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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claims 12-18 are 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 12 recites the broad recitation a plurality of cells, and the claim also recites immune cells which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 12, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 13, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 14-16 are considered indefinite due to their dependence on claim 13.
Regarding claim 17, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 18, is considered indefinite due to its dependence on claim 17.
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.
As a note: the claim set of this current application contains many optional limitations. To remain clear about which limitations were examined/rejected, the addressed limitations will be bolded in the rejections.
Claims 1-7, 10, and 13-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (WO 2020101884 A1).
Regarding claim 1, Lee teaches a method for making a sterile connection for transferring a liquid between at least two containers, comprising: (a) positioning a first connection surface and a second connection surface, wherein the first connection surface is integral to a first connector and the second connection surface is integral to a second connector; and wherein the first connection surface is linked to a first container and the second connection surface is linked to a second container (Figure 1B first connection surface “132” corresponds to first container “150” and second connection surface “134” corresponds to second container “160”); (b) coupling the first connector and the second connector, wherein the coupling defines a sterilization chamber comprising a gap between the first connection surface and the second connection surface (connector may form a tube connecting the first and second containers, paragraph [0014]); (c) activating a sterilization agent within the sterilization chamber to produce a sterile environment (Figure 1C sterilizing fluid “122” injected into sterilizable connector “130”; (d) fluidically coupling the first container with the second container through the first connection surface and the second connection surface (connecting ends of sterilizable connector, paragraph [0023]); (e) transferring a liquid between the first container and the second container (perform dialysis via fluid transfer path including sterilizable connector, paragraph [0026]); and optionally, (f) disconnecting the first connection surface and the second connection surface after step (e).
Regarding claim 2, Lee teaches wherein the gap between the connection surfaces is a closed space accessible through at least one opening (Figure 1A sterilizable connector “130” accessible from valve “124”), optionally a port.
Regarding claim 3, Lee teaches wherein (i) the sterilization agent is a fluid, gas, vapor, or stream (sterilization fluid, paragraph [0009]); and (ii) activating the sterilization agent comprises flowing the sterilization agent through the gap between the connection surfaces through the ports (sterilization fluid injected into the body via valve, paragraph [0011]).
Regarding claim 4, Lee teaches wherein the first and second connectors are loaded into a housing (reusable syringe shell connection piece, paragraph [0045]), optionally wherein any of the steps (a) – (f) or in combination is operated automatically by a controller.
Regarding claim 5, Lee teaches wherein the first and second connectors are loaded into a housing, and wherein positioning the first connection surface and the second connection surface in step (a) comprises robotically loading the first connector and the second connector within the housing (medical robotics device may automatically connect the first and second container to the connector, paragraph [0023], and reusable syringe shell connection piece, paragraph [0045]).
Regarding claim 6, Lee teaches wherein (i) activating the sterilization agent over the first connector and the second connector is performed prior to fluidically coupling the first container with the second container (figure 2 injection of sterilization fluid step “220” completed before performing peritoneal dialysis “240”); (ii) step (d) comprises fluidically coupling the first and second container with a fluid transfer conduit, wherein the fluid transfer conduit has connectors to couple either end of the fluid transfer conduit with to the first connector and the second connector; (iii) the first container comprises a cell culture medium and the second container comprises cultured cells, and wherein transferring a liquid between the first container and the second container comprises transferring the cell culture medium to the cultured cells; and/or (iv) the first connector and the second connector are connected via a third connector such that the first connector connects to one end of the third connector and the second connector connects to the other end of the third connector, optionally wherein the intermediate connector is sealable for removal of samples from the fluid flow path.
Regarding claim 7, Lee teaches wherein (i) transferring a liquid between the first container the second container in step (e) comprises interlocking one or more pinch valves and/or pumps (dialysate fluid may be injected using a peritoneal dialysis cycler, paragraph [0020]); (ii) transferring a liquid between the first container and the second container in step (e) comprises rotating a peristaltic pump to cause a positive or a negative pressure in a tubing between the first container and the second container; or (iii) transferring a liquid between the first container and the second container in step (e) comprises rotating a peristaltic pump between two interlocking valves prior to activating the interlocking valves.
Regarding claim 10, Lee teaches wherein transferring a liquid between the first container and the second container in step (e) comprises pumping the liquid from the first container to the second container (dialysate fluid may be injected using a peritoneal dialysis cycler, paragraph [0020]).
Regarding claim 13, Lee teaches wherein a first connection surface and a second connection surface wherein the first connection surface is integral to a first connector and the second connection surface is integral to a second connection; and wherein the first connection surface is linked to a first container and the second connection surface is linked to a second container (Figure 1B first connection surface “132” corresponds to first container “150” and second connection surface “134” corresponds to second container “160”); (ii) the first connector and the second connector configured to form a sterilization chamber comprising a gap between the first connection surface and the second connection surface (connector may form a tube connecting the first and second containers, paragraph [0014]); (iii) a pump configured to transfer a liquid from the first container to the second container (dialysate fluid may be injected using a peritoneal dialysis cycler, paragraph [0020]); and (iv) a sterilization agent that is activatable within the gap between the first connection surface and the second connection surface (Figure 1C sterilizing fluid “122” injected into sterilizable connector “130”), preferably, wherein the gap is an enclosed space accessible through at least one preferably optionally a port.
Regarding claim 14, Lee teaches wherein the first connector and/or second connector comprises ports suitable to provide access for the sterilization agent to the gap (Figure 1A sterilizable connector “130” accessible from valve “124”).
Regarding claim 15, Lee teaches (iv) an interlock valve configured to avoid back contamination between the first container and the second container; (v) a first controller configured to activate the sterilization agent over the first connector and the second connector (timer mechanism to enable automated control of injection of sterilization fluid, paragraph [0030]); (vi) a second controller configured to position the first connector and the second connector for sterilization and/or to remove the first connector or the second connector from the sterilization position after liquid transfer between the first container and the second container; (vii) a peristaltic pump between the first connector and the second connector to prevent backflow between the first container and the second container; and/or (viii) one or more interlocking pinch valve between the first container and the second container to prevent backflow between the first container and the second container.
Regarding claim 16, Lee teaches wherein the device contains a controller configured to automatically operate any of the steps (i)-(viii) or in combination (medical robotics device may automatically connect the containers to the connector, paragraph [0023], and medical robotics may automatically inject the sterilization fluid, paragraph [0024]).
Regarding claim 17, Lee teaches a connection interface for sterile connection and liquid transfer, wherein the connection interface comprises: a first connector; a second connector (Figure 1B first connection surface “132” corresponds to first container “150” and second connection surface “134” corresponds to second container “160”); wherein the first connector and the second connector define a sterilization chamber comprising a gap between the first connection surface and the second connection surface (connector may form a tube connecting the first and second containers, paragraph [0014]); preferably, wherein the gap is an enclosed space accessible through at least one opening, preferably optionally a port; wherein the gap optionally comprises a sterilization agent (sterilizable connector includes sterilization fluid reservoir connected to the body, paragraph [0009]); wherein the first connector is fluidically coupled with a first container and the second connector is fluidically coupled with a second container (perform peritoneal dialysis via a fluid transfer path that includes sterilizable connector, paragraph [0026]); and a liquid transfer device including pump and valves to allow for liquid transfer between the first container and the second container and/or avoid back contamination (dialysate fluid may be injected using a peritoneal dialysis cycler, paragraph [0020]).
Regarding claim 18, Lee teaches wherein (i) the first container includes a solution for transferring into a cell culture vessel; (ii) the second container comprises a cell culture vessel; (iii) a solution in the first container is a culture medium for culturing cells grown in the second container; (iv) a solution in the first container comprises a nucleic acid or a viral particle comprising such for transducing cells grown in the second container, and wherein the nucleic acid encodes a chimeric receptor; (v) the second container comprises a cell culture and the first container is a destination bag for receiving either a culture medium or multiple cells in the cell culture; (vi) the first container comprises a cell culture medium or a viral vector for transferring into the second container, which comprises a first cell culture, wherein the connection interface further comprises a third container including a second cell culture configured to receive the cell culture medium or the viral vector from the first container; (vii) the second container comprises a destination bag for receiving either a culture medium or multiple cells from a cell culture; (viii) the sterilization agent comprises a fluid, a gas, or a vapor (sterilization fluid, paragraph [0009]); (ix) the connection interface further comprises a pump for liquid transfer between the second container and the first container, a second container, and/or the third container; (x) the first connector, the second connector, and/or the third connector is removable, disposable, reusable, or a combination thereof; (xi) the first connector, the second connector, and/or the third connector comprises a septum and/or a cannula; (xii) the first connector, the second connector, and/or the third connector is ejectable from the connection interface; (xiv) the second container comprises a septum, and the first connector, the second connector, and/or the third connector is arranged to be attached to the septum; (xv) the first connector, and/or the second connector each comprise a first piece and a second piece, one end of the first piece being arranged to be attached to the first container, a second container, and/or the third container, and one end of the second piece being arranged to be attached to the second container; (xvi) the first connector or the second connector comprise a first piece and a second piece, further comprising an intermediate piece having a first end and a second end, which are arranged to be attached to a second end of the first piece and/or a second end of the second piece; (xvii) the first connector or the second connector each comprise a first piece and a second piece, the first container and the second container comprise a fluid conduit, and a first piece is arranged to be attached to the fluid conduit, and the second container comprises a septum, and the second piece is arranged to be attached to the septum; and/or (xviii) the first connector or the second connector comprise a first piece and a second piece wherein the first piece and the second piece form the first sterilizable space, a second sterilizable space, and/or a third sterilizable space; or the first connector or the second connector comprise a first piece and a second piece, the first piece and the second piece comprise: one or more valves, one or more seals, and one or more ports.
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.
Claims 8-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Lock (US 20180298316 A1).
Regarding claim 8, Lee teaches all aspects of the current invention except wherein (i) the first container comprises one or more source bags containing a culture medium or a waste medium, and the second container comprises one or more culture bags containing a cell culture, optionally wherein transferring a liquid between the first container and the second container in step (e) comprises transferring a solution including a nucleic acid or a viral particle comprising such to the second container for transducing a plurality of cells therein, optionally wherein the nucleic acid encodes a chimeric receptor; or (ii) the first container is a cell culture vessel, the second container is a designation bag, and transferring a liquid between the first container and the second container in step (e) comprises transferring a culture medium or a plurality of cells into the designation bag from a cell culture vessel. However, Lock teaches wherein (i) the first container comprises one or more source bags containing a culture medium or a waste medium, and the second container comprises one or more culture bags containing a cell culture, optionally wherein transferring a liquid between the first container and the second container in step (e) comprises transferring a solution including a nucleic acid or a viral particle comprising such to the second container for transducing a plurality of cells therein, optionally wherein the nucleic acid encodes a chimeric receptor; or (ii) the first container is a cell culture vessel, the second container is a designation bag, and transferring a liquid between the first container and the second container in step (e) comprises transferring a culture medium or a plurality of cells into the designation bag from a cell culture vessel (bag is fluidically connected to one fill tubing for aseptic filling of bag with culture media, paragraph [0019]).
Lee and Lock are considered analogous to the current invention because all are in the field of aseptic or sterile fluid connection methods. Therefore, it would have been obvious to one of ordinary skill in the art to combine the method taught by Lee with the use of aseptic fluid connection in cell culturing applications as taught by Lock because Lock teaches such a connection method reduces number of processing steps and reduces sterility breaches in bioreactor processing (paragraph [0005]).
Regarding claim 9, Lee teaches all aspects of the current invention except wherein the second container is a cell culture vessel, and wherein the method further comprises connecting a third container and the cell culture vessel, and transferring liquid between the cell culture vessel and the third container. However, Lock teaches wherein the second container is a cell culture vessel (culture vessel, paragraph [0031]), and wherein the method further comprises connecting a third container and the cell culture vessel, and transferring liquid between the cell culture vessel and the third container (Figure 3 shows method of process recovery out of the culture vessel/platform).
Lee and Lock are considered analogous to the current invention as described above. Therefore, it would have been obvious to one of ordinary skill in the art to combine the method taught by Lee with the use of aseptic fluid connection in cell culturing applications as taught by Lock because Lock teaches such a connection method reduces number of processing steps and reduces sterility breaches in bioreactor processing (paragraph [0005]).
Regarding claim 12, Lee teaches all aspects of the current invention except wherein the first container or the second container is a destination bag comprising a plurality of cells, preferably wherein the cells are immune cells, which optionally are T cells, more optionally wherein the immune cells express a chimeric receptor. However, Lock teaches wherein the first container or the second container is a destination bag comprising a plurality of cells (kit includes a container of frozen cells for seeding into media bag, paragraph [0031]), preferably wherein the cells are immune cells, which optionally are T cells, more optionally wherein the immune cells express a chimeric receptor.
Lee and Lock are considered analogous to the current invention as described above. Therefore, it would have been obvious to one of ordinary skill in the art to combine the method taught by Lee with the use of aseptic fluid connection in cell culturing applications as taught by Lock because Lock teaches such a connection method reduces number of processing steps and reduces sterility breaches in bioreactor processing (paragraph [0005]).
Claims 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Shimase (US 20190153377 A1).
Regarding claim 11, Lee teaches all aspects of the current invention except wherein the second container comprises a cell culture vessel (culture vessel, paragraph [0031]), and the method further comprises collecting a cell culture from an incubator housing a plurality of cell culture vessels. However, Shimase teaches wherein the second container comprises a cell culture vessel (cell culture device, paragraph [0001]), and the method further comprises collecting a cell culture from an incubator housing a plurality of cell culture vessels (plurality of cell culture vessels in closed system, paragraph [0007], and cell culture vessel is connected to collecting bag, paragraph [0064]).
Lee and Shimase are considered analogous to the current invention because all are in the field of aseptic or sterile fluid connection methods. Therefore, it would have been obvious to one of ordinary skill in the area to combine the connection method taught by Lee with the use in cell collection from multiple vessels as taught by Shimase because Shimase teaches such a method would provide easy access to a desired cell culture device while preventing contamination (paragraph [0012]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA ROSE SARANTAKOS whose telephone number is (703)756-5524. The examiner can normally be reached Mon-Fri 7:00-4:00.
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/K.R.S./
Examiner, Art Unit 1799
/DONALD R SPAMER/Primary Examiner, Art Unit 1799