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 references cited by applicants in the information disclosure statement filed 26 June 2026 have been made of record. Examiner has considered the voluminous references to the best of her ability.
While the statements filed do not comply with the guidelines set forth in MPEP § 2004 regarding both the number of references cited and the elimination of clearly irrelevant art and marginally cumulative information, compliance with these guidelines is not mandatory. Furthermore, 37 CFR §§1.97 and 1.98 do not require that the information be material; rather, they allow for submission of information regardless of its pertinence to the claimed invention. Also, there is no requirement to explain the materiality of the submitted references. However, the cloaking of a clearly relevant reference by inclusion in a long list of citations may not comply with Applicant’s duty of disclosure. See Penn Yan Boats, Inc. v. Sea Lark boats Inc., 359 F. Supp. 948, aff’d 479 F. 2d. 1338.
Applicant is advised that the MPEP states the following with respect to large information disclosure statements:
Although a concise explanation of the relevance of information is not required for English language information, applicants are encouraged to provide a concise explanation of why the English-language information is being submitted. Concise explanations (especially those that point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more is highly relevant to patentability. MPEP § 609.04(a)(III).
This statement is in accord with dicta from Molins PLC v. Textron, Inc., 48 F.3d 1172 (Fed. Cir. 1995), states that forcing the Examiner to find “a needle in a haystack” is “probative of bad faith.” Id. at 1888. This case presented a situation where the disclosure was in excess of 700 pages and contained more than fifty references. Id. 1888.
The MPEP provides more support for this position. In a subsection entitled “Aids to Compliance With Duty of Disclosure,” item thirteen states:
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant information and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to Applicant’s attention and/or are known to be of the most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F.Supp 948 (S.D. Fla. 1972) aff’d 479 F.2d 1338 (5th Cir 1974). See also MPEP § 2004.
Therefore, it is recommended that if any information that has been cited by Applicants in the previous disclosure statement is known to be material for patentability as defined by 37 CFR § 1.56, Applicant should present a concise statement as to the relevance of that/those particular documents therein cited.
Response to Amendments/Arguments
Applicant’s amendments and arguments, filed 26 June 2026, with respect to the rejection(s) of the pending claims over Newton et al in view of Russel have been fully considered and are partially persuasive. The Examiner has reviewed the amendment, which is enabled by the Specification, as pointed out in Applicant’s remarks (p6). The Examiner agrees that neither Newton nor Russel disclose a plurality of fibers oriented in generally the same direction. The Examiner has added a new reference, WO 2023/149903 to Siddiqui to teach the directional orientation of the fibers.
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, further in view of WO 2023/149903 to Siddiqui.
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 the direction of the fibers, Siddiqui discloses a fluid collection assembly that receives a user’s penis with an opening and a fluid outlet, and a porous material (see FIG 1 and accompanying text). The porous material may comprise a carded web comprising a plurality of fibers oriented in the same direction in order to create an anisotropic environment (see ¶0042). It would have been obvious at the time of filing to arrange a carded web comprising fibers oriented in the same direction, as disclosed by Siddiqui, in the absorbent article suggested by the prior art, in order to create and anisotropic environment, as taught by Siddiqui.
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, in view of WO2023/149903 to Siddiqui, 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, in view of WO2023/149903 to Siddiqui, 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
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 LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 10 July 2026
1 https://www.dictionary.com/browse/gauze, accessed 17 December 2025.
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