DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of group I and species a conjugate comprising AMBF3 of claim 63 and somatostatin in the reply filed on 8/26/25 is acknowledged.
Claims 69 and 72-90 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/26/25.
Claim Objections
Claim 67 is objected to because of the following informalities: the instant claim 67 recites “thyroid stimulating hormone” twice and is believed to be a duplicate. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 63,64,66-68,70 and 71 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Perrin et al. (WO2005/077967A1).
Perrin et al. (WO2005/077967A1) discloses the compounds of formula (F)mG(R)n, such as 18F-
boron-biomolecule compounds (abstract; p4, lines 10+; p16, lines 1-4).
The F moiety comprises F wherein at least one F is 18F and m is 1-3 (p4, lines 10+) that encompasses the fluorine moieties, such as 18F3 of the AMBF3
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of the instant claims.
The G moiety is boron (p4, lines 10+) that encompasses the boron of the AMBF3
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of the instant claims.
The G moiety is joined to R through a carbon (p4, lines 10+) that encompasses the -CH2- moiety of the AMBF3
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of the instant claims.
The R moiety comprises a secondary amine (NR2), tertiary amine, etc. (p19, lines 13+; claims 14,15) wherein the compounds comprising boron are coupled to a biomolecule via a linking group, such as an amino group (p5, lines 15+; p15, lines 9+) that encompasses the amino moiety of the AMBF3
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and bonding the biomolecule to the amino group of the instant claim 64.
The biomolecules comprise cancer targeting molecules, such as somatostatin peptide, etc. (p12, especially lines 5-6) that encompass the somatostatin peptide biomolecule of the instant claims 67 and 68 and the cancer targeting molecule of the instant claim 70.
Perrin et al. does not disclose a solvolytic de-18F-fluoridation half-life at physiological pH of about 1000 minutes or of about 5000 minutes or more.
At the time of the it would have been obvious to one of ordinary skill in the art that the 18F-
boron-biomolecule compounds of Perrin et al. comprise a solvolytic de-18F-fluoridation half-life at physiological pH of about 1000 minutes or of about 5000 minutes or more as they comprise an analogous structure to the biomolecule-containing AMBF3 compounds of the instant claim and therefore, they predictably have the same properties and are capable of the same functions.
Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977)
With regards to the instant claim 71, Perrin et al. further states trifluoroborate salts are well understood in the art and readily incorporate 18F. The synthesis of the 18F-boron-biomolecule compounds employs 18F-enriched metal fluorine salts to substitute a leaving group and yield the 18F trifluoroborate “ate” salts (p7, lines 19+; p9, lines 1-17) that encompass the salt of the instant claim 71.
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 63,64,66 and 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3,6,7 and 10-15 of U.S. Patent No. 10,556,023B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the positron emitting compound
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of U.S. Patent No. 10,556,023B2 comprises an analogous structure to the AMBF3 positron emitting moiety of the instant claims.
The positron emitting compound of U.S. Patent No. 10,556,023B2 may be bound to a biomolecule via the Q1 moiety that encompasses the biomolecule bound to the AMBF3 positron emitting moiety of the instant claims.
The Q1 moiety of U.S. Patent No. 10,556,023B2 encompasses the linking group of the instant claims.
The biomolecule of U.S. Patent No. 10,556,023B2 comprises a peptide that encompasses the peptide of the instant claims.
The Y1 and/or Y2 moieties of U.S. Patent No. 10,556,023B2 comprise 18F that encompass the 18F moieties of the instant claims.
The positron emitting compound of U.S. Patent No. 10,556,023B2 has a half-life with respect to solvolytic de-18F-fluoridation at physiological pH of about 1000 minutes or more that encompasses the solvolytic de-18F-fluoridation half-life at physiological pH of about 1000 minutes or more and the solvolytic de-18F-fluoridation half-life at physiological pH of about 5000 minutes or more of the instant claims.
The positron emitting compound of U.S. Patent No. 10,556,023B2 comprises a salt that
encompasses the salt of the instant claims.
The positron emitting compound of U.S. Patent No. 10,556,023B2 used for the method of
performing PET imaging encompasses the AMBF3 positron emitting moiety of the instant claims therefore the AMBF3 positron emitting moiety of the instant claims.
Claims 63-65,67,68 and 70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 11-19 of U.S. Patent No. 10,150,804B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the fluorinated somatostatin derivative
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of U.S. Patent No. 10,150,804B2 has an analogous structure to the AMBF3 positron emitting moiety of the instant claims.
The X moiety is a somatostatin analogue of U.S. Patent No. 10,150,804B2 encompasses the somatostatin peptide biomolecule and cancer targeting molecule of the instant claims.
The L linking group of U.S. Patent No. 10,150,804B2 encompasses the linking group of the instant claims.
The triazole linking moiety of U.S. Patent No. 10,150,804B2 encompasses the triazole linking moiety of the instant claims.
The 18F of U.S. Patent No. 10,150,804B2 encompasses the 18F of the instant claims.
The fluorinated somatostatin derivative of U.S. Patent No. 10,150,804B2 has an analogous structure to that of the instant claims, has the same properties and is capable of the same functions, such as a solvolytic de-18F-fluoridation half-life at physiological pH of about 1000 minutes or more and a solvolytic de-18F-fluoridation half-life at physiological pH of about 5000 minutes or more of the instant claims.
The positron emitting compound of U.S. Patent No. 10,150,804B2 used for the methods of imaging cells, tissues, cancer or treating a disease or disorder encompasses the AMBF3 positron emitting moiety of the instant claims.
Claims 63,64,66 and 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,4-6,9-12 and 15 of U.S. Patent No. 11,207,432B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the positron emitting compound
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of U.S. Patent No. 11,207,432B2 comprises an analogous structure to the AMBF3 positron emitting moiety of the instant claims.
The positron emitting compound of U.S. Patent No. 11,207,432B2 may be bound to a biomolecule through a linking moiety to the Q1 moiety that encompasses the biomolecule bound to the AMBF3 positron emitting moiety via a linking group of the instant claims.
The biomolecule of U.S. Patent No. 11,207,432B2 comprises a peptide that encompasses the peptide of the instant claims.
The Y1 and/or Y2 moieties of U.S. Patent No. 11,207,432B2 comprise 18F that encompass the 18F moieties of the instant claims.
The positron emitting compound of U.S. Patent No. 11,207,432B2 comprises a salt that
encompasses the salt of the instant claims.
The positron emitting compound of U.S. Patent No. 11,207,432B2 has a solvolytic de-18F-fluoridation half-life at physiological pH of about 5000 minutes or more that encompasses the solvolytic de-18F-fluoridation half-life at physiological pH of about 1000 minutes or more and the solvolytic de-18F-
fluoridation half-life at physiological pH of about 5000 minutes or more 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
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/MELISSA J PERREIRA/Examiner, Art Unit 1618