DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
Applicant's amendment filed 08/01/2026 has been entered. Claim 11 was amended.
Claims 4-15 are currently pending and considered below.
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 4-15 are rejected on the ground of nonstatutory double patenting over claims 1-13 of U.S. Patent No. 11,802,627 (hereinafter "the '627 patent'), the latter of which recites subject matter that contains all the subject matter of claims 4-15 of the current application except for the limitations (in the presently filed claims) of the valve being used "for regulating the flow of urine from a bladder". However, this subject matter is not patentably distinct from the subject matter claimed in the '627 patent because it recites mere intended use of the valve that does not limit its structure. Further, this recitation in the preamble is not necessary to give life, meaning or vitality to the claim (see Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165-66 (Fed. Cir. 1999)).
Moreover, the pending claims recite "an inlet for receiving the urine into the first housing 10 and an outlet for allowing the urine to leave the first housing 10"; but this subject matter is not patentably distinct from the subject matter claimed in the '627 patent because it recites mere function of the inlet and outlet that are inherent characteristics of the '627 patent.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 4, 6, 9, 10, 11 and 13 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Flinchbaugh (U.S. Pat. 6,673,051 B2, hereinafter "Flinchbaugh").
Regarding claim 4, Flinchbaugh discloses a valve for regulating the flow of urine from a bladder comprising (see col. 4, lines 11-17):
a first housing (combination of housing sections 2 and 3; see Fig. 2) having an inlet 11 (see Fig. 2) for receiving the urine into the first housing, and an outlet (at filter 6; see Fig. 2) for allowing the urine to leave the first housing;
a second housing 5 (see Fig. 2) removably attachable to the first housing (housing 5 can be slid onto the housing end 3, as illustrated in Fig. 1; Flinchbaugh makes no mention that the first and second housings are permanently attached);
a first magnet 7 (see Fig. 2) disposed in the first housing in a predetermined position, the first magnet being stationary relative to the first housing 10 (magnetic member 7 is disclosed as being "fixed" or held in place by prongs 4.6 extending from wall 4 having openings/slots 4.3 therebetween; see col. 5, lines 40-45);
a second magnet 20 (see Fig. 1) disposed in the first housing (both magnets are disposed in the combination of housing portions 2 and 3; see Fig. 3), the second magnet movable relative to the first magnet and the first housing between a first position and a second position and making contact with at least a portion of the first housing and closing a resealable opening in the first housing in the first position due to the attraction between the first magnet and the second magnet (see col. 8, lines 31-51).
Regarding claim 6, Flinchbaugh discloses the valve for regulating the flow of urine according to claim 4, further comprising a vent disposed in the second housing (see the longitudinally arranged rectangular channels in the cover 5 that would permit air or fluid to flow through them).
Regarding claim 9, Flinchbaugh discloses the valve for regulating the flow of urine according to claim 4, wherein the first housing comprises:
a catheter connector 11 (see Fig. 2) having a proximal end and a distal end, the proximal end of the catheter connector having the inlet, the inlet configured to engage a tubing (using barbs on the inlet; see col. 6, line 42);
a first magnet housing 2 (see Fig. 2) disposed in the distal end of the catheter connector, the first magnet housing having the first magnet 7 secured therein (see Fig. 3);
a second magnet housing 3 (see Fig. 2) attached to the first magnet housing, the second magnet housing having the second magnet 8 disposed therein (see Fig. 3);
and a drain end (at 11.2; see Fig. 5) attached to the second magnet housing and having the outlet, the outlet in fluid communication with the inlet in the catheter connector (when the valve is open).
Regarding claim 10, Flinchbaugh discloses the valve for regulating the flow of urine according to claim 9, wherein the second magnet is slidingly disposed in the second magnet housing and engages a portion of the first magnet housing in the first position to prevent the liquid from passing through the first housing (see col. 8, lines 31-51).
Regarding claim 11, Flinchbaugh discloses the valve for regulating the flow of urine according to claim 9, the tubing is configured to be inserted into the bladder of a person (see col. 6, lines 45-57).
Regarding claim 13, Flinchbaugh discloses a valve for regulating the flow of liquid therethrough (see col. 4, lines 11-17), comprising::
a first housing 2 (see Fig. 2) having an inlet 11 (see Fig. 2) for receiving the liquid into the first housing, and an outlet (at port 4; see Fig. 2) for allowing the liquid to leave the first housing, the inlet and outlet being in fluid communication with one another;
a second housing 5 (see Fig. 2) removably attachable to the first housing (housing 5 can be slid onto the housing end 3, as illustrated in Fig. 1; Flinchbaugh makes no mention that the first and second housings are permanently attached);
a magnetically sealable opening (defined by port wall 4) disposed in the first housing between the inlet and the outlet (see Fig. 5);
at least one magnet 20 (see Fig. 2) disposed in the first housing and disposed in the first housing adjacent the magnetically sealable opening to make contact with at least a portion of the first housing and seal the magnetically sealable opening (see col. 8, lines 31-51); and
and a sealing member 9 (see Fig. 8A) disposed in the first housing adjacent the outlet, the sealing member sealing the distal end of the outlet in the first housing when the second housing is disengaged from the first housing (i.e., the sealing member 9 seals the distal end of the outlet regardless of whether the cover 5 is engaged to the housing).
Response to Arguments
Applicant's arguments filed in Remarks on 08/01/2026 have been fully considered.
Applicant has amended claim 11 to depend from claim 9; this amendment obviated the rejection under 35 U.S.C. 112(b) made in the Office action dated 03/02/2026.
The rejection of claims 4-15 under nonstatutory double patenting is maintained because Applicant has not overcome the rejection or made any argument as to its propriety.
The rejection of claims 4 and 7 under 35 U.S.C. 102 is withdrawn in light of Applicant's arguments1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
THIS ACTION IS MADE NON-FINAL.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
08/11/2026
1 It is noted that claim 4 does not recite that "the releasable opening in the first housing in the first position is due to the attraction between the first magnet and the second magnet", as alleged by Applicant. Rather, the claim recites that "the closing" of the aforementioned resalable opening in the first housing in the first position is "due to the attraction between the first magnet and the second magnet".
Prosecution Insights