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 1-47 are the original claims filed 9/29/2022. In the Preliminary Amendment of 5/12/2025, Claims 4, 6, 10, 12-14, 21, 23-27, and 43-47 are amended and Claims 7, 8, 11, 15-20, 22, and 28-42 are cancelled. In the Response of 12/22/2025, claims 1, 13-14, 21 and 45 are amended and claims 2-6, 9-10 and 26-27 are canceled.
Claims 1, 12-14, 21, 23-25, and 43-47 are pending.
The Office Action is final.
Priority
2. USAN 17907,683, filed 09/29/2022, is a National Stage entry of PCT/IB2021/ 052589, International Filing Date: 03/29/2021, 17/907,683 Claims Priority from Provisional Application 63/002,631, filed 03/31/2020.
Information Disclosure Statement
3. As of 2/25/2026, a total of two (2) IDS are filed: 9/29/2022; and 7/12/2024. The corresponding initialed and dated 1449 is considered and of record.
Withdrawal of Objections
Specification
4. The objection to the disclosure because of informalities is withdrawn. Clean substitute 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., Tween, SYNAPT, MassLynx, UPLC, SoftMax, Envision, BiaCore, AlphaLisa, which is a trade name or a mark used in commerce.
b) The specification is amended to include sequence identifiers in the figure legend for Figure 8 for the amino acid sequences > 4 amino acids in length as depicted in the figure.
Claim Objections
5. The objection to Claims 1-6, 9-10, 12-14, 21, 23-27, and 43-47 for informalities is moot for the canceled claims and withdrawn for the pending claims.
a) Claims 1-6, 9-10, 12-14, 21, 23-27, and 43-47 are amended to recite for consistency “the IgG4 antibody” in the body of the claims.
b) Claims 1-6, 12-14, 21, 23-27, and 43-47 are amended to recite “mutations at Y291C, G220C and S228P of the heavy chain.”
c) Claims 2, 4, 6 and 10 are canceled.
d) Claim 14 is amended to delete parenthetical text.
Withdrawal of Rejections
Claim Rejections - 35 USC § 112(b)
6. The rejection of Claims 14 and 27 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is moot for canceled claim 27 and withdrawn for claim 14.
Claim 14 is amended to recite the broad recitation “a T cell receptor”, and to delete the phrase “TCR variable chain” which is the narrower statement of the range/limitation.
Claim 14 is amended to recite the broad recitation “a B cell receptor”, and to delete the term “CD79” which is the narrower statement of the range/limitation.
Claim 27 is canceled.
Claim Rejections - 35 USC § 112(d)
7. The rejection of Claim 6 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form is moot for the canceled claim.
Claim Rejections - 35 USC § 112(a)
Written Description
8. The rejection of Claims 1-6, 9-10, 12-14, 21, 23-27, and 43-47 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, 12-14, 21, 23-25, and 43-47 are amended to recite the mutations in the IgG4 constant region comprise Y219C, G220C and S228P according to EU numbering.
Enablement
9. The rejection of Claims 26-27 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is moot for the canceled claims.
Rejections Maintained
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
10. The rejection of Claim(s)
A) Applicants allege FIG 2A describes a number of various individual residues in the IgG4 antibodies of such disclosure where specific individual mutations have been tested, as well as very specific combinations thereof. However, there are no specific combinations of the particular combinations that is provided by Applicant. See, e.g., the legend to FIG 2A at paragraph [0043): [0043] FIG. 2a shows the CH I cysteine residue (C127) which forms the inter-chain disulphide bond with a cysteine in the light chain and the upper and core hinge residues of IgG1 wild type, IgG4 wild type and the positions where mutations have been introduced in the IgG4 antibodies of the present invention.
Response to Arguments
Examples under the decision of KSR, 550 U.S. at 418, 82 USPQ2d at 1396 to support a conclusion of obviousness include
“Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.
Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention- the teaching of UCB is for a finite and limited number of predictable residues for a generic IgG4 falling within the same scope of the instant claims. The teaching of UCB to test the function/activity of mutated residues uses standard methods (e.g., Quickchange® Lightening Multi Site Directed Mutagenesis (SDM) kit or the Quickchange® II DSM kit, thermofluor assay using SYPRO® Orange, sandwich MSD assay) for doing so, rendering the resulting antibody obvious.
B) Applicants allege an IgG4 molecule comprising a hinge sequence referred to as SEQ ID NO: 4 (Y219C+G220C+S228P) had the greatest overall stability towards reduction and also formed very little half mAb. See paragraphs [0078] and [0084] of the application as filed. None of the prior art provides a suggestion that the combination of amino acid substitutions provided would result in IgG4 molecules demonstrating improved properties as provided herein.
Response to Arguments
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., SEQ ID NO: 4) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The rejection is maintained.
Conclusion
11. No claims are allowed.
12. THIS ACTION IS MADE FINAL. 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.
13. 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 ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643