DETAILED ACTION
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/20/2026 has been entered.
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed 20 January 2026.
Claims 1, 3-6, 8-10, 13-14, and 20-25 are pending.
Claims 2, 7, 11-12, and 15-19 are cancelled.
Claims 1 and 3-6 are withdrawn.
No claims are newly added.
Claim Objections
Claim 8 is objected to because of the following informalities: The claim recites “at other end” and should be amended to recite on the order of “at an other end of the plurality of nano-wells”. Appropriate correction is required.
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.
Claim 8-10, 13-14, and 20-25 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.
Regarding Claim 8, the phrase "window-like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). For example, does Applicant intend to claim an optically transmissive window or opening?
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 8-10 and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Oviso et al. (US 2009/0220948 A1), referred to hereinafter as “Oviso”, in view of Genghis et al. (US PAT 9,211,537 B2), hereinafter “Genghis”.
Regarding Claim 8, Oviso teaches a method ([0017]) comprising the steps of:
providing a device 105 comprising plurality of Stationary Nanoliter Droplet Array (SNDA) components 11 (Figs. 1 and 10A);
each SNDA component comprising:
an individual primary channel 1, at least one secondary channel 3, and a plurality of nano-wells 15 each open to the primary channel 1, at one end (Fig. 10B), and each comprising or more window-like vents 19/23 to the at least one secondary channel 3, at other end (See para. [0079] discussing venting through the fluid isolation chambers and para [0062] discussing “…the multi-functional channel(s) 3 generally act(s) as a vent to allow for the release of entrapped air.”),
the vents are configured to enable passage of gas while preventing liquid passage ([0079]) from the nano-wells to the at least one secondary channel 3, such that when a fluid is introduced into the primary channel 1 it fills the nano-wells 15, and originally accommodated gas is evacuated via the vents and the at least one secondary channel 3 ([0062]: “In the absence of other fluid such as a fluid sample, the air in the multi-functional channel(s) 3 is therefore in contact with the air in the reactor module(s). This is in turn is in contact with the air in the sample transmission channel(s) 1, thus forming one integrated air-filled system. As a consequence, during the filling of the sample transmission channels 1 and the reactor modules 11 with a fluid sample, the multi-functional channel(s) 3 generally act(s) as a vent to allow for the release of entrapped air.”);
a common inlet port (Fig. 11 and [0052]: “The plurality of reactor modules may in some embodiments be arranged in such a way that external means or capillary action fill the plurality of reactor modules simultaneously with the fluid sample 31 via at least one sample transmission channel 1 from any of the one or more loading ports 5 and 6 etc.”);
a plurality of individual inlet ports 9, configured to enable individual introduction of fluid, each into a different individual primary channel of a different SNDA component; and at least one outlet port 4, and optionally an evacuation channel (Fig. 4: The short branch connected to outlet 4.), configured to enable a simultaneous evacuation of the gas out of all the secondary channels 3 (Fig. 10B – Further, as discussed above, given that Oviso teaches filling of each reaction chamber simultaneously, and Oviso provides a commensurately arranged structure for evacuating gas vis the other end of the chamber, Oviso inherently teaches said gas evacuation as occurring simultaneously.);
loading a first fluid into the nano-wells 15 of one of the SNDA components 11, via its associated individual inlet port 9 and its associated primary channel 1 ([0116]: “..any suitable reagent that is capable of lowering surface tension at the solid-liquid interface may be pre-loaded into the sample transmission channel…” – [0122]: “Subsidiary processes include the mixing of fluid samples with analytical reagents, homogenizing procedures to render heterogeneous samples suitable for analysis…”);
loading a second fluid into the nano-wells 15 of all the SNDA components 11 via the common inlet port and the primary channels 1 ([0017]: “(b) loading the fluid sample into said device…”); and
examining the fluid droplets 31 in the nano-wells 15 ([0017]: “(d) carrying out at least one analyte detection reaction, said reaction providing at least one qualitative or quantitative datum relating to the analyte.”); and
via an imaging device and at least one computing processor, wherein the examining comprises determining an effect of the first fluid on the second fluid ([0153]: “FIG. 16A depicts a photograph of the fluorescence emission images of a sample analyzed with a device of the present invention.” – [0125]: “…determination of optical density in a computer-interfaced microtiter plate reader.” – See also paras. [0163-0165].)
as in Claim 8.
Further regarding Claim 8, while Oviso teaches individually addressable SNDA components (Fig. 10B), Oviso does not specifically teach a plurality of primary channels connected by a distribution channel to a common inlet, providing fluid communication to simultaneously fill all of the plurality of SNDA components from the common inlet, as in Claim 8.
However, Genghis teaches a respective droplet array microfluidic device comprising reaction chambers 114 filled by primary channels 110 (Fig. 2C) wherein specific primary channels of the device are addressable by separate individual inlet ports 104, and commonly addressable by a common inlet port 106a and distribution channel 103 (see figs. 2A and 2B, and [col. 8, line 37]: “Fluid communication may be mediated by a barrier, valve, pump or other control device to allow for controlled interruption of the fluid communication and isolate one or more elements of the microfluidic device.” and [col. 11, line 61]: “Flow of fluid from injection port 104 is regulated by valve 108; valve 108 is opened or closed by fluid pressure in valve flow channel 102 a, b. All valves along valve flow channel 102 a may be operated simultaneously by injection port 106 a; all valves along valve flow channel 102 b may be operated simultaneously by injection port 106 b.”). Therein, this arrangement allows for a multiplexed chip device where different samples or reagents may be introduced into particular regions of the device, followed by simultaneous introduction of reagent or sample, thereby ensuring consistent results ([col. 27, line 59]: “A microfluidic device... was designed with 5 separate chamber arrays in order to test different samples on the same chip.”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Oviso further comprising a commonly addressable inlet port and distribution channel, as well as individually addressable inlet ports, such as suggested by Genghis, so as to provide a multiplexed chip device where different samples or reagents may be introduced into particular regions of the device, followed by simultaneous introduction of reagent or sample, thereby ensuring consistent results; and would have a reasonable expectation of success therein.
Regarding Claim 9, the prior art meets the limitations of Claim 8 as discussed above. Further, Oviso does not specifically teach the SNDA discussed above further comprising repeating the step of loading a first fluid, wherein the first fluid is replaced with a different first fluid into nano-wells of another SNDA component, via its associated individual primary channel, as in Claim 9.
However, Genghis teaches a respective microfluidic chip discussed above regarding Claim 8 wherein the valve 108 and division of individual channels 103 from the common channel 102, as actuated by valves 108, provides for repeating an injection step of a sample or reagent fluid into the separate chamber arrays to achieve the multiplexed analysis sought by Genghis ([col. 27, line 62]: Example 1).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the method of Oviso to include repeating the step of injecting a first fluid so as to fill each individual primary channel/region of chambers of the device, such as suggested by Genghis, so as to achieve multiplexed analysis of multiple samples or assays, as discussed above regarding Claim 8.
Regarding Claim 10, the prior art meets the limitations of Claim 8 as discussed above. Further, Oviso does not specifically teach the SNDA discussed above wherein the step of loading the second fluid to the nano-wells 15 of all the SNDA components 11 is simultaneous, as in Claim 10.
However, Genghis teaches a respective microfluidic chip discussed above regarding Claim 8 wherein a first solution containing a nucleic acid sample is individually injected to separate SNDA components of the device and are dehydrated, followed by a common filling step of adding a PCR amplification solution to the chambers of the device for PCR analysis ([col. 19, line 44]). Therein, the time-based PCR analysis discussed by Genghis benefits from simultaneous reagent introduction and reaction start time, reducing variability between sample runs.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the second Loading step of Genghis to Oviso wherein loading the second fluid to the nano-wells of all the SNDA components is simultaneous, such as suggested by Genghis, so as to enable simultaneous reagent introduction and reaction start time, thereby reducing variability between sample runs, and would have a reasonable expectation of success therein.
Regarding Claim 21, the prior art meets the limitations of Claim 8 as discussed above. Further, Oviso does not specifically teach the method discussed above further comprising a step of treating the nano-wells' droplets formed by first fluid, before the step of loading of the second fluid, as in Claim 21.
However, Genghis teaches a step of treating a first fluid contained within the chambers of each SNDA component by dehydrating the reagent prior to loading the second fluid, the PCR reaction fluid ([col. 19, line 44]). Therein, this method provides for easier loading of the second fluid to the channels as it must only displace air instead of liquid, wherein air is easier to displace.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the method of Oviso comprising a step of treating the nano-wells' droplets formed by first fluid, before the step of loading of the second fluid, such as dehydrating the first fluid, such as suggested by Genghis, so as to, for example, enable for easier introduction of the second fluid into the reaction chambers of the device, and would have a reasonable expectation of success therein.
Regarding Claim 22, the prior art meets the limitations of Claim 21 as discussed above. Further, Oviso does not specifically teach the method discussed above wherein the step of treating the nano-wells' droplets formed by first fluid comprises lyophilizing and/or drying the nano-well's first fluid droplets, as in Claim 22.
However, Genghis teaches a step of treating a first fluid contained within the chambers of each SNDA component by dehydrating/drying the reagent prior to loading the second fluid, the PCR reaction fluid ([col. 19, line 44]). Therein, this method provides for easier loading of the second fluid to the channels as it must only displace air instead of liquid, wherein air is easier to displace.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the method of Oviso wherein the step of treating the nano-wells' droplets formed by first fluid comprises lyophilizing and/or drying the nano-well's first fluid droplets, such as suggested by Genghis, so as to enable for easier introduction of the second fluid into the reaction chambers of the device, and would have a reasonable expectation of success therein.
Regarding Claim 23, the prior art meets the limitations of Claim 8 as discussed above. Further, Oviso does not specifically teach the method discussed above further comprising treating the nano-wells' droplets formed by the first- and second- fluids, as in Claim 23.
However, Genghis teaches treating nano-well droplets formed by a first DNA containing fluid and a second PCR reaction solution with a third oil solution so as to treat/compartmentalize the mixture of the first and second solutions in the reaction chamber, thereby preventing leaking from the reaction chamber (See Genghis Examples 1-4 beginning [col. 27, line 53].).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the method of Oviso comprising treating the mixture of the first and second fluids, such as with oil as suggested by Genghis, so as to, for example, seal the droplets within each respective reaction chamber, thereby preventing leaking and air bubble formation and errors drawn thereto, and would have a reasonable expectation of success therein.
Regarding Claim 24, the prior art meets the limitations of Claim 23 as discussed above. Further, Oviso does not specifically teach the method discussed above wherein the step of examining is provided after the steps of treating the nano-wells' droplets formed by the first- and second- fluids, as in Claim 24.
However, Genghis teaches the method discussed above regarding Claim 23 wherein measurement (rt-PCR) proceeds after treatment of the nano-wells of the device with immiscible oil to encapsulate fluid within the nano-well reaction chambers of the device (See Example 2: [col. 28, line 15]). Therein, this arrangement allows for stabilization/equilibration of each reaction chamber prior to analysis, reducing errors due to air bubbles or diffusion through the flow channel.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the method of Oviso when modified by Genghis as in Claim 23 as having the analysis step occur after the treatemtn step is complete, such as suggested by Genghis, so as to allow for stabilization/equilibration of each reaction chamber prior to analysis, thereby reducing errors due to air bubbles or diffusion through the flow channel, and would have a reasonable expectation of success therein.
Regarding Claim 25, the prior art meets the limitations of Claim 8 as discussed above. Further, Oviso does not specifically teach the method discussed above further comprising repeating the step of loading a first fluid, wherein the first fluid is loaded into nano-wells of another SNDA component, via its associated individual primary channel, as in Claim 25.
However, Genghis teaches a respective microfluidic chip discussed above regarding Claim 8 wherein the valve 108 and division of individual channels 103 from the common channel 102, as actuated by valves 108, provides for repeating an injection step of a sample or reagent fluid into the separate chamber arrays to achieve the multiplexed analysis sought by Genghis ([col. 27, line 62]: Example 1).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the method of Oviso further comprising repeating the step of loading a first fluid, wherein the first fluid is loaded into nano-wells of another SNDA component, via its associated individual primary channel, such as suggested by Genghis, so as to achieve multiplexed analysis of multiple samples or assays, as discussed above regarding Claim 8.
Claims 13-14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Oviso in view of Genghis, as applied to Claims xx above, and in further view of Zhou et al. (US 2007/0166199 A1), hereinafter as “Zhou”.
Regarding Claims 13 and 14, the prior art meets the limitations of Claim 8 as discussed above. Further, Oviso/Genghis does not specifically teach the SNDA discussed above further comprising temporarily applying pressure to at least one of the primary channels, after at least one of the steps of: loading the first fluid and loading the second fluid, configured to evacuate excessive fluid that has remained in the primary channel/s after filling the nano-wells, wherein a positive (as in Claim 13) or negative (as in Claim 14) pressure is applied via:
the common inlet port, such that the excessive fluid in the primary channels is evacuated via the individual inlet port/s;
or, at least one of the individual inlet ports, such that the excessive fluid in the associated primary channel/s is evacuated via the common inlet port,
as in Claims 13 and 14.
However, Zhou teaches a respective microfluidic device wherein “The microfluidic assay system 102 also includes a diaphragm pump 126 that supplies a positive and/or negative pressure to the solenoids in the solenoid array 108. In addition, a controller 106 of the microfluidic assay system 102 controls the pneumatic signals generated by the solenoids in the solenoid array 108, and thereby controls the resulting fluid flow pattern on the chip 104.” ([0060]). And “The solenoids, when actuated, transmit a sequence of pneumatic signals through the pneumatic manifold 110a to the chip manifold 110b (step 286). The chip manifold 110b includes channels that route the pneumatic signals to appropriate valves on the microfluidic chip (step 288). The pneumatic signals then actuate the valves on the microfluidic chip 104 (step 290), which transport and process fluid on the microfluidic chip 104 (step 291) in accordance with the user's instructions to the computer 118.” ([0062]). – See also fig. 1. Accordingly, this arrangement allows for fine-tuned control over fluids contained in the device by applying positive/negative pressure, thereby reducing error related to improperly flowing fluid.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the SNDA of Oviso/Genghis to include temporarily applying pressure to at least one of the primary channels, configured evacuate excessive fluid that has remained in the primary channel/s after filing the nano-wells, wherein a positive (as in Claim 13) or negative (as in Claim 14) pressure is applied via the common inlet port, such as suggested by Zhou, so as to allow for fine-tuned control over fluids contained in the device by applying positive/negative pressure, thereby reducing error related to improperly flowing fluid; and would have a reasonable expectation of success therein.
Further, given that Oviso is interested in eliminating excess fluid from the channels, thereby containing sample and reagent liquids only within the chamber 15 ([0072]), one of ordinary skill in the art would find it obvious to configure the pump of Zhou to empty the channels of Oviso/Genghis when combining the relevant elements of the two, thereby acting such that such that the excessive fluid in the primary channels is evacuated via the individual inlet port/s, as in Claims 13 and 14.
Regarding Claim 20, Oviso/Genghis does not specifically teach the method discussed above further comprising a step of applying negative pressure to at least one of the secondary channels, via the outlet port/s, during the step of loading the first fluid and/or during the step of loading the second fluid, configured to enable gas evacuation out of the nano-wells, via the vents and the secondary channel/s, without drawing liquid through the vents, as in Claim 20.
However, Zhou teaches a respective microfluidic device wherein “The microfluidic assay system 102 also includes a diaphragm pump 126 that supplies a positive and/or negative pressure to the solenoids in the solenoid array 108. In addition, a controller 106 of the microfluidic assay system 102 controls the pneumatic signals generated by the solenoids in the solenoid array 108, and thereby controls the resulting fluid flow pattern on the chip 104.” ([0060]). And “The solenoids, when actuated, transmit a sequence of pneumatic signals through the pneumatic manifold 110a to the chip manifold 110b (step 286). The chip manifold 110b includes channels that route the pneumatic signals to appropriate valves on the microfluidic chip (step 288). The pneumatic signals then actuate the valves on the microfluidic chip 104 (step 290), which transport and process fluid on the microfluidic chip 104 (step 291) in accordance with the user's instructions to the computer 118.” ([0062]). – See also fig. 1. Accordingly, this arrangement allows for fine-tuned control over fluids contained in the device by applying positive/negative pressure, thereby reducing error related to improperly flowing fluid.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the method of Oviso/Genghis further comprising a step of applying negative pressure to at least one of the secondary channels, via the outlet port/s, during the step of loading the first fluid and/or during the step of loading the second fluid, configured to enable gas evacuation out of the nano-wells, via the vents and the secondary channel/s, such as suggested by Zhou, so as to provide for fine-tuned and reproducible control over fluids flowing through the device, and would have a reasonable expectation of success therein.
Further, as discussed in Oviso para. [0079], the vents do not allow fluid passage therethrough. As such, such modification of Oviso with Zhou would remain as not allowing liquid to be drawn through the vents.
Response to Arguments
Election/Restrictions
Applicant’s request for rejoinder in view of the instant amendments is moot as the amendments have not risen the invention to the level of patentability. Upon discovery of allowable subject matter, Examiner will consider Claims 1 and 3-6 for rejoinder.
35 USC 103
Applicant’s arguments are on the alleged grounds that the outlet structures associated with the multi-functional channel of Oviso allow the passage of liquid, thereby allegedly failing to satisfy the Claim 8 requirement that “the vents are configured to enable passage of gas while preventing liquid passage”.
Applicant’s arguments are not persuasive because Oviso paras. [0078-0079] discuss configuring the outlets/vents/isolation chambers (Such as seen in Figs. 3 and 4) to “retard the conduction of a fluid sample”, thereby being configured to enable passage of gas while preventing liquid passage commensurately as claimed. Further, para. [0079] specifically discusses prevention of liquid flow into the multi-functional channel: “flow of fluid through the outlet(s) 18 of the reaction chamber(s) into the multi-functional channel(s) 3 is thus prevented by the fluid isolation chamber(s) 23”. While applicant points to Oviso disclosing all of the elements as being in fluid communication, this does not necessitate liquid be capable of passing therethrough, as a gas satisfies the “fluid” and as such gaseous communication satisfies “fluid communication”. Further, while Applicant points out that the outlet 24 allows fluid into the fluid isolation chamber 23, the fluid isolation chamber 23 remains as preventing liquid flow therebeyond into or out of the SNDA component. Given this, Applicant’s points regarding isolation media in the multi-functional channel are moot.
Additionally, Applicant’s assertion regarding the loading ports 6 and 8 merely shows that excess fluid injected through the port 5 is drained through the port 6, and excess fluid injected through the port 7 is drained through the port 8. Further, even if sufficient fluid/pressure is applied to overcome the vents and enter the multi-functional channel, this is not the intended configuration of the device wherein the vents are commensurately configured to retain liquid while allowing gas flow under normal operation. Fig. 12A shows where the device is filled with sample, showing the gas meniscus 36 at the channel 19 preventing liquid from flowing ([0160]: “FIG. 12A shows the reactor modules in its completely filled state. In this embodiment, the fluid sample does not enter the microcapillary channels 19, and instead forms a meniscus 36 at the inlet of the microcapillary channel 19 (cf. FIG. 11). This distribution profile results from the walls of the microcapillary channels 19 having been modified to be less hydrophilic than the reaction chamber 15.”). Examiner further asserts that the vents of Oviso are “window-like” in that they comprise an opening for gas to traverse.
Thus, as Oviso indeed teaches the claimed venting arrangement configured to allow the flow of gas while preventing the flow of liquid through mechanisms such as relative hydrophobicity/hydrophilicity ([0160]) and texturing of the channel walls ([0078]), Examiner maintains the rejection of Claim 8 as unpatentable under 35 USC 103 over Oviso in view of Genghis.
Applicant’s arguments are further on the alleged grounds that the ports and flow channels of Genghis are for operating valves (valve-control architecture) not performing sample distribution, and thereby does not teach a common inlet or distribution channel to distribute a sample needing analysis.
Applicant’s arguments are not persuasive because while the flow channel 102 of Genghis actuates a valve 108 as in Fig. 2b, the device of Genghis remains as providing a common inlet 104 and distribution channel 103 for filling a plurality of reaction chambers “B” via primary channels similarly as in Oviso (col. 11, line 51: “primary flow channels 103 in fluid communication with a cascading series of flow channels 105, 107, 109 for loading reaction chambers 114. Each primary flow channel services a sub-array and may be loaded with a fluid comprising a reaction mixture, sample or the like, and may be independent of flow channels, thus enabling more than one sample, or more than one reaction on the same sample to be loaded and processed on the same device.”). Therein, as discussed above in the body of the action, one skilled in the art would have found it obvious to provide this common sample distribution aspect to Oviso to ensure a simultaneous or near-simultaneous analysis start time among each of the individual SNDA components.
Thus, as Genghis indeed teaches the claimed common inlet and distribution channel, Examiner maintains the rejection of Claim 8 as unpatentable under 35 USC 103 over Oviso in view of Genghis.
Applicant further argues that Claims 9-10, 13-14, and 20-25 are patentable for their dependence on the allegedly allowable Claim 8. However, as discussed above, Claim 8 is unpatentable under 35 USC 103 over Oviso in view of Genghis. As such, claims depending from Claim 8 are not patentable merely by virtue of their dependence.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798