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 .
Response to Arguments
Applicant’s arguments, filed 12/03/25, with respect to the under 35 U.S.C. 103 as being unpatentable over Rutishauser et al. (US 6,368,561) in view of Hansen et al. (US 2002/0014443), and further in view of Krueger et al. (US 2011/0088491) have been fully considered and are persuasive. Applicant has amended claim 1 to recite “a shaker in orbital rotation to shake the microplate, the heating/cooling plate, and the magnetic support plate said magnetic support plate including a plurality of magnetic pins, the plurality of magnetic pins being capable of protruding through the plurality of holes of the heating/cooling plate and into the cavities of the microplate, the plurality of magnetic pins being adjustable height while the shaker has an orbital rotation speed between 300-500 rpm”. Applicant has also amended 10 to recite capture the magnetic microbeads, wherein the height of the magnetic pins protruding above the heating plate is adjustable between 1.5 mm to 4mm“ and then argued that these features are not taught or suggested by the cited prior art. The Examiner agrees that Kreuger does not recite a specific capability of orbital rotation speed as recited in the claim. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made below.
Inventorship
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 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.
Claims 1, 4-6, 10 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Rutishauser et al. (US 6,368,561) in view of Hansen et al. (US 2002/0014443), and further in view of Faustman et al. (US 2011/0177592). Rutishauser teaches an integrated magnetic microbeads processing apparatus. The embodiment(s) of the device most relevant to the instant claims are shown in Figures 1A-3C and described in columns 2-6.
Regarding claims 1, 10 and 12-14 - As shown in the cited Figures, Rutishauser teaches an integrated magnetic microbeads processing apparatus for treating magnetic particles in containers. The apparatus includes housing (1) with holder (2) for liquid containers that are processed. The housing includes a base plate (3) with a magnetic arrangement (4) for capturing magnetic beads and a heating device (hotplate 5) for heating the liquid containers. As shown in Figures 3A-3C, the containers that are processed can be a microplate (microtiter plate 16) having a plurality of magnetic microbeads (see column 5, line 36 - column 6, line 26) in a plurality of microwells (vessels 17) with a bottom of the microplate (plate 16) having a plurality of cavities (Figures 3A-3C and col. 4, lines 1-5) between the microwells (vessels 17) for mating with the magnetic arrangement 4a heating/cooling plate (hotplate 5) supporting of the microplate (plate 16). The magnetic arrangement (4) is a vertically movable magnet support plate including a plurality of magnetic pins (magnetic plates 14), the plurality of magnetic pins (magnetic plates 14) being capable of protruding through a plurality of holes in a heating/cooling plate and into the cavities of the microplate (Figures 3A-3C and col. 4, lines 1-5), the plurality of magnetic pins being adjustable height. See column 2, line 55 - column 5, line 23. With respect to the method of claims 10 and 12, Rutishauser teaches a bead processing method in column 5, line 36 - column 6, line 34. The method includes providing a microplate having a plurality of magnetic microbeads in a plurality of microwells (vessels 17) and a cavity between the microwells (17), providing a heating and cooling plate (hot plate 5), providing the vertically movable magnetic support (magnetic arrangement 4) having a plurality of magnetic pins (magnetic plates 14) and then raising the magnetic pins up for bead capture. Rutishauser does not teach a shaker to shake the microplate, heating/cooling plate and magnetic support plate. Rutishauser also does not teach a heating/cooling plate having a plurality of holes for receiving the plurality of magnetic pins.
Hansen teaches a system and method for manipulating magnetic particles. The portions of the system most relevant to the instant claims are shown in Figures 2 and 6-12 and described in Paragraphs 0037-0058. As shown in the Figures, the system of Hansen includes an extractor (102) having a removable rack (118) for holding a plurality of containers (tubes 120) with magnetically responsive particles (190). The extractor further includes a plurality of heat sink blocks (154) with thermoelectric heating elements (devices 168) supporting the tube block (170) having the tubes (210). The heat sink block (154) includes a plurality of openings (cam slots 158) for containing magnet carriers (164) having magnets (166) that are placed next to the tube (12) to lock the magnetic particles in place on the wall of the tube. During operation of the device, the magnet carriers (164) are moved in the openings (cam slots 158) to place the magnets (166) at a desired location. See Figures 6-7; and also Paragraphs 0043 and 0053-0058. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the heating block support having openings for magnets from Hansen with the device of Rutishauser. Rutishauser teaches a heat block (5) and magnetic pins (14) that may be applied to the wells (vessels) separately in an alternate fashion by moving the holder (2) between the two devices. See Figures 1A-1D, Abstract, column 3, lines 6-12, and column 6, line 9-26 Hansen teaches a heating block that supports and heats the tube, but Hansen also further teaches slots in the heating blocks that allows for magnets to be placed next to vessels while the vessels are supported in the heating block. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the heating blocks with openings for magnets from Hansen with the device of Rutishauser. One or ordinary skill in the art would add the heat blocks with openings for magnetic elements to Rutishauser in order to apply heat and magnetic force to the containers at the same time as taught by Hansen. The combination of Rutishauser and Hansen does not teach a shaker to shake the microplate, heating/cooling plate and magnetic support plate.
Faustman teaches a magnetic apparatus and method for blood separation. The embodiment(s) of the device most relevant to the instant claims are shown in Figures 1-4 and described in Paragraphs 0032-0056. The device includes a base having a magnetic base (150) having a plurality of apertures for holding tubes (200) of beads and sample material. The block contains a magnetic portion and a heating portion to selectively apply heat to the receptacle. During use, the base is placed on an orbital shaker device for shaking the beads and materials within the tubes. See Paragraphs 0032-0091 of Faustman. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the shaker from Faustman with the combined teachings of Rutishauser and Hansen. One of ordinary skill in the art would add the shaker to Rutishauser and Hansen to shake the both the heater and containers having the magnetic particles to mix the sample as taught by Faustman.
Regarding the rotation speed, Faustman teaches a shaker capable of a rotation speed of 0-1000 rpm in Paragraph 0045.
Regarding the pin height – Rutishauser is silent as to the height or length of the magnetic pins. The Examiner takes the position that the difference between the prior art and the claims is a difference of relative dimensions and that the magnetic pins of the claims would not perform the function of attracting beads different than the prior art. In Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPO 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Regarding claim 5 – Hansen discloses the capability of heating up to 70oC in Paragraphs 0051 and 0070.
Regarding claim 6 – Faustman teaches a robot and controller for moving the shaker in Paragraphs 0052-0060.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Rutishauser et al. (US
6,368,561) in view of Hansen et al. (US 2002/0014443), and further in view of Faustman et al. (US 2011/0177592) and Guhl et al. (US 4,657,867). Rutishauser, Hansen, and Faustman as combined above in Paragraphs 7-14 teach every element of claims 7 and 8 except for the microplate plastic cover and lip assembly; and also does not teach a plate having a flat and optically transparent bottom. Guhl teaches a multiwell plate assembly with features for reduced evaporation of material from the wells and also teaches wells having a flat transparent bottom. The portions of the device most relevant to the instant claims are shown in Figures 4-5 and described in columns 3-5. As shown in the Figures, the assembly (10) includes a lid (14) and a plate (12) having a plurality of wells (15) for containing liquids (13). The plate further includes a recessed ledge (22) between the upstanding rim (27) of the upper portion (18) sidewall (16) of the plate (!2) and upstanding rim (25) of the openings (24) of the wells (15). The lid (14) includes a substantially planar cover (21) and downwardly extending skirt (32) which forms a border around the lid (14). The lid further includes a plurality of rings (36) and flange (42). During use, the lid (14) is placed on the plate (15) such that the rings (36) overlie each opening (24) of the wells and the flange (42) makes contact with the ledge (22) such that spaces (34, 35, 41 and 44) form a pathway for air exchange between the wells and venting to the external environment, but also prevents evaporation of the liquids in the wells. See column 3, line 18 - column 5, line 15 of Guhl. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the microplate lid and lip assembly from Guhl with the combined teachings of Rutishauser, Hansen, and Faustman. One of ordinary skill in the art would add the microplate lid and lip to the combined teachings of Rutishauser, Hansen, and Faustman in order to allow for venting of the microplate while preventing excessive evaporation from the wells as taught by Guhl. With respect to the flat and transparent well bottom, Guhl teaches transparent wells in column 5, lines 16-22 and shows a flat bottom to the wells in Figures 4-5. The Examiner submits it would also have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to transparent flat bottom well from Guhl with the combined teachings of Rutishauser, Hansen, and Faustman. One of ordinary skill in the art would add the transparent flat well bottom to the combined teachings of Rutishauser, Hansen, and Faustman in order to allow for visual and optical sensor examination of material in the well.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Rutishauser et al. (US 6,368,561) in view of Hansen et al. (US 2002/0014443), and further in view of Faustman et al. (US 2011/0177592) and Ho et al. (US 2008/0234144). Rutishauser, Hansen, and Faustman as combined above in Paragraphs 7-14 teach every element of claim 9 except for the barcoded magnetic microbeads. Rutishauser, Hansen and Faustman all teach magnetic beads, but do not teach barcoded beads. Ho teaches a high throughput apparatus for digital magnetic bead analysis. The apparatus includes microbeads having a digitally coded structure that may be read like a barcode to process the beads. In Paragraphs 0096-0106, Ho teaches processing magnetic beads having compounds in a microplate. The beads are identified with an optical CCD to identify which beads have had positive or desired reactions. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the barcoded magnetic beads from Ho with the combined teachings of Rutishauser, Hansen, and Faustman. One of ordinary skill in the art would add the barcoded magnetic microbeads to the combined teachings of Rutishauser, Hansen, and Faustman in order to digitally process the beads as taught by Ho.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWAYNE K HANDY/Examiner, Art Unit 1798 March 17, 2026
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798