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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/16/2025 has been entered.
Claim Status
Claims 22-39 are pending. Claims 22, 31 and 34-39 have been amended. Claims 22-37 are being examined in this application. In the response to the restriction requirement, Applicants elected Group I, SEQ ID NO: 3 and intravenous administration. Claims 38-39 are withdrawn as being drawn to a nonelected invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
This rejection has been modified.
Claims 22-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bridon et al. (US 2018/0265549 or WO 2017/051135).
With respect to claims 22-30, Bridon et al. teach a method of treatment of neurodegenerative pathologies or trauma in which the regeneration of the central nervous system is sought, comprising administering a polypeptide to a patient in need thereof, wherein said polypeptide comprises SEQ ID NO: 59 (claim 25 of ‘549), which corresponds to instantly claimed SEQ ID NO: 1.
Bridon et al. also teach that the first administration is made within 15 minutes following the trauma (Example 8, para [0194] of ‘549).
Bridon et al. further teach that the polypeptide is SEQ ID NO: 2 (claim 3 of ‘549), which corresponds to the elected species (i.e. SEQ ID NO: 3).
Bridon et al. additionally teach that the method is for the treatment of spinal cord lesion (para [0121] of ‘549).
With respect to claim 31, Bridon et al. teach intravenous administration (paras [0011], [0120] of ‘549).
With respect to claim 32, Bridon et al. teach that the injury is a traumatic injury (para [0121] of ‘549).
With respect to claims 34-37, the instant specification does not teach the sufficient time to induce: (1) myelination; (2) functional recovery; (3) increase of MBP; and (4) increase of Olig2-positive progenitor recruitment and/or of Olig2-positive cell generation. Therefore, absent evidence to the contrary, it is believed that the method of Bridon et al. would necessarily induce (1)-(4).
Response to Arguments
Applicant’s arguments filed on 12/16/2025 have been fully considered but they are not persuasive.
Applicant argues that Bridon fails to disclose or suggest that the first administration is made within a period of 48 hours after the occurred injury, the suspected injury or the prognostic is made.
Applicant’s arguments are not persuasive because, as discussed in the rejection above, Bridon et al. also teach that the first administration is made within 15 minutes following the trauma (Example 8, para [0194] of ‘549).
Therefore, the reference of Bridon et al. is anticipatory.
For the reasons stated above the rejection is maintained.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658