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 .
Status of Claims
Claims 1-20 are pending, of which Claims 1 & 11 are amended. No new matter is found.
Response to Arguments
Applicant’s arguments with respect to claims 1 & 11 have been considered but are moot because the new limitations necessitate a change in the ground of rejection.
Applicant's arguments filed, specifically regarding the obviousness rejection of claims 9 & 10 in view of Cermak, have been fully considered but they are not persuasive. Applicant argues that the drawings of Cermak are not to scale and Examiner improperly used “common sense” as evidence to support missing claim limitations. Examiner respectfully contends that the placement of the check valve, in the absence of evidence of criticality, is a mere rearrangement of the valve within the urine removal system. Combined with the suggestion gleaned from Cermak’s figures, which seems to place the valve immediately below the external condom-style urinary catheter, one skilled in the art would find it obvious to experiment with the location of the valve by first following what Cermak’s figures suggest.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Cermak et al. (US 5,318,550) in view of Andersen et al. (US 3,598,124, already cited in Final Rejection mailed on 9/3/2025).
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.
However, Cermak does not disclose that the check valve is configured to automatically enable, without user intervention, air to enter the channel. Cermak appears to suggest that a user needs to press a button (38) to let air through the semipermeable membrane and thus relieving the suction on the user’s genitalia (col. 2 lines 67-68), thereby ensuring that no excessive suction is exerted on the user. Andersen discloses a urine drainage system with a flutter valve (7, Fig. 2) that automatically opens to let ambient air enter the drainage tube when the suction within the tube is greater than a threshold and prevents urine from exiting through the flutter valve (see col. 2 lines 50-71). It would have been obvious to one skilled in the art at the time of filing to modify Cermak by gleaning from Andersen’s automatic suction relief valve so that the suction exerted on the patient’s genitalia can never be too high.
Re Claim 2, Cermak and Andersen disclose claim 1 and Cermak further disclosing wherein the channel is operably coupled to a collection chamber (container 14, Fig. 2).
Re Claim 3, Cermak and Andersen disclose claim 2 and Cermak further disclosing wherein the collection chamber is operably coupled to a vacuum device (30, col. 2 lines 65-67).
Re Claim 4, Cermak and Andersen disclose claim 3 and Cermak further disclosing wherein the vacuum device is configured to pull urine into the collection chamber (col. 2 lines 48-60).
Re Claim 5, Cermak and Andersen disclose claim 4. While Cermak and Andersen do not explicitly mention wherein the vacuum device is configured to pull air bubbles into the channel through the check valve, but since the flutter valve (after the combination) is disclosed to allow air into the system, it is naturally expected 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 and Andersen disclose 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 valve.
Re Claim 7, Cermak and Andersen disclose claim 1 and Cermak implies wherein the seal is an air-tight seal (the flutter valve does not allow liquid or air to exit into the atmosphere).
Re Claim 8, Cermak and Andersen disclose 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 9, Cermak and Andersen disclose claim 1. While neither explicitly discloses wherein the check valve is within one inch of the outlet, 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.
Re Claim 10, Cermak and Andersen disclose claim 1 and Cermak 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).
However, Cermak does not disclose that the check valve is configured to automatically enable, without user intervention, air to enter the channel. Cermak appears to suggest that a user needs to press a button (38) to let air through the semipermeable membrane and thus relieving the suction on the user’s genitalia, thereby ensuring that no excessive suction is exerted on the user. Andersen discloses a urine drainage system with a flutter valve (7, Fig. 2) that automatically opens to let ambient air enter the drainage tube when the suction within the tube is greater than a threshold and prevents urine from exiting through the flutter valve (see col. 2 lines 50-71). It would have been obvious to one skilled in the art at the time of filing to modify Cermak by gleaning from Andersen’s automatic suction relief valve so that the suction exerted on the patient’s genitalia can never be too high.
Re Claim 12, Cermak and Andersen disclose claim 11, and Cermak 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 and Andersen disclose claim 13 and Cermak further discloses pulling, using the vacuum device, the urine into the collection chamber (col. 2 lines 48-60).
Re Claim 15, Cermak and Andersen disclose claim 14 and Cermak 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 and Andersen disclose 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 and Andersen disclose claim 11 and the combination further implies wherein the seal is an air-tight seal (because the flutter valve does not allow liquid or air to exit into the atmosphere).
Re Claim 18, Cermak and Andersen disclose claim 11 and the combination further discloses enabling, using the check valve, air to enter at least one of the channel (col. 2 lines 49-71 of Andersen) and the sheath portion to replace urine therein (since the suction within the entire system is diminished or completely eliminated, as desired by Cermak for relieving the suction/discomfort on the user, see col. 2 lines 67-68 of Cermak, it is expected that the air would also replace the urine in the sheath portion in order to relieve the suction that exists within the sheath portion.
Re Claim 19, Cermak and Andersen combine to disclose claim 11. While neither explicitly discloses wherein the check valve is within one inch of the outlet, 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.
Re Claim 20, Cermak and Andersen disclose claim 11 and Cermak further discloses wherein the channel is made up of flexible tubing (col. 2 lines 16-17).
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.
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/SUSAN S SU/ Primary Examiner, Art Unit 3781
27 July 2026
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