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
Claims 14-18, 20-29, and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group and Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/23/2025.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
In particular, the claim limitation “means for” that use the word “means” is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. In para. [0067, 0076, 0079, 0082, 0085, 0089, 0092], the specification states various ways the device is secured to the user’s undergarment. Therefore, the means for securing the fluid collection device to the user is construed as a pocket flap, straps, a patch, two pockets, alignment pads, arms, or a complementary recess fitting.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Staali et al. (US 20200229964 A1, hereafter “Staali”).
Regarding claim 1, Staali discloses a fluid collection assembly (figs. 1 and 2), comprising:
a fluid collection device (catheter 100, fig. 3(a)) including a fluid impermeable barrier (external catheter 100 is made of silicone or a polymer to direct fluid to a drainage outlet—not a permeable material, para. [0015, 0061]) defining a chamber (isolation chamber 15), an opening (inlet 10) having fluid communication with the chamber (15) and configured to be placed proximate to a urethra of a user (the genitals are surrounded by the chamber at the inlet 10 which would be proximate to both the bulbar and penile urethras, para. [0061]), and an aperture (drainage opening 132) configured to receive a conduit (see conduit in fig. 2(b)) therethrough to provide fluid communication between the chamber (15) and the conduit (figs. 2(b) and 7(c), para. [0065]); and
means for (flap 2b, straps 4a, plurality of fixing means 141) securing the fluid collection device to the user with the opening positioned proximate to the urethra of the user (para. [0061]).
Regarding claim 2, Staali discloses the assembly of claim 1 and further discloses wherein the means for securing the fluid collection device to the user includes at least an undergarment (2, para. [0061]).
Regarding claim 3, Staali discloses the assembly of claim 2 and further discloses wherein the undergarment (2) includes: a body portion (A, annotated fig. 1) defining a pelvic opening (see frontal opening in figs. 1 and 8a) positioned on the undergarment to expose the urethra of the user (the user’s genitals fit through the opening, fig. 1) through the pelvic opening when the undergarment is worn by the user (see frontal opening in figs. 1 and 8a); a pocket flap (2b) having a first end (B, annotated fig. 1) secured to the body portion (A, para. [0061] describes the flap being secured to the undergarment with a fastening means) and a second end (C, annotated fig. 1), the pocket flap (2b) being adjustable from an open position that exposes the pelvic opening (when the flap is not attached) and a closed position that covers the pelvic opening (when the flap is attached); and one or more fasteners (buttons with eyelets 2a, para. [0061]) configured to releasably fasten the second end (C) of the pocket flap (2b) to the body portion (A) in the closed position (when 2b is attached to points 2a) with the fluid collection device (100) positioned between the user and the pocket flap (2b) effective to retain the fluid collection device (100) with the opening (10) of the fluid impermeable barrier positioned proximate to the urethra of the user (para. [0061]).
Regarding claim 4, Staali discloses the assembly of claim 2 and further discloses wherein the undergarment (2) includes: a body portion (A) defining a pelvic opening (see frontal opening in figs. 1 and 8a) positioned on the undergarment to expose the urethra of the user ( the user’s genitals fit through the opening, fig. 1) through the pelvic opening when the undergarment is worn by the user (see frontal opening in figs. 1 and 8a); and one or more straps (4a) extending across the pelvic opening (figs. 1 and 2) and configured to retain the fluid collection device (100) between the user and the one or more straps (4a) effective to retain the fluid collection device with the opening of the fluid impermeable barrier positioned proximate to the urethra of the user (para. [0061, 0068]).
Regarding claim 5, Staali discloses the assembly of claim 2 and further discloses wherein the undergarment (2) includes: a body portion (A) defining a pelvic opening (see frontal opening in figs. 1 and 8a) positioned on the undergarment to expose the urethra of the user (the user’s genitals fit through the opening, fig. 1) through the pelvic opening when the undergarment is worn by the user (see frontal opening in figs. 1 and 8a): a patch (D, annotated fig. 7(a)) detachably fastened to the body portion over the pelvic opening (para. [0061-0063]); and one or more fasteners (141) configured to detachably fasten the patch (D) to the body portion with the fluid collection device positioned between the user and the patch effective to retain the fluid collection device with the opening of the fluid impermeable barrier positioned proximate to the urethra of the user (para. [0061-0063]).
Allowable Subject Matter
Claims 6-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 6, the prior art alone or in combination does not disclose an undergarment with a first and second pocket to retain a first and second end of the device. Figure 2(b) of Staali shows a bottom pocket of the undergarment that the device fits into and is supported by. However, Staali does not teach a second pocket that would retain the opposite end of the device. Similarly, references US 20060100596 A1, US 20130046258 A1, and US 8702667 B1 all disclose an undergarment with a pocket or pocket flap to retain the device to the user, but none of the references disclose a second pocket that would retain the other end of the device like Staali. The pockets all are positioned at the bottom of the frontal crotch region to hold up the device but no other pocket is taught, and it would not have been obvious to duplicate the pocket or incorporate a top pocket without a reference to rely on or a clear motivation to do so.
Regarding claims 7 and 8, no prior art could be found that teaches alignment pads secured to the inner surface of the undergarment and without a teaching to rely on, it would not have been obvious to incorporate or modify to reach such a securement method.
Regarding claim 9, no prior art alone or in combination discloses an undergarment with two arms that extend from the body to secure the device to the undergarment. Staali teaches straps, but they do not extend from the undergarment itself; rather, they extend from a separate and additional garment one wears over the undergarment. Without a teaching to rely on, a modification to add arms would change the prior art significantly without a motivation to do so.
Regarding claims 10 and 11, no prior art alone or in combination could be found that discloses an undergarment with a recess shaped complementary to a portion of the device wherein the recess holds the device against the user. It would not have been obvious to make a modification to the undergarment and incorporate a recessed securement configuration without a teaching to rely on.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 17 January 2026