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 .
Election/Restrictions
Applicant’s election without traverse of group I in the reply filed on 8/17/25 is acknowledged.
Claims 14-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/17/25.
Specification
The disclosure is objected to because of the following informalities: the specification recites “
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” but does not recite Figure 6 (b) or Figure 7 (b) as stated in Figures 6 and 7, respectively. Appropriate correction is required.
Claim Objections
Claim 3 is objected to because of the following informalities: line two of the instant claim recites “whit” and is understood to be a spelling error. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The instant claim 10 is confusing and unclear as it recites the structure
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(page 34) comprising ether bonds binding the cyclodextrins to the R5 moiety but the instant claim 10 further requires L to specifically comprise an ester bond to bind the cyclodextrins via the coupling reaction of the carboxyl group of the tricarbocyanine with the residue group R’” = OH of CD. The dependent claims fall therewith.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The instant claim 10 is confusing and unclear as it recites the structure
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(page 38) comprising ether bonds binding the cyclodextrins to the R5 moiety but the instant claim 10 further requires L to specifically comprise an ester bond to bind the cyclodextrins via the coupling reaction of the carboxyl group of the tricarbocyanine with the residue group R’” = OH of CD. The dependent claims fall therewith.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The instant claim 10 recites the structure
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(page 34)
wherein the
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moiety is coupled with cyclodextrins. The instant claim 1 to which the instant claim 10 depends does not comprise R5 is a
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moiety directly bound to the cyanine dye but does state that R5 is a
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moiety wherein a dichlorotriazine moiety is bound to the cyanine dye via a disubstituted phenyl ring.
Also, the substituent R5 is required and does not comprise dichlorotriazine therefore, the
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moiety cannot represent the linker group L of the instant claim 1. Therefore, the instant claim 10 does not further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The instant claim 10 recites structure
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(page 36) wherein R5 is a morpholine moiety. The instant claim 1 to which the instant claim 10 depends does not comprise R5 is morpholine moiety and therefore does not further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-4 and 6-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frangioni et al. (WO2010/091243A1) in view of Murthy et al. (WO2012/097223A2), Chung et al. (US
2011/0085974A1) and Flanagan et al. (Bioconj. Chem. 1997, 8, 751-756).
Frangioni et al. (WO2010/091243A1) discloses the dye conjugates for imaging of cells or tissue for diagnosis, therapy, image guided surgery (abstract; p2; p3, lines 16-19). The dye conjugates comprise the Formula
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wherein R2,R6,R9 and R10 comprise sulfonate, carboxylate, quaternary amines, etc. (p8, lines 1-8; p17, lines 14+; p22, lines 10+; Figures 1,4), such as
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(p18; p20, lines 15+).
The dyes emit and/or absorb radiation having a wavelength from about 300 nm to about 1000 nm (p32, lines 18-20) and encompass the tricarbocyanine dyes of the instant claims.
The linker
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encompasses the linker
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when X is O of the instant claims.
The targeting ligand (TL) refers to any molecular entity that contains a binding moiety that binds with some specificity or selectivity to a biological target, such as carbohydrates, etc. (p6, lines 12-18; p21, lines 1-16).
Frangioni et al. does not explicitly disclose the cyclodextrin, such as m is equal to 7 or 8 of the instant claims or various linkers of the instant claims.
Murthy et al. (WO2012/097223A2) discloses oligosaccharide conjugates comprising fluorescent dyes used for methods of detecting or treating infections (abstract; p2, [0007-0008]; p3, [0012]; p8,
[0037]).
The oligosaccharide conjugates comprise Formula IA
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wherein the
oligosaccharide comprises cyclodextrin; E is a linking group; G is a fluorescent moiety and n is 2-15 (claims 1,4; p9-10, [0048-0052], p19-20, [00147]).
R1-R4 comprise hydroxy, alkoxy, amino, etc. that encompasses the hydroxy, alkoxy, amino, etc. of the instant claims.
Conjugation may be accomplished by direct coupling the two molecular entities, e.g. creating an ester or amide from a hydroxyl group, amino group and a carboxylic acid (p20, [00148]) that encompasses the linker moiety is an amide or ester of the instant claim 9.
Chung et al. (US 2011/0085974A1) discloses ligand-drug conjugates having cyanine dyes bound to a drug compounds via various linkers, such as
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(abstract; p20; scheme 4).
The targeting ligand may be a dye having wavelength of maximum fluorescence emission greater than 700 nm (p7, [0025]; p11, [0066]).
The
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linker encompasses the linker
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when X is S of the instant claims.
Flanagan et al. (Bioconj. Chem. 1997, 8, 751-756) discloses water-soluble NIR fluorescent dyes
synthesized for covalent labeling of biomolecules
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(Figure 1; scheme 1).
The linker
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encompasses the linker
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when X is S of the instant claims.
The linker
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encompasses the linker
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whern X is O of the instant claims.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to substitute the carbohydrates of Frangioni et al. for the cyclodextrins, having 2-15 repeating units, of Murthy et al. to provide the advantage of site-specific targeting of the dye conjugates to a desired target cells or tissues for site-specific imaging and/or therapy.
The references of Frangioni et al. and Murthy et al. are drawn to analogous methods of imaging and/or treating a subject via site specific targeting of carbohydrate-containing fluorescent cyanine dyes having analogous core structures and therefore, it would have been predictable to substitute one known carbohydrate targeting ligand for another known carbohydrate targeting ligand with a reasonable expectation of success for providing site-specific imaging and/or therapy.
The cyclodextrins, having 2-15 repeating units, of Murthy et al. encompasses the repeating units
m is 6,7 or 8 of the cyclodextrins of the instant claims and therefore, are capable of having the R”’
substituent comprised between 0.5 and 1.5 for each unit of the instant claim 4.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to substitute the linkers of Frangioni et al. for the linkers of Chung et al. and/or
Flanagan et al. to tailor the dye moieties and provide the advantage of desired wavelength of the dye-conjugates, such as from about 300 nm to about 1000 nm for site specific imaging.
The dye-conjugates of the combined disclosures encompass the fluorescent compounds of the instant claims, have the same properties and are capable of the same functions, such as diagnosis of kidney function in a mammal, and/or determining the glomerular filtration rate.
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 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-13 of U.S. Patent No. 11,179,481B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the fluorescent compound F-Ln-CDn used for the method of diagnosing kidney function of a mammal of U.S. Patent No. 11,179,481B2 comprises the
tricarbocyanine residue
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that encompasses the fluorescent
compound F-Ln-CDn comprising the tricarbocyanine residue
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of the instant claims.
The R1 and R2 = H, SO3H, CO2H, NH2, etc. of U.S. Patent No. 11,179,481B2 encompasses the R1 and R2 comprises H, SO3H, CO2H, NH2, etc. of the instant claims.
The R3 and R4 = C1-4alkyl, (CH2)3C≡CH, (CH2)4C≡CH, etc. of U.S. Patent No. 11,179,481B2 encompasses the R3 and R4 comprises C1-4alkyl, (CH2)3C≡CH, (CH2)4C≡CH, etc. of the instant claims.
The R5
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and
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of U.S. Patent No. 11,179,481B2 encompasses the R5 comprises
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X is N and j is 1-4 and
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of the instant claims.
The cyclodextrin
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m is 6,7 or 8 of U.S. Patent No. 11,179,481B2 encompasses
the cyclodextrin
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m is 6,7 or 8 of the instant claims.
The R’,R” and R’” = OH, OCH3, OCH2CHOHCH3, etc. of U.S. Patent No. 11,179,481B2 encompasses
the R’,R” and R’” comprises OH, OCH3, OCH2CHOHCH3, etc. of the instant claims.
The fluorescent compound of U.S. Patent No. 11,179,481B2 encompasses the fluorescent compounds of the instant claims, have the same properties and are capable of the same functions, such as diagnosis of kidney function in a mammal, and/or determining the glomerular filtration rate.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA J PERREIRA/ Examiner, Art Unit 1618
/Michael G. Hartley/ Supervisory Patent Examiner, Art Unit 1618