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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 7, 2026 has been entered.
Detailed Action
This office action is a response to applicant’s communication submitted January 7, 2026, wherein claims 8 and 16 are amended and claims 1, 3-6, 9, 10, and 15 are canceled. This application is a national stage application of PCT/KR2021/014744, filed October 20, 2021, which claims benefit of foreign application KR10-2021-0005968, filed January 15, 2021.
Claims 8, 11, 13, 14, and 16 are pending in this application.
Claims 8, 11, 13, 14, and 16 as amended are examined on the merits herein.
Withdrawn Rejections
Applicant’s amendment, submitted January 7, 2026, with respect to the rejection of claims 1, 3, 4, and 6 under 35 USC 103 for being obvious over Conrad et al. in view of Sanchez-Rodriguez et al., has been fully considered and found to be persuasive to remove the rejection as the rejected claims have been canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, submitted January 7, 2026, with respect to the rejection of claims 1, 3, 4, 6, and 7 under 35 USC 103 for being obvious over Hillebrand et al., has been fully considered and found to be persuasive to remove the rejection as the rejected claims have been canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, submitted January 7, 2026, with respect to the rejection of claims 1-4, 6, 12, and 13 under 35 USC 103 for being obvious over Hillebrand et al. in view of Simms et al., has been fully considered and found to be persuasive to remove the rejection as the rejected claims have been canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, submitted January 7, 2026, with respect to the rejection of claims 1-4, 6, 12, and 13 under 35 USC 103 for being obvious over Hillebrand et al. in view of Simms et al. in view of Lai et al., has been fully considered and found to be persuasive to remove the rejection as the rejected claims have been canceled. Therefore the rejection is withdrawn.
The following new grounds of rejection are introduced:
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.
Claims 8, 11, 13, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Hillebrand et al. (US pre-grant publication 2001/0041332, of record in previous action) in view of Lai et al. (US pre-grant publication 2016/0108393, of record in previous action) in view of Gerdes et al. (US pre-grant publication 2002/0132242, cited in PTO-892) in view of Schrader et al. (Reference of record in previous action)
Independent claim 8 claims a method for isolating and amplifying nucleic acids from a sample comprising immersing the sample in a buffer defined as containing a number of specific components, incubating the solution at room temperature, transferring the solution to a column containing a membrane filter, immobilizing the nucleic acids on the filter and removing the buffer compositions, and subjecting the filter to a nucleic acid amplification reaction without performing any further washing or elution step.
Hillebrand et al. discloses a method for isolating nucleic acids such as DNA from complex starting materials comprising binding to a solid support using solutions comprising antichaotropic salts and not including chaotropic agents. (p. 2 paragraphs 18-20) In addition to the antichaotropic salt, the lysis buffer can contain Tris-HCl, EDTA, and sodium dodecylsulfate, and preferably an alcohol such as ethanol. (p. 2 paragraph 21) The solid phase can preferably be a conventional solid phase such as glass or silica. (p. 2 paragraph 23) Starting materials can include biological materials such as blood and tissues. (p. 2 paragraph 25) The antichaotropic salt can include sodium salts, and can have a preferred concentration of less than 1M. (p. 3 paragraphs 43-44) A specific lysis buffer is described containing 3M potassium chloride, 2% CTAB, 18.2 mM TRIS-HCl, 12.5 mM EDTA, and 2.8% polyvinyl pyrrolidone, to which 500 µL whole blood and 200 µL isopropanol (about 40%) is added before transfer to a centrifugation column. (p. 9 paragraphs 161-169) Hillebrand et al. specifically discloses a method comprising steps of lysis of the starting material using the lysis buffer, binding to a solid phase such as a spin column, washing, and elution. (p. 3 paragraphs 31-35) Elution is preferably carried out by Tris-HCl, or TE buffer. (pp. 3-4 paragraph 50)
While Hillebrand et al. does not specifically disclose an embodiment wherein sodium chloride is used as the antichaotropic salt, as discussed previously the reference exemplifies compositions comprising potassium chloride, and further suggests that the antichaotropic ions can include sodium ions. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use sodium chloride as the antichaotropic salt, in view of the teaching that these two ions are equivalents usable for the same purpose.
While Hillebrand et al. does not specifically disclose a buffer comprising all of the specific components ethanol, SDS, EDTA, and Tris-HCl, the reference does disclose all of these components as preferred additives for the lysis buffer, thereby motivating one of ordinary skill in the art to use them together. Regarding the specific concentrations recited in present claim 8, the concentrations described by Hillebrand et al. substantially overlap those in the claims, thereby rendering them obvious.
Furthermore while Hillebrand et al. describes adding the lysis buffer comprising the antichaotropic salt and other additives besides ethanol to the sample first, followed by adding the ethanol after the lysis is complete, after the step of adding ethanol the composition can include Tris-HCl, NaCl, SDS, and ethanol. Therefore at this step of the process the buffer would infringe the present claims. Furthermore as discussed in MPEP 2144(IV)(C), changes in the sequence of adding ingredients is considered to be prima facie obvious, so it would also have been obvious to one of ordinary skill in the art to combine the ethanol and the other lysis buffer components before adding the sample, in the absence of evidence that the sequence of adding ingredients is critical.
While Hillebrand does not disclose a method wherein the column is a syringe and the application of the sample to the column is performed by applying pressure to the column, Lai et al. discloses a device for rapid extraction of nucleic acids comprising a syringe comprising a filter membrane. (p. 1 paragraphs 6-10) A sample to be extracted is applied to the syringe and the plunger is activated to apply pressure and force the sample through the membrane, in accordance with the steps recited in present claim 8.
It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to use a syringe comprising a filter membrane as described by Lai et al. as the column in the method described by Hillebrand et al. One of ordinary skill in the art would have seen the disclosure of Lai et al. as describing these syringe columns as an improvement over prior art spin columns and therefore would have found it to be obvious to substitute them for spin columns, for example to produce a kit for DNA extraction that was fast and portable.
The method of claim 8 as presently amended further differs from the disclosure of Hillebrand and Lai in that it requires directly subjecting the membrane filter to a nucleic acid amplification reaction without performing a washing or elution step. However, Gerdes et al. discloses methods for directly performing nucleic acid manipulation and analysis without elution of the nucleic acid from the solid phase. (p. 7 paragraphs 12 and 13) The nucleic acid is tightly bound to a matrix and can be repeatedly analyzed without being eluted or washed off of the matrix. (p. 3 paragraph 49) Manipulations that can be performed include amplification. (p. 4 paragraph 59, p. 9 example 4) The matrix to which the nucleic acid binds can be coated on other materials such as plastic and glass, and can be in various forms including membranes. (p. 6 paragraph 76) Glass materials can also include filters. (p. 6 paragraph 78) Furthermore some of the protocols described (e.g. p. 9 example 4, p. 10 example 5) do not involve a wash step once the nucleic acid is bound to the matrix, indicating that a wash step is unnecessary.
It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to use a binding matrix as described by Gerdes et al. as the binding phase in the method according to Hillebrand et al. in view of Lai, and to furthermore use the binding matrix with the bound nucleic acid directly performing an amplification reaction on the bound solid phase without further washing or elution. One of ordinary skill in the art would have been motivated to do so in the expectation that this would allow for the tight binding and extended storage of the nucleic acid, as well as its reuse in multiple amplification reactions.
Still further, regarding the specific concentrations of SDS and ethanol in the lysis buffer, Schrader et al. discloses that these compounds are known to inhibit PCR reactions, and are furthermore known to be introduced during sample processing. (p. 1018right column second paragraph) Therefore one of ordinary skill in the art at the time of the invention would have been aware that these substances can inhibit PCR and would have found it to be obvious to use lower concentrations in order to minimize the amount of inhibitors ultimately introduced into the PCR reaction.
Regarding claim 11, Hillebrand et al. discloses that the lysis step can involve incubating for e.g. 5 minutes (p. 5 paragraph 73) or 10 minutes. (p. 8 paragraph 125)
Regarding claim 13, Hillebrand et al. notes a number of different biological materials from which nucleic acids can be extracted including for example whole blood. (p. 3 paragraph 42)
Regarding claim 14, Hillebrand et al. does not specifically disclose using this method to purify peptide nucleic acid. (PNA) However, Lai et al. discloses extraction of PNA on a membrane filter. (p. 3 claim 3) It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to use the method described by Hillebrand to isolate PNA. One of ordinary skill in the art would have found this to be obvious in view of the fact that it is known that there is a need in the art to isolate PNA and furthermore that binding to a filter membrane can be used to accomplish this.
Regarding claim 16, Hillebrand et al. describes using the bound nucleic acids in a PCR reaction. (p. 5 paragraph 78)
Response to Arguments
Applicant’s arguments, submitted January 7, 2026, have been fully considered as they apply to the newly introduced ground of rejection above. In particular, Applicant argues that the presently claimed method does not include washing or elution steps that would be believed to be necessary in the prior art in order to remove PCR inhibitors such as SDS and ethanol. According to Applicant, one of ordinary skill in the art would have expected that, in the absence of these steps, PCR of the isolated nucleic acids would not have been possible due to the presence of inhibitors from the lysis solution.
However, a review of the prior art indicates that this is not the case. Based on Hillebrand, in particular pp. 5-6 paragraphs 78-79, the reference discloses performing an amplification reaction by directly adding a PCR mix to the bound nucleic acid, performing extraction and amplification in a single step. This portion of Hillebrand’s disclosure also describes this process as reducing contamination of samples. Additionally, reduction of the number of pipetting steps (e.g. adding wash or elution buffers) is described as a benefit of this methods. (p. 6 paragraphs 83-92) Similarly, Gerdes et al. describes amplifying nucleic acids directly form a filter without any elution whatsoever. It is clear from this disclosure that the separate elution step is not necessary because the nucleic acids could be directly extracted during the PCR.
Additionally, Applicant discloses (e.g. figure 2 of the present disclosure) experimental examples showing that the yield of PCR products from samples isolated by a method as recited in the present claims is sensitive to the concentration of SDS and ethanol in the lysis buffer. However, as discussed in the body of the rejection, Schrader discloses that it was already known in the art that various substances introduced during sample handling can inhibit PCR, and that alcohols including ethanol and ionic detergents including SDS are among these. Therefore it is not surprising that large amounts of these reagents in a lysis buffer could negatively impact the effectiveness of a PCR amplification step downstream.
For all of these reasons the absence of the washing and elution steps in the presently claimed method is in fact obvious, and the fact that reducing the amounts of certain inhibitory substances in the lysis buffer can improve the yield of later PCR reactions is to be expected based on what is known in the art.
Conclusion
No claims are allowed in this action.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 1/23/2026