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 .
Receipt and entry of the response dated 1/28/2026 is acknowledged.
Claim Rejections - 35 USC § 101
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 1-4, 6-14, 22-25 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility. This rejection is maintained for reasons made of record in the Office Action dated 8/27/2025 and for reasons set forth below.
Independent claims 1 and 11 have been amended to recite the nucleic acids encoding the antibody are “genomically organized”. The specification provides no limiting definition for the term “genomically organized”. Mammalian cells that express antibody heavy and light chains typically do so from nucleic acids found within the genome of such cells, e.g., cells that have been transfected with the nucleic acids (as in instant claim 1) or express antibodies naturally (B cells) comprise the nucleic acids in their genomes. These nucleic acids are considered to be “genomically organized” because they are found within the genomes of cells found within the claimed scope.
Response to Arguments
Applicant's arguments filed 1/28/2026 have been fully considered but they are not persuasive. Applicants essentially assert that: 1) VDJ recombination does not occur in CHO or HEK 293 cells; 2) the specification provides examples of antibody production after removal of donor splice sites.
Regarding 1), although this may be true, it is unclear how this has any bearing on the instant rejection. Although claim 1 recites that the nucleic acids are transfected (claim 11 does not recite a transfection step) and thus not native to , e.g. a CHO or 293 cell, the nucleic acid sequences themselves were derived from antibody heavy or light chain sequences from a B or T cell specific for a given antibody. Thus, these sequences underwent VDJ recombination prior to being identified, cloned from the B or T cell and then transfected into a CHO or 293 cell. Further, this assertion provides no evidence or reasoning that the claimed sequences comprise a non-paired donor splice site in the heavy chain variable region, which is the crux of the rejection.
Regarding 2) the examples presumably referred to are prophetic in nature and do not identify the variable region donor splice site recited in the claims, nor does the table referred to by applicants (pages 28-29). It thus remains unclear where such sites, as claimed, could be found in antibody heavy chain variable regions by the skilled artisan as the specification does not teach them, nor does the relevant art.
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.
Claims 1-4, 6-14, 22-25 are also rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Specifically, because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention. This rejection is maintained for reasons made of record in the Office Action dated 8/27/2025 and for reasons set forth below.
Response to Arguments
Applicant's arguments filed 1/28/2026 have been fully considered but they are not persuasive. Applicants arguments are considered to have been addressed above.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 10 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 10 merely recites limitations already found in claim 1, which necessarily involves recovering the antibody from the CHO cells because the claim is directed to “…producing an antibody…” by “…cultivating a CHO cell…”. This objection is maintained for reasons made of record in the Office Action dated 8/27/2025 and for reasons set forth below.
Response to Arguments
Applicant's arguments filed 1/28/2026 have been fully considered but they are not persuasive. Applicants assert that the antibody of claim 1 could be used without recovery, thus recovery is a discreet step. Applicants fail to point out a specific use for the antibody that could not also be considered “recovery”, thus, the rejection stands.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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, Tracy Vivlemore can be reached at 571 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638
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