DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the third Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03 March 2026 has been entered.
Status of the Claims
Applicant amended claims 21-24 and 29, cancelled claims 25-28 and 30-40, and added thirteen new claims, i.e., claims 41-53. Claims 1-20 were cancelled previously by Applicant. Claims 21-24, 29, and 41-53 are pending.
Rejoinder
Pursuant to the procedures set forth in MPEP § 821.04, the entire scope of claim 21 has been fully examined for patentability under 37 CFR 1.104. Therefore, the election-of-species requirement concerning modified LPS compounds, set forth in paragraphs 21-22 of the Office Action issued 29 April 2025, is withdrawn-in-part. Specifically, it is withdrawn among only the three formulae presently recited in claim 21, i.e., Formula (I)(3)(a), Formula (I)(3)(b), and Formula (I)(3)(c). The examiner notes that Formula (I)(3)(b) is the species elected by Applicant and that all three formulae have been fully examined for patentability.
As indicated below, claim 21 complies with 35 U.S.C. 102 and 35 U.S.C. 103. Claim 29, which now depends on claim 21 and was previously withdrawn from consideration as a result of an election requirement, is REJOINED because it requires all the limitations of claim 21.
In the interest of clarity, the examiner notes that the restriction requirement between Groups I and II remains in force. See Office Action (29 April 2025) at paragraphs 12-15.
Status of the Rejections and Objections
The rejection of claims 21-27 under 35 U.S.C. 112(b) set forth in the previous Office action (09 January 2026) is withdrawn in view of Applicant’s amendments. The examiner appreciates Applicant’s effort to advance prosecution.
The rejection of claim 23 under 35 U.S.C. 112(d) set forth in the previous Office action is withdrawn in view of Applicant’s amendment thereto.
The rejection of claims 21-26 under 35 U.S.C. 102(a)(1) as being anticipated by Myers (GB 2 220 211 A), as evidenced by Rietschel (“Bacterial endotoxin: molecular relationships of structure to activity and function.” The FASEB Journal 8.2 (1994): 217-225) and/or Preston (“The lipooligosaccharides of pathogenic gram-negative bacteria.” Critical reviews in microbiology 22.3 (1996): 139-180) is withdrawn in view of Applicant’s narrowing amendment to claim 21. The examiner is mindful that “impermissible hindsight must be avoided and the legal conclusion must be reached on the basis of the facts gleaned from the prior art.” MPEP § 2142; see also MPEP § 2141.02(I) (“In determining the differences between the prior art and the claims, the question under 35 U.S.C. 103 is not whether the differences themselves would have been obvious, but whether the claimed invention as a whole would have been obvious.” (emphasis in original)).
The rejection of claim 27 under 35 U.S.C. 103 as being unpatentable over Myers (GB 2 220 211 A), as evidenced by Rietschel (“Bacterial endotoxin: molecular relationships of structure to activity and function.” The FASEB Journal 8.2 (1994): 217-225) and/or Preston (“The lipooligosaccharides of pathogenic gram-negative bacteria.” Critical reviews in microbiology 22.3 (1996): 139-180) is withdrawn in view of Applicant’s cancellation of the claim.
The objections to the claims are new.
The rejection of claim 29 under 35 U.S.C. 112(b) is new.
Objections to the Claims
Claims 21-24, 29, and 41-53 are objected to because of the following informalities:
Regarding claims 21, 29 and 51-53, the following phrase requires correction: “wherein R at position C6’ is a mono-, oligo- or polysaccharidic moiety.” The examiner recommends either one of the following: (i) “wherein R at position C6’ is a mono-, oligo-, or poly-saccharidic moiety” or (ii) “wherein R at position C6’ is a monosaccharidic, oligosaccharidic, or polysaccharidic moiety.”
In further regard to claim 21, the molecular weight caption for Formula (I)(3)(c) appears to obscure (i) part of the chemical structure and/or (ii) one or more of the carbon chain length numbers (presumably they are all “14”). Appropriate correction is required. As a courtesy, Applicant is referred to Figure 4 (Sheet 5/82) of corresponding WO 2021/180972, which contains a clear, unobscured version of Formula (I)(3)(c).
Regarding claim 22, the following word requires correction: “poly-saccharide.” The examiner recommends replacing it with “polysaccharide.”
Regarding claim 29, the chemical structure and molecular weights corresponding to Formula (II)(0) are too small and blurry to be reproducible in a printed patent. Applicant is referred to 37 CFR 1.58(b) (“Chemical and mathematical formulas and tables must be presented in compliance with § 1.52(a) and (b)”) and 37 CFR 1.52(a)(1)(iv) (“Plainly and legibly written either by a typewriter or machine printer in permanent dark ink or its equivalent”). Appropriate correction is required.
Claim Rejections - 35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
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.
Claim 29 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventors regard as the invention.
Formulae (I)(8)(a), (I)(8)(b) and (I)(8)(c), which are located near the end of claim 29, each contain moiety “X”; however, that moiety is undefined. This deficiency renders the claim indefinite.
Additional Remarks
An additional search of the relevant art revealed no prior art reference, or combination of prior art references, that would have adequately supported a rejection of claim 21 under either 35 U.S.C. 102 or 35 U.S.C. 103. Additional references considered for this purpose include those listed on the PTO-892 that accompanies this Office action. The examiner makes the following brief observations regarding the two most relevant newly-located references:
Compound 39 (page 36) of Zamyatina (“Aminosugar-based immunomodulator lipid A: synthetic approaches.” Beilstein Journal of Organic Chemistry 14.1 (2018): 25-53) is dephosphorylated at the C4’ position, instead of the C1 position. Additionally, the length of the acyl chains differs from what is now required by claim 21.
Claims 1 and 6 of Ernst (US 10,358,667 B2) are considered especially relevant; however, the configuration of the acyl chains differs significantly from what is now required by claim 21. Additionally, Ernst does not adequately suggest dephosphorylation at the C1 position only, which is represented therein by moiety R2 of claim 6.
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Conclusion
Claim 29 is rejected.
Claims 21-24, 29, and 41-53 are objected to.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
18 April 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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