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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-10 in the reply filed on 4/1/2026 is acknowledged. Claims 11-22, directed to a nonelected invention, were canceled. Claims 1-10 and 23-32 are pending.
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 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-10 and 23-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin (US 20070048177 A1, provided in Applicant’s IDS of 5/19/2023).
Regarding claim 1, Lin teaches A sterilization container for use with a sterilization apparatus for sterilizing an article, the sterilization container comprising:
a body defining an interior configured to receive the article (Fig. 25: container 20);
an exterior fluid connector port facing an environment surrounding the body, the exterior fluid connector port configured to be fluidly connected to a first fluid connector of the sterilization apparatus (Fig. 25: portion to the right of hinged valve 90 would be capable of mating with a fluid connector);
an interior fluid aperture facing the interior and in fluid communication with the interior of the body, the interior fluid aperture configured to be fluidly connected to the article, the interior fluid aperture being fluidly coupled to the exterior fluid connector port (Fig. 25: port 55, or portion occupied by filter 72; par. 141: FIG. 5A is a cross-sectional illustration of one embodiment of a diffusion restricted environment represented by a container 20 having a limited diffusion port or communication port 30, consisting of tubing, and a tubing connector 45 to connect a lumen device 15 to the communication port 30 of the container 20; NOTE: since the article is not positively recited in the claim preamble, then the prior art interior fluid aperture only needs to capable of being connected to the article and in this case, the aperture would be capable of this function since Lin teaches that a connector can be used to connect the article to a port, or alternatively, an article can be sized and shaped in such a way to connect to the port); and
a valve fluidly disposed between the exterior fluid connector port and the interior fluid aperture, the valve including a valve member movable to an open position in which the valve permits fluid flow between the exterior fluid connector port and the interior fluid aperture and to a closed position in which the valve blocks fluid flow between the exterior fluid connector port and the interior fluid aperture, the valve being arranged to be engaged by the sterilization apparatus to move the valve member toward the open position to permit fluid flow between the first fluid connector and the article when the sterilization container is used with the sterilization apparatus and when the article is fluidly connected to the interior fluid aperture (par. 199: The top port 55 is also equipped with a hinged valve 90, where the hinged valve 90 comprises a flap 92 on a hinge 94, where the flap 92 has a circular shape, an oval shape, a square shape or any other shape that closes the opening in the port 55. The hinge 94 is attached to the interior of the port 55, allowing the flap 92 to open and close by swinging on the hinge 94. The flap 92 forms a gas and vacuum-tight seal with the port 55 when the flap 92 is closed. The hinged valve 90 further comprises a spring (not shown) which returns the flap 92 to a closed position when there is no external force on the flap 92 to force the flap 92 open. The hinge 94 may be either on a side of the flap 92 inside the attachable/detachable container 20 or on a side of the flap 92 outside of the attachable/detachable container 20; par. 203: FIG. 27 shows the attachable/detachable container 20 of FIG. 25 attached to the connector 85 of FIG. 26. The upper and lower tubes 84 of the connector 85 are inserted into the hinged valves 90 on the attachable/detachable container 20, opening the flaps 92 on the hinged valves 90; NOTE: the spring reads on the valve member and would have open and closed positions).
Regarding claim 2, Lin teaches the sterilization container of claim 1, as set forth above, and teaches wherein the valve is arranged to be engaged by the first fluid connector of the sterilization apparatus to move the valve member to the open position (par. 203: FIG. 27 shows the attachable/detachable container 20 of FIG. 25 attached to the connector 85 of FIG. 26. The upper and lower tubes 84 of the connector 85 are inserted into the hinged valves 90 on the attachable/detachable container 20, opening the flaps 92 on the hinged valves 90; NOTE: moving the flap would move the spring).
Regarding claim 3, Lin teaches the sterilization container of claim 1, as set forth above, and teaches wherein the valve member is biased toward the closed position (par. 199: The hinged valve 90 further comprises a spring (not shown) which returns the flap 92 to a closed position when there is no external force on the flap 92 to force the flap 92 open).
Regarding claim 4, Lin teaches the sterilization container of claim 1, as set forth above, and teaches wherein the exterior fluid connector port defines an exterior port aperture sized and shaped to receive the first fluid connector (Fig. 27: tube 84 enters the port).
Regarding claim 5, Lin teaches the sterilization container of claim 1, as set forth above, and teaches further comprising an interior fluid connector port, the interior fluid connector port defining the interior fluid aperture, the interior fluid connector port configured to be fluidly connected to an article fluid connector associated with the article to fluidly connect the article to the interior fluid aperture (Fig. 25: port 55, or portion occupied by filter 72; par. 141: FIG. 5A is a cross-sectional illustration of one embodiment of a diffusion restricted environment represented by a container 20 having a limited diffusion port or communication port 30, consisting of tubing, and a tubing connector 45 to connect a lumen device 15 to the communication port 30 of the container 20; NOTE: since the article is not positively recited in the claim preamble, then the prior art interior fluid aperture only needs to capable of being connected to the article and in this case, the aperture would be capable of this function since Lin teaches that a connector can be used to connect the article to a port, or alternatively, an article can be sized and shaped in such a way to connect to the port).
Regarding claim 6, Lin teaches the sterilization container of claim 1, as set forth above, and teaches wherein the body includes an initial alignment guide configured to be engaged by the sterilization apparatus to initially position the sterilization container relative to the sterilization apparatus when the sterilization container is used with the sterilization apparatus (Fig. 25, 27: external lip of port 55 and/or the second port 55)
Regarding claim 7, Lin teaches the sterilization container of claim 6, as set forth above, and teaches wherein the body includes a final alignment guide configured to be engaged by the sterilization apparatus to align the exterior fluid connector port and the first fluid connector with one another when the sterilization container is used with the sterilization apparatus (Fig. 27: O-rings 86).
Regarding claim 8, Lin teaches the sterilization container of claim 1, as set forth above, and teaches wherein the article is a first article, the exterior fluid connector port is a first exterior fluid connector port, the interior fluid aperture is a first interior fluid aperture, and the valve is a first valve (Fig. 25, 27: top port 55 with the associated features), the sterilization container further comprising:
a second exterior fluid connector port facing the environment surrounding the body, the second exterior fluid connector port configured to be fluidly connected to a second fluid connector of the sterilization apparatus;
a second interior fluid aperture facing the interior of the body and in fluid communication with the interior of the body, the second interior fluid aperture configured to be fluidly connected to a second article, the second interior fluid aperture being fluidly connected to the second exterior fluid connector port; and
a second valve fluidly disposed between the second exterior fluid connector port and the second interior fluid aperture, the second valve including a valve member movable to an open position in which the second valve permits fluid flow between the second exterior fluid connector port and the second interior fluid aperture and to a closed position in which the second valve blocks fluid flow between the second exterior fluid connector port and the second interior fluid aperture, the second valve being arranged to be engaged by the sterilization apparatus to move the valve member of the second valve toward the open position to permit fluid flow between the second fluid connector and the second article when the sterilization container is used with the sterilization apparatus and when the second article is fluidly connected to the second interior fluid aperture (Fig. 25-27: bottom/second port 55 and associated features; par. 199: The second port 55 of the embodiment of the attachable/detachable container 20 shown in FIG. 25 is equipped with a hinged valve 90; par. 203: The upper and lower tubes 84 of the connector 85 are inserted into the hinged valves 90 on the attachable/detachable container 20, opening the flaps 92 on the hinged valves 90. In the embodiment where one side of the tube 84 is longer than the second side of the tube, the longer side of the tube 84 helps to push the flap 92 aside. The plurality of O-rings 86 on the outside of the tubes 84 contact the interior of the ports 55, making a gas and vacuum-tight seal with the interior of the ports 55; NOTE: since the bottom port 55 has the same structures, it reads on the same limitations as the top port 55).
Regarding claim 9, Lin teaches the sterilization container of claim 1, as set forth above, and teaches further comprising a sterilant permeable membrane configured to permit a sterilant in the environment surrounding the body to pass therethrough and into the interior of the body (Fig. 25, 27: filter 72; par. 165: In general, it is a preferred embodiment to have a filter 72 over and/or in the entry/exit port, where the filter 72 is permeable to gases but impermeable to microorganisms. If the entry/exit port is covered and/or filled with a filter 72, the container 20 can be vented without contaminating the interior of the container 20 or any article contained inside the container 20; par. 208: Preferably, a filter 72 is placed in the horizontal tube 74, where the filter 72 is permeable to gases but impermeable to microorganisms. The horizontal tube 74 allows germicide vapor to flow from the interior of the inner container 20A to the interior of the attachable/detachable container 20B).
Regarding claim 10, Lin teaches the sterilization container of claim 1, as set forth above, and teaches wherein the body includes a box and a lid attachable to the box (Fig. 25, 27: a lid on a box is illustrated; par. 37: where the lid of the container is thicker in the area of the hole than in the remainder of the lid; NOTE: the lid in Figure 10 is illustrated in much of the same manner as the structure in Figs. 25 and 27 and therefore Figs. 25 and 27 are interpreted to teach a lid).
Regarding claim 23, Lin teaches the sterilization container of claim 1, as set forth above, and teaches wherein the valve includes a valve actuator operatively coupled to the valve member, the valve actuator configured to move the valve member toward the closed position, the valve actuator being arranged to be engaged by the sterilization apparatus to move the valve member toward the open position (par. 199: The hinged valve 90 further comprises a spring (not shown) which returns the flap 92 to a closed position when there is no external force on the flap 92 to force the flap 92 open; NOTE: the flap 92 reads on the valve actuator).
Regarding claim 24, Lin teaches the sterilization container of claim 23, as set forth above, and teaches further comprising passaging extending between and fluidly coupling the interior fluid aperture and the exterior fluid connector port to one another, the valve actuator being disposed in the passaging (Fig. 25: passage between filter 72 and external lip of port 55, with flap 92 in between).
Regarding claim 25, Lin teaches the sterilization container of claim 24, as set forth above, and teaches wherein the valve actuator is configured to be pushed by the first fluid connector of the sterilization apparatus to move the valve member toward the open position (par. 203: The upper and lower tubes 84 of the connector 85 are inserted into the hinged valves 90 on the attachable/detachable container 20, opening the flaps 92 on the hinged valves 90. In the embodiment where one side of the tube 84 is longer than the second side of the tube, the longer side of the tube 84 helps to push the flap 92 aside).
Regarding claim 26, Lin teaches the sterilization container of claim 25, as set forth above, and teaches wherein the valve actuator comprises a push plate (Fig. 25, 27: the flap 92 is to be pushed by the fluid connector).
Regarding claim 27, Lin teaches the sterilization container of claim 23, as set forth above, and teaches wherein the valve actuator is configured to be pushed by the first fluid connector of the sterilization apparatus to move the valve member toward the open position (par. 203: The upper and lower tubes 84 of the connector 85 are inserted into the hinged valves 90 on the attachable/detachable container 20, opening the flaps 92 on the hinged valves 90. In the embodiment where one side of the tube 84 is longer than the second side of the tube, the longer side of the tube 84 helps to push the flap 92 aside).
Claim Rejections - 35 USC § 103
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 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Horacek (US 20100040521 A1, provided in Applicant’s IDS of 5/19/2023).
Regarding claim 28, Lin teaches the sterilization container of claim 1, as set forth above, but does not teach further comprising a bulkhead mounted on the body, the bulkhead including the exterior fluid connector port, the interior fluid aperture, and the valve.
However, in the absence of any teaching to the contrary, the shape of the box surrounding the exterior fluid connector port does not affect operation since the port would still be capable of delivering sterilant and connecting with a sterilizer. Absent a showing of significance or unexpected results, the shape of the container is prima facie obviousness and do not modify the operation of the invention and further, does not add patentable significance. MPEP 2144.04.B: In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant). Accordingly, the claimed dimensions and shapes are considered to be not patentably distinct from the disclosed device of Lin because in this case, the addition of a bulkhead would have the expected result of additional structural support for the ports.
Furthermore, prior art in the same field also teaches a bulkhead. Horacek teaches a sterilization device that connects with lumen devices (abstract: An apparatus for deactivating medical instruments and devices comprised of a deactivation chamber movable between a loading position and a deactivation position. A circulation system is provided to circulate a deactivating fluid through the deactivation chamber. The circulation system is connectable to the deactivation chamber when the deactivation chamber is in the deactivation position; par. 124: Connection fittings 846 are connectable to certain medical devices and instruments by flexible connectors 848 (depicted by phantom lines in FIG. 24) to direct a microbial deactivation fluid through lumens or passages within instruments 842; Fig. 4). Horacek teaches a bulkhead surrounding its connector ports which serves as support for its multiple ports (Fig. 19, 20: block 674, male connectors 672A-C) and also provides an alignment guide (Fig. 19: locating opening 724, aligning pin 772). The bulkhead/block is attached/sealed to the container (Fig. 19).
The device of Lin also has multiple ports which may need support and alignment with the sterilization connectors.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Lin to have a bulkhead encompassing the entirety of its two ports 55 and associated structures, wherein the bulkhead includes alignment openings and is sealed/attached to the container, as taught by Horacek, with a reasonable expectation that bulkhead would provide additional structural support for multiple ports in a sterilization device for lumen devices, as well as alignment guiding for connecting with external sterilization devices.
Regarding claim 29, Lin modified by Horacek teaches the sterilization container of claim 28, as set forth above, and teaches wherein the bulkhead includes a seal forming a fluid tight seal between the bulkhead and the body (see Horacek modification in claim 28 rejection).
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Horacek and Bunch (US 20200276414 A1).
Regarding claim 30, Lin teaches the sterilization container of claim 6, as set forth above, but does not teach wherein the initial alignment guide comprises a blind hole.
As set forth above, Horacek teaches a sterilization container with ports that connect a lumen device to a sterilization device. For this purpose, Horacek teaches having an alignment hole and alignment pin (Fig. 19; par. 116: Pins 772 are disposed to be in alignment with locating openings 724 in manifold block 674) which provides motivation for Lin to also have alignment holes on its container. However, it is unclear if Horacek teaches blind holes specifically, which are interpreted to be holes that do not extend all the way through a wall.
Bunch teaches a catheter manipulator device (Title). Bunch teaches attachable portions that are aligned via blind holes and alignment pins (Fig. 8: 289, 288; par. 66: The handle 270 may include alignment pins 288 configured to be received into alignment holes 289 when the handle mating halves 281, 282 are coupled together).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Lin to have multiple blind holes located near its ports, as taught by Horacek and Bunch, in order to help align the sterilization connectors for mating with its ports. One of the plurality of blind holes now reads on the initial alignment guide instead of the lip of the port 55, and another of the plurality of blind holes now reads on the final alignment guide instead of the O-ring.
Regarding claim 31, Lin modified by Horacek and Bunch teaches the sterilization container of claim 7, as set forth above, and teaches wherein the initial alignment guide and the final alignment guide each comprise a blind hole (see Horacek and Bunch modification in claim 30 rejection).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Lin.
Regarding claim 32, Lin modified by Horacek and Bunch teaches the sterilization container of claim 1, as set forth above, and teaches in combination with the article, the article disposed in the interior of the body (par. 71: The lumen to be sterilized is placed within a chamber), but does not teach the interior fluid aperture being fluidly connected to the article.
Lin teaches the interior fluid aperture being fluidly connected to the article for some embodiments (par. 28: FIG. 5A is a cross-sectional illustration of one embodiment of a diffusion restricted environment represented by a container having a limited diffusion port (communication port consisting of tubing or the lumen device) and a tubing connector to connect a lumen device to the communication port of the container) but does not specifically teach a tubing connector for the embodiments of Figs. 25 and 27. However, since the purpose of the invention is to sterilize the interior of lumen devices, connecting the lumens to the ports would be advantageous for all embodiments.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embodiments of Figs. 25 and 27 of Lin to have a tubing connector fluidly connecting the insides of the lumen devices with the ports 55, as taught by Lin, in order to disinfect the interior of the lumen devices effectively.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANGRU CHEN whose telephone number is (571)272-1201. The examiner can normally be reached Monday-Friday 7:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.C./Examiner, Art Unit 1796
/KEVIN JOYNER/Primary Examiner, Art Unit 1799
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