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 § 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.
Claim 5 is 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.
The phrase “through a first filter, a first disconnection device, or both” (and the corresponding phrase for the second container) renders the scope of the claim ambiguous, because it is unclear which structures are actually required in the claimed system.
Specifically, claim 5 encompasses at least the following mutually exclusive configurations without distinguishing among them:
a filter only,
a disconnection device only,
both a filter and a disconnection device.
Because these alternatives involve structurally and functionally different configurations, the claim fails to clearly define what structure must be present in order to fall within the scope of the claim.
This ambiguity prevents one of ordinary skill in the art from determining, with reasonable certainty, whether a given system infringes the claim.
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.
Claim(s) 1-11 and 13-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schick (US 7,052,603).
Regarding claim 1, Schick discloses a collection system (abstract) comprising:
one or more collection modules, each collection module in the one or more collection modules comprising:
a valve (41, 42, 43) comprising an inlet (31) and one or more outlet sets (24), wherein each outlet set in the one or more outlet sets comprises a first outlet and a second outlet (Fig. 2, col. 4, lines 34-40), and any outlet of any outlet set in the one or more outlet sets is individually selectable for fluidically coupling with the inlet (Fig. 2, col. 4, lines 34-40); and
one or more container sets, wherein each respective container set in the one or more container sets comprises a first container (21) fluidically connected to the first outlet (41) of a corresponding outlet set in the one or more outlet sets and a second container (22) fluidically connected to the second outlet (42) of the corresponding outlet set in the one or more outlet sets (Fig. 2, col. 4, lines 34-40),
wherein for a first collection module in the one or more collection modules: (i) the inlet of the valve is configured to be fluidically connected to an upstream system to receive a first stream of fluid from the upstream system (Fig. 2), (ii) the one or more outlet sets comprise a first outlet set (Fig. 2), (iii) the one or more container sets comprise a first container set (Fig. 2, col. 4, line 34-30), (iv) the first container of the first container set is fluidically connected to the first outlet of the first outlet set (Fig. 2, col. 4, lines 34-40), and (v) the second container of the first container set is fluidically connected to the second outlet of the first outlet set (Fig. 2, col. 4, line 34-40); and
a control unit electrically connected to the valve of each collection module in the one or more collection modules and configured to control operation of the valve of each collection module in the one or more collection modules (col. 5, lines 8-16),
wherein for the first collection module in the one or more collection modules, the control of operation of the valve comprises alternately coupling the first outlet and the second outlet of the first outlet set with the inlet a first plurality of times, thereby allowing the first container and the second container of the first container set to alternately collect the first stream of fluid (col. 5, line 17-19).
Regarding claim 2, Schick discloses that wherein the fluid comprises proteins, peptides, cells, nucleic acids, vaccines, diagnostics, reagents, raw materials, biopolymers, carbohydrates, polysaccharides, lipids, biosynthetic molecules, molecules produced by biocatalysis or enzymatic production, or any combination thereof (col. 1, lines 23-31, col. 2, lines 3-4).
Regarding claim 3, Schick discloses that wherein for each collection module in the one or more collection modules, at least one outlet set in the one or more outlet sets further comprises a third outlet (27) configured to be fluidically connected to a downstream system (recirculation) (Fig. 1, col. 4, lines 1-4).
Regarding claim 4, Schick discloses that wherein for each collection module in the one or more collection modules, each outlet set in the one or more outlet sets further comprises the third outlet (27) configured to be fluidically connected to the downstream system (recirculation) (Fig. 1, col. 4, lines 1-4).
Regarding claim 5, Schick discloses that wherein for each collection module in the one or more collection modules:
the first container of each respective container set in the one or more container sets is fluidically connected to the first outlet of the corresponding outlet set in the one or more outlet sets through a first filter (33), a first disconnection device (24), or both (Fig. 2, col. 4, lines 28, col. 3, lines 56-57); and
the second container of each respective container set in the one or more container sets is fluidically connected to the second outlet of the corresponding outlet set in the one or more outlet sets through a second filter (33), a second disconnection device (24), or both (Fig. 2, col. 4, lines 28, col. 3, lines 56-57).
Regarding claim 6, Schick discloses that wherein for at least one collection module in the one or more collection modules, the first and second containers of a respective container set in the one or more container sets are configured differently (col. 4, line 5-8, col. 5, lines 11-16).
Regarding claim 7, Schick discloses that wherein:
the first container of the respective container set in the one or more container sets is configured to collect a first amount of fluid (col. 4, line 5-8, col. 5, lines 11-16); and
the second container of the respective container set in the one or more container sets is configured to collect a second amount of fluid (col. 4, line 5-8, col. 5, lines 11-16).
Regarding claim 8, Schick discloses that wherein the first or second amount of the fluid is collected for sample testing (quality control) (col. 4, line 5-8).
Regarding claim 9, Schick discloses that wherein for at least one collection module in the one or more collection modules, the first or second container of a respective container set in the one or more container sets is a bag, a bottle or a carboy (col. 3, lines 55-56).
Regarding claim 10, Schick discloses that wherein for the first collection module in the one or more collection modules and at a respective alternation, the coupling of the first outlet of the first outlet set with the inlet lasts for a first period of time and the coupling of the second outlet of the first outlet set with the inlet lasts for a second period of time (col. 5, line 28-67).
Regarding claim 11, Schick discloses that wherein:
the first period of time is determined based at least in part on (i) a total amount of fluid to be collected by the first container of the first container set, (ii) a current amount of fluid in the first container of the first container set, (iii) a rate of filling the first container of the first container set, or any combination thereof (col. 5, line 28-67, col. 6, line 1-6); and
the second period of time is determined based at least in part on (i) a total amount of fluid to be collected by the second container of the first container set, (ii) a current amount of fluid in the second container of the first container set, (iii) a rate of filling the second container of the first container set, or any combination thereof (col. 5, line 28-67, col. 6, line 1-6).
Regarding claim 13, Schick discloses manifold systems with multiple outlet passageways and multiple collection bags (e.g. up to 12), where the controller sequentially operates different sets of pinch valves to direct the same fluid stream to different groups of containers in sequence (col. 5, lines 61-64).
After completing filling of one set of bags, Schick’s controller switches valve states to fill additional bags (col. 5, lines 61-64).
Thus, Schick discloses that wherein for the first collection module in the one or more collection modules:
the one or more outlet sets further comprise a second outlet set;
the one or more container sets further comprise a second container set;
the first container of the second container set is fluidically connected to the first outlet of the second outlet set;
the second container of the second container set is fluidically connected to the second outlet of the first outlet set; and
the control of operation of the valve further comprises, subsequent to alternately coupling the first outlet and the second outlet of the first outlet set with the inlet, alternately coupling the first outlet and second outlet of the second outlet set with the inlet a second plurality of times, thereby allowing the first container and second container of the second container set to alternately collect the first stream of fluid (col. 5, line 61-65).
Regarding claim 13, Schick discloses manifold systems with multiple outlet passageways and multiple collection bags (e.g. up to 12), where the controller sequentially operates different sets of pinch valves to direct the same fluid stream to different groups of containers in sequence (col. 5, lines 61-64).
After completing filling of one set of bags, Schick’s controller switches valve states to fill additional bags (col. 5, lines 61-64).
Thus, Schick discloses that wherein for the first collection module in the one or more collection modules:
the one or more outlet sets further comprise a second outlet set;
the one or more container sets further comprise a second container set;
the first container of the second container set is fluidically connected to the first outlet of the second outlet set;
the second container of the second container set is fluidically connected to the second outlet of the first outlet set; and
the control of operation of the valve further comprises, subsequent to alternately coupling the first outlet and the second outlet of the first outlet set with the inlet, alternately coupling the first outlet and second outlet of the second outlet set with the inlet a second plurality of times, thereby allowing the first container and second container of the second container set to alternately collect the first stream of fluid (col. 5, line 61-65).
Regarding claim 14, Schick discloses that wherein for the first collection module in the one or more collection modules, the coupling of the first and second outlets of the second outlet set with the inlet alternates at least 2 times, at least 3 times, at least 4 times, at least 5 times, at least 10 times, at least 15 times, at least 20 times, at least 30 times, at least 40 times, at least 50 times, at least 60 times, at least 70 times, at least 80 times, at least 90 times, or at least 100 times (col. 5).
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.
Claim(s) 12 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schick (US 7,052,603).
Regarding claim 12, Schick discloses that wherein for the first collection module in the one or more collection modules:
the first outlet set further comprises a third outlet fluidically connected to a downstream system (col. 4, line 1-4).
Schick further teaches controller-driven valve sequencing in which fluid is initially directed to waste or downstream flow paths prior to directing fluid to collection bags, including during system priming, equilibration, or flushing operations (col. 8).
Thus, it would have been obvious to one of ordinary skill in the art to configure Schick’s controller to first couple the inlet to a downstream outlet (e.g., waste or downstream processing equipment) before alternating collection, in order to flush the valve and associated flow paths with process fluid.
Such a modification would have been obvious because:
Flushing valves and manifolds before collection is a well-known and routine practice in bioprocessing to remove air, contaminants, or residual fluids;
Schick already teaches controller-driven sequencing of valve states and initial diversion of flow to non-collection paths (e.g., waste or downstream systems) during system preparation; and
implementing a flushing step using an already-disclosed downstream outlet would have involved only a predictable use of prior art elements according to their established functions, requiring no change in system structure and yielding no unexpected results.
Regarding claim 15, Schick discloses that wherein for the first collection module in the one or more collection modules:
the second outlet set further comprises a third outlet fluidically connected to a downstream system (col. 5, 61-64, col. 4, lines 1-4).
Schick further teaches controller-driven valve sequencing in which fluid is initially directed to waste or downstream flow paths prior to directing fluid to collection bags, including during system priming, equilibration, or flushing operations (col. 8). Thus, it would have been obvious to one of ordinary skill in the art to use the control of operation of the valve comprises, subsequent to alternately coupling the first outlet and the second outlet of the first outlet set with the inlet but prior to alternately coupling the first outlet and the second outlet of the second outlet set with the inlet, coupling the third outlet of the second outlet set with the inlet, thereby allowing flushing the valve with the first stream of fluid.
Regarding claim 16-20, Schick expressly teaches that its disclosed manifold, valve, and controller architecture is modular, repeatable, and suitable for handling multiple process fluids, buffers, eluents, permeate streams, or other biotechnology fluids within a bioprocessing system (see Fig. 1-9; col. 3-10). Nothing in Schick limits the system to a single collection module, and the same manifold/valve/controller structure is repeatedly used across different embodiments and processing stages.
It would have been obvious to one of ordinary skill in the art at the time of the invention to duplicate the collection module of Schick to provide a second collection module configured to collect a second fluid stream, as recited in claims 16–20. Such duplication represents the mere replication of a known module performing the same function, using the same structure and control logic, to accommodate additional fluid streams or parallel/sequential processing.
The motivation to duplicate the collection module arises from design needs commonly encountered in bioprocessing systems, including:
handling multiple fluid streams (e.g., buffers, products, permeate, eluate),
improving throughput and flexibility,
enabling parallel or sequential collection without redesigning the system architecture.
Duplicating a known, self-contained collection module to handle an additional stream would have been a predictable use of prior art elements according to their established functions, yielding no unexpected results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIAOYUN R XU, Ph. D. whose telephone number is (571)270-5560. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/XIAOYUN R XU, Ph.D./ Primary Examiner, Art Unit 1797