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 .
Claims 1, 8, 9, 16, 18, 26, 27, 29, 33, 34, 37, 38, 41-45, and 47 are pending and examined on their merits herein.
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 1, 8, 9, 16, 18, 26, 27, 29, 33, 34, 37, 38, 41-45, are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-19 and 21 of U.S. Patent No. US11673911B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patented claim is drawn to an mRNA encoded by the DNA of claim 1, which is drawn to a DNA comprising nucleotides encoding a poly-A tail located 3′ to nucleotides encoding a protein of interest, wherein the poly-A tail comprises: a. three or more homopolymer sequences of at least 8 consecutive adenine (A) nucleotides; and b. an interrupting sequence comprising: one non-adenine nucleotide; or a consecutive stretch of 2-10 non-adenine nucleotides, between each homopolymer sequence; and the DNA encoding such
The instant claims are drawn to an mRNA comprising a poly-A tail located 3' to nucleotides encoding a protein of interest, wherein the poly-A tail comprises three or more homopolymer sequences each comprising 8-50 consecutive adenine nucleotides, wherein the three or more homopolymer sequences each have a different length of consecutive adenine nucleotides; and an interrupting sequence of two or more consecutive non-adenine nucleotides positioned between each of the three or more homopolymer sequences so that a poly(A) binding protein can bind to a stretch of consecutive adenine nucleotides; and the DNA encoding such.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1, 8, 9, 16, 18, 26, 27, 29, 33, 34, 37, 38, 41-45, are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-19 and 21-22 of U.S. Patent No. US11673911B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patented claim is drawn to an mRNA encoded by claim 1 which is a DNA comprising nucleotides encoding a poly-adenylated (poly-A) tail located 3′ to nucleotides encoding a protein of interest, wherein the poly-A tail comprises:
(a) a plurality of homopolymer sequences of 8, 9, 10, 11, and/or 12 consecutive adenine (A) nucleotides; and
(b) an interrupting sequence between each homopolymer sequence, wherein the interrupting sequence comprises:
(i) a dinucleotide comprising two consecutive non-adenine nucleotides; or
(ii) a trinucleotide that does not include a terminal adenine (A).
Or an mRNA comprising a poly-adenylated (poly-A) tail located 3′ to nucleotides encoding a protein of interest, wherein the poly-A tail comprises:
(a) a plurality of homopolymer sequences of 11 or 12 consecutive adenine (A) nucleotides; and
(b) an interrupting sequence between each homopolymer sequence, wherein the interrupting sequence comprises:
(i) a dinucleotide comprising two consecutive non-adenine nucleotides; or
(ii) a trinucleotide that does not include a terminal adenine (A).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Conclusion
No claims are allowed.
Claims 1, 8, 9, 16, 18, 26, 27, 29, 33, 34, 37, 38, 41-45, are rejected. Claim 47 is objected for being dependent on rejected base claims.
Claims 1, 8, 9, 16, 18, 26, 27, 29, 33, 34, 37, 38, 41-45, and 47 are free of the prior art. The closest prior art is Eberle et al. (US 20170166905A1), which teaches a nucleic acid molecule comprising in the 5'-->3' direction of transcription a promoter; a transcribable nucleic acid sequence; and a nucleic acid sequence which encodes a nucleotide sequence of at least 80 consecutive nucleotides in the transcript, wherein said nucleotide sequence of at least 80 consecutive nucleotides in the transcript is a polyadenyl sequence comprising within the polyadenyl sequence a sequence of one or more consecutive nucleotides containing nucleotides other than A.
Eberle, however, does not teach a specific length of consecutive thymine nucleotides within the plurality of thymine nucleotides, or more than one additional interrupting sequences within the polyadenyl sequence in order to provide three or more homopolymeric poly-A sequences, wherein the interrupting sequences in poly-A tails between each of three or more homopolymer sequences of 8-50 consecutive adenine (A) nucleotides.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WEIHUA FAN whose telephone number is (571)270-0398. The examiner can normally be reached Monday-Friday, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A Abraham can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663
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