DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The present Office action replaces the Office action dated 08/17/2026, which has been vacated.
3. Applicant's amendment and remarks filed on 06/30/2026 are acknowledged.
Claims 1-10, 16-19, 24-36, 42-45, 50-53, 55, and 57-70 are pending.
Claims 16-19, 24-36, 42-45, 50-53, 55, and 57-66 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/30/2025.
Claims 1-10 and 67-70 are presently under consideration.
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
5. Claim 70 is 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 70 is indefinite in the recitation of “IgG4(P),” because the meaning of the term is unknown.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
6. 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)(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.
7. Claims 1-10 and 67 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Boitano et al. (US 20220249683; of record).
Boitano teaches at [0502]: “Anti-CD45 antibodies, and antigen-binding fragments thereof, as described herein (including e.g., bispecific and biparatopic antibodies) can be conjugated to a cytotoxin...” Accordingly, Boitano teaches biparatopic anti-CD45 antibodies, which are within the scope of at least instant claims 1 and 2, thereby anticipating these claims. Claims 3 and 10 are anticipated, because the antibodies are intended for administration to human subjects.
Claims 4 and 67 are included in the rejection because, in the absence of recitation of structural features which endow the antibody with the recited functional properties, the latter are assumed to be inherent properties of the prior art antibody.
Claim 5 is anticipated, because Boitano teaches that the antibody may lack Fc domain (e.g. [0246]).
Claims 6 and 7 are anticipated, because Boitano teaches that the antibody may be human or humanized, may be of IgG isotype, such as IgG1 or IgG4 (e.g. [0016]), and may be a diabody (e.g. [0148]).
Claims 8 and 9 are anticipated, because vectors and nucleic acids are inherent in recombinantly produced antibodies.
8. Claims 1-10 and 67 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ludwig et al. (US 20220202967; of record).
Ludwig teaches a bispecific antibody that binds to two different epitopes of a single cell surface target such as CD45RA [0043], which is within the scope of at least instant claims 1 and 2, thereby anticipating these claims.
Claims 3-4, 8-10 and 67 are included in the rejection for the same reasons as articulated in section 6 above.
Claims 5-7 are anticipated, because Ludwig teaches that antibodies may be IgG-Fc-silent, human or humanized (e.g. [0040]).
9. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
10. Claims 1, 6 and 68-69 are rejected under 35 U.S.C. 103 as being unpatentable over either Boitano et al. (US 20220249683) or Ludwig et al. (US 20220202967), each in view of Lupardus et al. (US 20230357424)
Each of Boitano and Ludwig teaches a biparatopic (i.e. structurally bispecific) anti-CD45 antibody, as articulated in sections 6 and 7 above, respectively.
Although these references do not specifically exemplify knob-in-hole modifications, such modifications were routinely used in the art in designing bispecific antibodies to promote heterodimerization of Fc regions. For example, Lupardus teaches bispecific anti-CD45 antibodies comprising Fc domains in the knob-in-hole format (e.g. [0186], [0439]). These teachings would have provided both the motivation and the expectation of success to a person of skill in the art to incorporate knob-in-hole modifications into biparatopic anti-CD45 antibodies taught by Boitano and Ludwig.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
11. Claims 1, 6 and 70 are rejected under 35 U.S.C. 103 as being unpatentable over either Boitano et al. (US 20220249683) or Ludwig et al. (US 20220202967), each in view of Lupardus et al. (US 20230357424) and further in view of Fox et al. (US 20190144549).
A biparatopic anti-CD45 antibody comprising knob-in-hole Fc modifications is taught by the combined teachings of Lupardus and either Boitano or Ludwig, as articulated in section 9 above. Each of these references teaches the antibody comprising the Fc region of IgG4 isotype (e.g. Boitano at [0016], Ludwig at [0040], Lupardus at [0021]).
Lupardus also teaches Fc regions modifications which reduce effector functions, including substitutions 234A and 235A (e.g. [0178]), which, in the context of IgG4, constitute F234A/L235A modification, sometimes referred to as “FALA.”
While it is not clear what “ IgG4(P)” recited in claim 70 stands for, as noted in section 4 above, it is provisionally assumed for examination purposes that it refers to substitution S241P according to Kabat numbering, or S288P according to EU numbering. This modification is commonly used in the art to stabilize the structure of IgG4 antibodies (e.g. Fox at [0183]).
In particular, Fox teaches bispecific anti-CD45 antibodies (e.g. [0022], [0225], and claim 23), in particular of IgG4 subclass comprising a S288P substitution (e.g. [0021], [0183]), i.e. IgG4(P), and modifications which reduce or ablate Fc-mediated effector functions, such as 234A and 235A (e.g. [0178]), i.e. FALA.
These teachings would have provided both the motivation and the expectation of success to a person of skill in the art to incorporate the modifications recited in claim 70 into biparatopic anti-CD45 antibodies taught by Boitano and Ludwig.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
12. Conclusion: no claim is allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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