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 .
Claim Objections
Claim 11 is objected to because of the following informalities: the abbreviation “mT” should be spelled out in the first occurrence. Appropriate correction is required.
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 7-9 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.
Claim 7 recites the limitations "the nucleic acid probe", “the single stranded DNAs”, and “the first member of the binding pair”, and “the first set of magnetic beads” in lines 2-4. There is insufficient antecedent basis for these limitations in the claim.
Claim 8 recites the limitations "the second set of magnetic beads", and “the second member of the binding pair” in lines 2-3. There is insufficient antecedent basis for these limitations in the claim.
Claim 9 recites the limitations "the magnetic beads of the first and second sets” in line 2. There is insufficient antecedent basis for these limitations in the claim.
Due to inability to determine the scope of the claims due to the lack of antecedent basis, these claims have not been further treated.
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.
Claim(s) 1-5 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burger et al. (Biosensors and Bioelectronics, Volume 76, Pages 54-67, 2016) and Donolato, et al. (Biosensors and Bioelectronics, Volume 67, Pages 649-655, 2015).
For claims 1 and 15, Burger et al. teach a method to detect an infectious agent by the method of Kim et al. for detecting food-borne pathogens (e.g. Salmonella) via isothermal recombinase polymerase amplification (RPA) … steps, such as bacteria lysis, DNA amplification, and detection were performed on disc. (Section 2.4 column 2).
For claim 2, Burger et al. teach a modified assay using RT-isothermal amplification for detecting influenza and one of ordinary skill in the art before the effective time of filing would have known about for amplifying the target nucleic acid and designing primer pairs.
For claims 3-5 and 15, one of ordinary skill in the art before the effective time of filing would know the sample can be a biological sample from an individual who is infected with Salmonella or influenza (a negative stranded virus).
Burger et al. suggest Donolato, et al. as a more sensitive detection method ((section 2.5).
Burger et al. do not teach RPA and magnetic -field agglutination assay together.
For claims 1 and 15, Donolato et al. demonstrated the use of a Blu-ray OPU for highly sensitive detection of magnetic nanobeads (MNBs) based agglutination assays in a magnetic field (abstract) and that the level of detection achieved is comparable in performance to bulky and costly lab equipment (abstract) and that the magnetic nanoparticles agglutinate (agglomerate) for detection (figure 4).
One of ordinary skill in the art before the effective time of filing would be motivated to use the detection of Donolato et al. because it is very sensitive and not bulky or costly as taught by Donolato et al. and because it is specifically suggested by Burger et al. One of ordinary skill in the art before the effective time of filing would have had the expectation of success because it is specifically suggested by Burger et al.
Thus, it would have been prima facie obvious to modify the RPA of Burger et al. with the more sensitive detection of Donolato et al.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burger et al. (Biosensors and Bioelectronics, Volume 76, Pages 54-67, 2016) and Donolato, et al. (Biosensors and Bioelectronics, Volume 67, Pages 649-655, 2015) as applied to claims 1-5 and 15 above, and further in view of El Wahed et al. (Analytical Chemistry 2021 93 (4), 2627-2634
DOI: 10.1021/acs.analchem.0c04779).
Burger et al. and Donolato, et al. are discussed above.
Burger et al. and Donolato, et al. do not teach coronavirus.
El Wahed et al. teach a SARS-CoV-2 RPA assay was developed.
One of ordinary skill in the art before the effective time of filing would be motivated to use the detection of Burger et al. and Donolato, et al. because it is very sensitive. One of ordinary skill in the art before the effective time of filing would have had the expectation of success because both use the RPA assay.
Thus, it would have been prima facie obvious to modify the Burger et al. and Donolato, et al. with the SARS-CoV-2 RPA assay of El Wahed et al.
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burger et al. (Biosensors and Bioelectronics, Volume 76, Pages 54-67, 2016) and Donolato, et al. (Biosensors and Bioelectronics, Volume 67, Pages 649-655, 2015) as applied to claims 1-5 and 15 above, and further in view of Daynes et al. (US10107801).
Burger et al. and Donolato, et al. are discussed above.
Additionally, Donolato, et al. teach about applying magnet field (page 632 col 1 and Figure 4).
Burger et al. and Donolato, et al. do not teach the specific recited parameters.
Daynes et al. teach magnetic particles and the use in agglutination (Example 2). Example 2 teaches that “After 2 minutes, the medium undergoes 5 field cycles, composed of 30 s under 10 mT, 30 s under 3 mT and 30 s of relaxation under 0 mT.”
One of ordinary skill in the art before the effective time of filing would be motivated to optimize the magnetic field of Burger et al. and Donolato, et al. in order to get the desired result of agglutination and know that magnetization, relaxation and different strengths of mT are used in agglutination.
One of ordinary skill in the art before the effective time of filing would have had the expectation of success because agglutination is a well know parameter of detecting.
Thus, it would have been prima facie obvious to modify the Burger et al. and Donolato, et al. with the knowledge of shill in the art as shown by Daynes et al.
Claim(s) 14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burger et al. (Biosensors and Bioelectronics, Volume 76, Pages 54-67, 2016) and Donolato, et al. (Biosensors and Bioelectronics, Volume 67, Pages 649-655, 2015) as applied to claims 1-5 and 15 above, and further in view of Steinhagen et al. (US202000385430).
Burger et al. and Donolato, et al. are discussed above.
Burger et al. and Donolato, et al. do not teach immunoassays.
Steinhagen et al. teach an assay to detect a flavivirus (claim 8 and para 71).
One of ordinary skill in the art before the effective time of filing would be motivated to use the detection of Burger et al. and Donolato, et al. to detect a Flavivirus and want to confirm an acute infection. One of ordinary skill in the art before the effective time of filing would have had the expectation of success because both assays are known to work.
Thus, it would have been prima facie obvious to modify the Burger et al. and Donolato, et al. with the immunoassay of assay of Steinhagen et al.
Conclusion
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/ Examiner, Art Unit 1671
/Shanon A. Foley/ Primary Examiner, Art Unit 1671