DETAILED CORRESPONDENCE
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 Amendment
As to the claim amendments filed on 8/11/25, the previous 112(b) rejections are withdrawn.
As to the claim amendments and applicants remarks filed on 8/11/25, the previous rejection is maintained with modifications to address the claim amendments.
Claim Status
Claims 1-3, 5-15 are pending.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-15 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Pollack et al (US 20090291433; hereinafter “Pollack”).
As to claim 1, Pollack teaches a digital microfluidic device (Pollack; Figs. 1-20) comprising:
an array of controllable electrode pads alignable with a fluid passageway (Pollack; Fig. 1-20);
a controller comprising a processor configured to execute instructions stored in a memory to cause electrowetting movement of a droplet within the fluid passageway through a circuit of multiple different zones of the electrode pads via iteratively: exposing the droplet within a current zone of the different zones for a selectable current time period at a current temperature of a list of consecutive temperatures; further exposing the droplet within the current zone, for each respective selectable subsequent time period, at each respective subsequent temperature of the list which is greater than the current temperature; and moving the droplet into a subsequent zone of the different zones in response to one of the respective subsequent temperatures being less than the current temperature (Pollack teaches a control program to control various electrodes and specific programming for zones; Fig. 20. Pollack teaches that one heater can be used to thermally cycle the drops; [115-118]. Thermal cycling would involve raising temperatures from an initial room temperature to an amplification or denaturing temperature and then subsequently lowering temperatures to an annealing temperature, and where tracks can connect high temperature zones to lower temperature zones; [115-118, 121, 101, 421]. Pollack also teaches that multiple heaters can be used to create respective zones, where a zone would have multiple temperature gradients to achieve the thermal cycling based on the temperature gradient, where multiple electrodes connected across the device make up a singular zone that includes multiple temperature gradients; [459-460]. Pollack teaches that the drop can be heated to created a heated droplet and then the droplet is then amplified at a higher temperature [12], where the droplets during amplification/thermal cycling undergo denaturing, annealing, and extending through various zones [115]. Pollack teaches that between zones there are heaters that can assist in ramping the droplets as they pass to the next zone [117, 118, 121, 101-102], where the heaters that increase/ramp the temperature prior to the next zone could still all be considered part of the same “zone” as instantly claimed as a “zone” is just a region of space. Therefore, as the temperature is increased across several heaters, those several heaters all read on the claimed “zone” that is heated from one temperature to another higher temperature as claimed. Further, the thermal cycling operation requires for cooling [117, 121, 103] where the region of space at which the droplet is moved for cooling is considered the next subsequent zone as claimed, where the drop is then moved to the subsequent zone for the subsequent lower temperature. In another interpretation, Pollack teaches that the drop is heated to 25 degrees as an initial temperature [12] and then denatured at a higher temperature in the same claimed zone where the region of space in which the drop is located encompasses the current claimed zone which heats to the higher temperature. As the droplet moves to be annealed at a cooler temperature, then as the droplet moves to the next subsequent zone which is the region of space encompassing the heaters for annealing, where the drop is then moved to the subsequent zone for the subsequent lower temperature. Then, the next zone is the region of space in which the droplet is moved for the higher tending phase).
Note: The instant Claims 1-13 contain functional language and/or language related to intended use. However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 2, Pollack teaches the device of claim 1, wherein the droplet comprises a nucleic acid amplification mixture and the controller is configured to cause the list of consecutive temperatures to comprise a first temperature and a second temperature, which exhibit a first substantial temperature difference, and wherein a respective one of the subsequent temperatures in the current zone which has a highest value of the respective temperatures of the list comprises the first temperature of a nucleic acid amplification process and is the last respective subsequent temperature in the current zone prior to the moving the droplet into the subsequent zone (Pollack teaches amplification; [12], Fig. 4. Pollack teaches thermal cycling; [115-118, 121, 101, 421]).
As to claim 3, Pollack teaches the device of claim 1, wherein the list of consecutive temperatures corresponds to a sequence of temperatures for performing nucleic acid amplification, and wherein the controller is configured to cause the list of consecutive temperatures to comprise three different temperatures including: a first temperature; a second temperature, wherein the second temperature is a first substantial difference from, and less than, the first temperature; and a third temperature, and wherein the third temperature comprise a second substantial difference from, and is greater than, the second temperature, and wherein the third temperature comprises a third substantial difference from, and is less than the first temperature, wherein a respective one of the subsequent temperatures of the list of consecutive temperatures which has a highest value comprises the first temperature; and where the controller is configured to, based on the list: increase the temperature of the current zone from the third temperature to the first temperature; maintain the first temperature in the current zone for a second time period; and in response to an end of the second time period and based on the second temperature being less than the first temperature, move the droplet from the current zone into the subsequent zone having the second temperature (Pollack teaches a control program to control various electrodes and specific programming for zones; Fig. 20. Pollack teaches that one heater can be used to thermally cycle the drops; [115-118]. Thermal cycling would involve raising temperatures from an initial room temperature to an amplification or denaturing temperature and then subsequently lowering temperatures to an annealing temperature, and where tracks can connect high temperature zones to lower temperature zones; [115-118, 121, 101, 421]. Pollack also teaches that multiple heaters can be used to create respective zones, where a zone would have multiple temperature gradients to achieve the thermal cycling based on the temperature gradient, where multiple electrodes connected across the device make up a singular zone that includes multiple temperature gradients; [459-460]. Pollack teaches that the drop can be heated to create a heated droplet and then the droplet is then amplified at a higher temperature [12], where the droplets during amplification/thermal cycling undergo denaturing, annealing, and extending through various zones [115]. Pollack teaches that between zones there are heaters that can assist in ramping the droplets as they pass to the next zone [117, 118, 121, 101-102], where the heaters that increase/ramp the temperature prior to the next zone could still all be considered part of the same “zone” as instantly claimed as a “zone” is just a region of space. Therefore, as the temperature is increased across several heaters, those several heaters all read on the claimed “zone” that is heated from one temperature to another higher temperature as claimed. Further, the thermal cycling operation requires for cooling [117, 121, 103] where the region of space at which the droplet is moved for cooling is considered the next subsequent zone as claimed, where the drop is then moved to the subsequent zone for the subsequent lower temperature. In another interpretation, Pollack teaches that the drop is heated to 25 degrees as an initial temperature [12] and then denatured at a higher temperature in the same claimed zone where the region of space in which the drop is located encompasses the current claimed zone which heats to the higher temperature. As the droplet moves to be annealed at a cooler temperature, then as the droplet moves to the next subsequent zone which is the region of space encompassing the heaters for annealing, where the drop is then moved to the subsequent zone for the subsequent lower temperature. Then, the next zone is the region of space in which the droplet is moved for the higher tending phase).
As to claim 5, Pollack teaches the device of claim 1, wherein the multiple different zones comprise: at least a pair of the respective different zones in which the respective temperatures of the list are applied; and a passive zone interposed between the pair of zones and through which the droplet is to move as the droplet travels between the pair of zones (Pollack teaches the zones with multiple electrodes and creating a gradient between the electrodes thereby having multiple zone with different temperatures, and where there are electrodes that would separate each of these zones spaced between the heaters thereby serving as passive zones; [459-460], Fig. 1, 2B, 6, 9, 17).
As to claim 6, Pollack teaches the device of claim 1, wherein the multiple different zones comprises: a pair of outer zones and a common zone interposed between, and spaced apart from, the outer zones, wherein movement of the droplet occurs between a respective one of the outer zones and the common zone; and a pair of passive zones with each respective passive zone interposed between the common zone and a respective one of the outer zones (Pollack teaches different configurations of zones with multiple electrodes and creating a gradient between the electrodes thereby having multiple zone with different temperatures, and where there are electrodes that would separate each of these zones spaced between the heaters thereby serving as passive zones that are spaced apart from the outer heated zones through a common zone defined by another region of electrodes spaced between heaters; [459-460], Fig. 1, 2B, 6, 9, 17).
As to claim 7, Pollack teaches the device of claim 1, the c controller is configured to cause: at least during exposure of the droplet to a respective one of the current temperature and respective subsequent temperatures within the respective zones, shuttling the droplet among different electrode pads within a respective one of the zones in which the droplet is present (Pollack teaches shuttling the electrodes to different pads within a respective zone, where different configurations of zones with multiple electrodes and creating a gradient between the electrodes thereby having multiple zone with different temperatures, and where there are electrodes that would separate each of these zones spaced between the heaters thereby serving as passive zones that are spaced apart from the outer heated zones through a common zone defined by another region of electrodes spaced between heaters; [459-460], Fig. 1, 2B, 6, 9, 17).
As to claim 8, Pollack teaches the device of claim 7, wherein the droplet comprises a first droplet of a plurality of droplets, and the controller is configured to cause the exposure of the first droplet to occur as simultaneous exposure of the plurality of droplet within the respective current zone and subsequent zone at the respective temperatures for the respective selectable time periods (Pollack teaches a plurality of sample droplets that can be processed, where the droplets can be merged and split accordingly between electrodes within a zone; [21, 343], Fig. 11, 12, 14, 15).
As to claim 9, Pollack teaches the device of claim 8, wherein the controller is configured to cause: maintaining separation of the first droplet from a second droplet of the plurality of droplets within the current zone during the exposing the plurality of droplets and during the moving of the droplets from the current zone of the subsequent zone (Pollack teaches a plurality of sample droplets that can be processed, where the droplets can be merged and split accordingly between electrodes within a zone; [21, 343], Fig. 11, 12, 14, 15).
As to claim 10, Pollack teaches the device of claim 8, wherein the controller is configured to cause, via the shuttling movement of the droplet back and forth between adjacent electrode pad, the first droplet to become merged with and subsequently separated from a second droplet of plurality of droplets, wherein the second droplet comprises a liquid compatible with the liquid of the first droplet (Pollack teaches a plurality of sample droplets that can be processed, where the droplets can be merged and split accordingly between electrodes within a zone; [21, 343], Fig. 11, 12, 14, 15).
As to claim 11, Pollack teaches a digital microfluidic device (Pollack; Figs. 1-20) comprising: a two-dimensional array of independently controllable electrodes couplable to a consumable microfluidic receptacle including a fluid passageway to receive at least one droplet, the fluid passageway defining a two-dimensional array of electrode locations corresponding the two-dimensional array of electrodes; and a controller comprising a processor configured to execute instructions stored in a memory to cause electrowetting movement of a droplet within the fluid passageway through a circuit of multiple different heating zones of the electrode locations via iteratively: exposing the droplet within a current heating zone of the different zones for a selectable current time period at a current temperature of a list of consecutive temperatures; further exposing the droplet within the current heating zone, for each respective selectable subsequent time period, at each respective subsequent temperature of the list which is greater than the current temperature; and moving the droplet into a subsequent heating zone of the different zones in response to one of the respective subsequent temperatures being less than the current temperature, wherein upon moving the droplet to the subsequent zone, the subsequent zone of circuit corresponds to a new current zone and the first respective subsequent temperature corresponds to a new current temperature (Pollack teaches a control program to control various electrodes and specific programming for zones; Fig. 20. Pollack teaches that one heater can be used to thermally cycle the drops; [115-118]. Thermal cycling would involve raising temperatures from an initial room temperature to an amplification or denaturing temperature and then subsequently lowering temperatures to an annealing temperature, and where tracks can connect high temperature zones to lower temperature zones; [115-118, 121, 101, 421]. Pollack also teaches that multiple heaters can be used to create respective zones, where a zone would have multiple temperature gradients to achieve the thermal cycling based on the temperature gradient, where multiple electrodes connected across the device make up a singular zone that includes multiple temperature gradients; [459-460]. Pollack teaches that the drop can be heated to create a heated droplet and then the droplet is then amplified at a higher temperature [12], where the droplets during amplification/thermal cycling undergo denaturing, annealing, and extending through various zones [115]. Pollack teaches that between zones there are heaters that can assist in ramping the droplets as they pass to the next zone [117, 118, 121, 101-102], where the heaters that increase/ramp the temperature prior to the next zone could still all be considered part of the same “zone” as instantly claimed as a “zone” is just a region of space. Therefore, as the temperature is increased across several heaters, those several heaters all read on the claimed “zone” that is heated from one temperature to another higher temperature as claimed. Further, the thermal cycling operation requires for cooling [117, 121, 103] where the region of space at which the droplet is moved for cooling is considered the next subsequent zone as claimed, where the drop is then moved to the subsequent zone for the subsequent lower temperature. In another interpretation, Pollack teaches that the drop is heated to 25 degrees as an initial temperature [12] and then denatured at a higher temperature in the same claimed zone where the region of space in which the drop is located encompasses the current claimed zone which heats to the higher temperature. As the droplet moves to be annealed at a cooler temperature, then as the droplet moves to the next subsequent zone which is the region of space encompassing the heaters for annealing, where the drop is then moved to the subsequent zone for the subsequent lower temperature. Then, the next zone is the region of space in which the droplet is moved for the higher tending phase).
As to claim 12, Pollack teaches the device of claim 1, wherein the multiple different heating zones comprises: a pair of outer heating zones; and a common heating zone interposed between, and spaced apart from, the outer heating zones, wherein movement of the droplet occurs between a respective one of the outer heating zones and the common heating zone; and a pair of passive zones with each respective passive zone interposed between the common heating zone and a respective one of the outer heating zones (Pollack teaches different configurations of zones with multiple electrodes and creating a gradient between the electrodes thereby having multiple zone with different temperatures, and where there are electrodes that would separate each of these zones spaced between the heaters thereby serving as passive zones that are spaced apart from the outer heated zones through a common zone defined by another region of electrodes spaced between heaters; [459-460], Fig. 1, 2B, 6, 9, 17).
As to claim 13, Pollack teaches the device of claim 1, wherein the controller is configured to cause the exposure of a plurality of droplets, including the droplet, simultaneously within the respective current zone (Pollack teaches a plurality of sample droplets that can be processed, where the droplets can be merged and split accordingly between electrodes within a zone; [21, 343], Fig. 11, 12, 14, 15).
As to claim 14, Pollack teaches a method (Pollack; abstract, Figs. 1-20) comprising: performing electrowetting movement of a droplet within a fluid passageway, aligned with an array of controllable electrode pads, through a circuit of multiple different zones of the electrode pads via repeating a sequence of: exposing the droplet within a current zone of the different zones for a selectable current time period at a current temperature of a list of consecutive temperatures; further exposing the droplet within the current zone, for each respective subsequent time period, at each respective subsequent temperature of the list which is greater than the current temperature, wherein the subsequent temperature becomes the current temperature in the current zone; and moving the droplet into a subsequent zone of the different zones responsive to one of the respective subsequent temperatures being less than the current temperature in the current zone (Pollack teaches a control program to control various electrodes and specific programming for zones; Fig. 20. Pollack teaches that one heater can be used to thermally cycle the drops; [115-118]. Thermal cycling would involve raising temperatures from an initial room temperature to an amplification or denaturing temperature and then subsequently lowering temperatures to an annealing temperature, and where tracks can connect high temperature zones to lower temperature zones; [115-118, 121, 101, 421]. Pollack also teaches that multiple heaters can be used to create respective zones, where a zone would have multiple temperature gradients to achieve the thermal cycling based on the temperature gradient, where multiple electrodes connected across the device make up a singular zone that includes multiple temperature gradients; [459-460]).
As to claim 15, Pollack teaches the method of claim 14, wherein, for each respective one of the multiple zones, the last predetermined temperature of the series is greater than a first predetermined temperature of the series of the another respective one of the zones (Pollack teaches thermal cycling where the temperature within the zones is ramped such that the last temperature is higher than the first temperature; [117-118]).
Response to Arguments
Applicant's arguments filed 8/11/25 have been fully considered but they are not persuasive. Applicants argue on page 8 of their remarks that Pollack does not disclose moving a droplet between different zones by moving the droplet into the subsequent zone in response to a subsequent temperature of the defined list being less than the current temperature. However, the examiner respectfully disagrees. Pollack teaches a control program to control various electrodes and specific programming for zones; Fig. 20. Pollack teaches that one heater can be used to thermally cycle the drops; [115-118]. Thermal cycling would involve raising temperatures from an initial room temperature to an amplification or denaturing temperature and then subsequently lowering temperatures to an annealing temperature, and where tracks can connect high temperature zones to lower temperature zones; [115-118, 121, 101, 421]. Pollack also teaches that multiple heaters can be used to create respective zones, where a zone would have multiple temperature gradients to achieve the thermal cycling based on the temperature gradient, where multiple electrodes connected across the device make up a singular zone that includes multiple temperature gradients; [459-460]. Pollack teaches that the drop can be heated to create a heated droplet and then the droplet is then amplified at a higher temperature [12], where the droplets during amplification/thermal cycling undergo denaturing, annealing, and extending through various zones [115]. Pollack teaches that between zones there are heaters that can assist in ramping the droplets as they pass to the next zone [117, 118, 121, 101-102], where the heaters that increase/ramp the temperature prior to the next zone could still all be considered part of the same “zone” as instantly claimed as a “zone” is just a region of space. Therefore, as the temperature is increased across several heaters, those several heaters all read on the claimed “zone” that is heated from one temperature to another higher temperature as claimed. Further, the thermal cycling operation requires for cooling [117, 121, 103] where the region of space at which the droplet is moved for cooling is considered the next subsequent zone as claimed, where the drop is then moved to the subsequent zone for the subsequent lower temperature. In another interpretation, Pollack teaches that the drop is heated to 25 degrees as an initial temperature [12] and then denatured at a higher temperature in the same claimed zone where the region of space in which the drop is located encompasses the current claimed zone which heats to the higher temperature. As the droplet moves to be annealed at a cooler temperature, then as the droplet moves to the next subsequent zone which is the region of space encompassing the heaters for annealing, where the drop is then moved to the subsequent zone for the subsequent lower temperature. Then, the next zone is the region of space in which the droplet is moved for the higher tending phase.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). As to some of the claim amendments made, applicants amendment necessitated the new ground(s) of rejection presented in this Office action.
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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/Benjamin R Whatley/Primary Examiner, Art Unit 1798