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 .
DETAILED ACTION
Claims 1-12 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/KR2022/005577, filed on 4/19/2022. The instant application claims foreign priority to KR 10-2021-0090890 filed on 7/12/2021. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application on 9/18/2023.
Information Disclosure Statement
The information disclosure statements (IDS) dated 9/18/2023 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
Claim Objection
Claims 9 and 10 are objected to for grammatical errors. The phrases “washing of washing”, “centrifugation of centrifuging” and “incubation of incubating” are grammatically incorrect. Appropriate correction is required.
Claim Rejections - 35 USC § 112—Second Paragraph
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.
Claims 5, 9 and 10 are rejected for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 5 recites the compound “ammonium aluminum”, which renders the claim indefinite because the compound as written does not describe a chemically proper salt, due to aluminum being described in its elemental state.
Claim 9 recites the limitation "the cultured product". There is insufficient antecedent basis for this limitation in the claim. Claim 9 is further indefinite because it contains multiple instances of the phrase “the mixture”. Initial instances of “the mixture” clearly refer back to base claim 8, however, later instances of “the mixture” refer to a supernatant isolated from the original mixture. The use of “the mixture” in different contexts results in lack of claim scope clarity. Clam 10 is indefinite for depending from claim 9.
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)(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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang et al. (CN 102533732, 2012, IDS).
Huang et al. discloses a process for extraction of DNA comprising contacting a sample with the following solutions:
Solution I: 50 mM Tris-HCl and 10 mM EDTA, 50 μg/mL RNase A;
Solution II: 0.2M NaOH and 1% SDS;
Solution III: 4M guanidine hydrochloride and 0.5M potassium acetate;
Solution V: 20mM NaCl, 2mM Tris-HCl, add ethanol at 80% before use. (Claim 2)
Solution I meets the limitation of a first buffer comprising Tris-HCl. Solution II meets the limitation of a second buffer comprising SDS, Solution V meets the limitation of a third buffer comprising sodium chloride. Solution III meets the limitation of a fourth buffer comprising guanidine hydrochloride.
Accordingly, the instant claims are anticipated by the prior art.
Claim 12 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pan et al. (CN 103911366A, 2014, PTO-892).
Pan et al. discloses a kit for extraction of DNA comprising:
a means for grinding a tissue sample;
solution A, which comprises the reducing agent beta-mercaptoethanol;
solution B, which comprises isopropanol;
solution C;
solution D; and
a purification column. (Claim 1)
Accordingly, the instant claims are anticipated by the prior art.
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 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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 2, 7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN112899271A, June 2021, PTO-892).
Liu et al. discloses a method of extracting microorganism DNA from livestock manure slurry comprising:
Filtering the slurry through a 100 micron cell sieve, to obtain a clear filtrate;
Centrifuge the filtrate and discard the supernatant, to obtain a microorganism precipitate;
Suspend the precipitate in 500 microL of a lysis buffer comprising 50-100 mM Tris-HCl, 50-100 mM NaCl, 30-50 mM EDTA and 1-2% PVP, then add RNase and incubate at RT for 5 min;
Add to the suspension of step 3, 100 microL of a second lysis buffer comprising 10-20% SDS, incubate at 65-75°C for 10 min, centrifuge and isolate supernatant;
Add to the supernatant of step 4, 200 microL of a precipitation solution comprising 2.0-2.5 M potassium acetate, incubate on ice for 10 min, centrifuge and isolate a second supernatant;
Add to the second supernatant of step 5, 400 microL of a binding solution comprising 5-6 M guanidine isothiocyanate and 50-80 mM Tris-HCl, mix and incubate at RT for 10 min.;
Transfer the second supernatant from step 6, onto a silica column, centrifuge and discard the eluate, to obtain a silica column with bound microorganism DNA;
Add to the DNA bound silica column of step 7, 700 microL of a wash buffer comprising 10-20 mM Tris-HCl, 80-100 mM NaCl and 70-80% ethanol, centrifuge, discard eluate, add second aliquot of wash buffer, centrifuge, discard eluate, to obtain a washed DNA bound silica column, centrifuge empty column, incubate at RT for 3-5 min.;
Add to the washed silica column of step 8, 50-100 microL of a DNA elution buffer, preheated to 65-75°C, comprising 10 mM Tris-HCl, incubate at RT for 3 min, then centrifuge to obtain an eluate comprising the extracted microorganism DNA. (¶0051-0072; Claims 5-10)
Liu further discloses that the precipitation step after SDS lysis may comprise adding a solution of 5 M NaCl and CTAB, followed by incubation at 65°C for 10 min. (¶0079) Liu also discloses a kit for extracting DNA comprising the buffers and solutions from steps 1) thru 9) above. (Claims 1-4)
Liu does not exemplify or claim a process where step 5), as detailed above, involves a solution of NaCl.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the precipitation solution of Liu could comprise 2-5M of either potassium acetate or sodium chloride, thereby arriving at the instant invention. Liu teaches that high molarity KAc or NaCl perform the equivalent function of precipitating out impurities prior to binding of the desired DNA onto a column, thus substituting the Kac, with NaCl, in the exemplified process as detailed above, with yield predictable equivalent results.
With respect to the claimed ranges of component concentrations, buffer volume ratios, temperatures and mixing/incubation times, the ranges disclosed by the prior art overlap with those claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 3, 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN112899271A, June 2021, PTO-892), in view of Zhou et al. (CN 102643800A, 2012, IDS).
The disclosure of Liu et al. is referenced as discussed above. Liu does not teach the first buffer as detailed in claim 3.
Zhou et al. discloses a process for extracting nucleic acids from plant material (e.g. grapes) where the plant material is first pulverized then mixed with an extraction buffer comprising 1 M Tris-HCl, 20-30 mM EDTA, 1.2-1.6 M NaCl, 2.5-3.5 g/100 ml CTAB, 0.5-1.5 g/100 ml sodium metabisulfite, 0.5-1.5 g/100 ml sodium ascorbate, 1-3 g/100 ml polyvinylpyrrolidone, 80-120 μL/100 ml β-mercaptoethanol. (¶0026; claim 2)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the buffer in step 3) of Liu could be replaced with the extraction buffer of Zhou, thereby arriving at the instant invention. One would be motivated to perform such a replacement because Zhou teaches that the extraction buffer therein is adapted to extract DNA from plant material. Thus, one desiring to achieve the most effective DNA isolation from plants using the method of Liu, would find it beneficial to employ the plant DNA extracting buffer of Zhou.
With respect to the claimed ranges of component concentrations and volumes, the ranges disclosed by the prior art overlap with those claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN112899271A, June 2021, PTO-892), in view of Xiao et al. (CN 107663521A, 2018, IDS).
The disclosure of Liu et al. is referenced as discussed above. Liu does not teach the second buffer as detailed in claim 4.
Xiao et al. discloses a process for extracting nucleic acids using a lysis buffer comprising 100mM-1M Tris-HCl, 10mM-500mM EDTA, 0.1%-30% (w/v) SDS, 0.1%-10% (w/v) sodium citrate, 1%-50% (w/v) polyethylene glycol, 0.1-10M guanidine isothiocyanate solution. (Claim 1)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the buffer in step 4) of Liu could be substituted with the lysis buffer of Xiao, thereby arriving at the instant invention. One would be motivated to perform such a substitution because the lysis buffers of both Liu and Xiao perform the equivalent function of breaking open cells to allow for the isolation of the desired nucleic acids. Selecting either the lysis buffer of Xiao or the lysis buffer of Liu, one would expect equivalent results.
With respect to the claimed ranges of component concentrations and volumes, the ranges disclosed by the prior art overlap with those claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN112899271A, June 2021, PTO-892), in view of Li et al. (CN 107312773A, 2017, IDS).
The disclosure of Liu et al. is referenced as discussed above. Liu does not teach the third buffer as detailed in claim 5.
Li et al. discloses a process for purifying nucleic acids using a buffer comprising a salt, at 2-5 M, and a solubilizer where the salt is selected from at least one of potassium chloride, potassium acetate, lithium chloride, lithium acetate, sodium chloride, and sodium acetate, and the solubilizer is selected from dextran sulfate, tetraethylene glycol, polyethylene glycol 4000, polyethylene glycol 6000, polyethylene glycol 8000, and polyvinylpyrrolidone. (Claims 1-3)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the salt solution in step 5) of Liu could be modified to be a mixture of salts (e.g. NaCl and LiCl) and contain a solubilizer, such as PVP or PEG, based on the teaching of Li. The intent of the high concentration salt solution in both Liu and Li is for the common purpose of causing precipitation of proteins and other compound, leaving the desired nucleic acid in solution, as a first step towards purifying and isolating nucleic acids. Either precipitation solution of Liu or Li could be used equivalently, to achieve this common purpose.
With respect to the claimed ranges of component concentrations and volumes, the ranges disclosed by the prior art overlap with those claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN112899271A, June 2021, PTO-892), in view of Huang et al. (CN 102533732, 2012, IDS).
The disclosure of Liu et al. is referenced as discussed above. Liu does not teach the fourth buffer as detailed in claim 6.
Huang discloses a process for isolating nucleic acids using a binding solution comprising 5M guanidine hydrochloride and 20mM Tris-HCl. (Claims 1-2)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the solution in step 6) of Liu could be substituted with the binding solution of Huang, thereby arriving at the instant invention. One of ordinary skill in the art recognizes that the purpose of treating a nucleic acid containing solution with a guanidine reagent is to facilitate bind of the nucleic acid to a solid support for further purification. Thus, the binding solution of Liu or that of Huang could be used interchangeably with a reasonable expectation of equivalent results.
With respect to the claimed ranges of component concentrations and volumes, the ranges disclosed by the prior art overlap with those claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN112899271A, June 2021, PTO-892), in view of Che et al. (CN 111057705A, 2020, PTO-892).
The disclosure of Liu et al. is referenced as discussed above. Liu does not teach the sequence of column loading, washing and elution as per claims 9 and 10.
Che discloses a process for purifying nucleic acids where the solution from the binding step is mixed with isopropanol then loaded onto a silica column. (¶0022) Once loaded onto the column the column is washed with a first buffer comprising 100-500 mM Tris-HCl, 0.1-10 M guanidine hydrochloride, 0.5-1.5 M sodium chloride, 10-60 mM EDTA buffer, and 20-70% anhydrous ethanol. The column is then washed with a second buffer comprising 10-500 mM Tris-HCl and 50-80% ethanol. The nucleic acids are then eluted with a solution comprising 1-10 mM Tris-HCl and water. (Claim 1)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the column loading, washing and elution steps 7)-9) of Liu could be modified to reflect the teachings of Che, thereby arriving at the instant invention. One of ordinary skill in the art recognizes that the procedure of Liu and Che are both directed to purifying DNA using a silica column. Thus, the column loading, washing and elution steps of Che could reasonably be used in place of those of Liu with a reasonable expectation of equivalent results.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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/DALE R MILLER/Primary Examiner, Art Unit 1693
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