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 .
Status of Claims
Applicant’s election for continued examination without traverse of Invention Group I, drawn to a bispecific antibody or antigen-binding portion thereof consisting of claims 27-39, 49-52, and 54-56 in the reply filed on 11/20/2025 is acknowledged. Claims 40-48, and 53 are withdrawn as directed to a nonelected invention group. Claims 27-39, 49-52, and 54-56 are currently pending and under examination.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 11/24/2022. It is noted, however, that applicant has not filed a certified copy of the PCT/CN2022/134047 or of PCT/CN2022/134163 application as required by 37 CFR 1.55. Therefore, for the purposes of applying prior art, the effective filing date is 11/22/2023, the date that PCT/CN2023/133153 was filed.
Claim Objections
Claims 27 and 56 are objected to because of the following informalities: the addition of “c” in claims 27 and 56 where the claim recites “a light CDR3 c comprising a sequence of SEQ ID NO: 12.” Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 54 in the present application uses “means for binding CD3” and “means for binding prostate-specific membrane antigen (PSMA).” Accordingly, claim 54 limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
Claims 32, and 55-56 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The phrase “one or more moieties” in claim 32 is a relative phrase which renders the claim indefinite. The phrase 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. As currently constructed, claim 32 recites a conjugate of the bispecific antibody plus “one or more moieties” without specifying the nature, number, and method of attachment of these moieties. Therefore, the metes and bounds of the claim are unclear rendering the scope unascertainable.
Furthermore, claims 55 and 56 depend from claim 54 and therefore invoke 112(f). However, claims 55 and 56 also specify the structure that provides the relevant function (i.e. binding to CD3 or PSMA). These claims are therefore indefinite, because while on the one hand the Applicant seems to invoke 112(f) in claim 54, they seem to go the opposite way in dependent claims 55 and 56 by specifying the structure that performs the relevant function. Therefore, it is unclear if the Applicant is attempting to invoke 112(f) in claims 55-56 and thus makes the metes and bounds of these claims also unclear rendering the scope unascertainable.
Allowable Subject Matter
Claim 27-29 are allowable over the prior art. The closest prior art that matches fused PSMA binding heavy chain CDRs of SEQ ID NO: 1, SEQ ID NO: 2, and SEQ ID NO: 3 is SEQ ID NO: 82 disclosed by Zdanovsky (US9631191) of an IgG antibody heavy chain that bindis to Clostridium botulinum neurotoxin serotype A (BONT/A) with 76% query match.
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The closest prior art that matches fused PSMA binding light chain CDRs of SEQ ID NO: 4, SEQ ID NO: 5, and SEQ ID NO: 6 is SEQ ID NO: 145 disclosed by Hinton et al (WO2022026475) of an anti-SRAR-CoV2 S protein antibody light chain variable region with 79.1% query match.
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The closest prior art that matches fused CD3 binding heavy chain CDRs of SEQ ID NO: 7, SEQ ID NO: 8, and SEQ ID NO: 9 is SEQ ID NO: 300 disclosed by Xu et al (WO2019057122) of an anti-CD3 antibody variable heavy region with 88.7% query match.
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The closest prior art that matches fused CD3 binding light chain CDRs of SEQ ID NO: 10, SEQ ID NO: 11, and SEQ ID NO: 12 is SEQ ID NO: 301 disclosed by Xu et al (WO2019057122) of an anti-CD3 antibody variable light region with 84.6% query match.
The closest prior art that matches PSMA binding heavy chain of SEQ ID NO: 19 is SEQ ID NO: 53 disclosed by Anderson et al (US2017210799-A1) of an anti-receptor tyrosine kinase-like orphan receptor 1 (ROR1) IgG4 monoclonal antibody heavy chain with 95.8% query match.
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The closest prior art that matches PSMA binding light chain of SEQ ID NO: 20 is SEQ ID NO: 46 disclosed by Li et al (CN114106171) of an anti-aquaporin 4 (AQP4) antibody light chain with 98.6% query match.
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The closest prior art that matches CD3 binding heavy chain of SEQ ID NO: 17 is SEQ ID NO: 85 disclosed by Chen et al (WO2020156405, cited on pg. 2 of IDS filed on 08/14/2025) of an anti-CD3/CD20 bispecific antibody heavy chain with 99.2% query match and 3 mismatch mutations.
The closest prior art that matches CD3 binding light chain of SEQ ID NO: 18 is SEQ ID NO: 26 disclosed by Liu et al (WO2019057124, cited on pg. 2 of IDS filed on 08/14/2025) of an anti-CD3 light chain with 98.9% query match and 1 mismatch mutation.
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Conclusion
Claims 27 and 56 are objected. Claim 32 is rejected. Claims 27-31, 33-39, 49-52, and 54-56 are allowable over prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS GEORGE whose telephone number is (571)270-0340. The examiner can normally be reached M-F 8:30am - 5pm EST.
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/DENNIS GEORGE/Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645