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 05/14/2026 has been entered. New claims 40-41 are added. Claims 1-2, 7-17, and 33-41 are pending. Claims 1-2, 7, 11-12, 34, and 39-41 are currently under consideration. Claims 8-10, 13-17, 33, and 35-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species.
In response to species election requirement, Applicants elected CDRs of SEQ ID Nos: 11-13 and 15-17 (claim 11), and the VH and VL of SEQ ID Nos: 43 and 44 (claim 12).
Withdrawn Objections and/or Rejections
The rejection of claims 2 and 7 under 35 U.S.C. 112(b) is withdrawn in view of amended claims.
The rejection of claims 1-2, 34, and 39 under 35 U.S.C. 102 (a)(2) as being anticipated by WO 2017/017446 A1 (2 February 2017) is withdrawn in view of amended claims.
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 1-2, 7, 34, and 39 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 02/10/2026. New claims 40-41 are also rejected on the same basis.
Applicant argues that each of the recited CDR-Hl, CDR-H2, CDR-H3, CDR-L1, CDR-L2, and CDR-L3 domains comprises or consists of SEQ ID NO: 11, 12, 13, 15, 16, or 17, respectively, or a variant having at least 75% sequence identity to SEQ ID NO: 11, 12, 13, 15, 16, or 17, respectively. With respect to the possible variants for each of the CDR domains, 75% sequence identity affects at most 4 amino acids of SEQ ID NO:12 (CDR-H2), at most 3 amino acids of SEQ ID NO: 15 (CDR-L1), at most 2 amino acids of SEQ ID NO: 13 (CDR-H3) and SEQ ID NO: 17 (CDR-L3), and 1 amino acid of SEQ ID NO: 11 (CDR-H1). Citing case law, Applicant argues that one of skill in the art would readily visualize and recognize these four representative species of the claimed antibody or antigen-binding fragment genus, as recited in claim 1. With respect to claims 7 and 40, Applicant provides similar arguments.
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 antibodies of four clones, including the elected antibody of clone 63A11 (see, e.g., Figure 13). Each antibody comprises a particular set of six CDRs, three CDRs in the heavy chain variable region and three CDRs in the light chain variable region, or a particular pair of a heavy chain variable region and a light chai variable region. The instant disclosure is insufficient to support the broad genus of anti-ZIP12 antibodies.
It is well established in the art that the formation of an intact antigen binding site of an antibody routinely requires the association of the complete heavy and light chain variable regions of a given antibody. It is expected that proper association of heavy and light chain variable regions is required in order to form a functional antigen binding site (Paul, Fundamental Immunology, 3rd Edition, 1993, pages 292-295; in particular page 293, column 1, lines 3-8; column 1, line 31 to column 2, line 9; column 2, lines 27-30). Vajdos et al. teach that amino acid sequence and conformation of each of the CDRs of the heavy and light chains is critical for maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin (J. Mal. Biol. 320:415-428, 2002; in particular page 416).
Furthermore, the prior art does not provide compensatory structural or correlative teachings sufficient to enable one of skill to identify what other anti- ZIP12 antibodies might be. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the genus of anti-ZIP12 antibodies.
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). A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 12 recites the broad recitation “wherein the antibody or antigen-binding fragment thereof comprises a heavy chain variable region comprising SEQ ID NO: 43 and a light chain variable region comprising SEQ ID NO: 44”, and claim 12 also recites “optionally wherein the antibody or antigen-binding fragment thereof comprises a heavy chain region comprising SEQ ID No: 14 and a light chain region comprising SEQ ID No: 18”, which is the narrower statement of the range/limitation.
Likewise, claim 34 recites the broad recitation “a pharmaceutical composition comprising an antibody or antigen-binding fragment thereof according to claim 1”, and the narrower statement of the range/limitation “optionally a pharmaceutically acceptable vehicle”.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Applicant has not addressed the above rejection in the response filed on 05/14/2026.
Claim Objection
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 May 26, 2026
Prosecution Insights