The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 25, 2025 has been entered.
The drawings were received on December 25, 2025. These drawings are acceptable.
Claims 1, 3-13 and 15-16 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. In claim 1, the “predetermined threshold” language is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Is the predetermined threshold 25%, 50%, 75%, 80%, 85%, 90%, 95%, 97% or some other percentage of the distribution trunk volume? Alternatively, is the predetermined threshold of the embodiment shown in figure 1A in which the distribution trunk channel extends beyond the last primary channel different from the predetermined threshold of the embodiments shown in figures 1B or 1C in which the distribution trunk channel ends at the final primary channel? For examination purposes, the “predetermined threshold” language will be treated as any volume as long as “a smaller side (hDCh)” of the distribution channel’s rectangular cross section is larger than “a smaller side (hPCh)” of the primary channels’ rectangular cross section.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Avesar (PNAS 2017) in view of Yadavali (US 2018/0369810). In the paper, with respect to claim 1, Avesar teaches a device having a plurality of Stationary Nanoliter Droplet Array (SNDA) components (see figure 3C and its accompanying explanation in the paragraph bridging the columns of page E5791 and the figure); each SNDA component comprising: at least one primary channel (the channels going through the 200 wells of antibiotics 1 and 2 respectively based on the structure shown in and described with respect to figure 1); at least one secondary channel (the channels going adjacent to the outsides of the 200 wells of antibiotics 1 and 2 respectively based on the structure shown in and described with respect to figure 1); and a plurality of nano-wells (the 200 wells of antibiotics 1 and 2 respectively based on the structure shown in and described with respect to figure 1) that are each open to the primary channel and are each connected by one or more vents to the secondary channel (see at least the structure shown in and described with respect to figure 1, restrictions labeled in figure 1B are the vents based in the description of their function in the last paragraph of page E5788 and the paragraph bridging the column of page E5789); the vents are configured to enable passage of air solely from the nano-wells to the secondary channel (see at least restrictions labeled in figure 1B, these are the vents allowing air to escape based in the description of their function in the last paragraph of page E5788 and the paragraph bridging the column of page E5789), such that when a liquid is introduced into the primary channel it fills the nano-wells, and the originally accommodated air is evacuated via the vents and the secondary channels (see at least restrictions labeled in figure 1B, these are the vents allowing air to escape based in the description of their function in the last paragraph of page E5788 and the paragraph bridging the column of page E5789); wherein the plurality of the SNDA components are aligned parallel to one another and laterally displaced relative to one another, such that the device comprises a rectangular form (see the structure shown in at least figure 3C); and a single inlet port (see the circle at the left of the structure shown in figure 3C) and a distribution trunk channel (the lines going from the circle on the left to the primary channels going through the 200 wells of antibiotics 1 and 2 respectively) configured to enable a simultaneous introduction of the liquid into all primary channels (the length of the distribution channels appears to be equal in figure 3C so that the liquid would be expected to reach the primary channels simultaneously). Avesar does not teach that a single outlet port and an evacuation channel are connected all the secondary channels to enable simultaneous evacuation of the air out of all the secondary channels or that there is a size difference in the cross section or the primary channels compared to the trunk channel.
In the patent publication Yadavali teaches a large scale microfluidic droplet generation apparatus. Figure 1A is a schematic illustration of one such microfluidic device. Figure 2A is a schematic illustration of an enlarged portion of a microfluidic device having T-junction droplet generators. Paragraph [0036] teaches that in conventional single-layer microfluidic devices, the number of inlets and outlets scales with the number of droplet generators, thus, creating a practical limit on the number of droplet generators that can be integrated onto a single device. Yadavali recognized that by incorporating a second layer of microfluidic channels to supply each droplet generator, large arrays of droplet generators can be operated using only a single set of inlets and outlets. Paragraph [0041] describes figures 1A and 1B as illustrating a microdroplet generator 100 for generating microdroplets on a commercial scale. As a general overview, microdroplet generator 100 includes a substrate 102 having defined therein an inlet 110 for receiving a continuous phase fluid; an inlet 112 for receiving a dispersed phase fluid; a plurality of droplet generators 120; a plurality of channels 130; and one or more outlets 190 for delivery of the microdroplets. Paragraph [0045] teaches that the substrate of microdroplet generator includes one or more inlets 110 and 112, for receiving the continuous phase (the fluid the droplets are contained in, see paragraph [0039]) and the dispersed phase (the fluid comprising the droplets, see paragraph [0039]), and one or more outlets 190 for delivering the produced microdroplets. In one embodiment (shown in figure 1A), microdroplet generator 100 has a single continuous phase inlet 110 and a single dispersed phase inlet 112. In another embodiment, the microdroplet generator 100 includes a single outlet 190 (also shown in figure 1A). Paragraph [0046] teaches that the microdroplet generator includes a plurality of droplet generators 120, e.g., to mass produce emulsion droplets, vesicles, microbubbles, or the like. The droplet generators 120 may comprise any known droplet generator geometry. For example, the droplet generators 120 may be chosen from T-junction droplet makers (e.g., as illustrated in figure 2A), flow focusing droplet makers (e.g., as illustrated in figures 3 and 11-12), Janus particle droplet makers, multiple emulsion droplet makers, and combinations thereof. In at least one embodiment, droplet generators 120 may all be the same type of droplet makers, or may comprise at least two different types of droplet generators. Paragraph [0049] teaches that the microdroplet generator 100 includes a plurality of channels 130 configured to provide each droplet generator 120 with a disperse phase fluid and a continuous phase fluid, and to deliver the mixture, e.g., the emulsion or microdroplets, to outlet channel 192 and, ultimately, to outlet 190. For example, the plurality of channels 130 may be in fluid communication with the disperse phase inlet 112, the continuous phase inlet 110 and the outlet channels 192. As illustrated in figures 2A-3, the plurality of channels 130 includes supply channels 132, delivery channels 134, and outlet channel 194. One or more portions of the plurality of channels 130, 132, 134, 194 may comprise a set of one or more channels. Paragraph [0050] teaches that the plurality of channels 130 may have a height at least 4 times greater than the height of the droplet generators 120. For example, the plurality channels 130 may have a height ranging from 4 to 100 times greater than the height of the droplet generators 120, such as, for example, from 4 to 50 times greater, from 5 to 25 times greater, or from 10 to 20 times greater. With respect to this, paragraph [0051] teaches that the plurality of channels 130 may have a height of at least 200 μm, such as, at least 250 μm, at least 300 μm, at least 400 μm, at least 500 μm, or greater. For example, the plurality of channels 130 may have a height ranging from about 200 μm to about 1000 μm, such as from about 250 μm to about 500 μm or from about 300 μm to about 400 μm. In accordance with at least one embodiment, the droplet generators 120 may have a height of 40 μm or less, 30 μm or less, 25 μm or less, 20 μm or less, etc. In at least one embodiment, the droplet generators 120 have a height ranging from about 1 μm to about 40 μm, such as from about 5 μm to about 30 μm, or from about 10 μm to about 20 μm. Paragraph [0052] teaches that desirably, the plurality of channels 130 is configured such that the flow rates in each droplet generator 120 is uniform to ensure uniformity in the distribution of droplet size. In one embodiment, uniform droplet formation is obtained using a ladder geometry, where the spine of the ladder is formed by at least two supply channel 132a and 132b and the rungs of the ladder are formed by the delivery channels 134a and 134b. The delivery channels 134 are coupled to be in fluid communication with droplet generators 120 by way of vias (e.g., through-holes 122a, b). Once droplets are generated, the droplets flow into the outlet channels rows 194 by way of vias (e.g., through-holes 122c) to outlet channel 192 to outlet 190 (see figures 2A and 2C-2D). Paragraphs [0055]-[0058] teach that preferably, the hydrodynamic resistance of the supply channels 132 is insignificant compared to that of the droplet generators 120. Additionally or alternatively, the pressure drop along the supply channel 132 remains small compared to the pressure drop across the individual droplet generators 120, such that Psupply channel<Pdroplet generators. The microdroplet generator 100 may be designed such that Equation 1 is satisfied.
2Ndg(Rdc/Rdg)<0.01 (Equation 1)
In equation 1, Rdc is the fluidic resistance along the delivery channel 134 between each droplet generator 120, Rdg is the fluidic resistance of individual droplet generators 120, and Ndg is the number of droplet generators 120 in one row (see figure 2A). The flow resistance of each rectangular channel can be estimated using R=12 μl/wh3, where μ is the dynamic viscosity of the fluid and w, h, and l are the width, height, and length of the channel. In one embodiment, height h is less than width w. To evenly distribute flow to each of the delivery channels 134, the resistance (Rsc) of the supply channel 132 and the total resistance of each delivery channel 134 (Rdc) is considered. Preferably, the resistance Rsc of the supply channel 132 is less than each of the associated resistances Rdc of the connected delivery channels 134, thereby promoting even distribution to each delivery channel 134. Additionally or alternatively, the resistance (Roc) of the outlet channel 192 may be less than the resistance (Ror) of each of the connected outlet channel rows 194. Paragraph [0059] teaches that in one embodiment, the supply channels 132 have a width of 2 mm, height of 0.4 mm, and length of 70 mm; the continuous phase delivery channels 134b have a width of 400 um, height of 400 um, and length of 55 mm; the dispersed phase delivery channels 134a have a width of 400 um, height of 400 um, and length of 55 mm; and the outlet channels 194 have a width of 400 um, height of 400 um, and length of 55 mm. The dimensions of the microdroplet generator (e.g., as depicted in FIG. 2 and FIG. 3) 120 may have a width 10 um, height of 8 um, and length of 2000 um for the continuous phase 140b; 10 um width, height of 8 um, and 300 um in length for the dispersed phase 140a. Based on these dimensions, up to 42,857 droplet generators 120 may be connected to each pair of delivery channels 134a and 134b. For example, if the maximum number of pairs of delivery channels 134 is 64, then 2,742,848 droplet generators 120 may be in fluid communication with such delivery channels 134. Examiner notes that the device of figure 1A appears to have 20 continuous phase delivery channels 134b, 20 the dispersed phase delivery channels 134a and 10 outlet channels 194 respectively connected to a single continuous phase inlet 110 by single supply channel 132, a single dispersed phase inlet 112 by a single delivery channel 134 and a single outlet 190 by a single outlet channel 192. Additionally, figure 1A in combination with figure 2A appears to show that outlet channels 194 receive droplets from two sets of adjacent droplet generators.
With respect to claim 1, it would have been obvious to one of ordinary skill in the art at the time the application was filed to join all of the vent structures of Avesar to a single channel and a single vent outlet as shown by as taught for the outlet channels of the Yadavali device as well as joining the liquid supply channels of Avesar in a configuration as shown by the continuous phase and dispersed phase channels of Yadavali figure 1A of Yadavali because it would have been recognized as enabling the ability to increase the number of parallel SNDA components without increasing the number of outlets to gain the advantage of having large arrays of SNDA components accessible using only a single set of inlets and outlets. Relative to the size of the smaller side of the distribution trunk and the primary channel, it would have been obvious to one of ordinary skill in the art to follow the teachings of Yadavali relative to the comparative size and/or pressure drop of the respective supply channel and delivery channel in the fluidic structure of Yadavali device because of the ability to provide an even distribution of flow from the supply channel to the delivery channels as taught by Yadavali.
With respect to claim 15, all of the SNDA components shown in figure 3C of Avesar are substantially identical.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Avesar in view of Yadavali as applied to claim 1 above, and further in view of Yue (US 2007/0014695). While Avesar teaches low-pressure loading enabled by restrictions in the well, allowing the volume of air in the wells to escape and be replaced by that of the liquid, Avesar does not teach a pressure device in communication with the outlet port, configured to apply simultaneous negative pressure to all the secondary channels via the evacuation channel.
In the patent publication Yue teaches systems and methods for multiple analyte detection include a system for distribution of a biological sample that includes a substrate, wherein the substrate includes a plurality of sample chambers, a sample introduction channel for each sample chamber, and a venting channel for each sample chamber. The system may further include a preloaded reagent contained in each sample chamber and configured for nucleic acid analysis of a biological sample that enters the substrate and a sealing instrument configured to be placed in contact with the substrate to seal each sample chamber so as to substantially prevent sample contained in each sample chamber from flowing out of each sample chamber. The substrate can be constructed of detection-compatible and assay-compatible materials. Relative to the distribution of sample, paragraph [0083] teaches that there are a variety of means for distributing the biological sample to the plurality of sample chambers. All of these include applying a force. The force can be a pulling force or a pushing force, depending on whether it provides a negative (pulling) or positive (pushing) force relative to the direction of fluid flow. Examples of forces and how the force is enacted upon the biological sample include spinning the substrate to provide centrifugal force to push the liquid, sizing the sample introductory channels to provide capillary force to pull the liquid, aspirating the sample through the vents to pull the liquid, evacuating the sample chamber to pull the liquid, and/or providing pressure, such as by pumping, compressing, plunging, etc. to push the liquid. In each of these configurations, the venting channels and vents can be used to accommodate the displaced venting gas, whether air or other gas such as nitrogen, that is pushed out by the sample or the venting channels and vents can be used to evacuate the gas in the sample chambers to create a vacuum for the sample or aspirate sample itself. Paragraph [0205] Various exemplary embodiments permit gas (e.g., air) to escape the substrate while preventing sample leakage therethrough. With reference to figure 44, an exemplary embodiment of a substrate 4410 for biological sample analysis is depicted. The substrate 4410 includes a base 4430 and a film layer 4420 covering the base 4430. The substrate 4410 defines a sample distribution network including an array of sample chambers 4480 in flow communication with a plurality of main fluid supply channels 4470 via sample introduction branch channels 4475. Each sample chamber 4480 also is in flow communication with a main venting channel 4472 via branch venting channels 4476. Thus, rather than each sample chamber 4480 terminating in an individual venting chamber, as described in other embodiments herein, a group of sample chambers 4480 terminates in a common venting channel 4472.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the Avesar device by connecting a pressure device to the secondary channel to remove air or gas simultaneously through the vents as taught by Yue because of its known ability to evacuate air or gas from a plurality of sample chambers through a venting channel as taught by Yue and the fact that it is one of a limited number of passible methods to perform that function as shown by Yue.
Applicant's arguments filed December 25, 2025 have been fully considered but they are not persuasive. In response to the amendments and replacement/new drawings the drawing objection has been withdrawn, the rejection under 35 U.S.C. 112(a) has been withdrawn, the rejection under 35 U.S.C. 112(b) has been modified and the obviousness rejection has been substantially maintained. The arguments are moot with respect to the withdrawn objections/rejection.
Relative to the clarity of the claims, the rejection under 35 U.S.C. 112(b) was modified to cover/focus on the prior issue which applicant did not address by either amendment or argument. The “predetermined threshold” language fails to clearly identify what volume is required to be filled prior to the fluid entering the primary channels. Examiner notes that paragraph [0059] of the instant specification gives a non-limiting example of 95%-99%. However, the threshold volume appears to be an inherent property related to the relative dimensions of the respective channels (predetermined by the relative dimensions of the respective channels). As such, for examination purposes, as long as the reference(s) teach and/or show the obviousness of “a smaller side (hDCh)” of the distribution channel’s rectangular cross section is larger than “a smaller side (hPCh)” of the primary channels’ rectangular cross section, the language has been treated as met.
Relative to the obviousness rejection, applicant has pointed to the following functional language as not being taught, “such that the distribution trunk channel is configured to be filled via the inlet port with liquid, while withholding the liquid from the primary channels, to a predetermined threshold of its volume, enabling a liquid pressure formed there-within, to then simultaneously load all the primary channels” (emphasis provided). Examiner notes that relative to this functional language, the fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). For example, the teachings of Yadavali directed toward the pressure difference of a fluid based on the cross section of two channels shows that modifying Avesar with the teachings of Yadavali would have been expected to produce an effect that would meet the functional language.
Relative to the argument that Yadavali cannot be combined with Avesar because it would fundamentally alter the operation of Avesar’s SNDA, it appears that applicant is arguing that incorporating the teachings of Yadavali would require some sort of bodily incorporation of the Yadavali structure. Relative to this argument, the Court has held, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In other words, Yadavali recognized that having multiple fluid input and outlet structures would be an impediment to scaling the structure of microfluidic elements. To overcome this limiting factor, they used a structure that included a single inlet and a single outlet connected to a plurality of parallel processing structures. Avesar is concerned with moving both liquid and gases through the microfluidic structure. Those of ordinary skill in the art would have recognized that the multiple outlets of Avesar would have caused a similar problem that could be overcome by following the teachings of Yadavali. This is a problem and solution that would have been recognized to apply to both gas and liquid flow in microfluidic devices. In other words, examiner is using the teaching Yadavali teaching that a single outlet can connect to a plurality of parallel channels to overcome a recognized scaling issue to modify the Avesar structure. There is no need to fundamentally alter the SNDA operation of Avesar. Thus the fact that Yadavali does not discuss air removal does not prevent it from being used to modify Avesar. Thus the argument is not persuasive.
Relative to the elements that are not taught by Yadavali, examiner notes that it they were taught by Yadavali, that reference would potentially anticipate the instant claims. As the Court has held, the test for obviousness is not that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Also the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). First, Yadavali is not required to teach structure that is already taught by Avesar. All that is required of Yadavali is to show how to modify the Avesar structure to meet the claimed structure and a reason to make the modification. Examiner notes that figure 3C of Avesar is described in the paragraph bridging the columns of page E5791 as a demonstration of the concept of multiplexing. In other words it is not particularly limiting to a structure having only two parallel SNDA components. However, one of ordinary skill in the art would have recognized that scaling up (increasing) the number of SNDA components would mean a corresponding increase in the number of ports in the channels to remove air from the wells. In that respect the applied Yadavali patent publication clearly shows how to overcome a microfluidic structure that is limited in scaling by the number of inlet ports and/or outlet ports. Yadavali shows what appears to be a structure having a plurality of 20 fluid distribution channels connected to a single inlet port coupled through droplet generators to 10 outlet channels connected to a single outlet port. Thus showing how to modify the structure of Avesar to overcome what would have been a recognized problem with scaling up the Avesar structure. The teaching that joining the plural parallel fluidic structures to a single fluid inlet and outlet overcomes the recognized problem. Thus there is sufficient motivation to modify the Avesar structure based on the Yadavali teachings.
With respect to the relative size of the primary channel to the common distribution channel, paragraph [0062] of the instant specification teaches that the wall dimension of the wide distribution channel 25 is selected to be larger than the wall dimension of the primary channel/s 16, such that the wide distribution channel 25 is configured to be filled with liquid to a predetermined threshold of its volume, before the liquid pressure that is formed there-within enables to liquid to enter into the primary channel/s 16, in other words, before the liquid pressure that is formed there-within raises high enough, to enable the liquid to flow against the primary channel/s resistance. In other words, the larger dimensions of the common distribution channels result in the channel being filled with a lower pressure than required to fill the primary channels. Thus a similar structure would be expected to have the same property. Paragraph [0055] of Yadavali teaches that preferably, the hydrodynamic resistance of the supply channels 132 is insignificant compared to that of the droplet generators 120. Additionally or alternatively, the pressure drop along the supply channel 132 remains small compared to the pressure drop across the individual droplet generators 120. Examiner notes that this appears to be equivalent to the pressure teachings in paragraph [0062] of the instant specification and results from the size/cross section of the rectangular distribution channels being smaller than the size/cross section of the supply channel (see paragraphs [0055]-[0059] of Yadavali and paragraph [0058] in particular). Additionally, paragraph [0057] of Yadavali teaches that in one embodiment, height h is less than width w. This clearly points to the smaller side of the rectangular cross section of each respective channel as the obvious choice to adjust the cross section of the respective channels to meet the flow resistance teachings of paragraph [0058]. Thus, again Yadavali shows the obviousness modifying the teachings of Avesar to meet the structural requirements of claim 1 and has teachings that point to the pressure needed to fill of the supply channel being less that the pressure needed to cause liquid to flow in the droplet generator channels. Thus, although it is not specifically taught by Yadavali, there is evidence that points to the property being claimed as a result of the Yadavali structure. For this reason the argument is not persuasive.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additionally cited art is directed toward microfluidic structures with various configurations of channels and chambers for moving fluid through the channels to either have fluids divided into portions for separate treatment and/or arrive at different chambers of the device in an equivalent amount of time or through a pathlength that is substantially equivalent to perform various types of analysis on the sample fluid.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Arlen Soderquist whose telephone number is (571)272-1265. The examiner can normally be reached 1st week Monday-Thursday, 2nd week Monday-Friday.
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/ARLEN SODERQUIST/ Primary Examiner, Art Unit 1797