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 .
DETAILED ACTION
Status of the Claims
Claims 1-20 are pending. Claims 1-7 are the subject of this NON-FINAL Office Action. This is the first action on the merits.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-7) in the reply filed on 12/16/2025 is acknowledged. Claims 8-20 are withdrawn.
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.
Claims 2-5 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 pre-AIA the applicant regards as the invention.
In claim 2, the phrase “nonstandard nucleic acid bases” is unclear. The specification fails to define this unconventional phrase, or compare to a “standard.” Thus, it is unclear in what way the bases are “nonstandard.”
In claim 3, the phrase “full set of primers for an isothermal amplification reaction” is unclear. Specifically, the specification never defines what constitutes a “full set,” or how this is measured, much less what an “un-full” set would be. This it is not clear what is a “full” set of primers.
In claim 4, the transduction reaction and “downstream amplification” are unclear. As to a “downstream amplification”: downstream of what? As to a “transduction reaction”: what is this unconventional phrase? At best, the specification states “[n]ucleic acid strand transduction is a reaction where one input nucleic acid strand is replaced with another output nucleic acid strand” (para. 0009). Does this encompass standard PCR in which a new strand replaces an old strand? Or does this “input strand” already exist in the solution without PCR (or other amplification)? This would mean that the “transduction reaction” before “amplification reaction” encompasses a single PCR. This would be an odd claim as it effectively claims PCR, rendering any distinction of “transduction reaction” meaningless. Simply put, the claim is so ambiguous that it is impossible to determine the metes and bounds.
In claim 5, the phrases “LAMP-like” reaction and “incomplete set” of LAMP primers are unclear. As to a “LAMP-like” reaction, at best the specification states “the disclosed molecular mechanisms may be leveraged to improve the specificity of various isothermal amplification techniques other than the conventional LAMP and/or RT-LAMP methods, for example, including but not limited to variations of LAMP-like amplification techniques based on dual-priming, swarm priming, stem priming, hairpin primers, etcetera.20-25” (para. 0012). However, first, the citations are not incorporated-by-reference. Second, even if they were, essential subject matter cannot be incorporated via non-patent literature. See MPEP § 608.01(p)(I)(A)(2). Finally, mere mention of dual-priming, swarm priming, stem priming, hairpin primers fails to explain the common metes and bounds that render “LAMP-like” reactions reasonably clear. Thus, it is unclear the metes and bounds of “LAMP-like” reaction.
As to “incomplete set” of LAMP primers, this is never defined. As explained above as a “complete” set, the opposite holds true as to an “incomplete” set: what are the metes and bounds? How are these two types of primer sets distinguished? No answer is provided.
Claim Interpretations
In claim 1, Applicants use intended use language of the claimed products at the potential point of novelty, which fail to distinguish over prior art products. Specifically, the following intended uses fail to distinguish the claimed double-stranded primers:
“such that when the armor strand hybridizes to the first primer, the 3' section of the first primer becomes sequestered while the 5' section of the first primer is free to hybridize to a first target location of a target nucleic acid”; and
“to enable, with the first primer, amplification of the target nucleic acid, wherein during the amplification, the 3' modification of the armor strand prevents polymerase extension of the armor strand.”
Thus, the claims amount to the following composition:
A first primer, with a strand of nucleic acid hybridized to any part of the 3’-half of the first primer and including a “modification” at 3’-end; and
A second primer “associated” with the first primer.
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 –
(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 1-3 and 6-7 are rejected under 35 U.S.C. § 102(a)(2) as being anticipated by PIEPENBURG (US 2005/0112631).
As to claims 1-2, PIEPENBURG teaches the following double-stranded primer just like in instant Figure 1A:
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PIEPENBURG, Fig. 34A
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INSTANT Fig. 1A
As is clear, PIEPENBURG teaches the exact same double-stranded primer structure with 3’-end block on the second strand hybridized to the 3’-portion of the first strand primer. The duplex primer of PIEPENBURG is designed for the same reason as here: to prevent spurious amplification in isothermal amplification reactions (c.f. Fig.34, as descriptions thereof with Spec., para. 0027). PIEPENBURG further teaches another primer associated with a second target location of the target nucleic acid (e.g. reverse primer, or second target primer, or nested primers; Figs. 2-4).
As to claim 3, the amplification is an isothermal amplification with two or more primers (recombinase polymerase amplification, or RPA; e.g. Abstract and Fig. 2).
As to claims 6-7, the RPA reaction can include DNA polymerase and reverse transcriptase (e.g. Abstract and Figs. 2-3; para. 0063 (“RNA can be turned into double stranded DNA by one of skill in the arts using known methods”)).
Prior Art
The following prior art also teaches double-stranded primers: US 2013/0274135; US20100279295.
Conclusion
No claims are allowed.
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/AARON A PRIEST/Primary Examiner, Art Unit 1681