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 1-19 are pending and examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, Claim 6 depends on itself. Examiner assumes that Claim 6 would depend from Claim 5 because of claim terms “the side wall” and “the valve housing”.
Allowable Subject Matter
Claims 1-5, 7-19 are allowed.
Claim 6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The currently claimed invention is directed to a valve assembly in a urinary catheter assembly, wherein the valve assembly comprises: a first configuration in which the valve assembly inhibits fluid flow in a direction from the fluid collection bag towards the catheter and permits fluid flow in a direction from the catheter towards the fluid collection bag; and a second configuration in which the valve assembly permits fluid flow in a direction from the fluid collection bag towards the catheter and inhibits fluid flow in a direction from the catheter towards the fluid collection bag.
Farnam (US 2023/0284893) discloses a urinary catheter assembly comprising a catheter (Foley catheter 1) connected via a three-way valve assembly (catheter valve 3) to a fluid collection bag (2). The valve in its first configuration allows fluid to flow from the catheter to the fluid collection bag (Figs. 5A & 5B) but does not inhibit fluid flowing from the collection bag to the catheter. The valve in a second configuration (Figs. 6A-6B) allows an unblocked communication between an irrigation source and the catheter, thus allowing fluid to flow from the irrigation source toward the catheter but does not inhibit fluid flowing from the catheter to the irrigation source. In a third configuration fluid flow is blocked in all directions (Figs. 7A-7B).
Gerow (US 4,957,487) discloses a condom-style urinary catheter having two tubes (24 & 26) connected to a collection receptacle (evacuator device 28). One tube (24) allows urine to flow from the urinary catheter into the collection receptacle via one check valve (98, Fig. 7A) while the other tube (26) allows air to escape from the collection receptacle into the urinary catheter via different check valves (70, Fig. 13).
Palmer (US 2019/0321212) discloses an intermittent urinary catheter having a receptacle (22, Fig. 1A) with an outlet valve (50, Fig. 1B) that is formed as a push button (56) that toggles between an open configuration in which urine is let out of the urine receptacle and a closed configuration that does not let out urine.
References found in the Search Report of the parent PCT Application of the current US Application also fail to disclose a valve that in one configuration allows fluid to flow in a first direction only (i.e., inhibited from flowing in the opposite direction) and in another configuration allows fluid to flow in the opposite direction only (i.e., inhibited from flowing in the first direction). While one-way valves are extremely common in urinary catheter systems to allow urine to drain away from the user and not flow in reverse back toward the user, such one-way valves cannot function in the same way as currently claimed.
Conclusion
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/SUSAN S SU/ Primary Examiner, Art Unit 3781
29 June 2026