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 .
Election/Restrictions
Applicant’s election without traverse of group I in the reply filed on 01/08/2026 is acknowledged. Claims 16-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/11/2023, 10/05/2023, 08/22/2024, 10/09/2024 and 04/04/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-18 are pending with claims 1-15 being examined, claims 16-18 are deemed withdrawn.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin, Microfluidic immunoessays; hereinafter “Lin” already of record).
Regarding claim 1, Lin teaches a droplet microfluidic chip (Lin; Title and Table 2. Legend, teaches the on-chip valves produce droplets with a radius of less than 10^-3m), comprising at least one droplet-producing unit (Lin; Table 2. “micropump”) and having a rotation center (Lin; fig. 4A (center of the disc), wherein the droplet-producing unit comprises:
a dispersion phase chamber being proximal to the rotation center and provided with a loading hole configured to introduce a dispersion phase liquid (Lin; fig. 5 “blood” illustrates a mixing chamber proximal to the rotation center and provided with a loading hole configured to introduce a dispersion phase liquid);
a quantitation chamber (Lin; fig. “detection chamber”. 5. G “Absorbance” and page 256. Col. 2 “micropneumatic pumping” lines 16-17 “optical measurement via the measurement of absorbance”). Examiner notes that absorbance value of a substance can be used to quantify analytes in the substance; being in communication with the dispersion phase chamber and further away from the rotation center than the dispersion phase chamber (Lin; fig. 5 “blood” and “detection chamber”);
a capillary nozzle, one end of the capillary nozzle being in communication with the quantitation chamber and extended in a direction away from the rotation center, and the capillary nozzle being further away from the rotation center than the quantitation chamber (Lin; fig. 4 teaches capillary valves in communication with chambers 1, 3, 5, 7, 9, that includes sample and detection chambers); and
a continuous phase chamber configured to pre-store a continuous phase liquid (Lin; fig. 5. Illustrates a washing buffer section), the continuous phase chamber being in communication with another end of the capillary nozzle away from the quantitation chamber, and the continuous phase chamber being further away from the rotation center than the capillary nozzle (Lin; fig. 5. B. “W” and “CD Center” illustrates the washing buffer “W” away from the quantitation chamber, and the continuous phase chamber being further away from the rotation center that the capillary nozzle).
Regarding claim 2, Lin teaches the droplet microfluidic chip of claim 1 (see above), wherein the droplet-producing unit further comprises a liquid-dispensing channel (Lin; page 256. Col. 1 line 21 microchannels designed for delivering solutions), the liquid-dispensing channel is in communication with the dispersion phase chamber and extended around the rotation center, and the liquid-dispensing channel is further away from the rotation center than the dispersion phase chamber (Lin; fig. 4A chambers are connected to microchannels wherein the solution in the chambers flow out when the CD rotates).
Regarding claim 3, Lin teaches the droplet microfluidic chip of claim 2 (see above), wherein the quantitation chamber is a plurality of quantitation chambers (Lin; fig. 4A-B (D)), the plurality of quantitation chambers are separately in communication with the liquid-dispensing channel, sequentially arranged at an outer side of the liquid-dispensing channel (Lin; fig. 4A-B (D) is connected to center microchannel), and extended in a radial direction (Lin; fig. 4A-B (D)).
Regarding claim 4, Lin teaches the droplet microfluidic chip of claim 3 (see above), wherein the capillary nozzle is a plurality of capillary nozzles (Lin; fig. 4B (valve), and the plurality of capillary nozzles are corresponding to the plurality of quantitation chambers in a one-to-one manner (Lin; fig. 4B (D) and (valve)).
Regarding claim 5, Lin teaches the droplet microfluidic chip of claim 2 (see above), wherein the liquid-dispensing channel is in a shape of a circular arc whose circular center is at the rotation center (Lin; fig. 5A-B illustrates the liquid microchannels in a shape of a circular arc whose circular center is at the rotation center).
Regarding claim 6, Lin teaches the droplet microfluidic chip of claim 2 (see above), wherein the droplet-producing unit further comprises a waste liquid chamber (Lin; fig. 5A. “waste”), the waste liquid chamber is in communication with a terminal end of the liquid-dispensing channel and extended in a direction away from the rotation center (Lin; fig. 5A. “waste”, and 14).
Regarding claim 7, Lin teaches the droplet microfluidic chip of claim 2 (see above), wherein the liquid-dispensing channel is in communication with the dispersion phase chamber (Lin; fig. 5 “blood” in communication with microchannels).
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.
Claims 9-10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lin, Microfluidic immunoessays; hereinafter “Lin” already of record).
Regarding claim 9, Lin teaches the droplet microfluidic chip of claim 1 (see above) to include a capillary nozzle (see above).
Lin does not explicitly teach wherein an equivalent diameter of the capillary nozzle is about 4 pm to about 50 pm.
Lin teaches the channel diameter expands (Lin; fig. 4 legend). Lin also teaches using beads sizing for the microfluidic assay that were in the range of 2pm to 10pm (Lin; page 264. Col 1 lines 10-12).
Lin and the claims differ in that Lin teaches the channel diameter expands to allow using beads in the range of 2pm to 10pm. However, corresponding overlapping ranges establish prima facie evidence of obviousness.
However, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have an equivalent diameter of the capillary nozzle is about 4 pm to about 50 pm because Lin teaches a channel that has an expansive diameter that is used with beads sizing for the microfluidic assay that were in the range of 2pm to 10pm that would provide an equivalent diameter within the range of the claimed 4 pm to about 50 pm. In re Malagari, 184 USPQ 549 (CCPA 1974).
Regarding claim 10, Lin teaches the droplet microfluidic chip of claim 1 (see above) to include a continuous phase chamber (see above).
Lin does not teach wherein a height of the continuous phase chamber is about 80 pm to about 150 pm.
However, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to adjust the continuous phase chamber of Lin to a height of about 80pm to 150 pm, in order to provide enough space to store enough amount of continuous phase liquid for the sample.
Regarding claim 15, Lin teaches the droplet microfluidic chip of claim 1 (see above) to include a droplet-producing unit (see above).
Lin does not explicitly teach a droplet-producing unit as a plurality of droplet-producing units evenly distributed, surrounding the rotation center.
Lin teaches the required components for the entire assay such as “micropumps” (droplet producing units, se claim 1 above) for liquid delivery. Examiner interprets the “micropumps” as a plurality of micropumps (droplet producing units).
Thus, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to evenly distribute Lin’s micropumps surrounding the rotation center, in order to balance the weight and prevent vibration while in use.
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Lin, Microfluidic immunoessays; hereinafter “Lin” already of record) in view of Wo et al. (US 8039249 B2; hereinafter “Wo”).
Regarding claim 11, Lin teaches the droplet microfluidic chip of claim 1 (see above) to include a droplet producing unit (see above).
Lin fails to teach wherein the droplet-producing unit further comprises a ventilating hole and a ventilating conduit, the ventilating hole is closer to the rotation center than the dispersion phase chamber, and the dispersion phase chamber and the continuous phase chamber are each in communication with the ventilating hole through the ventilating conduit.
However, Wo teaches the analogous art of a separation device (Wo; fig. 1. 100) which is a microfluidic device (WO; [0044]) that includes a ventilation hole (Wo; fig. 3. 233) and a ventilation conduit (Wo; fig. 3. Area between 232, 233 appears to be a conduit) the ventilating hole is closer to the rotation center (Wo; fig. 3. 233) than the dispersion phase chamber (Wo; fig. 3. 21), and the dispersion phase chamber (Wo; fig. 6. 21) and the continuous phase chamber (Wo; fig. 6. 231) are each in communication with the ventilating hole through the ventilating conduit (Wo; Col. 4 lines 19-25).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Lin’s droplet microfluidic chip to include a ventilating hole and a ventilating conduit, the ventilating hole is closer to the rotation center than the dispersion phase chamber, and the dispersion phase chamber and the continuous phase chamber are each in communication with the ventilating hole through the ventilating conduit as taught by Wo because Wo teaches a separation device (Wo; fig. 1. 100) which is a microfluidic device (WO; [0044]) that includes a ventilation hole (Wo; fig. 3. 233) and a ventilation conduit (Wo; fig. 3. Area between 232, 233 appears to be a conduit) the ventilating hole is closer to the rotation center (Wo; fig. 3. 233) than the dispersion phase chamber (Wo; fig. 3. 21), and the dispersion phase chamber (Wo; fig. 6. 21) and the continuous phase chamber (Wo; fig. 6. 231) are each in communication with the ventilating hole through the ventilating conduit (Wo; Col. 4 lines 19-25).
The modification will allow to ventilate pressure in the dispersion phase chamber and the continuous phase chamber.
Regarding claim 13, Lin teaches the droplet microfluidic chip of claim 1 (see above) to include the dispersion phase chamber, the quantitation chamber, the capillary nozzle, and the continuous phase chamber (see above).
Lin fails to teach the microfluidic chip further comprising a bottom plate, a middle plate, and a top plate which are sequentially stacked, wherein the dispersion phase chamber, the quantitation chamber, the capillary nozzle, and the continuous phase chamber are defined in the middle plate.
However, Wo teaches the analogous art of a separation device (Wo; fig. 1. 100) which is a microfluidic device (WO; [0044]) that includes a bottom plate (Wo; fig. 2. 14), a middle plate (Wo fig. 2. 15), and a top plate (Wo; fig. 2. 16) which are sequentially stacked (Wo; fig. 2. 1).
Wo does not teach the dispersion phase chamber, the quantitation chamber, the capillary nozzle, and the continuous phase chamber are defined in the middle plate.
However, Wo teaches microfluidic structures are cut into the middle device layers (Wo; [0095]).
It would have been obvious to include the dispersion phase chamber, the quantitation chamber, the capillary nozzle, and the continuous phase chamber are defined in the middle plate in Wo’s microfluidic device middle layer cut structures.
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Lin’s microfluidic chip that includes the dispersion phase chamber, the quantitation chamber, the capillary nozzle, and the continuous phase chamber to include a bottom plate, a middle plate, and a top plate which are sequentially stacked as taught by Wo because Wo teaches a separation device (Wo; fig. 1. 100) which is a microfluidic device (WO; [0044]) that includes a bottom plate (Wo; fig. 2. 14), a middle plate (Wo fig. 2. 15), and a top plate (Wo; fig. 2. 16) which are sequentially stacked (Wo; fig. 2. 1).
The modification allows to produce a microfluidic disc carrier that is easy to manufacture using low cost materials (WO; Col. 3. Lines 50-60).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Lin, Microfluidic immunoessays; hereinafter “Lin” already of record) in view of Wo et al. (US 8039249 B2; hereinafter “Wo”), further in view of Lee et al. (US 20110020194 A1; hereinafter “Lee).
Regarding claim 14, Lin teaches the droplet microfluidic chip of claim 13 (see above) to include a bottom plate, middle plate and top plate (see above).
Lin fails to teach the microfluidic chip further comprises double-faced adhesive layers respectively disposed between the bottom plate and the middle plate and between the middle plate and the top plate.
However, Lee teaches the analogous art of a microfluidic device (Lee; (Title) that includes a bottom plate, a middle plate, and a top plate (Lee; fig. 9. 110, 115, 120) wherein the microfluidic chip further comprises double-faced adhesive layers respectively disposed between the bottom plate and the middle plate and between the middle plate and the top plate (Lee; [0080]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Lin’s microfluidic chip that includes a bottom plate, middle plate and top plate to include double-faced adhesive layers respectively disposed between the bottom plate and the middle plate and between the middle plate and the top plate as taught by Lee because Lee teaches of a microfluidic device (Lee; (Title) that includes a bottom plate, a middle plate, and a top plate (Lee; fig. 9. 110, 115, 120) wherein the microfluidic chip further comprises double-faced adhesive layers respectively disposed between the bottom plate and the middle plate and between the middle plate and the top plate (Lee; [0080]).
The modification would allow to enclose the flow channel structures.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lin, Microfluidic immunoessays; hereinafter “Lin” already of record) in view of Wo et al. (US 8039249 B2; hereinafter “Wo”), further in view of Landers et al. (US 20180313765 A1; hereinafter “Landers”).
Regarding claim 12, Lin teaches the droplet microfluidic chip of claim 11 (see above) to include a droplet-producing unit (see above).
Lin fails to teach wherein the droplet-producing unit further comprises a filter, the filter is made of an air-permeable and liquid-tight material, and the continuous phase chamber and the ventilating hole each are in communication with the filter through the ventilating conduit.
However, Landers teaches the analogous art of a microfluidic device (Landers; fig. 1A and [0016]) that includes a droplet producing unit (Landers; [0083] “inkjet printing droplets”) further comprising a filter (Landers; fig. 4B. 100) the filter is made of an air-permeable and liquid-tight material (Landers; [0088] teaches using whatman 1 grade filter that allowed spotting reagents on the filter).
Landers does not teach the continuous phase chamber and the ventilating hole are each in communication with the filter through the ventilating conduit.
It would have been obvious to have the continuous phase chamber and the ventilating hole each are in communication with the filter through the ventilating conduit in order to prevent contamination from coming in through the ventilation hole.
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Lin’s microfluidic chip to include a filter made of an air-permeable and liquid-tight material as taught by Landers because Landers teaches a microfluidic device (Landers; fig. 1A and [0016]) that includes a droplet producing unit (Landers; [0083] “inkjet printing droplets”) further comprising a filter (Landers; fig. 4B. 100) the filter is made of an air-permeable and liquid-tight material (Landers; [0088] teaches using whatman 1 grade filter that allowed spotting reagents on the filter).
The filter allows to filter out any contamination.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX RAMIREZ whose telephone number is (571)272-9756. The examiner can normally be reached Monday - Friday 8:00 - 5:00.
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/A.R./ Examiner, Art Unit 1798
/CHARLES CAPOZZI/ Supervisory Patent Examiner, Art Unit 1798