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 .
CONTINUING DATA
This application is a 371 of PCT/US22/20849 03/18/2022
PCT/US22/20849 has PRO 63/163,668 03/19/2021
This office action is in response to Applicant’s amendment submitted August 26, 2026. Claims 1-10, 13, 20, 22, 32, 38, and 48-51 are pending.
Applicant’s election without traverse of Group I, claims 1-9 and 52, in the reply filed on May 12, 2026 is acknowledged.
Claims 10, 13, 20, 22, 32, 38, and 48-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 May 12, 2026.
Drawings
The objection to the drawings is withdrawn.
Specification
The disclosure is objected to because of the following informalities: the chemical structures in paragraph [0036] are pixelated and difficult to read. Applicant submitted a corrected paragraph [0036] on August 26, 2026. Except for the structure at the top of page 6, all the structures are still pixelated and difficult to read. Additionally, “[0001]” was inserted at the bottom of page 4, which might be an error.
Appropriate correction is required.
Withdrawn Rejections
The rejection of claim 4 under 35 U.S.C. 112(b) is withdrawn because the narrow limitation was removed from the claim.
The rejection of claim(s) 1-6 and 8 under 35 U.S.C. 102(a)(1) as being anticipated by Nitz is withdrawn because Nitz’s compounds do not comprise a 1-alpha-S-2-linked dimannose moiety at the non-reducing terminal end.
The rejection of claim(s) 1-6 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qiao is withdrawn because Qiao’s compounds do not comprise a 1-alpha-S-2-linked dimannose moiety at the non-reducing terminal end.
The rejection of claim(s) 1, 5-6, and 52 under 35 U.S.C. 102(a)(1) as being anticipated by Belz is withdrawn. Applicant’s argument that the Belz compounds are 1-6 linked is persuasive.
The rejection of claim(s) 1-2 and 6-8 under 35 U.S.C. 102(a)(1) as being anticipated by Ding is withdrawn because Ding’s compounds do not comprise a 1-alpha-S-2-linked dimannose moiety at the non-reducing terminal end.
The following rejections of record are maintained.
Claim Rejections - 35 USC § 112
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 9 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.
The chemical structures in claim 9 are pixelated and difficult to read, so it is unclear what is being claimed.
Applicant argues that claim 9 was amended per the Examiner’s recommendations, but the structures in claim 9 have not been clarified.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Krauss (US 2013/0116417 A1, May 9, 2013) in view of Ding (Eur. J. Org. Chem. 1999, 1143-1152), Belz (Carbohydrate Research 429 (2016) 38-47), Nguyen (ACS Cent. Sci. 2019, 5, 237-249) and Bruxelle (Scientific Reports (2020) 10:7582).
Krauss teaches oligosaccharides useful for preparing vaccines. See abstract. Paragraph [0124[ illustrates compounds which are similar to the compounds of current claim 9 except they are not S-linked. The reactive group in Krauss’s compounds is N3, and it is attached through an alkyl linker.
Ding teaches methods for preparing S-linked oligosaccharides. See page 1144. S-linked thio analogs of oligosaccharides might be expected to be less prone to enzymatic inactivation as compared to their O-linked natural counterpart. See Introduction.
Belz teaches the synthesis of S-linked mannooligosaccharides. Belz teaches that S-linked glycoconjugates typically do not undergo enzymatic transformation, so they are useful as oligosaccharide mimics. See first paragraph of Introduction.
Nguyen teaches oligomannose compounds for targeting antibodies. See title. The oligomannose compounds are illustrated on page 243. Nguyen observed significant trimming of the glycoconjugates (page 244, last paragraph). Mannosides trimming of the vaccine glycans may affect the glycan microspecificity of vaccine-elicited antibodies. Page 245. Trimming occurs at the glycan “tips.” See Conclusion.
Bruxelle teaches that serum mannosidase trimming of oligosaccharides in vivo lessens the likelihood of eliciting antibodies with capacity to bind full-sized oligomannose (see abstract). Bruxelle confirmed that Nguyen’s hypothesis of glycoside trimming does occur in vivo. See page 2, first paragraph. Bruxelle suggests preparing mannosidase-resistant glycosides. Page 5, end of Discussion section.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepare S-linked analogs of Krauss’s compounds because oligomannosides undergo trimming in vivo, which causes vaccines made from the oligomannosides to be less effective. Ding and Belz teach that S-linked oligosaccharides are less likely to undergo enzymatic inactivation, so the skilled artisan would have prepared S-linked analogs to overcome the problem of glycoside trimming. Ding and Belz teach methods for preparing S-linked oligosaccharides, so the skilled artisan would have had a reasonable expectation of success. The skilled artisan would have prepared compounds which are S-linked at the non-reducing end because trimming occurs at the “tips,” as taught by Nguyen.
Response to Arguments
Applicant argues that Krauss does not teach S-linked oligosaccharides and neither of Belz or Ding teaches compounds linked via a S-linked alpha-1,2 bond. Applicant further argues that Nguyen does not teach S-linked compounds. Applicant also argues that Bruxelle’s compound NIT68B has an unknown structure and that Bruxelle does not teach S-linked compounds. Applicant concludes that the combination of references does not provide any motivation or suggestion of the currently claimed compounds.
Applicant’s argument is not persuasive. Krauss teaches O-linked mannoside compounds. Nguyen and Bruxelle teach that glycoside trimming by mannosides occurs in vivo, and Bruxelle suggests preparing mannosidase-resistant glycosides. Ding and Belz teach that S-linked oligosaccharides are less prone to enzymatic inactivation than their O-linked counterparts and teach how to prepare S-linked compounds. The motivation to combine the references is as set forth above; O-linked mannosides are prone to enzymatic inactivation and S-linked analogs are less likely to undergo trimming. Krauss teaches O-linked mannosides. The skilled artisan would have prepared the S-linked analogs to avoid glycoside trimming in Krauss’s compounds. Krauss’s compounds are 1-2 linked, so the S-linked analogs would also be 1,2-linked.
It is noted that Applicant stated that a true and complete copy of Panophlet (cited by Bruxelle) was attached as Exhibit A. The examiner did not find Exhibit A in the file. Bruxelle was not cited for the purpose of providing any structure, however, only to establish that serum mannosidase trimming of oligosaccharides in vivo lessens the likelihood of eliciting antibodies with capacity to bind full-sized oligomannose. The rejection does not rely upon a disclosure of any structure by Bruxelle, and the examiner acknowledges that Bruxelle does not teach an S-linked compound.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached 7:00-3:00 CST, M-F.
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/LAYLA D BERRY/ Primary Examiner, Art Unit 1693
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