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 .
The amendments of 01/16/2026 have been entered in full. Claims 1-7, 9, 11-14, 16, 18-20, 22-25, and 28 are pending.
All prior objection/rejections not specifically maintained in this Office action are hereby withdrawn in view of Applicants’ amendment and/or arguments filed 01/16/2026.
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 1-7, 9, 11-14, 16, 18-20, and 22-25 remain 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.
Amended claims 1 and 13 each recite a composition comprising a CD244 agonist. These independent claims do not recite any structural description of the claimed agonist; only the function “agonist” is recited. Dependent claim 11 recites that this genus of compounds may encompass any of several broad categories of structures and functions: “at least one of a small molecule, a peptide, a polynucleotide, a genetically modified cell expressing a CD244 agonist or CD48 ligand, an antibody, an antibody fragment capable of at least one of activating the CD244, inhibiting CD48/2B4 interaction, or a combination thereof.”
In Remarks filed 01/16/2026, Applicant sets argues the specification conveys possession of the claimed invention by disclosing the agonist mechanism, a representative number of species that achieve CD244 agonism, and functional outcomes from CD244 activation.
These arguments are not persuasive for the following reasons. The antibody and the coculture are not representative the structurally unlimited genus of potential agonists in claim 1, nor of "a small molecule, a polypeptide or fragment thereof, a polynucleotide, genetically modified or synthesized molecule or an antibody or a fragment thereof" as recited in claim 11. Disclosure of the agonist mechanism and functional outcomes supports methods of identifying agonists but not actual possession of agonists that will be discovered by future experimentation. Disclosure of the functional outcome does not evidence a nexus between structure and function, because "CD244 agonist" is a function, not a structure.
Conclusion
Claims 1-7, 9, 11-14, 16, 18-20, and 22-25 are rejected.
Claim 28 is allowed.
THIS ACTION IS MADE FINAL. 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 DANIEL C GAMETT, Ph.D., whose telephone number is (571)272-1853. The examiner can normally be reached on M-W. Please note the examiner’s part-time schedule. 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, Joanne Hama can be reached on 5712722911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANIEL C GAMETT/Primary Examiner
Art Unit 1647
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