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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/3/2026 has been entered.
Status of Claims
Claims 1-20 are pending, of which Claims 1, 3, 11, & 13 are amended. All claims are examined on the merits. No new matter is found.
Response to Arguments
Applicant’s arguments filed 2/3/2026, with respect to the rejection(s) of claim(s) 1 & 11, specifically regarding replacing the check valve of Acosta with that of Andersen, under 35 USC 103 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 Therefore, the rejection has been withdrawn.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 Cermak et al. (US 5,318,550).
Claim Rejections - 35 USC § 102
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.
Claims 1-8, 10-18, 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cermak et al. (US 5,318,550).
Re Claim 1, Cermak discloses an apparatus for collecting urine from a user, the apparatus comprising:
a sheath portion (condom 12) comprising a first end and a second end, the first end configured to make a seal with a penis of a user (inherent since the condom is designed to guide urine away from the user and Cermak discloses the need to have a release valve 36 to relieve discomfort on the penis due to the suction generated by squeeze bulb 30);
an outlet (end that engages with hose connector 33, see Fig. 2) at the second end and configured to enable urine to exit the sheath portion;
a channel (e.g., hose connector 33 or conduit 18) operably coupled to the outlet to convey urine away from the sheath portion; and
a check valve (one-way valve 28 which also incorporates release valve 36, see Fig. 2 and col. 3 lines 1-4 “Alternatively, as shown in FIG. 2, the release valve 36 may be replaced by a semipermeable membrane 39 held in place by annular member 41. This allows air into the apparatus, but will not allow liquid to leak out.”) operably coupled to the channel at or near the outlet to enable air to enter the channel but prevent air or liquids from exiting the channel through the check valve.
Re Claim 2, Cermak discloses claim 1 and further disclosing wherein the channel is operably coupled to a collection chamber (container 14, clearly shown in Fig. 2).
Re Claim 3, Cermak discloses claim 2 and further disclosing wherein the collection chamber is operably coupled to a vacuum device (bulb 30, col. 2 lines 65-67).
Re Claim 4, Cermak discloses claim 3 and further disclosing wherein the vacuum device is configured to pull urine into the collection chamber (col. 2 lines 48-60).
Re Claim 5, Cermak discloses claim 4. While Cermak does not explicitly mention wherein the vacuum device is configured to pull air bubbles into the channel through the check valve, but since the release valve (36) is disclosed to allow air into the system, it is inherent that as suction is applied to the condom to remove urine, the air that enters the system would form air bubbles.
Re Claim 6, Cermak discloses claim 5 as explained above. The language “wherein the air bubbles assist in conveying the urine through the channel from the sheath portion to the collection chamber” is a natural result of the air bubbles entering through the release valve (36).
Re Claim 7, Cermak discloses claim 1 and implies wherein the seal is an air-tight seal (the release valve is to relieve discomfort due to the suction effect on the penis due to an otherwise completely air-tight system that is subjected to the suction from the bulb 30).
Re Claim 8, Cermak discloses claim 1 and further disclosing wherein the check valve enables air to enter at least one of the channel and the sheath portion to replace urine therein (col. 2 lines 48-60).
Re Claim 10, Cermak discloses claim 1 and further disclosing wherein the channel is made up of flexible tubing (col. 2 lines 16-17).
Re Claim 11, Cermak discloses a method for collecting urine from a user, the method comprising:
gathering urine in a sheath portion (12) comprising a first end and a second end, the first end configured to make a seal with a penis of a user (inherent since the system may generate enough vacuum to cause discomfort to the user’s penis);
enabling, through an outlet at the second end, urine to exit the sheath portion (e.g., col. 2 lines 48-60);
conveying the urine away from the sheath portion through a channel operably coupled to the outlet (Fig. 2, col. 2 lines 48-60, the channel can be valve 28 and/or conduit 18); and
enabling, using a check valve at or near the outlet, air to enter the channel while preventing air or liquids from exiting the channel through the check valve (col. 3 lines 1-4).
Re Claim 12, Cermak discloses claim 11, and further discloses conveying, through the channel, the urine to a collection chamber (col. 2 lines 48-60).
Re Claim 13, Cermak discloses claim 12 and further disclosing wherein the collection chamber is operably coupled to a vacuum device (bulb 30).
Re Claim 14, Cermak discloses claim 13 and further discloses pulling, using the vacuum device, the urine into the collection chamber (col. 2 lines 48-60).
Re Claim 15, Cermak discloses claim 14 and further discloses pulling, using the vacuum device, air bubbles into the channel through the check valve (since the release valve 36 can be a unidirectional semipermeable membrane 39 allowing air into the system without letting air/liquid out, as the vacuum draws urine away from the user, it would necessarily also pull air bubbles through the membrane).
Re Claim 16, Cermak discloses claim 15. The language “using the air bubbles to assist in conveying the urine through the channel from the sheath portion to the collection chamber” is considered to be a natural result of the air bubbles that enter the system through the semipermeable membrane.
Re Claim 17, Cermak discloses claim 11 and further implies wherein the seal is an air-tight seal (the release valve is to relieve discomfort due to the suction effect on the penis due to an otherwise completely air-tight system that is subjected to the suction from the bulb 30).
Re Claim 18, Cermak discloses claim 11 and further discloses enabling, using the check valve, air to enter at least one of the channel and the sheath portion to replace urine therein (col. 2 lines 48-60).
Re Claim 20, Cermak discloses claim 11 and further discloses wherein the channel is made up of flexible tubing (col. 2 lines 16-17).
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.
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.
Claims 9 & 19 are rejected under 35 U.S.C. 103 as being unpatentable over Cermak.
Re Claims 9 & 19, Cermak discloses claim 1 or 11 but does not explicitly disclose wherein the check valve is within one inch of the outlet. However, the Cermak shows that the check valve is immediately under the outlet of the sheath (see Fig. 2) and therefore it is very likely that the check valve is within an inch of the outlet. Furthermore, since Cermak discloses that the release valve (36) “allow[s] air to enter the body of valve 28 and thus into the condom 12” (col. 2 lines 61-68), it would be obvious to one skilled in the art to place the check valve very near, e.g., within one inch of, the outlet of the sheath such that air can quickly enter the sheath to relieve the patient of the discomfort from the suction.
Conclusion
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/SUSAN S SU/Primary Examiner, Art Unit 3781 2 March 2026