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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/3/24 and 2/29/24 is being considered by the examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 1-16 are pending and are examined.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 4, 5, 6, 7, 8, 11, 12, 13, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kinahan (US Pub 2016/0121329; already of record on the IDS received 1/3/2024).
Regarding Claim 1, Kinahan teaches a microfluidic device (Fig. 2, [0090] and [0091], Figs. 3 and 4, [0099]-[0106]) comprising:
a feed channel configured to guide a liquid, wherein the feed channel leads into a channel interface (first branch 310A, liquid 214, liquid 325, 300 for channel interface);
a first discharge channel configured to additionally guide the liquid (first fluid channel 211, downstream 311; liquid 214, liquid 325),
wherein the first discharge channel is fluidically connected to the feed channel by means way of the channel interface (fluid communication is between the feed channel and channel interface);
a valve pre-channel also configured to additionally guide the liquid (fluid channel 212 in front of the valve 220, second branch 310B), wherein the valve pre-channel (fluid channel 212, second branch 310B) is fluidically connected to the feed channel by way of the channel interface; and
a valve (valve 220, valve 301), which is disposed between the valve pre-channel (fluid channel 212, second branch 310B) and a second discharge channel (see channel to chamber, unpressurized reservoir 313)
wherein when the device is in the ready-for-operation state, the valve pre-channel comprises a gas volume for shielding the valve (through hole 115/126, valve 301) from the liquid (see fluid spacer 213 and [0090] and [0091] or gas pocket 327 in the channel, second branch 310B. See also [0102]).
Regarding Claim 3, Kinahan teaches the microfluidic device according to claim 1, wherein the valve is designed to isolate the valve pre-channel from the second discharge channel ([0090] FIG. 2 shows such an example of a portion of a microfluidic device 200 comprising a first valve 210 in fluid communication with an actuation member 220, which may be provided by a second valve. Each of the first and second valves is located in a fluid channel 211, 212. The first fluid channel 211 provides a fluid spacer 213 provided upstream of the first valve 210.).
Regarding Claim 4, Kinahan teaches the microfluidic device according to claim 1, wherein the valve pre-channel is disposed substantially perpendicular to the feed channel and/or to the first discharge channel ([0090] See Fig. 2A, FIG. 2 shows such an example of a portion of a microfluidic device 200 comprising a first valve 210 in fluid communication with an actuation member 220, which may be provided by a second valve. Each of the first and second valves is located in a fluid channel 211, 212. The first fluid channel 211 provides a fluid spacer 213 provided upstream of the first valve 210.).
Regarding Claim 5, Kinahan teaches the microfluidic device according to claim 1, wherein the valve pre-channel is hydrophobic and the feed channel and/or the first discharge channel is hydrophilic ([0032] In certain configurations a multi-layer functional film configuration may be utilised to fabricate a valve. Such a multi-layer construct may incorporate individual layers with different properties. For example a first layer may be hydrophobic whereas a second layer is hydrophilic.).
Regarding Claim 6, Kinahan teaches the microfluidic device according to claim 1, wherein the device is designed as a pressure-based system ([0066] FIG. 11A shows an example of an arrangement configured to provide an increased pressure source within a microfluidic network).
Regarding Claim 7, Kinahan teaches the microfluidic device according to claim 1, wherein the valve is membrane-based (dissolvable valve membrane. See Abstract).
Regarding Claim 8, Kinahan teaches the microfluidic device according to claim 1, wherein the valve comprises an actuation channel configured for the controlled deflection of a membrane into a valve recess ([0078] FIG. 17 is an example of an integrated fluidic network including the following network functions: sequential release (similar to FIG. 2A), parallel actuation type 1 similar to FIG. 2C), parallel actuation type 2 (similar to FIG. 2D), AND condition actuation similar to FIG. 2E, co-located control/release valves (similar to FIG. 5B).).
Regarding Claim 11, Kinahan teaches a method for operating a microfluidic device according to claim 1, wherein the method comprises the following steps: closing the valve; and introducing a liquid into the feed channel, wherein the liquid is held by the valve due to the gas volume ([0144] As shown in FIG. 12A, embedding the valve assembly within the channel of the microfluidic device creates a barrier between the two regions of the channel; the tacky nature of the PSAs allows for closing off of individual micro-channels by simply sticking the tab that forms the valve assembly into the recess 204 that is formed within the microfluidic device to seat the valve. Once located, the through hole of the valve remains isolated; the valve is essentially in a “closed state” until liquids come into contact with the dissolvable film surface. Once liquids are pumped to the interface, after a determined period of time the film liquefies and the valve is in an “open state”, further pumping will propel liquids through the valve site.).
Regarding Claim 12, Kinahan teaches the method according to claim 11, wherein; during the step of closing, a pressure is applied to a membrane of the valve in order to close the valve ([0101] The second valve 301 which serves as the actuation member is also provided initially as a gas-tight barrier and may be considered the control valve. In this example this second valve also comprises a sacrificial membrane which dissolves on contact with a liquid but it will be appreciated that this type of sacrificial valve is not necessary for the control valve. Other actuation techniques could also be employed—for example the valve could simply rupture on increasing the pressure applied to the valve.).
Regarding Claim 13, Kinahan teaches the method according to claim 11, wherein during the step of introduction, a pressure is applied to a storage chamber storing the liquid in order to introduce the liquid into the feed channel ([0102] When both valves 300, 301 are closed a gas pocket 327 is provided immediately upstream from the first valve 300 and prevents liquid 325 from a fluid reservoir 326 coming into contact with the sacrificial membrane of the first valve 300. The gas pocket 327 extends through the first and second branches 310A, 310B and as such is in intimate contact with each of the first and second valves.).
Regarding Claim 14, Kinahan teaches the method according to claim 11, further comprising: discharging the liquid via the first discharge channel, wherein the gas volume is compressed during the step of introduction and expanded during the step of discharging ([0014] When the valves are provided in a normally closed configuration a liquid, the working liquid, can be compressed into a pneumatic chamber/microchannel upstream of the release valve but, under normal operating conditions, cannot reach the release valve as it is separated by a fluid spacer formed by compressed gas. The bringing of the working liquid into contact with the release valve dissolves this valve and opens a path for the working liquid into another microchannel of the microfluidic network.)
Regarding Claim 15, Kinahan teaches the method according to claim 11, wherein an interface having a shape stabilized by capillary forces is formed in the valve pre- channel between the gas volume and the liquid, which causes a complete displacement of the liquid which penetrated into the valve pre-channel during the step of introduction from the valve pre-channel during the step of discharging ([0015] In certain configurations a channel defining a fluid communication path between the first and second valves is shaped such that the liquid cannot travel out the control valve. This effect can also be incorporated through blocking the channel defining the fluid communication path between the first and second valves using a gas permeable, but liquid impermeable membrane.).
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.
Claims 2, 9, 10, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kinahan (US Pub 2016/0121329; already of record on the IDS received 1/3/2024).
Regarding Claim 2, Kinahan teaches the microfluidic device according to claim 1.
Kinahan is silent to a width of the valve pre-channel is less than or equal to 1.5 times the capillary length of a liquid located in the device.
Regarding the width of the valve pre-channel, a particular parameter can be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, and the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation (see MPEP 2144.05.II.B.). There is no evidence indicating that width of the valve pre-channel is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the device such that the width of the valve pre-channel is less than or equal to 1.5 times the capillary length of a liquid located in the device of Kinahan, to allow for a decreased flow rate and velocity in the pre-channel.
Regarding Claim 9, Kinahan teaches the microfluidic device according to claim 1.
Kinahan is silent to the valve pre-channel has a length of 0.5 mm to 10 mm and/or a cross-section of 100 x 100 µm2 to 3 x 3 mm2 and/or a volume of 100 nL to 5 µL.
A microfluidic device has small (microliters or less) volumes in its channels. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the valve pre-channel to have a volume of 100 nL to 5 uL which is a standard volume for a channel in a microfluidic device.
Regarding Claim 10, Kinahan teaches the microfluidic device of claim 1.
Kinahan is silent to a further valve pre-channel which is fluidically connected to a further feed channel and/or a further first discharge channel via a further channel interface, wherein the further valve pre-channel is disposed between a further valve and the further channel interface, and wherein the further valve pre-channel comprises a gas volume for shielding the further valve from the liquid when the device is in the ready-for-operation state.
Regarding an additional valve pre-channel and a further feed channel that are fluidically connected, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.). See 2144.04 VI. B.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a further valve pre-channel and a further feed channel that are fluidically connected wherein the further valve pre-channel is disposed between a further valve and the further channel interface, and wherein the further valve pre-channel comprises a gas volume for shielding the further valve from the liquid when the device is in the ready-for-operation state in the device of Kinahan, for further sample processing or simultaneous processing of different samples.
Regarding Claim 16, Kinahan teaches the microfluidic device according to claim 1.
Kinahan is silent to a maximum lateral expansion of a cross-sectional area of the valve pre-channel is less than the capillary length of a liquid located in the feed channel.
Regarding the cross-sectional area of the valve pre-channel, a particular parameter can be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, and the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation (see MPEP 2144.05.II.B.). There is no evidence indicating that width of the valve pre-channel is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the device of Kinahan such that a maximum lateral expansion of a cross-sectional area of the valve pre-channel is less than the capillary length of a liquid located in the feed channel to prevent increased fluidic resistance which can impede the flow rate.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-5.
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/JB/
/JOHN MCGUIRK/Examiner, Art Unit 1798
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