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 .
Election/Restriction
The Election filed 7/13/26 in response to the Office Action of 5/13/26 is acknowledged and has been entered. With traverse, Applicant elected group I and the following species:
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Applicant cites MPEP 803 and indicates the restriction is not proper because search and examination of the entire application cannot be made with a serious burden. Applicant further argues restriction between Group I and Group II Is not proper and separating the claims of the two groups would result in redundant duplicate searching. Applicant further argues Claus et al does not disclose a common inventive concept of the groups or enable obtaining the recited combinations of antibodies or their effects. The traversal has been carefully considered and the restriction between the groups is withdrawn and group II is rejoined with elected group I.
All species recited by instant claim I have been rejoined.
Claims 1, 2, 4-11, 13-15, and 17-20 are pending and are currently under consideration.
Claim Objections
Claim 6 is objected to because of an apparent typographical issue. The term “and’ appears to be missing before step “xi)” of the claim. Proper correction is required.
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 1, 2, 4-11, 13-15, and 17-20 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.
Claims 1, 2, 4, 5, 7-11, 13-15, and 17 are rejected because lines 7-8 of claim 1 “…the TAA-targeting domain is a B7-H4-targeting domain or a Her-2-targeting domain….” Noting “bispecific antibody I” and “bispecific antibody II” are recited by claim 1 as each having a “TAA-targeting” domain (lines 1-5 of claim 1), there is insufficient antecedent basis for “the TAA-targeting domain” at lines 7-8 of claim 1 in the claims. In an effort to expedite prosecution, it is noted the following amendment to lines 7-8 of claim 1 could obviate this rejection: “…the TAA-targeting domain of bispecific antibody II is a B7-H4-targeting domain or a Her-2-targeting domain….”
Claims 1, 2, 4, 5, 7-11, 13-15, and 17 are rejected because steps “i)”, “iii)”, and “v)” of claim 1 each recite “…in the bispecific antibody II, the B7-H4-targeting domain comprises….” Because bispecific antibody II is not required to have a B7-H4-targeting domain (bispecific antibody II is required to have a TAA-targeting domain this a B7-H4-targeting domain or an Her2-targeting domain), the metes-and-bounds of the claims are unclear because it is unclear what is meant by “the B7-H4-targeting domain comprises” of antibody II when antibody II is not required to comprise a B7-H4-targeting domain. In an effort to expedite prosecution, the following amendments to each of steps “i)”, “iii)”, and “v)” of claim 1 is suggested: “…in the bispecific antibody II, the bispecific antibody II comprises a B7-H4-targeting domain and the B7-H4-targeting domain of bispecific antibody II comprises….”
Claims 1, 2, 4, 5, 7-11, 13-15, and 17 are rejected because steps “iv)”, “iv)”, and “vi)” of claim 1 each recite “…in the bispecific antibody II, the Her2-targeting domain comprises….” Because bispecific antibody II is not required to have a Her2-targeting domain (bispecific antibody II is required to have a TAA-targeting domain this a B7-H4-targeting domain or an Her2-targeting domain), the metes-and-bounds of the claims are unclear because it is unclear what is meant by “the Her2-targeting domain comprises” of antibody II when antibody II is not required to comprise a Her2-targeting domain. In an effort to expedite prosecution, the following amendments to each of steps “ii)”, “iv)”, and “vi)” of claim 1 is suggested: “…in the bispecific antibody II, the bispecific antibody II comprises a Her2-targeting domain and the Her2-targeting domain of bispecific antibody II comprises….”
Claims 2, 10, 17, and 19 are rejected because it is unclear how, or if, possible limitations following instances of “such as” limit the claims.
Claims 2, 4-6, 9, 10, 15, 19, and 20 are rejected because it is unclear how, or if, possible limitations following instances of “preferably” and “more preferably” limit the claims.
Claim 2 is rejected for reciting “…the linker peptide comprises the amino acid sequence of SEQ ID NOs: 93-96, 124, and more preferably….” The metes-and-bounds of the claim are unclear because it is unclear which of the numerous recited amino acid sequences is “the amino acid sequence” of the linker recited at lines 7-8 of claim 2.
The last two lines of claim 2 recite “…the liker peptide preferably comprises the amino acid sequence selected from SEQ ID NOs:93-96.” There is insufficient antecedent basis for “the amino acid sequence selected from SEQ ID NOs:93-96” in the claim.
Steps “i)” to “ix)” of claims 4-5 recite numerous instances of a targeting domain comprising “the amino acid sequence” of a heavy chain (or light chain) variable region comprising a recited SEQ ID NO. In each instance, there is insufficient antecedent basis for “the amino acid sequence” of the recited heavy chain (or light chain) variable region comprising the recited SEQ ID NO in the claim. In an effort to expedite prosecution, the following exemplary amendment for lines 2-4 of step “i)” of claim 4 is provided:
“…of SEQ ID NO: 122; the CD3-targeting domain comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 67, and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 70; in….”
Claim Rejections - 35 USC § 102
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 person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ali ("Designing a Low-Cost and Portable Infusion Pump," 2019 4th International Conference on Emerging Trends in Engineering, Sciences and Technology (ICEEST), Karachi, Pakistan, 2019, pp. 1-4).
Ali teaches a syringe infusion pump (Figure 2), that is an administration device comprising an infusion module equivalent to an infusion module that would administer a pharmaceutical composition comprising any combination of bispecific antibodies to a subject.
Conclusion
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642
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