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 1-21 are pending, of which Claims 1, 9, 12, & 20 are independent. All claims are examined on the merits.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brennan (US 2013/0327326) .
Re Claim 1, Brennan discloses a Y connector (“Y connector 32,” see Fig. 3) apparatus comprising
a) a primary inlet channel (branch 37a);
b) a secondary inlet channel (branch 37b);
c) a convergence channel (37c) into which fluids or gases from the primary inlet channel and secondary inlet channel may flow;
d) a first port (the top opening of branch 37a that meets suction tube 26a) that is oriented in line with the primary inlet channel; and
e) a second port (the top opening of branch 37b that meets suction tube 26b) that is oriented in line with the secondary inlet channel.
Re Claim 5, Brennan discloses claim 1 and further disclosing wherein the primary inlet channel, secondary inlet channel, and convergence channel have exterior ridges (ridges 34, Fig. 3, [0041]), multi-indentations, or a combination thereof at their peripheral openings.
Re Claim 6, Brennan discloses claim 1 and further disclosing wherein the primary inlet channel, secondary inlet channel, convergence channel, first port, and second port are in fluid communication with one another (since fluid is drained from the suction tubes 26a & 26b and passing through Y connector 32 before reaching the collection container 16, see Fig. 3).
Claims 12, 17, 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (US 2016/0120688).
Re Claim 12, Lee discloses a Y connector (double Y-shaped connection pipe 102) apparatus comprising
a) a single inlet channel (where urethral insertion pipe 4 integrally joins to pipe 102, see Fig. 2);
b) a convergence channel (main pipe 104) into which fluids or gases from the single inlet channel may flow;
c) a first port (outflow pipe 108) that deviates from being in line with the single inlet channel by an angle equal to or less than 45 degrees (clear from Fig. 2); and
d) a second port (branch pipe 106) that deviates from being in line with the single inlet channel by an angle equal to or less than 45 degrees (also clear from Fig. 2).
Re Claim 17, Lee discloses claim 12 and further disclosing wherein the single inlet channel, convergence channel, first port, and second port are in fluid communication with one another (see cross-sectional view in Fig. 4 showing all internal lumens are in fluid communication, with check valve 112-1 allowing reinforcement rod 108 to be inserted into the inlet channel).
Re Claim 20, Lee discloses a method of facilitating a postoperative drainage system comprising
a) attaching to the postoperative drainage system a Y connector apparatus having a single inlet channel (where urethral insertion pipe 4 integrally joins to pipe 102, see Fig. 2); a convergence channel (104); a first port (108) that is attached to the single inlet channel and deviates from being in line with the single inlet channel by an angle equal to or less than 45 degrees (Fig. 2); and a second port (106) that is attached to the single inlet channel and deviates from being in line with the single inlet channel by an angle equal to or less than 45 degrees (Fig. 2), wherein the single inlet channel is attached to a drainage tube (4) and the convergence channel is attached to a clearing tube (hose 22) such that fluid or gas can flow from the drainage system through the single inlet channel into the convergence channel and into the clearing tube; and
b) clearing a blockage in the drainage system by inserting a tool (reinforcement rod 32, since it is stiff and extends the full length of the drainage tube (4), it would necessarily disrupt any blockage inside the drainage tube and the single inlet channel), instrument, or suction catheter through the first port into the single inlet channel (Fig. 4 shows reinforcement rod 32 inserted) and into the drainage system to dislodge the blockage and then removing the tool, instrument, or suction catheter from the drainage system through the single inlet channel and the first port (Fig. 5 shows reinforcement rod 32 removed), or clearing the blockage in the drainage system by inserting a tool, instrument, or suction catheter through the second port into the single inlet channel and into the drainage system to dislodge the blockage and then removing the tool, instrument, or suction catheter from the drainage system through the single inlet channel and the second port.
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 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Brennan in view of Koelper et al. (US 2016/0143815).
Re Claim 2, Brennan discloses claim 1 but does not disclose a first cap configured to seal the first port and a second cap configured to seal the second port, wherein the first cap and second cap are tethered together. Koelper discloses first and second caps each covering a branch of a Y-shaped medical connector (Figs. 3-5), and that these caps are each individually tethered to the connector (via ring connectors 128 & 148) and thereby they are tethered together to the Y-shaped connector. It would have been obvious to one skilled in the art at the time of filing to modify with Koelper such that the branches of the Y connector may stay clean or prevent gas/liquid from exiting through these branches.
Re Claim 3, Brennan and Koelper combine to disclose claim 2. While Koelper is silent to the first cap and the second cap being composed of a rigid material, a flexible material, or a combination thereof, one skilled in the art would note that a solid material can only be either rigid or flexible. Additionally, since the claim does not expressly define how rigid a material needs to be considered “rigid,” the fact that the cap would hold its shape and can be screwed or press-fit onto the branches of the Y-shaped connector would imply that the material can be considered as “rigid” under broadest reasonable interpretation.
Re Claim 4, Brennan and Koelper combine to disclose claim 2, and Koelper further discloses wherein the first cap and the second cap each include a gripping extension (e.g., the dividing wall in the D-configuration 131 as shown in Figs. 6-7, [0039] discloses the D-configuration allows a caretaker to use a tool 195 to assist in dislodging a stuck cap).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Brennan in view of Lisitschew (US 2016/0361481).
Re Claim 7, Brennan discloses claim 1 but is silent to wherein the primary inlet channel, secondary inlet channel, convergence channel, first port, and second port are composed of a rigid material. However, it is likely that the entire Y connector of Brennan is made of rigid material, at least rigid enough to allow the Y connector to couple with suction tubes (26a & 26b, Fig. 3) as well as single tube (36). Lisitschew discloses a Y connector that is made from a rigid plastic material (see e.g., [0015]). It would have been obvious to one skilled in the art at the time of filing to modify Brennan with Lisitschew since the selection of a material suitable for its intended use (e.g., selecting a rigid plastic as taught by Lisitschew for making a Y connector in a medical system conducts fluid flow) establishes a prima facie case of obviousness (see MPEP 2144.07).
Re Claim 8, Brennan discloses claim 1, but does not disclose that wherein the primary inlet channel, secondary inlet channel, and convergence channel include a tube stop. Lisitschew discloses a Y-shaped medical connector (1) having multiple branches (2, 4, & 6) and a thickened portion on each branch that may serve as tube stops (central junction node 8 and axial stop 10, Fig. 1). It would have been obvious to one skilled in the art at the time of filing to modify with Lisitschew such that the connector junction can be strengthened while stopping tubes from possibly jamming at the junction.
Claims 13-15, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Koelper.
Re Claim 13, Lee discloses claim 12 but does not disclose a first cap configured to seal the first port and a second cap configured to seal the second port, wherein the first cap and second cap are tethered together. Koelper discloses first and second caps each covering a branch of a Y-shaped medical connector (Figs. 3-5), and that these caps are each individually tethered to the connector (via ring connectors 128 & 148) and thereby they are tethered together to the Y-shaped connector. It would have been obvious to one skilled in the art at the time of filing to modify with Koelper such that the branches of the Y connector may stay clean or prevent gas/liquid from exiting through these branches.
Re Claim 14, Lee and Koelper combine to disclose claim 13. While Koelper is silent to the first cap and the second cap being composed of a rigid material, a flexible material, or a combination thereof, one skilled in the art would note that a solid material can only be either rigid or flexible. Additionally, since the claim does not expressly define how rigid a material needs to be considered “rigid,” the fact that the cap would hold its shape and can be screwed or press-fit onto the branches of the Y-shaped connector would imply that the material can be considered as “rigid” under broadest reasonable interpretation.
Re Claim 15, Lee and Koelper combine to disclose claim 13, and Koelper further discloses wherein the first cap and the second cap each include an extension (e.g., the dividing wall in the D-configuration 131 as shown in Figs. 6-7).
Re Claim 21, Lee discloses claim 20 but does not disclose removing a first or second cap that seals the first or second port before inserting the tool, instrument, or suction catheter through the first or second port and replacing the first or second cap to seal the first or second port after removal of the tool, instrument, or suction catheter. Koelper discloses a Y connector that has first and second caps sealing the branches of the connector when one does not need to access said branches (see Figs. 3-5). It would have been obvious to one skilled in the art at the time of filing to modify Lee with the caps of Koelper to keep the branches clean or to prevent fluid leaking from the drainage system. After modification, since Lee requires the insertion of reinforcement rod (32) as part of the normal operation of the drainage system, it is inherent that one would need to remove the cap (which keeps the system clean) in order to insert the reinforcement rod (as shown in Fig. 4 of Lee) and then after the rod is removed (Fig. 5 of Lee), it is also inherently necessary for one to replace the cap so as to maintain the cleanliness of the connector and the entire system.
Claims 16 & 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Lisitschew.
Re Claim 16, Lee discloses claim 12 but does not disclose wherein the single inlet channel and convergence channel have exterior ridges, multi-indentations, or a combination thereof at or near their peripheral openings. Lisitschew discloses a Y-shaped medical connector (1) having multiple branches (2, 4, & 6), wherein each branch has exterior ridges on an exterior surface thereof (clear from Fig. 1). It would have been obvious to one skilled in the art at the time of filing to modify Lee with Lisitschew since the exterior ridges can help a generic medical tubing connect more securely to the connector.
Re Claim 18, Lee discloses claim 12 but is silent to wherein the single inlet channel, convergence channel, first port, and second port are composed of a rigid material. Lisitschew discloses a Y-shaped medical connector that is made of rigid material ([0035]). It would have been obvious to one skilled in the art at the time of filing to glean from Lisitschew such that a medical provider can more easily manipulate the entire device without deforming the connector.
Re Claim 19, Lee discloses claim 12 but does not disclose wherein the single inlet channel and convergence channel include a tube stop. While Lee discloses that the single inlet channel is integral with the urethral insertion pipe (4), one skilled in the art would find it obvious to separate an integral structure because this would allow for more flexibility in use of the device (e.g., the medical provider can choose a different catheter to be used with this connector). Lisitschew discloses a Y-shaped medical connector (1) having multiple branches (2, 4, & 6) and a thickened portion on each branch that may serve as tube stops (central junction node 8 and axial stop 10, Fig. 1). It would have been obvious to one skilled in the art at the time of filing to modify with Lisitschew such that the connector junction can be strengthened while stopping tubes from possibly jamming at the junction.
Allowable Subject Matter
Claims 9-11 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Re Claim 9, Brennan and Lee both teach Y connectors, but Brennan differs from Lee in that Brennan receives fluid at its two branches and converge the fluid into a single outlet (Fig. 3) whereas Lee receives fluid at a single inlet and drains it out a single outlet, with side ports along the flow path that allows for insertion of tools towards the fluid inlet (e.g., Fig. 3). Brennan does not disclose clearing a blockage by inserting a tool through the first/second port into the first/second drainage tube. While Lee discloses inserting a tool, but the Lee connector is not possible to meet the functional limitation “wherein the primary inlet channel is attached to a first drainage tube and the secondary inlet channel is attached to a second drainage tube and the convergence channel is attached to a clearing tube such that fluid or gas can flow from the first and second drainage tubes through the primary and secondary inlet channels into the convergence channel and into the clearing tube”.
No other reference is found to disclose the claimed method or ameliorate the deficiencies of either Brennan or Lee.
Claims 10-11 are allowable for being dependent from Claim 9.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Reekers (US 6,001,078) discloses a drainage catheter having a single inlet and an outlet (see Fig. 1), the catheter further comprises first and second ports that deviate from the inlet by an angle of less than 45 degrees. However, the first and second ports are not in fluid communication with the inlet or the outlet.
McIntyre (US 2020/0001045) discloses a urinary drainage catheter having first and second ports off the main drainage channel (see e.g., Fig. 3). However, the first and second ports are not in fluid communication with the drainage channel.
Vazales (US 2014/0150782) discloses a suction drainage catheter having side ports and a main channel, the main channel allowing a tool to be inserted into the catheter (see Fig. 3B).
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/SUSAN S SU/Primary Examiner, Art Unit 3781 29 November 2025