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 Status
Claims 10-13 are pending in the application.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cutherstson et al. (US 2010/0303727A1) in view of Achilefu et al. (US 2003/0202941A1) and Chen et al. (Nanoscale, 2012, 4, 6050-6064).
Cutherstson et al. (US 2010/030727A1) discloses in vivo optical imaging agents comprising
[BTM]-(L)n-CyD wherein BTM is a biological targeting molecule bound to a CyD near-infrared fluorescent
(NIR) cyanine dye via a linker L (p3, [0048-0060],[0068]).
The NIR cyanine dye has a Formula II
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wherein R1 and R2 may comprise -SO3M1 and R4 and R5 may comprise C1-4sulfoalkyl (p3, [0048-0060],[0068]).
The NIR cyanine dyes have a wavelength for excitation in the range 500-1200 nm, preferably 600-1000 nm (p4, [0075]; p9, [0165],[0168]).
The linker L comprises -(A)m- wherein -(A)m- is an amino acid, etc.; m is an integer from 1 to 20 and n is an integer from 0 or 1 (p3, [0060],[0062-0063]).
The amino acid may be naturally occurring (p4, [0073]). For example, 1 amino acid, such as a lysine or serine may be used to conjugate the BTM to the CyD (p6, [0115-0116]) that encompasses the single amino acid, such as lysine or serine of the instant claims.
The amino acids may function to modify the biodistribution, pharmacokinetics and blood clearance rates of the imaging agent in vivo (p4, [0076]).
Cutherstson et al. does not explicitly disclose the dye
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wherein the biological targeting molecule is bound to the amino acid via the central methine position.
Cutherstson et al. further discloses dyes known in the art having the formula
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wherein polymethine chain L1 to L7 comprises
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and that the dyes may be conjugated to biological detecting units that bind to specific cell populations, bind selectively to receptors and/or accumulate in tumors (p1, [0002-00013]).
The dyes comprising sulfonic acid groups to provide superior water solubility (p1, [0016-0017]).
Achilefu et al. (US 2003/0202941A1) discloses the sulfonate-substituted NIR cyanine dyes
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wherein W5 and X5 comprise CRcRd; Rc and Rd comprise C1-C10 alkyl, etc.; R37-44 comprise H, -SO3T, etc.; V5 comprises -O-, etc.; R45 comprises hydrophilic peptide; Y5 and Z5 comprise –(CH2)aSO3T, etc. (p, [0020-0021]).
The cyanine dyes are hydrophilic and absorb light in the near infrared region between 350 nm and 1300 nm (p2, [0010]).
Chen et al. (Nanoscale, 2012, 4, 6050-6064) discloses folate-modified gold nanoclusters for NIR imaging wherein a folate is bound to the central heptamethine unit of the NIR cyanine dye via a gold nanoparticle
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(abstract; Fig. 1).
It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to bind the BTM of Cutherstson et al. to sulfonate-substituted NIR cyanine dyes of Achilefu et al. at the central heptamethine unit as Chen et a. teaches that NIR fluorescence imaging in the range of 700-900 nm allows for real-time noninvasive whole body imaging and low absorption of light by intrinsic chromophores that allows light to penetrate into deeper tissues (p6051, left column, first full paragraph).
It would have been predictable to substitute the cyanine dyes of Cutherstson et al. for sulfonate-substituted NIR cyanine dyes of Achilefu et al. as different NIR cyanine dyes having differing wavelengths in the NIR region allow for the advantage of tailoring the wavelength of detection in various tumor tissues with a reasonable expectation of success.
Cutherstson et al. does not disclose that the BTM is a folate receptor targeting moiety.
Cutherstson et al. further discloses that the BTM may be of synthetic or natural origin, such as synthetic receptor-binding compounds, various peptides (somatostatin, octreotide, RGD, etc.) (p3, [0071]; p4, [0081]; p5, [0097-0107]) for imaging tumors (p3, [0067]).
Chen et al. further discloses that folate receptor (FR) is over-expressed in various tumor cells, including ovary, breast, colon, kidney, liver, testes, brain, lung and myelocytic (p6050, right column, last paragraph. The folic acid (FA) selectively targets the dye conjugate to high FR expressing tumors (abstract).
It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to bind the BTM of Cutherstson et al. to FA
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for the advantage of selectively targeting the dye conjugates of Cutherstson et al. to high FR expressing
tumors as Cutherstson et al. teaches that the BTM may comprise different targeting moieties to target
various tumors which predictably provides variety for tumor imaging and/or therapy.
It would have been predictable to substitute the BTM of Cutherstson et al. for the folic acid targeting moiety of Chen et al. for the advantage of targeting various tumors that over-express folate receptors with a reasonable expectation of success.
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 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9,061,057B2. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 9,061,057B2 teaches
of the compounds
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, etc. used for the method of identifying a target cell type in a biological sample that encompass the compounds comprising a pteroyl derivative and a dye moiety
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wherein the tyrosine is linked to a dye moiety
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of the instant claims.
The compounds of U.S. Patent No. 9,061,057B2 comprise 13C in the aromatic portion of the tyrosine moiety that encompasses the aromatic ring of tyrosine comprises a carbon isotope of the instant claims.
Claims 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5,17 and 19 of U.S. Patent No. 9,233,175B2. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 9,233,175B2 teaches of the compounds comprising
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wherein X is a single amino acid, such as tyrosine, cysteine, serine, lysine and Y is a
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that are used for the method of imaging an inflammatory disease and encompass the compounds comprising a pteroyl derivative and a dye moiety
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connected to the pteroyl derivative via a single amino acid, such as tyrosine, cysteine, serine and lysine of the instant claims. The amino acid of U.S.
Patent No. 9,233,175B2 preferably comprises tyrosine, such as
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, etc. that encompass the
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of the instant claims. The aromatic ring of the tyrosine of U.S. Patent No. 9,233,175B2 comprises carbon and hydrogen isotopes, such as 12C and 1H that encompass the aromatic ring of tyrosine comprises a carbon isotope and/or a hydrogen isotope of the instant claims.
Claims 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8-16 of U.S. Patent No. 9,333,270B2. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 9,333,270B2 teaches of the compounds comprising
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wherein X is a single amino acid, such as tyrosine, cysteine and Y is
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used for the method of optical imaging of a biological tissue encompass the compounds comprising a pteroyl derivative and a dye moiety
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connected to the pteroyl derivative via a single amino acid, such as tyrosine, cysteine of the instant claims. The amino acid of U.S. Patent No. 9,333,270B2 is preferably tyrosine, such as
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, etc.
that encompass the
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of the instant claims.
The aromatic ring of the tyrosine of U.S. Patent No. 9,333,270B2 comprises a carbon isotope or a hydrogen isotope, such as 12C and 1H that encompasses the aromatic ring of the tyrosine comprises a carbon isotope or a hydrogen isotope of the instant claims.
Claims 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,341,629B2. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 9,341,629B2 teaches of the compounds
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of a kit wherein X is a single amino acid, such as tyrosine, cysteine, serine, lysine and Y is
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that encompass the compounds comprising a pteroyl derivative and a dye moiety
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connected to the pteroyl derivative via a single amino acid, such as tyrosine, cysteine of the instant claims. The amino acid of U.S. Patent No. 9,341,629B2 is preferably tyrosine, such as
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, etc. that encompass the
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of the instant claims.
The compounds of U.S. Patent No. 9,341,629B2 comprise
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that encompasses the compounds of the instant claims.
The aromatic ring of the tyrosine of U.S. Patent No. 9,341,629B2 comprises a carbon isotope or a hydrogen isotope, such as 12C and 1H that encompasses the aromatic ring of the tyrosine comprises a carbon isotope or a hydrogen isotope of the instant claims.
Claims 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 11-13 of U.S. Patent No. 9,782,497B2. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 9,782,497B2 teaches of the compounds
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wherein X is a single amino acid, such as tyrosine, cysteine and Y is
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used for the method of optical imaging or identifying/diagnosing a target cell type in an infectious disease that encompasses the compounds comprising a pteroyl derivative and a dye moiety
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connected to the pteroyl derivative via a single amino acid, such as tyrosine, cysteine of the instant claims. The amino acid of U.S. Patent No. 9,782,497B2 is preferably tyrosine, such as
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, etc. that encompass the
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of the instant claims.
The aromatic ring of the tyrosine of U.S. Patent No. 9,782,497B2 comprises a carbon isotope or a hydrogen isotope, such as 12C and 1H that encompasses the aromatic ring of the tyrosine comprises a carbon isotope or a hydrogen isotope of the instant claims.
Claims 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 9,789,208B2. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 9,789,208B2 teaches of the compounds
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wherein X is a single amino acid, such as tyrosine, cysteine, serine or lysine and Y is
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used for the method of imaging a carcinoma that encompasses the compounds comprising a pteroyl derivative and a dye moiety
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connected to the pteroyl derivative via a single amino acid, such as tyrosine, cysteine of the instant claims.
The aromatic ring of the tyrosine of U.S. Patent No. 9,789,208B2 comprises a carbon isotope or a hydrogen isotope, such as 12C and 1H that encompasses the aromatic ring of the tyrosine comprises a carbon isotope or a hydrogen isotope of the instant claims.
Claims 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 10-17 of U.S. Patent No. 10,881,747B2. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 10,881,747B2 teaches of the compounds
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wherein X is a single amino acid, such as tyrosine, cysteine, serine or lysine and Y is
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used for the method of performing image guided surgery and diagnosing ovarian cancer that encompasses the compounds comprising a pteroyl derivative and a dye moiety
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connected to the pteroyl derivative via a single amino acid, such as tyrosine, cysteine of the instant claims.
The aromatic ring of the tyrosine of U.S. Patent No. 10,881,747B2 comprises a carbon isotope or a hydrogen isotope, such as 12C and 1H that encompasses the aromatic ring of the tyrosine comprises a carbon isotope or a hydrogen isotope of the instant claims.
Claims 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,4,6 and 7 of U.S. Patent No. 11,986,540B2. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 11,986,540B2 teaches of pafolacianine
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used for the method of treating a subject that encompasses the compounds comprising a pteroyl derivative and a dye moiety
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connected to the pteroyl derivative via a single tyrosine via
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of the instant claims.
The aromatic ring of the tyrosine of U.S. Patent No. 11,986,540B2 comprises a carbon isotope or a hydrogen isotope, such as 12C and 1H that encompasses the aromatic ring of the tyrosine comprises a carbon isotope or a hydrogen isotope of the instant claims.
Claims 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,576,165B2. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 12,576,165B2 teaches of the compounds comprising a folate receptor (FR) targeting moiety, a dye moiety
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and a single amino acid linker, such as tyrosine, cysteine, lysine and serine that encompasses the compounds of the instant claims comprising a pteroyl derivative, a dye moiety
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connected to the pteroyl derivative via a single amino acid, such as tyrosine, cysteine, serine or lysine of the instant claims.
The aromatic ring of the tyrosine amino acid of U.S. Patent No. 12,576,165B2 has a carbon isotope and/or a hydrogen isotope, such as 12C and 1H that encompasses the aromatic ring of the tyrosine comprises a carbon isotope or a hydrogen isotope of the instant claims.
Conclusion
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA JEAN PERREIRA whose telephone number is (571)272-1354. The examiner can normally be reached M9-3, T9-3, W9-3, Th9-2, F9-2.
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/MELISSA J PERREIRA/Examiner, Art Unit 1618
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