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 .
Claim Status
Applicant’s amendments and remarks, filed 01/30/2026, are acknowledged.
Claims 1-50, 52, and 57-63 are canceled.
Claims 51, 53-56, 64, 65, and 69-72 are amended.
Claims 73-77 are new.
Claims 51, 53-56, and 64-77 are pending.
Claims 67-69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/08/2025.
As such, claims 51, 53-56, 64-66, and 70-77 are pending examination and currently under consideration for patentability under 37 CFR 1.104.
DETAILED ACTION
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/30/2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The reference lined through was not considered because a copy of the reference was not provided (see 37 CFR 1.98(a)) (see 37 CFR 1.98(a) and MPEP 609.04(a)).
Withdrawn Objections
The specification objections are withdrawn. Issues regarding minor informalities and trademarks/names have been sufficiently addressed through amendments to the specification on 01/30/2026.
The claim objections are withdrawn. Issues regarding minor informalities have been sufficiently addressed through amendments to the claims filed on 01/30/2026.
Withdrawn Rejections
Applicant’s arguments, see page 10, filed 01/30/2026, with respect to claim 56 rejected under 35 USC 112(d) as allegedly being of improper dependent form have been fully considered and are persuasive. The issue regarding improper dependent subject matter have been sufficiently addressed through amendments to the claim(s). As such, the rejection under 35 USC 112(d) is withdrawn.
Applicant’s arguments, see pages 10-12, filed 01/30/2026, with respect to claims 51-66 and 70-72 rejected under 35 USC 112(b) as allegedly being indefinite have been fully considered and are persuasive. The issue regarding the claims comprising indefinite language have been sufficiently addressed through amendments to the claims. Further, Examiner acknowledges that claims 52 and 57-63 are canceled thus rendering the rejection moot. As such, the rejection under 35 USC 112(b) is withdrawn.
Applicant’s remarks, see page 12, filed 01/30/2026, with respect to claims 51-56 rejected under 35 USC 103 as allegedly being unpatentable over Makings et al in view of US Patent No. 7,537,923 and Vesci et al have been fully considered and are persuasive. Examiner acknowledges that claim 52 is canceled, thus rendering the rejection moot. Further, Examiner acknowledges that claim 51 was amended to recite the subject matter of claims 57-63 which was not disclosed by the cited art. As such, the rejection of claims 51-56 under 35 USC 103 is withdrawn.
New Objections and Rejections Necessitated by Amendment
Claim Objections
Claims 51 and 64 are objected to because of the following informalities:
Claims 51 and 64(c) contain subparts that are designated with a period. Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). Specifically, “…K336 in the heavy chain” should end with a semicolon (;) and not a period. Claims 53-56, 65-66, and 70-77 are also objected to because the depend from claims 51 and 64, and they do not remedy the deficiency.
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.
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.
Claim 56 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.
Claim 56(a) recites “the conjugates in the composition comprise conjugates having at least one molecule of an IR700 dye linked to a lysine (K) in a heavy chain of cetuximab at one or more of K5, K43, K75, K81, K135, K248, K250, K276, K290, K319, K328, K336, K362, or K394 in one or both light chains of the cetuximab”. This limitation is unclear because it first recites that the IR700 dye is linked to the heavy chain of cetuximab, but then recites one or both light chains of cetuximab. Thus, it is unclear where the conjugation is located.
Conclusion
Claim 56 is not allowed.
Claims 51, 53-55, 64-66, and 70-77 are objected to.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANAYA L MIDDLETON whose telephone number is (571)270-5479. The examiner can normally be reached M-F 9:30AM - 6PM with flex.
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, Vanessa Ford can be reached at (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAYA L MIDDLETON/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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