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 and species of 2'-deoxy-2'-[18F]fluoro-5-methyl-1-β-D-arabinofuranosyl-uracil (18F]FMAU) in the reply filed on February 2, 2026 is acknowledged.
Specification
The disclosure is objected to because of the following informalities:
The use of the terms UltiMate™, Luna™, Kryptofix®, Wizard2®, microPET® which are a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 Indefiniteness
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.
Claims 1-13 are 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.
Claims 1 and 11 recite the limitation “the components” in steps (c) and (d). The claims lack an antecedent basis for this limitation.
Claims 1 and 11 recite the limitation “the protecting groups” in step (d). The claims lack an antecedent basis for this limitation.
Claim 3 recites the limitation "the [18F]-labeled 2'-deoxy-arabino 5- substituted or unsubstituted uracil or cytosine nucleoside " in lines 1-2. The claim lacks an antecedent basis for this limitation as the claim 1 only refers to “2'-deoxy-2'-[18F]-fluoro-5-substituted-l-β-D-arabinofuranosyl-uracil or cytosine compounds.” It is suggested that claim 16 be amended to “The method according to claim 1 wherein the 2'-deoxy-2'-[18F]-fluoro-5-substituted-l-β-D- arabinofuranosyl-uracil or cytosine compounds…” to obviate this rejection.
Claim 10 recites the limitation “the fully automated synthesis” in line 1. The claims lack an antecedent basis for this limitation.
Claim 11 recites the limitation "the silylated uracil or cytosine derivatives” in step (C). The claim lacks an antecedent basis for this limitation.
The dependent claims fall therewith.
Clarification and/or amendment is required.
Claim Rejections - 35 USC § 112 Improper dependency
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.
Claims 3 and 12 are 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.
Claims 3 and 12 recite “2′-fluoro-5-ethyl-1-β-d-arabinofuranosyluracil ([18F]FEAU), 2′-deoxy-2′-fluoro-5-fluoro-1-β-d-arabinofuranosyluracil ([18F]FFAU), 1-(2-deoxy-2-fluoro-β-d-arabinofuranosyl)-5-chlorouracil ([18F]FCAU), 1-(2-deoxy-2-fluoro-β-d-arabinofuranosyl)-5-bromouracil ([18F]FBAU), 1-(2-deoxy-2-fluoro-β-d-arabinofuranosyl)uracil ([18F]FAU), 2′-fluoro-2′-deoxy-1-β-d-arabinofuranosyl-5-iodouracil ([18F]FIAU), 1-(2-deoxy-2-fluoro-β-d-arabinofuranosyl)cytosine ([18F]FAC), 2′-deoxy-2′-fluoro-5-methyl-1-β-d-arabinofuranosylcytosine ([18F]FMAC), 2′-fluoro-5-ethyl-1-β-d-arabinofuranosyl-cytosine ([18F]FEAC), 2′-Deoxy-2′-fluoro-5-fluoro-1-β-d-arabinofuranosyluracil ([18F]FFAC), 1-(2-deoxy-2-fluoro-β-d-arabinofuranosyl)-5-chlorocytosine ([18F]FCAC), 1-(2-deoxy-2-fluoro-β-d-arabinofuranosyl)-5-bromocytosine ([18F]FBAC), and 2′-deoxy-2′-fluoro-5-hydroxymethyl-1-β-d-arabino-furanosylcytosine ([18F]FHMAC)”, which are broader than the preamble recitation of “the [18F]-labeled 2′-deoxy-arabino 5-substituted or unsubstituted uracil or cytosine nucleoside” (underlined for emphasis). Because these recitations omit the “[18F]” prefix immediately preceding the term “fluoro”, which specify the radioactive isotope label within the chemical name, the claims fail to include all limitations of the parent claims.
Claims 3 and 12 recite “2′-fluoro-5-ethyl-1-β-d-arabinofuranosyluracil ([18F]FEAU)” and “2′-fluoro-5-ethyl-1-β-d-arabinofuranosyl-cytosine ([18F]FEAC),” which are broader than the preamble recitation of “the [18F]-labeled 2′-deoxy-arabino 5-substituted or unsubstituted uracil or cytosine nucleoside” (underlined for emphasis). Because these recitations omit the “2’-deoxy” limitation, the claims fail to include all limitations of the parent claims.
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
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 8,912,319, 2014; cited on IDS filed August 28, 2023) in view of Wüst and Kniess (Journal of Labelled Compounds and Radiopharmaceuticals, 2004; cited on PTO-892).
Regarding claims 1 and 11, Li discloses a method of synthesizing 2′-deoxy-2′-[18F]-fluoro-5-substituted-1-β-D-arabinofuranosyl-uracil or -cytosine compounds in a one-pot reaction comprising: a) radiolabeling a precursor sugar with 18F; b) contacting the 18F radiolabeled sugar with a silylated uracil or cytosine in the presence of trimethylsilyl trifluorosulfonate (TMSOTf) and hexamethyldisilazane (HMDS); c) incubating the components in step (b) under conditions which allow for conjugation of the 18F radiolabeled sugar and the silylated uracil or cytosine; d) removing the protecting groups of the components in step (c); and e) purifying the deprotected product (claim 1). Regarding claims 2, 3, and 12, Li discloses that the 2′-deoxy-2′-[18F]-fluoro-5-substituted-1-β-D-arabinofuranosyl-uracil cab be [18F]FMAU (claim 2). Regarding claim 4, Li discloses that various solvent can be added to the one-pot reaction (column 12, lines 40-54; Tables 2 and 3). Regarding claims 5-8, Li discloses that the conjugation step can be performed at 80-85 °C for 60 minutes (column 15, line 7; Tables 2 and 3). Regarding claims 10 and 13, Li discloses a method for the fully automated synthesis of [18F]FMAU, wherein synthesis takes place in a fully automated cGMP-compliant radiosynthesis module (claim 3).
Regarding claims 1 and 11, Li does not disclose the use of 1,4-dioxane in step (b).
Wüst discloses the use of 1,4-dioxane in optimizing the method for synthesizing 18F-labelled nucleosides (Summary; Table 1). Wüst discloses that the use of 1,4-dioxane as a solvent can improve the synthesis of the labelled compounds (page 459, lines 1-2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Li to include 1,4-dioxane to synthesize [18F]-labeled compound more efficiently. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Wüst teaches that 1,4-dioxane can be used as a solvent to improve the synthesis of [18F]-labeled compound. Further, a person of ordinary skill in the art would have been motivated to select 1,4-dioxane as a solvent in order to improve the yield of the desired product thereby reduce manufacturing costs. Accordingly, applying the teaching of Wüst to the method of Li constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders claims 1 and 11 obvious.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 8,912,319, 2014; cited on IDS filed August 28, 2023) and Wüst and Kniess (Journal of Labelled Compounds and Radiopharmaceuticals, 2004; cited on PTO-892) as applied to claims 1-8 and 10-13 above, and further in view of USP 30 (USP 30, Chemical Tests <467> Residual Solvents, 2007; cited on PTO-892).
Li and Wüst are discussed above.
Neither Li nor Wüst discloses that an amount of residual methanol is 3000 parts per million (PPM) or less, acetonitrile is 410 PPM or less, and 1,4-dioxane is 380 PPM or less.
USP 30 discloses concentration limits of residual solvents in drug substances, excipients, and drug products because of the inherent toxicities of such solvents (page 2, column 2, ¶ 2; Table 2) USP 30 discloses that the residual methanol, acetonitrile, and 1,4-dioxane should be limited to no more than 3000 PPM, 410 PPM, and 380 PPM, respectively (Table 2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Li and Wüst to produce a compound having residual solvent concentrations within the limits taught by USP 30. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because USP 30 teaches limiting residual solvents such as methanol, acetonitrile, and 1,4-dioxane for pharmaceutical applications. Further, a person of ordinary skill in the art would have been motivated to reduce residual solvent levels in order to decrease product toxicity and ensure safe pharmaceutical use. Accordingly, applying the teachings and guidelines of USP 30 to the method of Li and Wüst constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders claim 9 obvious.
Claims 1-8 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Chen and Conti (WO 2019 191642; cited on IDS filed August 28, 2023) in view of Wüst and Kniess (Journal of Labelled Compounds and Radiopharmaceuticals, 2004; cited on PTO-892).
Regarding claims 1-3 and 11-12, Chen discloses a method of synthesizing [18F]FMAU in a one-pot reaction comprising incubating 2-trifluoromethane-sulfonyl- l ,3,5-tri-G-benzoyl ribofuranose (precursor sugar) with an [18F]-containing compound, thereby generating 2-[18F]fluoro-l,3,5-tri-0-benzoyl ribofuranose; incubating the 2-[18F]fluoro-l,3,5-tri-0-benzoyl ribofuranose (18F radiolabeled sugar) with a solution containing 2,4-bis-trimethylsilyl-5-methyl-uracil (silylated uracil), a Friedel-Crafts catalyst, and HMDS, thereby generating a mixture; and purifying the mixture via HPLC (removing the protecting groups), thereby obtaining [18F]FMAU (claim 15). Chen discloses that discloses that the Friedel-Crafts catalyst can be TMSOTf (claim 21). Regarding claim 4, Chen discloses that dichloroethane can be added as solvent for the synthesis reaction (¶ 85). Regarding claims 5-8, Chen discloses that the conjugation reaction can be performed at 85°C for 1 hour (¶ 85). Regarding claims 10 and 13, Chen discloses the method can be carried out in a cGMP-compliant environment and an automated synthesis module (claims 19 and 20).
Regarding claims 1 and 11, Li does not disclose the use of 1,4-dioxane in step (b).
As discussed above, Wüst discloses the use of 1,4-dioxane in optimizing the method for synthesizing 18F-labelled nucleosides (Summary; Table 1). Wüst discloses that the use of 1,4-dioxane as a solvent can improve the synthesis of the labelled compounds (page 459, lines 1-2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Chen to include 1,4-dioxane to synthesize [18F]-labeled compound more efficiently. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Wüst teaches that 1,4-dioxane can be used as a solvent to improve the synthesis of [18F]-labeled compound. Further, a person of ordinary skill in the art would have been motivated to select 1,4-dioxane as a solvent in order to improve the yield of the desired product thereby reduce manufacturing costs. Accordingly, applying the teaching of Wüst to the method of Chen constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders claims 1 and 11 obvious.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Chen and Conti (WO 2019 191642; cited on IDS filed August 28, 2023) and Wüst and Kniess (Journal of Labelled Compounds and Radiopharmaceuticals, 2004; cited on PTO-892) as applied to claims 1-8 and 10-13 above, and further in view of USP 30 (USP 30, Chemical Tests <467> Residual Solvents, 2007; cited on PTO-892).
Chen and Wüst are discussed above.
Neither Chen nor Wüst discloses that an amount of residual methanol is 3000 parts per million (PPM) or less, acetonitrile is 410 PPM or less, and 1,4-dioxane is 380 PPM or less.
As discussed above, USP 30 discloses concentration limits of residual solvents in drug substances, excipients, and drug products because of the inherent toxicities of such solvents (page 2, column 2, ¶ 2; Table 2) USP 30 discloses that the residual methanol, acetonitrile, and 1,4-dioxane should be limited to not more than 3000 PPM, 410 PPM, and 380 PPM, respectively (Table 2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Chen and Wüst to produce a compound having residual solvent concentrations within the limits taught by USP 30. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because USP 30 teaches limiting residual solvents such as methanol, acetonitrile, and 1,4-dioxane for pharmaceutical applications. Further, a person of ordinary skill in the art would have been motivated to reduce residual solvent levels in order to decrease product toxicity and ensure safe pharmaceutical use. Accordingly, applying the teachings and guidelines of USP 30 to the method of Chen and Wüst constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders claim 9 obvious.
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 1-3 of U.S. Patent No. US 8,912,319 (cited on IDS filed August 28, 2023) in view of Wüst and Kniess (Journal of Labelled Compounds and Radiopharmaceuticals, 2004; cited on PTO-892), Chen and Conti (WO 2019 191642; cited on IDS filed August 28, 2023), and USP 30 (USP 30, Chemical Tests <467> Residual Solvents, 2007; cited on PTO-892).
Regarding claims 1 and 11, claim 1 of the ‘319 recites a method of synthesizing 2′-deoxy-2′-[18F]-fluoro-5-substituted-1-β-D-arabinofuranosyl-uracil or -cytosine compounds in a one-pot reaction comprising: a) radiolabeling a precursor sugar with 18F; b) contacting the 18F radiolabeled sugar with a silylated uracil or cytosine in the presence of trimethylsilyl trifluorosulfonate (TMSOTf) and hexamethyldisilazane (HMDS); c) incubating the components in step (b) under conditions which allow for conjugation of the 18F radiolabeled sugar and the silylated uracil or cytosine; d) removing the protecting groups of the components in step (c); and e) purifying the deprotected product. Claims of the ‘319 does not disclose the use of 1,4-dioxane in step (b). As discussed above, Wüst discloses the use of 1,4-dioxane in optimizing the method for synthesizing 18F-labelled nucleosides (Summary; Table 1). Wüst discloses that the use of 1,4-dioxane as a solvent can improve the synthesis of the labelled compounds (page 459, lines 1-2). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the ‘319 to include 1,4-dioxane to synthesize [18F]-labeled compound more efficiently. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Wüst teaches that 1,4-dioxane can be used as a solvent to improve the synthesis of [18F]-labeled compound.
Regarding claims 2, 3, and 12, claim 2 of the ‘319 recites that the 2′-deoxy-2′-[18F]-fluoro-5-substituted-1-β-D-arabinofuranosyl-uracil cab be [18F]FMAU.
Regarding claim 4, Claims of the ‘319 does not disclose that the contacting step (b) further comprises one or more solvents. As discussed above, Chen discloses that dichloroethane can be added as solvent for the synthesis reaction (¶ 85). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the ‘319 and Wüst to include additional solvent to optimize the efficiency of the synthesis reaction. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Chen teaches that other solvent such as dichloroethane can be added for the synthesis of [18F]FMAU.
Regarding claims 5-8, claims of the ‘319 does not disclose that the temperature and time conditions of the incubating step (c). As discussed above, Chen discloses that the reaction can be performed at 85°C for 1 hour (¶ 85). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the ‘319 and Wüst to incubate the reaction mixture at 85°C for 1 hour as taught by Chen to optimize the efficiency of the synthesis reaction. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Chen teaches that the reaction mixture can be incubated at 85°C for 1 hour for the synthesis of [18F]FMAU.
Regarding claim 9, claims of the ‘319 does not disclose an amount of residual methanol is 3000 parts per million (PPM) or less, acetonitrile is 410 PPM or less, and 1,4-dioxane is 380 PPM or less. As discussed above, USP 30 discloses concentration limits of residual solvents in drug substances, excipients, and drug products because of the inherent toxicities of such solvents (page 2, column 2, ¶ 2; Table 2) USP 30 discloses that the residual methanol, acetonitrile, and 1,4-dioxane should be limited to not more than 3000 PPM, 410 PPM, and 380 PPM, respectively (Table 2). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the ‘319 and Wüst to produce a compound having residual solvent concentrations within the limits taught by USP 30. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because USP 30 teaches limiting residual solvents such as methanol, acetonitrile, and 1,4-dioxane for pharmaceutical applications.
Regarding claims 10 and 13, claim 3 of the ‘319 discloses a method for the fully automated synthesis of [18F]FMAU, wherein synthesis takes place in a fully automated cGMP-compliant radiosynthesis module.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618