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
Restriction/Election
1. Applicant’s election Group I (claims 1-2, 7-17, 34, and 39) in the reply filed on 12/16/2025 is acknowledged. 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).
2. Claims 1-2, 7-17, and 33-39 are pending. Claims 1-2, 7, 11-12, 34, and 39 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 Claims 8-10, 13-17, 33, and 35-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species.
Information Disclosure Statement
3. The information disclosure statement filed on 03/24/203 and 12/16/2025 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to this communication.
Drawings
4. The drawing filed on 03/24/2023 are accepted by the examiner.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (a)
5. 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.
6. Claims 1-2, 7, 11, 34, and 39 are rejected under 35 U.S.C. 112(a), 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 at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
Claims 1-2, 34, and 39 are drawn to an antibody or antigen-binding fragment thereof that specifically binds to an extracellular region of ZIP12. Claims 1-2, 34, and 39 do not require that the anti-ZIP12 antibodies possess any particular conserved structure nor other disclosed distinguishing feature. Claim 7 is, in part, drawn to an antibody or antigen-binding fragment comprising a variant or a fragment of CDRs of recited in claim 7. Claim 11 is, in part, drawn to an antibody or antigen-binding fragment comprising a variant CDR-H3 domain having at least 85% sequence identity to SEQ ID No: 13, or a variant CDR-L1 domain having at least 85% sequence identity to SEQ ID No: 15. Claims 7 and 11 do not require that the anti-ZIP12 antibodies possess a set of intact CDRs.
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 an anti- ZIP12 antibody or antigen-binding fragment thereof comprising 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.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (b)
7. 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.
8. 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 7 (i) recites the broad recitation “a CDR-H1 domain comprising a sequence as substantially set out in SEQ ID No: 36, or a variant or fragment thereof, in which X is any amino acid, and claim 7 (i) also recites “optionally wherein X is H or Y”, which is the narrower statement of the range/limitation. 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. Likewise, claim 7 (ii), and (vi), claim 12, and claim 34 are rejected on the same basis.
9. Claims 2 and 7 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.
Claim 2 recites “wherein the antibody or antigen binding fragment thereof does not substantially bind to human ZIP4 and/or ZIP 13”. The term “substantially” in claim 2 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Likewise, claim 7 is rejected on the same basis.
Claim Rejections[Symbol font/0xBE]35 USC § 102 (a)(2)
10. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
11. Claims 1-2, 34, and 39 are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by WO 2017/017446 A1 (2 February 2017).
WO 2017/017446 A1 teaches an anti-ZIP antibody that was raised against the last five amino acids (QNIKI) at the C-terminus of human and rat ZIP12 (page 27, lines 15-25). Said five amino acids fall within the C-terminal extracellular region of ZIP12. WO 2017/017446 A1 teaches diagnosis of pulmonary hypertension by measuring ZIP2 levels in a sample of lung tissue (page 5, line 34- page 6, line 7; claim 8) and the use of an inhibitory anti-ZIP12 antibody in the treatment of pulmonary hypertension (page 6, lines 9-18; claims 10, 13). Thus, the teachings of WO 2017/017446 A1 meet the limitations of claims 1-2, 34, and 39.
Conclusion
12. No claims are allowed.
Advisory Information
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.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674
February 6, 2026