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 .
DETAILED ACTION
Status of Application, Amendments, and/or Claims
Applicant's amendment filed on 01/20/2026 has been entered. Claims 1, 3-4, 7, and 9-20 are pending. Claims 1, 3-4, 7, and 9-12 are currently under consideration. Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Withdrawn Objections and/or Rejections
All the rejections of claims 2, 5-6, and 8 set forth in the office action mailed on 07/18/2025 are made moot by cancellation of the claims.
Information Disclosure Statement
The information disclosure statement filed on 01/14/2026, 09/25/2025, and 01/29/2026 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to this communication.
Claim Rejections under 35 USC § 112 (a)
(i). The following is a quotation of the first paragraph of 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.
(ii). Claims 1, 3-4, 7, and 9-12 are rejected under 35 U.S.C. 112(a), 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 at the time the application was filed, had possession of the claimed invention. The basis for the rejection is set forth in the office action mailed on 07/18/2025.
Applicant argues that claim 1 as currently amended clearly describes the target antigen, the first antibody, the second antibody, and the non-overlapping epitopes by both structural and functional limitations.
Applicant’s argument has been fully considered but is not deemed to be persuasive because amended claim 1 does not require that the first antibody, the second antibody, and the non-overlapping first epitope and second epitope of FRα possess any particular conserved structural features. Claims 3-4, 7, and 9-12 depend from claim 1. Thus, the claims encompass a huge genus of first immunotherapeutic agents and second immunotherapeutic agents without defined structural features.
Applicant argues that the working examples in the present Application demonstrate possession of the claimed subject matter in commensurate scope.
Applicant’s argument has been fully considered but is not deemed to be persuasive. For each claim drawn to a genus, MPEP §2163 II.A.3(a) ii) (page 2100-189) states, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406”. In the instant case, the specification discloses pairs of human FRα antibodies that bind to non-overlapping B-cell epitopes on the human FRα. The specification discloses that the four secondary antibodies, MED019-008-007, MED019-008-033, MED019-008-051, and MED019-008-086 antibodies, bind to an epitope that does not overlap with the epitope bound by the primary antibody, A070 (page 68, paragraph [0179]; Table 25, Figure 8). However, the instant disclosure does not provide sufficient support for the genus of the first antibodies, the second antibodies, and the non-overlapping epitopes, and thus the genus of the first immunotherapeutic agents and the second immunotherapeutic agents. For the reasons above, the rejection is maintained.
Claim Rejections under 35 USC § 112 (b)
(i). The following is a quotation of the second paragraph of 35 U.S.C. 112:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
(ii). Claims 1, 3-4, 7, and 9-12 are 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.
The preamble of claim 1 recites “…to functionally increase the copy number of a target antigen of a human subject”, which is inconsistent with the wherein clause recited in the claim, “wherein the functional increase in copy number comprises increasing the number of antibody-payload conjugates bound per FRα molecule without increasing the expression level of FRα on the cell surface”. Such inconsistency renders the claim indefinite. Claims 3-4, 7, and 9-12 are rejected as dependent claims from claim 1.
Claim Objection
Claim 12 is objected to because “the method induces cell death for the cells that express folate receptor alpha” is redundant to “the immunotherapeutic agent is administered at an effective amount that is effective to induce cell death in at least a portion of the cells that express folate receptor alpha”.
Conclusion
No claims are allowed.
Advisory Information
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax 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, please contact the Electronic Business Center (EBC) at the toll-free phone number 866-217-9197.
/RUIXIANG LI/Primary Examiner, Art Unit 1674 January 30, 2026