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 without traverse of the invention of Group I (claims 1-18 drawn to methods) in the reply filed on 03/25/2026 is acknowledged.
Claims 19-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/26/2025.
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.
Claim 17 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 17 is unclear over recitation of the limitation “incubating is conducted in the absence of albumin or a blocking agent”. Initially it is unclear if the claim is intended to require the absence of both the recited albumin the absence of the recited blocking agent (i.e.: both elements are excluded form the claimed method); or if the limitation intends to require that only one of the recited elements is required to be excluded form the claimed methods. The claim is further unclear over recitation of the limitation “a blocking agent” as the limitation provides a functionality (i.e.: blocking) but it is unclear what the agent is blocking, or even if there is a requirement related to the actual act of blocking in the claimed method. For example, seemingly any agent could block something, so it is unclear what may be included in the method.
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.
Claim(s) 1-3, 5-8, 11, 12, 14, 17 and 18 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sampson et al (US PG Pub 2010/0112556).
Relevant to the methods of the rejected claims, Sampson et al teaches methods (e.g.: para 0160-0190; Fig. 9) that include providing a single stranded DNA template (relevant to claim 2) (e.g.: para 0174) that is a linear product of rolling circle amplification (relevant to claim 3), and incubating the template with an ssDNA oligonucleotide (e.g.: para 0174-0180) (relevant to claims 7 and 12) and cleavage enzyme (e.g.: BspDI restriction enzyme (para 0175)) (relevant to claims 11 and 14) that binds to a recognition site created by the hybridization of the oligonucleotide to the template (relevant to claims 6, 7 and 8), where cleavage of the template with the enzyme creates a ssDNA ladder (e.g.: para 0188). Relevant to claims 17 and 18, Sampson et al does not teach the inclusion of a blocking agent (relevant to claim 17), and in so far as the ladder is present in the digestion mixture upon incubation with the enzyme such a ladder is not “further purified or diluted” (relevant to claim 18).
Claim(s) 1-3, 5-11, 13-15, 17 and 18 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al (2021), including the supplementary data.
Relevant to the methods of the rejected claims, Wang et al teaches methods (e.g.: p.2 - Site-specific cleavage of ssRNA and ssDNA using CRISPR/Cas9 system; Fig 2; Fig 7) that include providing a single stranded DNA template (relevant to claim 2) (e.g.: para 0174) that is a linear construct (relevant to claim 3), and incubating the template with an sgRNA ( relevant to claims 7-10) and a PAMmer (e.g.: Fig 7) and a Cas9 cleavage enzyme (e.g.: p. 2- Site-specific cleavage of ssRNA and ssDNA using CRISPR/Cas9 system) (relevant to claim 11) that is bound to the sgRNA (relevant to claims 13 and 14) where the sgRNA/Cas complex binds to the template (relevant to claims 6, 7 and 8), where cleavage of the template with the enzyme creates ssDNA fragments that are a ladder. Relevant to claim 15, Wang et al teaches that the mixture is heated to 90o C for 10 min, thus providing all the nucleic acids as ssDNA.
Relevant to claims 17 and 18, Sampson et al does not teach the inclusion of a blocking agent (relevant to claim 17), and in so far as the ladder is present in the digestion mixture upon incubation with the enzyme such a ladder is not “further purified or diluted” (relevant to claim 18).
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) 4 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sampson et al (US PG Pub 2010/0112556) in view of Jordan (US PG Pub 2014/0248705).
Sampson et al teaches, as detailed earlier in this Office Action, the method of claim 1, from which claims 4 and 16 each depend, including providing a template comprising single stranded nucleic acid, incubating the template with a guided oligonucleotide and a cleavage enzyme, where the template is cleaved to form a ladder of single-stranded nucleic acids.
Sampson et al teaches a template created by rolling circle amplification, but does not explicitly state that the template comprises more than 500 bases (relevant to claim 4), or that at least 50% of the single stranded nucleic acids has a length of 500 or more bases (claim 16).
However, ssDNA ladders used as markers in which comprises the lengths encompassed by the rejected claims were known in the prior art and are taught by Jordan.
Jordan provides teachings related to nucleic acid ladders, and teaches that such ladders may be single stranded DNA (e.g.: para 0032), and may include nucleic acid fragments of different lengths depending upon the applications for which the ladder is used as a marker, including ladders with fragments greater than 500 bases in length (e.g.: Fig. 2; para 0049-0075).
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 methods of Sampson et al to make ssDNA ladder according to the teachings of Jordan. Using the methods of Sampson to make ssDNA ladders with fragments greater than 500 nucleotides in length would include a template that is a concatemer of sequences that are greater than 500 nucleotides, and thus 100% of the cleaved template would have a length of 500 or more bases. The skilled artisan would be motivated to apply the methods of Sampson et al in order to provide an alternative method of producing ssDNA fragments that does not require the heating or chemical denaturation that is taught by Jordan.
Conclusion
No claim is allowed.
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Stephen Kapushoc
Primary Examiner
Art Unit 1683
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683
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