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 .
Status of Claims/Application
The preliminary amendment dated 04/19/2024 is acknowledged. Claims 4 and 5
are amended. Claims 6 and 7 are newly added.
Claims 1 – 7 are currently pending and are examined on the merits herein.
Priority
The instant application is a National Stage Application of PCT/ KR2022/016412, filed on 10/26/2022, and claims
priority to Korean Patent Application No. KR10-2021-0145494, filed on 10/28/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted in the instant application
on 04/19/2024 and 03/10/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Objection to the Specification
The use of the term Tris in Tris-HCl, which is a trade name or a mark used in commerce, has been noted in this application. In the instant disclosure, Tris is noted pg. 10, lines 19, 22, and 25, pg. 17, line 22 and pg.18, lines 1 and 3. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 and 3 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 an impurity precipitant composition comprising 1.3-2.1 %(w/v) phosphotungstic acid hydrate, 1.2-1.8 %(w/v) zinc acetate dihydrate, 13.0-19.0 %(v/v) acetic acid, with the remainder being water. The concentration of acetic acid 13.0-19.0 %(v/v) is indefinite as it could be w/v or v/v.
Claim 3 contains the trademark/trade name Tris. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a buffering agent and, accordingly, the identification/description is indefinite.
Claim 3 recites “The method of extracting DNA of claim 2, wherein the lysis buffer …., the washing buffer …., the DNA elution buffer ….” without a conjunction “and/or” between the washing buffer and the DNA elution buffer making the scope of the claim indefinite.
Claim 3 recites “25-35mM Tris-HCl (pH 8.0±0.2)” and “13-17 mM EDTA (pH 8.0±0.2)”. It is not clear if the Tris-HCl or EDTA is meant to be limited to that pH range or can be outside of that pH as it is provided in the parenthesis.
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.
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.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Rodríguez-Gómez et al (Talanta, 2014) (IDS 04/19/2024).
Rodríguez-Gómez teaches that a method based on a simplified sample treatment involving steps of precipitation, evaporation and clean-up of the extracts with C18 in human breast milk samples is proposed and validated (Abstract). Rodríguez-Gómez teaches that the aim was to develop a sensitive multi-residue method based on a precipitation of fat and proteins followed by a clean-up step in human milk samples (pg. 562, col. 1, para. 5). The fat/proteins precipitation solution was prepared at time of use by dissolving 9.10 g of zinc acetate hydrated, 5.46 g of hydrated phosphotungstic acid and 5.8 mL of glacial acetic acid in 100 mL final volume of deionized water (pg. 562, col. 2, para. 2). After a careful study of possible sample treatments for cow milk-related products a simple precipitation procedure with a solution containing zinc and tungsten salts in an acidic media was selected. It was decided to evaluate a similar procedure to remove fat and proteins from human milk by precipitation. The results were excellent in terms of sensitivity and sample handling and on the one hand a white solid fraction corresponding to protein, fat and other precipitated salts was obtained, and it was also separated a clear solution containing the analytes that after filtering was completely transparent (pg. 563, col. 2, para. 2).
Regarding claim 1, “used for precipitating and removing impurities that inhibit the pure separation of DNA during the process of extracting DNA by lysis of cells in a sample”, it is noted that the prior art does not teach the composition can be used in the manner instantly claimed. However, the cited recitations are considered as an “intended use” of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since the composition would be capable of performing the intended use. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
The teachings of Rodríguez-Gómez differ from the instantly claimed invention in that Rodríguez-Gómez does not teach the recited concentrations of the components of the impurity precipitant composition in the fat/proteins precipitation solution.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the instantly claimed invention to optimize the quantities of the various components of the fat/proteins precipitation solution of Rodríguez-Gómez to arrive at the composition of the instantly claimed invention. Even though the recited concentrations of the components differ in the fat/proteins precipitation solution of Rodríguez-Gómez, one of ordinary skill in the art would arrive at the recited concentrations with optimization within prior art conditions and through routine experimentation to yield expected results. MPEP 2144.05 (II) (A) states “Generally, 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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)”.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over CN 112195177 B (IDS 03/10/2025, English Translation provided) in view of Rodríguez-Gómez et al (Talanta, 2014) (IDS 04/19/2024).
CN’177 teaches a nucleic acid extraction method and a kit. The kit comprises a nucleic acid chemical cracking solution and an inhibition component removing solution, wherein the nucleic acid chemical cracking solution comprises guanidinium isothiocyanate, N-lauroyl sarcosine sodium salt and PBS; and the inhibiting component removing solution comprises a mixed solution of an aluminum ammonium sulfate dodecahydrate solution and cross-linked polyvinylpyrrolidone (PVPP) and ammonium acetate. The nucleic acid extraction method comprises the following steps of chemically cracking a sample by adopting the nucleic acid chemical cracking solution, removing impurities, adsorbing the nucleic acid, and performing washing, eluting, and collecting to obtain the nucleic acid (Abstract).
CN’177 teaches that the nucleic acid extraction method further comprises one or more of the following features (pg. 7, [n0015 – n0019]):
1) The samples are lysed by combining chemical lysis, high temperature incubation lysis and physical impact lysis;
2) When removing impurities, the inhibitory component removal solution and protein removal agent in the kit are used to remove impurities in the system respectively;
3) When extracting nucleic acid based on a silica-based centrifugal column method, the binding buffer in the kit is used to allow the centrifugal column to adsorb nucleic acid;
4) washing with the protein detergent and/ or ion detergent in the kit.
CN’177 teaches the various components of the DNA extraction method in Example 2 (pg. 21 – 23, [n0125 – n0134]) as given below.
1) Nucleic acid chemical lysis solution: 4 M guanidine isothiocyanate solution; 10% w/v N-lauroyl sarcosine sodium salt solution; 5% (w/v) N-lauroyl sarcosine sodium salt solution prepared with 0.1 M phosphate buffer [pH 8.0].
2) Solutions related to impurity removal: 150 mM ammonium acetate solution; 120 mM aluminum ammonium sulfate dodecahydrate solution (containing 30% v/v PVPP); 20 mg/mL proteinase K room temperature storage solution: 25 mM Tris-base, 10 mM calcium chloride; 200 mM sodium chloride, 50% v/v glycerol, 1% v/v Tween 20, and HCl adjusted to pH 8.0.
3) DNA Binding Buffer: 5 M guanidine hydrochloride; 30 mM Tris-base; 300 mM sodium acetate; 2% v/v Triton X-100.
4) Washing related solutions:
a) Clean Buffer: 2 M guanidine hydrochloride, 10 mM Tris-base, 100 mM sodium chloride, 50% v/v anhydrous ethanol.
b) Wash Buffer: 0.01% v/v 1M Tris-base, 0.01% v/v 0.1 M EDTA, 0.372% v/v 1N HCl, 0.5% v/v 10% v/v Tween 20, 97.128% v/v sterile water, add 4 times the volume of anhydrous ethanol to the total volume of the above solution.
5) DNA elution solution: 10 mM Tris-base.
CN’177’s Claim 1 recites a DNA extraction kit comprising of nucleic acid chemical lysis solution, inhibitory component removal solution, protein removal agent, binding buffer, protein washing solution, ion washing solution and eluent. The lysis solution comprises 0.03 – 0.05% (w/v) N-lauroyl sarcosine, 0.6-1.6 M guanidine isothiocyanate and a pH buffer solution. The inhibitory component removal solution includes a mixture of aluminum sulfate dodecahydrate solution, cross-linked polyvinylpyrrolidone (PVPP), and ammonium acetate. The protein removal solution comprises proteinase K. The washing and elution buffer comprises Tris-base.
The teachings of CN’177 differ from the instantly claimed invention in that CN’177 does not teach the impurity removal solution comprising of 1.3-2.1% (w/v) phosphotungstic acid hydrate, 1.2-1.8% (w/v) zinc acetate dihydrate, 13.0-19.0% (v/v) acetic acid.
The teachings of Rodríguez-Gómez are as discussed above.
It would have been obvious to combine CN’177 with Rodríguez-Gómez before the effective filing date of the instantly claimed invention by using the fat/proteins precipitation solution taught by Rodríguez-Gómez in the place of the impurity removal solution of CN’177 in the extraction of DNA from a sample to arrive at the instantly claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to modify the impurity removal solution of CN’177 with the fat/proteins precipitation solution of Rodríguez-Gómez and have a reasonable expectation of success because Rodríguez-Gómez teaches that results of using the precipitation solution were excellent in terms of sensitivity and sample handling and on the one hand a white solid fraction corresponding to protein, fat and other precipitated salts was obtained, and it was also separated a clear solution containing the analytes that after filtering was completely transparent (pg. 563, col. 2, para. 2).
Claims 3 is rejected under 35 U.S.C. 103 as being unpatentable over CN 112195177 B (IDS 03/10/2025, English Translation provided) and Rodríguez-Gómez et al (Talanta, 2014) (IDS 04/19/2024) as applied to claim 2 above, and further in view of CN 109797148 B (IDS 04/19/2024).
The teachings of CN’177 and Rodríguez-Gómez are as discussed above.
The combined teachings of CN’177 and Rodríguez-Gómez differ from the instantly claimed invention in that CN’177 and Rodríguez-Gómez do not teach Tris-HCl and EDTA as part of the lysis solution.
CN’148 teaches a DNA extraction reagent, a DNA extraction method and a DNA extraction kit. The lysis solution includes guanidine isothiocyanate with a final
concentration of 1 M to 5M, Tris-HCI with a final concentration of 0.01 M to 0.2M, and a final mass volume percentage of 1 % to 10 % N-lauroyl sarcosine (Abstract). CN’148 teaches that the lysis solution used in Example 2 consists of guanidine isothiocyanate with a final concentration of 1 M, Tris-HCl with a final concentration of 0.05 M, N-lauroylsarcosine with a final mass volume percentage of 5%, and phosphate buffer with a final concentration of 0.05 M pH 8.0. The TENP buffer consists of a final concentration of 100 mM Tris pH 8.0, a final concentration of 50 mM EDTA pH 8.0, a final concentration of 500 mM NaCl, and a final mass volume percentage of 6% PVPP (pg. 11, [n0053]) and in Example 3 the 2% SDS lysis buffer consists of a final concentration of 500 mM NaCl, 50 mM Tris-HCl (pH 8), 50 mM EDTA and a final mass volume percentage of 2% SDS (pg. 11 – 12, [n0060]).
It would have been obvious to combine CN’177 and Rodríguez-Gómez with CN’148 before the effective filing date of the instantly claimed invention by using Tris-HCl and EDTA in the lysis solution as taught by CN’148 in the place of the phosphate buffer of the lysis solution of CN’177 to arrive at the instantly claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to substitute the phosphate buffer of CN’177 with the Tris-HCl and EDTA of CN’148 in the lysis solution and have a reasonable expectation of success as it is a simple substitution of one known element for another to obtain predictable results (See MPEP 2143(I)(B)). As CN’177 teaches Wash Buffer comprises 0.01% v/v 1M Tris-base, 0.01% v/v 0.1 M EDTA, 0.372% v/v 1N HCl, 0.5% v/v 10% v/v Tween 20, 97.128% v/v sterile water, add 4 times the volume of anhydrous ethanol to the total volume of the above solution (pg. 23, [n0133]), and DNA elution solution comprises 10 mM Tris-base (pg. 23, [n0134]), one of ordinary skill in the art would arrive at the recited concentrations with optimization within prior art conditions and through routine experimentation to yield expected results.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over CN 112195177 B (IDS 03/10/2025, English Translation provided) and Rodríguez-Gómez et al (Talanta, 2014) (IDS 04/19/2024) as applied to claim 2 above, and further in view of Sajali et al (Journal of Food Science, 2018) (PTO-892).
The teachings of CN’177 and Rodríguez-Gómez are as discussed above.
The combined teachings of CN’177 and Rodríguez-Gómez differ from the instantly claimed invention in that CN’177 and Rodríguez-Gómez do not teach the method of extracting DNA from an emulsified food.
Sajali is a review that teaches various approaches in DNA extraction and factors in structure and texture of various food matrices affecting DNA extraction (Abstract). DNA extraction methods consists of three common steps: lysis, purification, and DNA recovery, with lysis being the most critical step. In addition, DNA can be extracted using either a conventional method or a commercial extraction kit. Table 1 shows various DNA separation principles for respective DNA extraction methods. Generally, all methods employ proteinase K in the lysis step. The protein precipitation, DNA purification, binding, and precipitation steps vary among the methods. Table 1 shows various DNA separation principles for respective DNA extraction methods. Suitability of DNA extraction methods for various food matrices are summarized in Table 2 (pg. 2409 – 2410). Food authentication requires DNA of high quality, as it is vital for polymerase chain reaction (PCR)-based analysis (pg. 2410, col. 1, para. 3). To ensure successful PCR amplification, the purity of the DNA extracted is of greater importance than the yield of DNA (pg. 2410, col. 1, para. 4). Sajali teaches many inhibitors and contaminants such as polysaccharides, humic acid, protein, lipids, phenolic compounds, chemical agents used during DNA extraction, etc. affect PCR amplification (pg. 2410, col. 1, para. 4-5). Sajali teaches that DNA extraction from milk may be influenced by the components in milk, such as proteins, fats, and calcium. In a comparative study of DNA extraction from dairy products, four commercial methods, Nucleo-Spin® Food, Charge Switch® Forensic DNA Purification Kit, Wizard® Resin and QIA-amp DNA Stool® Mini Kit were compared with three noncommercial methods, Tween-based method, CTAB-based method and SDS-based method. Among these methods, the CTAB method returned the highest concentration of DNA, with robust quantities of DNA being detected by agarose gel and early cycle detection in qPCR (pg. 2413, col. 1, para. 3).
It would have been obvious to combine CN’177 and Rodríguez-Gómez with Sajali before the effective filing date of the instantly claimed invention to apply the DNA extraction method taught by CN’177 modified with Rodríguez-Gómez to extract DNA from a sample of emulsified food as Sajali teaches DNA extraction from various food matrices to arrive at the instantly claimed invention. It would have been prima facie obvious to combine CN’177 and Rodríguez-Gómez with Sajali as Sajali teaches in Table 1 various DNA separation principles for respective DNA extraction methods and the suitability of DNA extraction methods for various food matrices in Table 2 (pg. 2410, col. 1, para. 2) and that food authentication requires DNA of high quality, as it is vital for polymerase chain reaction (PCR)-based analysis (pg. 2410, col. 1, para. 3). One of ordinary skill in the art would have a reasonable expectation of success because Sajali teaches that DNA extraction from milk may be influenced by the components in milk, such as proteins, fats, and calcium and to ensure successful PCR amplification, the purity of the DNA extracted is of greater importance than the yield of DNA (pg. 2410, col. 1, para. 4).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sajali et al (Journal of Food Science, 2018) (PTO-892) in view of CN 112195177 B (IDS 03/10/2025, English Translation provided) and Rodríguez-Gómez et al (Talanta, 2014) (IDS 04/19/2024).
Sajali is a review that teaches that high-quality DNA extracts are imperative for downstream applications in molecular identification. Most processed food products undergo heat treatments causing DNA degradation, which hampers application of DNA-based techniques for food authentication. Moreover, the presence of inhibitors in processed food products is also problematic, as inhibitors can impede the process of obtaining high qualities and quantities of DNA (Abstract). DNA extraction methods consists of three common steps: lysis, purification, and DNA recovery, with lysis being the most critical step (pg. 2409, col. 2, para. 5). Food authentication requires DNA of high quality, as it is vital for polymerase chain reaction (PCR)-based analysis (pg. 2410, col. 1, para. 3). To ensure successful PCR amplification, the purity of the DNA extracted is of greater importance than the yield of DNA (pg. 2410, col. 1, para. 4). Sajali teaches many inhibitors and contaminants such as polysaccharides, humic acid, protein, lipids, phenolic compounds, chemical agents used during DNA extraction, etc. affect PCR amplification (pg. 2410, col. 1, para. 4-5). Sajali teaches in conclusion that it is indispensable that the presence of inhibitors in food matrices should be eliminated in order to acquire high purity, amount, and intact DNA for downstream applications (pg. 2413, col. 1, para. 6).
The teachings of Sajali differ from the instantly claimed invention in that Sajali does not teach all the steps of DNA extraction as recited in the instant claim 2.
The teachings of CN’177 and Rodríguez-Gómez are as discussed above.
It would have been obvious to combine Sajali with CN’177 and Rodríguez-Gómez before the effective filing date of the instantly claimed invention to apply the DNA extraction method taught by CN’177 modified by Rodríguez-Gómez to extract DNA from a sample of emulsified food and then amplify the DNA extracted to arrive at the instantly claimed invention. It would have been prima facie obvious to combine Sajali with CN’177 and Rodríguez-Gómez because the combined teachings would result in the extraction of DNA of high purity as CN’177 teaches the nucleic acid extraction method comprises of a lysis solution, impurity removal solution, DNA extraction based on a silica-based centrifugal column and washing solutions (pg. 7, [n0015 – n0019]) and Rodríguez-Gómez teaches that results of using the precipitation solution were excellent in terms of sensitivity and sample handling and on the one hand a white solid fraction corresponding to protein, fat and other precipitated salts was obtained, and it was also separated a clear solution containing the analytes that after filtering was completely transparent (pg. 563, col. 2, para. 2). One of ordinary skill in the art would
have a reasonable expectation of success as Sajali teaches that it is indispensable that the presence of inhibitors in food matrices should be eliminated in order to acquire high purity, amount, and intact DNA for downstream applications (pg. 2413, col. 1, para. 6) and to ensure successful PCR amplification, the purity of the DNA extracted is of greater importance than the yield of DNA (pg. 2410, col. 1, para. 4).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over CN 112195177 B (IDS 03/10/2025, English Translation provided), Rodríguez-Gómez et al (Talanta, 2014) (IDS 04/19/2024) and CN 109797148 B (IDS 04/19/2024) as applied to claim 3 above, and further in view of Sajali et al (Journal of Food Science, 2018) (PTO-892).
The teachings of CN’177, Rodríguez-Gómez and CN’148 are as discussed above.
The combined teachings of CN’177, Rodríguez-Gómez, and CN’148 differ from the instantly claimed invention in that CN’177, Rodríguez-Gómez, and CN’148 do not teach the method of extracting DNA from an emulsified food.
The teachings of Sajali are as discussed above.
It would have been obvious to combine CN’177, Rodríguez-Gómez, and CN’148 with Sajali before the effective filing date of the instantly claimed invention to apply the DNA extraction method taught by CN’177 modified with Rodríguez-Gómez and CN’148 to extract DNA from a sample of emulsified food as Sajali teaches DNA extraction from various food matrices to arrive at the instantly claimed invention. It would have been prima facie obvious to combine CN’177, Rodríguez-Gómez, and CN’148 with Sajali as Sajali teaches in Table 1 various DNA separation principles for respective DNA extraction methods and the suitability of DNA extraction methods for various food matrices in Table 2 (pg. 2410, col. 1, para. 2) and that food authentication requires DNA of high quality, as it is vital for polymerase chain reaction (PCR)-based analysis (pg. 2410, col. 1, para. 3). One of ordinary skill in the art would have a reasonable expectation of success because Sajali teaches that DNA extraction from milk may be influenced by the components in milk, such as proteins, fats, and calcium and to ensure successful PCR amplification, the purity of the DNA extracted is of greater importance than the yield of DNA (pg. 2410, col. 1, para. 4).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sajali et al (Journal of Food Science, 2018) (PTO-892) in view of CN 112195177 B (IDS 03/10/2025, English Translation provided), Rodríguez-Gómez et al (Talanta, 2014) (IDS 04/19/2024) and CN 109797148 B (IDS 04/19/2024).
The teachings of Sajali are as discussed above in the rejection of claim 5.
The teachings of Sajali differ from the instantly claimed invention in that Sajali does not teach all the buffers used in extracting DNA from a sample of food as recited in instant claim 3.
The teachings of CN’177, Rodríguez-Gómez and CN’148 are as discussed above.
It would have been obvious to combine Sajali with CN’177, Rodríguez-Gómez, and CN’148 before the effective filing date of the instantly claimed invention to apply the DNA extraction method taught by CN’177 modified by Rodríguez-Gómez and CN’148 to extract DNA from a sample of emulsified food and then amplify the DNA extracted to arrive at the instantly claimed invention. It would have been prima facie obvious to combine Sajali with CN’177, Rodríguez-Gómez, and CN’148 because the combined teachings would result in the extraction of DNA of high purity as CN’177 teaches the nucleic acid extraction method comprises of a lysis solution, impurity removal solution, DNA extraction based on a silica-based centrifugal column and washing solutions (pg. 7, [n0015 – n0019]), Rodríguez-Gómez teaches that results of using the precipitation solution were excellent in terms of sensitivity and sample handling and on the one hand a white solid fraction corresponding to protein, fat and other precipitated salts was obtained, and it was also separated a clear solution containing the analytes that after filtering was completely transparent (pg. 563, col. 2, para. 2), and CN’148 teaches a lysis buffer comprising of Tris-HCl and EDTA. One of ordinary skill in the art would have a reasonable expectation of success as Sajali teaches that it is indispensable that the presence of inhibitors in food matrices should be eliminated in order to acquire high purity, amount, and intact DNA for downstream applications (pg. 2413, col. 1, para. 6) and to ensure successful PCR amplification, the purity of the DNA extracted is of greater importance than the yield of DNA (pg. 2410, col. 1, para. 4).
Conclusion
Claims 1 – 7 are rejected. No claims allowed.
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/J.A.M./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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