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 and examined on the merits.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20, respectively, of copending Application No. 18/117,761 (reference application) in view of Cocker et al. (US 2010/0249586). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application recites a “check valve” while the current claims require a “throttle valve.” Additionally, the reference application claims 1 & 11 now recite an additional limitation (per Amendment filed on 8/21/2025), thus making the reference application claims more detailed than the current claims. Examiner notes that while a check valve and a throttle valve are different, in that a check valve completely prevents backflow and a throttle valve controls the amount of flow (not necessarily preventing backflow), but Cocker discloses that in a medical fluid delivery system, check valves and throttle valves may be known as equivalents (see [0015]). Therefore it would have been obvious to one skilled in the art at the time of filing to modify the current claim with Cocker’s teaching that check valves and throttle valves because they are both useful in controlling fluid flow in the medical field (see MPEP 2144.06).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-2, 7-12, 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Acosta (WO 2022/094173) in view of Andersen (US 3,598,124).
Re Claim 1, Acosta discloses an apparatus for collecting urine from a user, the apparatus comprising:
a sheath portion (external male catheter 16) comprising a first end and a second end, the first end configured to make a seal (at rim 21) with a penis of a user;
an outlet (outer end 32) at the second end and configured to enable urine to exit the sheath portion; and
a channel (28) operably coupled to the outlet to convey urine away from the sheath portion.
Acosta does not teach a throttle valve operably coupled to the channel at or near the outlet to enable air to enter the channel in a regulated manner.
Andersen discloses a urine drainage system having an indwelling catheter (1), the outlet (5) of which is connected to a valve (4, Fig. 2) that allows air into a drainage tube through filter disc, which would allow air to enter the drainage tube at very low vacuums (col. 2 lines 56-60) but would restrict air entering the drainage tube until all urine in the bladder is substantially emptied (col. 3 lines 53-59). The Andersen valve performs a regulating, or throttling, function on the airflow into the drainage tube, and can thus be considered as a throttle valve. It would have been obvious to one skilled in the art at the time of filing to modify Acosta by adding the Andersen vent valve that allows urine to flow to the collection container more smoothly.
Re Claim 11, Acosta discloses a method for collecting urine from a user, the method comprising:
gathering urine in a sheath portion (16) comprising a first end and a second end, the first end configured to make a seal with a penis of a user (at rim 21);
enabling, through an outlet at the second end, urine to exit the sheath portion ([0048]); and
conveying the urine away from the sheath portion through a channel operably coupled to the outlet (e.g., [0048]).
Acosta does not teach enabling, using a throttle valve at or near the outlet, air to enter the channel in a regulated manner. Andersen discloses a urine drainage system having an indwelling catheter (1), the outlet (5) of which is connected to a valve (4, Fig. 2) that allows air into a drainage tube through filter disc, which would allow air to enter the drainage tube at very low vacuums (col. 2 lines 56-60) but would restrict air entering the drainage tube until all urine in the bladder is substantially emptied (col. 3 lines 53-59). The Andersen valve performs a regulating, or throttling, function on the airflow into the drainage tube, and can thus be considered as a throttle valve. It would have been obvious to one skilled in the art at the time of filing to modify Acosta by adding the Andersen vent valve that allows urine to flow to the collection container more smoothly.
Re Claim 2, Acosta and Andersen disclose claim 1, Acosta also discloses wherein the channel is operably coupled to a collection chamber (30).
Re Claim 12, Acosta and Andersen combine to teach claim 11, Acosta further teaches conveying, through the channel, the urine to a collection chamber (that is the implied function of the system).
Re Claims 7 & 17, Acosta and Andersen disclose claim 1 or 11, Acosta does not disclose that the seal is an air-tight seal. However, a person of ordinary skill has good reason to pursue the known options (putting sheath on in an airtight manner or loosely) within his or her technical grasp. If this leads to the anticipated success (draining urine into a collection bag rather than spilling on the user/patient), it is likely that product was not of innovation but of ordinary skill and common sense. In that instant the fact that a combination was obvious to try might show that it was obvious under § 103. See MPEP 2143 (E). In this case, one skilled in the art may be motivated to make an airtight seal between the sheath and the user’s penis so as to reduce the likelihood of urine spilling out, in particular if the user is seated/supine.
Re Claims 8 & 18, Acosta and Andersen disclose claim 1 or 11, wherein the check valve enables air to enter at least one of the channel and the sheath portion to replace urine therein.
Re Claims 9 & 19, Acosta and Andersen disclose claim 1 or 11, while neither expressly teaches wherein the check valve is within one inch of the outlet, one skilled in the art may be motivated to put the check valve close to the outlet because this would allow air to easily enter the entire length of the channel/tubing so as to prevent vacuum build-up at the penis.
Re Claims 10 & 20, Acosta and Andersen combine to teach claim 1, wherein the channel is made up of flexible tubing.
Claims 3-6, 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Acosta and Andersen as applied to claim 2 or 12 above, and further in view of Forral (US 2004/0176746).
Re Claims 3-6 & 13-16, Acosta and Andersen disclose claim 2, but they do not disclose wherein the collection chamber is operably coupled to a vacuum device. Forral discloses a urine collection system wherein a vacuum source (60) is couple to a penile sheath (20) and the collection container (42) so as to more quickly and efficiently remove urine away from the user. It would have been obvious to one skilled in the art at the time of filing to further modify with a vacuum source like that taught by Forral for quick drainage of fluid away from the user. After the modification, the vacuum device is necessarily configured to pull urine from the sheath portion into the collection chamber (because the vacuum source is connected to the sheath), the vacuum device is configured to pull air bubbles into the channel through the throttle valve (because the throttle valve naturally cracks open when the external air pressure is higher than what is in the channel/system), and the air bubbles assist in conveying the urine through the channel from the sheath portion to the collection chamber (air bubbles would break up a fluid column within the tube and thus allowing the urine to be suctioned by the vacuum source).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN S SU whose telephone number is (408)918-7575. The examiner can normally be reached M-F 9:00 - 5:00 Pacific.
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/SUSAN S SU/Primary Examiner, Art Unit 3781 23 August 2025