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
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 Claims 38-39 are withdrawn as being drawn to a nonelected invention.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 is maintained.
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 5/6/2026 have been fully considered but they are not persuasive.
Applicant argues that “[B]ridon does not disclose or suggest the method of treating spinal cord injury in accordance with the present claims which (i) is applied to a human patient in need thereof, (ii) is performed through a systemic route; and (iii) wherein 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.
With respect to (i), Bridon et al. teach that the contusion model is recognized and used to mimic the spinal cord injury observed in humans (para [0191]; Example 8). Thus, it is clear that the teachings of Bridon et al. relate to a method of treating a human. One of ordinary skill in the art would have at once envisaged treating a human.
With respect to (ii), Bridon et al. teach that “[O]ther routes of administration known to those skilled in the art may also be used such as subcutaneous, intravenous, intraluminal, or intranasal routes. When one or more of these routes of administration are used, the doses to be used may range from 1 μg/kg to 50 mg/kg. (para [0120]).
With respect to (iii), Bridon et al. clearly teach that the first administration is made within 15 minutes following the trauma (Example 8; para [0194]).
For the reasons stated above the rejection is maintained.
Conclusion
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 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
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