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 .
Claims 1-66, 68-85, 95, 97-98, and 102-104 have been cancelled. Claims 106-110 have been newly introduced.
Applicant's arguments filed 6/23/2026 have been fully considered but they are not fully persuasive.
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 105 and 110 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.
Claim 105 is not an original claim. It was added by amendment on 11/25/2025.
Claim 110 is not an original claim. It was added by amendment on 6/23/2026. No basis was pointed to for this claim and none is apparent.
The originally filed specification and claims did not disclose a composition comprising two isolated nucleic acid molecules having the characteristics recited in claim 105. The originally filed specification and claims did not disclose a host cell comprising the composition of claim 105.
Original claims 67-69 (10/12/2022 claim set) are presented below:
67. An isolated nucleic acid molecule encoding the antigen binding protein or antigen- binding fragment thereof of any one of the preceding claims.
68. An expression vector comprising the nucleic acid molecule of claim 67.
69. A host cell comprising the expression vector of claim 68.
Original claims 67-69 were directed to a single isolated nucleic acid molecule, a single expression vector containing that single isolated nucleic acid molecule, and a host cell containing that single expression vector. See also specification paragraph [0126].
Applicant’s 6/23/2026 response argues that numerous species of isolated nucleic acid molecules encoding antibody VH domains and isolated nucleic acid molecules encoding antibody VL domains are found in the specification. However, applicant is not claiming an isolated nucleic acid encoding the VH alone or an isolated nucleic acid encoding the VL alone. Claim 105 is directed to a composition comprising both an isolated nucleic acid encoding a VH and an isolated nucleic acid encoding a VL (i.e. two separate nucleic acids). One of skill in the art would recognize that the applicant was in possession of separate isolated nucleic acids encoding the VH and VL domains but not a composition containing both an isolated nucleic acid encoding a VH and an isolated nucleic acid encoding a VL as in claim 105. Likewise, there is no basis for a host cell containing the composition of claim 105 as in claim 110.
The claims constitute new matter.
Claims 67, 86-94, 96, 99-101, and 106-109 are allowable.
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 MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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