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 .
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 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 1-3, 10-14 and 18-20 are rejected under 35 U.S.C. 102a1 as being anticipated by Staton (US 2015/0203258 A1 – hereafter ‘258).
‘258 discloses a closure for a labware device where the device defines an inner chamber (Abstract) that includes the following limitations for claim 1:
“An aseptic cell culture system”: ‘258 discloses a culture system (container 20; Fig. 4; [0038]) that is used to culture cells.
It should be noted that the system of ‘258 is being interpreted as aseptic since the system actively attempts to eliminate the introduction of microorganisms into the cell culture.
“a cell culture device including an interior chamber and a first opening extending through a wall defining a part of the interior chamber”: ‘258 discloses that the container (container 20) includes trays (trays 90a-d; [0039]) that provides a cell culture surface. Furthermore, the trays have walls that define a part of the interior chamber.
“a first aseptic port including a first coupling end and an second coupling end”:
“the first coupling end extending through the first opening and integrated with the wall”: ‘256 discloses a first closure (closure 10, i.e. the first port; Fig. 3; [0035]) that fits into the port of the container (port 92; container 20; Fig. 4; [0035]). This closure includes a port (port 68; Fig. 8A; [0047]) that is being interpreted as the first coupling end and a second coupling end (closure 12; Fig. 3; [0037]) that is the second coupling end and allows the closure to connect with the container.
“the first aseptic port including a fluid pathway in fluid communication with the interior chamber and extending between the fist coupling end and the second coupling end”: ‘258 discloses that the port (port 68; Fig. 3; [0047]) provides a fluid communication with the interior of the container.
“the second coupling end including a connecting component configured to allow one or more of a fluid line and a filter to be connected to the first aseptic port.”: The second end of ‘258 includes a component configured to allow a filter to be connected (filter 50; Fig. 3; [0044]).
For claim 2, ‘258 discloses a filter (filter 50, i.e. the membrane; Fig. 3; [0044]) that is placed across the port and reduces or eliminates the passage of microorganisms within the closure.
For claim 3, the filter of ‘258 would be positioned along a planar surface of the second coupling and covers the distal end of the fluid pathway. (Fig. 3; [0044]).
For claim 10, ‘258 that the closure body connects to the opening of the container by the use of a gripping structure (structure 22; Fig. 3) where this structure can be indentations, at least one thread, ridges, ribs (ribs 30), threaded or friction fit ([0035]).
For claim 11, ‘258 discloses that the locked engagement is by mechanical means ([0035]).
For claim 12, ‘258 discloses that the material used for the port and container can be polystyrene ([0045]) which is the same material used by the instant application and would therefore be fully capable of handling gamma-irradiation of at least 50 kGy.
For claim 13, ‘258 discloses a second opening (opening 92’) and a second closure/port (closure 10’; Fig. 4) that provides a second fluid pathway for the container ([0039]).
For claim 14, ‘258 discloses that the container is a multi-layer device with multiple trays (trays 90a-d; Fig. 4; [0039]).
For claim 18, ‘258 discloses the following limitations:
“An aseptic cell culture kit”: ‘258 discloses a culture system (container 20; Fig. 4; [0038]) that is used to culture cells.
It should be noted that the kit of ‘258 is being interpreted as aseptic since the system actively attempts to eliminate the introduction of microorganisms into the cell culture.
“a cell culture device including an interior chamber and a first opening extending through a wall defining a part of the interior chamber”: ‘258 discloses that the container (container 20) includes trays (trays 90a-d; [0039]) that provides a cell culture surface. Furthermore, the trays have walls that define a part of the interior chamber.
“a first aseptic port including a first coupling end and an second coupling end”:
“the first coupling end extending through the first opening and integrated with the wall”: ‘256 discloses a first closure (closure 10, i.e. the first port; Fig. 3; [0035]) that fits into the port of the container (port 92; container 20; Fig. 4; [0035]). This closure includes a port (port 68; Fig. 8A; [0047]) that is being interpreted as the first coupling end and a second coupling end (closure 12; Fig. 3; [0037]) that is the second coupling end and allows the closure to connect with the container.
“the first aseptic port including a fluid pathway in fluid communication with the interior chamber and extending between the fist coupling end and the second coupling end”: ‘258 discloses that the port (port 68; Fig. 3; [0047]) provides a fluid communication with the interior of the container.
“the second coupling end including a connecting component configured to allow one or more of a fluid line and a filter to be connected to the first aseptic port.”: The second end of ‘258 includes a component configured to allow a filter to be connected (filter 50; Fig. 3; [0044]).
For claim 19, ‘258 that the closure body connects to the opening of the container by the use of a gripping structure (structure 22; Fig. 3) where this structure can be indentations, at least one thread, ridges, ribs (ribs 30), threaded or friction fit ([0035]). This is being interpreted as the locked engagement of the instant application and is fully capable of preventing an uncoupling during use.
For claim 20, ‘258 discloses that the closure can be removed 9[0035]).
Therefore, ‘258 meets the limitations of claims 1-3, 10-14 and 18-20.
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 (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 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 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Staton (US 2015/0203258 A1 – hereafter ‘258) in view of Pankratz et al. (US 2021/0269756 A1 – hereafter ‘756).
‘258 discloses a closure for a labware device where the device defines an inner chamber (Abstract) that includes the following limitations:
“A method of manufacturing an aseptic cell culture system”: ‘258 discloses a method for assembling a culture system after molding ([0037]).
It should be noted that the method of ‘258 is being interpreted as aseptic since the system actively attempts to eliminate the introduction of microorganisms into the cell culture.
“coupling a first aseptic port to a first opening of a cell culture device to form the aseptic cell culture system”: ‘258 discloses the step where the closure body connects to the opening of the container by the use of a gripping structure (structure 22; Fig. 3) where this structure can be indentations, at least one thread, ridges, ribs (ribs 30), threaded or friction fit ([0035]).
“wherein the coupling comprises forming a locked engagement and a fluidic seal between the first aseptic port and the cell culture device”: , ‘258 discloses the step where the locked engagement is by mechanical means ([0035]). This forms a fluidic seal between the port and device.
‘258 does not explicitly disclose the step of sterilizing the device and port.
‘756 (Pankratz) discloses a cell culturing device that includes a sterilization step ([0026]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to employ the sterilization step of ‘756 within ‘258 in order to prevent contamination to the cell culture from the culture container. The suggestion for doing so at the time would have been in order to reduce the risk of microbial contamination ([0027]).
For claim 16, ‘258 differs from the instant claim regarding the specific sterilization methods used.
For claim 16, ‘756 discloses using sterilization methods such as irradiation (beta or gamma radiation), steam autoclave, ethylene oxide, chemical disinfectants or dry heat sterilization ([0026]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to employ the type of sterilization steps of ‘756 within ‘258 in order to prevent contamination to the cell culture from the culture container. The suggestion for doing so at the time would have been in order to reduce the risk of microbial contamination ([0027]).
For claim 17, ‘258 discloses the step of using a second opening (opening 92’) and a second closure/port (closure 10’; Fig. 4) that provides a second fluid pathway for the container ([0039]).
Allowable Subject Matter
Claims 4-9 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 a statement of reasons for the indication of allowable subject matter: For claim 4, the prior art fails to teach or fairly suggest an aseptic cell culture system where the connecting component is positioned along the planar surface, the connecting component and the planar surface forming at least a part of a first genderless connecting interface of the first aseptic port.
Claims 5-9 would be allowable for the same reasons as claim 4.
The closest prior art is Staton (US 2015/0203258 A1) discloses a closure for labware that includes a closure that allows for the connection of a tube, but Staton does not teach or fairly suggest the genderless connection of the instant application.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Williams et al. (US 2015/0323114 A1) discloses an aseptic coupling device, but Williams does not disclose connecting to a cell culture device as discussed in the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 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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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799