Prosecution Insights
Last updated: April 19, 2026
Application No. 18/027,413

ANTI-EPHA4 ANTIBODY

Non-Final OA §112
Filed
Mar 21, 2023
Examiner
LANDSMAN, ROBERT S
Art Unit
1647
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Eisai R&D Management Co. Ltd.
OA Round
1 (Non-Final)
81%
Grant Probability
Favorable
1-2
OA Rounds
2y 4m
To Grant
94%
With Interview

Examiner Intelligence

Grants 81% — above average
81%
Career Allow Rate
1007 granted / 1239 resolved
+21.3% vs TC avg
Moderate +13% lift
Without
With
+13.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 4m
Avg Prosecution
43 currently pending
Career history
1282
Total Applications
across all art units

Statute-Specific Performance

§101
3.8%
-36.2% vs TC avg
§103
18.6%
-21.4% vs TC avg
§102
15.0%
-25.0% vs TC avg
§112
38.5%
-1.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1239 resolved cases

Office Action

§112
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. 1. Formal Matters A. In the response submitted 11/14/25, Applicants elected “Antibody B”. However, upon further review, all species have been examined. B. Claims 1-24 are pending and are the subject of this Office Action. 2. Specification A. The use of at least the terms Sigma-Aldrich® (page 68, lines 6 and 17) and ProLong TM (page 68, line 27) , which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. B. The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicants’ cooperation is requested in correcting any errors of which Applicants may become aware. 3. Claim Rejections - 35 USC § 112(a) – written description 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 6 -9 and 11 -14 are rejected under 35 U.S.C. 112, first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention. These are genus claims . Claims 6 and 9 are drawn to anti-EphA4 antibodies which comprise constant regions “derived from” a human antibody. Therefore, these regions would have one or more amino acid substitutions, deletions, insertions and/or additions to the constant regions in SEQ ID NO:20, 21, 26 and 27 . Other than binding EphA4, t he specification and claims do not indicate what distinguishing attributes are shared by the members of the genus. Thus, the scope of the claims includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between/among genus members is permitted. The specification and claims do not provide any guidance as to what changes should be made while retaining the desired function. The p rior art only provides minimal guidance as to what changes can be made to the Fc region while maintaining functional characteristics (Table 4 of Wilkinson). The Table, while listing 75 mutants, teaches that nearly all have an L234 and L235 mutation . It is noted, however, that these mutations are limited to IgG, to which claims 6 and 11 are not. In addition, o ther than this description in the prior art, s tructural features that could distinguish compounds in the genus from others in the antibody class are missing from the disclosure. No common structural attributes identify the members of the genus. For example, Su (Introduction) teaches – Recently, there are increasing reports of distant effects (likely allosteric communications) between the Fc region and the antigen-binding regions, with these studies typically based on IgG antibodies. Similar to the case of IgG, our previous work demonstrated that the heavy-chain constant regions can modulate antigen binding, most obviously for IgM and IgD , and to a lesser extent for IgA and its subtypes. To further investigate these effects, we generated mutations in the IgA constant regions and measured the antigen binding experimentally alongside computational analyses of allosteric communications between the constant and variable regions of these IgA antibodies. Similarly, Janda (e.g. Conclusion) teaches – Since the initial findings that Ig C regions can change the Ag binding parameters of their V regions, more recent studies have begun to attempt to elucidate the allosteric mechanisms through which these effects may be occurring. Many studies have now shown that inter-molecular interactions between heavy and light chains, V and C regions, hinges and elbow relationships, all can play a vital role in the overall molecular structure of the Ig paratope in relationship to its affinity and specificity for Ag. Furthermore, Su (Introduction) teaches - While the antibody Fc effector cell activity has been a focus point, recent research showed that the Fc could also influence antigen binding, challenging the conventional idea of region-specific antibody functions. Finally, Torres (Introduction) teaches – A central dogma in immunology is that antibody specificity is solely the result of variable (V)-region interactions with an antigen. However, this view is not tenable in light of numerous reports that constant heavy (CH) domains can affect binding affinity and specificity and V-region structure. Therefore, t he general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed. Since the disclosure fails to describe the common attributes or characteristics that identify members of the genus, and because the genus is highly variant, the Ig constant region s in SEQ ID NO:20, 21, 26 and 27, along with the mutations in Wilkinson, alone, are insufficient to describe the genus. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. Thus, Applicant was not in possession of the claimed genus at the time the invention was made. Claims 7-9 and 12-14 are rejected since they depend from claims 6 and 11. 4. Conclusion A. Claims 6 -9 and 11 -14 are not allowable. B. Claims 1-5, 7-10 and 12-24 are allowable. Advisory information Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT ROBERT S LANDSMAN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT 571-272-0888 . The examiner can normally be reached M-F 8 AM – 6 PM (eastern). 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 at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-2911 . 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). /ROBERT S LANDSMAN/ Primary Examiner, Art Unit 1647
Read full office action

Prosecution Timeline

Mar 21, 2023
Application Filed
Dec 14, 2025
Non-Final Rejection — §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
81%
Grant Probability
94%
With Interview (+13.0%)
2y 4m
Median Time to Grant
Low
PTA Risk
Based on 1239 resolved cases by this examiner. Grant probability derived from career allow rate.

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