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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, Item 23 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 1-7 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 1 recites in the preamble, “disposable, portable, LAMP, detection, magnetic,” in the preamble. The body of the claim does not make it clear how the box is disposable, portable, function/structure for LAMP, detection, or magnetic.”
Dependent claims are included in this 112 rejection.
Claim 3 is 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 3 recites the limitation "the nucleic acid extraction assembly" in Claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 8 & 9 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.
Claims 8 & 9 recite, “a constant temperature heating device for a disposable portable LAMP detection magnetic box,” in the preamble. The body of Claim 8 does not provide sufficient structure and/or function as to how or what components of the heating device provide for constant temperature heating. It is unclear how the heating device provides for the function/structure of constant heating. Dependent Claims are also included in this rejection.
Claim Rejections - 35 USC § 102
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)(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, & 8 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Roswech et al (US20220176371).
Applicants’ claims are directed to apparatuses.
Regarding Claims 1, 3, & 8, Roswech et al discloses the disposable portable LAMP detection magnetic box, comprising a box body (See Figure 1B Item 1000 diagnostic device) and a detection mechanism arranged in the box body, the detection mechanism (See Figure 1B) comprises a first pipeline opened in the box body downward from the top end of the box body along the length direction of the box body and used for putting a nasopharyngeal swab of a patient (See Figure 1B Item 1002 First Chamber and swab, Item 1100), a second pipeline connected to an end of the first pipeline away from the top end of the box body, and a nucleic acid extraction component arranged in the second pipeline to extract the nucleic acid of the nasopharyngeal swab of the patient (See Figure 1B Item 1002 Sample Chamber & Item 1022 reagent), a third pipeline communicated with the other end of the second pipeline and has a reaction solution therein (See Figure 1B Item 1008 Third Chamber and fluid), and an isolation component arranged between the second pipeline and the third pipeline and used for isolating the nucleic acid and the reaction solution (See Figure 1b Item 1010 second seal), wherein the third pipeline is fixed to the box body along the width direction of the box body, and the third pipeline is a transparent pipeline, and its peripheral side walls are exposed outside the box body (See Figure 1B and [0039] window embodiment of third pipeline).
Regarding Claim 3, Roswech et al, discloses the disposable portable LAMP detection magnetic box according to claim 1, wherein the nucleic acid extraction assembly comprises lysate, and the lyse is placed in the second pipeline, the nasopharyngeal swab enters the second pipeline from the first pipeline and is soaked in the lysate (See Figure 1B Item 1022 reagent fluid/lysate/lysis fluid).
Regarding Claim 8, Roswech et al discloses the constant temperature heating device for a disposable portable LAMP detection magnetic box, comprising a housing, a docking slot opened downwards along the top end of the housing and used for inserting the magnetic box, and a heating component arranged in the housing and used for heating the magnetic box (See Figure 4E Item 4360 is a heater with a housing and a docking slot opened downwards along the top end of the housing and functions as recited in instant application Claim 8).
Claim Rejections - 35 USC § 103
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Roswech et al (US20220176371) in view of Liu et al (US12186757).
Applicant’s claim is directed to an apparatus.
Regarding Claim 2, Roswech et al discloses the disposable portable LAMP detection magnetic box according to claim 1, except wherein the third pipeline (24) is thermoplastically molded with an acrylic plate. Liu et al discloses a LAMP box that is made of acrylic (See Column 15 line 64 to Column 16 line 6).
It would have obvious to one skilled in the art at the time of filing of the application to make the magnetic box and any part of it out of acrylic components because according to Liu et al when using LAMP detection components and reagents, acrylic as well as other materials are suitable for LAMP detection apparatuses and methods (See Column 15 line 64-65).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Roswech et al (US20220176371) in view of He et al, “Rapid and highly sensitive one-tube colorimetric RT-LAMP assay for visual detection of SARS-CoV-2 RNA”, Biosensors and Bioelectronics, 2021, 113330, pages 1-7).
Regarding Claim 4, Roswech et al discloses the disposable portable LAMP detection magnetic box according to claim 3, except wherein the nucleic acid extraction component further comprises several magnetic beads evenly distributed in the lysate. He et al discloses the use of LAMP detection methods that are configured to include magnetic beads to detect viral concentrations of SARS-CoV-2 (See Page 2, Section 2.2 Viral RNA concentration utilizing Si-OH magnetic beads). It would have been obvious to one skilled in the art to incorporate the lysate solution with magnetic beads of Lui et al into/as the nucleic acid extraction component of Roswech et al because according to Roswech et al, the system of Roswech et al can be configured to detect SARS-CoV-2 (See [0080]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Roswech et al (US20220176371) in view of Abercrombie et al (US11246523).
Regarding Claim 9, Roswech et al discloses the constant temperature heating device of Claim 8, except wherein a temperature display lamp arranged on the outer wall of the housing and used to receive the temperature signal from the temperature sensor, wherein when the temperature received by the temperature display lamp reaches the set temperature, the temperature display lamp lights up in green; when the temperature received by the temperature display lamp does not reach the set temperature, the temperature display lamp lights up in red.
Abercrombie et al discloses a portable medical device in which LED lamps are used for a variety of parameters and a variety of functions/reasons (See Column 38 lines 30-55).
It would have been obvious to one skilled in the art at the time of filing of the invention to include temperature displays with LED lamps to indicate the status of the heating or temperature in order to easily visualize whether the heater is working, not working, or at temperature.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BOBBY RAMDHANIE whose telephone number is (571)270-3240. The examiner can normally be reached Monday thru Friday.
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/Bobby Ramdhanie/Supervisory Patent Examiner, Art Unit 1779