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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/05/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 06/07/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 13 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim 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 13 recites the limitation "the sealed PCR tube" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 is rejected under 35 U.S.C. 112b since the claim incorporates and depends upon claim 13.
Appropriate corrective 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.
Claims 1, 2 and 11-13 are rejected under 35 U.S.C. 102a1 as being anticipated by Tajima (WO 2017/204274 A1 – hereafter ‘274 with reference made to the enclosed translation).
‘274 discloses a sample processing system (Abstract) that includes the following limitations for claim 1:
“A nucleic acid extraction and fluorescent PCR test system”: ‘274 discloses a system for the real-time PCR of purified DNA which includes the extraction and fluorescent measurement of the amplified nucleic acids.
“an extraction strip”: ‘274 discloses an extraction cartridge (cartridge 112, i.e. the strip; Fig. 11; page 3, fourth paragraph).
“an extraction-strip loading device which has a function of on-line adding the extraction strip and is configured to load the extraction strip”: ‘274 discloses a cartridge processing preparation stage (stage 2110), a cartridge supply unit (unit 2120) and a cartridge push-out mechanism (2122; Fig. 21) where this reads on the extraction-strip loading device which adds the cartridge and loads the cartridge (page 9 paragraphs 3 and 4).
“a sample-holder loading device which is configured to load and unload a sample”: ‘274 discloses a sample loading unit (unit 2160a; Fig. 21) that is fully capable of loading and unloading the sample holders (page 9 paragraphs 3; page 10, paragraph 2).
“an extraction-strip transfer gripper which is configured to drive the extraction strip to move to a preset position”: ‘274 discloses a cartridge picker (picker 310, i.e. the transfer gripper) that moves the strip from the loading device to a prepositioned process lane (page 6, paragraph 1 (first full paragraph on page 6)).
“a nucleic-acid extraction device which is configured to refine the sample to obtain nucleic acid”: ‘274 discloses an extraction unit (unit 400; Fig. 21) that extracts the nucleic acid (page 7, first full paragraph and second paragraph).
“a PCR test device which is configured to perform a fluorescent PCR test on the nucleic acid”: ‘274 discloses a measurement unit (unit 900) that performs real-time measurement of the amplified DNA and analyzes the fluorescence amount/fluorescence curve (page 7, third paragraph). This being interpreted as the PCR test device of the instant application.
“a control device”: ‘274 discloses a control unit (page 3, first full paragraph).
“wherein the extraction-strip loading device, the sample-holder loading device, the extraction-strip transfer gripper, the nucleic-acid extraction device and the PCR test device are connected to the control device.”: The control unit operates all the elements of the system (the paragraph spanning page 9 and 10).
For claim 2, ‘274 discloses the extraction-strip loading device includes a track(i.e. a channel) that is moved into position to be picked up by a cartridge push-out mechanism (mechanism 2122; Fig. 21; page 9, third and fourth paragraphs). The push-out device is being interpreted as operating in a transverse direction. This device would be connected to the control unit.
For claim 11, ‘274 discloses a reagent storage unit (unit 2152; Fig. 21; page 9, third paragraph) that keeps reagents cool and is capable of providing different reagents.
For claim 12, ‘274 discloses a disposal box (box 2170; Fig. 21; page 10, fourth paragraph) that can be used for recycling a cartridge and would be connected to the control unit.
For claim 13, the measurement device (device 900; Fig. 5) of ‘274 is performs a fluorescence test on the sample (page 7, third paragraph) and is fully capable of performing this on a sealed PCR tube.
Therefore, ‘274 meets the limitations of claims 1, 2 and 11-13.
Allowable Subject Matter
Claims 3-10 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: For claim 3, the prior art fails to teach or fairly suggest a nucleic acid extraction and fluorescent PCR test system that includes the following limitations: the gripping position is provided with a jacking device which is configured to move up and down to separate the extraction strip, and the jacking device is connected to the control device.
For claim 4, the prior art fails to teach or fairly suggest a nucleic acid extraction and fluorescent PCR test system that includes the following limitations: a sample holder which is configured to load the sample, a loading pusher, an emergency pusher, a scanner, a transfer pusher and an unloading pusher, wherein the transfer pusher is configured to transfer the sample to a scanning position of the scanner and to move the sample after scanning to a sampling position, and the unloading pusher is configured to convey the sample after sampling to a sample recovery area; and the loading pusher, the emergency pusher, the scanner, the transfer pusher, and the unloading pusher are all connected to the control device.
For claim 5, the prior art fails to teach or fairly suggest a nucleic acid extraction and fluorescent PCR test system that includes the following limitations: an openable gripper device which is configured to grip the extraction strip, a gripper lifting device which is configured to drive the gripper device to move up and down, and a gripper transverse-movement device which is configured to drive the gripper lifting device to move transversely, wherein the gripper device is arranged on the gripper lifting device, and the gripper lifting device is slidably connected with the gripper transverse-movement device; and the gripper device, the gripper lifting device and the gripper transverse-movement device are all connected to the control device.
For claim 6, the prior art fails to teach or fairly suggest a nucleic acid extraction and fluorescent PCR test system that includes the following limitations: a sealing- film piercing device which is configured to pierce through a sealing film of the extraction strip, a filling device which is configured to add the sample to be tested to the extraction strip, a reagent needle, a magnetic-bead washing device, a high-temperature dissociation device which is configured to perform high-temperature incubation on the sample, and a refined-solution magnetic-absorption device which is configured to perform magnetic absorption refinement on the sample to obtain a nucleic acid refined solution; and the reagent needle is configured to add a corresponding reagent into the extraction strip or a PCR tube and to add the nucleic acid refined solution of the extraction strip into the PCR tube.
Claims 7-10 would be allowable for the same reasons as claim 6.
Claim 14 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.
For claim 14, the prior art fails to teach or fairly suggest a nucleic acid extraction and fluorescent PCR test system that includes the following limitations: a housing, a photometry assembly and temperature control components, wherein the housing is provided with a plurality of test positions for placing the PCR tube, and each of the plurality of test positions is provided with the corresponding temperature control component, so that the temperatures in the plurality of test positions are independently controlled to rise or fall; wherein the photometry assembly and the temperature control components are both connected to the control device; and the photometry assembly comprises a light source assembly which is configured to provide a test light source and a driving component which is configured to drive the light source assembly to move; the number of the light source assembly is plural, the plurality of light source assemblies provide different types of light sources, and each light source assembly illuminates, driven by the driving component, the corresponding test position.
The closest prior art is Tajima (WO 2017/204274 A1) that discloses a system for PCR that includes an extraction cartridge and cartridge loading system with a sample holder and sample holder loading system. Tajima further includes a system to grip and move the cartridges with an optical system to detect the fluorescence of the target molecule. Tajima does not teach or suggest the limitations of claims 3-10 and 14 with regards to the jacking device, the gripping element, the pusher elements of the sample-holding device and the specifics of the nucleic acid extraction device like the reagent needle, the magnetic bead washing device and the refined-solution magnetic absorption device.
The next closest art is Getein Biotech (CN108865659 A; listed on the IDS submitted on 06/05/2025) that discloses a system for nucleic acid extraction and amplification that includes cartridge that is griped with a gripping mechanism with a jaw assembly. However, Getein does not teach or suggest the limitations of claims 3-10 and 14 with regards to the jacking device, the gripping element, the pusher elements of the sample-holding device and the specifics of the nucleic acid extraction device like the reagent needle, the magnetic bead washing device and the refined-solution magnetic absorption device. Moreover, one of ordinary skill in the art would not incorporate the gripping kit of Getein within Tajima as that would render the cartridge picker of Tajima inoperable for its intended use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gajewski et al. (US 2014/0193826 A1) discloses a system for processing samples for DNA analysis by PCR that includes moving plates by a gripper, but does not disclose the extraction strip, sample-holder loading device and the PCR test device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799