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 .
Status of Claims
Claims 1-12 and 15-17 are pending and have been examined.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-3 and 12, in the reply filed on 10/16/2025 is acknowledged. The traversal is on the ground(s) that the claims have been amended to establish unity and to include all the features of claim 1. In view of the cancellation of claim 14 and the amendments to claims 4, 8, 10 and 15 to ultimately depend from claim 1, the arguments are found to be persuasive and the restriction requirement has been withdrawn.
Priority
This application 18/009,649 (PGPub: US2023/0221308) was filed 12/09/2022. This application is a 371 of PCT/EP2021/062680 filed 05/12/2021. This application claims priority to foreign application EPO 20179317.1 filed 06/10/2020.
Information Disclosure Statement
The Information Disclosure Statements filed 12/09/2022, 11/30/2023, 04/23/2024 (2) and 09/08/2025 have been considered by the Examiner.
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 (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 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.
Claim(s) 1-5, 8-9, 12 and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schroeder et al. (US 2006/0133954, Pub Date: 06/22/2006, IDS).
Regarding claim 1, Schroeder teaches throughout the publication a method of dispersing magnetic particles, said method comprising: (a) in a vessel, combining at least one permanent magnet and said magnetic particles in a liquid phase; and (b) triggering a fluctuating or oscillating motion of said permanent magnet using a magnetic field; thereby dispersing said magnetic particles (paragraphs 0012 and 0021).
Regarding claim 2, Schroeder teaches the method wherein said magnetic particles carry at least one moiety on their surface, wherein said moiety is selected from: (i) a moiety capable of binding a target molecule, said moiety being a an antibody, a portion of an antibody, or a tracer (paragraph 0009) or (ii) a moiety capable of converting at least one starting molecule into at least one product molecule, said moiety being an enzyme or a chemical catalyst (paragraph 0040) or (iii) a moiety capable of forming an adduct with said target molecule (paragraph 0022, invention may be used to immobilize an antibody to provide a binding reagent); wherein said target molecule, is present or suspected to be present in said liquid phase (paragraph 0026).
Regarding claim 3, Schroeder teaches the method further comprising: (c) removing, rendering static, and/or rendering said magnetic field incapable of triggering said motion; and allowing said magnetic particles to gather on said permanent magnet (paragraph 0042); and (d) removing said liquid phase (paragraph 0036).
Regarding claim 4, Schroeder teaches the method wherein after the binding of said target molecule to said moiety, a) a fluctuating or oscillating motion of said permanent magnet is triggered using a magnetic field; and b) said molecule is separated from the remainder of constituents of said liquid phase (paragraph 0036).
Regarding claim 5, Schroeder teaches the method further comprising: (c) removing, rendering static, and/or rendering said magnetic field incapable of triggering said motion; and allowing said magnetic particles to gather on said permanent magnet; and (d) removing remaining components of a mixture from said vessel (paragraphs 0042 and 0036).
Regarding claim 8, Schroeder teaches the method wherein after said at least one starting molecule is converted into at least one product molecule, a) a fluctuating or oscillating motion of said permanent magnet is triggered using a magnetic field; and b) at least one product molecule is obtained (paragraph 0040).
Regarding claim 9, Schroeder teaches the method further comprising: (c) removing, rendering static, and/or rendering said magnetic field incapable of triggering said motion; and allowing said magnetic particles to gather on said permanent magnet; and (d) removing said at least one product molecule from said vessel (paragraphs 0042 and 0036).
Regarding claim 12, Schroeder teaches the method wherein said magnetic field is generated by at least one external magnet (see magnet 12 in Figure 1) selected from: (1) an electromagnet, wherein a fluctuating or oscillating electric current flows through said electromagnet; or (2) a further permanent magnet or an electromagnet, wherein said vessel and said further permanent magnet or said electromagnet are moved relative to each other in a fluctuating or oscillating manner (paragraphs 0021 and 0023).
Regarding claim 15, Schroeder teaches a device (paragraph 0010) comprising: (i) means for generating a magnetic field (magnetic field driver) ; and (ii) a control unit configured to modify said magnetic field over time in order to perform the method of claim 1 (paragraph 0024), wherein said means for generating a magnetic field is a coil which received a vessel (paragraph 0023); said vessel comprising a permanent magnet and functionalized magnetic particles (paragraphs 0020-0021).
Regarding claims 16-17, Schroeder teaches the device wherein said means for generating a magnetic field is configured to receive a vessel such that said vessel is exposed to said magnetic field when in use, wherein said device further comprises said vessel (paragraph 0037).
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.
Claim(s) 6 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Schroeder et al., as applied to claim 1-2 and 4 above.
Regarding claim 6, Schroeder teaches the method as described above and further teaches that a wash fluid may be added to the vessel (paragraph 0026). While Schroeder does not explicitly teach the method steps to be conducted for an embodiment utilizing a wash solution, the reference clearly teaches that depending on which embodiments are conducted, a fluctuating or oscillating motion of said permanent magnet is triggered using a magnetic field to obtain the desired component and further, removing, rendering static, and/or rendering said magnetic field incapable of triggering said motion and allowing said magnetic particles to gather on said permanent magnet; and (d) removing material not bound to said particles from said vessel (paragraphs 0036, 0040 and 0042). As such, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to extend the general method steps taught by Schroeder to an embodiment incorporating a wash solution of Schroder in order to properly conduct the assay and wash away undesired components.
Regarding claims 10-11, Schroeder teaches the method as described above and further teaches that the invention may be used to immobilize an antibody to provide a binding reagent in an immunoassay, cell fractionations, protein purification, ligand capture or nucleic acid hybridization (paragraphs 0022 and 0040). While Schroeder does not explicitly teach the method steps to be conducted for the embodiment of immobilizing an antibody to create a binding reagent (claimed “forming an adduct”), the reference clearly teaches that depending on which embodiments are conducted, a fluctuating or oscillating motion of said permanent magnet is triggered using a magnetic field to obtain the desired component and further, removing, rendering static, and/or rendering said magnetic field incapable of triggering said motion and allowing said magnetic particles to gather on said permanent magnet; and (d) removing material not bound to said particles from said vessel (paragraphs 0036, 0040 and 0042). As such, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to extend the general method steps taught by Schroeder to the embodiment of creating an antibody binding agent immobilized on the magnetic particles of Schroder in order to properly obtain the desired binding reagent by magnetic resuspension means described in the method.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Schroeder et al., as applied to claim 1 above, and further in view of a’Brassard (US 2005/0013741, hereinafter “Brassard”).
Schroeder teaches the method as described above wherein the method can comprise adding various reagents to the vessel (paragraph 0026). Additionally, Schroeder generally teaches triggering a fluctuating or oscillating motion of said permanent magnet using said magnetic field; removing, rendering static, and/or rendering said magnetic field incapable of triggering said motion; and allowing said magnetic particles to gather on said permanent magnet (paragraph 0036, 0040 and 0042).
While Schroder fails to specifically teach that an eluent is one of the reagents that can be added to the vessel and then separating the eluate from particles and magnet, Brassard teaches throughout the publication magnetic separation of magnetic particles (abstract). More specifically, Brassard teaches that an elution liquid can be added to the reaction vessel to abolish binding and obtain the highest concentration possible of the target substance (paragraph 0047) and elute target substances bound to the particles (paragraph 0075).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the magnetic particle manipulation method of Schroeder, use of elution liquid as taught by Brassard because it would have been desirable to have the ability to stop binding and separate desired compounds from the magnetic particles.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677