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 .
Status of Application/Amendment/Claims
This Office action is in response to the communications filed on July 16, 2026.
Currently, claims 64, 81-84, and 87-92 are pending in the instant application. Claims 87-92 are withdrawn from further consideration as being drawn to a nonelected invention. Accordingly, claims 64 and 81-84 are under examination on the merits in the instant application.
The following rejections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on July 16, 2026 and July 22, 2026 have been considered by the examiner. Note that applicant has misidentified that an English translation of each of foreign patent document Citation Nos. 001 and 002 of the IDS filed on July 22, 2026 is attached. Note that ALL NINE foreign patent documents filed on July 22, 2026 are considered only for the English language title and abstract. That is, none of the actual teachings of the foreign patent documents are considered as they are in non-English language.
Response to Arguments and Amendments
Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.
New Objections/Rejections Necessitated by Amendment
Specification
The amendment filed on July 16, 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The sequence listing filed on July 16, 2026 contains mismatched information. For instance, SEQ ID NO:182, which is 5’-AGGATTCCGCAGTATGGAT thus is clearly a DNA sequence, is now identified as “other RNA” for molecule type (“mol_type”). Not only does the “mol_type” misidentify the DNA sequence, it also introduces new matter that is different from what is actually disclosed in the description within the specification itself. That is, the table listing SEQ ID NO:182 identifies 5’-AGGATTCCGCAGTATGGAT as “Complementary nucleotide sequence of the target sequence”, which is a DNA sequence. Hence, SEQ ID NO:182 is clearly disclosed and described as a target DNA sequence, not as a guide RNA sequence having “other RNA” molecule type. Accordingly, the sequence listing contains misinformation that is newly introduced, which is not at all supported by the specification as originally filed. Note that SEQ ID NO:182 is merely exemplary and the new matter issues in the sequence listing filed on July 16, 2026 is not limited to SEQ ID NO:182.
Applicant is required to cancel the new matter in the reply to this Office Action.
In the remarks filed on July 16, 2026, applicant states that the contents of the sequence listing “do not include any new matter that goes beyond the disclosure of the application as filed.” Contrary to applicant’s argument, SEQ ID NO:182 is clearly identified as a DNA target sequence in the specification as explained above thus, the new identification of SEQ ID NO:182 as “other RNA” introduces new matter that goes beyond the disclosure of the specification as originally filed.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 64 and 81-84 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.
Claims 64 and 81-84 recite “wherein the sgRNA comprises a nucleotide sequence as set forth in SEQ ID NO: 182.” It is noted that the nucleotide sequence of SEQ ID NO:182 is 5’-AGGATTCCGCAGTATGGAT as evidenced by the specification and the sequence listing. Hence, the claims recite structurally conflicting limitations (RNA vs. DNA) regarding the sgRNA, thereby rendering the claims indefinite.
Claims 82 and 84 each recite “the nucleic acid(s)”. It is unclear whether “nucleic acid(s)” is meant to read on a single nucleic acid as well as a plurality of nucleic acids because “(s)” is conventionally used for indicating an option.
Claim 82 recites that “the nucleic acid(s) encoding the fusion molecule and the sgRNA are packaged in one or more liposomes or one or more lipid nanoparticles.” It is unclear whether each of the two different “nucleic acid(s)” encoding each of the fusion molecule and the sgRNA is separately packaged, thereby resulting in a plurality (two) of “liposomes” or “lipid nanoparticles” or whether the single combination of the “nucleic acids” encoding two different molecules is packaged in multiple “liposomes” or “lipid nanoparticles”, thereby rendering the exact structure of the claimed composition indefinite.
Claim 84 recites that “the nucleic acid(s) encoding the fusion molecule and the sgRNA are packaged in one or more AAV vectors.” It is unclear whether each of the two different “nucleic acid(s)” encoding each of the fusion molecule and the sgRNA is separately packaged, thereby resulting in a plurality (two) of “AAV vector” or whether the single combination of the “nucleic acids” encoding two different molecules is packaged in multiple “AAV vectors”, thereby rendering the exact structure of the claimed composition indefinite.
Double Patenting
The text of the judicially created doctrine not included in this action can be found in a prior Office action.
Claims 64 and 81-84 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-10, 13, 18-19, 21-22, 25-31, 36, and 53-58 of copending Application No. 19/245,463 in view of Bae et al. (US 2022/0228133 A1, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘463 claims drawn to a fusion protein comprising DNMT3A-DNMT3L. It is noted that the ‘463 specification defines the fusion protein comprising DNMT3A and DNMT3L as encompassing and reading on SEQ ID NO:90 (see pages 34 and 50-51), which is 100% identical to SEQ ID NO:1194 claimed in the instant case. It would have been obvious to further include Bae’s sgRNA of SEQ ID NO:61 corresponding to the RNA counterpart of the DNA sequence of SEQ ID NO:182 claimed in the instant case in an LNP or an AAV vector composition because making a CRISPR system comprising Bae’s sgRNA formulated in liposomes or AAV vectors was an art-recognized goal as evidenced by Bae.
Claims 64 and 81-84 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 14, 17-18, 20-21, 26-27, 39-40, 42, 44-45, 47-49, 53, 55, 58-59, 62-63, and 75-77 of copending Application No. 19/245,469 in view of Bae et al. (US 2022/0228133 A1, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘463 claims drawn to a fusion protein comprising SEQ ID NO:90 (see claim 48), which is 100% identical to SEQ ID NO:1194 claimed in the instant case. It would have been obvious to further include Bae’s sgRNA of SEQ ID NO:61 corresponding to the RNA counterpart of the DNA sequence of SEQ ID NO:182 claimed in the instant case in an LNP or an AAV vector composition because making a CRISPR system comprising Bae’s sgRNA formulated in liposomes or AAV vectors was an art-recognized goal as evidenced by Bae.
Relevant Prior Art
The following is found relevant to the claimed subject matter:
Taipale et al. (US 2023/0287391 A1) disclose the 100-amino acid long sequence of ZIM3-KRAB, a heterologous transcriptional repressor, which is SEQ ID NO:3. It is noted that Taipale’s SEQ ID NO:3 is 100% identical to amino acid residues 625-724 of SEQ ID NO:1194. Taipale teaches that SEQ ID NO:1 encoding dCas9 is operably linked to the ZIM3-KRAB sequence, wherein amino acid residues 791-2157 of SEQ ID NO:1194 correspond to amino acid residues 2-1368 of Taipale’s SEQ ID NO:1.
Conclusion
No claim is 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 DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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, RAM SHUKLA can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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