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 .
Information Disclosure Statements
The Examiner appreciates Applicant’s effort to identify the most relevant art that pertains to the instant application. The IDS filed 8 December 2025 has been entered and considered.
Response to Arguments
Applicant’s arguments, filed 8 December 2025, with respect to the rejection(s) of the pending claims over WO 2022/216776 to Newton et al have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 2018/0028349 to Newton in view of US 2018/0169281 to Russel et al, presented below.
This action is NON-FINAL.
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.
Claims 1-4, 6-14 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0028349 to Newton in view of US 2018/0169281 to Russel et al.
In the specification and figures, Newton discloses the apparatus substantially as claimed by Applicant. With regard to claims 1-4, 6-8, 14, 18-20, Newton discloses a fluid collection assembly that receives a user’s penis, wherein the assembly comprises an impermeable casing 450 comprising a chamber 410, inlet opening 432, fluid outlet 420, and a nonwoven porous membrane 430 disposed in the chamber near the urethral opening, wherein the membrane provides a wicking force to fluid introduced therein towards an external receptacle 460 using a vacuum 470 (see at least FIG 5 and accompanying text, ¶0009, 0074).
Newton does not disclose the dimensions of the porous material, nor that the material is configured to wick one or more bodily fluids in a vertical and horizontal direction. However, Applicant’s Specification discloses that vertical lapped nonwoven fabrics, carded webs, spunlaced web, needle punched webs or a combination thereof may provide vertical and horizontal wicking (see Spec at ¶0027). Russell discloses a permeable material with a wicking layer configured to discharge liquids in a controlled manner towards a desired location (see ¶0001). The wicking layer may comprise carded web, spunlace web, vertical lapped webs, cross-lapped webs (which combine horizontal and vertical lapped webs), needle punched web (see ¶0055, 0062, 0064). Russell further illustrates that the porous material comprises hydrophilic fibers, a length longer than a width, and a thickness smaller than the width, a density of 20-90 kg/m3 , a thickness of 4-25mm, and a weight of 200-900 g/m2, within the ranges claimed by Applicant (see FIG 1, ¶0016-0019). It would have been obvious to a person having ordinary skill in the art at the time of filing to use the porous material disclosed by Russell in the fluid collection assembly disclosed by Newton in order to provide multidirectional wicking forces to a fluid, directing the fluid to a desired location, as taught by Russell.
With regard to claims 9 and 10, Newton does not disclose that the nonwoven material is configured to withstand a certain vacuum pressure without collapsing. However, Newton does disclose that the vacuum may operate at 20-40mmHg, wherein 40 mmHg is 5.33 kPa, within the range of claim 10. Newton further discloses that the force of the vacuum is higher or lower depending on the size of the user (see¶0043). Applicant discloses that the resiliency of the nonwoven material is a result-effective variable based on density, thickness, and weight basis of the nonwoven material, changing the orientation of the fibers, or increasing the yield strength of the material. It has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP § 2144.05(II)(A). As such, it would be within the skill of a worker in the art to vary the density, thickness, weight basis, orientation and yield strength of the nonwoven material to achieve a desired resiliency based, at least in part, on patient size.
With regard to claim 16, Newton fails to disclose the length of fibers used. However, it has been 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. See MPEP 2144.04(IV)(B). In the instant case, Applicant has not demonstrated the criticality of the 1cm fiber length, lending credence to the idea that fiber size selection is within the skill of a worker in the art.
With regard to claim 17, Newton discloses that the apparatus may comprise a cushion assembly 180 comprising a membrane layer 182 in contact with a head of a user’s penis and a second layer 184 spaced apart from the patient by the membrane layer 182, wherein the membrane layer may be made of a similar material as permeable membrane 130, wherein the permeable layer may be constructed of gauze, which is an absorbent material with a loose open weave1 (see ¶0039, 0031). Accordingly, Newton suggests a membrane layer that comprises a woven layer.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0028349 to Newton in view of US 2018/0169281 to Russel et al, further in view of WO 2019/212955 to Eckert.
In the specification and figures, the cited prior art suggests the article substantially as claimed by Applicant with the exception of using an air-laid material. Eckert discloses a fluid collection device with an impermeable member 102, a chamber 104, and a fluid permeable membrane 120 (see FIG 1B). the fluid permeable membrane may comprise an air-laid nonwoven pad (see ¶0026). ). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use an air laid nonwoven pad as disclosed by Eckert in the fluid management system suggested by the prior art, 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. See MPEP § 2144.07.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0028349 to Newton in view of US 2018/0169281 to Russel et al , further in view of WO 2017/100511 to Scholl et al.
In the specification and figures, the cited prior art suggests the article substantially as claimed by Applicant with the exception of using hollow fibers. With regard to claim 15, Scholl discloses an absorbent article that may use hollow fibers to distribute fluid away from a user (see p22, lines 4-10). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use hollow fibers as disclosed by Scholl in the fluid management system suggested by the prior art, 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. See MPEP § 2144.07.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 6 January 2026
1 https://www.dictionary.com/browse/gauze, accessed 17 December 2025.