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 5/16/2024 is acknowledged and has been entered.
Priority
This application is a 371 of PCT/US2022/050352 filed 11/18/2022 and claims benefit of 63/281,377 filed 11/19/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/11/2024 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 5/16/2024. These drawings are found acceptable by the examiner.
Improper Markush
Claim 15 is rejected under the judicially approved ‘‘improper Markush grouping’’ doctrine. (See Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, page 7166). This rejection is appropriate when the claim contains an improper grouping of alternatively useable species. See In re Harnisch, 631 F.2d 716, 719–20 (CCPA 1980). A Markush claim contains an ‘‘improper Markush grouping’’ if: (1) the species of the Markush group do not share a ‘‘single structural similarity,’’ or (2) the species do not share a common use. Members of a Markush group share a ‘‘single structural similarity’’ when they belong to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent. When the Markush group occurs in a claim reciting a process, it is sufficient if the members of the group are disclosed in the specification to possess at least one property in common which is mainly responsible for their function in the claimed relationship and it is clear from their very nature or from the prior art that all of them possess this property. See MPEP § 803.02.
In this case the claim 15 recites “wherein displacing seed strands from the crisscross ribbon performed by (i) toehold-mediated strand displacement; (ii) inclusion of gamma cut slats; inclusion of an engineered restriction site in a slat strand; (iii) inclusion of an unnatural or modified base in a strand of the crisscross ribbon and/or a slat strand; (iv) inclusion of small molecules that can function to accelerate scission in the reaction mixture; (v) inclusion of pH responsive elements in a strand of the crisscross ribbon and/or a slat strand; (vi) inclusion of a crosslinking or ligation junction in a strand of the crisscross ribbon and/or a slat strand; (vii) mechanical rupturing of crisscross ribbons; (viii) inclusion of photothermal elements in a strand of the crisscross ribbon and/or a slat strand; (ix) polymerase-based scission; (x) inclusion of thermoactivated slat strands; (xi) inclusion of nicking sites in a strand of the crisscross ribbon and/or a slat strand; and/or (xii) inclusion of exonucleases in the reaction mixture.”
Here the method claims recite a set of different technology in Markush format capable of performing seed strand displacement that do not share any structural similarities and are not functionally equivalent to each other. Additionally, the different methodologies target different molecular components that are unrelated and would not be considered to belong to the same recognized physical or chemical class.
The recited alternative species in the groups set forth here do not share a single structural similarity, as member of the Markush group represents technology for displacing seed strands that have no substantial common structural similarity is readily apparent.
Following this analysis, the claims are rejected as containing an improper Markush grouping.
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 1-18 and 35 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 1-18 and 35 are indefinite in the claims 1 at step (c) and claim 4 at step (b) at the recitation of “slat strands, each of which binds to multiple strands of the crisscross ribbon that are bound to the seed strands, thereby displacing the seed strands from the crisscross ribbon” and “slat strands, each of which binds to multiple strands of the first layer of strands that are bound to the strands of the second layer, thereby displacing the strands of the first layer from the strands of the second layer”, respectively because it because the slat strands are not defined in terms of structure and it is unclear how one is to distinguish the slate strands from any other strand and further how the slat strand enables the displacement of either the seed strands or the strands in one layer from another strands in another layer. Given the ambiguity a clear interpretation cannot be ascertained.
(b) Claim 15 is indefinite at confusing at the recitation of “wherein displacing seed strands from the crisscross ribbon is performed by (i) toehold-mediated strand displacement; (ii) inclusion of gamma cut slats; inclusion of an engineered restriction site in a slat strand; (iii) inclusion of an unnatural or modified base in a strand of the crisscross ribbon and/or a slat strand; (iv) inclusion of small molecules that can function to accelerate scission in the reaction mixture; (v) inclusion of pH responsive elements in a strand of the crisscross ribbon and/or a slat strand; (vi) inclusion of a crosslinking or ligation junction in a strand of the crisscross ribbon and/or a slat strand; (vii) mechanical rupturing of crisscross ribbons; (viii) inclusion of photothermal elements in a strand of the crisscross ribbon and/or a slat strand; (ix) polymerase-based scission; (x) inclusion of thermoactivated slat strands; (xi) inclusion of nicking sites in a strand of the crisscross ribbon and/or a slat strand; and/or (xii) inclusion of exonucleases in the reaction mixture” because no actual method steps are recited and cannot clearly be determined what is intended to be included or excluded or what is required in order for the claimed displacement to occur. Thus, the metes and bounds of the claimed limitation is unclear.
Claim Rejections - 35 USC § 103
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 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.
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.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Minev et al ( US 20190203277, published July 2019; effective filing date August 2016, citation made of record on IDS filed herein).
Regarding claim 19, Minev et al teach a method of detection of a biomarker (Para. [0018] Biomolecule (analyte) detection methods), comprising: combining in a reaction mixture (a) a sample comprising a biomarker (Para. [0019] the methods may comprise combining in a reaction mixture {e.g., with hybridization buffer} a sample comprising a biomolecule); and (b) a nucleic acid nanostructure comprising (i) a nucleic acid scaffold strand and nucleic acid staple strands capable of assembling into multiple stacked parallel loops (Para. [0019] a nucleic acid nanostructure comprising
(i) a nucleic acid scaffold strand capable of folding into repeating loop-like shapes {e.g., 2-15 vertically-stacked loops}; Para. [0015] nucleic acid nanostructures comprising a nucleic acid scaffold strand folded (e.g., M13 or M13-derived} into repeating loop-like shapes secured by shorter nucleic acid staple strands), and
(ii) a crisscross ribbon (Para. [0019] two crisscross nucleic acid slats) comprising a first layer of strands and a second layer of strands, wherein the strands of the first layer are nonparallel to and bound to the strands of the second layer (Para. [0013] crisscross nucleic acid slats, comprising: a first plurality of at least four nucleic acid strands parallel to each other and a second plurality of at least four nucleic acid strands parallel to each wherein the at least four nucleic acid strands of the first plurality are bound to and perpendicular to the at least four nucleic acid strands of the second plurality); wherein the crisscross ribbon binds to the loops of (i) (Para. [0015] wherein the repeating loop structures are bound to at least one crisscross nucleic acid slat); wherein a biomarker binding partner that specifically binds to the biomarker is linked to each of the crisscross ribbons such that in the presence of the biomarker the biomarker binding partners bind to the biomarker and the nucleic acid nanostructure folds into multiple stacked parallel loops (Para. [0019] wherein a biomolecule binding partner {e.g., an antibody} that specifically binds to the biomolecule is linked to each of the crisscross nucleic acid slats such that in the presence of the cognate biomolecule the biomolecule binding partner binds to the biomolecule and the nucleic acid nanostructure folds into repeating loop-like shapes); and incubating the reaction mixture to assemble multiple stacked parallel loops (Para. [0018] incubating the reaction mixture under conditions that permit binding of the biomolecule binding partners to the biomolecule; Para. [0104] in the presence of biomolecule, they hold the structure together and growth can occur from the parallel loops).
Minev et al do not expressly teach slat strands, wherein each of the slat strands binds to multiple strands of the first layer of strands that are bound to the strands of the second layer in (b)(ii).
However, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to have modified the method of Minev to include slat strands, wherein each of the slat strands binds to multiple strands of the first layer of strands that are bound to the strands of the second layer in (b)(ii), since Minev teaches at Para. [0013] crisscross nucleic acid slats, comprising: a first plurality of at least four nucleic acid strands parallel to each other and a second plurality of at least four nucleic acid strands parallel to each wherein the at least four nucleic acid strands of the first plurality are bound to and perpendicular to the at least four nucleic acid strands of the second plurality; Para. [0156] "crisscross DNA slats" (short: "DNA slats"). A schematic of the base unit is shown in FIGS. 21A-21B. The 21 nucleotide (nt) long oligonucleotide per DNA slat shown in FIGS. 21A-21B allows the 4 by 4 DNA slats array to retains the correct 10.5 bases/turn. The length of the DNA slats can be expanded by repeats of 21 nt, for example, achieving larger structures. FIG. 21A shows an abstraction of the DNA slats architecture and a matrix with the number of base pairs (bp) ID NO: 684)), including a slat strand to generate crisscross DNA slat involves only routine skill in the art.
The motivation of doing so would be to self-assemble crisscross DNA slats using a slat strand.
Conclusion
No claims are allowed. However, the claims 1-18 and 35 have not been rejected under prior art but have been rejected for other reasons. The cited prior art noted above is deemed the closest prior art the claims of the instant invention.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, GARY BENZION can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CYNTHIA B WILDER/Primary Examiner, Art Unit 1681
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