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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Claims 1, 6, 7 and 35 are pending in the application.
Response to Amendment
Applicant's arguments filed April 10, 2026 have been fully considered with the following effect:
The applicant's amendments and arguments are sufficient to overcome the 35 U.S.C. 102(a)(1), anticipation rejection, maintained in the last office action, the applicants’ arguments have been fully considered but they are not persuasive. The applicants’ stated that first that subject is construed to mean any animal, including human as set forth on page 16 of the Specification; second that claim 1 does not expressly recite the terms “in vivo” or “in vitro”, the administration of C9-BADANA to the subject to treat idiopathic pulmonary fibrosis in the subject is clearly understood to be an in vivo method of treatment and not an in vitro method; and finally, claim 1 does not expressly recite a time restraint where the sialidase activity within a time course of only four hours following administration of flagellin to mice.
However, Hyun does recite that the “lead candidate C9-BADANA (Fig 5) represents approach to stopping – even reversing – the course of IPF”; “this NEU1-inhibitory activity holds for primary human lung cells, and for murine lungs, in vivo”; and “our data indicate that C9-BADANA at 15 µg/kg body weight dramatically reduces lung sialidase activity and collagen deposition”. Hyun states that “we recently reported that human lung fibroblasts (HLFs) express NEU1, and NEU1 expression is increased in fibroblasts obtained from the lungs of IPF patients” and “C9-BADANA, at concentrations ≥1.34µM, dose-dependently inhibited HLF sialidase activity with an IC50 of 4.82µM”.
Claim(s) 1, 6, 7 and 35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hyun et al., Glycobiology, for reasons of record and stated above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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