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 .
Response to Amendment
Claims 1, 5, 9, 11-13, 15 have been amended; Claims 22-28 have been newly added as requested in the amendment filed on 23 October 2025. Following the amendment, claims 1-5, 9-15 and 22-28 are pending in the instant application, and are under examination in the instant office action.
The support for the newly added limitation of “stem cell” can be found on pages 6, 87, and Figures 7, 8, 13 and 14. The support for newly added claims directed to “post-concussive syndrome” can be found on pages 22 and 53 of the disclosure as filed.
Specification (Objection Withdrawn)
The amendment to the specification filed on 23 October 2025, has remedied the presence of an embedded hyperlink and/or other form of browser-executable code. Therefore, the objection is withdrawn.
Claim Rejections - 35 USC § 112 (Withdrawn)
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.
Claims 7 and 19 have been cancelled. Therefore, the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is moot.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5, 9-15 and 22-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 8 of U.S. Patent No. 7,723,290. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to a method of treating an immune-related disorder in a subject comprising administering a PIF peptide selected from PIF-1 (SEQ ID NO:13), wherein said immune-related disorder is multiple sclerosis, which overlaps in scope with the enabled embodiment of peripheral or CNS neurotrama of the instant claims. While Applicant has added the limitation, “co-administering to the subject; stem cells and …PIF”, this does not overcome the rejection because the patented claims recite “comprising administering a PIF peptide,” which is open-ended claim language (see 2111.03(I)) that does not exclude additional elements such as stem cells. Therefore, the patented claims still anticipate the instant claims and a terminal disclaimer must be filed in order to obviate this rejection.
As currently amended, Claims 1-5, 9-15 and 22-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,090,355, for reasons of record in the previous Office action. The patented claims are directed to a method of improving the clinical outcome in a subject suffering with, diagnosed with, or suspected of having acute neurotrauma comprising administering to the subject a pharmaceutical composition comprising: (i) a therapeutically effective amount of preimplantation factor (PIF) peptide, an analog thereof, or a pharmaceutically acceptable salt thereof; and (ii) a pharmaceutically acceptable carrier, wherein the acute neurotrauma comprises acute traumatic brain injury (TBI), acute spinal cord injury (SCI) and/or acute peripheral nerve injury. This anticipates the traumatic injury of instant claim 11 and the peripheral nerve injury of instant claim 12. Additionally, although not claimed per se, the disclosure of the ‘355 Patent teaches the traumatic injury to the CNS encompassed by the reference claims includes concussion (see Column 3, lines 20-21). Therefore, Patented claims drawn to acute neurotrauma comprising acute traumatic brain injury (TBI), acute spinal cord injury (SCI) and/or acute peripheral nerve injury, also encompass the concussion of instant claims 24-28.
As stated above, although Applicant has added the limitation, “co-administering to the subject; stem cells and …PIF”, this does not overcome the rejection because the patented claims recite open-ended claim language (“comprising administering a PIF peptide”) that does not exclude additional elements such as stem cells (see MPEP 2111.03(I)). Therefore, the patented claims still anticipate the instant claims and a terminal disclaimer must be filed in order to obviate this rejection.
Conclusion
No claim is allowed at this time.
Applicant's amendment necessitated any new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STACEY NEE MACFARLANE whose telephone number is (571)270-3057. The examiner can normally be reached M-F 7:30-5 (EST) & Sat. A.M..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STACEY N MACFARLANE/Examiner, Art Unit 1675
/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675