DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Application, Amendments and/or Claims
1. Claims 1 and 5 have been amended, claims 4 and 6-22 have been canceled, and new claims 23-29 have been added as requested in the amendment filed October 21, 2021. Following the amendment, claims 1-3, 5 and 23-29 are pending in the present application.
2. Claims 1-3, 5 and 23-29 are under examination in the current office action.
Information Disclosure Statement
3. The information disclosure statement (IDS) filed 02/25/2021 has been considered and the references therein are of record.
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.
4. Claims 1-3, 5 and 23-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 1-26 of U.S. Patent No. 10,383,887 (hereinafter the ‘887 patent); and
Claims 1-18 of U.S. Patent No. 10,960,019 (hereinafter the ‘019 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the claims encompass the therapeutic administration of at least one unmethylated class B CpG motif, having a phosphorothioate backbone with one or more CpG dinucleotides (CpG ODNs) to a subject having amyloid deposits, one per month, for a period of at least 10 months, and at the same dosage (i.e., 1 mg to 10 mg per administration; 10 mg to 10 mg per administration; 2.5 mg/kg body weight). The patented ‘887 and ‘019 claims each recite that the subject has Alzheimer’s disease (AD) or cerebral amyloidosis; both of these diseases are characterized by amyloid deposits within the brain and central nervous system (CNS). The patented methods also recite that the administering step is effective to stimulate an innate immune response that reduces brain amyloid-beta deposition, aggregated tau deposition, and cerebral vascular amyloid-beta deposition, without causing cerebral microhemorrhage and without toxicity. Hence, the methods for treating AD or cerebral amyloidosis, as recited by the ‘887 and ‘019 patented claims, anticipate the presently claimed method of reducing amyloid deposition in a subject.
The patented claims further recite that the administered oligonucleotide has a nucleotide sequence selected from SEQ ID NOs: 1-9, which are identical sequences to the instantly claimed SEQ ID NOs: 1-9 in present claim 5.
Finally, the ‘887 claims recite that the administration is once per month for 10-14 months, with individual claims reciting administration for 11, 12, 13 and 14 months, which anticipates present claims 25-29. Similarly, and the ‘019 patent recites administration for at least 10 months, which renders obvious present claims 25-29.
Conclusion
5. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly A. Ballard whose telephone number is (571)272-2150. The examiner can normally be reached Mon-Fri 8AM - 5PM EST.
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/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675