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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or
under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application claims benefit of Application No. 63/168,837 filed 03/31/2021. Based on the filing receipt, the effective filing date of this application is March 31, 2021 which is the filing date of Application No. 63/168,837.
Withdrawn Rejections
The rejection of claims 24-32 on the grounds of 35 U.S.C. 102 has been withdrawn, necessitated by amendments filed 12/12/2025. New grounds of rejection are disclosed below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 28 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 28 depends on claim 24, which is directed at a product, but does not further limit claim 24. Claim 28 is directed to the analyte of interest which is not a structural limitation of the product of claim 24.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claims 24-32 are rejected under 35 U.S.C. 103 as being unpatentable over Gopinath (WO 2019059961 A1, published 2019-03-28, cited in IDS filed 2022-10-11) in view of Tsukanov, et al. (“Developing DNA Nanotechnology Using Single-Molecule Fluorescene”, published 2014-05-14).
[AltContent: textbox ([img-media_image1.png])]With respect to claim 24, Gopinath teaches several embodiments of a bistable polynucleotide device for the sensing and quantification of molecular events as exemplified by Figure 1A.
With respect to claim 24, Gopinath teaches a substrate comprising a plurality of supramolecular structures (see, e.g., substrate – para. [0036]: “Devices that are open have available purification tags (Fig. 2A, e.g. biotin), which can bind an affinity column (e.g. comprising streptavidin beads)”; and sheet 1/23, under “FIG. 1A”, labeled “Purification tag”), each supramolecular structure comprising:
a core structure comprising a plurality of core molecules (see, e.g., para. [0030]; and sheet 1/23, under “FIG. 1A”, labeled “Polynucleotide shape 1” and “Polynucleotide shape 2”),
one or more capture molecules linked to the supramolecular core at a first set of locations (see, e.g., para. [0030]; and sheet 1/23, under “FIG. 1A”, labeled “Primary binding molecule”),
one or more detector molecules linked to the supramolecular core at a second set of locations (see, e.g., para [0030]; and sheet 1/23, under “FIG. 1A”, labeled “Secondary binding molecule”),
and one or more barcode sequences linked to the supramolecular core at locations other than the first set of locations and the second set of locations,
wherein the one or more barcode sequences identify the core structure, the capture molecules, the detector molecules, or combinations thereof and lastly (see, e.g., para. [0035]: “a unique DNA barcode which encodes the identity of the analyte being quantified”; and under sheet 1/23, under “FIG. 1A”, labeled “Barcode strand”),
one or both of the capture molecules or the detector molecules selectively bind to an analyte of interest, (see, e.g., para. [0030]: “each of the polynucleotide shapes carry a binding molecule (e.g. aptamer or antibody) that binds a unique non- overlapping region of the analyte molecule or particle”). It is understood that because the “Solution Version” embodiment of “FIG. 1A” contains purification tags, the device will be bound to a solid substrate comprising streptavidin beads as described in para. [0036]. It is also understood that due to the selectivity of binding molecules (capture molecules or detector molecules) such as antibodies and aptamers, the identification of the analyte (see, e.g., para. [0035]) also identifies the capture and detector molecules.
With respect to claim 25, Gopinath teaches the barcode sequences comprise nucleic acid sequences (see, e.g., para. [0030]: “In some embodiments, at least one of the origami carries a unique DNA barcode”; and para. [0036]: “For some "solution version" embodiments which provide detection via output of a DNA barcode signal”). A “solution version” embodiment is exemplified in Figure 1A.
With respect to claim 26, Gopinath teaches each core structure of the plurality of supramolecular structures is identical to each other (see, e.g., para. [0050]; and para. [0029]). Due to the miniscule size of supramolecular DNA structures, it is understood that an artisan would be unable to create a single supramolecular DNA structure, instead they would create a plurality of supramolecular DNA structures which are identical in structure.
With respect to claim 27, Gopinath teaches the substrates comprises a solid substrate, specifically a bead (see, e.g., para. [0036]: “Devices that are open have available purification tags (Fig. 2A, e.g. biotin), which can bind an affinity column (e.g. comprising streptavidin beads)”; and sheet 1/23, under “FIG. 1A”, labeled “Purification tag”). It is understood that because the “Solution Version” embodiment of “FIG. 1A” contains purification tags, the device will be bound to a solid substrate comprising streptavidin beads as described in para. [0036].
With respect to claim 28, Gopinath teaches the analyte of interest is protein (see, e.g., para. [0069]).
With respect to claim 29, Gopinath teaches each supramolecular structure is a nanostructure (see, e.g., para. [0031]).
With respect to claim 30, Gopinath teaches the core molecules for each core structure comprise one or more nucleic acid strands (see, e.g., para. [0030]: “polynucleotide shapes”).
With respect to claim 31, Gopinath teaches each core structure comprises a scaffolded deoxyribonucleic acid origami (see, e.g., para. [0026]: “Polynucleotide platforms include but are not limited to scaffolded deoxyribonucleic acid (DNA) origami”).
With respect to claim 32, Gopinath teaches the one or more captures molecules and one or more detector molecules for each supramolecular structure comprises an antibody or aptamer (see, e.g., capture molecules - sheet 1/23, under “FIG. 1A”, labeled “Primary binding molecule”; detector molecule - sheet 1/23, under “FIG. 1A”, labeled “Secondary binding molecule”; binding molecules are aptamers or antibodies – para. [0030]: “each of the polynucleotide shapes carry a "binding molecule" (e.g. aptamer or antibody)”).
Gopinath fails to teach the substrate is contained within a flow-cell, as in claim 24. However, in a journal article on DNA nanotechnology, Tsukanov rectifies this deficiency. Tsukanov teaches DNA Origami used with a flow-cell, as in claim 1 (see, e.g., p. 1790, under “Figure 1.”, panel “D”).
Gopinath and Tsukanov are analogous to the field of the claimed invention because they are both in the field of DNA nanotechnology. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to use the flow cell of Tsukanov with the bistable polynucleotide device of Gopinath. An artisan would have been motivated to do so because Tsukanov discloses “by using a flow-cell,38,39 the surrounding solution can be replaced while the sample molecule remains in position and is continuously observed. This is a significant advantage because it enables introduction of various components” (see, p. 1791, col. 1, para. 1). An artisan would have had a reasonable expectation of success based on the given disclosures.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 24-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 9, 17, 22-26, and 31 of copending Application No. 17/677,255 (referred to as ‘255 henceforth). Although the claims at issue are not identical, they are not patentably distinct from each other because '255 teaches all of the limitations of pending claims 24-31.
With respect to claim 24, ‘255 teaches a substrate with supramolecular structures comprising core molecules, capture molecules linked to the supramolecular core at a first location, detector molecules linked to the supramolecular core at a second location, and a barcode linked to the supramolecular core at a third location, wherein one or both of the capture molecules or detector molecules selectively bind to an analyte of interest (see, e.g., claim 1 of ‘255; and claims 22, 24, 31 of ‘255). Claim 1 of ‘255 recites, “associating the detected analyte molecule with the supramolecular structure based on an identity of the capture barcode”. It is understood that basing the detected analyte molecule with the supramolecular structure on an identify of the capture barcode allows the identification of the core molecules and capture molecules as well. Claim 24 of ‘255 recites, “each supramolecular structure has a unique capture barcode”. It is also understood that the unique capture barcodes of claim 22 of ’255 have the same function as the capture barcodes of claim 1 of ‘255.
With respect to claim 25, ‘255 teaches barcode sequences comprise nucleic acid sequences (see, e.g., claim 17 of ‘255).
With respect to claim 26, ‘255 teaches the core structures are identical to each other (see, e.g., claim 23 of ‘255).
With respect to claim 27, ‘255 teaches the substrate comprises a solid support (see, e.g., claim 25 of ‘255).
With respect to claim 28, ‘255 teaches the analyte molecule comprises a protein, a peptide, a peptide fragment, a lipid, a DNA, a RNA, an organic molecule, an inorganic molecule, complexes thereof, or any combinations thereof (see, e.g., claim 4 of ‘255).
With respect to claim 29, ‘255 teaches each supramolecular structure is a nanostructure (see, e.g., claim 5 of ‘255; and claim 26 of ‘255).
With respect to claim 30, ‘255 teaches the plurality of core molecules for each core structure comprises one or more nucleic acid strands or one or more branched nucleic acids (see, e.g., claim 9 of ‘255).
With respect to claim 31, ‘255 teaches the core structure comprises a scaffolded deoxyribonucleic acid (DNA) origami, a scaffolded ribonucleic acid (RNA) origami, a scaffolded hybrid DNA:RNA origami, a single-stranded DNA tile structure, a multi-stranded DNA tile structure, a single-stranded RNA origami, a multi-stranded RNA tile structure, hierarchically composed DNA or RNA origami with multiple scaffolds, a peptide structure, or combinations thereof. (see, e.g., claim 9 of ‘255).
These are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 12/12/2025 have been fully considered but they are not persuasive.
The applicant argues that the amendment to claim 28 necessitates the withdrawal of the 35 U.S.C. 112(d) rejection of that claim. However, the rejection was based on the fact that claim 28 depends on claim 24, which is directed to a product, but does not further limit claim 24. Claim 28 is directed to the analyte of interest which is not a structural limitation of the product of claim 24. The amendment to claim 28 filed 12/12/2025 merely modifies the analyte of interest. Therefore, the rejection of claim 28 on the grounds of 35 U.S.C. 112(d) is maintained.
The applicant argues that the Gopinath (cited above) does not anticipate the amended claims 24-32. The office agrees and has added prior art rejections under 35 USC 103 (discussed above), necessitated by amendments filed 12/12/2025.
The applicant requests that the nonstatutory double patenting rejections above be held in abeyance until at least one claim is found to be allowable. The nonstatutory double patenting rejections will be maintained until otherwise appropriate.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL C SVEIVEN whose telephone number is (703)756-4653. The examiner can normally be reached Monday to Friday - 8AM to 5PM PST.
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/MICHAEL CAMERON SVEIVEN/ Examiner, Art Unit 1678
/GREGORY S EMCH/ Supervisory Patent Examiner, Art Unit 1678