DETAILED ACTION
Status of the Claims
Claims 264-283 are currently pending and are examined herein.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 06/16/2023, 03/25/2024, and 11/13/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Restriction Requirement
Applicant’s election without traverse of Species I-IV in the reply filed on 11/10/2025 is acknowledged.
Subsequent to a prior art search and upon further consideration, all species election requirements are withdrawn.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 264-278, 280, and 282-283 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
Claim 264 recites a product comprising a fluorescent dye moiety and a linker that is connected to said fluorescent dye moiety and wherein said linker comprises at least five non-proteinogenic amino acids. The claim reasonably encompasses embodiments that are either naturally occurring, or are non-naturally occurring but lacking markedly different characteristics as compared to their naturally occurring counterparts, and therefore are “product of nature” judicial exceptions as per MPEP 2106.04(c). Specifically, the product encompasses mature human Type III collagen as detailed in the anticipation rejection herein. Claims 265-278, 280, and 282-283 are similarly rejected as they also read on the naturally occurring protein (also detailed herein).
Therefore, it can be reasonably concluded that the analysis for patent eligibility fails Prong One of Step 2A, and the claim must be further analyzed in the Step 2A Prong Two and Step 2B to determine whether the claim as a whole integrates the exception into a practical application or there are additional elements that amount to significantly more than the judicial exception. Relevant considerations for evaluating whether additional elements integrate a judicial exception into a practical application, based on the Supreme Court and Federal Circuit, are discussed at length in MPEP 2106.04(d) and in the Federal Register (Vol. 84, No. 4, from January 7, 2019). In the present case, there are no “additional elements” and therefore nothing that can transform the claim into something patent eligible. See MPEP 2106.04(d).
For further information, please see the latest revision of MPEP § 2104-2106 {Patent Subject Matter Eligibility Under 35 U.S.C. 101}, including MPEP § 2106.04 {Eligibility Step 2A: Whether a Claim is Directed to a Judicial Exception} and 2106.05 {Eligibility Step 2B: Whether a Claim Amounts to Significantly More}, as well as any additional guidance on Subject Matter Eligibility, provided on the USPTO website at
https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility.
Claim Rejections – 35 U.S.C. 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Boudko et al.
Claims 264-278, 280, and 282-283 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boudko et al. (J. Mol. Biol. (2004) 335, 1289–1297) as evidenced by Banerjee et al. (Journal of Investigative Medicine, 1999, 47(6):326-332), Seyer et al. (Biochemistry, 1981, 20:2621-2627), and Uniprot (Uniprot entry P02461).
Regarding claim 264, Boudko discloses a reagent comprising:
(a) a fluorescent dye moiety (e.g., autofluorescence from tryptophans and tyrosines as per Banerjee et al., see Table 2); and
(b) a linker that is connected to said fluorescent dye moiety and configured to couple to a substrate for fluorescently labelling said substrate, wherein said linker comprises at least five non-proteinogenic amino acids (e.g., hydroxyprolines as per Fig. 1 of Seyer et al.).
Regarding claim 265, Boudko discloses the fluorescent labeling reagent of claim 264, further comprising a second fluorescent dye moiety, wherein said fluorescent dye moiety and said second fluorescent dye moiety are connected by said linker (e.g., amino acids between tryptophans and/or tyrosines as per Fig. 1 of Steyer et al.).
Regarding claim 266, Boudko discloses the fluorescent labeling reagent of claim 265, wherein said fluorescent dye moiety and said second fluorescent dye moiety are capable of energy transfer mediated via fluorescence resonance energy transfer (e.g., tryptophans and/or tyrosines are fluorescent as per Banerjee et al.).
Regarding claim 267, Boudko discloses fluorescent labeling the reagent of claim 264, wherein at least a subset of said at least five non-proteinogenic amino acids are hydroxyproline moieties (e.g., as per Fig. 1 of Seyer et al.).
Regarding claim 268, Boudko discloses the fluorescent labeling reagent of claim 267, wherein said linker comprises twenty or more hydroxyproline moieties (e.g., as per Fig. 1 of Seyer et al.).
Regarding claim 269, Boudko discloses the fluorescent labeling reagent of claim 268, wherein said linker comprises thirty or more hydroxyproline moieties (e.g., as per Fig. 1 of Seyer et al.).
Regarding claim 270, Boudko discloses the fluorescent labeling reagent of claim 264, wherein said linker further comprises one or more glycine moieties (e.g., as per Fig. 1 of Seyer et al.).
Regarding claim 271, Boudko discloses the fluorescent labeling reagent of claim 264, wherein said linker comprises a repeating unit, wherein said repeating unit comprises one or more of said at least five non-proteinogenic amino acid moieties (e.g., as per Fig. 1 of Seyer et al.).
Regarding claim 272, Boudko discloses the fluorescent labeling reagent of claim 271, wherein said repeating unit comprises a glycine moiety (e.g., as per Fig. 1 of Seyer et al.).
Regarding claim 273, Boudko discloses the fluorescent labeling reagent of claim 271, wherein said repeating unit is repeated at least three times (e.g., as per Fig. 1 of Seyer et al.).
Regarding claim 274, Boudko discloses the fluorescent labeling reagent of claim 264, wherein, when said fluorescent labeling reagent is coupled to said substrate, said linker provides an average physical separation between said fluorescent dye moiety and said substrate of at least about 30 Angstroms (e.g., as per Uniprot structures).
Regarding claim 275, Boudko discloses the fluorescent labeling reagent of claim 274, wherein, when said fluorescent labeling reagent is coupled to said substrate, said linker provides an average physical separation between said fluorescent dye moiety and said substrate of at least about 60 Angstroms (e.g., as per Uniprot structures).
Regarding claim 276, Boudko discloses the fluorescent labeling reagent of claim 264, wherein said fluorescent labeling reagent further comprises a cleavable group that is configured to be cleaved to separate said fluorescent labeling reagent or portion thereof from said substrate (e.g., disulfide bonds as per Boudko).
Regarding claim 277, Boudko discloses the fluorescent labeling reagent of claim 276, wherein said cleavable group is selected from the group consisting of an azidomethyl group, a disulfide bond, a hydrocarbyldithiomethyl group, and a 2-nitrobenzyloxy group (e.g., disulfide bonds as per Boudko).
Regarding claim 278, Boudko discloses the fluorescent labeling reagent of claim 277, wherein said cleavable group is said disulfide bond (e.g., disulfide bonds as per Boudko).
Regarding the limitations of claims 280 and 282, which state that the substrate of claim 264 is a protein, it is noted that claim 264 recites that the reagent is “configured to couple to a substrate for fluorescently labelling said substrate”, which is a recitation of intended use of the instant claimed reagent and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, as per MPEP § 2115, “[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)), and that the manner or method in which a machine is to be utilized is not germane to the issue of patentability of the machine itself. See also MPEP § 2111.02, citing In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus).
Regarding claim 283, Boudko discloses the fluorescent labeling reagent of claim 264, wherein said substrate is a fluorescence quencher, a fluorescence donor, or a fluorescence acceptor (e.g., tryptophans and/or tyrosines as per Banerjee et al., see Table 2).
Yu et al.
Claims 264-267, 270-278, 280, and 282-283 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al. (Mol. Pharmaceutics (2019) 14:1906-1915).
Regarding claim 264, Yu discloses a reagent (e.g., collagen hybridizing peptides as per Table 2) comprising:
(a) a fluorescent dye moiety (e.g., carboxyfluorescein as per Table 2); and
(b) a linker that is connected to said fluorescent dye moiety and configured to couple to a substrate for fluorescently labelling said substrate, wherein said linker comprises at least five non-proteinogenic amino acids (e.g., linkers comprising hydroxyprolines as per Table 2).
Regarding claim 265, Yu discloses the fluorescent labeling reagent of claim 264, further comprising a second fluorescent dye moiety, wherein said fluorescent dye moiety and said second fluorescent dye moiety are connected by said linker (e.g., NIRF dyes as per the NIRF-CHP Conjugation Reaction section on pp. 1907-1908).
Regarding claim 266, Yu discloses the fluorescent labeling reagent of claim 265, wherein said fluorescent dye moiety and said second fluorescent dye moiety are capable of energy transfer mediated via fluorescence resonance energy transfer (e.g., carboxyfluorescein and NIRFs are fluorescent and are therefore capable of energy transfer via FRET).
Regarding claim 267, Yu discloses fluorescent labeling the reagent of claim 264, wherein at least a subset of said at least five non-proteinogenic amino acids are hydroxyproline moieties (e.g., as per Table 2).
Regarding claim 270, Yu discloses the fluorescent labeling reagent of claim 264, wherein said linker further comprises one or more glycine moieties (e.g., as per Table 2).
Regarding claim 271, Yu discloses the fluorescent labeling reagent of claim 264, wherein said linker comprises a repeating unit, wherein said repeating unit comprises one or more of said at least five non-proteinogenic amino acid moieties (e.g., as per Table 2).
Regarding claim 272, Yu discloses the fluorescent labeling reagent of claim 271, wherein said repeating unit comprises a glycine moiety (e.g., as per Table 2).
Regarding claim 273, Yu discloses the fluorescent labeling reagent of claim 271, wherein said repeating unit is repeated at least three times (e.g., as per Table 2).
Regarding claim 274, Yu discloses the fluorescent labeling reagent of claim 264, wherein, when said fluorescent labeling reagent is coupled to said substrate, said linker provides an average physical separation between said fluorescent dye moiety and said substrate of at least about 30 Angstroms (e.g., reagents comprise ~30 amino acids).
Regarding claim 275, Yu discloses the fluorescent labeling reagent of claim 274, wherein, when said fluorescent labeling reagent is coupled to said substrate, said linker provides an average physical separation between said fluorescent dye moiety and said substrate of at least about 60 Angstroms (e.g., reagents comprise ~30 amino acids).
Regarding claim 276, Yu discloses the fluorescent labeling reagent of claim 264, wherein said fluorescent labeling reagent further comprises a cleavable group that is configured to be cleaved to separate said fluorescent labeling reagent or portion thereof from said substrate (e.g., disulfide bonds or 2-nitrobenzyloxy group as per Table 2 and the NIRF Conjugation Reaction section on pp. 1907-1908).
Regarding claim 277, Yu discloses the fluorescent labeling reagent of claim 276, wherein said cleavable group is selected from the group consisting of an azidomethyl group, a disulfide bond, a hydrocarbyldithiomethyl group, and a 2-nitrobenzyloxy group (e.g., disulfide bonds or 2-nitrobenzyloxy group as per Table 2 and the NIRF Conjugation Reaction section on pp. 1907-1908).
Regarding claim 278, Yu discloses the fluorescent labeling reagent of claim 277, wherein said cleavable group is said disulfide bond (e.g., disulfide bonds as per the NIRF Conjugation Reaction section on pp. 1907-1908).
Regarding the limitations of claims 280 and 282, which state that the substrate of claim 264 is a protein, it is noted that claim 264 recites that the reagent is “configured to couple to a substrate for fluorescently labelling said substrate”, which is a recitation of intended use of the instant claimed reagent and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, as per MPEP § 2115, “[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)), and that the manner or method in which a machine is to be utilized is not germane to the issue of patentability of the machine itself. See also MPEP § 2111.02, citing In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus).
Regarding claim 283, Yu discloses the fluorescent labeling reagent of claim 264, wherein said substrate is a fluorescence quencher, a fluorescence donor, or a fluorescence acceptor (e.g., carboxyfluorescein and NIRFs are fluorescence donors and acceptors).
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
U.S. 18/803,016
Claims 264-269, 271, and 273-283 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 101-120 of copending Application No. 18/803,016 (the ‘016 application). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 264, The claims of the ‘016 application disclose a fluorescent labeling reagent comprising (a) a fluorescent dye moiety; and (b) a linker that is connected to said fluorescent dye moiety and configured to couple to a substrate for fluorescently labelling said substrate, wherein said linker comprises at least five non-proteinogenic amino acids (e.g., as per claim 101 of the ‘016 application).
Regarding claim 265, The claims of the ‘016 application disclose the fluorescent labeling reagent of claim 264, further comprising a second fluorescent dye moiety, wherein said fluorescent dye moiety and said second fluorescent dye moiety are connected by said linker (e.g., as per claim 101 of the ‘016 application).
Regarding claim 266, The claims of the ‘016 application disclose the fluorescent labeling reagent of claim 265, wherein said fluorescent dye moiety and said second fluorescent dye moiety are capable of energy transfer mediated via fluorescence resonance energy transfer (FRET) (e.g., as per claim 101 of the ‘016 application).
Regarding claim 267, The claims of the ‘016 application disclose fluorescent labeling the reagent of claim 264, wherein at least a subset of said at least five non-proteinogenic amino acids are hydroxyproline moieties (e.g., as per claim 105 of the ‘016 application).
Regarding claim 268, The claims of the ‘016 application disclose the fluorescent labeling reagent of claim 267, wherein said linker comprises twenty or more hydroxyproline moieties (e.g., as per claim 105 of the ‘016 application).
Regarding claim 269, The claims of the ‘016 application disclose the fluorescent labeling reagent of claim 268, wherein said linker comprises thirty or more hydroxyproline moieties (e.g., as per claim 105 of the ‘016 application).
Regarding claim 271, The claims of the ‘016 application disclose the fluorescent labeling reagent of claim 264, wherein said linker comprises a repeating unit, wherein said repeating unit comprises one or more of said at least five non-proteinogenic amino acid moieties (e.g., as per claim 105 of the ‘016 application).
Regarding claim 273, The claims of the ‘016 application disclose the fluorescent labeling reagent of claim 271, wherein said repeating unit is repeated at least three times (e.g., as per claim 105 of the ‘016 application).
Regarding claim 274, The claims of the ‘016 application disclose the fluorescent labeling reagent of claim 264, wherein, when said fluorescent labeling reagent is coupled to said substrate, said linker provides an average physical separation between said fluorescent dye moiety and said substrate of at least about 30 Angstroms (Å) (e.g., as per claim 105 of the ‘016 application).
Regarding claim 275, The claims of the ‘016 application disclose the fluorescent labeling reagent of claim 274, wherein, when said fluorescent labeling reagent is coupled to said substrate, said linker provides an average physical separation between said fluorescent dye moiety and said substrate of at least about 60 Angstroms (Å) (e.g., as per claim 105 of the ‘016 application).
Regarding claim 276, The claims of the ‘016 application disclose the fluorescent labeling reagent of claim 264, wherein said fluorescent labeling reagent further comprises a cleavable group that is configured to be cleaved to separate said fluorescent labeling reagent or portion thereof from said substrate (e.g., as per claim 109 of the ‘016 application).
Regarding claim 277, The claims of the ‘016 application disclose the fluorescent labeling reagent of claim 276, wherein said cleavable group is selected from the group consisting of an azidomethyl group, a disulfide bond, a hydrocarbyldithiomethyl group, and a 2-nitrobenzyloxy group (e.g., as per claim 110 of the ‘016 application).
Regarding claim 278, The claims of the ‘016 application disclose the fluorescent labeling reagent of claim 277, wherein said cleavable group is said disulfide bond (e.g., as per claim 111 of the ‘016 application).
Regarding claim 279, The claims of the ‘016 application disclose the fluorescent labeling reagent of claim 264, wherein said fluorescent labeling reagent comprises a moiety selected
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(e.g., as per claim 113 of the ‘016 application)
Regarding claim 280, The claims of the ‘016 application disclose the fluorescent labeling reagent of claim 264, wherein said substrate is a nucleotide, polynucleotide, protein, lipid, cell, saccharide, polysaccharide, or antibody (e.g., as per claim 1 of the ‘016 application).
Regarding claim 281, The claims of the ‘016 application disclose the fluorescent labeling reagent of claim 280, wherein said substrate is said nucleotide and said fluorescent labeling reagent is attached to said nucleotide via the nucleobase of said nucleotide (e.g., as per claim 102 of the ‘016 application).
Regarding claim 282, The claims of the ‘016 application disclose the fluorescent labeling reagent of claim 280, wherein said substrate is said protein (e.g., as per claim 103 of the ‘016 application).
Regarding claim 283, The claims of the ‘016 application disclose the fluorescent labeling reagent of claim 264, wherein said substrate is a fluorescence quencher, a fluorescence donor, or a fluorescence acceptor (e.g., as per claim 101 of the ‘016 application).
11,946,097 B2
Claims 264-269, 271, and 273-283 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,946,097 B2 (the ‘097 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claim 264, The claims of the ‘097 patent disclose a fluorescent labeling reagent comprising (a) a fluorescent dye moiety; and (b) a linker that is connected to said fluorescent dye moiety and configured to couple to a substrate for fluorescently labelling said substrate, wherein said linker comprises at least five non-proteinogenic amino acids (e.g., as per claims 1-8 of the ‘097 patent).
Regarding claim 265, The claims of the ‘097 patent disclose the fluorescent labeling reagent of claim 264, further comprising a second fluorescent dye moiety, wherein said fluorescent dye moiety and said second fluorescent dye moiety are connected by said linker (e.g., as per claims 1-8 of the ‘097 patent).
Regarding claim 266, The claims of the ‘097 patent disclose the fluorescent labeling reagent of claim 265, wherein said fluorescent dye moiety and said second fluorescent dye moiety are capable of energy transfer mediated via fluorescence resonance energy transfer (FRET) (e.g., as per claims 1-8 of the ‘097 patent).
Regarding claim 267, The claims of the ‘097 patent disclose fluorescent labeling the reagent of claim 264, wherein at least a subset of said at least five non-proteinogenic amino acids are hydroxyproline moieties (e.g., as per claims 1-8 of the ‘097 patent).
Regarding claim 268, The claims of the ‘097 patent disclose the fluorescent labeling reagent of claim 267, wherein said linker comprises twenty or more hydroxyproline moieties (e.g., as per claims 1-8 of the ‘097 patent).
Regarding claim 269, The claims of the ‘097 patent disclose the fluorescent labeling reagent of claim 268, wherein said linker comprises thirty or more hydroxyproline moieties (e.g., as per claims 1-8 of the ‘097 patent).
Regarding claim 271, The claims of the ‘097 patent disclose the fluorescent labeling reagent of claim 264, wherein said linker comprises a repeating unit, wherein said repeating unit comprises one or more of said at least five non-proteinogenic amino acid moieties (e.g., as per claims 1-8 of the ‘097 patent).
Regarding claim 273, The claims of the ‘097 patent disclose the fluorescent labeling reagent of claim 271, wherein said repeating unit is repeated at least three times (e.g., as per claims 1-8 of the ‘097 patent).
Regarding claim 274, The claims of the ‘097 patent disclose the fluorescent labeling reagent of claim 264, wherein, when said fluorescent labeling reagent is coupled to said substrate, said linker provides an average physical separation between said fluorescent dye moiety and said substrate of at least about 30 Angstroms (Å) (e.g., as per claims 1-8 of the ‘097 patent).
Regarding claim 275, The claims of the ‘097 patent disclose the fluorescent labeling reagent of claim 274, wherein, when said fluorescent labeling reagent is coupled to said substrate, said linker provides an average physical separation between said fluorescent dye moiety and said substrate of at least about 60 Angstroms (Å) (e.g., as per claims 1-8 of the ‘097 patent).
Regarding claim 276, The claims of the ‘097 patent disclose the fluorescent labeling reagent of claim 264, wherein said fluorescent labeling reagent further comprises a cleavable group that is configured to be cleaved to separate said fluorescent labeling reagent or portion thereof from said substrate (e.g., as per claim 12 of the ‘097 patent).
Regarding claim 277, The claims of the ‘097 patent disclose the fluorescent labeling reagent of claim 276, wherein said cleavable group is selected from the group consisting of an azidomethyl group, a disulfide bond, a hydrocarbyldithiomethyl group, and a 2-nitrobenzyloxy group (e.g., as per claim 13 of the ‘097 patent).
Regarding claim 278, The claims of the ‘097 patent disclose the fluorescent labeling reagent of claim 277, wherein said cleavable group is said disulfide bond (e.g., as per claim 14 of the ‘097 patent).
Regarding claim 279, The claims of the ‘097 patent disclose the fluorescent labeling reagent of claim 264, wherein said fluorescent labeling reagent comprises a moiety selected
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(e.g., as per claim 14 of the ‘097 patent)
Regarding claim 280, The claims of the ‘097 patent disclose the fluorescent labeling reagent of claim 264, wherein said substrate is a nucleotide, polynucleotide, protein, lipid, cell, saccharide, polysaccharide, or antibody (e.g., as per claim 1 of the ‘097 patent).
Regarding claim 281, The claims of the ‘097 patent disclose the fluorescent labeling reagent of claim 280, wherein said substrate is said nucleotide and said fluorescent labeling reagent is attached to said nucleotide via the nucleobase of said nucleotide (e.g., as per claim 1 of the ‘097 patent).
Regarding claim 282, The claims of the ‘097 patent disclose the fluorescent labeling reagent of claim 280, wherein said substrate is said protein (e.g., as per claim 3 of the ‘097 patent).
Regarding claim 283, The claims of the ‘097 patent disclose the fluorescent labeling reagent of claim 264, wherein said substrate is a fluorescence quencher, a fluorescence donor, or a fluorescence acceptor (e.g., as per claim 1 of the ‘097 patent).
12,378,600 B2
Claims 264-269, 271, and 273-283 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,378,600 B2 (the ‘600 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claim 264, The claims of the ‘600 patent disclose a fluorescent labeling reagent comprising (a) a fluorescent dye moiety; and (b) a linker that is connected to said fluorescent dye moiety and configured to couple to a substrate for fluorescently labelling said substrate, wherein said linker comprises at least five non-proteinogenic amino acids (e.g., as per claims 1 and 16-17 of the ‘600 patent).
Regarding claim 265, The claims of the ‘600 patent disclose the fluorescent labeling reagent of claim 264, further comprising a second fluorescent dye moiety, wherein said fluorescent dye moiety and said second fluorescent dye moiety are connected by said linker (e.g., as per claims 1 and 16-17 of the ‘600 patent).
Regarding claim 266, The claims of the ‘600 patent disclose the fluorescent labeling reagent of claim 265, wherein said fluorescent dye moiety and said second fluorescent dye moiety are capable of energy transfer mediated via fluorescence resonance energy transfer (FRET) (e.g., as per claims 1 and 16-17 of the ‘600 patent).
Regarding claim 267, The claims of the ‘600 patent disclose fluorescent labeling the reagent of claim 264, wherein at least a subset of said at least five non-proteinogenic amino acids are hydroxyproline moieties (e.g., as per claims 1 and 16-17 of the ‘600 patent).
Regarding claim 268, The claims of the ‘600 patent disclose the fluorescent labeling reagent of claim 267, wherein said linker comprises twenty or more hydroxyproline moieties (e.g., as per claims 1 and 16-17 of the ‘600 patent).
Regarding claim 269, The claims of the ‘600 patent disclose the fluorescent labeling reagent of claim 268, wherein said linker comprises thirty or more hydroxyproline moieties (e.g., as per claims 1 and 16-17 of the ‘600 patent).
Regarding claim 271, The claims of the ‘600 patent disclose the fluorescent labeling reagent of claim 264, wherein said linker comprises a repeating unit, wherein said repeating unit comprises one or more of said at least five non-proteinogenic amino acid moieties (e.g., as per claims 1 and 16-17 of the ‘600 patent).
Regarding claim 273, The claims of the ‘600 patent disclose the fluorescent labeling reagent of claim 271, wherein said repeating unit is repeated at least three times (e.g., as per claims 1 and 16-17 of the ‘600 patent).
Regarding claim 274, The claims of the ‘600 patent disclose the fluorescent labeling reagent of claim 264, wherein, when said fluorescent labeling reagent is coupled to said substrate, said linker provides an average physical separation between said fluorescent dye moiety and said substrate of at least about 30 Angstroms (Å) (e.g., as per claims 1 and 16-17 of the ‘600 patent).
Regarding claim 275, The claims of the ‘600 patent disclose the fluorescent labeling reagent of claim 274, wherein, when said fluorescent labeling reagent is coupled to said substrate, said linker provides an average physical separation between said fluorescent dye moiety and said substrate of at least about 60 Angstroms (Å) (e.g., as per claims 1 and 16-17 of the ‘600 patent).
Regarding claim 276, The claims of the ‘600 patent disclose the fluorescent labeling reagent of claim 264, wherein said fluorescent labeling reagent further comprises a cleavable group that is configured to be cleaved to separate said fluorescent labeling reagent or portion thereof from said substrate (e.g., as per claim 18 of the ‘600 patent).
Regarding claim 277, The claims of the ‘600 patent disclose the fluorescent labeling reagent of claim 276, wherein said cleavable group is selected from the group consisting of an azidomethyl group, a disulfide bond, a hydrocarbyldithiomethyl group, and a 2-nitrobenzyloxy group (e.g., as per claim 19 of the ‘600 patent).
Regarding claim 278, The claims of the ‘600 patent disclose the fluorescent labeling reagent of claim 277, wherein said cleavable group is said disulfide bond (e.g., as per claim 20 of the ‘600 patent).
Regarding claim 279, The claims of the ‘600 patent disclose the fluorescent labeling reagent of claim 264, wherein said fluorescent labeling reagent comprises a moiety selected
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(e.g., as per claim 20 of the ‘600 patent)
Regarding claim 280, The claims of the ‘600 patent disclose the fluorescent labeling reagent of claim 264, wherein said substrate is a nucleotide, polynucleotide, protein, lipid, cell, saccharide, polysaccharide, or antibody (e.g., as per claim 1 of the ‘600 patent).
Regarding claim 281, The claims of the ‘600 patent disclose the fluorescent labeling reagent of claim 280, wherein said substrate is said nucleotide and said fluorescent labeling reagent is attached to said nucleotide via the nucleobase of said nucleotide (e.g., as per claim 1 of the ‘600 patent).
Regarding claim 282, The claims of the ‘600 patent disclose the fluorescent labeling reagent of claim 280, wherein said substrate is said protein (e.g., as per claim 1 of the ‘600 patent).
Regarding claim 283, The claims of the ‘600 patent disclose the fluorescent labeling reagent of claim 264, wherein said substrate is a fluorescence quencher, a fluorescence donor, or a fluorescence acceptor (e.g., as per claim 1 of the ‘600 patent).
Conclusion
No claims are allowed.
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/JEREMY C FLINDERS/
Primary Examiner, Art Unit 1684
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