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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection on January 21, 2026. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Claim Status
Applicant’s amendment filed January 21, 2026 has been received and entered.
Claims 1 and 30-35 have been amended.
Claims 22-28, 36-41, 43-44, 46, and 49 have been canceled.
Claims 4-7 and 9-11 were previously canceled.
Claims 51-54 have been added.
Claims 1-3, 8, 12-21, 29-35, 42, 45, 47-48, and 50-54 are pending and under consideration.
Election/Restrictions
Claims 31-32 and 34-35 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 12, 2024.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application claims the benefit of U.S. Provisional Application 63/421,541 filed on November 1, 2022, which claims the benefit of U.S. Provisional Application 63/394,483 filed on August 2, 2022, which claims the benefit of U.S. Provisional Application 63/342,542 filed on May 16, 2022, which claims the benefit of U.S. Provisional Application 63/297,333 filed on January 7, 2022.
Applicant is reminded that one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 has not been met as set forth in the Office Action mailed July 22, 2025.
However, in view of Applicant’s amendments filed January 21, 2026, the priority of the instant application has been updated as follows:
Prior application 63/297,333 filed on January 7, 2022 does not disclose the subject has visceral metastases as recited in claim 2, or that the subject has a baseline MUC16 immunohistochemical staining score of 2+ in greater than 75% of tumor cells as recited in claims 45 and 50. The first occurrence of these claim limitations is in prior application 63/342,542 filed on May 16, 2022. Therefore, the May 16, 2022 filing date of prior application 63/342,542 will be used for the purpose of applying prior art to claims 2, 45, and 50.
Prior applications 63/297,333 filed on January 7, 2022 and 63/342,542 filed on May 16, 2022 do not contemplate CA-125 levels equal or greater than 700 U/mL. The first occurrence of this claim limitation is in prior application 63/394,483 filed on August 2, 2022. Therefore, the August 2, 2022 filing date of prior application 63/394,483 will be used for the purpose of applying prior art to claim 21.
No prior application discloses the subject does not have liver metastases. Therefore claim 53 is entitled to the benefit of the filing date of the instant application of January 6, 2023.
Claim 1 has been amended to recite the dosing schedule for the bispecific antibody, which was previously part of claim 36 (now canceled). The previous objection over the benefit of priority for the bispecific antibody dosing schedule has been withdrawn after further consideration. The dosing schedule as recited in amended claim 1 was first disclosed in prior application 63/297,333 [see Table 5, pg. 54]. Accordingly, claim 1 has the benefit of priority the January 7, 2022 date of the 63/297,333 provisional application.
In summary, the dates for the benefit of priority for the instant claims is/are:
Claims 1, 3, 8, 12-20, 29-30, 33, 42, and 47-49, and 51-52 - January 7, 2022
Claims 2, 45, and 50 - May 16, 2022
Claim 21 - August 2, 2022
Claim 53 - January 6, 2023
Should Applicant disagree with the examiner' s factual determination as to the disclosure of the various limitations, Applicant may point out the particular places within the prior applications which discloses those features.
Specification
This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.831(a) and 1.831(b). However, this application fails to comply with the requirements of 37 CFR 1.831-1.834.
The disclosure is objected to because the specification recites SEQ ID NO: 12 and SEQ ID NO: 39, which refer to blank (skipped) amino acid sequences in the sequence listing.
Applicant must amend the specification to include the three-letter amino acid code for of SEQ ID NO: 12 and SEQ ID NO: 39 for each occurrence throughout the specification. Applicant should also delete reference to these particular SEQ ID NOs, since they do not contain any sequences.
Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure.
• A statement that identifies the location of all additions, deletions, or replacements of sequence information in the “Sequence Listing XML” as required by 1.835(b)(3).
• A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4).
• A statement that the “Sequence Listing XML” includes no new matter in accordance with 1.835(b)(5).
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version).
A copy of the amended specification without markings (clean version).
A statement that the substitute specification contains no new matter.
Appropriate correction is required.
Claim Rejections - Withdrawn
In view of the Applicant’s claim amendments, the previous grounds of rejection under 35 U.S.C. 112(d) and 35 U.S.C. 103 are withdrawn.
Claim Objections
Claim 51 is objected to because of the following informalities:
Claim 51 recites “wherein the MUC 16-expressing ovarian cancer, fallopian tube cancer, or primary peritoneal cancer is ovarian cancer”. However, the phrase MUC 16-expressing ovarian cancer is ovarian cancer is a redundant statement. The claim should be amended to recite “wherein the MUC 16-expressing .
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-3, 8, 12-21, 29-30, 33, 42, 45, 47-48, and 50-54 are 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 1 recites SEQ ID NOs for the MUC16xCD3 bispecific antibody heavy chain variable regions (HCVR) and light chain variable regions (LCVR), however LCDR2 comprising the amino acid sequence of SEQ ID NO: 12 is three amino acids (TAS) in length, therefore the amino acid sequence of SEQ ID NO: 12 refers to a blank sequence in the sequence listing.
Accordingly, SEQ ID NO: 12 is indefinite because it refers to a blank sequence which makes the scope of the claim(s) unclear.
Applicant must amend the claim(s) to delete all reference to “SEQ ID NO: 12” and replace with the three-letter amino acid code (TAS) for the LCDR2 region. For example, claim 1 can be amended to read “…wherein the HCDR1, HCDR2, and HCDR3 comprise, respectively, the amino acid sequences of SEQ ID NOs: 8, 9, and 10, and the LCDR1 comprises the amino acid sequence of SEQ ID NO: 11, the LCDR2 comprises the amino acid sequence TAS, and the LCDR3 comprises the amino acid sequence of SEQ ID NO: 13…”.
Claims 2-3, 8, 12-21, 29-30, 33, 42, 45, 47-48, and 50-54 are included in the rejection because they depend from or otherwise require all the limitations of the rejected independent claim.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Written Description - New Matter
Claim 53 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Claim 53 recites “the subject does not have liver metastases”.
However, there is no disclosure or contemplation of subjects without liver metastases. In fact, the instant specification allows for patients with liver metastases as long as ULN levels are ≤5x [see Inclusion Criteria, 6(f)].
Accordingly, while the instant application contemplates other exclusion criteria for treating ovarian cancer with the instantly claimed MUC16xCD3 bispecific antibody, excluding subjects with liver metastases was contemplated. Thus, one of skill in the art would conclude that the specification fails to provide adequate written description to support the claim limitation.
Double Patenting - Withdrawn
In view of the Applicant’s amendment, the previous nonstatutory double patenting rejections are withdrawn.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN DRISCOLL whose telephone number is (571) 270-0730. The examiner can normally be reached Monday through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached on (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/MAUREEN VARINA DRISCOLL/ Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642