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 .
Claims 1-5, 10-12, 21, 35-40, and 45-49 are pending.
Claims 6-9,13-20,22-34,41-44,50-55 have been cancelled.
An action on the merits is set forth below.
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 1-5, 10-12, 21, 35-36, 45, 48-49 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 1-5, 10-12, 21, are indefinite over the step of claim 1. In particular the preamble states “preparing nucleic acids for nucleic acid amplification”, however, the active step only requires contacting the sample. As such the nucleic acids are not “prepared” from a sample, as there is not active step other than “contacting”.
Claim 10 is indefinite over the composition. In particular claim 1 does not require betaine and as such it is not clear if the claim is intending to limit one of the chemicals in claim 1 or if the claim is intending to have betaine in addition to the chemicals in claim 1. Therefore the metes and bounds are unclear.
Claim 21 is indefinite. Claim 21 recites the limitation "the reaction sample" in line 2. There is insufficient antecedent basis for this limitation in the claim. In particular the sample in claim 1 is not indicated to be “reaction sample”. It is suggested that the CLiams be amended to reflect the language of claim 1.
Claim 35-36 are indefinite over the steps of the claims. In particular it is not clear which of the steps following “optionally” are intended to be required. As such it is not clear if the claim requires the performing step which would be the step of detection as it is not clear if the step is optional or not based upon the language of the claims.
Claim 45, 48-49 are indefinite over the composition. In particular claim 37 does not require betaine, NaOH, isopropanol and as such it is not clear if the claim is intending to limit one of the chemicals in claim 37 or if the claim is intending to have betaine in addition to the chemicals in claim 37. Therefore the metes and bounds are unclear.
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.
Claim(s) 1-5,10,12,35-40,45-47 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Previte et al. (US Patent Application Number 2021/0318294 October 14, 2021).
With regard to claim 1, Previte et al. teaches a method of DNA amplification (para 490). Previte et al. teaches contacting a sample with a composition comprising a quaternary ammonium compound of betaine (para 844), a denaturing agent of either NaOH or KOH (para 840), and a precipitation agent of methanol ethanol or isopropanol (para 840).
With regard to claim 2, the specification teaches that salt, metal ions, and detergents can render an infectious agent as non-infectious (para 190, 129). As Previte et al. teaches the use of the same betaine, NaOH or KOH, and methanol, ethanol or isopropanol as that is suggested by the specification, the compositions of Previte et al. would be capable of rendering an infectious agent. Further it is noted the claims do not require that the sample is infectious.
With regard to claim 3, Previte et al. teaches that use of betaine (para 844).
With regard to claim 4, Previte et al. teaches that either NaOH or KOH can be used (para 840).
With regard to claim 5, Previte et al. teaches that isopropanol, ethanol, or methanol can be used (para 840).
With regard to claim 10, Previte et al. teaches that the betaine can be 1.5M (para 1100).
With regard to claim 12 , Previte et al. teaches that the percentage of the precipitating agent can be 10%-80% (para 92 and 138).
With regard to claim 35, Previte et al. teaches a method of DNA amplification (para 490). Previte et al. teaches contacting a sample with a composition comprising a quaternary ammonium compound of betaine (para 844), a denaturing agent of either NaOH or KOH (para 840), and a precipitation agent of methanol ethanol or isopropanol (para 840).
With regard to claim 36, the specification teaches that salt, metal ions, and detergents can render an infectious agent as non-infectious (para 190, 129). As Previte et al. teaches the use of the same betaine, NaOH or KOH, and methanol, ethanol or isopropanol as that is suggested by the specification, the compositions of Previte et al. would be capable of rendering an infectious agent. Further it is noted the claims do not require that the sample is infectious.
With regard to claim 37, Previte et al. teaches a sample with a composition comprising a quaternary ammonium compound of betaine (para 844), a denaturing agent of either NaOH or KOH (para 840), and a precipitation agent of methanol ethanol or isopropanol (para 840).
With regard to claim 38, Previte et al. teaches a composition with a betaine (para 844).
With regard to claim 39, Previte et al. teaches a composition comprising NaOH and KOH (para 840).
With regard to claim 40, Previte et al teaches a composition comprising isopropanol, ethanol or methanol (para 840).
With regard to claim 45, Previte et al. teaches that the betaine can be 1.5M (para 1100).
With regard to claim 46-47 , Previte et al. teaches that the percentage of the precipitating agent can be 10%-80% (para 92 and 138).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Previte et al. (US Patent Application Number 2021/0318294 October 14, 2021).
Previte et al. teaches a method of DNA amplification (para 490). Previte et al. teaches contacting a sample with a composition comprising a quaternary ammonium compound of betaine (para 844), a denaturing agent of either NaOH or KOH (para 840), and a precipitation agent of methanol ethanol or isopropanol (para 840).
With regard to claim 21, Previte et al. teaches that nucleic may be separated (para 781), however, does not explicitly teach “not separated” prior to amplification. However it would be an obvious embodiment of the teaching of Previte et al. as it suggests that separation is optional. As such it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Previte et al. to not separate the nucleic acids from the sample as the amplification techniques used by Previte et al. can be used on cells.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Previte et al. (US Patent Application Number 2021/0318294 October 14, 2021) in view of Liu et al. (US Patent Application Publication 2017/0145428 May 25, 2017)
Previte et al. teaches a method of DNA amplification (para 490). Previte et al. teaches contacting a sample with a composition comprising a quaternary ammonium compound of betaine (para 844), a denaturing agent of either NaOH or KOH (para 840), and a precipitation agent of methanol ethanol or isopropanol (para 840).
With regard to claim 11, Previte et al teaches a denaturing agent but does not teach that denaturing agent is 15mM to about 1000 mM.
With regard to claim 11, Liu et al. teaches that 20mM of NaOH can be used to lyse enzymes in a sample that is used in PCR analysis (para 35).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to use a known amount of NaOH in the composition of Previte et al. The ordinary artisan would have a reasonable expectation of success of using any of the known amounts of NaOH to produce a composition that would be capable of obtaining nucleic acids for PCR analysis.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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