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 1 – 9 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.
Claim 1 recites the limitation "the buffer channel" in line 9. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the examiner interprets “the buffer channel” to mean “each buffer channel.”
Claim 1 recites the limitation "the pop-up blister" in line 9. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the examiner interprets “the pop-up blister” to mean “each segmented buffer channel.”
Claim 1 recites the limitation "the pop-up valve" in line 17. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the examiner interprets “the pop-up valve” to mean “each pop-up valve.”
Claims 2 – 9 are rejected under 35 U.S.C. 112(b) due to their dependence on claim 1.
Claim 7 recites the limitation "the pop-up valve" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the examiner interprets “the pop-up valve” to mean “each of the three pop-up valves.”
Claim 8 is rejected under 35 U.S.C. 112(b) due to their dependence on claim 1.
Claim 8 recites the limitation "the pop-up valve" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the examiner interprets “the pop-up valve” to mean “each of the three pop-up valves.”
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.
Claims 1, 2, 4 – 6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Kayyem et al (US 20160129437 A1) in view of Eberhart et al (US 20150024436 A1).
With regards to claim 1, Kayyem et al teaches;
The claimed “a microfluidic device” has been read on the taught ([0096], “In general, liquid samples are contained within a microfluidic device…”);
The claimed device comprising “a feeder layer” wherein “the feeder layer is provided with a plurality of main channels and […] blister openings” has been read on the taught ([0111], “The sample preparation module 70 includes various wells, inlet and outlet ports, fluid channels, mixing mechanisms, valves, and other components…”; [0113], “A plurality of deformable compartments (or blisters) […] are supported on top of the substrate sample preparation module 70.”; Sample preparation module 70 reads on a feeder layer. Blisters on top of sample preparation module 70, combined with inlets, read on blister openings.);
Regarding the limitation of specifically “three blister openings”, this is held to be mere duplication of parts. According to MPEP 2144.04(VI)(B), duplication of parts has no patentable significance unless a new and unexpected result is produced; please see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
The claimed device comprising “a buffer layer,” wherein “the buffer layer is provided with segmented buffer channels,” and wherein “the buffer channel is communicated with the main channel” has been read on the taught ([0167], “The top plate 241 further includes a rehydration (elution) buffer compartment 276 having an inlet port 278 that is in fluid communication with the second outlet port 188 of the sample preparation module 70... In various embodiments, top plate 241 includes a connecting passage 274 between the detection buffer compartment 280 and the rehydration buffer compartment 276.”; The buffer compartment and connecting passage reads on a segmented buffer channel.);
The claimed device having “a pneumatic layer” has been read on the taught ([0259], “A pneumatic connector 518 is attached to pneumatic ports 519a, 519b of the cover plate 550. The pneumatic connector 518 provides a connection between the pressure source, e.g., pump 458, and the cartridge 10 via pump port 104…”; The pneumatic connector and ports reads on a pneumatic layer.);
“A pump connected to an inlet, and configured to inject a lysate sample into a main channel” has been read on the taught ([0154], “The pump port 104 is connected, via a pressure conduit 106 to the sample well 78 so that pressure applied at the pump port 104 will pressurize the sample well 78 to motivate the contents of the sample well 78 out of the well.”). The language of “a lysate sample” describes the intended use of the device, and has been given the appropriate patentable weight.
The claimed wherein “the pop-up blister is connected to an inlet of each segmented buffer channel” and “the pop-up blister is arranged at the top of the feeder layer and is communicated with the inlet of each segmented buffer channel after passing through the blister opening” has been read on the taught ([0113], “A plurality of deformable compartments (or blisters) […] are supported on top of the substrate sample preparation module 70.”);
The claimed “each pop-up blister is filled with different type of buffer solutions, and these buffer solutions comprise a magnetic binding buffer solution, a washing buffer solution, and an elution buffer solution” has been read on the taught ([0097], “…a sample preparation module positioned above the substrate, allows for specific addition of buffers and other reagents such as wash buffers…”; [0136], “…the deformable compartment 36a contains a binding buffer to facilitate the binding of target capture beads, such as magnetic beads…”; [0143], “…the deformable compartment 40a contains an elution buffer.”);
Kayyem et al additionally teaches a magnet, as read on the taught ([0356], “…the cartridge magnet assembly 552 is again deployed […] to attract and retain (immobilize) the magnetic beads).
However, Kayyem et al does not explicitly disclose wherein the feeder layer, the buffer layer, and the pneumatic layer are stacked in sequence and sealed; wherein an electromagnetic plate is arranged between the buffer layer and the pneumatic layer; wherein each segmented buffer channel is provided with a plurality of subchannels, and each segmented buffer channel corresponds to one pop-up blister; wherein each segmented buffer channel is provided with a plurality of convergence nodes, a pop-up valve is arranged at each convergence node, and the pop-up valve is pneumatically controlled by the pneumatic layer; and wherein the pump is a syringe pump.
In the analogous art of microfluidic devices, Eberhart et al teaches;
The claimed “a syringe pump” has been read on the taught ([0246], “…a fluidics system incorporating a syringe pump for accurately metering volumes…”);
The claimed “an electromagnet” has been read on the taught ([0273], “…the presence of an actuator that applies and retracts a rare-earth magnet to control the movement of magnetically responsive (e.g., magnetic or paramagnetic) particles can be eliminated by using an electromagnet…”);
Eberhart et al additionally teaches a pneumatic layer and wherein “the pop-up valve is pneumatically controlled by the pneumatic layer”, as read on the taught ([0104], “…the sample cartridge comprises a fluidic chip that comprises a fluidics layer comprising fluidic channels, an actuation layer comprising actuation channels and an elastomer layer sandwiched between them. The chip can include valves and pumps actuated by the actuation layer.”; [0122], “The one or more valves can be pneumatically-actuated valves, such as actuated with the aid of positive pressure or negative pressure (vacuum).”);
Eberhart further teaches that the microfluidic cartridge may be sealed, as read on the taught ([0106], “Accordingly, the cassette is configured to prevent leakage of the reagents from the cassette, or of mixture of the reagents until desired. Such a configuration is useful for shipping or otherwise transporting reagents in isolation.”);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microfluidic device of Kayyem et al with the teachings of Eberhart et al, for the benefit of creating an improved system which can introduce accurate volumes of fluid using a syringe pump and which does not require an actuator to physically move a magnet ([0246], “…a fluidics system incorporating a syringe pump for accurately metering volumes…”; [0273], “…the presence of an actuator that applies and retracts a rare-earth magnet to control the movement of magnetically responsive (e.g., magnetic or paramagnetic) particles can be eliminated by using an electromagnet…”).
Regarding the limitation “wherein the feeder layer, the buffer layer, and the pneumatic layer are stacked in sequence,” this is held to be rearrangement of parts and a matter of obvious engineering choice. Eberhart et al teaches a single fluidics layer with a pneumatic layer at the bottom of the stack. In view of Kayyem et al’s disclosure of a multilayer multifluidic device, one of ordinary skill in the art would arrive at a teaching of an inlet layer, a routing layer with valves, and a pneumatic layer to operate the valves.
Regarding the limitation “wherein an electromagnetic plate is arranged between the buffer layer and the pneumatic layer,” according to MPEP 2144.04(VI)(C), rearrangement of parts may be prima facie obvious when shifting the position of the components does not modify the operation of the device. Eberhart et al specifies that the magnet should be adjacent to the chamber containing the magnetic beads (see [0192]). Further arrangements of the electromagnet plate are held to be mere rearrangement of parts obvious to one of ordinary skill in the art.
Regarding the limitations “wherein each segmented buffer channel is provided with a plurality of subchannels, and each segmented buffer channel corresponds to one pop-up blister; wherein each segmented buffer channel is provided with a plurality of convergence nodes, and a pop-up valve is arranged at each convergence node,” this is held to be a rearrangement of parts that would be obvious to one of ordinary skill in the art.
Taken together, the device of claim 1 would have been obvious to one of ordinary skill in the art in light of the teachings of Kayyem et al in view of Eberhart et al.
With regards to claim 2, the device of claim 1 is obvious over Kayyem et al in view of Eberhart et al.
The limitation of “wherein the feeder layer, the buffer layer, and the pneumatic layer each have a length of 10 cm and a thickness of 1 mm” relates exclusively to the dimensions and proportions of the device. According to MPEP 2144.04(IV)(A), if a device with the claimed dimensions would not perform differently from the prior art device, then the claimed device was not patentably distinct from the prior art device; please see In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). As the instant specification does not disclose any unexpected results from the recited dimensions, the device of claim 2 is obvious over the prior art of Kayyem et al in view of Eberhart et al.
With regards to claim 4, the device of claim 1 is obvious over Kayyem et al in view of Eberhart et al.
The limitation of “wherein a pop-up blister containing the magnetic binding buffer solution, a pop-up blister containing the washing buffer solution, and a pop-up blister containing the elution buffer solution are arranged in sequence in a direction from the inlet of the main channel to the outlet of the main channel” relates exclusively to the arrangement of the blisters on the cartridges.
According to MPEP 2144.04(VI)(C), rearrangement of parts may be prima facie obvious when shifting the position of the components does not modify the operation of the device. As the instant specification does not disclose any unexpected results from the recited blister locations, this limitation does not distinguish the current invention over the prior art of Kayyem et al in view of Eberhart et al.
With regards to claims 5 and 6, the device of claim 1 is obvious over Kayyem et al in view of Eberhart et al.
The limitations of “wherein eight main channels are provided in the feeder layer, and each segmented buffer channel includes eight subchannels in the buffer layer” and “wherein each segmented buffer channel is provided with an eight-valve channel separator with three pop-up valves” relate exclusively to the number of components in the device. According to MPEP 2144.04(VI)(B), duplication of parts has no patentable significance unless a new and unexpected result is produced; please see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). As the instant specification does not disclose any unexpected results from the recited number of channels and subchannels, these limitations does not distinguish the invention of claims 5 and 6 over the prior art of Kayyem et al in view of Eberhart et al.
With regards to claim 9, the device of claim 1 is obvious over Kayyem et al in view of Eberhart et al.
The limitation of “wherein the microfluidic device is reusable after washing with a bleaching agent with a concentration of 1% to 2%, and rinsing with double distilled water followed by air-drying” is functional language and has been given the appropriate patentable weight. Please see MPEP 2114(II), and Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). As no structural limitations are given in the limitations of claim 9, this additional limitation does not define the instant application over the prior art of Kayyem et al in view of Eberhart et al.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kayyem et al (US 20160129437 A1) in view of Eberhart et al (US 20150024436 A1) as applied to claim 1 above, and further in view of Chen et al (US 20230294093 A1, effectively filed 18 March 2022).
With regards to claim 3, the device of claim 1 is obvious over Kayyem et al in view of Eberhart et al.
Kayyem et al teaches that a processed sample may exit an outlet for downstream processing (see [0204]), but neither Kayyem et al nor Eberhart et al explicitly discloses a collection device arranged at an outlet of each main channel, wherein the collection device is configured to collect a DNA sample.
In the analogous art of microfluidic systems, Chen et al teaches;
The claimed “wherein a collection device is arranged at an outlet of each main channel” has been read on the taught ([0073], “For example, the output reservoir 336 is configured to capture a sample for analysis and measurement.”);
The claimed “wherein the collection device is configured to collect a DNA sample” has been read on the taught ([0022], “In some embodiments, the system is configured to perform one of: (i) a DNA isolation protocol with an immobilized filter or (ii) a DNA isolation protocol with magnetic beads.”);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microfluidic device of Kayyem et al in view of Eberhart et al with the output reservoir as taught by Chen et al. According to MPEP 2143(I)(C), use of a known technique to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, the prior art of Kayyem et al in view of Eberhart et al teaches a “base” device upon which the claimed invention can be seen as an improvement. The prior art of Chen et al teaches a comparable microfluidic device that has been improved with a collection device in the same way as the claimed invention. One of ordinary skill in the art could have applied the known “improvement” technique in the same way to the “base” device, for the predictable result of capturing a DNA sample after it exits the device.
Claim 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kayyem et al (US 20160129437 A1) in view of Eberhart et al (US 20150024436 A1) as applied to claim 6 above, and further in view of Ball et al (US 20200038864 A1).
With regards to claim 7, the device of claim 6 is obvious over Kayyem et al in view of Eberhart et al.
However, this combination does not explicitly disclose wherein the pop-up valve is a check valve for limiting fluid entering one subchannel or eight subchannels simultaneously.
In the analogous art of microfluidic systems, Ball et al teaches;
The claimed “wherein the pop-up valve is a check valve for limiting fluid entering one subchannel or eight subchannels simultaneously” has been read on the taught ([0028], “[0028] Fluid flow can be controlled by these check valves.”; [0030], “Any useful network of valves may be employed to produce the desired fluidic network.”).
It would have been obvious to one of ordinary skill in the art to modify the microfluidic devices including pneumatic valves as taught by Kayyem et al in view of Eberhart et al with the specific check valve as taught by Ball et al. According to MPEP 2143(I)(C), use of a known technique to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, the prior art of Kayyem et al in view of Eberhart et al teaches a “base” device upon which the claimed invention can be seen as an improvement. The prior art of Chen et al teaches a comparable microfluidic device that has been improved with a check valve in the same way as the claimed invention. One of ordinary skill in the art could have applied the known “improvement” technique in the same way to the “base” device, for the predictable result of limiting fluid flow according to a desired pattern.
With regards to claim 8, the device of claim 7 is obvious over Kayyem et al in view of Eberhart et al and further in view of Ball et al.
Kayyem et al in view of Eberhart et al does not explicitly disclose wherein
The claimed “wherein the pop-up valve is a T-shaped free-moving polydimethylsiloxane structure” has been read on the taught ([0058], “The present check valves and cartridges can be formed from any useful material. Exemplary materials include […] poly(dimethylsiloxane) (PDMS)…”); Figure 2B and 2C show the free-moving elastomeric pad 220 having an indent to accommodate a ridge. This reads on the pop-up valve being T-shaped).
It would have been obvious to one of ordinary skill in the art to modify the microfluidic devices including pneumatic valves as taught by Kayyem et al in view of Eberhart et al with the specific check valve as taught by Ball et al. According to MPEP 2143(I)(C), use of a known technique to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, the prior art of Kayyem et al in view of Eberhart et al teaches a “base” device upon which the claimed invention can be seen as an improvement. The prior art of Chen et al teaches a comparable microfluidic device that has been improved with a T-shaped pop-up check valve in the same way as the claimed invention. One of ordinary skill in the art could have applied the known “improvement” technique in the same way to the “base” device, for the predictable result of limiting fluid flow according to a desired pattern.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gray et al (US 20140287966 A1) teaches a microfluidic device with multiple main fluidic channels and outlet ports.
O’Connor et al (US 20020166582 A1) teaches a microfluidic device with branched microfluidic channels.
White et al (US 20200023355 A1) teaches a branched microfluidic system with fluid routing designed to control the order in which reagents interact with a sample.
Blackburn (US 20050009101 A1) teaches a reusable microfluidic system.
Stern et al (US 20150258544 A1) teaches a multilayered microfluidic chip with a pneumatic layer.
Taylor et al (US 20160175835 A1) teaches a multilayered fluidic cartridge with blisters and branching channels.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON CLAIRE GERHARD whose telephone number is (571)270-0945. The examiner can normally be reached M-F, 9:00 - 5:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALISON CLAIRE GERHARD/ Examiner, Art Unit 1797 /LYLE ALEXANDER/ Supervisory Patent Examiner, Art Unit 1797