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 .
Election/Restrictions
Applicant’s election of the particular species that is “a polymer” in the reply filed on 07/21/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 7, directed to limitations pertaining to the non-elected “chemical-based blocking reagent” withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/21/2026.
Claim Objections
Claim 15 is objected to because of the following informalities: the claim recites the term “eluded” where the term “eluted” is likely intended. Appropriate correction is required.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Page 13 of the specification as filed provides “References” at paragraphs 45 and 46. These items are not listed on any proper IDS, furthermore it is noted that the references themselves do not appear to be properly formatted, and as such the intended references are not clear.
Claim Rejections - 35 USC § 112 - Indefiniteness
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 1-20 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 1-20 are unclear over recitation of the intended purpose of the claimed methods as “using a solid phase for purifying a nucleic acid from a sample”, as recited in the preamble of claim 1. The claims are unclear because there are no required practical steps in which a nucleic acid from a sample is purified. For example, claim 1 recites a step of “modifying a surface of the solid phase with a blocking reagent”, but such a step is not itself a step of purifying a nucleic acid. Claim 1 recites an intended use of the modifying as “to control and/or fix binding ability of the nucleic acid bound to the surface of the solid phase”, but this recited intended use or intended result is also not any practical step of “purifying”. It is unclear how the intended use of the methods is accomplished using the require steps.
Claims 1-20 are unclear over recitation of the intended use of the modifying step as “to control and/or fix binding ability of the nucleic acid bound to the surface of the solid phase”. It is unclear what is intended or required for any “binding ability” to be controlled or fixed.
Claim 9 is unclear over recitation of the limitation “an amount of the solid phase being modified with the blocking agent is adjusted”, because it is unclear what the initially basis for comparison is to establish that any amount is or has been adjusted.
Claim 10 is unclear over recitation of the limitation “a time duration of the surface of the solid phase being modified with the blocking agent is adjusted”, because it is unclear what the initially basis for comparison is to establish that any time duration is or has been adjusted.
Claims 11 and 12 are unclear over recitation of the limitation “the nucleic acid binds to the surface of the solid phase in a solution comprising one or more salts”, as recited in claim 11 form which claim 12 depends. It is unclear if this is intended to be a step of binding a nucleic acid, or is intended to indicate some biding property of the solid surface.
Claim 12 is unclear because the limitations of the claim are directed to “the salt is selected from the group consisting”, but the group includes “polyethylene glycol” which is not a salt.
Claim 13 is unclear over recitation of the limitation “the nucleic acid bound to the surface of the magnetic beads or microparticles” because there is no proper antecedent basis for any “nucleic acid bound to the surface of the magnetic beads or microparticles”.
Claim 15 is unclear over recitation of the limitation “Tris-based buffer (TE buffer)” because the recitation of ‘TE buffer’ as a parenthetical expression makes it unclear if the claim is intended to require that the “Tris-based buffer” is a buffer including EDTA (e.g.: where TE is typically used in the art to indicated a Tris -EDTA buffer), or if a TE buffer is only an example of a suitable “Tris-based buffer”.
Claim 20 is unclear over recitation of the limitations “with 2x washing buffer”. It is unclear if the “2x” in the limitation is intended to require some particular concentration that is twice the concentration of some thing else, or if it is intended to require two distinct steps of washing with a buffer.
Claim Rejections - 35 USC § 102
It is noted that the claims have been addressed previously in this Office Action under 35 USC 112 as unclear. In so far as in interpretation of the requirements of the claimed methods can be assessed, the claims are addressed under 35 USC 102 as they may be compared to the prior art.
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, 2, 4-6, 8-11, 13-15, 18 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haddad et al (2016).
Relevant to the practical requirements of the method of claims 1, 2, 4, ,5 and 6, Haddad et al teaches purification of a nucleic acid comprising the modification of a solid surface with a blocking agent that is PVP (e.g.: p.1 - MAN127 - surface modifications of nanomaghemite (polyvinylpyrrolidone-coated)). The reference teaches maghemite was mixed with a polyvinylpyrrolidone solution (PVP, 10k, 0.2 g, Sigma-Aldrich) and stirred overnight, relevant to claims 8-10. The reference teaches purification of nucleic acids that were purified from a enzymatic amplification reaction, including binding a fixed amount of DNA to PVP blocked beads in the presence of sodium acetate salt, separation using a magnet, washing beads, and eluting nucleic acid in a Tris based buffer (e.g.: p.8 - DNA Isolation Efficiency Test of Magnetic Particles Using Quantitative PCR) (relevant to claims 11, 13, 14, 15, 18 and 19).
Claim Rejections - 35 USC § 103
It is noted that the claims have been addressed previously in this Office Action under 35 USC 112 as unclear. In so far as in interpretation of the requirements of the claimed methods can be assessed, the claims are addressed under 35 USC 102 as they may be compared to the prior art.
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.
Claim(s) 1, 2, 4-6, 8-11, 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haddad et al (2016).
Haddad et al teaches the methods of claims 1, 2, 4-6, 8-11, 13-15, 18 and 19, as detailed above in this Office Action. Further relevant to the instant rejection of claim 17, Haddad et al teaches the purification of DNA from the solid surface in a fixed amount (e.g.: Table 1). Further relevant to the instant rejection of claim 20, Haddad et al teaches the modification of a solid surface including providing a PVP solution, and combining the PVP with the solid phase with stirring overnight, and rinsing the resulting MAN127 with water.
Haddad et al does not specifically teach than an amount of an input nucleic acid exceeds the binding capacity of the solid phase, as recited in claim 16. However, using an excess of input nucleic acid would have been obvious to one of ordinary skill in the art. The skilled artisan would recognize that using an excess of input nucleic acid would ensure that the binding capacity of the solid support is reached, thus providing for more efficient use of the solid support reagent. With regard to the limitations of claim 20 where the prior art teaches that the reagents (i.e.: solid support and PVP) are stirred, the mixing of reagents by shaking (as recited in the claim) would have been the simple substitution of one known method of reagent mixing for another with predictable results. Where claim 20 requires washing in a buffer and resuspending in the a washing buffer, such steps would be obvious in view of the teachings of Haddad et al which include the use of buffers suitable for the handling of nucleic acid reagents, and the purification of nucleic acids by adding a volume (i.e.: 8 µL) of magnetic particles. The skilled artisan would thus recognize that having the prepared particles in a volume of buffer would lead to the ease of use of magnetic particles in the isolation of a target nucleic acid.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haddad et al (2016), as applied to claims 1, 2, 4-6, 8-11, 13-20 above, and further in view of Timin et al (2014).
The teachings of Haddad et al are applied to the instant rejection of claim 3 as they were previous applied to claims 1, 2, 4-6, 8-11, 13-20. Haddad et al teaches the modification of a solid support with PVP for the isolation of nucleic acids, as required by claim 1 from which instantly rejected claim 3 depends.
Haddad et al does not suggest the modification of a solid support that is a porous silica surface, as require by claim 3.
However, the modification of mesoporous silica particles with PVP was known in the prior art and is taught by Timin et al (e.g.: p.675 - Synthesis of PVP functionalized silicas).
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to have used the mesoporous silica particles of Timin et al as a support for the deposition of PVP to create a particle for the purification of nucleic acids as taught by Haddad et al. Where Timin et al teaches that the silica solid support can be functionalized with PVP and isolated by centrifugation, the use of the silica support of Timin et al in place of the nanomaghemite support of Haddad et al would have been the simple substitution of one known element for another with predictable results.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yuan et al (2022) teaches the purification of nucleic acids using mesoporous magnetic silica beads in the presence of other agents such as BSA, glucose, fulvic acid, and NaCl.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN THOMAS KAPUSHOC whose telephone number is (571)272-3312. The examiner can normally be reached M-F, 8am-5pm.
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Stephen Kapushoc
Primary Examiner
Art Unit 1683
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683
