the simple substitution of one known element (polypropylene and polyethylene outer layer) for another (polyethylene film and nonwoven polypropylene outer layer) to obtain predictable results (the prevention of liquid leaving the device), and thus a prima facie case of obviousness exists.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johannes in view of Butler and further in view of Rezai et al. US 6878647, hereafter Rezai.
Regarding Claim 4, Johannes and Butler teach the fluid collection device of claim 2, wherein the first inner portion includes a nonwoven polypropylene and the first outer portion includes a polyethylene film. Per the rejection of claim 2, a nonwoven polypropylene is provided for the inner portion, and a polyethylene film is provided for the outer portion. However a microporous polyethylene film is not disclosed.
Rezai teaches a construction of an absorbent garment and is thus considered analogous to the claimed invention. Rezai teaches that the outer layer (backsheet (22)) includes a impervious film (68) that is impervious to liquids but allows gas to escape. Such a suitable material is a polyethylene microporous film (column 19 lines 60-67 and column 20 lines 1-11). Therefore as Johannes and Butler teach a polyethylene film is suitable for absorbent articles, and Rezai further teaches that microporous polyethylene films are suitable for absorbent articles to allow gas to escape, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use the film taught in Rezai as the first layer of Johannes and Butler. Doing so would merely involve the simple substitution of one known element (polyethylene film) for another (polyethylene microporous film) to obtain predictable results (the prevention of liquid leaving the device), and thus a prima facie case of obviousness exists.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johannes in view of Butler and further in view of Ito US 2022/0015958, hereafter Ito.
Regarding Claim 5, Johannes and Butler teach the fluid collection device of claim 2, wherein the first inner portion includes a nonwoven polypropylene material (see rejection of claim 2). The examiner notes that as the nonwoven polypropylene is a suitable material for the impermeable layer, it would have further have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the outer layer of the device of Johannes and Butler to also be a nonwoven polypropylene. However, it is not specifically disclosed that the first layer includes a first intermediate portion including polyethylene between the first inner portion and the first outer portion.
Ito teaches an absorbent article construction and is thus considered analogous to the claimed invention. Ito teaches that the device comprises a liquid impermeable sheet (40) where said sheet may suitably made from a SMS construction. Said construction includes a suitable meltblown material sandwiched between two spunbonded materials, where suitable materials for the device includes both polypropylene and polyethylene (para. 0112). Therefore are the prior art references teach two spunbonded nonwoven polypropylene layers, and Ito teaches that a suitable construction may include a melt blown material (suitably polyethylene) between two spunbonded layers (suitably polypropylene) it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a meltblown polyethylene layer between the two spunbonded polypropylene layers. Doing so would merely be combining prior art elements according to known methods to yield predictable results, that being the formation of an impermeable sheet.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johannes in view of Butler and further in view of Oreglia et al. US 5455091, hereafter Oreglia
Regarding Claim 6, Johannes teaches the fluid collection device of claim 1, wherein the first inner portion includes a nonwoven polyester material and the first outer portion includes a polyethylene material. As Johannes teaches that polyethylene and polyester (para. 0041, in the form of porous polymers, and thus it is interpreted that the polyester is nonwoven) are suitable materials for the first layer and thus it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use both polyethylene and polypropylene for the layers as a prima facie case of obviousness per "Obvious to try" choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.
However, Johannes fails to teach that the first layer has a density of about 25-120gsm.
Oreglia teaches materials for use in production of fluid collection devices (ostomy) and is thus considered analogous to the claimed invention. Oreglia teaches that said device comprises nonwoven plastics, where suitable materials include both polyester and polyethylene (column 2, lines 3-7). Oreglia further teaches that said films have a suitable weight of 15-40g/m2 (gsm). Therefore, as Johannes teaches that polyethylene and polyester are known materials for fluid collection device and Orelia teaches that nonwoven plastics including polyethylene and polyester used for fluid collection devices may suitably have a density of 15-40gsm, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use both polyethylene and polypropylene with a weight of 15-40gsm for the layers of Johannes. The examiner notes that 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) (See MPEP 2144.05).Therefore the density of the first layer, including the first inner layer would be within the claimed range per the obviousness rejection.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johannes in view of in view of Furukawa US 2021/0007910, hereafter Furukawa, and further in view of Ito.
Regarding Claim 8, Johannes teaches the fluid collection device of claim 1, the first outer portion includes polyethylene. The examiner notes that per the rejection of claim 1, para. 0041 discloses various materials for the first layer, including polyethylene and natural materials and thus is would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use both polyethylene and polypropylene for the layers as a prima facie case of obviousness per "Obvious to try" choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. However, cellulose is not specifically disclosed and there is no disclosure of including a spunbonded fabric.
Furukawa teaches an absorbent article and is thus considered analogous to the claimed invention. Furukawa teaches that cellulose fibers may be included and attached to the region below an outer impermeable layer (abstract, para. 0030). Therefore, as Johannes, per the rejection of claim 1 teaches a multilayer construction where natural materials are one suitable material for the construction, and Furukawa teaches that cellulose fibers are known to be used in absorbent articles, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use cellulose as the natural fiber layer of Johannes.
Ito teaches an absorbent article construction and is thus considered analogous to the claimed invention. Ito teaches that the device comprises a liquid impermeable sheet (40) where said sheet may suitably made from a SMS construction. Said construction includes a suitable meltblown material sandwiched between two spunbonded materials, where suitable materials for the device includes both polypropylene and polyethylene (para. 0112). Therefore are the prior art references teach two spunbonded nonwoven polypropylene layers, and Ito teaches that a suitable construction may include a melt blown material (suitably polyethylene) between two spunbonded layers (suitably polyethylene as well) it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a meltblown polyethylene layer between the two spunbonded polyethylene layers. Doing so would merely be combining prior art elements according to known methods to yield predictable results, that being the formation of an impermeable sheet. The examiner notes that using said construction would provide a prior art device with at least an outer layer of spunbonded polyethylene.
Claim(s) 9,11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johannes in view of Ito.
Regarding Claim 9, Johannes teaches the fluid collection device of claim 1, where polyethylene and polypropylene are suitable materials for the first layer (para. 0041). However, Johannes fails to teach wherein the first inner portion and the first outer portion include spunbonded polypropylene, and the first layer further includes an intermediate portion including melt blown polypropylene between the first inner portion and the first outer portion, the first layer including a density of about 12 gsm to about 60 gsm.
Ito teaches an absorbent article construction and is thus considered analogous to the claimed invention. Ito teaches that the device comprises a liquid impermeable sheet (40) where said sheet may suitably made from a SMS construction. Said construction includes a suitable meltblown material sandwiched between two spunbonded materials, where suitable materials for the device includes synthetic resins such as both polypropylene and polyethylene (para. 0112). Further per para. 0112, Ito teaches that the synthetic resin sheet may have a weight of 10-50g/m2 (gsm) to ensure flexibility. Therefore are the prior art references teach two spunbonded nonwoven polypropylene layers, and Ito teaches that a suitable construction may include a melt blown material (suitably polyethylene) between two spunbonded layers (suitably polypropylene) it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a meltblown polyethylene layer between the two spunbonded polypropylene layers with a weight of 10-50gsm for a fluid to ensure flexibility. Doing so would merely be combining prior art elements according to known methods to yield predictable results, that being the formation of an impermeable sheet. The examiner further notes that as 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) (See MPEP 2144.05).Therefore as the prior art range of 10-50 overlaps with the claimed range of 12-60 a prima facie case of obviousness exists.
Regarding Claim 11, Johannes teaches the fluid collection device of claim 1, but fails to teach wherein the first inner portion includes spunbonded polypropylene and the first outer portion includes nonwoven polyethylene, the first layer further including a first intermediate portion including melt blown polypropylene adjacent to the first inner portion, a second intermediate portion including spunbonded polypropylene adjacent to the first intermediate portion, and a third intermediate portion including melt blown polypropylene between the second intermediate portion and the first outer portion.
Ito teaches an absorbent article construction and is thus considered analogous to the claimed invention. Ito teaches that the device comprises a liquid impermeable sheet (40) where said sheet may suitably made from a SMS construction. Said construction includes a suitable meltblown material sandwiched between two spunbonded materials, where suitable materials for the device includes both polypropylene and polyethylene (para. 0112). Therefore are the prior art references teach two spunbonded nonwoven polypropylene layers, and Ito teaches that a suitable construction may include a melt blown material (suitably polypropylene) between two spunbonded layers (suitably polypropylene and polyethylene) it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a meltblown polyethylene layer between the two spunbonded polypropylene layers. Doing so would merely be combining prior art elements according to known methods to yield predictable results, that being the formation of an impermeable sheet. The prior art device however fails to teach the second and third intermediate portions. Per MPEP section 2144.04 VI B the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.) Therefore modifying the SMS composition of Johannes and Ito to include an additional “S” and “M” layer would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention. Doing so would provide a SMSMS configuration. The examiner notes that as both meltblown layers are surrounded by spunbonded layers, it is interpreted that the function would not change as the construction (in terms of layer organization) remains consistent.
Regarding Claim 12, Johannes teaches the fluid collection device of claim 1, but fails to teach wherein the first inner portion includes spunbonded polypropylene and the first outer portion includes nonwoven polyethylene, the first layer further including a first intermediate portion including melt blown polypropylene adjacent to the first inner portion and a second intermediate portion including spunbonded polypropylene between the first intermediate portion and the first outer portion, the first layer including a density of about 25 gsm to about 85 gsm.
Ito teaches an absorbent article construction and is thus considered analogous to the claimed invention. Ito teaches that the device comprises a liquid impermeable sheet (40) where said sheet may suitably made from a SMS construction. Said construction includes a suitable meltblown material sandwiched between two spunbonded materials, where suitable materials for the device includes both polypropylene and polyethylene (para. 0112). Further per para. 0112, Ito teaches that the synthetic resin sheet may have a weight of 10-50g/m2 (gsm) to ensure flexibility. Therefore are the prior art references teach two spunbonded nonwoven polypropylene layers, and Ito teaches that a suitable construction may include a melt blown material (suitably polypropylene) between two spunbonded layers (suitably polypropylene and polyethylene) it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a meltblown polyethylene layer between the two spunbonded polypropylene layers with a weight of 10-50gsm for a fluid to ensure flexibility. Doing so would merely be combining prior art elements according to known methods to yield predictable results, that being the formation of an impermeable sheet. The examiner further notes that as 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) (See MPEP 2144.05).Therefore as the prior art range of 10-50 overlaps with the claimed range of 12-60 a prima facie case of obviousness exists.
Claim(s) 17,30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johannes in view of Ewell US 2021/0206144, hereafter Ewell.
Regarding Claim 17, Johannes teaches the fluid collection device of claim 14, but fails to teach wherein the fluid collection device includes at least the second layer including the spacer fabric and at least the spacer fabric having a density of about 190gsm to about 260gsm.
Ewell teaches an absorbent article construction and is thus considered analogous to the claimed invention. Ewell teaches that the innermost layers (D1) may be composed of various materials (para. 0035). The examiner notes that D1 is interpreted as the second layer. Under the second layer is layer D2, where D2 is suitably polyester or microfiber, or other material such as Coolplus (para. 0036). D2 is interpreted as a spacer layer. D2 is taught to have a gsm of 100 to 300. D2 allows for temperature cooling as well as rapid absorption and drying. The examiner notes that therefore it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a layer, such as the Coolplus layer as a spacer layer of the second layer, where said layer aids in cooling and drying of the article. Doing so would merely involve combining prior art elements (additional layer further exterior to the innermost layer) according to known methods to yield predictable results (that being the drying of the article), and as such a prima facie case of obviousness exists.
Regarding Claim 30, Johannes teaches the fluid collection device of claim 1, but fails to teach wherein the first layer is welded to the second layer.
Ewell teaches an absorbent article construction and is thus considered analogous to the claimed invention. Ewell teaches that layer B (of a suitable materials, including cotton (per para. 0031) of the device may be affixed to layer C (polyurethane per para. 0032) by applying heat (para. 0033). Therefore, it would have been obvious to one having ordinary skill in the art to affix the first (suitably polyurethane per para. 0041) and second (suitably cotton per para. 0040) layer via heat (interpreted to be welding). Doing so would merely require applying a known technique (heat affixation for layers) to a known device (fluid collection device)) ready for improvement to yield predictable results (the affixation of two layers), and thus a prima facie case of obviousness exists.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johannes in view of Huchthausen US 2019/0029869.
Regarding Claim 22, Johannes teaches the fluid collection device of claim 1. The examiner notes that Johannes does support that cotton may be used for the defined second layer (para. 0040) and that fabric may be used, but fails to teach wherein the second layer includes a polyester-spandex knit fabric and at least the second inner portion including the polyester-spandex knit fabric and the second outer portion including the polyester-spandex knit fabric; the second inner portion including a cotton fabric and the second outer portion including the polyester-spandex knit fabric.
Huchthausen teaches an incontinence article and is thus considered analogous to the claimed invention. Huchthausen teaches that said articles are known in the art to comprise elastic netting made from spandex/polyester knit. Therefore as Huchthausen teaches that spandex/polyester knit is a known material to be used in the art, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a spandex/polyester knit as a fabric material of the second layer. The examiner notes that it would have further been obvious to use cotton (per discloses of Johannes) as the other layer in the multilayer configuration as cotton is also a suitable material. As such the combination of art establish a prima facie case of obviousness per "Obvious to try" choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (both cotton and spandex polymer knits are known to be used for external fluid collection devices).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781