FINAL 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 15 May 2026 have been fully considered but are not persuasive.
Applicant argues that Cavuto “teaches away” from the use of centrifugation (page 6, Remarks). This argument is not persuasive. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). Furthermore, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See MPEP 2145. Cavuto’s statement that its process does not require a centrifuge describes an advantage of one mode of operation, but it does not criticize, discredit, or discourage the use of a centrifuge with the disclosed apparatus, nor does it state or suggest that centrifugation would be unsuitable for use. Accordingly, Cavuto does not teach away from the combination applied in this and the previous Office action.
Applicant argues that Sarofim does not disclose a lid that closes opening 15, and thus the combination of Cavuto, Hitoshi, and Sarofim does not teach applying centrifugal acceleration while the magnetic bead is magnetically attracted to the lid, as claimed. However, the examiner notes that Sarofim is relied upon solely for its teaching of applying a centrifugal acceleration to a container while magnetic beads are magnetically attracted to an external magnetic field, and while the container is tilted such that the bottom of the container is located further from the rotation axis than the opening of the container. Cavuto teaches the lid (closure part 20, Fig. 8). Because the rejection does not require Sarofim to disclose a lid, Applicant’s argument is not persuasive.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings were received on 29 August 2022. These drawings are acceptable.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 9 is rejected under 35 U.S.C. 122(a) as failing to comply with the written description requirement. Claim 9 recites “a head portion that is unitary with the lid portion and housing a magnet.” The specification does not describe a head portion that is unitary (i.e., integrally or non-separably formed) with the lid portion. The specification as filed states that “[t]he head portion 162 is attachable to and detachable from the lid portion 56” (para. [0062]). The examiner did not find in the abstract, specification, drawings, or claims of the original disclosure filed on 29 August 2022 any support for the limitation that the head portion is unitary with the lid portion.
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 8, 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/180376 (Cavuto et al., hereinafter Cavuto) in view of JP 2017176023 (Hitoshi et al., hereafter Hitoshi), and further in view of Sarofim et al. (U.S. Patent Application Pub. No. 2010/0120599, hereinafter Sarofim).
Regarding claim 8, Cavuto discloses a magnetic bead separation method (page 1 lines 10-15), comprising: storing, in a container (“sample tube”, page 1 line 11; sample tube 30, Fig. 8) having a bottomed, cylindrical body and a lid (closure part 20, Fig. 8) that closes the body, a mixed liquid containing a magnetic bead (“magnetic beads”, page 1 line 11; magnetic beads 42, Fig. 6) and a liquid containing a target molecule (“target biomolecules from a solid or liquid sample”, page 1 lines 13-14), and adsorbing the target molecules on the magnetic bead (“enabling the beads to attach to biomolecules or other chemical or biological species”, page 2 line 1-2), the magnetic bead containing a Fe-based metal magnetic particle (“a magnetic material (often iron, nickel or cobalt)”, page 1 lines 31-32); and the container has a cylindrical body and a lid, the cylindrical body has a bottom and an opening, the lid closes the opening of the cylindrical body (Fig. 8); adsorbing the target molecule on the magnetic bead (“enabling the beads to attach to biomolecules or other chemical or biological species”, page 2 lines 1-2); applying an external magnetic field to the container and magnetically attracting at least a part of the magnetic bead to the lid by the external magnetic field (“when the magnet is present within the magnet-receiving cavity, the magnet is capable of holding magnetic beads against the bead-collecting surface”, page 3 lines 16-18, Fig. 5 and 6; the bead-collecting surface 26 forms part of the closure part 20, i.e., the lid), and desorbing the liquid adhering to the magnetic bead (the bead-collecting surface 26 is able to hold magnetic beads, which allows for any liquid on the beads to evaporate quickly, page 21 lines 1-11), but does not disclose the magnetic bead containing a soft magnetic particle and a coating film with which the Fe-based metal soft magnetic particles is coated, and having a saturation magnetization of 50 emu/g or more and 250 emu/g or less; desorbing the liquid by a centrifugal acceleration; applying a centrifugal acceleration to the container while the magnetic bead is magnetically attracted to the lid by the external magnetic field and while the container is tilted so that the bottom is located farther from the rotation axis than an opening of the cylindrical body, the container being rotated around the rotation axis so as to apply the centrifugal acceleration to the container.
Hitoshi discloses analogous art related to a method for extracting a nucleic acid using a magnetic carrier, comprising the magnetic bead containing a Fe-based metal soft magnetic particle (“magnetic particles of amorphous metals comprising Fe, Cr, Si and B”, para. [0009] of machine translation) and a coating film which the Fe-based metal soft magnetic particle is coated (“a silicon film provided on a surface of the magnetic particle”, para. [0010]), and having a saturation magnetization of 50 emu/g or more (claim 2) and 250 emu/g or less (claim 3). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the separation method of Cavuto with the Fe-based soft magnetic particle and coating film taught by Hitoshi for the purpose of providing a nucleic acid-binding solid phase carrier which can extract a nucleic acid efficiently (Abstract, Hitoshi).
The combination of Cavuto and Hitoshi does not disclose desorbing the liquid by a centrifugal acceleration, or applying a centrifugal acceleration to the container while the magnetic bead is magnetically attracted to the lid and while the container is tilted so that the bottom is located farther from the rotation axis than an opening, the container being rotated around the rotation axis so as to apply the centrifugal acceleration.
Sarofim discloses analogous art related to a lid separation device, applying a centrifugal acceleration to the container while the magnetic bead (magnetic particles 8, Fig. 7) is magnetically attracted by the external magnetic field (produced by magnets 7, Fig. 7) and while the container is tilted so that the bottom is located farther from the rotation axis than an opening of the main body (“said centrifuging is performed with a swing-out rotor or a fixed angle rotor”, para. [0041]; swing-out or fixed angle rotor positions the container in a tilted manner so that the bottom is located farther from the rotation axis than the opening), the container being rotated around the rotation axis so as to apply the centrifugal acceleration to the container (para. [0067]). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of the combination of Cavuto and Hitoshi with the tilted container centrifugation of Sarofim, applied while the magnetic bead remains magnetically attracted to the lid of Cavuto’s container, for the purpose of achieving separation of liquid and solid phase (para. [0041], Sarofim).
Regarding claim 2, the combination of Cavuto, Hitoshi, and Sarofim discloses wherein the saturation magnetization of the magnetic bead is 100 emu/g or more and 200 emu/g or less (claim 3, Hitoshi).
Regarding claim 4, the combination of Cavuto, Hitoshi, and Sarofim discloses wherein the acceleration is a centrifugal acceleration having a magnitude of 8-19 G (para. [0076], Sarofim). It has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of the combination of Cavuto, Hitoshi, and Sarofim with a centrifugation acceleration magnitude in the claimed range of 10 G to 1000 G, which overlaps the range disclosed by Sarofim, without producing any new or unexpected results.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Cavuto in view Hitoshi, and further in view of Sarofim, as applied to claim 8, and further in view of Tung et al. (U.S. Patent Application Pub. No. 2011/0147278, hereinafter Tung).
Regarding claim 3, the combination of Cavuto, Hitoshi, and Sarofim does not disclose wherein the external magnetic field has a magnetic flux density of 0.5 T or more and 1.5 T or less.
Tung discloses a magnetic separation device wherein the external magnetic field has a magnetic flux density in the range of about 0.25 T to 2.4 T (Fig. 15). It has been held that “a prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See MPEP 2144.05. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of the combination of Cavuto, Hitoshi, and Sarofim with a magnetic flux density in the claimed range, as taught by Tung, for the purpose of improving bio-separation efficiency (para. [0005], Tung), without producing any new or unexpected results.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Sarofim, in view of Hitoshi, further in view of Piramoon et al. (U.S. Application Pub. No. 2010/0216622, hereinafter Piramoon), and further in view of Cavuto.
Regarding claim 10, Sarofim discloses a magnetic bead separation device (Fig. 6 and 7), comprising: a container mounting unit (a swing-out rotor or a fixed angle rotor, para. [0041]) on which a container (purification chamber 1, Fig. 7) is mounted that holds a mixed liquid containing magnetic beads (magnetic particles 8, Fig. 7) and a liquid containing target molecules (liquid comprising the analyte, para. [0067]); a rotating body (a swing-out rotor or a fixed angle rotor, para. [0041]) that rotates about a rotation axis to apply centrifugal acceleration to the container; and an external magnetic field application unit (magnets 7, Fig 7) that applies an external magnetic field to the container, but does not disclose Fe-based soft magnetic metal particles and a coating covering the Fe-based soft magnetic metal particles, the magnetic beads having a saturation magnetization of 50 emu/g or more and 250 emu/g or less; wherein the container mounting unit has an insertion hole through which the container is inserted, the insertion hole being inclined so that a bottom thereof is located farther from the rotation axis than its opening, and wherein the external magnetic field application unit has a head unit having a magnet, and the head unit is attached to the lid of the container inserted into the insertion hole; the external magnetic field application unit applying the external magnetic field by the magnet to magnetically attract the magnetic bead to the lid of the container; and the rotating body rotates while the magnetic bead is magnetically attracted to the lid of the container.
Hitoshi discloses analogous art related to a method for extracting a nucleic acid using a magnetic carrier, comprising the magnetic bead containing a Fe-based metal soft magnetic particle (“magnetic particles of amorphous metals comprising Fe, Cr, Si and B”, para. [0009] of machine translation) and a coating film which the Fe-based metal soft magnetic particle is coated (“a silicon film provided on a surface of the magnetic particle”, para. [0010]), and having a saturation magnetization of 50 emu/g or more (claim 2) and 250 emu/g or less (claim 3). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the device of Sarofim with the magnetic beads taught by Hitoshi for the purpose of providing a nucleic acid-binding solid phase carrier which can extract a nucleic acid efficiently (Abstract, Hitoshi).
The combination of Sarofim and Hitoshi does not disclose wherein the container mounting unit has an insertion hole through which the container is inserted, the insertion hole being inclined so that a bottom thereof is located farther from the rotation axis than its opening.
Piramoon discloses analogous art related to a centrifuge rotor, wherein the container mounting unit (rotor body 10, Fig. 2) has an insertion hole (well 20, Fig. 2) through which the container is inserted, the insertion hole being inclined so that a bottom thereof is located farther from the rotation axis than its opening. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the device of the combination of Sarofim and Hitoshi with the fixed angle rotor as taught by Piramoon for the purpose of centrifuging samples in high rotation (para. [0002] and [0004], Piramoon).
The combination of Sarofim, Hitoshi, and Piramoon does not disclose wherein the external magnetic field application unit has a head unit having a magnet that is attached to the lid of the container inserted into the insertion hole, and the rotating body rotates while the magnetic bead is magnetically attracted to the lid of the container.
Cavuto discloses analogous art related to a magnetic bead separation device, wherein the external magnetic field application unit has a head unit (magnet-bearing part 10, Fig. 1) having a magnet (18, Fig. 1), and the head unit is attached to the lid (closure part 20, Fig. 1) of the container (sample tube 30, Fig. 8), the magnet being capable of holding magnetic beads against the lid while the container is manipulated (page 3, lines 16-18; page 21, lines 1-11, Cavuto). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the device of the combination of Sarofim, Hitoshi, and Piramoon with external magnetic field application unit as taught by Cavuto, and to have operated the resulting device such that the rotating body rotates while the magnetic bead is magnetically attracted to the lid (consistent with Sarofim’s teaching of centrifuging while beads are magnetically attracted, para. [0067]), for the purpose of holding magnetic beads against the lid so that any liquid on the beads may evaporate quickly (page 21 lines 1-11, Cavuto).
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 SHUYI S LIU whose telephone number is (571)272-0496. The examiner can normally be reached MON - FRI 9:30AM - 2:30PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached at 571-270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Shuyi S. Liu/Examiner, Art Unit 1774
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