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 .
Double Patenting
1. Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 12 and 13 of copending Application No. 18/292847 in view of U.S. Patent Application Publication No. 2017/0058277 to Dalton.
I.) Regarding applicant’s claim 1, claim 1 of copending Application No. 18/292847 recites at least one well to receive a polymerase chain reaction (PCR) mixture and including a bottom comprising: an electrically resistive sheet, which is to receive a signal from a signal source to cause the resistive sheet to generate heat to form a pulse-controlled amplification, thermal cycling zone within the at least one well in close thermal proximity to the bottom, wherein the resistive sheet comprises a single, unitary first opening aligned in a central portion of the well; and a carrier layer co-extensive with at least the first opening of the resistive sheet to contain the reaction mixture within the at least one well and including a transparent portion; and an optical detector aligned with the first opening in the resistive sheet to optically detect, through the transparent portion of the carrier layer, a fluorophore signal intensity within the at least one well as an output of a reaction process from the PCR mixture.
Dalton teaches wells that are molded from fluoropolymer and suitable for PCR processing. [0004], [0011].
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to make the well in claim 1 of copending Application No. 18/292847 from fluoropolymer as taught by Dalton.
Dalton teaches that fluoropolymers effect the contact angle of liquids. [0026]
Since the fluoropolymer provides a contact angle of a least 45 degrees in applicant’s invention, the fluoropolymer in claim 1 of copending Application No. 18/292847 in new of Dalton would provide a similar contact angle of at least 45 degrees.
Therefore, claim 1 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 1 obvious.
II.) Regarding applicant’s claim 2, as noted above claim 1 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 1 obvious from which claim 2 depends.
Applicant’s claim 2 recites that via the pulse-controlled amplification, within the at least one well, the thermal cycling zone subject to a denaturation temperature comprises less than about 5 percent of an overall volume of the PCR mixture.
In claim 1 of copending Application No. 18/292847 in view of Dalton the pulse-controlled amplification within the at least one well can be controlled to provide any temperature including, a denaturation temperature comprises less than about 5 percent of an overall volume of the PCR mixture.
The temperature does not encompass any structural limitations to the claims device.
Therefore, claim 1 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 2 obvious.
III.) Regarding applicant’s claim 3, as noted above claim 1 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 1 obvious from which claim 3 depends.
Applicant’s claim 3 recites that the contact angle is greater than 45 degrees to cause an overall volume of the PCR mixture to exhibit a generally uniform height profile within the at least one well in which a height of the overall volume exhibits a variance of less than 5 percent across a diameter of the at least one well.
The fluoropolymer in claim 1 of copending Application No. 18/292847 in view of Dalton would function in the same manner as in applicant’s invention and would cause an overall volume of the PCR mixture to exhibit a generally uniform height profile within the at least one well in which a height of the overall volume exhibits a variance of less than 5 percent across a diameter of the at least one well.
Therefore, claim 1 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 3 obvious.
IV.) Regarding applicant’s claim 4, as noted above claim 1 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 1 obvious from which claim 4 depends.
Applicant’s claim 4 recites that the polymer material comprises cyclic olefin copolymer (COC).
Dalton does not teach that the polymer material comprises cyclic olefin copolymer (COC).
However, Dalton teaches that the fluoropolymer provides a fluorophilic inner surface to the wells. (Abstract).
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to make the well in claim 1 of copending Application No. 18/292847 in view of Dalton to have any suitable fluoropolymer surface, including one of a cyclicolefin copolymer that would provide a fluorophilic inner surface as taught by Dalton.
Therefore, claim 1 of copending Application No. 18/292847in view of Dalton renders applicant’s claim 4 obvious.
V.) Regarding applicant’s claim 5, as noted above claim 1 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 3 obvious from which claim 5 depends.
Applicant’s claim 5 recites that the polymer material comprises a carbon-based fluoropolymer material.
Dalton does not teach that the polymer material comprises a carbon-based fluoropolymer material.
However, Dalton teaches that the fluoropolymer provides a fluorophilic inner surface to the wells. (Abstract).
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to make the well in claim 1 of copending Application No. 18/292847 to have any suitable fluoropolymer surface, including a carbon-based fluoropolymer material that would provide a fluorophilic inner surface as taught by Dalton.
Therefore, claim 1 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 5 obvious.
VI.) Regarding applicant’s claim 6, as noted above claim 1 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 3 obvious from which claim 6 depends.
Applicant’s claim 6 recites that the fluoropolymer component further comprises a fluoroacrylic copolymer solution in a fluorosolvent.
Dalton does not teach that the fluoropolymer component further comprises a fluoroacrylic copolymer solution in a fluorosolvent.
However, Dalton teaches that the fluoropolymer provides a fluorophilic inner surface to the wells. (Abstract).
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to make the well in claim 1 of copending Application No. 18/292847 to have any suitable fluoropolymer surface, including a fluoropolymer component that would provide a fluorophilic inner surface including a fluoroacrylic copolymer solution in a fluorosolvent.
Therefore, claim 1 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 6 obvious.
VII.) Regarding applicant’s claim 7, as noted above claim 1 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 1 obvious from which claim 7 depends.
Applicant’s claim 7 recites that the side walls comprise an injection-molded structure of a compounded mixture comprising a polymer solids material and at least one of a fluoropolymer material and a fluorosurfactant material.
Dalton teaches that the multiwell support was prepared using an injection molding procedure with a fluoropolymer. [0011]
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to make the well in claim 1 of copending Application No. 18/292847 by an injection molding process using a fluoropolymer as taught by Dalton.
Therefore, claim 1 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 7 obvious.
VIII.) Regarding applicant’s claim 8, as noted above copending Application No. 18/292847 renders applicant’s claim 1 obvious from which claim 8 depends.
Applicant’s claim 8 recites an external magnet aligned to apply a magnetic force to superparamagnetic beads, functionalized with single-stranded nucleic acids, within the PCR mixture to draw the beads toward, and into, the thermal cycling zone.
Claim 8 of copending Application No. 18/292847 which depends from claim 1 recites that the PCR mixture comprises beads functionalized with single-stranded nucleic acids of the PCR mixture and wherein the beads comprise superparamagnetic material with a relative magnetic permeability greater than 1, and the device comprising: at least one external magnet aligned to apply a magnetic force to the beads with the single-stranded nucleic acids, into the thermal cycling zone, within the at least one well to cause the beads with the nucleic acid strands to travel into, and remain present within, the pulse- controlled amplification, thermal cycling zone.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify the well recited in claim 8 of copending Application No. 18/292847 to be made from a fluoropolymer as taught by Dalton.
Therefore, claim 8 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 8 obvious.
IX.) Regarding applicant’s claim 9, claim 9 recites a device comprising at least one well to receive a polymer chain reaction (PCR) mixture and comprising: a bottom comprising an electrically resistive sheet including at least one opening and to receive a signal from a signal source to generate heat for pulse-control amplification, within the at least one well, in a thermal cycling zone in close thermal proximity to the resistive sheet and subject to a denaturation temperature less than 5 percent of an overall volume of the PCR mixture; and side walls comprising a polymer material and a fluoropolymer component to cause the PCR mixture to form at least one of a convex meniscus and a flat meniscus; and an optical detector alignable with the at least one opening of the resistive sheet to detect fluorophores as an output of the PCR mixture.
As noted above, claim 1 of copending Application No. 18/292847 recites at least one well to receive a polymerase chain reaction (PCR) mixture and including a bottom comprising: an electrically resistive sheet, which is to receive a signal from a signal source to cause the resistive sheet to generate heat to form a pulse-controlled amplification, thermal cycling zone within the at least one well in close thermal proximity to the bottom, wherein the resistive sheet comprises a single, unitary first opening aligned in a central portion of the well; and a carrier layer co-extensive with at least the first opening of the resistive sheet to contain the reaction mixture within the at least one well and including a transparent portion; and an optical detector aligned with the first opening in the resistive sheet to optically detect, through the transparent portion of the carrier layer, a fluorophore signal intensity within the at least one well as an output of a reaction process from the PCR mixture.
Dalton teaches wells that are molded from fluoropolymer and suitable for PCR processing. [0004], [0011].
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to make the well in claim 1 of copending Application No. 18/292847 from fluoropolymer as taught by Dalton.
In claim 1 of copending Application No. 18/292847 in view of Dalton the pulse-controlled amplification within the at least one well can be controlled to provide any temperature including, a denaturation temperature comprises less than about 5 percent of an overall volume of the PCR mixture.
The temperature does not encompass any structural limitations to the device.
The use of a fluoropolymer would cause the mixture to form at least one of a convex meniscus and a flat meniscus inasmuch as the claimed shape if applicant’s meniscus is developed by the fluoropolymer.
Claim 1 of copending Application No. 18/292847 recites permitting optical detection which renders obvious the use of an optical detector aligned with the opening in the resistive sheet.
Therefore, claim 1 of copending Application No. 18/292847 in view of Dalton renders obvious applicant’s claim 9 obvious.
X.) Regarding applicant’s claim 10, as noted above claim 1 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 9 obvious from which claim 10 depends.
Applicant’s claim 10 recite that the side walls comprise at least one of: a molded polymer material coated with the fluoropolymer component; and an injection-molded structure of a compounded mixture comprising a polymer solids material and at least one of a fluoropolymer material and a fluorosurfactant material.
As noted above, Dalton teaches that the multiwell support was prepared using an injection molding procedure with a fluoropolymer. [0011]
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to make the well in claim 1 of copending Application No. 18/292847 by an injection molding process using a fluoropolymer as taught by Dalton.
Therefore, claim 1 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 10 obvious.
XI.) Regarding applicant’s claim 11, claim 11 recites a method comprising: receiving a volume of a polymer chain reaction (PCR) mixture within at least one well in which a fluoropolymer component of side walls of the at least one well causes an overall volume of the PCR mixture to form a contact angle relative to the side walls to cause the overall volume to exhibit a generally uniform distribution across a diameter of an interior of the at least one well; applying heat, via an electrically resistive sheet of a bottom of the at least one well, to thermally cycle, via pulse-controlled amplification, the PCR mixture within a zone in close thermal proximity to the resistive sheet; and optically detecting, in alignment with an opening of the resistive sheet, fluorophores as an output of the reaction mixture.
Claim 12 of copending Application No. 18/292847 recites a method comprising: receiving a polymerase chain reaction (PCR) mixture within at least one well; applying heat, via an electrically resistive metal sheet of a bottom of the at least one well, to thermally cycle, via pulse-controlled amplification, the PCR mixture within a zone in close thermal proximity to the bottom of the at least one well, with the metal sheet comprising a first portion; optically detecting, in alignment with a single, unitary first opening defined in the first portion of the metal sheet and in alignment with a transparent portion of a carrier layer coextensive with at least the first opening, fluorophores as an output of a reaction process from the PCR mixture.
As noted above, Dalton teaches wells that are molded from fluoropolymer and suitable for PCR processing. [0004], [0011].
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to make the well in claim 12 of copending Application No. 18/292847 from fluoropolymer as taught by Dalton.
As for the limitation that the fluoropolymer component of side walls of the at least one well causes an overall volume of the PCR mixture to form a contact angle relative to the side walls to cause the overall volume to exhibit a generally uniform distribution across a diameter of an interior of the at least one well, the fluoropolymer in claim 12 of copending Application No. 18/292847 in view of Dalton would cause the same result as applicant’s fluoropolymer.
Therefore, claim 12 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 11 obvious.
XII.) Regarding applicant’s claim 12, as noted above claim 12 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 11 obvious from which claim 12 depends.
Claim 13 of copending Application No. 18/292847 which depends from claim 12 recites that the PCR mixture comprises beads, which are functionalized with single-stranded nucleic acids of the PCR mixture, and which are superparamagnetic with a relative magnetic permeability greater than 1, and the method comprises: applying an external magnetic force to the superparamagnetic beads within the at least one well to cause the superparamagnetic beads with the single-stranded nucleic acids to travel into, and remain present within, the pulse-controlled amplification, thermal cycling zone.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify the well recited in claim 13 of copending Application No. 18/292847 to be made from a fluoropolymer as taught by Dalton.
Therefore, claim 13 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 12 obvious.
XIII.) Regarding applicant’s claim 13, as noted above claim 12 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 11 obvious from which claim 13 depends.
Applicant’s claim 13 recites the contact angle is at least 60 degrees.
Since claim 12 of copending Application No. 18/292847 in view of Dalton uses fluoropolymer as applicant discloses, the contact angle would be at least 60 degrees as that provided by applicant’s fluoropolymer.
Therefore, claim 12 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 13 obvious.
XIV.) Regarding applicant’s claim 14, as noted above claim 12 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 11 obvious from which applicant’s claim 14 depends.
Applicant’s claim 14 recites that via the fluoropolymer component, the contact angle is to cause the PCR mixture to exhibit the substantially uniform distribution, within the at least one well, as at least one of a flat meniscus and a convex meniscus.
Since claim 12 of copending Application No. 18/292847 in view of Dalton uses fluoropolymer as applicant discloses, the PCR mixture to exhibit the substantially uniform distribution, within the at least one well, as at least one of a flat meniscus and a convex meniscus inasmuch as applicant’s fluoropolymer provides this claimed feature.
Therefore, claim 12 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 14 obvious.
XV.) Regarding applicant’s claim 15, as noted above claim 12 of copending Application No. 18/292847 in view of Dalton renders applicant’s claim 11 obvious from which applicant’s claim 15 depends.
Applicant’s claim 15 recites forming the side walls to comprise a cyclic olefin copolymer (COC) material and including the fluoropolymer component as at least one of: a coating on the COC material; and part of a compounded mixture together with the COC material injection-molded to form the at least one well.
As noted above Dalton teaches injection molding a fluoropolymer, but does not teach that the polymer material comprises cyclic olefin copolymer (COC).
However, Dalton teaches that the fluoropolymer provides a fluorophilic inner surface to the wells. (Abstract).
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to make the well in claim 12 of copending Application No. 18/292847 to have any suitable fluoropolymer surface, including one of cyclicolefin copolymer that provides a fluorophilic inner surface as taught by Dalton.
Therefore, claim 12 of copending Application No. 18/292847in view of Dalton renders applicant’s claim 15 obvious.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/MICHAEL STANLEY GZYBOWSKI/Examiner, Art Unit 1798
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