DETAILED ACTION
Response to Amendment
Applicant’s response to the office action filed on January 21, 2026 has been entered. The claims pending in this application are claims 1, 3-7, 10-13, 16, 17, and 19-26 wherein claim 12 has been withdrawn due to the restriction requirements mailed on October 13, 2023. The objections and rejection not reiterated from the previous office action are hereby withdrawn in view of applicant’s amendment filed on January 21, 2026. Claims 1, 3-7, 10, 11, 13, 16, 17, and 19-26 will be examined.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
New Matter
Note that new matter rejection on claims 21, 24 and 25 have been withdrawn in view of the response filed on January 21, 2026.
Claims 1-7, 10, 11, 13, 16, 17, and 19-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The limitation “(a) providing a structured nucleic acid particle, wherein the structured nucleic acid particle comprises a nucleic acid origami, wherein the nucleic acid origami comprises a first oligonucleotide, and wherein the nucleic acid origami comprises a first surface and a second surface; (b) coupling the first oligonucleotide of the nucleic acid origami to a second oligonucleotide, wherein the second oligonucleotide comprises a reactive functional group, thereby forming a linker comprising double-stranded nucleic acid extending from the second surface of the acid origami” is added to independent claim 1. Although the specification describes that “[G]enerally, nucleic acid origami can comprise at least one or more long nucleic acid strand and one or more short nucleic acid strands. Commonly, these nucleic acid strands are single stranded, although they can have segments which can be double stranded. One of the short strands can comprise at least a first segment which can be complementary to a first segment of the long strand, as well as a second segment which can be complementary to a second segment of the long strand. When the short and long strands are incubated under conditions that can allow hybridization of nucleotides, the shorter oligonucleotide can hybridize with the longer oligonucleotide. This hybridization can give shape to the nucleic acid molecule. For example, if the two segments on the first strand are separated, then these two segments can be brought together during hybridization to create a shape. In some cases, a short strand can bind to at least 2, 3, 4, 5, or 6 segments which can bind to at least 2, 3, 4, 5, or 6 complementary segments of the long nucleic acid strand” (see paragraph [0165] of US 2022/0017567 A1, which is US application of this instant application), paragraphs [0015], [0083] to [0085], [0161] to [0163], [0165], [0170], [0176], [0180], and [0181] of the specification suggested by applicant do not describe such limitation recited in claim 1 since the specification only describes an origami comprising either a single stranded oligonucleotide or a double stranded oligonucleotide and does not describe a step for coupling a single stranded oligonucleotide to a single stranded oligonucleotide of an origami, thereby forming a linker comprising double-stranded nucleic acid extending from the second surface of the acid origami. Furthermore, claim 26 contains a limitation “wherein the linker forms a rigid outpost from the structured nucleic acid particle”. Although the specification describes that “[N]ucleic acid origami can be used to construct a SNAP with a linker which can attach a biological or chemical entity, wherein the linker is positioned relative to the landing surface such that the biological or chemical entity can be distal or approximately distal to the solid support. The linker may also comprise a region of dsDNA to force a rigid outpost from the SNAP” (see paragraphs [0183] of US 2022/0017567 A1, which is US application of this instant application), paragraph [0181] of the specification suggested by applicant does not describe such limitations recited in claim 26 because paragraph [0181] of the specification only describes that the linker forms a rigid outpost from the structured nucleic acid particle only when the linker comprises a region of dsDNA.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” MPEP 2163.02 teaches that “Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application.” MPEP 2163.06 further notes “When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure” (emphasis added).
Response to Arguments
I. In page 6, last paragraph bridging to page 9, last paragraph of applicant’s remarks, applicant argues that “[S]tep (a) of claim 1 recites: ‘providing a structured nucleic acid particle, wherein the structured nucleic acid particle comprises a nucleic acid origami, wherein the nucleic acid origami comprises a first oligonucleotide, and wherein the nucleic acid origami comprises a first surface and a second surface.’ Regarding the claimed structured nucleic acid particle comprising a nucleic acid origami, as required in part (a) of claim 1, Applicant teaches ‘[i]n some cases, a SNAP may be formed by nucleic acid origami, or DNA origami.’ See, e.g., paragraph [0161]; emphasis added. Applicant teaches that a nucleic acid origami can comprise a plurality of oligonucleotides, such as the claimed first oligonucleotide. See, e.g., paragraph [00163] of the application as filed – ‘Generally, nucleic acid origami can comprise at least one or more long nucleic acid strand and one or more short nucleic acid strands.’ (Emphasis added.) Applicant further teaches that DNA origami can provide a multidimensional structure having two or more surfaces. See, e.g., paragraph [0161] of the application as filed – ‘DNA origami generally refers to the nanoscale folding of DNA to create non-arbitrary two- and three- dimensional shapes at the nanoscale.’ (Emphasis added.) Applicant further teaches that a nucleic acid origami can comprise an engineered shape. See, e.g., paragraph [00162] of the application as filed – ‘Nucleic acid origami can result in a nucleic acid molecule which has an engineered shape.’ (Emphasis added.) Applicant further provides examples of an engineered shape, including shapes whose three-dimensional structures can have more than one unique surface. See, e.g., paragraph [00170] of the application as filed – ‘An engineered shape can [sic] any shape, such as oblong, rectangular, round, circular, spherical, flat, textured, smooth, symmetrical, asymmetrical, conical, or irregular. An engineered shape can be a cube, pyramid, boxe [sic], cage, ladder, or tree.’ (Emphasis added.) One skilled in the art would recognize that such a three- dimensional nucleic origami can contain multiple surfaces, including a first surface and second surface. The specification further provides teachings that would encourage one of skill in the art to produce nucleic acid origami with two or more surfaces. See, e.g., paragraph [00180] -
‘Nucleic acid origami may be used to preferentially choose how the SNAP will ‘land’ on the solid support. For example, nucleic acid origami may be used to construct a SNAP with a landing surface that can preferentially contact the solid support, A SNAP such as one made via nucleic acid origami can be designed to comprise a region that can create steric or electrostatic interactions with the support that can influence the orientation of the SNAP on the support.’ (Emphasis added.) An additional surface for forming a linker is also distinctly described. See, e.g., paragraph [00181] of the application as filed – ‘Nucleic acid origami can be used to construct a SNAP with a linker which can attach a biological or chemical entity, wherein the linker is positioned relative to the landing surface such that the biological or chemical entity can be distal or approximately distal to the solid support. The linker may also comprise a region of dsDNA to force a rigid outpost from the SNAP. In some cases, protein origami may also be used.’ (Emphasis added.) One skilled in the art would recognize that a linker positioned distal to a first landing surface of a nucleic acid origami can be formed on a second surface of a multidimensional nucleic acid origami” and “[R]egarding the claimed feature of coupling the first oligonucleotide to a second oligonucleotide of the nucleic acid origami, Applicant teaches hybridizing two oligonucleotides of a nucleic acid origami. See, e.g., paragraph [00165] of the application as filed – ‘When the short and long strands are incubated under conditions that can allow hybridization, the shorter oligonucleotide can hybridize with the longer oligonucleotide.’ See, e.g., paragraph [00168] of the application as filed – ‘Short nucleic acid strands can have complementarity to one long nucleic acid strand or more than one long nucleic acid strand. In some cases, a short nucleic acid strand can also have complementarity to one or more short nucleic acid strands.’ (Emphasis added.) See, e.g., paragraph [00176] of the application as filed – ‘Assembly can be performed stepwise. In such cases, a subset of the nucleic acid molecules can be incubated together first. After these molecules are allowed to hybridize, one or more additional nucleic acid molecules can be added and allowed to hybridize.’ (Emphasis added.)
Applicant also teaches that a second oligonucleotide comprises a reactive functional group, as required in part (b) of claim 1. See, e.g., paragraph [0015] of the application as filed – ‘In some cases, the oligonucleotides are modified on the 3' end with a functional group. In some cases, the oligonucleotides are modified on the 5' end with a functional group.’ (Emphasis added). e.g., paragraphs [0083]-[0085] of the application as filed – ‘The biological or chemical entities of this disclosure may be attached to seeds. These seeds are molecules which can be used as a starting 'seed' to grow a larger polymeric molecule. [...] The seeds may comprise a monomer and a functional group able to bind to a biological or chemical entity to be separated. Examples of such functional groups may include, but are not limited to, amines, thiols, carboxylic acids, triple bonds, double bonds, epoxides, alkynes, alkenes, cycloalkynes, azides, cyclo-octynes, cycloalkynes, norbornenes, tetrazines, cyclloctanes, epoxides, and hydroxyls. In some cases, the seed may comprise a functional group that is compatible with a click chemistry.’ (Emphasis added.) Applicant also teaches forming a linker comprising double-stranded nucleic acid extending from the second surface of the nucleic acid origami, as required in part (b) of claim 1. See, e.g., paragraph [00181] of the application as filed – ‘Nucleic acid origami can be used to construct a SNAP with a linker which can attach a biological or chemical entity, wherein the linker is positioned relative to the landing surface such that the biological or chemical entity can be distal or approximately distal to the solid support. The linker may also comprise a region of dsDNA to force a rigid outpost from the SNAP. In some cases, protein origami may also be used.’ (Emphasis added.) Based on at least the reasoning and factual evidence provided above, Applicant submits that the claim language and scope of claim 1 are adequately described and supported by the application as filed as to reasonably convey to one skilled in the art that the inventors had possession of the claimed invention at the time the application was filed”.
These arguments have been fully considered but they are not persuasive toward the withdrawal of the rejection. Although paragraph [0181] of the specification describes that
the specification describes that “[N]ucleic acid origami can be used to construct a SNAP with a linker which can attach a biological or chemical entity, wherein the linker is positioned relative to the landing surface such that the biological or chemical entity can be distal or approximately distal to the solid support. The linker may also comprise a region of dsDNA to force a rigid outpost from the SNAP. In some cases, protein origami may also be used”, the paragraph [0181] of the specification does not describe that coupling the first oligonucleotide of the nucleic acid origami to a second oligonucleotide, thereby forming a linker comprising double-stranded nucleic acid extending from the second surface of the acid origami as recited in step (b) of claim 1 and only describes that the linker may also comprise a region of dsDNA to force a rigid outpost from the SNAP.
II. In page 11, last paragraph bridging to page 12, first paragraph of applicant’s remarks, applicant argues that “[A]pplicant teaches a linker that forms a rigid outpost from the structured nucleic acid particle. See, e.g., paragraph [00181] of the application as filed – ‘In some cases, the biological or chemical entity may be functionalized with a linker. In some cases, functionalizing the biological or chemical entity with a linker may decrease steric hindrance. A linker may comprise a rigid or semi-rigid moiety which can hold the biological or chemical entity away from the SNAP.’ (Emphasis added.) Also see, e.g., paragraph [00181] of the application as filed – ‘Nucleic acid origami can be used to construct a SNAP with a linker which can attach a biological or chemical entity, wherein the linker is positioned relative to the landing surface such that the biological or chemical entity can be distal or approximately distal to the solid support. The linker may also comprise a region of dsDNA to force a rigid outpost from the SNAP.’
(Emphasis added.)”.
These arguments have been fully considered but they are not persuasive toward the withdrawal of the rejection because paragraph [0181] of the specification only describes that the linker comprising a region of dsDNA forces a rigid outpost from the SNAP and does not describe that any kind of linker forms a rigid outpost from the structured nucleic acid particle (SNAP) as recited in claim 26.
Conclusion
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.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Frank Lu, Ph. D., whose telephone number is (571)272-0746. The examiner can normally be reached Monday to Friday, 9 AM to 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow, Ph.D., can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRANK W LU/
Primary Examiner, Art Unit 1683
March 27, 2026
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