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
Responsive to communication entered 11/17/2025.
Priority
This application, Pub No. US 2023/0314417 A1, published 10/05/2023, is a § 371 National Stage of International Patent Application No. PCT/US2021/023538, filed 03/22/2021, Pub. No. WO 2021/194999, published 09/30/2021, which claims benefit of US provisional application 62/993,575, filed 03/23/2020.
Status of Claims
Claims 1-13 and 47 are currently pending. Claims 1-46 have been originally filed. Claims 4, 7-9, 13, 24, 33 and 40 have been amended, and Claims 14, 16, 18, 20-23, 26-32, 34-39 and 41-46 have been cancelled, as set forth in Applicant’s Preliminary amendment filed 05/23/2023. Claims 1-13, 15, 17, 19, 24, 25, 33 and 40 have been subject to election/restriction requirement mailed 09/15/2025. Claims 15, 17, 19, 24, 25, 33 and 40 have been cancelled, and Claim 47 has been added, as set forth in Applicant’s amendment filed 11/17/2025. Claim 7 is withdrawn from further consideration. Claims 1-6, 8-13 and 47 are examined.
Election/Restriction
Applicant's election, without traverse, of Group I, Claims 1-13, drawn to a method for generating a monoclonal antibody that specifically binds to a chemically-modified nucleic acid molecule, and the species:
(1) an immunogen comprising streptavidin nanobeads having a mean diameter of 0.1 µm coated with 1851 RNAi construct biotinylated at the 5' end of the antisense strand via a PEG4-carbon six linker as an immunogen; and
(2) a rabbit as an animal to which the immunogen is administered,
in the reply filed on 11/17/2025 is acknowledged.
It is noted that the newly added Claim 47 is dependent upon Claim 1, and, therefore belongs to the elected Group I.
Because Applicant did not distinctly and specifically point out the supposed errors in the species election requirement, the species election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant identified Claims 1-6, 8-13 and 47 as readable on the elected species.
Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/17/2025.
Information Disclosure Statement
The information disclosure statements, submitted on 09/22/2022 and 04/25/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the Examiner.
Specification
The use of the terms Texas Red and Alexa Fluor, which are a trade name or a mark used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
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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.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 1-6, 8-13 and 47 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
The claims, as recited in independent Claim 1, are drawn to:
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Given the broadest reasonable claim interpretation, the recitation “conjugating a plurality of nucleic acid molecules to a bead to form an immunogen, wherein the nucleic acid molecules each comprise one or more modified nucleotides” means that the immunogen comprises different nucleic acid molecules, whereas the instant disclosure is limited to conjugation of multiple copies of the same nucleic acid molecule to a bead to form an immunogen, as shown in the single specific example of the instant disclosure:
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Emphasis added.
Claim Rejections - 35 USC § 102/103
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 –
(a)(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.
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 4, 8 and 13 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Agris, US 2002/0045167 A1, published 04/18/2002.
Agris, throughout the publication and, for example, in the claims, teaches:
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Emphasis added.
In paragraphs [0028], [0032] and [0111], Agris teaches:
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Emphasis added.
The Examiner notes that, although Agris does not expressly teach “conjugating a plurality of nucleic acid molecules to a bead to form an immunogen,” one of skill in the art would have understood that "a plurality of nucleic acid molecules" are bound (conjugated) to the solid carrier in the immunogen, taught by Agris, because the solid carrier has a plurality of reaction starting points in the solid-phase oligonucleotide synthesis method, taught by Agris.
Claims 1-6, 8-13 and 47 are rejected under 35 U.S.C. 103 as obvious over Rajeev et al., US 2017/0044591 A1, published 02/16/2017, in view of Zeng et al., WO 2014/100216 A1, published 06/26/2014.
Rajeev et al., throughout the publication, teach a method of making a monoclonal antibody that binds to a chemically-modified nucleic acid molecule such as modified RNA molecule, e.g., a fluoro group (e.g., a fluoro group in the 2′-position of a ribonucleotide) of the RNA molecule; or a ligand in a conjugate of the RNA molecule, e.g., a ligand that includes one or more N-acetylgalactosamine (GalNAc) ligands as follows:
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Emphasis added.
As such, Rajeev et al. teach all limitations of the instant Claims 1-6, 8-13 and 47 except for a bead as an immunogenic carrier.
Zeng et al., throughout the publication, teach a method of generating a monoclonal antibody that binds to a chemically-modified nucleic acid molecule such as miRNA molecule, e.g., a methyl group, using a bead as an immunogenic carrier as follows:
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Emphasis added.
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The Examiner notes that one of skill in the art would have known that siRNA (small interfering RNA), taught by Rajeev et al., and miRNA (microRNA), taught by Zeng et al., are both short, non-coding RNA molecules, typically 18-25 nucleotides long:
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Therefore, the use of a bead as an immunogenic carrier, taught by Zeng et al., to boost immune response instead of KLH in the method, taught by Rajeev et al., would have been considered to be predictable and suitable to a person of ordinary skill in the art. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved (see MPEP § 2143, B.).
As such, Rajeev et al. in combination with Zeng et al. teaches all limitations of the instant Claims 1-6, 8-13 and 47 and the elected species (2).
With regard to the elected species (1), no prior art specifically teaching an immunogen comprising streptavidin nanobeads having a mean diameter of 0.1 µm coated with 1851 RNAi construct biotinylated at the 5' end of the antisense strand via a PEG4-carbon six linker was found. However, the nucleotide sequence of RNAi construct 1851 has been disclosed by Melquist et al., US 2017/0096665 A1, published 04/06/2017 in Table 3A as RNAi construct AD03851:
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Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GALINA M YAKOVLEVA whose telephone number is (571)270-3282. The examiner can normally be reached on M-F 8:30 AM-5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, GREGORY S EMCH can be reached on (571)272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GALINA M. YAKOVLEVA/Primary Examiner, Art Unit 1678