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 .
Withdrawn Rejections
The rejection of claims 14, 16 and 17 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/440546 (now U.S. Patent No. 12589149) (reference application) has been withdrawn in view of applicant’s submission and the Office’s approval of a Terminal Disclaimer.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 14 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Douce et al. (Infection and Immunity, Sept. 1999, 67(9):4400–4406) and as evidenced by Scherzad et al. (Journal of Inflammation Research, 2019,12: 309–317).
The instant claims are directed to a method for inducing IFNα production in epithelial cells of a subject, comprising administering to the epithelial cells of the subject a therapeutically effective amount of an immunomodulator, wherein the immunomodulator is a detoxified Escherichia coli labile toxin (LT) or Vaxfectin.
Douce et al. teaches administering Escherichia coli heat-labile toxin (LT) intranasally (see, for example, the abstract). As evidenced by Scherzad et al., the nasal passages contain epithelial cells (see page 309). Accordingly, the method of Douce et al. will induce IFNα production in the epithelial cells present in the nasal passages, which is part of the respiratory tract.
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 14, 16 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of copending Application No. 18/374118 (reference application).
The instant claims are directed to a method of inducing IFNα production in epithelial cells of a subject, comprising administering to the epithelial cells of the subject a therapeutically effective amount of an immunomodulator, wherein the immunomodulator is a detoxified Escherichia coli labile toxin (LT) or Vaxfectin.
The copending claims are directed to a method for vaccinating a subject against a mucosal virus infection, comprising administering to the subject an immunologically effective amount of an intranasal booster, wherein the intranasal booster comprises detoxified Escherichia coli labile toxin (LT) and an antigen from the mucosal virus, and wherein the subject has been previously primed, where wherein the detoxified Escherichia coli labile toxin (LT) is LTh(αK).
The nasal passages are part of the respiratory tract, and because the copending claims teach the same active steps of claim 14, the method of the copending claims will also induce IFNα production in the epithelial cells present in the nasal passages.
Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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