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 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, 4, 6, 9, 10, 13, 14, 16-18, and 20-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hudson, et al (WO 2018/217778 A1; cited in IDS; copy in IFW).
Regarding claim 1, Hudson discloses a system of analyzing a sample, the system comprising:
A sample preparation sub-system (210) for preparing at least one sample in a sample vessel;
A magnetic bead storage sub-system (paragraph 0163 – the magnetic beads that are added must come from somewhere);
A sample intake sub-system (230) for receiving the at least one sample;
A mass spectrometer (240A) communicatively coupled to the sample intake sub-system; and
A transfer sub-system comprising a tool for moving the sample vessel from the sample preparation sub-system to the sample intake sub-system (paragraph 0077 – “The sample introduction process module 230 could also include mechanical reaction vessel transport devices. Such transport devices may include pick and place apparatuses such as pick and place transfer gantries, transfer shuttles such as extended linear reaction shuffles, or combinations of the pick and place transfer gantries and extended linear reaction shuttles”; “pick and place gripper” 408; “pick and place gripper” 409).
Regarding claim 4, Hudson discloses a mixing sub-system for mixing a plurality of magnetic beads in a liquid (paragraph 0163).
Regarding claim 6, it is implicit by the disclosure of adding magnetic beads to the sample that Hudson must include a magnetic bead transfer system for moving a plurality of magnetic beads from the magnetic bead storage sub-system to a predetermined sub-system of the system.
Regarding claim 9, Hudson discloses wherein the sample intake sub-system comprises a liquid chromatography column (paragraph 0142).
Regarding claim 10, Hudson discloses wherein the sample intake sub-system comprises an open port interface (paragraph 0074).
Regarding claim 13, Hudson discloses an automated method of analyzing a sample, the automated method comprising:
Introducing a plurality of magnetic beads to the sample, wherein the sample is contained within a sample vessel (paragraph 0163);
Transferring the sample vessel to a sample intake sub-system (paragraph 0164);
Introducing the sample from the sample vessel to the sample intake sub-system, wherein the sample intake sub-system is communicatively coupled to a mass spectrometer (paragraph 0174);
Analyzing the sample with the MS (paragraph 0174); and
Removing the plurality of magnetic beads from the sample prior to analysis of the sample by the MS (paragraph 0166).
Regarding claim 14, Hudson discloses removing the plurality of magnetic beads from the sample prior to introducing the sample to the sample intake sub-system (Fig. 8).
Regarding claim 16, Hudson discloses wherein introducing the sample from the sample vessel to the sample intake sub-system comprises ejecting the sample and the plurality of magnetic beads from the sample vessel to the sample intake sub-system (paragraph 0184).
Regarding claim 17, Hudson discloses introducing at least one reagent to the sample vessel containing the sample and the plurality of magnetic beads (paragraph 0163).
Regarding claim 18, Hudson discloses incubating the at least one reagent, the sample, and the plurality of magnetic beads (paragraph 0108).
Regarding claim 20, Hudson discloses removing the plurality of magnetic beads from the sample vessel (816) prior to analyzing the sample (828); and removing the sample from the sample vessel containing the sample and the plurality of magnetic beads prior to analyzing the sample (paragraphs 0183-0184).
Regarding claim 21, Hudson discloses wherein removing the plurality of magnetic beads from the sample vessel comprises inserting a magnet into the sample vessel (paragraph 0172).
Regarding claim 22, Hudson discloses wherein removing the plurality of magnetic beads from the sample comprises capturing a plurality of magnetic beads in at least one of an open port interface, a transfer conduit, an ionization source, and a vacuum chamber (paragraph 0172).
Regarding claim 23, Hudson discloses wherein analyzing the sample comprises eluting the sample (paragraph 0056).
Regarding claim 24, Hudson discloses wherein introducing the sample from the sample vessel to the sample intake sub-system comprises ejecting the sample (paragraphs 0072-0075).
Claim Rejections - 35 USC § 103
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) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hudson.
Regarding claims 2 and 3, Hudson teaches using a mixer for mixing the sample with a plurality of magnetic beads, but does not specify if it is an electromagnetic mixer or a mechanical mixer; however, as electromagnetic and mechanical mixers are members of a finite list of types of mixers known in the art that can be interchanged with a reasonable expectation of success, one of ordinary skill in the art would have found it obvious before the effective filing date of the invention to use either an electromagnetic or mechanical mixer as the mixer in Hudson’s apparatus. MPEP 2143(E).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hudson in view of Ghislain, et al (“A new platform for high-throughput mass spectrometry: acoustic droplet ejection with an open port sampling interface” 1 January 2018, pp. 1749-1756; cited in IDS, copy in IFW).
Regarding claim 11, Hudson discloses the system of claim 10, but fails to teach wherein the sample intake sub-system comprises an acoustic droplet ejector; however, Ghislain teaches that combining an acoustic droplet ejector with an open port interface like Hudson’s is advantageous because it allows the generation of calibration curves with excellent linearity (abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine an acoustic droplet ejector with Hudson’s open port interface as taught by Ghislain, because doing so was known to be advantageous.
Allowable Subject Matter
Claims 7 and 15 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 following is a statement of reasons for the indication of allowable subject matter: Regarding claim 7, the prior art does not teach wherein the magnetic bead transfer sub-system comprises at least one of an electromagnetic tool and a magnetic tool. Regarding claim 15, the prior art fails to teach transferring the plurality of magnetic beads from a suspension to the sample.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P MASKELL whose telephone number is (571)270-3210. The examiner can normally be reached M-F 10A-6P.
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/MICHAEL MASKELL/Primary Examiner, Art Unit 2881 10 January 2026