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 .
Remarks
This Office Action fully acknowledges applicant’s remarks filed 07/09/2026. Claims 1-15 remain pending. Claims 1 and 12-15 have been amended.
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.
1. Claims 1-9 and 11 are rejected under 35 USC 103 as being unpatentable over U.S. Patent Application Publication No. 2020/0009559 to Webster in view of U.S. Patent No. 10,184,884 to Anderson et al.
Regarding applicant’s claim 1, Webster teaches a cartridge body 110 may also define a fluidic channel 120 (e.g., microfluidics) in fluid communication with the sample well port 112 and configured to provide a passage for the sample material 102 within the cartridge body 110.
Elements of the cartridge (“microfluidic structure”) of Webster are illustrated and identified by annotated Fig. 2 as follows. These elements are disclosed by Webster at [0037]-[0038]
[AltContent: arrow][AltContent: textbox (Inlet microfluidic
channel)][AltContent: arrow][AltContent: textbox (Outlet port)][AltContent: arrow][AltContent: textbox (Overflow chamber)][AltContent: arrow][AltContent: textbox (Sample chamber)][AltContent: arrow][AltContent: textbox (Inlet port)]
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Webster teaches that the outlet port noted above function as vent that is configured to relieve any pressure from within the fluid reservoir 150 and that the vent 154 may include a hydrophobic material such as a liquid impermeable membrane. (e.g., the sample material 102).
Webster teaches that capillary stops “may” be included and “may” be used to control fluid flow. [0009]
In Fig, 2 the portion connection between the overflow chamber to the inlet microfluidic channel is actually drawn with a smaller diameter than the inlet microfluidic channel.
However, Webster does not specifically teach a capillary break positioned between the inlet microfluidic channel and the overflow chamber, wherein the capillary break comprises a narrowed opening with a smaller width than a width of the inlet microfluidic channel.
Anderson et al. teaches an over-flow tolerant microfluidic structure in the form of an assay cartridge that includes a sample chamber 2710 having a sample introduction port 2720 and an overflow chamber 4742. The sample chamber is connected to a sample conduit for transferring fluids from the sample chamber to other fluidic components in the cartridge, indicating a necessary inlet to which the sample chamber and overflow chamber connect. (column 43, line 25 through column 44, line 53)
Anderson et al. teaches that the ample chamber 2710 has sample introduction port 2720 and is linked to sample conduit 2730 and sample vent port 2740 (through vent conduit 2750) and that a gas -permeable membrane can be between the inlet and vent port. (column 59, lines 19-28) Sample chamber 2710 has sample introduction port 2720 and is linked to sample conduit 2730 and sample vent port 2740. (column 43, lines 30-33)
Anderson et al. further teaches capillary breaks to control flow. (column 59, lines 49-66 and column 61, lines 25-43).
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Webster in view of Anderson et al. to include a capillary break between the inlet microfluidic channel and the overflow chamber that is sized for purposes of controlling the flow into the overflow chamber.
I.) As noted above, Webster in view of Anderson et al. renders all the limitations of claim 1 obvious.
Therefore, Webster in view of Anderson et al. renders claim 1 obvious.
II.) Regarding applicant’s claim 2, as noted above Webster in view of Anderson et al. renders claim 1 obvious from which claim 2 depends.
Claim 2 recites that the overflow chamber is connected upstream of the sample chamber.
As noted above, in Webster the overflow chamber 135 is connected upstream of the sample chamber 150.
Therefore, Webster in view of Anderson et al. renders claim 2 obvious.
III.) Regarding applicant’s claim 3, as noted above Webster in view of Anderson et al. renders claim 1 obvious from which claim 3 depends.
Claim 3 recites that the capillary break prevents liquid from passing up to a break pressure and wherein the gas-permeable liquid barrier allows gas to flow out of the sample chamber at a pressure lower than the break pressure, but prevents liquid from flowing out of the sample chamber at the break pressure.
In Webster in view of Anderson et al. it would have been obvious to configure the capillary break to allow gas to flow out of the sample chamber at a pressure lower than the break pressure, but prevents liquid from flowing out of the sample chamber at the break pressure, in view of Webster teaching the hydrophobic membrane 154 allows air or gases, but not fluids, to escape. [0037]
Therefore, Webster in view of Anderson et al. renders claim 3 obvious.
IV.) Regarding applicant’s claim 4, as noted above Webster in view of Anderson et al. renders claim 1 obvious from which claim 4 depends.
Claim 4 recites that he gas- permeable liquid barrier comprises a gas-permeable liquid-impermeable membrane, a pore having a hydrophobic surface, a labyrinth seal, a dry hydrogel precursor, or a second capillary break having a smaller width than the capillary break between the inlet microfluidic channel and the overflow chamber.
As noted above, Webster teaches a hydrophobic membrane.
Therefore, Webster in view of Anderson et al. renders claim 3 obvious.
V.) Regarding applicant’s claim 5, as noted above Webster in view of Anderson et al. renders claim 1 obvious from which claim 5 depends.
Claim 5 recites that the narrowed opening has a width from 2 pm to 20 pm.
Neither Webster nor Anderson et al. teach sizes for the capillary structures.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to conduct routine engineering optimization experimentation to determine a suitable width of the capillary breaks based on the overall size of the cartridge and fluid pressures used and provide the capillary breaks with a suitable width including a width of from 2 µm to 20 µm.
Therefore, Webster in view of Anderson et al. renders claim 5 obvious.
VI.) Regarding applicant’s claim 6, as noted above Webster in view of Anderson et al. renders claim 1 obvious from which claim 6 depends.
Claim 6 recites a second gas-permeable liquid barrier connected to the overflow chamber and positioned to allow gas to flow out of the overflow chamber.
Webster teaches a gas-permeable membrane connected to the overflow chamber at 137 and positioned to allow gas to flow out of the overflow chamber. [0038]
Therefore, Webster in view of Anderson et al. renders claim 6 obvious.
VII.) Regarding applicant’s claim 7, as noted above Webster in view of Anderson et al. renders claim 1 obvious from which claim 7 depends.
Claim 7 recites that the sample chamber comprises a first fraction chamber, a second fraction chamber upstream of the first fraction chamber, and a microfluidic connection channel connecting the first fraction chamber to the second fraction chamber.
Webster in view of Anderson et al. does not teach that the sample chamber comprises a first fraction chamber, a second fraction chamber upstream of the first fraction chamber, and a microfluidic connection channel connecting the first fraction chamber to the second fraction chamber.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Webster in view of Anderson et al. to include first and second fraction chambers and a microfluidic connection channel connecting the first fraction chamber to the second fraction chamber, since duplication or parts has no patentable significance unless a new and unexpected result is produced. (MPEP 2144.04(VI)(B))
Therefore, Webster in view of Anderson et al. renders claim 7 obvious.
VIII.) Regarding applicant’s claim 8, as noted above Webster in view of Anderson et al. renders claim 1 obvious from which claim 8 depends.
Claim 8 recites a containment chamber connected downstream of the gas-permeable liquid barrier to contain aerosolized material that passes through the gas-permeable liquid barrier.
As noted above, Webster in view of Anderson et al. teaches a gas-permeable membrane at the outlet port, but does not teach a containment chamber connected downstream of the gas-permeable liquid barrier to contain aerosolized material that passes through the gas-permeable liquid barrier.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Webster in view of Anderson et al. to provide a containment chamber connected downstream of the gas-permeable membrane to collect and contain aerosolized material the passes through the gas-permeable membrane for purposes of preventing release of any undesirable aerosolized material.
Therefore, Webster in view of Anderson et al. renders claim 8 obvious.
IX.) Regarding applicant’s claim 9, as noted above Webster in view of Anderson et al. renders claim 1 obvious from which claim 9 depends.
Claim 9 recites that the sample chamber comprises a bubble-excluding region having an area of increased hydrophilicity on an interior surface of the sample chamber compared to surrounding areas of the interior surface.
Webster teaches that at least one surface of the fluidic channel 120 may be made from or coated with hydrophilic material to optimize or control the ability for fluids to flow through the fluidic channel. [0036] such hydrophilic portions structurally read on applicant’s claimed bubble-excluding region.
Therefore, Webster in view of Anderson et al. renders claim 9 obvious.
X.) Regarding applicant’s claim 11, as noted above Webster in view of Anderson et al. anticipates claim 1 from which claim 11 depends.
Claim 11 recites comprising a bubble remover on the inlet microfluidic channel to remove gas bubbles from the liquid before the liquid flows into the sample chamber.
Anderson et al. teaches removing bubbles from the sample material in the sample chamber. (column 43, lines 33-51).
However, Weber in view of Anderson et al does not teach a bubble remover on the inlet microfluidic channel to remove gas bubbles from the liquid before the liquid flows into the sample chamber.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Webster in view of Anderson et al. to include a bubble remover on the inlet microfluidic channel to remove gas bubbles from the liquid before the liquid flows into the sample chamber, for purposes of removing bubbles upstream of the sample chamber so that only liquid enters the sample chamber. Otherwise, the hydrophilic portions of the channel taught above by Webster would exclude/remove bubbles.
Therefore, Webster in view of Anderson et al. renders claim 11 obvious.
2. Claim 10 is rejected under 35 USC 103 as being unpatentable over Webster in view of Anderson et al. in view of U.S. Patent Application Publication No. 2005/0243647 to Gray et al.
I.) Regarding applicant’s claim 10, as noted above Webster in view of Anderson et al. renders claim 1 obvious from which claim 10 depends.
Claim 10 recites that the inlet microfluidic channel comprises an in-line mixer.
Anderson et al. teaches mixing samples with reagents (column 8, lines 32-41), but Webster in view of Anderson et al. does not teach that the inlet microfluidic channel comprises an in-line mixer.
Gray et al. teaches a mixing canal that includes a hollow through which constituents are passed and mixed and includes, for example, a tortuous or sinuous path, a channel, a mixing channel, and a baffle. [0016]
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Webster in view of Anderson et al. to include an in-line mixer in the inlet channel having baffle structures as taught by Gray et al. to effect mixing of the fluid in the inlet channel.
Therefore, Webster in view of Anderson et al. and Gray et al. renders claim 10 obvious.
3. Claim 12 is rejected under 35 USC 103 as being unpatentable over webster in view of Anderson et al. in view of U.S. Patent No. 7,588,727 to Parng et al.
As noted above, Webster teaches a cartridge body 110 may also define a fluidic channel 120 (e.g., microfluidics) in fluid communication with the sample well port 112 and configured to provide a passage for the sample material 102 within the cartridge body 110.
Elements of the cartridge (“microfluidic structure”) of Webster are illustrated and identified by annotated Fig. 2 above. These elements are disclosed by Webster at [0037]-[0038]
Webster teaches that the outlet port noted above function as vent that is configured to relieve any pressure from within the fluid reservoir 150 and that the vent 154 may include a hydrophobic material such as a liquid (e.g., the sample material 102).
Webster teaches that capillary stops “may” be included and “may” be used to control fluid flow. [0009]
In Fig, 2 the portion connection between the overflow chamber to the inlet microfluidic channel is actually drawn with a smaller diameter than the inlet microfluidic channel.
However, Webster does not specifically teach a capillary break positioned between the inlet microfluidic channel and the overflow chamber, wherein the capillary break comprises a narrowed opening with a smaller width than a width of the inlet microfluidic channel.
Anderson et al. teaches an over-flow tolerant microfluidic structure in the form of an assay cartridge that includes a sample chamber 2710 having a sample introduction port 2720 and an overflow chamber 4742. The sample chamber is connected to a sample conduit for transferring fluids from the sample chamber to other fluidic components in the cartridge, indicating a necessary inlet to which the sample chamber and overflow chamber connect. (column 43, line 25 through column 44, line 53)
Anderson et al. teaches that the ample chamber 2710 has sample introduction port 2720 and is linked to sample conduit 2730 and sample vent port 2740 (through vent conduit 2750) and that a gas -permeable membrane can be between the inlet and vent port. (column 59, lines 19-28) Sample chamber 2710 has sample introduction port 2720 and is linked to sample conduit 2730 and sample vent port 2740. (column 43, lines 30-33)
Anderson et al. further teaches capillary breaks to control flow. (column 59, lines 49-66 and column 61, lines 25-43).
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Webster in view of Anderson et al. to include a capillary break between the inlet microfluidic channel and the overflow chamber that is sized for purposes of controlling the flow into the overflow chamber.
Anderson et al. teaches that heaters may be integrated into the cartridge reader. (column 80, lines 58-61),
However, Webster in view of Anderson et al. does not teach a heater on or embedded in the substrate.
Parng et al. teaches providing heater wires 70 and 80 on a microfluidic substrate to heat microfluidic channels as shown in Figs. 6A and 6B. (column 7, lines 19-26)
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Webster in view of Anderson et al. to include a heater on or embedded in the substrate as taught by Parng et al. for purposes of controlling the temperature of fluid in the cartridge.
Therefore, Webster in view of Anderson et al. and Parng et al. renders claim 12 obvious.
II.) Regarding applicant’s claim 13, as noted above Webster in view of Anderson et al. and Parng et al. renders claim 12 obvious from which claim 13 depends.
Claim 13 recites that the substrate comprises glass, silicon, a printed circuit board, a polyimide film, plastic, metal, sapphire, or a combination thereof.
Anderson et al. teaches that the skilled practitioner will be able to readily select materials suitable for the fabrication of the cartridges of the invention. Suitable materials include glass, ceramics, metals and/or plastics such as acrylic polymers such as Lucite), acetal resins (such as Delrin), polyvinylidene fluoride (PVDF), polyethylene terephthalate (PET), polytetrafluoroethylene (e.g., Teflon), polystyrene, polypropylene, ABS, PEEK and the like. (column 41, lines 31-38)
It would have been obvious to one of ordinary skill in the art before applicant’ effective filing date to make the microfluidic device of Webster in view of Anderson et al. of any suitable material, including the materials taught by Anderson et al.
Therefore, Webster in view of Anderson et al. renders claim 13 obvious.
4. Claim 14 is rejected under 35 USC 103 as being unpatentable over Webster in view of Anderson et al. in view of U.S. Patent No. 7,588,727 to Parng et al.
As noted above, Webster teaches a cartridge body 110 may also define a fluidic channel 120 (e.g., microfluidics) in fluid communication with the sample well port 112 and configured to provide a passage for the sample material 102 within the cartridge body 110.
Elements of the cartridge (“microfluidic structure”) of Webster are illustrated and identified by annotated Fig. 2 above. These elements are disclosed by Webster at [0037]-[0038]
Webster teaches that the outlet port noted above function as vent that is configured to relieve any pressure from within the fluid reservoir 150 and that the vent 154 may include a hydrophobic material such as a liquid (e.g., the sample material 102).
Webster teaches that capillary stops “may” be included and “may” be used to control fluid flow. [0009]
In Fig, 2 the portion connection between the overflow chamber to the inlet microfluidic channel is actually drawn with a smaller diameter than the inlet microfluidic channel.
However, Webster does not specifically teach a capillary break positioned between the inlet microfluidic channel and the overflow chamber, wherein the capillary break comprises a narrowed opening with a smaller width than a width of the inlet microfluidic channel.
Anderson et al. teaches an over-flow tolerant microfluidic structure in the form of an assay cartridge that includes a sample chamber 2710 having a sample introduction port 2720 and an overflow chamber 4742. The sample chamber is connected to a sample conduit for transferring fluids from the sample chamber to other fluidic components in the cartridge, indicating a necessary inlet to which the sample chamber and overflow chamber connect. (column 43, line 25 through column 44, line 53)
Anderson et al. teaches that the ample chamber 2710 has sample introduction port 2720 and is linked to sample conduit 2730 and sample vent port 2740 (through vent conduit 2750) and that a gas -permeable membrane can be between the inlet and vent port. (column 59, lines 19-28) Sample chamber 2710 has sample introduction port 2720 and is linked to sample conduit 2730 and sample vent port 2740. (column 43, lines 30-33)
Anderson et al. further teaches capillary breaks to control flow. (column 59, lines 49-66 and column 61, lines 25-43).
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Webster in view of Anderson et al. to include a capillary break between the inlet microfluidic channel and the overflow chamber that is sized for purposes of controlling the flow into the overflow chamber.
Introducing a liquid into the inlet port would allow the liquid to flow through microfluidic channel and into the sample chamber as well as into the overflow chamber.
Anderson et al. teaches that heaters may be integrated into the cartridge reader. (column 80, lines 58-61),
However, Webster in view of Anderson et al. does not teach a heater on or embedded in the substrate.
Parng et al. teaches providing heater wires 70 and 80 on a microfluidic substrate to heat microfluidic channels as shown in Figs. 6A and 6B. (column 7, lines 19-26)
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Webster in view of Anderson et al. to include a heater on or embedded in the substrate as taught by Parng et al. for purposes of controlling the temperature of fluid in the cartridge.
Therefore, Webster in view of Anderson et al. and Parng et al. renders claim 14 obvious.
5. Claim 15 is rejected under 35 USC 103 as being unpatentable over Webster in view of Anderson et al. Parng et al. as applied to claim 14 above and further in view of U.S. Patent Application Publication No. 2017/0095818 to Liu et al.
I.) Regarding applicant’s claim 15, as noted above Webster in view of Anderson et al. and Parng Gray et al. renders claim 13 obvious from which claim 15 depends.
Claim 15 recites that the liquid comprises a target nucleic acid and a master mix reagent to amplify the target nucleic acid, and wherein the heating is repeated such that the target nucleic acid is amplified via a polymerase chain reaction process.
Webster in view of Anderson et al. and Parng et al. does not teach that the liquid comprises a target nucleic acid and a master mix reagent to amplify the target nucleic acid, and wherein the heating is repeated such that the target nucleic acid is amplified via a polymerase chain reaction process.
Liu et al. teaches using a microfluidic device to amplify a target nucleic acid wherein heating is repeated such that the target nucleic acid is amplified via a polymerase chain reaction process.
It would have been obvious to one of ordinary skill in the art to modify Webster in view of Anderson et al. and Parng et al. to amplify a target nucleic acid wherein heating is repeated such that the target nucleic acid is amplified via a polymerase chain reaction process as taught by Liu et al. for purposes of using the microfluidic device of Anderson et al. as modified by Gray et al. for such use.
Therefore, Webster in view of Anderson et al., Parng et al. and Liu et al. renders claim 15 obvious.
Response to Arguments
Applicant’s arguments with respect to claim 1-15 have been considered but are moot because the new ground of rejection necessitated by applicant’s amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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