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 .
Response to Arguments
Applicant’s arguments, see Remarks page 7, filed, with respect to the rejections under 112(b) have been fully considered and are persuasive in light of the amendments to the claims. The 112(b) rejections of the claims have been withdrawn.
Applicant’s remarks did not address the claim interpretation under 112(f). However, applicant’s amendments to the claims introduce the new claim language of “a magnetic component” and “a magnet.” The examiner believes that the language of “a magnetic component comprising a feeding beam and a magnet” recites sufficient structure modifying the placeholder of “component.” The examiner is not interpreting this claim under 112(f).
Applicant's arguments filed 07 January 2026 have been fully considered but they are not persuasive.
Regarding applicant’s arguments that Handique et al 2020 does not teach a sample collecting reservoir; the inclusion of a sample collecting reservoir is addressed on page 14 of the non-final office filed 26 September 2025. The sample collecting reservoir is taught in publication US 20190060902 A1, which is fully incorporated into Handique et al 2020 by reference (see [0064]). Regarding the location of the sample collecting reservoir, this is held to be rearrangement of parts. Moreover, making integral is also considered to be prima facie obvious, per In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). Given Handique et al’s teaching of reservoirs located in the container, one of ordinary skill in the art would be able to modify the cartridge of Handique et al 2020 to include a sample connecting reservoir in the container, for the predictable result of having a self-contained cartridge for processing and collecting a sample.
Regarding applicant’s arguments that Handique et al 2020 does not teach a physical gap between a chip and middle portion of the container; this argument is convincing in light of applicant’s amendments to the claim which changes the language of “a snap gap” to “a first gap […] and the feeding beam is configured to be driven by the motor component to insert the magnet into the first gap…”. The examiner believes that the amended claim amounts to a rotation of the access region taught by Handique et al 2020 by 90 degrees. However, in the interest of furthering prosecution, and in light of the amendments to the claims, a further rejection is provided in view of Yung et al (US 20140220617 A1).
Regarding applicant’s arguments that Handique et al 2020 does not teach the magnetic component; these arguments are not within the scope of the claim. Amended claim 1 recites that “the feeding beam is configured to be driven by the motor component…” There is no discussion in the claim about direct versus indirect driving. Applicant’s arguments Handique teaches complex movement vs the linear driving is likewise not reflected in the claim language. Regarding Handique drawing material into the sleeve, the language of “to lift a sample comprising magnetic beads” is functional language; Even so, lifting the magnetic beads out of the channel reads on lifting a sample. The language used in the remarks of “suspended at an upper portion of the microchannel” is not present in the amended claim 1 of the claim set filed 7 January 2026.
Status of Claims
Applicant's amendments to the claims filed 07 January 2026 have been entered. Applicant's remarks filed 07 January 2026 are acknowledged.
Claims 1, 9, and 17 are in status “Currently amended.” Claims 2 – 8, 10 – 16, and 18 – 20 are in status “Previously presented.”
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Handique et al (US 20200354715 A) in view of Yung et al (US 20140220617 A1).
With regards to claim 1,
Handique et al teaches;
The claimed “a single-cell processing instrument” has been read on the taught (Abstract, “A system and method for automated single cell capture and processing is described…”);
The claimed “a motor component” has been read on the taught ([0035], “…a gantry 170 for actuating tools for interactions with the set of sample processing elements supported by the deck 110…”);
The claimed “a processing component” has been read on the taught ([0061], “…the deck 110 also includes at least one region 112 for supporting a unit of the sample processing cartridge 130…”; Region 112 reads on a processing component);
The claimed “a processing chamber” has been read on the taught ([0063], “…an example of the sample processing cartridge 130′ can include a base substrate 131 to which other elements are coupled and/or in which other elements are defined.”; Base substrate 131 reads on a processing chamber.);
The claimed “a plurality of first connecting holes” has been read on the taught ([0070], “…the inlet reservoir 132 includes an aperture…”; [0071], “… the opening 37 of the access region 134 can function as a microwell to provide access to contents of the microwells…”; [0079], “…waste containment region 137 can include a pump outlet 51…”; [0084], “the base substrate 131 can include one or more openings, recesses, and/or protrusions that provide further coupling with the sample processing chip 132, in order to promote or inhibit flow through the sample processing chip 132. For instance, as shown in FIG. 6A, the base substrate can include a pump opening 46 that couples the base substrate 131 to a pumping element of the pumping subsystem 157 (e.g., through deck 110), in order to drive and/or stop fluid flow through the sample processing chip 132.”).”; Taken together, the various inlets, apertures, and openings taught by Handique et al read on a plurality of first connecting holes.);
The claimed “a container located inside the processing component” has been read on the taught ([0062], “The sample processing cartridge 130 functions to provide one or more sample processing regions in which cells are captured and optionally sorted, processed, or otherwise treated for downstream applications…”; Processing cartridge 130 reads on a container located inside the processing component.);
A “sample loading reservoir” has been read on the taught ([0068], “The base substrate 131, as described above, can also include an inlet reservoir 133…”; an inlet reservoir reads on a sample loading reservoir.);
The claimed “a waste collecting reservoir” has been read on the taught ([0077], “…the base substrate 131 can also include a waste containment region 137 for receiving waste material from the sample processing chip 132.”);
“A first microchannel” has been read on the taught ([0067], “…a first fluid distribution network 33 downstream of the inlet opening 32…”; [0070] clarifies that distribution network may me a microchannel, “the microchannel defined in 33 in FIG. 4C…”.);
“A second microchannel” has been read on the taught ([0067], “…a second fluid distribution network 35 downstream of the set of microwells 34, and an outlet opening 36 coupled to a terminal portion of the second fluid distribution network 35, for transfer of waste fluids from the sample processing chip 132.”);
“Wherein a first end of a sample loading reservoir connects with a first connecting hole” has been read on the taught ([0070], “…the inlet reservoir 132 includes an aperture that can be accessed by a pipette tip or any other suitable attachment of a fluid handling subsystem…”; An aperture reads on a connecting hole. The inlet reservoir including an aperture reads on a first end of the sample loading reservoir connecting with a first connecting hole.);
“A second end of a sample loading reservoir connects with a first microchannel” has been read on the taught ([0068], “The inlet reservoir functions to receive sample material […] for delivery into the inlet opening 32...”; [0067], “…the sample processing chip 132 can include an inlet opening 32, a first fluid distribution network 33 downstream of the inlet opening…”; The inlet reservoir connecting to an inlet opening, which connects to fluid distribution network 33 reads on a second end of a sample loading reservoir connecting with a first microchannel.);
“A first end of the waste collecting reservoir connects with a first connecting hole” has been read on the taught ([0080], “The valve 43 can interface with the outlet opening 36 of the sample processing chip 132 described above, in order to enable and/or block flow out of the outlet opening 36 and into the waste containment region 137.”; Outlet opening 36 which has flow into the waste containment region 137 reads on a first end of the waste collecting reservoir connecting with a connecting hole.).
The claimed “a chip located under the container” has been read on the taught ([0067], “In this variation, the sample processing chip 132 is coupled to a first side (e.g., under-side) of the base substrate 131…”);
The claimed “a third microchannel” and “the third microchannel comprises a microwell array at a bottom of the third microchannel” have been read on the taught ([0067], “…the sample processing chip 132 can include […] a set of microwells 34…”);
The claimed “the third microchannel comprises an inlet and an outlet”, “the inlet connects with multiple first microchannels of the plurality of first microchannels”, and “the outlet connects with the waste collecting reservoir separately through the second microchannel” has been read on the taught ([0067], “the sample processing chip 132 can include an inlet opening 32, a first fluid distribution network 33 downstream of the inlet opening, for distribution of fluids to a set of microwells 34, a second fluid distribution network 35 downstream of the set of microwells 34, and an outlet opening 36 coupled to a terminal portion of the second fluid distribution network 35, for transfer of waste fluids from the sample processing chip 132.”);
The claimed, “a second gap is formed between the inlet and the container” has been read on the taught ([0071], “…the access region 134 can be defined as a recessed region within the base substrate 131, and include an opening 37 aligned with the region of the sample processing chip 132 that includes the set of microwells.”; Access region 134, including opening 37, allowing access to the microwells beneath reads on a second gap. Under the broadest reasonable interpretation, opening 37 extending to one side of the inlet and through the container reads on the gap being formed between the inlet and the container.);
The claimed “a magnetic component comprising a feeding beam and a magnet, wherein a first end of the feeding beam connects to the magnet, a second end of the feeding beam connects to the motor component” and wherein the magnet is configured “to lift a sample comprising magnetic beads located inside the third microchannel” have been read on the taught ([0120], “…the separation subsystem 160 can include a first body 161 including an interface 162 to the fluid handling subsystem (e.g., pipette interface) of the gantry 170 described below, and a magnetic distal region 163 configured to provide magnetic forces for target material separation.”; Separation subsystem 160 reads on a magnetic component. First body 161 reads on a feeding beam. Magnetic Sleeve 1410 reads on the magnet configured to lift a sample comprising magnetic beads located inside the third microchannel. Magnetic distal region 163 reads on a first end of the feeding beam connecting to the snap body. Interface 162 reads on a second end of the feeding beam connecting to the motor component.);
The claimed “the feeding beam is configured to be driven by the motor component to insert the snap body into the first gap” has been read on the taught ([0126], “…the magnetic sleeve 1410 couples, at a first region 1410a, to a region of the sample processing chip 132 exposed through access region 134…”);
The claimed “a pneumatic component connecting with multiple first connecting holes of the plurality of first connecting holes and configured to control air flow to each of the multiple first connecting holes of the plurality of first connecting holes” has been read on the taught ([0044], “In embodiments, the deck 110 can support a set of sample processing elements including one or more units of […] a pumping subsystem 157…”; [0063], “The cartridge may have additional gasketed ports to also connect with off-cartridge pumping system present in the instrument.”; The pumping system reads on a component. The pumping system connecting with gasketed ports on the cartridge reads on a pneumatic component connecting with multiple first connecting holes. [0077] and [0079] for example detail how the pumping systems may control air flow through the cartridge).
Handique et al does not explicitly disclose “a plurality of sample loading reservoirs” or “a plurality of first microchannels.”
According to MPEP 2144.04(VI)(B), “mere duplication of parts has no patentable significance unless a new and unexpected result is produced.”—see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). 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 device as taught by Handique et al to include multiple sample loading reservoirs and first microchannels, for parallel processing of samples. As each component would continue to function as an expected component of the fluid handling system, the examiner holds that the presence of a plurality of sample loading reservoirs and a plurality of first microchannels would not have yielded a new and unexpected result.
Regarding the limitations “a sample collecting reservoir”, “a first end of the sample collecting reservoir connects with a first connecting hole”, “a second end of the sample collecting reservoir connects with the second microchannel”, and “the outlet connects with the sample collecting reservoir through the second microchannel”;
Handique et al incorporates by reference several patent applications which teach further details about the sample processing chip 132, as read on the taught ([0064], “Embodiments, variations, and examples of the sample processing chip 132 are described in one or more of: […] U.S. application Ser. No. 16/115,370, filed 28 Aug. 2018 […] which are each incorporated in their entirety by reference above.”);
Publication US 20190060902 A1 is associated with U.S. application Ser. No. 16/115,370, which is incorporated by reference as detailed in the citation above. This publication teaches variations on fluid handling pathways for use in systems for isolating and analyzing single cells, including;
The claimed “a sample collecting reservoir” and “the outlet connects with the sample collecting reservoir through the second microchannel” have been read on the taught ([0075], “…some variations of the fluid delivery module 140 can include a set of inlet and outlet channels (e.g., a set of fluidic pathways 146 associated with respective manifold inlets 440 and manifold outlets 442) linking an inlet 142 of the system 100 to each of the array of wells 120 and additionally or alternatively, the array of wells 120 to an outlet 144, wherein the outlet is fluidly coupled to a receptacle for collecting removed fluids and/or sample fluid from the array of wells (e.g., to contain waste, to contain excess reagent, to collect desired sample for downstream processing)… The set of fluid pathways 146 can have any suitable correspondence with the set of wells…”).
While Handique et al does not explicitly disclose “a second end of the sample collecting reservoir connects with the second microchannel” “a first end of the sample collecting reservoir connects with a first connecting hole”, per MPEP 2144.04(VI)(C), mere rearrangement of parts is not sufficient to define an instant application over the prior art—see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
Given Handique et al’s clear teaching of an inlet leading to a microchannel, the microchannel leading to a set of wells, the set of wells leading to a second microchannel, and the second microchannel leading to a waste collection, as well as the teaching that an outlet can lead from wells to a sample fluid collection receptacle, and that any number of holes can be provided in the base substrate for sample flow, the fluidic components of the claimed invention cannot be considered sufficient to distinguish the claimed invention from the prior art.
Regarding the limitation, “a first gap formed between the chip and a middle portion of the container.” Handique et al does teach that the chip may be attached to the container by appropriate means, as read on the taught ([0067], “In this variation, the sample processing chip 132 is coupled to a first side (e.g., under-side) of the base substrate 131 e.g., by laser welding, glue bonding, solvent bonding, ultrasonic welding or another technique).”). Handique et al additionally teaches that other components of the system can be attached with a snap fit, as read on the taught ([0121], “The coupling region of the interface 162 can operate by […] a snap fit…”; [0095], “The set of retention elements can include mechanical retention elements (e.g., recesses, protrusions, etc.) configured provide retention byway of a snap fit...” ).
However, Handique et al does not explicitly disclose “a first gap formed between the chip and a middle portion of the container.”
In the analogous art of microfluidic devices, Yung et al teaches;
“Stacked microfluidic components which are fluidically connected, which have a gap, wherein the gap can be used to insert a magnet” has been read on the taught ([0071], “In a multiplex system, multiple microfluidic devices can be connected together using spacers. […] The spacers can provide gaps between the individual microfluidic devices for insertion of magnets and can contain holes for interconnecting source channel and collection channel ports of individual microfluidic devices.”).
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 including a container and a chip as taught by Handique et al with the spacers as taught by Yung et al. According to MPEP 2143(I)(D), applying a known technique to a known device ready for improvement to yield predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Handique et al contains a “base” device, upon which the claimed invention (which has a first gap formed between the chip and a middle portion of the container) can be seen as an improvement. The prior art of Yung et al contains a known technique of using spacers to introduce a gap between microfluidic components, which is applicable the stacked container and chip of Handique et al. One of ordinary skill in the art would have recognized that applying the known technique of spacers would have the predicable result of introducing a gap between the container and the chip which could be used to introduce a magnet, a sensor, or other insertable components.
With regards to claim 5, the instrument according to claim 1 is obvious over Handique et al in view of Yung et al.
Handique et al additionally teaches;
The claimed “wherein the container comprises a first boss, the first boss comprises an exhaust hole, the exhaust hole connects with each of the plurality of first microchannels” has been read on the taught ([0079], “…the waste containment region 137 can include a pump outlet 51 distinct from the cover, where the pump outlet 51 can allow the residual air in the waste chamber to be pressurized by an off-cartridge pump (e.g., by pumping mechanisms, etc.”; Pump outlet 51 reads on the first boss comprising an exhaust hole. As outlined in the rejection of claim 1, the waste chamber is fluidically connected with each of the microchannels, which reads on the exhaust hole connecting with each of the plurality of first microchannels.);
The claimed wherein “the chip comprises a second boss, the second boss comprises a inlet reservoir, the inlet reservoir connects with the third microchannel” has been read on the taught ([0068], “…the inlet reservoir 133 can be defined as a recessed region within a surface of the base substrate 131, wherein the recessed region includes an aperture that aligns with and/or seals with the inlet opening 32 of the sample processing chip 132.”; Inlet reservoir 133 reads on a second boss. Inlet reservoir aligning with opening 32 reads on the reservoir connecting with the third microchannel.);
The claimed “an exhaust gap is formed between the first boss and the second boss” has been read on the taught ([0072] through [0074] detail access region 134, which is an opening capable of venting to the ambient atmosphere, and which is located between the inlet reservoir and waste outlet as shown in Figure 4C; See also [0063], “the base substrate can include one or more openings, recesses, and/or protrusions that provide further coupling with the sample processing chip 132, in order to collectively define valve regions for opening and closing flow through the sample processing chip 132.”);
Handique et al does not explicitly disclose wherein “the first boss locates inside the second boss, or the second boss locates inside the first boss.” However, per MPEP 2144.04(VI)(C), mere rearrangement of parts is not sufficient to define an instant application over the prior art—see In reJapikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). The specification of the instant invention does not disclose any unexpected results occurring from the location of the first boss inside the second boss, or the second boss inside the first boss. As such, this limitation is not sufficient to distinguish the claimed invention from the prior art as taught by Handique et al.
With regards to claim 6, the instrument according to claim 1 is obvious over Handique et al.
Handique et al additionally teaches;
The claimed “wherein the container further comprises a third boss, the third boss comprise a mounting hole, the mounting hole connects with the sample collecting reservoir and the waste collecting reservoir separately through the second microchannel” has been read on the taught ([0081], “…the outlet opening 37 and the opening 44 may be displaced from the each other and connected by another microfluidic channel. As such, closure of the valve 43 can block flow from the outlet opening 37 into the waste containment region 137...”; Opening 44 reads on a third boss comprising a mounting hole. The opening being connected by a microfluidic channel to outlet opening 37 reads on the mounting hole connecting through the second microchannel. See Figure 6B, which illustrates the flow path of the device.);
The claimed “the chip comprises a fourth the fourth boss comprises a through hole, the through hole connects with the third microchannel” has been read on the taught ([0071], “…the access region 134 can be defined as a recessed region within the base substrate 131, and include an opening 37 aligned with the region of the sample processing chip 132 that includes the set of microwells.” Access region 134 with opening 37 reads on a fourth boss comprising a through hole);
The claimed “the third boss is air tightly connected to the fourth boss” has been read on the taught ([0072], “…the base substrate 131 can include or otherwise couple to a lid 135 covering the access region 134, where the lid 135 can include a gasket 136 providing sealing functions… The lid 135 can […] serve as the top surface of a fluidic pathway between the set of wells and the waste chamber, etc…”; One of ordinary skill in the art will recognize that fluidic pathways are air tight connections.);
Handique et al does not explicitly disclose wherein “the fourth boss is under the third boss.” However, per MPEP 2144.04(VI)(C), mere rearrangement of parts is not sufficient to define an instant application over the prior art—see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). The specification of the instant invention does not disclose any unexpected results occurring from the location of the fourth boss under the third boss. As such, this limitation is not sufficient to distinguish the claimed invention from the prior art as taught by Handique et al.
Claims 2-4 and 7-20 are rejected under 35 U.S.C. 103 as being unpatentable over Handique et al (US 20200354715 A1) in view of Yung et al (US 20140220617 A1) as applied to claim 1 above, and further in view of Chen (CN 110373310 A, cited on the IDS submitted 12/08/2022).
With regards to claim 2, the instrument according to claim 1 is obvious over Handique et al in view of Yung et al.
Handique et al further teaches “wherein the pneumatic component comprises an air pump”, “a plurality of valves”, and a “a plurality of connecting tubes” as read on the taught ([0109], “…the pumping subsystem 157 can include one or more ports 58 (e.g., vacuum ports) configured to interface with the sample processing cartridge 130 through openings in the deck 110, one or more pumps (e.g., vacuum pumps, peristaltic pumps, etc.) coupled to the ports 58, one or more manifolds to provide pressure driving pathways coupled to the pump(s)…”; One or more pumps reads on an air pump. One or more ports reads on a plurality of valves. One or more manifolds reads on a plurality of connecting tubes.).
Handique et al additionally teaches that the pneumatic component couples with the sample processing cartridge at a plurality of ports for actuating fluid (See [0111], also [0063], “…the base substrate can include one or more openings, recesses, and/or protrusions that provide further coupling with the sample processing chip 132, in order to collectively define valve regions for opening and closing flow through the sample processing chip 132.”).
However, Handique et al does not explicitly disclose wherein the valves are solenoid valves or the specified connections of claim 2.
In the analogous art of single cell processing devices, Chen teaches;
The claimed “wherein the pneumatic component comprises an air pump” has been read on the taught ([0010], “The airflow power control system includes a diaphragm air pump…”);
The claimed “a plurality of solenoid valves, and a plurality of connecting tubes, wherein a solenoid valve of the plurality of solenoid valves locates on a connecting tube of the plurality of connecting tubes, a first end of the connecting tube connects with the air pump, a second end of the connecting tube connects with one first connecting hole of the plurality of first connecting hole, each of the plurality of connecting tubes relates to one of the plurality of first connecting holes, each of the plurality of solenoid valves relates to one of the plurality of first connecting holes, and the solenoid valve is configured to make the air pump connect with the connecting tubes or disconnect from the connecting tubes” has been read on the taught ([0013], “…the double-cylinder diaphragm air pump is provided with a first air inlet, a first air outlet and a second air outlet; the first air outlet is connected to a first exhaust solenoid valve through an air pipe, the solenoid valve control assembly includes an air intake solenoid valve and a second exhaust solenoid valve, the second air outlet is connected to the air intake solenoid valve through an air pipe, and the air intake solenoid valve is connected to the gas inlet; the gas inlet is connected to the second exhaust solenoid.”; [0014] specifies that there can be multiple air inlets and air pipes. [0012] specifies how the air pipes correspond with the microfluidic chip. The solenoid valves read on a solenoid valve. The air pipes read on connecting tubes.).
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 system including a pneumatic system as taught by Handique et al, with the details of the pneumatic system as taught by Chen, for the benefit of controlling the sample fluid flow rate smoothly, efficiently, with a wide control range and high adjustment precision (Chen, [0024], “The airflow dynamic control system of the present invention is used to adjust the airflow flow rate, overcome the pulsation of the airflow, and is integrated with the pressure-tight control system and the microfluidic chip to control the sample fluid flow rate and droplet formation. The working process is smooth and efficient.”; [0025], “…a plurality of electromagnetic air valves are used in conjunction with each other to achieve a wide airflow control range while having a high adjustment precision.”).
With regards to claim 3, the instrument according to claim 1 is obvious over Handique et al in view of Yung et al.
Handique et al teaches some details of a pneumatic component including an air pump as detailed in [0109].
However, Handique et al does not teach an integrated air flow control board, or the structural details of the air flow control board.
In the analogous art of single cell processing devices, Chen teaches;
The claimed “wherein the pneumatic component comprises an air pump and an integrated air flow control board” has been read on the taught ([0010], “The airflow power control system includes a diaphragm air pump and an electromagnetic air valve control component, and the electromagnetic air valve control component is connected to the diaphragm air pump.”; the electromagnetic air valve control component reads on the integrated air flow control board).
The claimed “wherein the integrated air flow control board comprises air inlet holes, a plurality of air flow channels, and a plurality of air flow control valves” has been read on the taught ([0055], “Under the action of the air pipe connection, the diaphragm air pump, the first exhaust solenoid valve 16, the second exhaust solenoid valve 18 and the intake solenoid valve 17 form an airflow control system…”; The air pipe connection reads on a plurality of air flow channels.);
The claimed “a first end of an air flow channel of the plurality of air flow channels connects with the air inlet hole, a second end of the air flow channel connects with one first connecting hole of the plurality of first connecting holes, an air flow control valve of the plurality of air flow control valves is configured to be integrated in the air flow channels and controls air flow in the air flow channel, each of the plurality of air flow channels relates to one of the plurality of first connecting holes, each of the plurality of air flow control valves relates to one of the plurality of air flow channels, and the air flow control valve is configured to make the air pump connect with the first connecting holes or make the air pump disconnect from the first connecting holes” have been read on the taught ([0044] and [0048] teach the details of the air flow channel connections with the connecting holes of the chips. [0046] and [0047] teach the details of the air inlet holes, the air flow channel connections with the pump, and the air flow channel connections with the valves. [0055] teaches additional embodiments of the airflow control system).
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 system including a pneumatic system as taught by Handique et al, with the details of the pneumatic system as taught by Chen, for the benefit of controlling the sample fluid flow rate smoothly, efficiently, with a wide control range and high adjustment precision (Chen, [0024], “The airflow dynamic control system of the present invention is used to adjust the airflow flow rate, overcome the pulsation of the airflow, and is integrated with the pressure-tight control system and the microfluidic chip to control the sample fluid flow rate and droplet formation. The working process is smooth and efficient.”; [0025], “…a plurality of electromagnetic air valves are used in conjunction with each other to achieve a wide airflow control range while having a high adjustment precision.”).
With regards to claim 4, the instrument according to claim 1 is obvious over Handique et al in view of Yung et al.
Handique et al teaches that gaskets may be provided within the device ([0063], “The cartridge may have additional gasketed ports to also connect with off-cartridge pumping system present in the instrument.”).
However, Handique et al does not explicitly disclose a sealing gasket sandwiched between the processing component and the container so that the processing component is air tightly connected to the container, wherein the sealing gasket comprises a plurality of second connecting holes, a first end of the second connecting hole of the plurality of second connecting holes connects with one first connecting hole of the plurality of first connecting holes, a second end of the second connecting hole connects with one sample loading reservoir of the plurality of sample loading reservoirs, or the waste collecting reservoir, or the sample collecting reservoir.
In the analogous art of single cell processing devices, Chen teaches;
The claimed “a sealing gasket sandwiched between the processing component and the container so that the processing component is air tightly connected to the container” has been read on the taught ([0054], “…the lifting sealing plate 2 slowly descends downward and fits tightly with the gasket 29 of the microfluidic chip on the stage 31, thereby achieving tight fit between the air inlet and outlet channels and the microfluidic chip.”);
The claimed “wherein the sealing gasket comprises a plurality of second connecting holes, a first end of the second connecting hole of the plurality of second connecting holes connects with one first connecting hole of the plurality of first connecting holes, a second end of the second connecting hole connects with one sample loading reservoir of the plurality of sample loading reservoirs, or the waste collecting reservoir, or the sample collecting reservoir” has been read on the taught ([0054], “The gasket 29 is provided with air holes 30 corresponding to the sample inlet and the sample collection port 11.”).
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 system including a pneumatic system as taught by Handique et al, with the details of the pneumatic system as taught by Chen, for the benefit of controlling the sample fluid flow rate smoothly, efficiently, with a wide control range and high adjustment precision (Chen, [0024], “The airflow dynamic control system of the present invention is used to adjust the airflow flow rate, overcome the pulsation of the airflow, and is integrated with the pressure-tight control system and the microfluidic chip to control the sample fluid flow rate and droplet formation. The working process is smooth and efficient.”; [0025], “…a plurality of electromagnetic air valves are used in conjunction with each other to achieve a wide airflow control range while having a high adjustment precision.”).
With regards to claim 7, the instrument according to claim 1 is obvious in view of Handique et al in view of Yung et al.
Handique et al additionally discloses that a first end of a cover can be connected to a body with a rotatable connection, as read on the taught ([0076], “…the lid 135 can include another lid actuator, for instance, including a motor that rotates the lid about an access parallel to a broad surface of the sample processing cartridge 130.” See also figure 4A and 4B, which show a hinged rotatable lid 135.).
Handique et al additionally teaches that a cover can be tightly sealed to a body so that a chamber is formed between the cover and the body, as read on the taught ([0063], “…a lid 135 covering the access region and including a gasket 136 providing sealing functions…”; [0072], “…the lid 135 can […] (e.g. serve as the top surface of a fluidic pathway between the inlet and the set of microwells, serve as a boundary of a fluid pathway adjacent the microwell region, serve as the top surface of a fluidic pathway between the set of wells and the waste chamber, etc.)…”);
However, Handique et al does not explicitly disclose wherein the processing component comprises an upper cover and a processing component body, wherein the upper cover comprises the plurality of first connecting holes.
In the analogous art of single cell processing devices, Chen teaches;
The claimed “processing component comprising an upper cover and a processing component body” has been read on the taught ([0054], “…the lifting sealing plate 2 slowly descends downward and fits tightly with the gasket 29 of the microfluidic chip on the stage 31, thereby achieving tight fit between the air inlet and outlet channels and the microfluidic chip.”; The sealing plate 2 reads on an upper cover. The microfluidic chip reads on a processing component body.);
The claimed “wherein the upper cover comprises the plurality of first connecting holes” has been read on the taught ([0043], “…the lifting sealing plate 2 is provided with through holes 33 corresponding to the positions of the air holes 7 on the air intake duct 3 and the exhaust duct 4 .”; Through holes 33 reads on the plurality of first connecting holes.).
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 system including a pneumatic system as taught by Handique et al, with the pneumatic system including the processing component as taught by Chen, for the benefit of controlling the sample fluid flow rate smoothly, efficiently, with a wide control range and high adjustment precision (Chen, [0024], “The airflow dynamic control system of the present invention is used to adjust the airflow flow rate, overcome the pulsation of the airflow, and is integrated with the pressure-tight control system and the microfluidic chip to control the sample fluid flow rate and droplet formation. The working process is smooth and efficient.”; [0025], “…a plurality of electromagnetic air valves are used in conjunction with each other to achieve a wide airflow control range while having a high adjustment precision.”).
With regards to claim 8, the instrument according to claim 1 is obvious in view of Handique et al in view of Yung et al.
Handique et al additionally teaches that a cover can be slidably disposed on a body so that the cover is tightly sealed to the body, forming a chamber between the cover and the body, as read on the taught ([0076], “The actuator can additionally or alternatively be configured to translate the lid 135 (e.g. slide the lid 135 parallel to a broad surface of the sample processing cartridge 130, translate the lid 135 perpendicular to the broad surface, etc.) or otherwise move the lid 135 to selectively cover and uncover one or more predetermined regions (e.g. the set of microwells).”; [0072], “…the lid 135 can […] (e.g. serve as the top surface of a fluidic pathway between the inlet and the set of microwells, serve as a boundary of a fluid pathway adjacent the microwell region, serve as the top surface of a fluidic pathway between the set of wells and the waste chamber, etc.)…”);
However, Handique et al does not explicitly disclose wherein the processing component comprises an upper cover and a processing component body, wherein the upper cover locates above the processing component body, and the upper cover comprises the plurality of first connecting holes.
In the analogous art of single cell processing devices, Chen teaches;
The claimed “processing component comprising an upper cover and a processing component body” has been read on the taught ([0054], “…the lifting sealing plate 2 slowly descends downward and fits tightly with the gasket 29 of the microfluidic chip on the stage 31, thereby achieving tight fit between the air inlet and outlet channels and the microfluidic chip.”; The sealing plate 2 reads on an upper cover. The microfluidic chip reads on a processing component body.);
The claimed “wherein the upper cover locates above the processing component body” has been read on the taught (Figure 4 shows sealing plate 2 arranged above the microfluidic chip. [0054] additionally discloses that the sealing plate descends downwards in order to achieve a tight fit with the microfluidic chip.);
The claimed “wherein the upper cover comprises the plurality of first connecting holes” has been read on the taught ([0043], “…the lifting sealing plate 2 is provided with through holes 33 corresponding to the positions of the air holes 7 on the air intake duct 3 and the exhaust duct 4 .”; Through holes 33 reads on the plurality of first connecting holes.).
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 system including a pneumatic system as taught by Handique et al, with the pneumatic system including the processing component as taught by Chen, for the benefit of controlling the sample fluid flow rate smoothly, efficiently, with a wide control range and high adjustment precision (Chen, [0024], “The airflow dynamic control system of the present invention is used to adjust the airflow flow rate, overcome the pulsation of the airflow, and is integrated with the pressure-tight control system and the microfluidic chip to control the sample fluid flow rate and droplet formation. The working process is smooth and efficient.”; [0025], “…a plurality of electromagnetic air valves are used in conjunction with each other to achieve a wide airflow control range while having a high adjustment precision.”).
With regards to claim 9, the instrument according to claim 7 is obvious over Handique et al in view of Yung et al and further in view of Chen.
Handique et al additionally teaches;
Wherein a lid and the processing body snap fit to each other to define a sealed chamber between them, as read on the taught ([0075], “…the lid 135 can include a one or more tabs 39 that interface with corresponding tab receiving portions of the base substrate 131, where, the tabs 39 are configured to flex when pushed into the base substrate 131 until they interface with the tab receiving portions of the base substrate 131 and return from a flexed configuration to a latched state.”).
With regards to claim 10, the instrument according to claim 7 is obvious over Handique et al in view of Yung et al and further in view of Chen.
Handique et al additionally teaches;
The claimed “a heating stage” has been read on the taught ([0103], “…the heating and cooling subsystem 150 can include one or more units of: heating elements…”);
The claimed “an insulation wall, wherein the insulation wall locates around a periphery of the heating stage” has been read on the taught ([0163], “…a sample processing cartridge thermal body 832 (configured to mate with the microwell region of the sample processing cartridge 130 or other region of the sample processing cartridge 130)…”; Sample processing cartridge thermal body 832 reads on an insulation wall. [0105] specifies that the thermal bodies interface with heating elements; Figure 6A shows the thermal body located at the periphery of the heating stage.);
The claimed wherein “the upper cover, the insulation wall and the heating stage define the processing chamber” has been read on the taught ([0063], “…an example of the sample processing cartridge 130′ can include a base substrate 131 to which other elements are coupled and/or in which other elements are defined.”; Base substrate 131 reads on a processing chamber.);
With regards to claim 11, the instrument according to claim 1 is obvious over Handique et al in view of Yung et al.
Handique et al additionally teaches pressure sensors, as read on the taught ([0109], “…the pumping subsystem 157 can include […] one or more pressure sensors configured to detect pressure levels along pressure pathways…”).
However, Handique et al does not explicitly disclose wherein at least one of the at least two pressure sensors is configured to measure pressure of an inlet of an air pump of the pneumatic component, and at least one of the at least two pressure sensors is configured to measure pressure of an outlet of the air pump of the pneumatic component.
In the analogous art of single cell processing devices, Chen teaches;
The claimed “wherein at least one of the at least two pressure sensors is configured to measure pressure of an inlet of an air pump of the pneumatic component, and at least one of the at least two pressure sensors is configured to measure pressure of an outlet of the air pump of the pneumatic component” has been read on the taught ([0020], “The present invention is further configured such that air pressure sensors are provided on the air intake duct and the exhaust duct.”).
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 system including a pneumatic system as taught by Handique et al, with the pneumatic system including the processing component as taught by Chen, for the benefit of controlling the sample fluid flow rate smoothly, efficiently, with a wide control range and high adjustment precision (Chen, [0024], “The airflow dynamic control system of the present invention is used to adjust the airflow flow rate, overcome the pulsation of the airflow, and is integrated with the pressure-tight control system and the microfluidic chip to control the sample fluid flow rate and droplet formation. The working process is smooth and efficient.”; [0025], “…a plurality of electromagnetic air valves are used in conjunction with each other to achieve a wide airflow control range while having a high adjustment precision.”).
With regards to claim 12, the instrument according to claim 2 is obvious over Handique et al in view of Yung et al and further in view of Chen.
Handique et al in view of Yung et al and further in view of Chen additionally teaches the limitations of claim 12, following the rejection of claim 8.
With regards to claim 13, the instrument according to claim 3 is obvious over Handique et al in view of Yung et al and further in view of Chen.
Handique et al in view of Yung et al and further in view of Chen additionally teaches the limitations of claim 13, following the rejection of claim 8.
With regards to claim 14, the instrument according to claim 4 is obvious over Handique et al in view of Yung et al and further in view of Chen.
Handique et al in view of Yung et al and further in view of Chen additionally teaches the limitations of claim 14, following the rejection of claim 8.
With regards to claim 15, the instrument according to claim 5 is obvious over Handique et al in view of Yung et al.
Handique et al in view of Yung et al and further in view of Chen additionally teaches the limitations of claim 15, following the rejection of claim 8.
With regards to claim 16, the instrument according to claim 6 is obvious over Handique et al in view of Yung et al.
Handique et al in view of Yung et al and further in view of Chen additionally teaches the limitations of claim 16, following the rejection of claim 8.
With regards to claim 17, the instrument according to claim 8 is obvious over Handique et al in view of Yung et al and further in view of Chen.
Handique et al in view of Yung et al and further in view of Chen additionally teaches the limitations of claim 17, following the rejection of claim 9.
With regards to claim 18, the instrument according to claim 8 is obvious over Handique et al in view of Yung et al and further in view of Chen.
Handique et al in view of Yung et al and further in view of Chen additionally teaches the limitations of claim 18, following the rejection of claim 10.
With regards to claim 19, the instrument according to claim 2 is obvious over Handique et al in view of Yung et al and further in view of Chen.
Handique et al in view of Yung et al and further in view of Chen additionally teaches the limitations of claim 19, following the rejection of claim 11.
With regards to claim 20, the instrument according to claim 3 is obvious over Handique et al in view of Yung et al and further in view of Chen.
Handique et al in view of Yung et al and further in view of Chen additionally teaches the limitations of claim 20, following the rejection of claim 11.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALISON CLAIRE GERHARD/ Examiner, Art Unit 1797 /LYLE ALEXANDER/ Supervisory Patent Examiner, Art Unit 1797