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 .
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 1-20 and 28-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18715009 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an amphoteric copolymer comprising at least one type of cationic constituent unit (1) selected from the group consisting of a constituent unit (1-1) having a structure represented by general formula (I-a) or general formula (I-b), or a structure of an acid addition salt thereof of identical formula; a constituent unit (1-4) having a structure represented by general formula (1-f), or a structure of an acid addition salt thereof of identical formula; and at least one type of anionic constituent unit (2) selected from the group consisting of a constituent unit (2-1) having a structure represented by general formula (II-a) and a constituent unit (2-4) having a structure represented by general formula (II-d) of identical formula. They both claim that the amphoteric polymer can further comprise a nonionic constituent unit (3) derived from methacrylamide-based monomer, or an acrylamide-based monomer. The present method claims are a contemplated utility of the product described by the potentially conflicting claims of the reference application. See: MPEP 804(II)(B)(1) and MPEP 804(II)(B)(2)(a).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Closest prior arts
HAN, Jialun et al., Fluorescent DNA Biosensor for Single-Base Mismatch Detection Assisted by Cationic Comb-Type Copolymer, Molecules, 05 February 2019, vol. 24, no. 3, 575.
Han Jialun et al. describes a "fluorescent DNA biosensor for single-base mismatch detection that uses a cationic comb-type copolymer." Page 7 indicates that the copolymer (PLL-g-Dex) raises the Tm of dsDNA and thereby stabilizes multilevel DNA structures, the enhancement of the Tm being cDNA>M2>M1>M3 (C-G>C-A>C-T>C-C).
US 2004/0265823 describes a "method for determining mismatches between single-stranded nucleic acid molecules." In example 2, "A completely complementary double strand and a double strand that included a single-base mutation were prepared from F2 and each of M2, M2misG, M2misA, and M2misC. The melting temperatures under each condition are shown in table 1. The melting temperatures were close regardless of the presence of PLL-g-Dex. with a maximum difference of 7°C. Moreover, the melting shifts for all of the sequences overlapped. This shows that it would be difficult to strictly distinguish these sequences by melting temperature measurement or common hybridization methods."
US 2002/0164614 describes a "method and kit for enhancing the association rates of polynucleotides." Paragraphs [0092]-[0101] describe "polycationic polymers." Paragraph [0094] indicates that "polycationic polymers are known to significantly increase the Tₘ of nucleic acid duplexes."
However, none of these prior arts disclose an "an amphoteric copolymer containing: at least one type of cationic structural unit (1) are a constituent unit (1-1), (1-3), or (1-4) having a structure represented by general formula (I-a), (I-b) (I-e) or (I-f) or a structure of an acid addition salt thereof, a structural unit (1-4) having a structure represented by general formula (I-f) or a structure of an acid addition salt thereof; and at least one type of anionic structural unit (2) are a constituent unit (2-1), (2-2), or (2-4) having a structure represented by general formula (II-a), (II-b) or (II-d).
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/JEZIA RILEY/ Primary Examiner, Art Unit 1681 22 August 2026
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