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
Applicant’s arguments, filed 9/22/2025, have been fully considered but they are not deemed to be fully persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 31-32, 34-36 and 38-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 13 of U.S. Patent No. 11045491. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to a method of treatment of a parenteral viral infection in a subject comprising systemically administering to the subject a copolymer comprising an acrolein-derived segment and a polyalkylene glycol oligomer segment, the copolymer having a molecular weight of no more than 1000 Daltons, wherein the copolymer is administered by a route selected from the group consisting of: oral administration, inhalation, transdermal delivery, injection and infusion (patent claim 1), wherein the acrolein-derived segment is a polyacrolein oligomer comprising two or more acrolein residues (patent claim 2), wherein the copolymer has a molecular weight of from 300 to 1000 Daltons (patent claim 3), wherein the polyalkylene glycol oligomer segment has a molecular weight in the range of from 200 to 600 Daltons (patent claim 4), wherein the polyalkylene glycol oligomer segment has a molecular weight in the range of from 200 to 400 Daltons (patent claim 5), wherein a polyalkylene glycol of the polyalkylene glycol oligomer segment is polyethylene glycol (patent claim 6), wherein the copolymer is administered by oral administration (patent claim 7), wherein the copolymer is administered by intravenous injection or infusion (patent claim 8), wherein the copolymer is administered as an aqueous solution comprising a copolymer concentration in the range of from 0.01% by weight to 20% by weight of the aqueous solution (patent claim 9), wherein the copolymer is administered orally in the form of a tablet, caplet, syrup or liquid (patent claim 10), wherein the copolymer is administered systemically at a dose in the range of from 1 mg to 1000 mg per kilogram of bodyweight per day (patent claim 11), wherein the parenteral viral infection is selected from the group consisting of a influenza viral infection, an HIV infection, a hepatitis viral infection, a Ross River viral infection, and a herpes viral infection (patent claim 12), wherein the parenteral viral infection is an influenza viral infection (patent claim 13). The difference between the instant and patent claims is that the instant claims are directed to a molecular weight of 400 to 800 Daltons, whereas the patent claims recite a molecular weight of no more than 1000 Daltons, and the more narrower from 300 to 1000 Daltons (patent claim 3), and from 200 to 600 Daltons (patent claim 4). However, it would have been obvious to find the present range of 400 to 800 daltons through routine experimentation in the course of optimizing the molecular weight to provide for an improved method of treatment of a parenteral viral infection in a subject, and in this way, would find the present range of 400 to 800 daltons. The patent claims provide sufficient guidance to his end, as no more than 1000 Daltons, 300 to 1000 Daltons, and 200 to 600 Daltons overlaps with the presently claimed range.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
September 29, 2025
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