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.
1. Claims 1, 4 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2010/0158761 to Chung et al.
Chung et al. discloses a system for loading at least one fluid. In the Abstract, Chung et al. teaches: “Provided is a microfluidic control apparatus that includes at least one control means and a microfluidic control chip. When the microfluidic control chip is loaded to the control means, a needle provided on the control means is inserted into a reaction solution storage chamber of the microfluidic control chip.”
In [0012] Chung et al. teaches: “The microfluidic control chip provides a working fluid through the needle to the reaction solution storage chamber, and a reaction solution in the reaction solution storage chamber moves to the branch microchannel to control the flow of the microfluid.”
In [0065] Chung et al. teaches that: “One side of the fixture 140 may be provided with a loading part (not shown) that is extended and bent, so that the microfluidic control chip 200 is placed on the loading part. Referring to FIG. 2, one side of the fixture 140 is provided with a loading part that is extended and bent downward, and then, bent again and extended in parallel to the lower surface of the microfluidic control chip 200, so that the microfluidic control chip 200 is placed on the loading part.”
This loading part is interpreted as reading on applicant’ claimed bay.
In Chung et al. the microfluidic control chip 200 includes at least one reaction solution storage chamber 210. The control means 110 in Chung et al. includes a tube 130 through which a working fluid 120 flows, a needle 160 connected to a first end of the tube and penetrating the sealing tape 230, a pump 11O connected to a second end of the tube 130 to pump the working fluid 120, a sealing elastic plate 150 being in contact with the sealing tape 230 to firmly fix the needle 160.
The structure in Chung et al. between the pump and tube 130 forms a manifold in fluid connectivity with at least one needle.
In Chung et al. fluidic connectivity is established between the at least one fluid and the at least one needle by at least one of (i) raising the fluid container and (ii) lowering the manifold for purposes of causing the needle 160 to penetrate the sealing tape 230 when applying a force to the sealing tape 230 in a predetermined direction. [0061]
Regarding the newly added limitation to claim 1 that recites “the manifold being positioned above the bay,” it is noted that the manifold 130 in Chung et al. (Figs. 1 and 5) is above the loading part in Chung et al. that is interpreted as reading on applicant’ claimed bay.
Regarding the newly added limitation that a pump in fluid connectivity with the manifold and configured to flow at least one fluid from a fluid container into the at least one needle and into the manifold, in Chung et al. when the needles 160 are lowered into the chambers 210 (“fluid containers”) the pump 110 and manifold 130 are “configured” to allow the illustrated pump (which is shown as having a movable plunger) to cause fluid in the chambers to flow backwards into the needles 160 and manifold 160.
I.) Regarding applicant’s claim 1, as noted above Chung et al. teaches all the elements of claim 1.
Therefore, Chung et al. anticipates claim 1.
II.) Regarding applicant’s claim 4, as noted above, above Chung et al. anticipates claim 1 from which claim 4.
Claim 4 recites that the at least one fluid comprises at least one reagent.
The fluid in the fluid container is not claimed, only the bay housing the fluid container. Further the type of fluid does not incorporate any structural limitations to the claimed system for loading at least one fluid. As such, no patentable weight is afforded to the fluid recited in claim 4.
Therefore, Chung et al. as applied to claim 1 anticipates claims 4.
III.) Regarding applicant’s claim 5, as noted above, above Chung et al. anticipates claim 4 from which claim 5.
Claim 4 recites that the at least one fluid is polymerase chain reaction (PCR) reagents.
As noted above, the fluid in the fluid container is not claimed, only the bay housing the fluid container. Further the type of fluid does not incorporate any structural limitations to the claimed system for loading at least one fluid. As such, no patentable weight is afforded to the fluid recited in claim 5.
Therefore, Chung et al. as applied to claim 1 anticipates claims 5.
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.
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.
2. Claims 6, 7, 14-17 and 27 are rejected under 35 USC 103 as being unpatentable over Chung et al.
I.) Regarding applicant’s claim 6, as noted above, Chung et al. anticipates claim 5 from which claim 6 depends.
Claim 6 recites that the polymerase chain reaction (PCR) reagents are in an aqueous solution with a volume of at least 200 microliters (µL).
As noted above, the type of fluid is not afforded patentable weight in the system claims.
As for the volume of the fluid, it would have been obvious to one of ordinary skill in the art to modify Chung et al. to scale the elements of the system up or down as desired to process any volumes of fluids, including providing at least 200 microliters of reagents.
Therefore, Chung et al. renders claim 6 obvious.
II.) Regarding applicant’s claim 7, as noted above Chung et al. anticipates claim 1 from which claim 7 depends.
Claim 7 recites that the manifold comprises at least one microfluidic channel comprising an inlet and an outlet, wherein the at least one needle is in fluidic connectivity with the inlet, and wherein the volume of the at least one microfluidic channel is not greater than 20 microliters (µL).
As noted above, the structure in Chung et al. between the pump and tube 130 forms a manifold in fluid connectivity with at least one needle. The tube includes opposite ends that can be interpreted as an inlet and outlet with the needles being in fluid connectivity with the inlet of the tube.
Chung et al. does not teach that the microfluidic channel (tube 130) has a volume that is not greater than 20 microliters (µL).
It would have been obvious to one of ordinary skill in the art adjust the size the apparatus of Chung et al. to provide tube 130 with a volume that is not greater than 20 microliters (µL). Note, changes in size are obvious when performance does not change. (MPEP 2144.04(IV)(A))
Therefore, Chung et al. renders claim 7 obvious.
III.) Regarding applicant’s claim 14, as noted above Chung et al. anticipates claim 1 from which claim 14 depends.
Claim 14 recites that the bay is configured to raise to establish fluid connectivity between the fluid container and the at least one needle.
Chung et al. requires that the control means 100 and bay (loading part) in Fig. 4 be brought together so that the needles 160 enter chambers 210.
Modifying Chung et al to either lowering the upper portion that includes the manifold 130 and needles or raising the loading part would have been obvious to one skilled in the art for purposes of positioning the needles 160 into chambers 210.
Therefore, Chung et al. renders claim 14 obvious.
IV.) Regarding applicant’s claim 15, as noted above Chung et al. anticipates claim 1 from which claim 15 depends.
Claim 15 recites an elevator configured to raise and lower the bay relative to the manifold.
As noted above, modifying Chung et al to either lowering the upper portion that includes the manifold 130 and needles or raising the loading part would have been obvious to one skilled in the art for purposes of positioning the needles 160 into chambers 210.
Any mechanism used to lower the upper portion or raise the loading part would be considered an “elevator.”
Therefore, Chung et al. renders claim 15 obvious.
V.) Regarding applicant’s claim 16, as noted above Chung et al. anticipates claim 1 from which claim 16 depends.
Claim 16 recites a valve in fluid connectivity with the manifold.
Chung et al. does not teach a valve in fluid connectivity with the manifold.
It would have been obvious to one of ordinary skill in the art to include a valve in connection with the manifold in Chung et al. for purposes of controlling or stopping flow through the manifold when changing/replacing the microfluid chip for as to prevent fluid leaking.
Therefore, Chung et al. renders claim 16 obvious.
VI.) Regarding applicant’s claim 17, as noted above Chung et al. anticipates claim 1 from which claim 17 depends.
Claim 17, recites that the at least one needle is mounted on a side of the manifold, and the valve is mounted on another side of the manifold.
As noted above, it would have been obvious to one of ordinary skill in the art to include a valve in connection with the manifold in Chung et al. for purposes of controlling or stopping flow through the manifold when changing/replacing the microfluid chip for as to prevent fluid leaking.
It would have been obvious to one or ordinary skill in the art to position the valve upstream of the needles in Chung et al. to prevent fluid leaking when changing/replacing the microfluid chip.
Therefore, Chung et al. renders claim 17 obvious.
VII.) Regarding applicant’s claim 27, as noted above, Chung et al. renders claim 16 obvious from which claim 27 depends.
Claim 27 recites that the at least one fluid is a plurality of reagents, and wherein the valve is configured to selectively allow one of the plurality of reagents to flow out of the valve.
Chung et al. teaches a plurality of fluids/reagents. (see Fig. 4)
As noted above, it would have been obvious to one of ordinary skill in the art to include a valve in connection with the manifold in Chung et al. for purposes of controlling or stopping flow through the manifold when changing/replacing the microfluid chip for as to prevent fluid leaking.
As noted above, it would have been obvious to one of ordinary skill in the art to include a valve in connection with the manifold in Chung et al. for purposes of controlling or stopping flow through the manifold that controls the fluid of selected fluids for purposes of controlling the individual fluids.
Therefore, Chung et al. renders claim 27 obvious.
3. Claims 18, 20, 21 and 24-26 and 28-30 are rejected under 35 U.S.C. 102 103 as being unpatentable over Chung et al.
As noted above, Chung et al. discloses a system for loading at least one fluid. In the Abstract, Chung et al. teaches: “Provided is a microfluidic control apparatus that includes at least one control means and a microfluidic control chip. When the microfluidic control chip is loaded to the control means, a needle provided on the control means is inserted into a reaction solution storage chamber of the microfluidic control chip.”
In [0012] Chung et al. teaches: “The microfluidic control chip provides a working fluid through the needle to the reaction solution storage chamber, and a reaction solution in the reaction solution storage chamber moves to the branch microchannel to control the flow of the microfluid.”
In [0065] Chung et al. teaches that: “One side of the fixture 140 may be provided with a loading part (not shown) that is extended and bent, so that the microfluidic control chip 200 is placed on the loading part. Referring to FIG. 2, one side of the fixture 140 is provided with a loading part that is extended and bent downward, and then, bent again and extended in parallel to the lower surface of the microfluidic control chip 200, so that the microfluidic control chip 200 is placed on the loading part.”
This loading part is interpreted as reading on applicant’ claimed bay.
In Chung et al. the microfluidic control chip 200 includes at least one reaction solution storage chamber 210. The control means 110 in Chung et al. includes a tube 130 through which a working fluid 120 flows, a needle 160 connected to a first end of the tube and penetrating the sealing tape 230, a pump 11O connected to a second end of the tube 130 to pump the working fluid 120, a sealing elastic plate 150 being in contact with the sealing tape 230 to firmly fix the needle 160.
The structure in Chung et al. between the pump and tube 130 forms a manifold in fluid connectivity with at least one needle.
In Chung et al. fluidic connectivity is established between the at least one fluid and the at least one needle by at least one of (i) raising the fluid container and (ii) lowering the manifold for purposes of causing the needle 160 to penetrate the sealing tape 230 when applying a force to the sealing tape 230 in a predetermined direction. [0061]
Regarding the newly added limitation to claim 1 that recites “flowing the at least one fluid from the fluid container into the at least one needle and into the manifold,” as noted above, Chung et al. shows that the illustrated pump (which is shown as having a movable plunger) which can easily cause fluid in the chambers to flow backwards into the needles 160 and manifold 160.
It would have been obvious to one of ordinary skill in the art to operate the pump of Chung et al. cause fluid in the chambers to flow backwards into the needles 160 and manifold 160 when too much fluid has been dispensed of when throttling the dispensing of the fluid into the chambers.
I.) Regarding applicant’s claim 18, as noted above Chung et al. teaches all the method steps of claim 18.
Therefore, Chung et al. renders claim 18 obvious.
II.) Regarding applicant’s claim 20, as noted above Chung et al. anticipates claim 18 from which claim 20 depends.
Claim 20 recites that the fluid container is front-loaded into the bay to receive the fluid container in the bay.
Chung et al teaches “One side of the fixture 140 may be provided with a loading part (not shown) that is extended and bent, so that the microfluidic control chip 200 is placed on the loading part. Referring to FIG. 2, one side of the fixture 140 is provided with a loading part that is extended and bent downward, and then, bent again and extended in parallel to the lower surface of the microfluidic control chip 200, so that the microfluidic control chip 200 is placed on the loading part.” [0065].
As shown in Fig. 2 the fixture 140 in Chung et al. is a bay that receives the microfluidic chip 200 from the front.
Therefore, Chung et al. renders claim 20 obvious.
II.) Regarding applicant’s claim 21, as noted above Chung et al. renders claim 18 obvious from which claim 21 depends.
Claim 21 recites that the at least one fluid comprises at least one reagent.
Chung et al. teaches reaction solutions which renders obvious reagents. [0003]
Therefore, Chung et al. renders claim 21 obvious.
III.) Regarding applicant’s claim 24, as noted above Chung et al. anticipates claim 18 from which claim 24 depends.
Claim 24 recites moving the bay toward the manifold.
As noted above, Chung et al. teaches lowering the manifold toward the bay so the needle 160 to penetrate the sealing tape 230 when applying a force to the sealing tape 230 in a predetermined direction, but does not teach moving the bay toward the manifold.
It would have been obvious to one of ordinary skill in the art to raise the bay toward the manifold as an alternative method of causing the needle 160 to penetrate the sealing tape 230.
Therefore, Chung et al. renders claim 24 obvious.
IV.) Regarding applicant’s claim 25, as noted above Chung et al. renders claim 24 obvious from which claim 25 depends.
Claim 25 recites that the step of moving the bay toward the manifold comprises raising the bay toward the manifold using an elevator.
Chung et al. does not teach using an elevator to raise the bay.
As noted above, it would have been obvious to one of ordinary skill in the art to raise the bay toward the manifold as an alternative method of causing the needle 160 to penetrate the sealing tape 230.
It would have been obvious to use any conventional mechanism to raise the bay, including an elevator.
Therefore, Chung et al. renders claim 25 obvious.
V.) Regarding applicant’s claim 26, as noted above Chung et al. render claim 18 obvious from which claim 26 depends.
Claim 26 recites that the at least one needle comprises a plurality of needles, and the at least one fluid comprises a plurality of fluids, each fluid having a corresponding needle of the plurality of needles.
Chung et al. teaches an embodiment in Fig. 4 that includes a plurality of needles and a plurality of fluids.
Therefore, Chung et al. anticipates claim 26.
VI.) Regarding applicant’s claim 28, as noted above, Chung et al. renders claim 26 from which claim 28 depends.
Claim 28 recite that the step of flowing the at least one fluid from the fluid container into the at least one needle and into the manifold further comprises selectively flowing one fluid of the plurality of fluids out of a valve at a time.
Chung et al. teaches a plurality of fluids as shown in Fig. 4, but does not teach valves.
Providing valves in each of the fluid flow areas 120 in Fig. 4 of Chung et al. would have been obvious for purposes of controlling or stopping fluid flow. In such as modification each valve would selectively allow one of the plurality of reagents to flow through each valve.
Therefore, Chung et al. renders claim 28 obvious.
VII) Regarding applicant’s claim 29, as noted above, Chung et al. renders claim 18 obvious from which claim 29 depends.
Claim 29 recites that establishing fluid connectivity between the fluid container and the at least one needle includes moving the at least one needle at least partly into the at least one fluid and wherein the at least one needle is configured to permit a flow of the at least one fluid from the fluid container into the at least one needle.
In Chung et al. the needles 160 are moved into the chambers and are “configured” to allow a flow of the at least one fluid from the fluid container into the at least one needle.
Therefore, Chung et al. anticipates claim 29.
VIII.) Regarding applicant’s claim 30, as noted above Chung et al. renders claim 18 obvious from which claim 30 depends.
Claim 30 recites a pump in fluid connectivity with the manifold and configured to flow the at least one fluid from a fluid container into the manifold.
As noted above, Chung et al. when the needles 160 are lowered into the chambers 210 (“fluid containers”) the pump 110 and manifold 130 are “configured” to allow the illustrated pump (which is shown as having a movable plunger) to cause fluid in the chambers to flow backwards into the needles 160 and manifold 160.
Therefore, Chung et al renders claim 30 obvious
4. Claims 2, 3 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Chung et al. as applied to claims 1, 4 and 18 above, and further in view of U.S. Patent Application Publication No. 2019/0054471 to Williams et al.
I.) Regarding applicant’s claim 2, as noted above Chung et al. anticipates claim 1 from which claim 2 depends.
Claim 2 recites that the bay is configured to cool at least part of the fluid container.
Chung et al. does not teach the bay is configured to cool at least part of the fluid container.
Williams et al. is directed to a technology that particularly relates to microfluidic systems that carry out PCR on multiple samples of nucleotides of interest within microfluidic channels, and detect those nucleotides. (Abstract).
Williams et al. teaches a rack 970 that receives sample holders 972 and teaches heating or cooling the rack as illustrated in Fig. 1B.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Chung to provide for the loading part (“bay”) to be configured to cool at least part of the fluid container as taught by Williams et al. for purposes of carrying out sample preparation on biological samples that are sensitive to temperature variations.
Therefore, Chung et al. in view of Williams et al. renders claim 2 obvious.
II.) Regarding applicant’s claim 3, as noted above Chung et al. in view of Williams et al. renders claim 2 obvious from which claim 3 depends.
Claim 3 recites that the fluid container is front-loaded into the bay.
Chung et al teaches “One side of the fixture 140 may be provided with a loading part (not shown) that is extended and bent, so that the microfluidic control chip 200 is placed on the loading part. Referring to FIG. 2, one side of the fixture 140 is provided with a loading part that is extended and bent downward, and then, bent again and extended in parallel to the lower surface of the microfluidic control chip 200, so that the microfluidic control chip 200 is placed on the loading part.” [0065].
As shown in Fig. 2 the fixture 140 in Chung et al. is a bay that receives the microfluidic chip 200 from the front.
Therefore, Chung et al. in view of Williams et al. renders claim 3 obvious.
III.) Regarding applicant’s claim 19, as noted above Chung et al. renders claim 18 obvious from which claim 19 depends.
Claim 19 recites that the bay is configured to cool at least part of the fluid container.
Chung et al. does not teach the bay is configured to cool at least part of the fluid container.
Williams et al. is directed to a technology that particularly relates to microfluidic systems that carry out PCR on multiple samples of nucleotides of interest within microfluidic channels, and detect those nucleotides. (Abstract).
Williams et al. teaches a rack 970 that receives sample holders 972 and teaches heating or cooling the rack as illustrated in Fig. 1B.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Chung to provide for the loading part (“bay”) to be configured to cool at least part of the fluid container as taught by Williams et al. for purposes of carrying out sample preparation on biological samples that are sensitive to temperature variations.
Therefore, Chung et al. in view of Williams et al. renders claim 19 obvious.
5. Claims 22 and 23 are rejected under 35 USC 103 in view of Chung et al. as applied to claim 21 above and further in view of U.S. Patent Application Publication No. 2006/0233670 to Lehto.
I.) Regarding applicant’s claim 22, as noted above Chung et al. renders claim 21 obvious from which claim 22 depends.
Claim 22 recites that the at least one reagent is polymerase chain reaction (PCR) reagents.
Chung et al. does not teach that the at least one reagent is polymerase chain reaction (PCR) reagents.
Lehto teaches conducting a polymerase chain reaction in a microfluidic device as shown in Fig. 52 in which PCR is provided in well 426.
It would have been obvious to one of ordinary skill in the art to modify Chung et al. to dispense the fluids, including PCR reagents into a microfluidic device as taught by Lehto to conduct PCR reactions.
Therefore, Chung et al. in view of Lehto renders claim 22 obvious.
II.) Regarding applicant’s claim 23, as noted above Chung et al. in view of Lehto renders claim 22 obvious from which claim 22 depends.
Claim 23 recites that the polymerase chain reaction (PCR) reagents are in an aqueous solution with a volume of at least 200 microliters (µL).
As noted above, it would have been obvious to one of ordinary skill in the art to modify Chung et al. to dispense the fluids, including PCR reagents into a microfluidic device as taught by Lehto to conduct PCR reactions.
it would have been obvious to one of ordinary skill in the art to modify Chung et al. in view of Lehto to scale the elements of the system up or down as desired to process any volumes of fluids, including providing at least 200 microliters of reagents.
Therefore, Chung et al. in view of Lehto renders claim 23 obvious.
Response to Arguments
Applicant’s arguments with respect to claims 18-26 and 28-30 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
As to the system claims, while applicant argues that Chung does not teach or suggest flowing of a fluid from a fluid container and into the at least one needle and into a manifold, the structural elements of Chung et al. can (are configured) to flow fluid from the chambers 210 into the manifold 130 through the needles 160 as noted above.
Conclusion
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/M.S.G./Examiner, Art Unit 1798
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798