DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 3-6, 8-13, 16-23, and 25-29 are pending in the application.
Applicant’s amendment to the claims, filed April 8, 2026, is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Applicant’s remarks filed April 8, 2026 in response to the non-final rejection filed October 8, 2025 are acknowledged and have been fully considered.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in a prior Office action.
Restriction/Election
Claims 1 and 13 are allowable and claims 5, 11, 17, 18, 22, and 28, previously withdrawn from consideration as a result of a requirement for election of species, are hereby rejoined and fully examined for patentability.
The requirement for an election of species between species A2) and A6), the requirement for an election of species between species B1) and B2), the requirement for an election of species among species C1) to C15), and the requirement for an election of species between species D1) and D2) as set forth in the Office action mailed on November 8, 2023 is hereby withdrawn.
Accordingly, claims 1, 3-6, 8-13, 16-23, and 25-29 are being examined on merits.
Claim Objections
Claims 1, 3, 6, 8, 9, 13, 16-18, 20, 23, 25, and 26 are objected to and in the interest of improving claim form, it is suggested that the claims be amended as set forth in the attached Appendix.
Claim Rejections - 35 USC § 112(b)
The rejection of claims 1, 3, 4, 6, 8-10, and 12 under 35 U.S.C. 112(b) as being indefinite in the recitation of “…the genomic DNA comprises SEQ ID NO: 12 or homolog thereof…integrating the at least one exogenous sequence into the genomic DNA at a target site between nucleotides 859,501 and 1,053,101 of SEQ ID NO: 12” is withdrawn in view of applicant’s amendment to claim 1.
Claim 5 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. This rejection is necessitated by applicant’s amendment to claim 1, which resulted in rejoinder of claim 5.
Claim 5 is indefinite in the recitation of “small interfering RNA ()” because it is unclear what text is intended to be present in the parenthetical expression “().” It is suggested that applicant clarify the meaning of the noted phrase, particularly with regard to the recitation of “().”
Claim Rejections - 35 USC § 112(a)
The rejections of claims 1, 3, 4, 6, 8-10, 12, 13, 16, 19-21, 23, 25-27, and 29 under 35 U.S.C. 112(a) for failing to comply with the enablement and written description requirements are withdrawn in view of applicant’s amendments to claims 1 and 13.
Conclusion
Status of the claims:
Claims 1, 3-6, 8-13, 16-23, and 25-29 are pending.
Claim 5 is rejected.
Claims 1, 3, 6, 8, 9, 13, 16-18, 20, 23, 25, and 26 and claims dependent therefrom are objected to for minor informalities.
No claim is in condition for allowance.
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 DAVID J STEADMAN whose telephone number is (571)272-0942. The examiner can normally be reached Monday to Friday, 7:30 AM to 4:00 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, MANJUNATH N. RAO can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/David Steadman/Primary Examiner, Art Unit 1656
APPENDIX
1. (Currently Amended) A method for stable integration of at least one exogenous nucleic acidnucleic acidof the CHO cell at the nucleotide corresponding to nucleotide 284534 of SEQ ID NO: 16.
2. (Canceled)
3. (Currently Amended) The method of claim 1, wherein the at least one exogenous nucleic acid
4. (Original) The method of claim 3, wherein the protein is a therapeutic protein, a recombinant protein, or an industrial protein.
5. (Currently Amended) The method of claim 3, wherein the RNA molecule is a small interfering RNA (siRNA), a micro RNA (miRNA), a guide RNA (gRNA), or a precursor thereof.
6. (Currently Amended) The method of claim 3, wherein the at least one exogenous nucleic acid
7. (Canceled)
8. (Currently Amended) The method of claim 1, wherein the at least one exogenous nucleic acid
9. (Currently Amended) The method of claim 8, wherein the at least one recognition sequence comprises a nucleic acid sequence that does not exist endogenously in the genomic DNA of the CHO
10. (Original) The method of claim 8, wherein the polynucleotide modification enzyme is a site-specific recombinase or a targeting endonuclease.
11. (Original) The method of claim 10, wherein the site-specific recombinase is Bxb1 integrase, Cre recombinase, FLP recombinase, gamma delta resolvase, lambda integrase, phi C31 integrase, R4 integrase, Tn3 resolvase, or TP901-1 recombinase.
12. (Original) The method of claim 10, wherein the targeting endonuclease is a zinc finger nuclease (ZFN), a clustered regularly interspersed short palindromic repeats (CRISPR)/ CRISPR-associated (Cas) (CRISPR/Cas) nuclease system, a CRISPR/Cas dual nickase system, a transcription activator-like effector nuclease (TALEN), a mega nuclease, or a fusion protein comprising a programmable DNA-binding domain and a nuclease domain.
13. (Currently Amended) A method for preparing a CHO cell comprising an exogenous nucleic acid of a CHO cell, wherein the genomic DNA comprises SEQ ID NO: 16, the method comprising:
a) introducing into the cell (i) a targeting endonuclease or nucleic acid encoding a targeting endonuclease, which cleaves at a target site at the nucleotide corresponding to nucleotide 284534 of SEQ ID NO: 16, and (ii) a donor polynucleotide comprising the exogenous nucleic acid
b) maintaining the cell under conditions such that the exogenous nucleic acidDNA
14-15. (Canceled)
16. (Currently Amended) The method of claim 13, wherein the exogenous nucleic acid
17. (Currently Amended) The method of claim 13, wherein the exogenous nucleic acid
18. (Currently Amended) The method of claim 17, wherein the exogenous nucleic acid
19. (Original) The method of claim 13, wherein the targeting endonuclease is a zinc finger nuclease (ZFN), a clustered regularly interspersed short palindromic repeats (CRISPR)/ CRISPR- associated (Cas) (CRISPR/Cas) nuclease system, a CRISPR/Cas dual nickase system, a transcription activator-like effect or nuclease (TALEN), a meganuclease, or a fusion protein comprising a programmable DNA-binding domain and a nuclease domain.
20. (Currently Amended) The method of claim 13, wherein the exogenous nucleic acid
21. (Original) The method of claim 20, wherein the protein is a therapeutic protein, a recombinant protein, or an industrial protein.
22. (Original) The method of claim 20, wherein the RNA molecule is a small interfering RNA (siRNA), a micro RNA (miRNA), a guide RNA (gRNA), or a precursor thereof.
23. (Currently Amended) The method of claim 20, wherein the exogenous nucleic acid
24. (Canceled)
25. (Currently Amended) The method of claim 13, wherein the exogenous nucleic acid
26. (Currently Amended) The method of claim 25, wherein the at least one recognition sequence comprises a nucleic acid sequence that does not exist endogenously in the genomic DNA of the CHO
27. (Previously Amended) The method of claim 25, wherein the polynucleotide modification enzyme is a site-specific recombinase or a targeting endonuclease.
28. (Original) The method of claim 27, wherein the site-specific recombinase is Bxb1 integrase, Cre recombinase, FLP recombinase, gamma delta resolvase, lambda integrase, phi C31 integrase, R4 integrase, Tn3 resolvase, or TP901-1 recombinase.
29. (Original) The method of claim 27, wherein the targeting endonuclease is a zinc finger nuclease (ZFN), a clustered regularly interspersed short palindromic repeats (CRISPR)/CRISPR-associated (Cas) (CRISPR/Cas) nuclease system, a CRISPR/Cas dual nickase system, a transcription activator-like effector nuclease (TALEN), a mega nuclease, or a fusion protein comprising a programmable DNA-binding domain and a nuclease domain.
Prosecution Insights