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 .
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 09/01/2026 has been entered.
Claims 35-36 and 39-50 are pending and under consideration for their full scope.
Applicant’s IDS document filed on 09/01/2026 has been considered.
Claim 36 is objected to because of the following informalities: claim 36 recites “wherein R1 and R2 are same anti-CD40L hu5c8 scFv.” and it is suggested that the claim be amended to recite “wherein R1 and R2 are the same anti-CD40L hu5c8 scFv.” for proper grammar.
Appropriate correction is required.
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.
Claims 35-36 and 39-50 are 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 1 recites the structural formula
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154
495
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The claim goes on to recite “wherein R3 and R4 are bioactive effector moieties linked to a C-terminus of the Fab, each linked to a heavy chain variable domain or a light chain variable domain of the Fab; wherein m is 0; and wherein n is 0” in the last three lines.
The specification does not provide any definition for what is meant by the “m” and “n” in R3m and R4n in the structural formula, but it would appear to indicate the number of copies of each of the R3 and R4 moieties to be present in the formula. As such, m and n being 0 would seem to indicate that the R3 and R4 moieties are not present.
It is unclear and indefinite to present limitations in a claim that are never encompassed by the claim scope. It is unclear to recite R3 and R4 moieties in a structural formula in a claim wherein those moieties are necessarily never present within the claim scope of any of the claims. The claims are confusing and unclear because of this recitation. It is suggested that the structural formula be amended to remove the R3 and R4 moieties and to delete claim language referring to those moieties.
Correction is required.
8. No claim is allowed.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
September 24, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641
