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 . Applicant’s preliminary amendment filed 3/30/2023 is acknowledged. Claims 3-4, 7-10, 12-13, 17, 20-24, 29-30, 36, 38-40 have been amended. Claims 1-41 are pending.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-13 in the reply filed on 2/13/2026 is acknowledged. The traversal is on the ground(s) that the Office has not shown that a serious burden would be required to examine all of the claims. Applicant stats that claim 1 is a linking claim and joins Groups I and II and Groups I and III.
This is not found persuasive because the restriction requirement is deemed to be independent and distinct because the inventions have acquired a separate status in the art in view of their different classification, their recognized divergent subject matter and non-overlapping subject matter requiring different field of search. The requirement is still deemed proper and is therefore made FINAL. Accordingly, the claims 14-41 are withdrawn from consideration as being drawn to non-elected subject matter.
Priority
This application claims benefit of 63/325,851 filed 03/31/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/19/2024, 11/20/2024 and 7/11/2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 3/30/2023. These drawings are found acceptable by the Examiner.
Specification
The use of the term “SYBR Green”, “Eva Green” at pages 15, 36 and “QScript” at pages 46 and 50, “Maverick Blue” at pages 15 and 50, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
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 1-13 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.
(a) Claims 1-13 lacks proper antecedent basis and is indefinite in the claim 1 at step b. for “the first nucleic acid” and “the first nucleic acid sequence” because the step a. from which the step b. depends recites “a first extendable nucleic acid sequence”. It not clear if Applicant is referencing the “first extendable nucleic acid sequence” or something entirely different since the claims reference several different nucleic acid sequences in the nucleic acid molecule construct.
(b) Claim 4 lacks proper antecedent basis and is indefinite for “the first nucleic acid sequence” because it is unclear if Applicant is making reference to a “first extendable nucleic acid sequence” or another sequence that is deemed as a “first nucleic acid sequence”.
Clarification is required.
Closest prior art
9. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The claim 1 is directed to a nucleic acid molecule comprising: a. a first extendable nucleic acid sequence configured to hybridize to a first region of a target nucleic acid; b. a second nucleic acid sequence that comprises a non-extendable 3' terminus, wherein said second nucleic acid sequence is located on a 5' side of the first nucleic acid on the molecule and is configured to hybridize to a second region of the target nucleic acid downstream from a binding site of the first nucleic acid sequence relative to its direction of extension; c. a first spacer connecting the first and second nucleic acid sequences configured to allow both sequences to hybridize to their targets, and comprising at least one non- nucleotide linker; d. a third nucleic acid sequence that comprises a non-extendable 3' terminus, wherein said third nucleic acid sequence is located on a 5' side of the second nucleic acid on the molecule and is configured to hybridize to a third region of the target nucleic acid between where the 3' end of the first nucleic acid sequence hybridizes and where the 5' end of the second nucleic acid sequence hybridizes (claim 1).
The closest prior art, Kent et al (US 20210395800. 12/23/2021) teach a nucleic acid molecule comprising: from 3′ to 5′: i) a first nucleic acid sequence, wherein the first nucleic acid sequence is complementary to a first region of a target nucleic acid, and further wherein a penultimate nucleotide of the 3’ end of the first nucleic acid sequence is complementary to the target nucleic acid, but is not complementary to the differing nucleic acid, and yet further wherein the first nucleic acid is extendable on the 3′ end; ii) a second nucleic acid sequence, wherein the second nucleic acid sequence is complementary to a second region of the target nucleic acid, wherein the complementarity between the second nucleic acid sequence and the target nucleic acid starts within one nucleotide or less of the first region of the target nucleic acid, such that it hybridizes to the target nucleic acid downstream from the 3′ end of the first nucleic acid sequence, or overlaps on the 5′ end with the 3′ end of the first nucleic acid sequence; iii) a linker connecting said first and second nucleic acid sequences in a manner that allows both the said first and second nucleic acid sequences to hybridize to the target nucleic acid at the same time [0003].
Kent teaches at paragraph [0032] The term “linker” means the composition joining the first and second nucleic acids to each other. The linker comprises at least one non-extendable moiety, but may also comprise extendable nucleic acids, and can be any length. The linker may be connected to the 3′ end, the 5′ end, or can be connected one or more bases from the end (“the middle”) of both the first and second nucleic acid sequences. The connection can be covalent, hydrogen bonding, ionic interactions, hydrophobic interactions, and the like. The term “non-extendable” has reference to the inability of the native Taq polymerase to recognize a moiety and thereby continue nucleic acid synthesis. A variety of natural and modified nucleic acid bases are recognized by the polymerase and are “extendable.” Examples of non-extendable moieties include among others, fluorophores, quenchers, polyethylene glycol, polypropylene glycol, polyethylene, polypropylene, polyamides, polyesters and others known to those skilled in the art. In some cases, even a nucleic acid base with reverse orientation (e.g. 5′ ACGT 3′ 3′A 5′ 5′ AAGT 3′) or otherwise rendered such that the Taq polymerase could not extend through it could be considered “non-extendable”.
Kent teaches that the capture is linked to the primer by a flexible, non-extendable linker attached to the 5’ end of the primer and either the 3’ or 5’ end of the capture. Generally, the capture is not extendable due to either the linker or a fluorescent label attached to its 3′ end. The capture, with its Tm near reaction temperature, is able to bind to its target. The capture target is generally near the primer target so that when the capture hybridizes to its target, the primer by virtue of the linker is brought into artificially close proximity to its target. This increases the local concentration of the primer, which increases its effective Tm to the target in the vicinity, facilitating binding and extension. Since the linker blocks extension, any non-specific product or primer dimer will not contain both the primer and capture targets, which will eliminate possible future amplification of that product [0068].
Kent differs from the instant invention in that Kent does not teach a third nucleic acid sequence that comprises a non-extendable 3' terminus, wherein said third nucleic acid sequence is located on a 5' side of the second nucleic acid on the molecule and is configured to hybridize to a third region of the target nucleic acid between where the 3' end of the first nucleic acid sequence hybridizes and where the 5' end of the second nucleic acid sequence hybridizes. Kent also does not teach wherein the molecule comprises at least one additional nucleic acid sequence which comprises at least one non-extendable moiety at its terminus, wherein said non-extendable moiety renders said additional nucleic acid sequence non-extendable, wherein said additional nucleic acid sequence hybridizes to the target nucleic acid.
Conclusion
10. No claims are allowed. However, the claims have not been rejected under prior art. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA B WILDER whose telephone number is (571)272-0791. The examiner can normally be reached Flexible.
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/CYNTHIA B WILDER/ Primary Examiner, Art Unit 1681
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