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 .
This application is a domestic application, filed 31 Oct 2023.
Claims 1-20 are pending in the current application. Claims 1-10, drawn to non-elected inventions, are withdrawn. Claims 11-20 are examined on the merits herein.
Election/Restrictions
Applicant's election with traverse of Group II, claims 11-20, in the reply filed on 31 March 2026 is acknowledged. The traversal is on the ground(s) that the examiner has not provided evidence that the claimed product can be used in a materially different process. This is not found persuasive because in the Requirement for Restriction mailed 03 March 2026 at the top of page 3 the examiner provided the example that the product as claimed can be used in a method for purification of proteins or polysaccharides from a sample, which is a materially different process from claimed process of use. MPEP 806.05(h) provides “The burden is on the examiner to provide an example, but the example need not be documented.” MPEP 808.01 provides “The particular reasons relied on by the examiner for holding that the inventions as claimed are either independent or distinct should be concisely stated.” In this case the examiner has provided a concise statement of reasoning or example for holding that the inventions as claimed are distinct, and this example does not need to be documented with evidence.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 31 March 2026.
Applicant's election of species with traverse of species of solid matrix comprising magnetic nanoparticles and sample of blood in the reply filed on 31 March 2026 is acknowledged. The traversal is on the ground(s) that there is no serious burden to examine the different species of sample together, especially with regard to blood, plasma, and serum. This is not found persuasive because, for example, blood plasma is the liquid component of blood in which blood cells, and one of skill in the art would expect that genomic DNA is commonly found within cells, therefore these different species of sample are materially distinct and do not comprise essentially the same components, particularly in the context of the claimed method of extracting a nucleic acid from a sample.
The requirement is still deemed proper and is therefore made FINAL.
Search and examination has expanded to include the species of solid matrix in a spin column and the species comprising magnetic nanoparticles not in a spin column.
Specification
The disclosure is objected to because of the following informalities: the text of Table A at the top of page 2 is not legible as filed.
Appropriate correction is required.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
For example, the specification at page 1, paragraph 2; at page 4 describing Figure 1C; at page 5 describing Figure 6A-6C; and at top of page 6 includes references to websites in the form of an embedded hyperlink and/or other form of browser-executable code which include the prefix “https://”. The specification at page 4 describing Figure 1C. includes references to a website in the form of an embedded hyperlink and/or other form of browser-executable code which include the prefix “https://”.
Claim Objections
Claims 15 and 20 are objected to because of the following informalities: claims 15 and 20 each recite “10-50 mm monovalent salt ions” (emphasis added). This recitation is a clear typographical error, and the filed specification at page 9 describes an example of this unit as “mM” meaning millimolar.
Appropriate correction is required.
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.
Claims 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gautam-47 (Gautam, A., DNA and RNA Isolation Techniques for Non-Experts, Techniques in Life Science and Biomedicine for the Non-Expert, 2022, Springer Nature Switzerland AG, p47-53, cited in PTO-892).
Gautam-47 discloses spin column technique is a solid-phase extraction commercial strategy to extract nucleic acid from a wide range of crude biological samples, including tissues, plant extracts, viruses, and bacteria. It is a five-stage process consisting of cell lysis, purification, washing, dry spin, and elution using appropriate buffers (page 47, abstract). Gautam-47 discloses the five different major types of spin columns are solid phase matrices (section 2 spanning pages 48-49). The five-stage process involves a first stage of cell lysis where the samples are treated with lytic buffers to break the cell membrane and remove nucleic acid, a second stage of purification where the optimal amount of ethanol or isopropanol is added to further accelerate the binding of nucleic acids to the column, a third stage of washing where the sample is first centrifuged to bind the desired nucleic acids to the column’s silica membrane and the impurities remain in flow-through which are removed through washing, a fourth stage of dry spinning, and a final stage of elution where an elution buffer removes the nucleic acid from the column. Further, the nucleic acid is collected from the base of the column (section 3.3 Procedure spanning pages 50-51), where these first, second, third, and final stages meet the limitations of the steps of claim 11. This extraction technique can be used to extract nucleic acids from a wide range of crude biological samples, including blood, tissues, plant parts and extracts, viruses, and bacteria (page 48, paragraph 1), disclosing the elected species of blood and meeting limitations of claim 12.
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.
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.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Gautam-47 (Gautam, A., DNA and RNA Isolation Techniques for Non-Experts, Techniques in Life Science and Biomedicine for the Non-Expert, 2022, Springer Nature Switzerland AG, p47-53, cited in PTO-892) in view of Hall, JR. et al. (US 2006/0270843, published 30 Nov 2006, cited in PTO-892).
Gautam-47 teaches as above. Gautam-47 further teaches the general working solutions of the lytic buffer comprising a chaotropic salt + detergent + enzyme, the purifying buffer comprising 1.25 M NaCl + ethanol + deionized water, the washing buffer comprising low concentration chaotropic salt + ethanol, and the elution buffer comprising 10 mM Tris base (pH 8–9) for DNA and water (pH 4–5) for RNA (page 50, section 3.2). Various chaotropic salts such as urea, guanidine thiocyanate, guanidine HCl, and lithium perchlorate are used in the first cell lysis stage (page 50, section 3.3). The washing stage is a two-step washing procedure. In the first step, washing is done by using a low concentration of chaotropic salts to remove remnant proteins and pigments. This step is followed by two-time ethanol washing to remove remnant chaotropic salts (page 51, paragraph 2).
Gautam-47 does not specifically teach the method wherein the lysis buffer comprises Tris-HCl, NaCl, guanidine thiocyanate, Na-EDTA and has a pH suitable for lysis or digestion of the sample and release of nucleic acids and wherein the binding buffer comprises 70-100% v/v isopropyl alcohol (claim 13). Gautam-47 does not specifically teach the method wherein the washing comprises contacting the solid phase matrix bound to the nucleic acid with a first and second wash buffer, wherein the first wash buffer comprises Tris-HCl, guanidine thiocyanate, and ethanol; and wherein the second wash buffer comprises Tris-HCl and ethanol (claim 14). Gautam-47 does not specifically teach the method wherein the elution buffer is water, a low salt buffer containing 10-50 mm monovalent salt ions (claim 15).
Hall, JR. et al. teaches methods and kits for collecting different biopolymers from a single sample, such as RNA and genomic DNA (abstract). Hall, JR. et al. teaches the general protocol for isolation of RNA and DNA wherein tissue is lysed with a lysis solution comprising 4M guanidine isothiocyanate, 25 mM Tris pH7.5, 10 mM EDTA, 1% β-mercaptoethanol (page 7, paragraph 80; page 5, paragraph 67). The protocol for DNA isolation includes a prefilter wash solution (0.5 M guanidine isothiocyanate, 80% ethanol), adding isopropanol to bind the sample to an isolation column, and washing the isolation column with a wash solution (25 mM Tris pH 7.5, 80% ethanol). The wash step is repeated for a total of two times and the column is spun for 2 minutes at full speed to completely remove trace amounts of wash solution (page 7, paragraph 82). Hall, JR. et al. teaches the use of high salt in the elution buffer can interfere with subsequent procedures in which the nucleic acids are used (page 1, paragraph 2). In another aspect the kit comprises a DNA elution/releasing buffer (e.g., comprising a low ionic strength solution) for eluting DNA from the separation module (page 6, paragraph 75). In one aspect, the elution/releasing solution comprises a low ionic strength solution comprising a surfactant, and may be an ionic detergent, such as 0.01-5% sarcosyl (e.g., N-lauroylsarcosine) (page 6, paragraph 70).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention Gautam-47 in view of Hall, JR. et al. in order to select the composition of the buffers used in the method through routine optimization. One of ordinary skill in the art would have been motivated to combine Gautam-47 in view of Hall, JR. et al. because both Gautam-47 and Hall, JR. et al. are drawn to methods for collecting RNA and DNA from a sample, Gautam-47 teaches the general conditions used for the spin column technique as a solid-phase extraction commercial strategy to extract nucleic acid, and Hall, JR. et al. suggests varying the buffers used such as the lysis buffer, binding buffer, wash buffer, and eluting buffer, suggesting it would have been routine experimentation for one of ordinary skill in the art to select the optimal composition of the buffers used from within the components taught by Gautam-47 and Hall, JR. et al. Regarding the concentration of the elution buffer, Hall, JR. et al. teaches the use of high salt in the elution buffer can interfere with subsequent procedures in which the nucleic acids are used, Hall, JR. et al. teaches in one aspect, the elution/releasing solution comprises a low ionic strength solution, and Gautam-47 teaches the example where the elution buffer comprises 10 mM Tris base, suggesting it would have been obvious to select a low salt concentration of the elution buffer.
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gautam-111 (Gautam, A., DNA and RNA Isolation Techniques for Non-Experts, Techniques in Life Science and Biomedicine for the Non-Expert, 2022, Springer Nature Switzerland AG, p111-117, cited in PTO-892) in view of Hall, JR. et al. (US 2006/0270843, published 30 Nov 2006, cited in PTO-892).
Gautam-111 teaches magnetic bead-based techniques are majorly used to extract and purify the nucleic acids directly from all types of crude samples like tissues of blood, hair or nails, soil, fungal growth, and viruses. This strategy is based upon the principle of paramagnetism or superparamagnetism. An external magnetic field is applied to a solution containing these tiny nanoparticles/beads, which behaves as small paramagnets due to induced spin. The major processing steps include binding target biomolecule with beads, immobilization through applying external magnetic field, washing, and extraction of nucleic acid from beads (page 111, abstract). A particular type of bead with the required appropriate chemistries and coating is used to separate specific target biomolecules, as listed in Table 1, such as streptavidin-coated magnetic beads or silica-coated magnetic beads (page 112, section 2; table 1 at page 113). Gautam-111 teaches the basic steps of magnetic bead-based isolation of nucleic acid include combining nucleic acids with an incubation buffer, adding magnetic beads and a binding buffer to a sample containing nucleic acids, applying an external magnetic field to immobilize the magnetic pellet (DNA/RNA with beads), washing the obtained magnetic pellet using ethanol and air-dry it, and resuspending the pellet in an elution buffer to elute the DNA/RNA (page 114, figure 1; section 3.3 spanning pages 114-115). Examples of the solutions used include the incubation buffer comprising 30 μL of 1% (w/v) SDS solution for 30 μL of sample, the elution buffer comprising Tris base (pH 10–11) and EDTA in deionized water, and the wash buffer comprising ethanol and water (page 114, section 3.2).
Gautam-111 does not specifically disclose the method comprising the step of contacting the sample with a lysis buffer for a time and under conditions suitable to release the nucleic acid from other components in the sample (claim 16). Gautam-111 does not specifically disclose the method wherein the lysis buffer comprises wherein the lysis buffer comprises Tris-HCl (pH 7), NaCl, guanidine thiocyanate, Na-EDTA, SDS, β-mercaptoethanol and wherein the binding buffer comprises 70-100% v/v isopropyl alcohol (claim 18). Gautam-111 does not specifically disclose the method wherein said washing comprises contacting the solid phase matrix bound to the nucleic acid with a first and second wash buffer, wherein the first wash buffer comprises Tris-HCl, guanidine thiocyanate, ethanol; and wherein the second wash buffer comprises a diluted NaOH solution at pH 10.8 (claim 19). Gautam-111 does not specifically disclose the method wherein said elution buffer is water, a low salt buffer containing 10-50 mm monovalent salt ions (claim 20).
Hall, JR. et al. teaches methods and kits for collecting different biopolymers from a single sample, such as RNA and genomic DNA, as detailed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention Gautam-111 in view of Hall, JR. et al. in order to select the composition of the buffers used in the method through routine optimization and to modify the wash step to include a first and a second wash buffer. One of ordinary skill in the art would have been motivated to combine Gautam-111 in view of Hall, JR. et al. because both Gautam-111 and Hall, JR. et al. are drawn to methods for collecting RNA and DNA from a sample, Gautam-111 teaches the general conditions used for magnetic bead-based techniques used to extract and purify the nucleic acids, and Hall, JR. et al. suggests varying the buffers used such as the lysis buffer, binding buffer, wash buffer, and eluting buffer, suggesting it would have been routine experimentation for one of ordinary skill in the art to select the optimal composition of the buffers used from within the components taught by Gautam-111 and Hall, JR. et al. Regarding the concentration of the elution buffer, Hall, JR. et al. teaches the use of high salt in the elution buffer can interfere with subsequent procedures in which the nucleic acids are used, Hall, JR. et al. teaches in one aspect, the elution/releasing solution comprises a low ionic strength solution, suggesting it would have been obvious to select a low salt concentration of the elution buffer.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
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