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
Response to Amendment
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 CFR 1.114.
Applicant’s submission of the Declaration of Dr. Kazuko Shibuya under 37 CFR 1.132 on 1 July 2026 is acknowledged. Applicant’s amendment of the claims filed 1 July 2026 has been entered. Applicant’s remarks filed 1 July 2026 are acknowledged.
Claims 2 and 12 are cancelled. Claim 19 has been added. Claims 1, 3-11 and 13-19 are pending. Claims 5-11 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Claims 1, 3-4, 13-17 and 19 are under examination.
Claim Rejections Withdrawn
The objection to claim 1 for informalities is withdrawn in response to Applicant’s amendment of the claim.
The rejection of claim 1 under 35 U.S.C. 112(b), as being indefinite for reciting a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim), is withdrawn in response to Applicant’s amendment of the claim to recite “administering an effective amount of an anti-CD96 neutralizing antibody or a fragment thereof that inhibits the binding of CD96 to CD155 and that inhibits or reduces CD96 signal transduction to the subject”.
The rejection of claims 1-4 and 15-16 under 35 U.S.C. 102(a)(1), as being anticipated by Smythe (US 2016/0200814 A1, Pub. Date: Jul. 14, 2016), is withdrawn in response to Applicant’s amendment of independent claim 1 to recite “A method of treating psoriasis or multiple sclerosis in a subject”.
The rejection of claims 14 and 17 under 35 U.S.C. 103, as being unpatentable over Smythe (US 2016/0200814 A1), is withdrawn in response to Applicant’s amendment of the claims as above.
The rejection of claims 12-13 under 35 U.S.C. 103, as being unpatentable over Smythe (US 2016/0200814 A1), in view of Morar et al. (Lancet Infect. Dis., 2010, Vol. 10(7): 470-478), is withdrawn.
Claim Rejections Maintained
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, 3-4, 13-17 and 19 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.
Applicant argues that amended independent claim 1 does not encompass anti-CD96 antibodies in general; rather, the claim is directed to a method of treatment using a limited group of anti-CD96 neutralizing antibodies or fragments thereof that satisfy specific functional requirements, namely CD96-CD155 binding inhibitory activity and CD96 signal transduction inhibitory/reducing activity. Applicant argues that determining whether an antibody according to amended independent claim 1 satisfies the above functions does not require undue experimentation.
Applicant further provides the Declaration of Kazuko Shibuya under 37 C.F.R. § 1.132 to support that Applicant was in possession of the anti-CD96 neutralizing antibodies or fragments thereof as claimed. In the Declaration, Declarant states that as of October 30, 2019 (the foreign priority date of the present application), there were only nine antibodies that were publicly known to be anti-CD96 antibodies (see Table in paragraph 5 of the Declaration); among the nine antibodies, Antibody No. 1 and Antibody No. 3 are the same antibody, and only Antibody Nos. 1/3 and Antibody No. 9 exhibit the CD96-CD155 binding inhibition (Declaration at paragraphs 5, 8). Declarant states that NK92.39 (Antibody Nos. 1/3) was a representative example showing that an antibody targeting CD96 can inhibit IL-17 production and suppress an IL-17-related immune response (Declaration at paragraph 10). Declarant states that the inventors of the present application generated the anti-CD96 neutralizing antibody TX111.2 (Antibody No. 10), which was shown to have CD96-CD155 binding inhibitory activity and the therapeutic efficacy in psoriasis and multiple sclerosis (Declaration at paragraphs 11-13). Declarant states that the group of anti-CD96 neutralizing antibodies recited in amended independent claim 1 does not constitute a broad and undefined genus of anti-CD96 antibodies, but rather constitutes a small universe limited by specific functional requirements, and it is expected that an anti-CD96 neutralizing antibody that similarly inhibits CD96-CD155 binding and inhibits or reduces CD96 signal transduction would: (1) suppress IL-17 production or an IL-17-related immune response; and (2) be useful for treating psoriasis or multiple sclerosis (Declaration at paragraphs 14-16).
Applicant’s arguments have been fully considered but have not been found to be persuasive. The Declaration of Kazuko Shibuya under 37 C.F.R. § 1.132, filed 1 July 2026, is insufficient to overcome the rejection under 35 U.S.C. 112(a), as failing to comply with the written description requirement, for reasons set forth in the previous Office Action and the following.
Amended claim 1 now recites:
“A method of treating psoriasis or multiple sclerosis in a subject, the method comprising: administering an effective amount of an anti-CD96 neutralizing antibody or a fragment thereof that inhibits the binding of CD96 to CD155 and that inhibits or reduces CD96 signal transduction to the subject, thereby suppressing IL-17 production or IL-17-mediated immune responses of an IL-17-producing cell.”
The claimed method requires the use of an anti-CD96 neutralizing antibody or a fragment thereof defined by function, i.e., capable of inhibiting the binding of CD96 to CD155 and inhibiting/reducing CD96 signal transduction. The specification, however, fails to provide adequate written description for the limited group (subgenus) of anti-CD96 neutralizing antibodies and antigen-binding fragments thereof that exhibit these activities. A person skilled in the art cannot envision the detailed structures of the encompassed anti-CD96 antibodies and antigen-binding fragments thereof as claimed.
With regard to the statement that there were only nine anti-CD96 antibodies that were commercially available or publicly known at the time of invention, however, the claimed subgenus of anti-CD96 neutralizing antibodies and antigen-binding fragments are not limited to the antibodies from the nine commercially available or publicly known antibodies. For example, Renart-Depontieu et al. (WO 2019/030377 A1, Int’l. Pub. Date: 14 February 2019) (reference provided in the IDS filed 02/19/2024) describes generation of monoclonal antibodies that specifically bind to CD96. Renart-Depontieu et al. teaches that the antibodies include those that inhibit binding of CD96 to CD155, those that do not inhibit binding of CD96 to CD155, and those that inhibit the binding of CD96 to CD155 only weakly (p. 4, paragraphs 3-4). Renart-Depontieu et al. describes that a total of 160 pairs of VH and VL were amplified and the resulting IgG antibodies were confirmed for specific binding to human CD96; among them, 19 antibodies were produced and purified; and from those 19 antibodies, 12 inhibited hCD155-hCD96 interaction (p. 55, 3rd paragraph). Without testing, a person skilled in the art cannot envision which antibodies obtained from the 160 pairs of VH and VL would exhibit the activities of inhibiting binding of CD96 to CD155 and reducing the CD96 signaling. Such is further evidenced by the Antibody Nos. 7 and 8 shown in the Declaration, in which the answers to “Direct Evidence of CD96-CD155 Binding Inhibition?” are “Not Clear” (see Table in paragraph 5 of the Declaration). Also, it is unpredictable whether those antibodies, particularly those having a relatively week potency in inhibiting the CD96-CD155 binding and reducing the signaling of CD96, as disclosed by Renart-Depontieu et al., are capable of suppressing IL-17 or IL-22 production or mediating an immune response of an IL-17-producing cell, let alone knowing whether they can provide therapeutic treatment for psoriasis or multiple sclerosis. The specification does not provide sufficient teachings regarding the correlation of structure to function. Clearly, the disclosures of NK92.39 and TX111.2 are not adequate to represent the subgenus of the antibodies that exhibit the required functions. Applicant argues that determining whether an antibody according to amended independent claim 1 satisfies the above functions does not require undue experimentation. However, adequate written description requires more than a mere statement that is part of the invention and reference to a method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. The skilled artisan cannot envision the detailed structures of the encompassed subgenus of antibodies, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation.
As set forth in the previous Office Action, the specification provides that the antibodies TX111.2 and NK92.39 exhibit the activities required by the present claims, e.g., inhibiting the binding of CD96 to CD155, inhibiting or reducing CD96 signal transduction, and suppressing IL-17 production, one skilled in the art would expect that anti-CD96 antibodies comprising the heavy chain and light chain CDRs (e.g., the six CDRs set forth in SEQ ID NOs: 14-19) or the variable domains of these antibodies (TX111.2 and NK92.39) would also exhibit such properties/activities. Applicant, however, does not demonstrate possession of the subgenus of anti-CD96 antibodies as claimed, and there is no representative number of species or common structural features allowing a skilled artisan to visualize the full scope of the molecules. Therefore, the instant application does not satisfy the written description requirement under 35 U.S.C. 112(a).
Conclusion
NO CLAIM IS ALLOWED.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Xiaozhen Xie, whose telephone number is 571-272-5569. The examiner can normally be reached on M-F, 8:30-5.
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/XIAOZHEN XIE/ Primary Examiner, Art Unit 1674
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