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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/09/2026 has been entered.
Status of Claims
Claims 1 is amended. Claims 34 and 48-58 are cancelled. Claims 1, 17, 24, 26, 28-29, 32-33, 35-38, and 40-41 are currently pending and under examination.
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. Claims 1, 17, 24, 26, 28-29, 32-33, 35-38, and 40-41 have an effective filing date of 04/20/2020, corresponding to provisional applications 63/012,786 and 63/012,783.
Rejections Withdrawn
35 U.S.C. 103
The Affidavit filed 07/09/2026 and the Exhibits submitted in support of the Affidavit have been fully considered and are persuasive. The data presented by Applicant demonstrates that the claimed invention, which requires a 15 mg/kg dose of the claimed anti-TLR4 antibody, is surprisingly safe and efficacious, see p. 7 and 8 of Applicant Arguments, dated 07/09/2026. Therefore the 35 USC 103 rejection is withdrawn.
Claim Rejections
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.
The term “about” in claims 1 and 33 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One of ordinary skill in the art would be unable to determine the metes and bounds of the term “about. Therefore claims 1, 17, 24, 26, 28-29, 32-33, 35-38, and 40-41 are rejected.
Conclusion
No claims are allowed.
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/J.K.D./Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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