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. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 29, 2025 has been entered.
Applicant’s amendments and remarks have been reviewed. Claims 1, 4-7, 9-10, 13-14, 16-17 and 22-26 are now pending in this application.
Allowable Subject Matter
Claims 1, 4-7, 13, 16 and 17 are allowed.
Claim Rejections - 35 USC § 112
Claims 9-10, 14 and 22-26 are again 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 nature of the “Linker” as a “heterobifunctional crosslinking group resulting from reactions between X within the compound or pharmaceutically acceptable salt of claim 1, an amine or thiol within an antibody Z and one of the following compounds,” wherein the structural formula of these compound is given, remains unclear. Applicants’ remarks have been fully considered but not found persuasive. There is an amino group at “X.” Applicants argue that this amino group is reacted with one of the compounds depicted and this compound is also reacted with an amino or mercapto group of an amino acid.
During the reaction of the amino group (X) with any one of these five compounds, an amide is formed between X and one of these compounds after the a succinimide (optionally substituted by sulfonyl) is cleaved off. An amino or mercapto group is reacted with the amide. Here it is unclear what the point of attachment when the maleimide is not present. That is what is the point of attachment on the fourth and fifth compound? Applicants could easily depict the structural formula of “Linker” to overcome this rejection. Applicants need to provide points of attachment of the “Linker” to the rest of the compound and the antibody. Clarity is lacking at this point of the conjugate. Appropriate clarification is still required.
The Examiner has used his discretion of not making this action Final to give Applicants the opportunity to place the claims in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCK KIFLE whose telephone number is (571)272-0668. The examiner can normally be reached 8 AM - 6 PM, M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
February 4, 2026
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
Prosecution Insights