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 .
Applicant’s amendments, filed 12/04/2025, is acknowledged.
Claims 2, 16, 19, 23, and 25 are cancelled.
Claims 1, 3-15, 17, 18, 20-22, 24, and 26-31 are currently pending.
Claims 5-7, 9, 11, 13-15, 17, 18, 20-22, 24, and 26-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions and/or Species.
Claims 1, 3, 4, 8, 10, and 12 are currently under examination.
In view of the amendments and remarks filed on 2/25/2026, the following rejections remain.
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, 3, 4, 8, 10, and 12 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 inventors, at the time the application was filed, had possession of the claimed invention. This is a new grounds of rejection necessitated by Applicant’s amendments.
Amended claim 1 uses the open language “antibody comprises” and “an amino acid sequence as set forth in …”. For example, Claim 1(a) recites “an amino acid sequence as set forth in SEQ ID NO: 4”. The phrase results in an antibody comprising the claimed antibody or any portion of the claimed sequences. The claim terminology “an amino acid sequence of SEQ ID NO…” does not place size limits on the CDRs, but rather reads on any portion of the claimed CDRs of each sequence. The CDRs are generic with respect to size, encompassing anything from dimers on up to the full size of the claimed SEQ ID NOs. Claims 3, 4, 8, 10, and 12 do not resolve this issue and are also rejected under 35 U.S.C. 112(a) WD for this reason.
Amending the claim to recite “…the amino acid sequence as set forth in SEQ ID NO…” would resolve this issue.
Additionally, claims 1, 3, 4, 8, and 12 encompass a genus of polypeptide structures with little to no recited structure and the function of “sMIC”, and these claims are rejected for the same reasons discussed in the Office Action mailed on 8/25/2025.
Applicant’s arguments, filed 2/25/2026, have been fully considered, but are found to be not convincing.
Applicant argues that the amendments to the claims obviates the previous rejections. However, the amendments do not address the genus of polypeptides with little to no structure and the function of “sMIC” recited in the claims, and these broadly claimed genera currently do not have written description support for the same reasons set forth in the Office Action mailed on 8/25/2026. Amending claim 1 to recite specific polypeptide structures with the function of “sMIC” would resolve this issue.
Claims 1, 3, 4, 8, 10, and 12 do not meet the requirements of 35 U.S.C. 112(a) for written description. Applicant is invited to point to clear support or specific examples of the claimed invention in the specification as-filed. Amending claim 1 to recite specific polypeptide structures with the function of “sMIC” would resolve this issue.
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 ALEC JON PETERS whose telephone number is (703)756-5794. The examiner can normally be reached Monday-Friday 8:30am - 6:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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