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 .
Claim Objections
Claim 16 is objected to because of the following informalities: The examiner suggests amending claim 16 to depend from 14 instead of claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 1 and 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belz et al. (US 9,696,327 B2) in view of Wang et al. (WO 2019/213096 A1).
Regarding claim 1, Belz et al. discloses an apparatus, comprising: a plate receptacle (separation station, 201) comprising an insert (203); and a magnet (202); and an actuator (all fixtures (204, 204a) are interconnected by a base (217)), since the magnets (202, 203) are movable; the separation station (201) comprises a mechanism to move the fixtures (204, 204a) and the bases (205); all fixtures (204, 204a) are interconnected by a base (217) and are, thus, moved coordinately; all magnets (203) are joined to one base (218) and are, thus, moved coordinately; and the mechanism for moving the magnetic plates (202) and (203) is constructed and arranged to move the two types of magnetic plates (202, 203) to a total of four end positions) (see figures 40-41 and column 23, lines 13-21), wherein the plate receptacle (201) is to receive a plate (1 component plate, 101) having a well (vessel, 103), wherein the actuator is to move the magnet relative to the plate receptacle (201), and wherein the insert (203) is operable to transfer a magnetic field from the magnet (202) to the plate receptable (201) (see figures 28, 34, and 40-41; column 7, lines 1-18; column 18, lines 27-30; column 20, line 43-54; and column 22, line 42 through column 23, line 31).
Belz et al. fails to disclose an apparatus, comprising: a plate receptacle comprising a thermal block thermocycler in heat communication with the plate receptacle, wherein the thermocycler is to adjust a temperature of a sample within the well of the plate.
However, Belz et al. disclose that the automated analyzer further comprises a reaction station disposed in a third location, wherein said reaction station is constructed and arranged to analyze said analyte to obtain a detectable signal; another preferred embodiment of a reaction station is a station comprising an incubator; preferably, said incubator is a temperature-controlled incubator; more preferably, said incubator is held at one constant temperature; and another preferred embodiment of an incubator is a thermocycler block (see column 7, lines 1-18) and that the multiwell plate is optimized for incubating or separating an analyte in an automated analyzer (see column 18, lines 27-30).
Wang et al. discloses an apparatus, comprising: a plate receptacle (assay cartridge) comprising a thermal block (aluminum heating block); a magnet (permanent magnets around the cartridge by actuation of the Z-θ manipulator, see paragraph 00149); a thermocycler (a traditional PCR thermocycler) in heat communication with the plate receptacle (assay cartridge); and an actuator, since the magnetofluidic device includes a magnetic particle manipulation assembly having a pair of permanent magnets arranged to be on opposing sides of a magnetofluidic cartridge with one of a plurality of wells therebetween; and the magnetic particle manipulation assembly has a first actuator operatively connected to the pair of permanent magnets such that the pair of permanent magnets can be moved in unison, back and forth along an axis to move magnetic particles into and out of the one of the plurality of wells, and a second actuator assembly operatively connected to the pair of permanent magnets such that the pair of permanent magnets can be moved in unison from a location of the one of the plurality of wells there between to a location with a second one of the plurality of wells therebetween (see paragraph 0090), wherein the actuator is to move the magnet relative to the plate receptacle (assay cartridge) (see figures 3A-B and 12A-D; paragraphs 0090, 0098-00101, 00135-00137, and 00158-00160).
Wang et al. fails to disclose an apparatus, comprising: a plate receptacle comprising an insert, wherein the plate receptacle is to receive a plate having a well and the thermocycler is to adjust a temperature of a sample within the well of the plate, and wherein the insert is operable to transfer a magnetic field from the magnet to the plate receptable.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Belz et al. with the teachings of Wang et al. resulting in an apparatus, comprising: a plate receptacle comprising a thermal block thermocycler in heat communication with the plate receptacle, wherein the thermocycler is to adjust a temperature of a sample within the well of the plate, since the use of the apparatus isn't limiting or the material the apparatus acts upon isn't limiting, in order to optimize the multiwell plate for both an incubator at constant temperature and for separation (see column 7, lines 1-18 and column 18, lines 27-30).
Regarding claims 6-7, Belz fails to disclose an apparatus further comprising a heat sink coupled to the thermocycler; and wherein the heat sink comprises a liquid cooled heat sink.
Wang et al. discloses an apparatus further comprising a heat sink coupled to the thermocycler; and wherein the heat sink comprises a liquid cooled heat sink, since Wang et al. discloses PCR well of the cartridge mounts directly into an aluminum heat block directly attached to a thermoelectric element
and heatsink (see paragraph 00160 and figures 12A-D) and since the use of the apparatus isn't limiting or the material the apparatus acts upon isn't limiting.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the teachings of Belz et al. with the teachings of Wang et al. resulting in an apparatus further comprising a heat sink coupled to the thermocycler; and wherein the heat sink comprises a liquid cooled heat sink for improved heat dissipation and temperature control.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belz et al. (US 9,696,327 B2) and Wang et al. (WO 2019/213096 A1) as applied to claim 1 above, and further in view of Spero et al. (US 2021/0039096 A1).
Regarding claim 4, Belz et al. fails to explicitly disclose an apparatus wherein the insert comprises at least one of a ferrous material, Nickel, a mu-metal, or a Cobalt alloy.
However, Belz et al. discloses that the insert (203) is a magnet (see column 22, line 42 through column 23, line 31).
Spero et al. disclose a microfluidics cartridge that includes a reaction (or assay) chamber (114); a actuation mechanism (150) is arranged in close proximity to reaction (or assay) chamber (114) of microfluidics device (105) (see figure 1 and paragraph 0075-0076); examples of magnetically responsive materials include, but are not limited to, paramagnetic materials, ferromagnetic materials, ferrimagnetic materials, and metamagnetic materials; and examples of suitable paramagnetic materials include iron, nickel, and cobalt, as well as metal oxides, such as, but not limited to, ferroferric oxide (Fe3O4), barium hexaferrite (BaFe12O19), cobalt(II) oxide (CoO), nickel(II) oxide (NiO), manganese(III) oxide (Mn2O3), chromium(III) oxide (Cr2O3), and cobalt manganese phosphide (CoMnP) (see paragraph 0063).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the insert comprises at least one of a ferrous material, Nickel, a mu-metal, or a Cobalt alloy, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (as a magnet) as a matter of obvious design choice.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belz et al. (US 9,696,327 B2) and Wang et al. (WO 2019/213096 A1) as applied to claim 1 above, and further in view of Howe et al. (US 5.897,783).
Regarding claims 11-12, Belz et al. fails to disclose an apparatus wherein the magnet comprises a switchable magnet; and wherein the actuator is to actuate the switchable magnet.
Howe et al. discloses that automated systems could potentially use mechanically actuated permanent magnets or switched electromagnets, although no such systems are yet commercially available (see column 1, lines 58-63).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the magnet comprises a switchable magnet, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Because Belz et al. disclose that the insert (203) and a magnet (202) are both magnets the actuator is to actuate the switchable magnet.
Claim(s) 2-3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belz et al. (US 9,696,327 B2) and Wang et al. (WO 2019/213096 A1) as applied to claim 1 above, and further in view of Andrulat et al. (EP 2618157 A1).
Regarding claims 2-3, the combined teachings of Belz et al. and Wang et al. fail to disclose an apparatus wherein the plate receptacle comprises well receptacles and wherein the insert is positioned within the thermal block; and wherein the insert at least partially defines the well receptacles.
Andrulat et al. discloses an apparatus (1) wherein the sample reception device (2), which is further configured to be a thermorack (10), which is stationary mounted by connection means (8) to the base (9) and is used to control the temperature of the samples in the single sample tubes (12), which are held by the recesses (11) in the top surface of the thermorack (10) (see figure 2 and paragraph 0071); the thermorack, preferably, has at least two block sections or, preferably, multiple block sections, which can be part of an integral block or which are, preferably, arranged in an array, preferably a periodic array; a block section, preferably, is made from metal, in particular, from aluminum and/or silver and/or any other material with, preferably, a good thermal conductivity; the block sections can be connected to (or be integral with) a plate, which preferably has a good thermal conductivity, e.g. made from the same metal; and the block or the block sections, preferably, are arranged in the sample reception zone or form and/or provide the sample reception zone (see paragraph 0036) resulting in an apparatus wherein the plate receptacle comprises well receptacles and a thermal block.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the plate receptacle comprises well receptacles, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves routine skill in the art (see MPEP 2144.04 (V-A)).
The integrated plate receptacle and well receptacles would result in the inserts in the thermal block.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the insert at least partially defines the well receptacles, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves routine skill in the art (see MPEP 2144.04 (V-A)).
Regarding claim 5, the combined teachings of Belz et al. and Wang et al. fail to disclose an apparatus wherein a thermal block and as such fails to discloses an apparatus wherein the insert extends horizontally through the thermal block.
Andrulat et al. discloses an apparatus (1) wherein the sample reception device (2), which is further configured to be a thermorack (10), which is stationary mounted by connection means (8) to the base (9) and is used to control the temperature of the samples in the single sample tubes (12), which are held by the recesses (11) in the top surface of the thermorack (10) (see figure 2 and paragraph 0071); the thermorack, preferably, has at least two block sections or, preferably, multiple block sections, which can be part of an integral block or which are, preferably, arranged in an array, preferably a periodic array; a block section, preferably, is made from metal, in particular, from aluminum and/or silver and/or any other material with, preferably, a good thermal conductivity; the block sections can be connected to (or be integral with) a plate, which preferably has a good thermal conductivity, e.g. made from the same metal; and the block or the block sections, preferably, are arranged in the sample reception zone or form and/or provide the sample reception zone (see paragraph 0036) resulting in an apparatus wherein the plate receptacle comprises well receptacles and a thermal block.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the plate receptacle comprises well receptacles, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves routine skill in the art (see MPEP 2144.04 (V-A)).
The integrated plate receptacle and well receptacles would result in the inserts in the thermal block.
It would have been an obvious matter of design choice to have the insert extends horizontally through the thermal block, since applicant has not disclosed that having the insert extends horizontally through the thermal block solves any stated problem or is for any particular purpose and it appears that the invention would perform well with the insert extends horizontally through the thermal block.
Allowable Subject Matter
Claims 8-10 and 13-22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art references are Belz et al. (US 9,696,327 B2), Wang et al. (WO 2019/213096 A1), Spero et al. (US 2021/0039096 A1), Howe et al. (US 5.897,783), and Ammann et al. (EP 1614474 B1).
Regarding claim 8, the prior art references fail to disclose or suggest an apparatus further comprising opposing first and second brackets positioned on either side of the plate receptacle, wherein the magnet comprises a first magnet coupled to the first bracket and a second magnet coupled to the second bracket and wherein the actuator includes a first actuator that moves the first bracket and a second actuator that moves the second bracket relative to the plate receptacle to allow the first magnet and the second magnet to act on the plate receptacle.
Regarding claim 9, Wang et al. discloses a plate receptacle (assay cartridge), a thermoelectric (TE) module, a heat sink, and a fan; and the heat sink and fan were used to dissipate heat on the TE module during cooling phases of thermal cycling (see paragraph 00137).
Ammann et al. discloses an incubator for receiving a plurality of reaction receptacles containing
reaction fluids and for maintaining the reaction fluids in a temperature controlled environment (see paragraph 0001); a thermoelectric module (704) (also known as a Peltier device) in thermal contact with a heat sink structure (706) is attached to the housing (702); and or ramp-down stations (i.e., chillers), thermoelectric modules (704) are preferably used (see figures 17-18 and paragraph 0160).
The prior art references fail to disclose or suggest an apparatus wherein the thermocycler comprises a first thermoelectric cooler positioned on a first side of the plate receptacle and a second thermoelectric cooler positioned on a second side of the plate receptacle.
Claim 10 depends on claim 9.
Regarding claims 13-14, the prior art references fail to disclose an apparatus wherein the plate receptacle comprises a plurality of well receptacles and wherein the insert comprises a plurality of cupped pins, wherein each cupped pin is positioned beneath one of the well receptacles; and further comprising a U-shaped bracket carrying the magnet and having ends and wherein the insert comprises a magnetic permeability material extending from the thermal block, the thermal block and the magnetic permeability material defining well receptacles.
Claims 15-16 depend on claim 14.
Regarding claim 17, Belz et al. discloses an apparatus wherein the magnet (202) and a magnetic base (205) (see figure 41 and column 22, line 41 through column 23, line 12).
Belz et al. fails to disclose an apparatus wherein the magnet comprises a first magnet and a second magnet, further comprising a first bracket carrying the first magnet and having first and second ends and a second bracket carrying the second magnet and having first and second ends, the first bracket and the second bracket opposing one another, wherein the insert comprises a first magnetic permeability material extending from the thermal block and a second magnetic permeability material extending from the thermal block, wherein the thermal block, the first magnetic permeability material, and the second magnetic permeability material defining well receptacles.
Claim 18 depends on claim 17.
Regarding claim 19, Belz et al. discloses an apparatus wherein the magnet (202) and a magnetic base (205) (see figure 41 and column 22, line 41 through column 23, line 12).
Belz fails to disclose or suggest an apparatus wherein the magnet comprises a first magnet and a second magnet, further comprising a first U-shaped bracket carrying the first magnet and having ends and a second U-shaped bracket carrying the second magnet and having ends, wherein the insert comprises a first magnetic permeability material extending from the thermal block and a second magnetic permeability material extending from the thermal block, wherein the thermal block, the first magnetic permeability material, and the second magnetic permeability material defining well receptacles.
Claim 20 depend on claim 19.
Regarding claim 21, Belz et al. fails to disclose or suggest a thermal block and as such fails to discloses an apparatus further comprising a stage comprising the thermocycler comprising the thermal block defining first well receptacles and the magnet comprising second well receptacles spaced from the first well receptacles.
Claim 22 depends on claim 21.
The following is a statement of reasons for the indication of allowable subject matter:
Claims 23 and 25-29 are allowed.
Regarding claim 23, Belz et al. discloses a method, comprising: adjusting a temperature of a sample within a well of a plate disposed in a plate receptacle (the contents of the vessels (103) can be incubated at an elevated, controlled temperature when the processing plate (101) is placed on the heating device (128)); dispensing beads (216) into the well (vessel, 103) of the plate (1 component plate, 101) and a first reagent (one of the shorter side walls (109) of the vessel (103) comprises an reagent inlet channel (105) which extends to the circumferential rib (104) into the well (103) of the plate with the plate disposed in the plate receptacle (201), since the magnetic particles (216) comprised in liquid (215) which can be held in the vessel (103) results in the particles (216) and liquid (215) are dispensed into the vessel (103) (see figures 28, 31, 35-36, and 38 column 19, line 60 through column 20, line 42); moving the magnet (202) toward the insert (203) to allow the insert (203) to transfer a magnetic field from the magnet (202) to the plate receptable receptacle (201) and draw the beads (216) toward the magnet (202) (see figures 28, 34, and 40-41 and column 22, line 42 through column 23, line 31); and that said vessels are pipette tips for aspirating and dispensing liquids (see column 14, lines 37-60)
Wang et al. discloses an apparatus, comprising: a plate receptacle (assay cartridge) comprising a thermal block (aluminum heating block); a magnet (permanent magnets around the cartridge by actuation of the Z-θ manipulator, see paragraph 00149); a thermocycler (a traditional PCR thermocycler) in heat communication with the plate receptacle (assay cartridge); and an actuator, since the magnetofluidic device includes a magnetic particle manipulation assembly having a pair of permanent magnets arranged to be on opposing sides of a magnetofluidic cartridge with one of a plurality of wells therebetween; and the magnetic particle manipulation assembly has a first actuator operatively connected to the pair of permanent magnets such that the pair of permanent magnets can be moved in unison, back and forth along an axis to move magnetic particles into and out of the one of the plurality of wells, and a second actuator assembly operatively connected to the pair of permanent magnets such that the pair of permanent magnets can be moved in unison from a location of the one of the plurality of wells there between to a location with a second one of the plurality of wells therebetween (see paragraph 0090), wherein the actuator is to move the magnet relative to the plate receptacle (assay cartridge) (see figures 3A-B and 12A-D; paragraphs 0090, 0098-00101, 00135-00137, and 00158-00160).
The prior art references fail to disclose or suggest a method, comprising: adjusting a temperature of a sample within a well of a plate disposed in a plate receptacle comprising a thermal block and an insert using a thermocycler; and aspirating the first reagent from the well with the plate disposed in the plate receptacle.
Claims 25-28 depend on claim 23.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATASHA E YOUNG whose telephone number is (571)270-3163. The examiner can normally be reached M-F 7:00 am - 6:00 pm.
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NATASHA E. YOUNG
Examiner
Art Unit 1774
/NATASHA E YOUNG/Primary Examiner, Art Unit 1774
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