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 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 and 28-30 of copending Application No. 18718194 (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 method claims of the reference application are a contemplated utility of the instant product claims. 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. discloses a "fluorescent DNA biosensor for detecting base mismatching using a cationic comb-shaped copolymer". Page 7 indicates that the copolymer (PLL-g-Dex) increases the Tm of dsDNA, and as a consequence, stabilizes the multistage DNA structure, and that the increase in Tm is such that cDNA > M2 >M1 > M3 (C-G > C-A > > C-C).
US 2004/0265823 discloses "a method for determining mismatching between single-strand nucleic acid molecules". Example 2 contains the wording " a complementary double strand and a double-strand containing a single nucleotide mutation were respectively prepared from F2 and M2, M2misG, M2misA and M2misC.. The melting temperature under different conditions are brought together in Table 2. Regardless of the presence/absence of PLL-g-Dex, the melting temperatures were all close to one another, with the maximum difference being 7°C. In addition, the transcription width of melting overlaps for all sequences. That is to say, this shows that it is difficult to strictly distinguish between these sequences in measuring melting temperature and in normal hybridization.
US 2002/0164614 discloses "a method and kit for increasing the association rate of a polynucleotide". Paragraphs [0101]-[0110] disclose a "polycationic polymer". Paragraph [0094] indicates that "it is known that a polycationic polymer markedly raises the T,,, of the double strand of a nucleic acid".
However, none of these prior arts disclose an "agent for raising the melting temperature of a double-strand nucleic acid containing an amphoteric copolymer containing: at least one type of cationic structural unit (1) selected from the group consisting of a structural 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, 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) selected from the group consisting of a structural unit (2-1) having a structure represented by general formula (II-a), and a structural unit (2-4) having a structure represented by general formula (II-d).
Claims 4-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEZIA RILEY whose telephone number is (571)272-0786. The examiner can normally be reached 7:30-6:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEZIA RILEY/Primary Examiner, Art Unit 1681 20 August 2026
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