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 § 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 4-5, 7-8 and 15-20 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.
On line 8 of claim 4, the phrase “an optional high pressure sensor” is indefinite since it is not clear what constitutes “high” in this phrase. What pressure levels are considered “high” in this phrase?
On line 10 of claim 7, the phrase “an optional low pressure sensor” is indefinite since it is not clear what constitutes “low” in this phrase. What pressure levels are considered “low” in this phrase?
On lines 4-5 of claim 15, the phrase “fluidically connecting a first pressure module to a control layer of said microfluidic device” is indefinite since it is not clear whether this phrase is referring to the first pressure module and the control layer of the microfluidic device recited in claim 1. Since step (a) of claim 15 recites providing a system of claim 1, lines 4-5 of claim 15 should be amended to recite --fluidically connecting the first pressure module to the control layer of said microfluidic device--. On lines 6-7 of claim 15, the phrase “fluidically connecting a second pressure module to a flow layer of said microfluidic device” is indefinite since it is not clear whether this phrase is referring to the second pressure module and the flow layer of the microfluidic device recited in claim 1. Since step (a) of claim 15 recites providing a system of claim 1, lines 6-7 of claim 15 should be amended to recite -- fluidically connecting the second pressure module to the flow layer of said microfluidic device--.
Inventorship
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.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al (US 2017/0095810).
With regards to claim 1, Li et al teach of an integrated system for controlling fluid flow in a microfluidic device (see paragraph 0109 in Li et al where it states “A handheld automated microfluidic liquid handling system is presented that is controlled by a smartphone, which is enabled by combining elastomeric on-chip valves and a compact pneumatic system.”). The integrated system comprises a first pressure module (see reservoir 1 in Figure 13 of Li et al) configured to control pressure within a control layer of a microfluidic device, wherein the control layer comprises one or more valves, and a second pressure module (see reservoir 2 in Figure 13 of Li et al) configured to control pressure within a flow layer of the microfluidic device, wherein the flow layer comprises one or more flow channels, and wherein the one or more valves of the control layer are configured to control flow within at least one of the one or more flow channels of the flow layer. See paragraph 0113 in Li et al where it states:
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and paragraph 0115 in Li et al where it states:
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Also, see paragraph 0136 in Li et al which describes the microfluidic device as comprising a control layer having one or more valves, and a flow layer having one or more channels therein:
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The integrated system further comprises an electronics module configured to transmit and receive one or more signals between the electronics module and one of the first pressure module 1, the second pressure module 2, or both the first and second pressure modules 1, 2. See paragraphs 0127-0128 in Li et al which state:
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The integrated system also comprises a user interface in the form of a Bluetooth enabled Android smartphone which is configured to transmit and receive one or more signals between the user interface and the electronics module. See paragraph 0128 in Li et al provided above, and paragraph 0141 in Li et al which states:
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See Figures 12 and 13, and paragraphs 113, 115, 127-128, 136 and 141 in Li et al cited above.
Li et al fail to teach that the integrated system for controlling fluid flow also comprises a housing configured to house the first pressure module (reservoir 1 in Figure 13), the second pressure module (reservoir 2 in Figure 13), and the electronics module. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place each of the first pressure module (reservoir 1 in Figure 13 of Li et al), the second pressure module (reservoir 2 in Figure 13 of Li et al), and the electronics module of the integrated system for controlling fluid flow in a microfluidic device taught by Li et al into a housing because Li et al teach that improving the sealing of the pneumatic system will improve the overall performance of the system in terms of pressure and power, and a housing for the first pressure module, the second pressure module, and the electronics module of the integrated system taught by Li et al would provide such sealing of these components from the environment thereby making the system more stable and consuming less power (see paragraph 0146 in Li et al).
With regards to claim 2, Li et al teach that the first pressure module (reservoir 1 in Figure 13 of Li et al) is configured to provide pressure to the control layer of the microfluidic device in a range of 10-20 psi, which falls within the range of about 10 to about 100 psi, or greater than about 10 psi. See paragraphs 0112 and 0115 in Li et al.
With regards to claim 3, Li et al teach that the second pressure module (reservoir 2 in Figure 13 of Li et al) is configured to provide pressure to the flow layer of the microfluidic device below 5 psi or 0 to 5 psi, which falls within the range of from about -10 to about 10 psi or about -20 to about 20 psi.
With regards to claim 4, Li et al teach that the first pressure module 1 (reservoir 1 in Figure 13 of Li et al) comprises one or more control valves, a pump configured to provide increased pressure to at least one of the control valves, a vent configured to decrease pressure in the first pressure module 1, and a high pressure sensor configured to provide a pressure reading within the first pressure module 1. See paragraphs 0117-0121 and 0086 in Li et al where it states:
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It is noted that the accumulator recited in claim 4 is optional, and therefore, not required in the system taught by Li et al.
With regards to claim 5, Li et al teach that the one or more control valves of the first pressure module comprise a solenoid valve. See paragraphs 0120-0121 in Li et al.
With regards to claim 6, Li et al teach that the first pressure module 1 is configured to provide positive pressure to the control layer of the microfluidic device. See paragraph 0115 in Li et al where it states “A miniature DC diaphragm pump is used to pump air into Reservoir 1 to generate the primary pressure source for actuating on-chip elastomeric valves”.
With regards to claim 7, Li et al teach that the second pressure module (reservoir 2 in Figure 13 of Li et al) comprises one or more control valves, a pump configured to provide increased pressure to at least one of the control valves (i.e. the pump depicted in Figure 13 of Li et al), a vent configured to decrease pressure in the second pressure module 2, and a low pressure sensor configured to provide a pressure reading within the second pressure module 2. See paragraphs 0122-0126 and 0086 in Li et al where it states:
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It is noted that the accumulator recited in claim 7 is optional, and therefore, not required in the system taught by Li et al. With regards to the vacuum source recited in claim 7 as part of the second pressure module, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a vacuum source in the second pressure module 2 of the system taught by Li et al that is configured to provide decreased pressure to at least one of the flow channels in the flow layer of the microfluidic device because Li et al teach that negative pressure can be generated in the system in a pressure reservoir (see paragraphs 0105-0106 in Li et al), and a vacuum source operates to create negative pressure relative to the surrounding atmosphere.
With regards to claim 8, Li et al teach that the one or more control valves of the second pressure module 2 comprise a solenoid valve. See paragraphs 0124 and 0126 in Li et al.
With regards to claim 9, Li t al teach that the second pressure module 2 is configured to provide positive pressure to the flow layer of the microfluidic device. See paragraph 0126 in Li et al where it states:
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With regards to claim 10, Li et al teach that the electronics module comprises a controller (i.e. a first and a second microcontroller) configured to provide instructions to the first pressure module 1 and the second pressure module 2, a power module comprising a battery pack, and pressure sensors configured to receive real-time pressure data from the first and second pressure modules 1, 2. See paragraphs 0127-0130 in Li et al. It is noted that the driver and the transistor array recited in claim 10 are optional, and therefore, not required in the system taught by Li et al.
With regards to claims 11-12, Li et al fail to teach that the integrated system for controlling fluid flow also comprises a housing configured to house the first pressure module (reservoir 1 in Figure 13), the second pressure module (reservoir 2 in Figure 13), and the electronics module, and that the housing comprises a first port for connecting the first pressure module 1 to the control layer of the microfluidic device, a second port for connecting the second pressure module 2 to the flow layer of the microfluidic device, and a third port for connecting the electronics module to the user interface (i.e. Smartphone). However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place each of the first pressure module (reservoir 1 in Figure 13 of Li et al), the second pressure module (reservoir 2 in Figure 13 of Li et al), and the electronics module of the integrated system for controlling fluid flow in a microfluidic device taught by Li et al into a housing for the reasons set forth above with regards to claim 1, and to provide such first, second and third ports in the housing for making the various connections recited in claims 11 and 12 because connection ports in a housing allow different physical and electronic devices to communicate with one another and share power to run the devices.
With regards to claim 13, Li et al teach that the system comprises a data transmitter configured to transmit or receive data between the user interface (Smartphone) and the electronics module, or between the user interface and a storage medium. See paragraph 0128 in Li et al.
With regards to claim 14, Li et al teach that the system does not include an external pressure source or external pressure regulator since the only components which serve to provide and regulate pressure in the system are the first pressure module (Reservoir 1, P1 in Figure 13 of Li et al) and the second pressure module 2 (Reservoir 2, P2 in Figure 13 of Li et al).
With regards to claim 15, Li et al teach of a method for controlling fluid flow in a microfluidic device comprising providing the system of claim 1 (see the rejection of claim 1 above), fluidically connecting the first pressure module 1 to the control layer of the microfluidic device, fluidically connecting the second pressure module 2 to the flow layer of the microfluidic device, and adjusting a pressure within one or both of the first and second pressure modules to control fluid flow within the flow channels of the microfluidic device. See paragraphs 0115, 0118, 0120-0121, 0123-124 and 0126 in Li et al.
With regards to claim 16, Li et al teach that adjusting the pressure within the first pressure module 1 comprises actuating the one or more valves in the control layer of the microfluidic device. See paragraph 0115 in Li et al.
With regards to claim 17, Li et al teach that adjusting the pressure within the second pressure module 2 comprises flowing a fluid in one or more flow channels of the flow layer in the microfluidic device. See paragraph 0115 in Li et al.
With regards to claim 18, Li et al teach that the first pressure module (reservoir 1 in Figure 13 of Li et al) is configured to provide pressure to the control layer of the microfluidic device in a range of 10-20 psi, which falls within the range of about 10 to about 100 psi. See paragraphs 0112 and 0115 in Li et al. Li et al also teach that the second pressure module (reservoir 2 in Figure 13 of Li et al) is configured to provide pressure to the flow layer of the microfluidic device below 5 psi or 0 to 5 psi, which falls within the range of from about -20 to about 20 psi.
With regards to claim 19, Li et al teach that the first pressure module 1 is configured to provide positive pressure to the control layer of the microfluidic device. See paragraph 0115 in Li et al where it states “A miniature DC diaphragm pump is used to pump air into Reservoir 1 to generate the primary pressure source for actuating on-chip elastomeric valves”. Li et al also teach that the second pressure module 2 is configured to provide positive pressure to the flow layer of the microfluidic device. See paragraph 0126 in Li et al where it states:
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With regards to claim 20, Li et al teach that the method for controlling fluid flow in a microfluidic device further comprises delivering a test sample to one or more of the flow channels in the flow layer of the microfluidic device, and reacting the sample with one or more reagents. See paragraphs 0096, 0102, 0115, 0126 and 0139 in Li et al.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Please make note of: Pieprzyk et al (US 2012/0261007) who teach of a system and a method for supplying controlled pressure to a microfluidic device; Hodko et al (US 2022/0168738) who teach of a microfluidic system containing a plurality of pressure-generating chambers; Hong et al (US 2008/0248960) who teach of a microfluidic array chip comprising a fluidic layer comprising a plurality of flow channels and a control layer comprising control channels that are pressurized to form a valve system for controlling fluid flow in the flow channels; and Oldham et al (US 2015/0238919) who teach of a microfluidic device having a flow layer with channels and a control layer comprsing a valve system for regulating solution flow through the channels.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 July 7, 2026
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