DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 27 October 2025 has been entered.
Information Disclosure Statement
The IDS filed 01 October 2025 has been considered. The U.S. Pat. Publication references listed (cite nos. 1 and 2) have been “lined out” because they were previously listed in the IDS filed 10 January 2024. All references have been considered.
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 21, 23, 24, 26, 27, 30, 32, 34-37 and 39-42 are rejected under 35 U.S.C. 103 as being unpatentable over Ririe (US 20100105029) in view of Wegener (US 20170204371).
With respect to claims 21 and 41, Ririe discloses a reader (Figure 8:800) configured to receive a microfluidic device (Figure 1:10). Ririe states in paragraph [0041] that the reader includes at least one valve actuator (“the bladder assembly may have additional pneumatic actuators, such as bladders or pneumatically-driven pistons, corresponding to various channels of pouch 10. When activated, these additional pneumatic actuators form pinch valves to pinch off and close the corresponding channels”) to close a valve (Figure 1:16, 36) of the microfluidic device. Furthermore, the reader includes a heater element (Figure 8:886, 888) configured to apply localized heating to a region of the microfluidic device. The reader additionally includes a plunger actuator (Figure 8:869) configured to push/pull the plungers (Figure 1:67-69) of the microfluidic device, as well as a detector (Figure 8:896) configured to provide measurement values that indicate a presence or absence of a target within a sample. Ririe, however, does not expressly state that the plunger actuator is configured to bidirectionally actuate the plunger of the pump. Ririe teaches the plunger is configured to drive a liquid reagent from a pumping chamber of the pump into the microfluidic device, but does not clearly state that air is withdrawn from the microfluidic device into the pumping chamber and then driven from the pumping chamber back into the microfluidic device.
Wegener discloses a microfluidic device comprising a plurality of valves (Figure 2:78, 80, 82, 84, 86) operated by a plurality of corresponding valve actuators. A bidirectional pump (Figure 2:28) having a plunger and a pump actuator is configured as a syringe is used to transfer fluid through the microfluidic device. Wegener shows how the plunger is depressed to drive a liquid reagent from the pump’s pumping chamber into the microfluidic device. See, for example, Figs. 11-18. Wegener further shows how the plunger moves in a reverse direction to withdraw air from the microfluidic device into the pumping chamber. See Fig. 4. The air captured in the pumping chamber may then be ejected and driven into the microfluidic device to cause reagents and fluids to move to a desired location. See Fig. 5 and paragraph [0037].
Before the effective filing date of the claimed invention, it would have been obvious to ensure that the Ririe plunger actuator is configured to bidirectionally actuate a plunger of the pump. Wegener teaches that repeated upward and downward strokes of a plunger-activated pump allow one to continuously pump fluid through a microfluidic system at different speeds over time. By selectively opening and closing valves, fluid is transferred to different processing chambers when reagents and air are pressurized through the operation of the plunger. Wegener further shows how this can be advantageous over a single-use pump characterized by only a single downward translation of a plunger.
With respect to claims 23, 26 and 27, Ririe and Wegener disclose the combination as described above. Ririe further teaches that a control element (Figure 8:894) is used to initiate an assay in the microfluidic device and control a function of the microfluidic device. For example, Ririe teaches that the control element regulates valve configuration, heating, pumping and optical monitoring.
With respect to claim 24, Ririe and Wegener disclose the combination as described above. Ririe states in paragraph [0037] that the detector comprises fluorescence detection optics.
With respect to claim 30, Ririe and Wegener disclose the combination as described above. Ririe teaches that the heater element is configured to conduct PCR, which requires an annealing temperature between 55-65°C.
With respect to claim 32, Ririe and Wegener disclose the combination as described above. Although Ririe does not expressly state what force is applied by the valve actuator, it would have been obvious to consider different values, including between 6 to 8 N. Those of ordinary skill would understand that enough force must be applied in order to fully close a valve and/or to ensure that sufficient pumping and flow rate is produced. Those of ordinary skill would also understand that too much force would potentially damage the microfluidic device. Accordingly, it would be obvious to select an optimum value through routine experimentation. See MPEP 2144.05.
With respect to claims 34 and 35, Ririe and Wegener disclose the combination as described above. Ririe further states that the microfluidic chip includes an inlet port (Figure 1:12) configured to receive a sample, a first reaction chamber (Figure 1:20) fluidically coupled to the inlet, and a first pump (Figure 6:268a) coupled to the inlet port, wherein the first pump is configured to move fluid from the inlet port to the first reaction chamber and from the first pump to the inlet port. A second pump (Figure 1:67) is fluidically coupled to a mixing chamber (Figure 1:58), a metering channel (Figure 1:38) is fluidically coupled to the first reaction chamber and to the mixing chamber, and one or more second reaction chambers (Figure 1:60, 80) is fluidically coupled to the mixing chamber.
In the alternative, it is noted that the microfluidic device is not part of the claimed “reader”, but rather is a feature that is inserted into and used in combination with the claimed reader. Accordingly, the features that define the microfluidic device do not define the structure of the reader itself and therefore are afforded reduced patentable weight.
With respect to claims 36 and 37, Ririe and Wegener disclose the combination as described above. Although it is unclear if Ririe teaches the required flow path order of claim 36 or a heated first reaction chamber as required by claim 37, it would have been obvious to rearrange the flow channels, chambers and heaters disclosed by Ririe to produce a variety of configurations. A mere rearrangement of parts that produces a predictable effect is considered to be prima facie obvious. See MPEP 2144.04. Those of ordinary skill would have understood the benefit of sequentially processing a sample under different conditions in first and second reaction chambers, as well as understood that many reactions require an elevated temperature produced by a heater element.
With respect to claim 39, Ririe and Wegener disclose the combination as described above. Ririe shows in Figs. 6 and 8 that the first pump is coupled to the plunger actuator, and that the valves 16, 36 are connected to the valve actuator.
With respect to claim 40, Ririe and Wegener disclose the combination as described above. Ririe teaches that the detector is configured to detect the reaction product in the one or more second reaction chambers 60, 80.
With respect to claim 42, Ririe and Wegener disclose the combination as described above. As previously discussed, Ririe shows a plurality of pumps 67, 68, 69 that are each configured to transfer reagents through the microfluidic device. Wegener additionally teaches that the first bidirectional pump 28 is operated in cooperation with a second bidirectional pump 30 having a second plunger.
Claims 22 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Ririe (US 20100105029) in view of Wegener (US 20170204371)as applied to claim 21, and further in view of Besemer (US 6114122).
With respect to claim 22, Ririe and Wegener disclose the combination as described above, however do not appear to teach that the reader includes a pin configured to engage an alignment hole of the microfluidic device.
Besemer discloses a reader (Figure 3A:300) configured to receive a cartridge (Figure 1:100). Besemer teaches that the reader includes a plurality of pins (Figure 3A:352, 354) that correspond to alignment holes (Figure 1:116, 118) of the microfluidic device. This is taught in column 4, lines 16-67.
Before the effective filing date of the claimed invention, it would have been obvious to provide the Ririe reader with pins configured to interact with alignment holes disposed on the microfluidic cartridge. Besemer teaches that this is an effective way to ensure that the cartridge is properly aligned when it is inserted in to the reader (“The cartridge also typically includes alignment structures, e.g., alignment pins, bores, and/or an asymmetrical shape to ensure correct insertion and/or alignment of the cartridge in the assembly devices, fluidics stations, and reader devices”).
With respect to claim 31, Ririe, Wegener and Besemer disclose the combination as described above. Besemer further states in claim 29 that piezoelectric elements are useful when used in mixing systems to agitate a sample in a microfluidic environment.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Ririe (US 20100105029) in view of Wegener (US 20170204371) as applied to claim 21, and further in view of Kayyem (US 20080202927) and Nielsen (US 20130115607).
Ririe and Wegener disclose the combination as described above. Ririe further teaches that the microfluidic device includes a cap (Figure 1:90), but does not appear to teach a cap position detection component for detecting cap leaks.
Kayyem discloses a reader (Figure 4E, 4F, 9) configured to receive a microfluidic device. Kayyem teaches in paragraphs [0031], [0320] and [0350] that cap position detection components are provided on the microfluidic devices for detecting cap leaks.
Nielsen discloses a reader (Figure 1:100) configured to receive a microfluidic device. Nielsen teaches in paragraphs [0090] and [0249] that cap position detection components are provided on the microfluidic devices for detecting cap leaks.
Before the effective filing date of the claimed invention, it would have been obvious to provide the Ririe system with means for detecting leaks from the microfluidic device, including leaks originating at the cap. Kayyem and Nielsen are evidence that leak detectors (e.g., pressure sensors) are commonly used to ensure that microfluidic devices are processed properly during automatic detection within a reader module.
Claims 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Ririe (US 20100105029) in view of Wegener (US 20170204371) as applied to claim 21, and further in view of Johnson (US 9260693).
Ririe and Wegener disclose the combination as described above. Ririe further teaches that the reader includes a magnet actuator (Figure 8:850) configured to manipulate beads located within the microfluidic device. Ririe, however, does not state that the magnet actuator rotates a magnet of the microfluidic device.
Johnson discloses a microfluidic device comprising a magnet provided in a mixing chamber or a reaction chamber. Johnson teaches in column 12, line 31 to column 13, line 9 that a magnet actuator is configured to rotate the magnet (“a rotating magnet may be brought close to a chamber containing a conventional magnetic stir bar, causing that stir bar to rotate and stir or mix the suspension in that chamber”).
Before the effective filing date of the claimed invention, it would have been obvious to provide the Ririe reader with a magnet actuator configured to rotate a magnet within the microfluidic device. Johnson teaches that would allow for effective mixing of reagents in a mixing chamber or reaction chamber. Those of ordinary skill would have recognized that Ririe would be interested in noninvasive mixing means to prepare the nucleic acid sample for amplification, and would have understood that the existing Ririe magnet actuator could be adapted for rotational movement with minimal modification.
Response to Arguments
In response to Applicant’s amendment filed 27 October 2025, the previous rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Ririe with Wegener.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Hammes (US 20200009549) and Bargh (US 20060097013) references teach the state of the art regarding microfluidic devices in communication with a bidirectional pump.
This is a non-final rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799