DETAILED ACTION
Response to Arguments
Applicant's arguments filed September 4, 2025 have been fully considered but they are not persuasive. Regarding Applicant’s arguments that the catheter of Sauer is not removable from coupling element 14, the Examiner respectfully disagrees. As argued, the interpretation of “force-fit” is not, in its broadest reasonable interpretation, considered to be a non-reversable connection. Force fit in a broad sense is a frictional coupling of two elements, however, a pen cap is an example of an element which is force-fit to a pen body tip to retain the cap thereon and is easily removable to access the pen tip. It would be improper to limit the disclosure of a force fit connection to be irreversible even if one example (e.g., using glue or adhesive) would generally be considered to be. For this reason, the rejection is considered proper and is maintained below.
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.
Claim(s) 1, 7, 8, 12, 15, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sauer (WO 2005092419) in view of Hight (US 6,361,751).
Regarding claims 1 and 16, Sauer discloses (Figure 1) a reusable urinary catheter kit, comprising: a housing (3) including a base defining a disinfecting chamber (8), the base having a bottom end and a top end, the top end of the base defining an opening of the disinfecting chamber (e.g., page 2); a lid (11) associated with the top end of the base, in the closed condition the lid overlaying the base and covering the opening of the disinfecting chamber and in the open condition the lid being moved away from the base to uncover the opening of the disinfecting chamber; a chassis (14) removably positioned within the housing (it’s fully capable of being removed); a reusable urinary catheter (2) removably secured to the chassis (the catheter is intended to be placed inside the housing and subsequently removed for use after a sterilization procedure; it may be considered secured via the caps 11); a removable supply of sterilization fluid in fluid communication with the disinfecting chamber (claim 15); and a waste tank in communication with the disinfecting chamber (e.g., claim 15 discloses the disinfection container directly or indirectly connected to the chamber which may be interpreted as the waste tank as separate from the quiver 8; e.g., the waste tank is a disclosed as a separate reservoir attached to the quiver for fluid transfer). Sauer fails to explicitly disclose the lid movable between an open and closed configuration.
Hight teaches (Figure 1A) an apparatus for disinfecting a medical device (4) comprising a lid (14) for selectively opening and closing the apparatus (Col. 4, lines 23-29).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the closure member of Sauer with the lid of Hight so as to form a water-tight seal on the container to prevent spills or evaporation during use as taught by Hight.
Regarding claim 7, Sauer further discloses wherein the waste tank is removably secured to the housing (as per claim 15, the disinfection container is attachable to the quiver to provide the disinfection solution).
Regarding claim 8, Sauer further discloses wherein the supply of sterilization fluid comprises a cartridge of sterilization fluid (the disinfection container which is disclosed as removably couplable to the quiver is considered to meet the limitation of a cartridge as is provide a disconnected source of cleaning solution attachable to the system as claimed).
Regarding claim 12, Sauer further discloses wherein the chassis (14) has a shape similar to that of a shape of the disinfecting chamber (Figure 1, the chassis and chamber are both cylindrical).
Regarding claim 15, Sauer further discloses wherein the supply of sterilization fluid is disposable (the source of fluid, used to sterilize the catheter of Sauer is removably attachable to the assembly and therefore the supply is considered disposable after use as claimed).
Regarding claim 17, Sauer further discloses wherein said sterilizing the reusable urinary catheter includes dispensing a sterilization fluid into the housing (the disinfectant liquid could be poured into the quiver and remain there for a certain exposure time or until the next time the catheter is used; for the safe filling or for the disinfectant to flow through the quiver, a disinfection container that can be plugged directly or indirectly onto the quiver is provided, which also belongs to the system claimed here; an indirect flow connection between the disinfection container and the tube containing the catheter can be established, for example, by means of a hose; however, in order to reduce the required material or equipment, it is also possible to use the disinfection container e.g., a plastic bag, for example act with disinfectant liquid can be connected or plugged directly into the quiver, specifically to a free end of the quiver; from there, the disinfectant liquid can flow into the quiver and through the catheter).
Regarding claim 18, Sauer fails to explicitly disclose the step of draining the fluid.
Hight teaches a drain (15) on the distal end of the device for draining the fluid after sterilization (Col. 4, lines 30-42).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Sauer to include the draining valve of Hight so as to allow a user to quickly and efficiently drain the disinfecting solution from the assembly after sterilization as taught by Hight.
Claim(s) 2 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sauer in view of Hight, and further in view of Schneider et al. (US 5,037,623).
Regarding claim 2, Sauer/Hight teach the claimed invention substantially as set forth above for claim 1, but fails to explicitly disclose the use of a pivoting lid for covering the chamber.
Schneider et al. (henceforth Schneider) teaches a sterilization assembly (Figure 1) comprising a lid (24), pivotally secured to a housing (base assembly).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the cap closure of Sauer/Hight to comprise a pivoting lid assembly, such as that taught by Schneider, so as to provide a closure means which maintains the covering portion on the body of the assembly. Such a feature is known from Schneider and allows for a secure means of preventing lid or cap loss during uncovering via the attachment to the housing portion as depicted by Schneider. For this reason, it would have been obvious to modify the sealing lid of the combined device to be pivotally attached to retain the cap on the device throughout use as claimed.
Regarding claim 6, Sauer discloses the claimed invention substantially as set forth above for claim 1, but fails to explicitly disclose the use of a pump for the sterilization fluid.
Schneider teaches a sterilizing injection system using a pump for moving a fluid through a sterilization chamber (Col. 4, lines 10-24).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sterilization system of Sauer to comprise a pump for delivering the sterilization fluid since Schneider teaches that it is known to use a pump to deliver a fluid through a sterilization system from a fluid source. Such a modification ensures that the sterilization fluid flows around the medical device thereby ensuring sufficient sterilization during such a procedure.
Claim(s) 14 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sauer in view of Hight, and further in view of Bushnell et al. (US 5,768,853).
Regarding claims 14 and 19, Sauer/Hight discloses the claimed invention substantially as set forth above for claims 1 and 16, but fails to explicitly disclose the use of a light source in the chamber.
Bushnell et al. (henceforth Bushnell) teaches the use of a light source for sterilizing medical devices (Col. 1, lines 8-15).
It would have been obvious to one of ordinary skill in the art to modify the catheter sterilization system of Sauer/Hight to comprise the light source of Bushnell so as to provide an additional means of destroying microorganisms which are present on the catheter assembly during the sterilization process as taught by Bushnell.
Allowable Subject Matter
Claims 3-5, 9-11, and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: the prior art made of record and relied upon does not anticipate or render obvious, alone or in combination, the features of the cited claims. Regarding claim 3, Sauer fails to teach a lifting member in the housing to lift the chassis when the lid is opened as claimed. Such a feature is not reasonably taught to provide sufficient motivation for one of ordinary skill in the art to modify the housing assembly of Sauer to achieve such a function. Claims 4 and 5 would be allowed due to their dependence from claim 3. Regarding claim 9, Sauer teaches the catheter as secured within the chamber, but makes no disclosure of the catheter wrapping around the chassis. There would be no motivation to install the catheter in this manner within the chamber and there is no disclosed structure sufficient for performing the claimed function. Regarding claim 10, Sauer fails to teach one or more clips for holding the catheter. The catheter is held through the manifold and there is no structure analogous to a clip for holding it within the housing. It would not have been obvious to one of ordinary skill in the art to modify the housing assembly to comprise such a retaining means. Regarding claim 11, Sauer fails to teach one or more groove walls in the chassis for receiving a catheter within such a groove as claimed. It would not have been obvious to one of ordinary skill in the art to modify the securing means of Sauer to comprise a groove for receiving the catheter therein. Regarding claim 13, as above, Sauer fails to teach the clips or groove as claimed. For at least these reasons, the claims would be allowable over the prior art made of record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783