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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08JUN2026 has been entered.
Response to Arguments
Applicant’s arguments and associated revisions, see p. 5, filed 08JUN2026, with respect to the Drawings have been fully considered and are persuasive. The objection to the Drawings has been withdrawn.
Applicant’s arguments, see page 4, filed 08JUN2026, with respect to the rejection(s) of claim(s) 20-27 under 35 U.S.C. § 103 have been fully considered and are moot in view of new grounds of rejection prompted by Applicant’s amendment to claims. A new ground(s) of rejection is made in view of US 5520671 A (Bouser) in view of US 4626250 A (Schneider) and US 4840625 A (Bell). While the attachment means of Bouser is a harness-style component which differs from the claimed adhesive base, both harness/garment style attachment devices and adhesive attachments are well-known in the art, and it would be reasonable for a person having ordinary skill in the art to consider all commonly known attachment means.
Claim Interpretation
Amended Claim 20 recites a sheath which comprises a condom. As understood from the Specification, Claims, and Drawings, the sheath is itself a condom-style component. For the purpose of examination, the sheath is considered to be a condom instead of the condom being an individual component of the sheath.
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.
Claim(s) 20, 22, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5520671 A (Bouser) in view of US 4626250 A (Schneider) and US 4840625 A (Bell).
Regarding Claim 20, Bouser teaches a collection device (10) (Figs. 1-3) comprising:
an anchor (14) designed to be secured near a pelvic area of a user (via 12, Col. 3: ll. 33-37), the anchor comprising a central opening designed to accommodate a user's penis (Col. 3: ll. 63-65);
a sheath (20) having a proximal end (22) and a distal end (24), the proximal end of the sheath designed to be in contact with and attached to the anchor around the central opening (Col. 3: ll. 55-56) and the distal end of the sheath comprising an opening (Col. 3: ll. 57-59, the opening shown in Fig. 2 after being sized for the user);
wherein the sheath is configured to wrap at least a portion of a shaft of a user's penis (as seen in Fig. 2); and
a pouch (46) having an opening (where it attaches to 18 as seen in Fig. 1) to accommodate the sheath when the sheath is wrapped on at least a portion of a shaft of a user's penis (the penis being inserted through the anchor and thereby extending into the pouch, Col: 3: l. 30);
wherein the pouch is configured to be a urine reservoir and is releasably attached to the anchor (Col. 4: ll. 18-20);
wherein the sheath with the opening at the distal end comprises a condom (Col. 4: ll. 26-27) with an opening at the distal end (Col. 4: ll. 30-31) in a leak proof manner (Col. 4: ll. 32-34).
Bouser fails to teach the distal end of the sheath is configured to be affixed to the shaft of a user's penis with a suitable adhesive circumferentially surrounding the shaft at a distal end of the shaft or a stem at the distal end of the sheath, or a base with an adhesive back to secure the collection device to the skin.
Schneider teaches a collection device (10) (Figs. 1-5) wherein a sheath (11 and 12) comprises a stem (14) at the distal end and the distal end of the sheath is configured to be affixed to the shaft of a user's penis with a suitable adhesive (30) circumferentially surrounding the shaft at a distal end of the shaft (being a ring, Col. 7: ll. 21-23).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sheath of Bouser with the sheath of Schneider to provide an adhesive which prevents disrupting the seal (Col. 7: ll. 26-29) and a stem to create a surge volume (Col. 4: ll. 40-43) which resists kinking and obstructions (Col. 4: ll. 35-38).
By incorporating the sheath of Schneider into the device of Bouser, the combined device is considered to teach the sheath being configured to fit within or affixed to the opening of the pouch in a leak proof manner.
Bell teaches a collection device (10) comprising a base (20) with an adhesive back designed to adhesively secure the collection device to the skin in the pelvic area of a user (Col. 3: l. 63 – Col. 4: l. 1) to provide a secure seal without negatively impacting the user’s scrotum (Col. 4: ll. 47-49).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bouser in view of Schneider with the adhesive base of Bell as an alternate form of adhering the device to the user to insure a secure seal (Bell, Col. 4: ll. 66-69).
Regarding Claim 22, Bouser further teaches the sheath (20) comprises latex (Col. 3: ll. 50-51).
Regarding Claim 24, Bouser further teaches the proximate end of the sheath (20) is designed to be releasably attached to the anchor (14) (Col. 4: ll. 11-16).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bouser in view of Schneider and Bell, and further in view of US 4022213 A (Stein).
Regarding claim 21, Bouser in view of Schneider fails to explicitly teach the pouch and anchor are releasably attached via a snapping mechanism.
Stein teaches a collection device (Figs. 1-3) wherein the pouch (12) and anchor (40) are releasably attached via a snapping mechanism (44).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the attachment means of Bouser in view of Schneider and Bell with the snapping mechanism of Stein as it would be obvious to try when choosing from the finite number of identified, predictable solutions, with a reasonable expectation of joining two objects MPEP 2143 I.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bouser in view of Schneider and Bell, and further in view of US 1229423 A (Eckenrode).
Regarding Claim 23, Bouser in view of Schneider and Bell fails to teach the pouch comprises a valve.
Eckenrode teaches a collection device comprising a sheath (35) and pouch (42), wherein the pouch comprises a valve (50).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pouch of Bouser in view of Schneider and Bell with the valve of Eckenrode to allow for the user to control drainage at their convenience (“The lower neck 43 is fitted with a connection 50 wherein is a turncock 51 and this connection is threaded to receive the swivel coupling 52 of a tube 53 which may extend down the leg of the wearer so that the bag 42 may be emptied from time to time in an unobtrusive manner by turning the turncock 51”).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bouser in view of Schneider and Bell, and further in view of US 20030195484 A1 (Harvie).
Regarding claim 25, Bouser in view of Schneider and Bell fails to teach the proximate end of the sheath is designed to be selectively detachable to the anchor using a press to close zip type fastener.
Harvie teaches a urine collection device (Fig. 1A) wherein the collection bag (corresponding to the sheath of Dwork) is a press to close zip-type fastener bag [0096].
As resealable bags similar to zip top bags are well-known, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the securement means of Bouser in view of Schneider and Bell with a press to close zip-type fastener to allow for easy installation and removal via a well-known mechanism MPEP 2143 I.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bouser in view of Schneider and Bell, and further in view of US 6248096 B1 (Dwork et al.).
Regarding Claim 26, Bouser in view of Schneider and Bell fails to teach the proximate end of the sheath is designed to be selectively detachable to the anchor using a hook and loop type fastener.
Dwork teaches a collection device (Figs. 1-3) comprising an anchor (at least 20) designed to be secured near a pelvic area of a user (Col. 6: ll. 47-49), and a sheath (40) wherein the proximate end of the sheath is designed to be selectively detachable to the anchor using a Velcro-type fastener (the sheath securing itself to the base through use of adhesive 44, which may be replaced with Velcro, Col. 7: ll. 48-50).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fitment of Bouser in view of Schneider and Bell with the hook and loop fastener of Dwork as a simple substitution of one known fastening system for another with a reasonable expectation of successfully joining device components MPEP 2143 I.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bouser in view of Schneider and Bell in view of US 3526227 A (Appelbaum).
Regarding claim 27, Bouser in view of Schneider and Bell fails to teach the proximate end of the sheath is permanently attached to the anchor.
Appelbaum teaches a collection device (Fig. 1) wherein the proximate end (body side) of the sheath (26) is permanently attached to the anchor (at least 24) (Col. 1: ll. 38-40).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the attachment means of Dwork from being releasable to permanent as it would be obvious when considering the finite number of identified connection types (all connections being either permanent or temporary) MPEP 2143 I.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2310505 A, US 3353538 A, US 1490793 A, US 20030204176 A1, US 3559651 A, and US 3604424 A disclose urine collection devices comprising a sheath and pouch arrangement.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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/HANS KALIHER/ Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781
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