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 .
Claim Status
Claim listing filed on February 26, 2026 is pending. Claims 1-47, 51-52, 55, and 58-59 are canceled. Claims 48, 56-57, and 62-63 are amended. Claims 48-50, 53-54, 56-57, and 60-64 are examined upon their merits.
Withdrawn Claim Objections and Rejections
The claim objection pertaining to Claim 48 has been overcome by Applicant’s amendments to the claim, and the objection to Claim 48 of record is withdrawn.
The rejection of Claim 56 under 35 U.S.C. 112(b) as being indefinite is withdrawn in view of Applicant’s amendments. The claims are no longer directed to an IgG type antibody containing two other IgG type antibodies.
The rejection of Claims 57 and 62 under 35 U.S.C. 112(d) as being of improper dependent form is withdrawn in view of Applicant’s amendments. Specifically,l replacing “an immune cell” with “T cells or APCs” and replacing “DAMP” with the first antigens of Claim 48 overcomes the rejection.
The rejection of Claims 48-50, 53-54, 56-57, 60-62, and 64 under 35 U.S.C. 112(a) for lack of enablement pertaining to Clec9A or mClec4e as a means for binding all of the first antigens defined in Claim 48 is withdrawn in view of Applicant’s amendments to Claim 48. It is now clear that Clec9A can only be used as a non-Ig-type binding moiety wherein the first antigen is actin and mClec4e can only be used as a non-Ig-type binding moiety wherein the first antigen is a histone deacetylase complex subunit (such as SAP130 as defined in the specification page 16, line 21).
Claim Objections (New, necessitated by amendment)
Claim 48 is objected to because of the following informalities: In line 15, “consisting of , VHH, VH” should not recite a comma between “of” and “VHH.” Appropriate correction could recite “consisting of [[,]] VHH, VH…”
Claim Objections (Maintained)
Claim 63 is objected to because of the following informalities:
Claim 63, lines 3-8 should have a hyphen after every recitation of “anti.” For example, “anti-CD3” instead of “anti CD3.” As Claim 60 recites “anti-”, this correction is for both clarity and consistency.
Appropriate correction is required.
Applicant's arguments filed February 26, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims have been amended as requested; however, Claim 63 still recites “anti HSP90,” “anti GRP78,” and “anti phosphatidylserine” which do not have a hyphen after “anti.” Appropriate correction would recite “anti-HSP90,” “anti-GRP78,” and “anti-phosphatidylserine.”
Claim Rejections - 35 USC § 112 (Maintained)
The rejection of Claims 48-50, 53-54, 56-57, and 60-64 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 is maintained.
Applicant's arguments filed February 26, 2026 have been fully considered but they are not persuasive.
Applicant argues that the teachings of Amgen v. Sanofi do not apply to the instant claims because the instant claims are not directed to a functional genus. Applicant lists examples of functional genus claims as reciting “all antibodies that bind antigen X”; “any antibody that binds actin”; or “any antibody that binds any membrane protein.” Claim 48 recites wherein the first means and second means for binding can comprise “an Ig type binding moiety selected from the group consisting of VHH, VH, VL, sdAb, scFv, single chain antibody, Fab, and F(ab’)2.” This list consists of antibody fragments. Therefore, the claims are directed to a first means for binding comprising any antibody fragment that binds to a genus of possible antigens (actin, a heat shock protein, a phosphatidylserine, a histone, a histone deacetylase complex subunit, a HMGN protein, a hepatoma-derived growth factor, BCL-2, calreticulin, or cyclophilin A). The claims are further directed to a second means for binding comprising any antibody fragment that binds to a genus of possible antigens (any membrane protein on a T cell or APC). Considering the language of Claim 48, the instant functional genera are broader than teachings of Amgen v. Sanofi, because the instant genera are directed to antibody fragments binding multiple antigens wherein Amgen v. Sanofi was directed to antibodies binding a single antigen. In Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1335 (Fed. Cir. 2021), claim language directed to “an scFv that binds an antigen X” is considered a functional genus (page 7) which further supports that the instantly claimed antibody fragments are not structural limitations which provide more than the functional genus claim language.
Applicant argues that CDR level sequence disclosure is not required. Examiner agrees that CDR level sequence disclosure is not required for proper written description and enablement; however, providing CDR level sequences of the antigen-binding molecules described in the specification (Table 1) would overcome the 112(a) rejections of record. While not required, Examiner recommends this amendment to potentially overcome the instant 112(a) rejections. Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1335 (Fed. Cir. 2021) states “It is not fatal that the amino acid sequences of these two scFvs were not disclosed as long as the patent provided other means of identifying which scFvs would bind to which targets, such as common structural characteristics or shared traits. But this patent provides nothing to indicate that the inventors possessed the full scope of the genus that they chose to claim. Thus, the ’190 patent’s disclosure does not demonstrate the inventors possessed the entire class of possible scFvs that bind to various selected targets” (page 11). Similarly, the instant specification fails to teach a representative number of species for the genus of binding moieties claimed and fails to teach common structural characteristics or shared traits that could accomplish the recited binding functions.
Specifically, the specification teaches: two species of anti-CD3/Clec9A molecules (comprising SEQ ID NOs: 2, 4, 6, and 8; and SEQ ID NOs: 2, 5, 6, and 8) that only differ in Clec9A structure; one species of anti-phosphatidylserine/anti-CD3 molecule (comprising SEQ ID NOs: 39, 49, 44, 31, 19, 50, 30, and 31); two species of anti-HSP90/anti-CD3 molecules (comprising SEQ ID NOs: 40, 49, 45, 31, 19, 50, 30, and 31; and SEQ ID NOs: 41, 49, 46, 31, 19, 50, 30, and 31) that only differ in anti-HSP90 structure; one species of anti-CD137/Clec9A molecule (comprising SEQ ID NOs: 43, 52, 47, and 38); and one species of anti-phosphatidylserine/anti-CD137 molecule (comprising SEQ ID NOs: 43, 54, 47, 38, 39, 55, 44, and 38) (Table 1). Zero to two representative species per antigen-binding molecule claimed is not sufficient evidence that the inventor was in possession of the claimed invention at the time of filing, especially considering that hundreds of CDR sequences can effectively bind a single antigen (as evidenced by Edwards et al. J. Mol. Biol. 2003 and Lloyd et al. Protein Eng. Des. Sel. 2008).
Applicant argues that In re Xencor, Inc., No. 24-1870 (Fed. Cir. Mar. 13, 2025), the Board determined that a “means for binding human C5 protein” was adequately described under 35 USC 112(a) and 112(b) because the specification identified two specific antibodies known in the prior art that were the corresponding structure for a “means for binding human C5 protein.” Examiner believes these arguments are made out of context because the Xencor quotations cited are specifically directed to the 112(f) interpretation of a “means for binding human C5 protein” and the written description and indefinite rejections that follow a 112(f) interpretation (see Xencor pages 28-37). Xencor specifically states “a person of ordinary skill in the art would understand the meaning of 5G1.1 [anti-C5 antibody] and thus the limitation ‘means for binding human C5 protein’ is definite” (page 33) because “the disclosure of equivalents is not necessary to satisfy the written description and indefiniteness requirements for a means-plus-function claim term” (page 35, emphasis added). As the instant claims are no longer interpreted under 112(f), this section of Xencor is not applicable.
Instead, the applicable sections of Xencor are from pages 18-25 that explain why “the specification does not provide adequate written description support for the broad genus of any ‘anti-C5 antibody’” (page 18, emphasis added). Appellant argued that anti-C5 antibodies were well-known in the art prior to filing, and the Board upheld that even though antibodies and antibody fragments were known, the realm of possible antibodies and fragments thereof that bind to a single antigen is vast (page 21). The genus of anti-C5 antibodies encompasses various specificities and epitopes, and the disclosure of a single representative species of the genus of anti-C5 antibodies is not enough to provide a representative number of species to sufficiently support the functionally-defined genus of all antibodies that bind C5 (page 22). This decision was also upheld in Juno as it pertains to a genus of scFvs that bind to CD19 (Xencor page 21). Thus, the Xencor case law cited by Applicant supports a lack of written description for the instant claims which broadly encompass any antibody fragments that bind various antigens wherein the instant specification teaches zero to two representative species per antigen-binding molecule claimed. The arguments are not persuasive and the rejections are maintained.
The rejection of Claims 48-50, 53-54, 56-57, and 60-64 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for lack of enablement is maintained.
Applicant's arguments filed February 26, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments were addressed in the written description rejection above. Examiner maintains that in regard to enablement, MPEP § 2164.01(a) states “Amgen identified 26 exemplary antibodies that performed the claimed function by their amino acid sequences, the claims at issue were directed to a class which included "a ‘vast’ number of additional antibodies" that Amgen had not described by their amino acid sequences. Id. at 613. The Court found that Amgen sought to monopolize an entire class by their function, even though that class was much broader than the 26 exemplary antibodies disclosed by their amino acid structure. Id. at 613” (underlined emphasis added). Similarly to Amgen, the instant claims monopolize classes of antibodies that are defined by their antigen-binding function, and no amino acid sequences are claimed.
A skilled artisan would have to make multiple variants of the first and second binding moieties claimed that are essentially identical (except that the variants have one or more changes in a CDR(s)), validate their function as null variants according to the specification, formulate the binding moieties into the antigen-binding molecule claimed, and validate that the required dual-binding functions are maintained in order to demonstrate successful binding against the appropriate targets with a reasonable expectation of success. This amount of experimentation goes beyond what is considered “a reasonable degree of experimentation” and constitutes undue further experimentation in order to enable the antigen-binding molecules claimed. The arguments are not persuasive and the rejections are maintained.
Allowable Subject Matter
No claim is allowed. However, Applicant is reminded that the anti-CD3-Clec9A-ECD comprising SEQ ID NOs: 2, 4, 6, 8; the anti-CD3-Clec9A-CTLD comprising SEQ ID NOs: 2, 5, 6, 8; and the anti-PS/CD3 comprising SEQ ID NOs: 39, 49, 44, 31, 19, 50, 30, 31 disclosed in specification Table 1 are fully enabled and free of the prior art (of record in the non-final office action filed 11/15/2024).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH COOPER PATTERSON whose telephone number is (703)756-1991. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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/SARAH COOPER PATTERSON/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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