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 .
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6 of U.S. Patent No.: 12002595. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of ‘595 teaches all the features of Claim 1 except the dissolution feature. Claim 6 teaches all the other features.
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.
Claim(s) 3, 7, 8, 9, 10, 16, 17, 18, 20, 21, 22, 25, 30, 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramdahl (WO 2011/098611) and in view of “thorium extraction process” Britannica.
As to Claims 3, 7 and 10, Ramdahl describes a method of complexing thorium isotopes with octadentate ligands (page 1, lines 1-5) for use in the treatment of diseases (page 5, lines 3-8). This can be considered a medical use. The process employs a reaction solution combining a HOPO-based compound with a thorium isotope in a DMSO solution to form a thorium-bonded HOPO composition (Example 7). The DMSO solution is an organic solvent. The thorium isotope was commercially obtained in a HCl solution (Example 7). The mixed solution is then separated and analyzed (see example 7, under LC-MS separation). The separation step is described in example 5, para. 3. The HOPO-based compound can be considered an octadentate ligand.
The compound is a tissue-targeting complex (title), which can be considered a medical use.
As to the thorium isotope being dissolved in acid, example 5 explains that the precursor solution is obtained in a thorium-acid solution, where the acid is HNO3 (example 5). The reference does not state that the thorium is dissolved in the acid solution.
Britannica explains that known thorium extraction processes isolate thorium from ore and then add the final product in a nitric acid solution for purification (see “Acid Digestion”).
Therefore, since Ramdahl explains that their thorium can be commercially obtained (see examples 5 and 7 which use thorium from a commercial source) and one of these sources is a thorium source in nitric acid, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the thorium obtained is dissolved in nitric acid because Britannica explains that dissolution of thorium in nitric acid can be beneficial for purification.
As to Claim 8, Ramdahl teaches that one of extractants used has the formula shown on page 38, middle. This can be considered a spermine scaffold (see page 38).
As to Claim 9, Ramdahl teaches that the octadentate ligand used can have 1,2-HOPO chelating moieties attached to them (page 25, middle of page and bottom).
As to Claims 16 and 17, Ramdahl teaches that a stock solution that can contain triethylamine (page 41, last para) is added to the process of chelating the target metal (example 6).
As to Claim 18, Ramdahl teaches that the solution is filtered (see example 8).
As to Claim 20, Ramdahl explains that the separation step at the end (example 5, last para on page 42) is performed in an acid-modified acetonitrile solution (see example 5).
As to Claims 21, 22 and 25, Ramdahl does not teach adjusting the pH after the metal is dissolved (see example 5).
As to Claims 30 and 31, Ramdahl teaches that actinium-227 is separated from the other metals (see example 1). The actinium is separated from thorium, which has a 4+ oxidation state (example 1).
Claim(s) 6, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramdahl and evidenced by Britannica as applied to claim 3 above, and further in view of Mazza (US Pat.: 3676081).
Mazza describes a method of isolating metals from a monazite ore (title) to include thorium (example 2). The monazite ore contains thorium (col. 2, lines 28-32). In their process of isolating thorium, Mazza explains that a HCl solution is added to thorium at a pH of about 1-0 (col. 2, lines 46-51).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the pH from 1-0, as taught by Mazza for use with the process of Ramdahl and Britanicca because Mazza explains that this pH is an effective pH to isolate thorium.
As to Claim 15, Mazza teaches that the pH can range from 1-0 or less (col. 2, lines 49-50). The obviousness statement is re-iterate here.
Claim(s) 16, 17, 23, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramdahl and Britannica as applied to claim 3 above, and further in view of Fassbender (US Pub.: 2015/0292061).
Fassbender shows that actinium and thorium and other isotopes are related in Fig. 1 and 2. The reference explains that after formation, these isotopes require separation from each other (para. 8, title, abstract). In examples, Fassbender teaches dissolving thorium metal in acid (para. 31) and then passing extractants useable to remove the different isotopes (para. 34). Fassbender teaches that among the extractants that can be removed, the HDEHP extractant can be used to remove actinium (para. 34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ a HDEHP extractant, as taught by Fassbender for use in extracting different isotope in Ramdahl and Britannica because Fassbender explains that this is a known and effective extractant for use in removing isotopes, such as actinium.
As to Claims 23 and 24, regarding the selectivity of the extractant, the specification of this application states that HDEHP is a non-selective extractant (see published specification, para. 158).
References Made of Record
The following additional references from the examiner’s search are made of record: Durbin-Heavey (US Pub.: 2012/0214843) (D-H).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHENG HAN DAVIS whose telephone number is (571)270-5823. The examiner can normally be reached 9-5:30.
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/SHENG H DAVIS/Primary Examiner, Art Unit 1732 September 3, 2026
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