NON-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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3 February 2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claims 1, 6, and 7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 § 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, 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 1, 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); 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), 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 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; applying a centrifugal acceleration to the container while the magnetic bead is magnetically attracted 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 main 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 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 Cavuto and Hitoshi does not explicitly disclose applying a centrifugal acceleration to the container while the magnetic bead is magnetically attracted 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 main body, the container being rotated around the rotation axis so as to apply the centrifugal acceleration to the container.
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 and 8) is magnetically attracted by the external magnetic field (produced by magnets 7, Fig. 7 and 8) 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 would position the container in a tilted manner so that the bottom is located farther from the rotation axis than an opening of the main body), 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 arrangement during centrifugation as taught by Sarofim 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, Shuji, 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, Shuji, and Sarofim with a centrifugation acceleration magnitude in the claimed range 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 1, 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 Tung with a magnetic flux density in the claimed range without producing any new or unexpected results. It would have been further obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the external magnetic field in the separation method of the combination of Cavuto, Hitoshi, and Sarofim with the magnetic flux density of taught by Tung for the purpose of improving bio-separation efficiency (para. [0005], Tung).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Cavuto.
Regarding claim 6, Cavuto discloses a sample tube (“sample tube”, page 1 line 11; sample tube 30, Fig. 8), comprising: a main body portion having a bottomed tubular shape (Fig. 8; a tubular shape is a well-known shape for sample tubes) and an opening (33, Fig. 8); a lid portion (closure part 20, Fig. 1) configured to open and close the opening of the main body portion; and a head portion (magnetic bearing part 10, Fig. 1) attached to the lid portion that houses a magnet (18, Fig. 1), wherein the head portion is unitary with the lid portion (magnetic bearing part 10 and closure part 20 together form the lid assembly 100, Fig. 8), but does not disclose that the lid portion is hingedly attached to the main body portion. However, Cavuto teaches the sample container 30 having a hinged lid 34. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the lid assembly 100 as a hinged lid, as shown for lid 34 in Cavuto, as a predictable design alternative , in order to facilitate repeatedly opening and closing of the sample tube. The examiner notes that there are finite number of ways to attach the lid assembly to the sample tube main body portion and that one of ordinary skill int heart could have pursued the known potential solutions with a reasonable expectation of success. Accordingly, the rationale to support a conclusion that the claims would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.” KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Claim 7 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 7, 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.
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 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 explicitly 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, and the head unit is attached to the lid of the container inserted into the insertion hole.
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). 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 for the purpose of holding magnetic beads, which allows for any liquid on the beads to evaporate quickly (page 21 lines 1-11, Cavuto).
Conclusion
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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/Shuyi S. Liu/Examiner, Art Unit 1774