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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/23/2021 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 27-36 are pending with claims 27-36 being examined. Claims 1-26 are canceled.
Specification
The abstract of the disclosure is objected to because:
In line 2 “the chamber” should read –the chambers—.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 27-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Claim 27 recites “preferably a transfer port in an "alpha part door design””. The term "preferably" renders the claim indefinite because it is unclear whether the limitation following the term is part of the claimed invention. See MPEP § 2173.05(d).
Claims 28-32 are rejected based on dependency on a rejected base claim.
Claim 29 recites “preferably a transfer port in an "alpha part door design””. The term "preferably" renders the claim indefinite because it is unclear whether the limitation following the term is part of the claimed invention. See MPEP § 2173.05(d).
Claims 30-34 are rejected based on dependency on a rejected claim.
Claim 30 recites “preferably a transfer port in an "alpha part door design””. The term "preferably" renders the claim indefinite because it is unclear whether the limitation following the term is part of the claimed invention. See MPEP § 2173.05(d).
Claim 31 recites “preferably a transfer port in an "alpha part door design””. The term "preferably" renders the claim indefinite because it is unclear whether the limitation following the term is part of the claimed invention. See MPEP § 2173.05(d).
Claim 32 recites “preferably a transfer port in an "alpha part door design””. The term "preferably" renders the claim indefinite because it is unclear whether the limitation following the term is part of the claimed invention. See MPEP § 2173.05(d).
Appropriate action is required.
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.
Claims 27-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao (translation of CN 212955086 U; hereinafter “Zhao” already of record).
Regarding claim 27, Zhao teaches a sample extraction device (Zhao; fig. 4) comprising a plurality of chambers (Zhao; fig. 4. 131, 132, 133, 134, 135, 136, 137, 138) arranged on a pedestal (Zhao; fig. 1 and 3. 10),
wherein the chambers comprise a plurality of first chambers (Zhao; fig. 4. 135, 136) and two mixing chambers (Zhao; fig. 4. 131, 138 and [0072], [0075]);
the pedestal is internally provided with a first passage (Zhao; fig. 4. 120) for communicating the two mixing chambers (Zhao; fig. 4. 131, 138), and a sample extraction chamber (Zhao; fig. 4. 140) is arranged in the first passage (Zhao; fig. 4. 120); and
the pedestal is further internally provided with a second passage (Zhao; fig4. 110) for transfer and export of a liquid, and connection or disconnection between the two mixing chambers and the second passage is controlled by a valve [0058]-[0066]);
preferably, the plurality of first chambers comprise: a sample suction tube (Zhao; fig. 4. 100), a lysis solution chamber (Zhao; fig. 4. 134), an empty chamber (Zhao; fig. 4. 135), at least one washing solution chamber (Zhao; fig. 4. 136), and an eluent chamber (Zhang; fig. 4. 137); and the two mixing chambers comprise a first mixing chamber (Zhao; fig. 4. 131) and a second mixing chamber (Zhao; fig. 4. 138); wherein the sample suction tube, the lysis solution chamber, the empty chamber, the at least one washing solution chamber, the eluent chamber, the first mixing chamber and the second mixing chamber are sequentially arranged on the pedestal (Zhao; fig. 4. 131, 132, 133, 134, 135, 136, 137, 138) arranged on a pedestal (Zhao; fig. 1. 10).
Regarding claim 28, Zhao teaches the sample extraction device according to claim 27 (see above), wherein the plurality of first chambers further comprise a sealant chamber (Zhao; fig. 8. 139, and [0027] “water blocking chamber”) and the sample suction tube, the lysis solution chamber, the empty chamber, the at least one washing solution chamber, the eluent chamber, the sealant chamber, the first mixing chamber, and the second mixing chamber are sequentially arranged on the pedestal (Zhao; fig. 4. 131, 132, 133, 134, 135, 136, 137, 138, 139) arranged on a pedestal (Zhao; fig. 1. 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 29 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao (translation of CN 212955086 U; hereinafter “Zhao” already of record) as applied to claim 27 above, and in further view of Gwynn et al. (US 20130132006 A1; hereinafter “Gwynn”) and Malik et al. (US 20140127796 A1’ hereinafter “Malik”).
Regarding claim 29, Zhao teaches the sample extraction device according to claim 27 (see above), further comprising a valve assembly configured to control connection or disconnection between the second passage and the plurality of first chambers (Zhao; fig. 4. 110, 120 and fig. 5. 30, 203, and [0052], [0063]-[0064]); wherein, the plurality of chambers are sealed by a sealing element selected from a membrane (Zhao; fig. 3. 60 and [0038]); preferably, the two mixing chambers are arranged with a preset interval (Zhao; [0072] “heating device can be added to sample processing chamber (mixing chamber)).
Zhao fails to teach at least one of the plurality of first chambers is preloaded with a reagent required for sample extraction; preferably, a magnetic bead reagent is prepackaged in the sample extraction chamber.
However, Gwynn teaches the analogous art of an extraction device (Gwynn; [0031]) that includes a plurality of chambers (Gwynn; fig. 4a-1. 204) wherein, at least one of the plurality of first chambers is preloaded with a reagent required for sample extraction (Gwynn; “reagent used in DNA extraction”); a magnetic bead reagent is prepackaged in the sample extraction chamber (Gwynn; [0041] “a well containing a magnetically responsive particle”).
Gwynn does not explicitly teach the magnetic bead is in the sample extraction chamber.
However, Gwynn teaches isolating (extracting) nucleic acids, among the reagents are microparticles or other reagents.
It would have been obvious to add the beads in the sample extraction chamber in order to extract a solid particulate phase in the liquid sample (Gwynn; [0501]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Zhao’s sample device to include at least one of the plurality of first chambers is preloaded with a reagent required for sample extraction; preferably, a magnetic bead reagent is prepackaged in a chamber as taught by Gwynn because Gwynn teaches an extraction device (Gwynn; [0031]) that includes a plurality of chambers (Gwynn; fig. 4a-1. 204) wherein, at least one of the plurality of first chambers is preloaded with a reagent required for sample extraction (Gwynn; “reagent used in DNA extraction”); a magnetic bead reagent is prepackaged in a chamber (Gwynn; [0041] “a well containing a magnetically responsive particle”).
The modification allows extraction of a solid particulate phase in the liquid sample (Gwynn; [0501]).
Zhao fails to teach the sample extraction device further comprises: a quantitation chamber positioned within the second passage.
However, Malik teaches the analogous art of an extraction device (Malik; [0068]) that includes one or more reaction chambers (Malik; 0068 “the portable device may also contain one or more reaction chambers”), wherein the sample extraction device further comprises: a quantitation chamber positioned within the second passage (Malik; [0092] “qPCR chamber”). Examiner will interpret the second passage as the middle connection plate in fig. 7, as sample passes through the section connected by microfluidic channels the qPCR chamber.
Allowable Subject Matter
Claims 30-36 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
In addition to the remarks of record, the instant claims define over the prior art for the reasons stated below:
The cited prior art of record, whether alone or in combination, fails to teach or fairly suggest, in the context of claims 27, 29, and 30, wherein the valve assembly is consisted of a plurality of valves; and the second passage has branches extending towards the first chambers and the mixing chambers, and connection or disconnection between each of the branches and a first chamber or a mixing chamber is independently controlled by one of the plurality of valves; preferably, the valve is a rotating member, and the plurality of valves are arranged linearly at a bottom of the pedestal; preferably, the bottom of the pedestal is provided with a plurality of first cavities, and each of the plurality of first cavities is provided with a valve having an adapter channel; and when the valve is placed in the first cavity, one end of the adapter channel is communicated with a chamber, and another end of the adapter channel is communicated with a second passage under an external force; preferably, the sample extraction device further comprises a sealing plug arranged in the first cavity, wherein the sealing plug is respectively communicated with a chamber and a second passage, and the adapter channel is placed in the sealing plug; preferably, the sealing plug is a column structure, a through hole is provided in a center of the sealing plug, and at least one open hole is provided on a side wall of the sealing plug; preferably, the valve comprises a valve handle and a valve shaft; the valve handle is movably connected to the pedestal, and the adapter channel is arranged inside the valve shaft; preferably, the valve handle and valve shaft are of an integrated or detachable structure; and preferably, one end of the valve handle is provided with a limiting slot.
The cited prior art of record, whether alone or in combination, fails to teach or fairly suggest, in the context of claims 27, 29, and 31, a first sample loading tube and a first sample loading runner arranged on the pedestal, wherein the first sample loading runner is controlled by a valve to connect the first sample loading tube to one of the first chambers, and/or one of the first chambers is internally provided with a first push-pull piston rod; or a branch tube is communicated with at least one of the first chambers, and/or the at least one of the first chambers is internally provided with a third push-pull piston rod, a top of the third push-pull piston rod is provided with a sealing ring, wherein when the third push-pull piston rod is pushed to a bottom, the sealing ring is positioned above the branch tube; wherein, preferably, the at least one of the first chambers is a sample suction tube.
The cited prior art of record, whether alone or in combination, fails to teach or fairly suggest, in the context of claims 27, 29, and 32, wherein the second passage comprises a liquid outlet channel; the sample extraction device further comprises: a second sample loading tube, a second sample loading runner and a sample collection tube arranged on the pedestal; wherein the sample collection tube is arranged at a liquid outlet of the liquid outlet channel; and the second sample loading runner is controlled by a valve to connect the second sample loading tube to the liquid outlet channel; wherein the second sample loading tube has a branch tube; preferably, wherein the second sample loading tube is internally provided with a third push-pull piston rod, a top of the third push-pull piston rod is provided with a sealing ring, and wherein when the third push-pull piston rod is pushed to a bottom, the sealing ring is positioned above the branch tube.
The cited prior art of record, whether alone or in combination, fails to teach or fairly suggest, in the context of claims 27, 29, and 33, a sample collection tube arranged on the pedestal; and a gas exhaust channel controlled by a valve to connect one of the plurality of first chambers to the sample collection tube.
The cited prior art of record, whether alone or in combination, fails to teach or fairly suggest, in the context of claims 27, 29, and 34, wherein the pedestal comprises a pedestal body and an outer protective plate positioned on a front face and a back face of the pedestal body; at least one groove is provided on the front face and/or back face of the pedestal body; and the groove and the outer protective plate form the first passage and the second passage.
The cited prior art of record, whether alone or in combination, fails to teach or fairly suggest, in the context of claims 27, 28, and 35, a sample collection tube arranged on the pedestal; wherein the second passage comprises: a first channel controlled by a valve respectively to connect the at least one washing solution chamber, the eluent chamber, and the first mixing chamber; a second channel controlled by a valve respectively to connect the sample suction tube, the lysis solution chamber, the empty chamber, and the first mixing chamber; a sample quantification channel controlled by a valve respectively to connect the sealant chamber and/or the purge chamber and the second mixing chamber, wherein the sample quantification channel is internally provided with a quantification chamber; a liquid outlet channel controlled by a valve respectively to connect the sample quantification channel and the sample collection tube; and a gas exhaust channel controlled by a valve to connect the eluent chamber and the sample collection tube.
The cited prior art of record, whether alone or in combination, fails to teach or fairly suggest, in the context of claims 27, 28, and 36, a sample collection tube arranged on the pedestal; wherein the second passage comprises: a third channel controlled by a valve respectively to connect the at least one washing solution chamber and the first mixing chamber; a fourth channel controlled by a valve respectively to connect the eluent chamber and the second mixing chamber; a fifth channel controlled by a valve respectively to connect the sample suction tube, the lysis solution chamber, the empty chamber, and the first mixing chamber; a sample quantification channel controlled by a valve respectively to connect the second mixing chamber, the sealant chamber and/or the purge chamber, wherein the sample quantification channel is internally provided with a quantification chamber; a liquid outlet channel controlled by a valve respectively to connect the sample quantification channel and the sample collection tube; and a gas exhaust channel controlled by a valve to connect the purge chamber and the sample collection tube.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX RAMIREZ whose telephone number is (571)272-9756. The examiner can normally be reached Monday - Friday 8:00 - 5:00.
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/A.R./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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