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 49-68 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10, 14, 23 and 26 of U.S. Patent No. 10,669,299. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a dye-labeled compound of identical structural formula comprising a donor dye; an acceptor dye; a shield element; a terminal coupling element; and a dye compound linker element; wherein the dye compound linker element covalently connects the terminal coupling element to the donor dye, the acceptor dye, or the shield element; wherein the shield element can comprises a plurality of side chains; wherein at least one side chain comprises a negatively-charged component; and at least two terminal coupling elements (see formula of patent claim 1 comprising 2 B” being terminal coupling elements). With regards to claims 60-64, the formula of patent claim 1 can comprise multiple donors and acceptors see integers r” and s.
Claims 49-60, 65-68 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 12, 21 and 22 of U.S. Patent No. 11,203,689. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a dye-labeled compound of identical structural formula comprising a donor dye; an acceptor dye; a shield element; a terminal coupling element; and a dye compound linker element; wherein the dye compound linker element covalently connects the terminal coupling element to the donor dye, the acceptor dye, or the shield element; wherein the shield element can comprises a plurality of side chains; wherein at least one side chain comprises a negatively-charged component; and at least two terminal coupling elements.
Claims 49-68 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-11, 15, 24-25 and 26 of U.S. Patent No. 11,884,826. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a dye-labeled compound of identical structural formula comprising a donor dye; an acceptor dye; a shield element; a terminal coupling element; and a dye compound linker element; wherein the dye compound linker element covalently connects the terminal coupling element to the donor dye, the acceptor dye, or the shield element; wherein the shield element can comprises a plurality of side chains; wherein at least one side chain comprises a negatively-charged component; and at least two terminal coupling elements (see formula of patent claim 1 comprising 2 B” being terminal coupling elements). With regards to claims 60-64, the formula of patent claim 1 can comprise multiple donors and acceptors see integers r” and s.
Claims 49-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 14 of U.S. Patent No.9957291. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a compound of similar formula comprising a fluorescent dye element which is viewed to be inclusive of the instant donor and acceptor dyes; a shield element which comprise a plurality of side chains; a terminal coupling element; a branching element (which is viewed to be identical to the instant linker element ) which connects to the terminal coupling element. With regards to claims 50-64, the formula of patent claim 1 can comprise multiple donors and acceptors see integers in the US patent claims 31-33.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 49-68 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bjornson et al. US 20130316912.
Bjornson et al. discloses a compound identical to the instant compound. For example Figure 28 shows two dyes linked to a terminal coupling element via a linker element, wherein the terminal coupling element comprises a biotin moiety. Bjornson et al. teaches introducing sulfonate groups to include one or more six membered aromatic rings each having multiple sulfonate groups attached to it, which they refer to as a kinetic modifier group, for example, a six membered aromatic ring having 2, 3, 4, or 5 sulfonate groups attached. (Page 16). They have found that the inclusion of 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 of these kinetic modifier groups can produce a protein shielded nucleotide analog with improved kinetic performance in sequencing (which is viewed as the instant shield element comprising negatively-charged component). Figure 36 shows a shield element comprising a plurality of side chains and two terminal coupling elements. ([0161]-[163]; [0171]; Figure 36). Bjornson et al. also teaches “The dye component can have one or more dye moiety. For example, the nucleotide analog can have from about 1 to about 100 dye moieties, about 1 to 50 dye moieties, about 1 to about 18 dyes moieties, or 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, or 18 dye moieties. In some cases, the nucleotide analog has at least about 1 to about 18 dyes moieties, or at least about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, or 18 dye moieties. In some cases the dye component includes FRET dyes, for example having one donor and one acceptor, two donors and one acceptor, two donors and two acceptors, etc.[0138]. Bjornson et al. teaches a wide variety of different types of fluorophores are readily available and applicable to the compounds of the invention and include fluorescein, or rhodamine based dyes, cyanine dyes and the like. [0175]
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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/JEZIA RILEY/Primary Examiner, Art Unit 1681 21 July 2026
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