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
Status of the Claims
1. Claims 1-43 are the original claims filed 12/21/2022. In the Preliminary Amendment of 6/23/2023, Claims 1, 3, 5-12, 18, 21-25, 30-33 and 42 are amended, and Claims 2, 4, 13-17, 19-20, 26-29, 34-41 and 43 are canceled. In the Response of 2/2/2026, Claims 1, 3, 6-12, 18, 21, 22, 30, 32, 33 and 42 are amended, claims 5 and 24-25 are canceled, and new Claims 44-45 are added.
Claims 1, 3, 6-12, 18, 21-23, 30-33, 42, and 44-45 are pending.
The amendment of the claims raises new grounds for objection and rejection. The Office Action is final.
Priority
2. USAN 18/069,847, filed 12/21/2022, is a Continuation of PCT/EP2021/067244, filed 06/23/2021, claims foreign priority to EP 20182307.7, filed 06/25/2020.
Information Disclosure Statement
3. As of 3/28/2026, a total of three (3) IDS are filed: 8/14/2023; 10/9/2025; and 12/23/2025. The corresponding initialed and dated 1449 form is considered and of record.
Withdrawal of Objections
Specification
4. The objection to the abstract of disclosure is withdrawn. The amended language for the phrase “in particular” is deleted.
5. The objection to the disclosure because of informalities is withdrawn. Both clean and marked-up copies of the specification are provided in the Response.
a) The specification is amended to rectify the improper use of the term, i.e., Biacore, Sepharose, Sephadex, UniProt, NCBI, ATCC, GenBank, HiTrap, Expi293, Ultracell, nanobody, Megalign, DNASTAR, Tris, Tween 20, UNIX, VI-CELL, glutaMAX, Histopaque, COOL CELL, Expifectamine, FACSDiva, ProteOn, maXis, TSKgel, Amicon, Geneart, Genscript, DARPin, Affilin, Keytruda, Opdivo, Yervoy, which is a trade name or a mark used in commerce.
b) The specification is amended to rectify the omission of sequence identifiers (SEQ ID NO) for amino acid sequences that are > 4 amino acids in length, e.g., PMAKK,
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, YMNM.
c) The specification is amended to correct the spelling for “VI-Cell.”
d) The specification is amended to correct the spelling for “GLUTAMAX.”
Claim Objections
6. The objection to Claims 1, 3, 5-12, 18, 21-25, 30-33 and 42 because of informalities is moot for the canceled claims and withdrawn for the pending claims.
a) Claims 1, 3, 5-12, 18, 21-25, 30-33 and 42 are amended to correct the misspelling of “complementarity determining region.”
b) Claims 1, 3, 5-12, 18, 21-25, 30-33 and 42 are amended to delete the phrase “capable of” with respect to specific binding or binding
c) Claim 30 is amended to recite “polynucleotide(s).”
d) Claim 32 is amended to delete the reference to one of the two sets of claims for different inventions, i.e., 31.
e) Claim 33 is amended to recite “
f) Claim 42 is amended to include language for “an individual in need thereof” but which presentation raises new grounds for objection set forth below.
g) Claims 21-24 are amended to recite "[the] an idiotype of the second antigen binding moiety" in Claim 21. Claim 33 is amended to depend from Claim 32.
Withdrawal of Rejections
Claim Rejections - 35 USC § 112(b)
7. The rejection of Claims 3, 18, 25, 31-33 and 42 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is moot for the canceled claims and withdrawn for the pending claims.
a) Claim 3 is amended replace the phrase “SEQ ID NO: 30” that is otherwise a skipped sequence with the sequence for SEQ ID NO 30 as shown in Table B:
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”.
b) Claim 18 is amended to delete the parenthetical text and to reinstate the text without parentheses.
c) Claim 25 is canceled.
d) Claims 31-32 that recite the limitation "polynucleotide(s)” now find antecedent basis in amended Claim 30 that recites “polynucleotide(s)”.
e) Claim 33 is amended to depend from claim 32.
f) Claim 42 is amended to delete the broad recitation “a disease” and to recite the genus and species of cancers.
Written Description
8. The rejection of Claims 1, 3(i), 9-12, 18, 21-25, 30-33 and 42 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 moot for the canceled claims and withdrawn for the pending claims. Claims 1, 3(i), 9-12, 18, 21-23, 30-33 and 42 are amended to recite the full VH and full VL domains for the first antigen binding site of the bispecific anti-CD28 x anti-CD3 molecule, claim 21 is amended to recite the VH/VL CDR1-3 (i)-(vii) for the masking moiety.
Claim Rejections - 35 USC § 103
9. The rejection of Claim(s) 1(i), 9, 11, 18, 30-33 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jeyaraju et al (US 20230172923 (USAN 17/921,893); filed 4/29/2021; priority 4/30/2020) in view of Tipton et al (WO 2017011580; filing date 7/13/2016) is withdrawn. Claim 1 is amended to include the full VH and VL domains for the agonist anti-CD28 binding domain for the bispecific anti-CD28 x anti-CD3 construct of the invention.
10. The rejection of Claims 1, 9, 11, 18, 30-33 and 42 is/are rejected under 35 U.S.C. 103 as being obvious over Amann et al (US 20240043535 (USAN 18/067,330; 6/19/2020) are withdrawn. Claim 1 is amended to include the full VH and VL domains for the agonist anti-CD28 binding domain for the bispecific anti-CD28 x anti-CD3 construct of the invention.
New Grounds for Objection
Claim Objections
11. Claim 42 is objected to because of the following informalities:
a) Claim 42 is not properly amended to include underlining for the newly introduced subject matter, i.e., “in need thereof”. Compare claim 42 from the claim set of 6/23/2023:
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to the claim set of 2/6/2026:
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This claim is not entered in the claim set of 2/6/2026.
b) Claim 42 recites “squamous cancer” but the specification teaches “squamous cell cancer” at [0174, 0315] and “squamous cancer” at [0316]. Clarification is requested.
Appropriate correction is required.
New Grounds for Rejection
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.
12. Claim 42 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 42 recites the broad recitation “epithelial cancer”, and the claim also recites breast, lung, colorectal, prostate, pancreatic, ovarian, and bladder cancers, which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 42 recites the broad recitation “squamous (cell) cancer”, and the claim also recites lung and esophageal cancers, which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
14. Claim 3(i) is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 3(i) is amended to recite “wherein said CDRL2 comprises the amino acid sequence X12X13SX14LX15X16, wherein X12 is K or Y, X13 is A or T, X14 is N or S, X15 is H or Y, and X16 is T or S.” The breath and scope of all possible CDRL2 domains much less within the combined subsets for the LCDR1-3 is beyond what is claimed in amended claim 1 for the LCDR1-3 comprising the VLCD28 for SEQ ID NOS: SEQ ID NO:25, SEQ ID NO:42, SEQ ID NO:43, SEQ ID NO:44,SEQ ID NO:45, SEQ ID NO:46, SEQ ID NO:47, SEQ ID NO:48, SEQ ID NO:49,SEQ ID NO:50 and SEQ ID NO:51.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
15. No claims are allowed.
16. 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.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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/LYNN A BRISTOL/Primary Examiner, Art Unit 1643