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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. CN202110801973.5, filed on 07/15/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5, 7-8, 10-12, 16-20, 22, and 24-27 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Vahidi et al. (US20210008566A1).
Regarding Claim 1, Vahidi et al. teaches an automatic extraction device for extracting a target biological substance (See the Abstract, the automatic system, and Claim(s) 1-13 in [0003]-[0009], [0021]-[0050] in Fig. 1A-6), the automatic extraction device (See in Fig. 1A-5C) comprising:
a sample processing apparatus (See the multi-function rack 100, i.e. a sample processing apparatus, in [0025]-[0028] in Fig. 1-5C),
a consumable assembly (See how the multi-function rack 100, i.e. a sample processing apparatus and a consumable assembly, can be configured to accommodate various processes, pipettes, sections, and/or vials in [0025]-[0028] in Fig. 1-5C),
a pipetting apparatus (See the automated pipettor in [0027]-[0032] in Fig. 1-5C) and a portal frame (illustrated in [0031]-[0032] in Fig. 4A-H),
wherein the sample processing apparatus comprises a uniform mixing mechanism (See in [0005]-[0009], [0027]-[0028], [0040]-[0041] and in Claim 1) and a magnetic attraction mechanism (See the actuatable magnets 120 in [0026]-[0034] in Fig. 1-5C), which are respectively configured to perform uniform mixing processing and magnetic attraction processing on a biological sample (See Claim(s) 1-13);
the portal frame comprises a base (See in Fig. 1-5C) and a moving beam capable of moving relative to the base (See the rails/backplate arrangement 125, i.e. a moving beam, in [0006], [0029] in Fig 1-5C and in Claim 5); and
the sample processing apparatus and the consumable assembly are provided on the base (See in Fig. 1-5C), and the pipetting apparatus is provided on the moving beam and configured to be capable of implementing a pipetting operation between the consumable assembly and the sample processing apparatus (See the automated pipettor in [0027]-[0032] in Fig. 1-5C).
Regarding Claim 2, Vahidi et al. teaches the device limitations of claim 1.
Vahidi et al. further teaches an automatic extraction device for extracting a target biological substance (See the Abstract, the automatic system, and Claim(s) 1-13 in [0003]-[0009], [0021]-[0050] in Fig. 1A-6), wherein the sample processing apparatus comprises at least one of a sample tube and a reaction tube (See the vials 110 in [0003]-[0025] in Fig. 1-5C); and the
magnetic attraction mechanism (See the actuatable magnets 120 in [0026]-[0034] in Fig. 1-5C) comprises a magnet capable of moving relative to the sample tube and/or the reaction tube so as to perform magnetic attraction processing on a biological sample in the sample tube and/or a biological sample in the reaction tube (See a how variety of magnet/vial positioning could be employed in [0017]-[0031] in Fig. 1-4G and in Claim(s) 2 and 9).
Regarding Claim 3, Vahidi et al. teaches the device limitations of claim 1.
Vahidi et al. further teaches an automatic extraction device for extracting a target biological substance (See the Abstract, the automatic system, and Claim(s) 1-13 in [0003]-[0009], [0021]-[0050] in Fig. 1A-6), wherein the uniform mixing mechanism comprises (See in [0005]-[0009], [0027]-[0028], [0040]-[0041] and in Claim 1) a uniform mixing driving motor (See in [0029], [0032]), and a tube holder (See in [0003]-[0004], [0017][0052] in Fig. 1-5C),
the uniform mixing driving motor being in transmission connection with the tube holder (See in [0005]-[0009], [0027]-[0028], [0040]-[0041] and in Claim 1);
the sample tube and/or the reaction tube are provided in the tube holder (See the vials 110 in Fig. 1-5C); and
the uniform mixing driving motor is capable of driving the tube holder to move, so as to drive the biological sample in the sample tube and/or the biological sample in the reaction tube to undergo uniform mixing processing (See in [0005]-[0009], [0027]-[0032] [0040]-[0041] and in Claim 1),
wherein the tube holder is connected to a rotating shaft of the uniform mixing driving motor, and the uniform mixing driving motor is capable of driving the tube holder to rotate axially (See in [0025], [0029]-[0032] in Fig. 1-5C).
Regarding Claim 5, Vahidi et al. teaches the device limitations of claim 2.
Vahidi et al. further teaches an automatic extraction device for extracting a target biological substance (See the Abstract, the automatic system, and Claim(s) 1-13 in [0003]-[0009], [0021]-[0050] in Fig. 1A-6), wherein the magnetic attraction mechanism comprises a first magnetic attraction mechanism (See the actuatable magnets 120 in [0026]-[0034] in Fig. 1-5C), the first magnetic attraction mechanism comprising a first magnet and a first magnetic attraction driving motor (See in [0029], [0032]),
wherein the first magnet is in transmission connection with the first magnetic attraction driving motor; the first magnet is provided between the sample tube and the reaction tube (See in Fig. 1-5C); and
the first magnetic attraction driving motor is capable of driving the first magnet to move between the sample tube and the reaction tube, so as to perform magnetic attraction processing on the biological sample in the sample tube or in the reaction tube (See Claim(s) 1-13),
wherein the first magnetic attraction mechanism further comprises a second magnetic attraction driving motor (See how a plurality of rows of vials positions 110 are adjacent to one or two rows of magnets 120 in [0026] in Fig. 1-5C); and
the second magnetic attraction driving motor is configured to drive the first magnet to move in a vertical direction (See in [0021]-[0050] in Fig. 1-6).
Regarding Claim 7, Vahidi et al. teaches the device limitations of claim 5.
Vahidi et al. further teaches an automatic extraction device for extracting a target biological substance (See the Abstract, the automatic system, and Claim(s) 1-13 in [0003]-[0009], [0021]-[0050] in Fig. 1A-6), wherein the magnetic attraction mechanism further comprises a second magnetic attraction mechanism (See in [0021]-[0050] in Fig. 1-6),
the second magnetic attraction mechanism comprising a second magnet and a third magnetic attraction driving motor, wherein the second magnet is in transmission connection with the third magnetic attraction driving motor; the second magnet and the first magnet are provided on two opposite sides of the reaction tube; and the third magnetic attraction driving motor is capable of driving the second magnet to move relative to the reaction tube, so as to perform magnetic attraction processing on the biological sample in the reaction tube (See how a plurality of rows of vials positions 110 are adjacent to multiple rows of magnets 120 in [0026]-[0050] in Fig. 1-5C and in Claim(s) 1-13).
Regarding Claim 8, Vahidi et al. teaches the device limitations of claim 1.
Vahidi et al. further teaches an automatic extraction device for extracting a target biological substance (See the Abstract, the automatic system, and Claim(s) 1-13 in [0003]-[0009], [0021]-[0050] in Fig. 1A-6), wherein the consumable assembly comprises a reagent kit and a pipette tip box (See how the multi-function rack 100, i.e. a sample processing apparatus and a consumable assembly, can be configured to accommodate various processes, pipettes, sections, boxes, tips, and/or vials in [0025]-[0028] in Fig. 1-5C),
the reagent kit comprising one or more cavities for containing reagents, and the pipette tip box comprising one or more pipette tips (See the disposable pipettes 170 with the pipettor head 130 in [0032] in Fig. 1-5C); and
the pipetting apparatus comprises a pipette capable of being detachably and sealingly connected to the pipette tip, and when the pipette is sealingly connected to the pipette tip, the pipette is capable of controlling the pipette tip to implement liquid aspiration and dispensing (See the pipette disposal station 150 and the slots 155 in [0030] in Fig. 4F),
wherein the pipette tip box corresponds to the reagent kit on a one-to-one basis (Fig. 1-5C).
Regarding Claim(s) 10-12, Vahidi et al. teaches the device limitations of claim 8.
Vahidi et al. further teaches an automatic extraction device for extracting a target biological substance (See the Abstract, the automatic system, and Claim(s) 1-13 in [0003]-[0009], [0021]-[0050] in Fig. 1A-6), wherein the reagent kit comprises a plurality of cavities (See the rack 100 in Fig. 1-5C), and the pipette tip box comprises a plurality of pipette tips (See the disposable pipettes 170 with the pipettor head 130 in [0032] in Fig. 1-5C);
the plurality of cavities are arranged in one or more rows in a first direction, each row of cavities extends in a second direction in which the moving beam moves relative to the base, and the first direction is perpendicular to the second direction; and the plurality of pipette tips are arranged in one or more rows in the first direction, and each row of pipette tips extends in the second direction (See in Fig. 1-5C);
further comprising a consumable assembly driving motor configured to drive the consumable assembly to move in the first direction (See in [0005], [0029]-[0032] and in Claim 1 in Fig. 1-5C);
wherein the pipette tip box comprises a box body having an upper end open, and a cover plate, the cover plate being connected to an opening of the box body; the inside of the box body is divided into a plurality of accommodating cavities by partitions, and the cover plate is provided with a plurality of through holes corresponding to the plurality of accommodating cavities; and at least some of the accommodating cavities and the through holes corresponding thereto are configured to load the one or more pipette tips, wherein the pipette tip box further comprises a target biological substance collection tube, at least one of the accommodating cavities and the through hole(s) corresponding thereto are configured to load the target biological substance collection tube (See the pipette disposal station 150 and the slots 155 in [0030] in Fig. 4F).
Regarding Claim(s) 16-19, Vahidi et al. teaches the device limitations of claim 1.
Vahidi et al. further teaches an automatic extraction device for extracting a target biological substance (See the Abstract, the automatic system, and Claim(s) 1-13 in [0003]-[0009], [0021]-[0050] in Fig. 1A-6), wherein the waste liquid box is fixed relative to the base (See the disposal station 150, i.e. a waste box, in [0130] in Fig. 4F); and
the pipetting apparatus is configured to be capable of implementing a pipetting operation between the sample processing apparatus and the waste liquid box (See the automated pipettor in [0027]-[0032] in Fig. 1-5C and Claim(s) 1-13);
wherein the sample processing apparatus comprises a plurality of sample tubes and a plurality of reaction tubes (See the multi-function rack 100, i.e. a sample processing apparatus, and the vials 110 in [0025]-[0028] in Fig. 1-5C),
the consumable assembly comprises a plurality of reagent kits and a plurality of pipette tip boxes (See how the multi-function rack 100, i.e. a sample processing apparatus and a consumable assembly, can be configured to accommodate various processes, pipettes, sections, and/or vials in [0025]-[0028] in Fig. 1-5C), and
the pipetting apparatus comprises a plurality of pipettes (See the automated pipettor in [0027]-[0032] in Fig. 1-5C and see the disposable pipettes 170 with the pipettor head 130 in [0032] in Fig. 1-5C)) ;
the automatic extraction device comprises a plurality of extraction channels arranged at intervals in a first direction, which is perpendicular to a second direction in which the moving beam moves relative to the base, and each extraction channel extends in the second direction; and each extraction channel comprises one sample tube, one or more reaction tubes, one reagent kit, one pipette tip box, and one pipette (See the rails/backplate arrangement 125, i.e. a moving beam, in [0006], [0029]-[0032] in Fig 1-5C and in Claim 5);
wherein the magnetic attraction mechanism comprises a magnet capable of covering the plurality of extraction channels so as to perform magnetic attraction processing on biological samples in the plurality of sample tubes and/or the plurality of reaction tubes of the plurality of extraction channels (See the actuatable magnets 120 in [0026]-[0034] in Fig. 1-5C and how variety of magnet/vial positioning could be employed in [0017]-[0031] in Fig. 1-4G and in Claim(s) 2 and 9);
wherein the magnetic attraction mechanism comprises a plurality of magnets, each magnet being configured to perform magnetic attraction processing on a biological sample in the sample tube and/or the reaction tube in one extraction channel (See how a plurality of rows of vials positions 110 are adjacent to multiple rows of magnets 120 in [0026]-[0050] in Fig. 1-5C and in Claim(s) 1-13).
Regarding Claim 20, Vahidi et al. teaches the device limitations of claim 1.
Vahidi et al. further teaches an automatic extraction device for extracting a target biological substance (See the Abstract, the automatic system, and Claim(s) 1-13 in [0003]-[0009], [0021]-[0050] in Fig. 1A-6), wherein the biological sample comprises a microorganism, blood, saliva, an animal tissue, a plant, or food, wherein the target biological substance comprises a plasmid, a protein, or a nucleic acid (See in [0002]-[0031] in Fig. 1A-B and Claim 13).
Regarding Claim 22, Vahidi et al. teaches the device limitations of claim 1.
Vahidi et al. further teaches a use method for an automatic extraction device of claim 1 (See the Abstract, the automatic system, and Claim(s) 1-13 in [0003]-[0009], [0021]-[0050] in Fig. 1A-6), the use method comprising the steps of: controlling the pipetting apparatus to add a first reagent and a first magnetic bead of the consumable assembly into the sample tube of the sample processing apparatus, with a biological sample being contained in the sample tube; controlling the uniform mixing mechanism to drive the sample tube for uniform mixing processing (See the step(s) 600-601 and the pumping/control/aspiration systems in [0039]-[0050], [0088]-[0104] in Fig. 6);
controlling the magnetic attraction mechanism to perform magnetic attraction processing on a uniformly mixed liquid in the sample tube (See the step(s) 613, 617, 620 and the pumping/control/aspiration systems in [0039]-[0050], [0088]-[0104] in Fig. 6); and
after standing for a first preset time, controlling the pipetting apparatus to collect a first supernatant from the sample tube, or to remove the first supernatant from the sample tube while retaining the attracted first magnetic bead and adding the first supernatant collected from the sample tube into the reaction tube of the sample processing apparatus (See the step(s) 630, 640 and the pumping/control/aspiration systems in [0039]-[0050], [0088]-[0104] in Fig. 6);
controlling the pipetting apparatus to add a second reagent and a second magnetic bead of the consumable assembly into the reaction tube: controlling the uniform mixing mechanism to drive the reaction tube for uniform mixing processing: controlling the magnetic attraction mechanism to perform magnetic attraction processing on the uniformly mixed liquid in the reaction tube: and after standing for a second preset time, controlling the pipetting apparatus to remove a second supernatant from the reaction tube while retaining the attracted second magnetic bead, or to collect the second supernatant from the reaction tube (See the step(s) 600-640 and the pumping/control/aspiration systems in [0039]-[0050], [0088]-[0104] in Fig. 6).
Regarding Claim(s) 24-27, Vahidi et al. teaches the device limitations of claim 22.
Vahidi et al. further teaches an automatic extraction device for extracting a target biological substance (See the Abstract, the automatic system, and Claim(s) 1-13 in [0003]-[0009], [0021]-[0050] in Fig. 1A-6),
wherein the first magnetic bead is configured to bind to impurities, and the second magnetic bead is configured to bind to the target biological substance (See in [0004]-[0009], [0021], [0037]-[0050] and in Claim(s) 2 and 9-10); and the use method further comprises:
after standing for the second preset time, controlling the pipetting apparatus to remove the second supernatant from the reaction tube; controlling the pipetting apparatus to add a third reagent of the consumable assembly into the reaction tube, the third reagent being capable of eluting the target biological substance from the second magnetic bead; controlling the uniform mixing mechanism to drive the reaction tube for uniform mixing processing; controlling the magnetic attraction mechanism to perform magnetic attraction processing on the uniformly mixed liquid in the reaction tube; and after standing for a third preset time, controlling the pipetting apparatus to collect a third supernatant from the reaction tube (See the step(s) 600-640 and the pumping/control/aspiration systems in [0037]-[0050], [0088]-[0104] in Fig. 6);
wherein the first magnetic bead and the second magnetic bead are both configured to bind to impurities (An obvious assay protocol control standard to one with skills in the arts); and the method further comprises: after standing for the second preset time, controlling the pipetting apparatus to collect the second supernatant from the reaction tube (See the step(s) 600-640 and the pumping/control/aspiration systems in [0037]-[0050], [0088]-[0104] in Fig. 6);
wherein the first reagent is the same as the second reagent, and the first magnetic bead is the same as the second magnetic bead (An obvious assay protocol control standard to one with skills in the arts in [0004]-[0009], [0021], [0037]-[0050] and in Claim(s) 2 and 9-10);
wherein the first reagent is different from the second reagent, and/or the first magnetic bead is different from the second magnetic bead (An obvious assay protocol control standard to one with skills in the arts in [0004]-[0009], [0021], [0037]-[0050] and in Claim(s) 2 and 9-10).
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Vahidi et al. (US20210008566A1) as applied to claim 8 above, and further in view of Lapham et al. (US20170045542A1).
Regarding Claim 14, Vahidi et al. teaches the device limitations of claim 8.
Vahidi et al. fails to explicitly teach an automatic extraction device, wherein the reagent kit comprises a sealing layer configured to seal the one or more cavities, wherein the pipetting apparatus further comprises a piercing mechanism configured to pierce the sealing layer.
However, in the analogous art of modular liquid handling devices, Lapham et al. teaches an automatic extraction device for extracting a target biological substance (See the Abstract, the integrated modular liquid handling system 1, and Claim(s) 1-47 in [0003]-[0009], [0129]-[0141] in Fig. 1-26), wherein the reagent kit (See the platform 2 in [0122]-[0130] in Fig. 1 and Claim 11, 21, and 26) comprises a sealing layer configured to seal the one or more cavities (See in [0022],[0058], [0067]),
wherein the pipetting apparatus (See the modular device 5, i.e. a pipetting apparatus, in [0130] in Fig. 1) further comprises a piercing mechanism configured to pierce the sealing layer (See the aspirating tips 6 and tips 170 in [0022],[0058], [0067], [0112]-[0114] in Fig. 1 and 15-21).
Thus, it would be obvious to modify the device of Vahidi et al. by incorporating a sealing layer and piercing mechanism (as taught by Lapham et al.) for the benefit of reducing the contamination of samples on the device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following prior art teaches similar devices and methods: Zu et al. (US20210299677A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITNEY N WASHINGTON whose telephone number is (703)756-5959. The examiner can normally be reached Monday-Friday 7:00am - 3:30pm CT.
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/BRITNEY N. WASHINGTON/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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