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 .
Claim Status
1. Claims 1-20 are pending and examined herein.
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.
2. Claims 1-6 and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Fawcett US 2007/0133731 in view of Melville, Graeme, and P. Melville. "A theoretical model for the production of Ac-225 for cancer therapy by neutron capture transmutation of Ra-226." Applied Radiation and Isotopes 72 (2013): 152-157.
3. Regarding claim 1, Fawcett teaches a method for producing radioisotopes using a thermal nuclear reactor (see Fig. 1; Title; Abs.), the method comprising inserting an irradiation target assembly (310) into a core of the thermal nuclear reactor ([0018]); generating a neutron flux in the core of the thermal nuclear reactor to produce electrical power ([0019]), wherein the neutron flux comprises thermal neutrons and fast neutrons1; and producing the radioisotopes ([0020]).
Melville suggests irradiating an irradiation target assembly comprising Ra-226 isotopes in a thermal nuclear reactor, wherein the neutron flux comprises fast neutrons and thermal neutrons (section 2.4) and producing Ra-225 isotopes from a portion of the Ra-226 isotopes via a Ra-226 (n, 2n) reaction based on exposing the irradiation target to the neutron flux, wherein the Ra-225 isotopes decay to produce Ac-225 isotopes (section 1.2; section 2.5). Melville states that “commercial activities (mCi) of Ra-225 can be produced in hours (Section 5).
Accordingly, one of ordinary skill in the art at the time of invention/filing would have found it obvious to use the method of Fawcett to produce commercial quantities Ac-225 from Ra-226 in hours.
4. Regarding claim 2, the combination of Melville’s Ra-226 target with Fawcett’s radioisotope production method makes claim 1 obvious. Fawcett further discloses a method wherein the thermal nuclear reactor is a commercial reactor configured to produce at least 100 mW of the electrical power ([0017]), and wherein generating the neutron flux in the core of the thermal nuclear reactor to produce the electrical power comprises operating the commercial reactor continuously for at least a year ([0019]).
Fawcett further suggests that irradiation targets can be inserted and removed from the reactor “at times other than a planned reload at a planned outage” to “produce isotope material for those isotopes having shorter half-lives.” Melville teaches that commercial quantities of Ra-226 can be produced in a matter of several hours in a nuclear reactor (Section 5). Accordingly, a step of “repeatedly during the at least one year of operating the commercial reactor inserting the irradiation target assembly into the core of the thermal nuclear reactor, each time replenished with new Ra-226 isotopes, and producing the Ra-225 isotopes from a portion of the new Ra-226 isotopes” would have been obvious to the skilled artisan at the time of the invention/filing. One would take Melville’s statement to mean that would irradiate a first set of Ra-226 targets in the reactor for several hours, remove them, retrieve the “commercial” quantities of Ra-226, and insert fresh targets into the reactor for several hours.
One of ordinary skill in the art at the time of invention/filing would have found it obvious to use the method of Fawcett to produce commercial quantities Ac-225 from Ra-226 in hours.
5. Regarding claim 3, the combination of Melville’s Ra-226 target with Fawcett’s radioisotope production method makes claim 2 obvious. Fawcett is silent as to the mass if its irradiation targets, suggesting that such a parameter is a matter of obvious design choice (see [0027]). Melville suggests that only “grams” of Ra-226 are needed for commercial production of Ac-225 (see the “Highlights” on the first page). Accordingly, one of ordinary skill in the art at the time of invention/filing would have found it obvious to perform a step of “for each time the irradiation target assembly is inserted into the core of the thermal nuclear reactor, the irradiation target assembly comprises greater than 1g of a Ra-226 salt material comprising the Ra-226 isotopes” in the method of Fawcett as combined with Melville.
One of ordinary skill in the art at the time of invention/filing would have found it obvious to use the method of Fawcett to produce commercial quantities Ac-225 from Ra-226 in hours.
6. Regarding claim 4, the combination of Melville’s Ra-226 target with Fawcett’s radioisotope production method makes claim 3 obvious. Melville further teaches a method wherein producing the Ra-225 isotopes from a portion of the Ra-226 isotopes via the Ra-226 (n, 2n) reaction based on exposing the irradiation target assembly to the neutron flux comprises exposing the Ra-226 isotopes to the thermal neutrons and the fast neutrons (see at least Section 4.2).
One of ordinary skill in the art at the time of invention/filing would have found it obvious to use the method of Fawcett to produce commercial quantities Ac-225 from Ra-226 in hours.
7. Regarding claim 5, the combination of Melville’s Ra-226 target with Fawcett’s radioisotope production method makes claim 4 obvious. Fawcett further discloses a method wherein the irradiation target assembly does not comprise a thermal neutron jacket configured to block the thermal neutrons from being exposed to the Ra-226 isotopes (see [0026-29]). Melville also does not suggest that such a jacket is present.
One of ordinary skill in the art at the time of invention/filing would have found it obvious to use the method of Fawcett to produce commercial quantities Ac-225 from Ra-226 in hours.
8. Regarding claim 6, the combination of Melville’s Ra-226 target with Fawcett’s radioisotope production method makes claim 4 obvious. Fawcett further discloses a method wherein a ratio of the thermal neutrons to the fast neutrons in the neutron flux exposed to the irradiation target assembly is greater than 10 to 1 (see “Thermal Neutron” attached hereto). Melville also establishes that such a condition is present in nuclear fission reactors (see Fig. 6; Section 2.4).
One of ordinary skill in the art at the time of invention/filing would have found it obvious to use the method of Fawcett to produce commercial quantities Ac-225 from Ra-226 in hours.
9. Regarding claim 13, Regarding claim 1, Fawcett teaches a method for producing radioisotopes using a commercial nuclear reactor (see Fig. 1; Title; Abs.), the method comprising inserting an irradiation target assembly comprising a target material (310) into a core of the commercial nuclear reactor ([0017]’, [0018]); producing electricity using the commercial nuclear reactor by generating a neutron flux in the commercial nuclear reactor ([0019]); and irradiating the target material with the neutron flux generated in the commercial nuclear reactor to produce the radioisotopes ([0020]).
Melville suggests irradiating an irradiation target assembly comprising Ra-226 material with the neutron flux of a commercial nuclear reactor (section 2.4) to produce a Ra-225 material, wherein the Ra225 material decays to produce an Ac-225 material (section 1.2; section 2.5). Melville states that “commercial activities (mCi) of Ra-225 can be produced in hours (Section 5).
Accordingly, one of ordinary skill in the art at the time of invention/filing would have found it obvious to use the method of Fawcett to produce commercial quantities Ac-225 from Ra-226 in hours.
10. Regarding claim 14, the combination of Melville’s Ra-226 target with Fawcett’s radioisotope production method makes claim 13 obvious. Fawcett further discloses a method wherein producing the electricity using the commercial nuclear reactor comprises producing at least 100 mW of electrical power ([0017]).
11. Regarding claim 15, the combination of Melville’s Ra-226 target with Fawcett’s radioisotope production method makes claim 14 obvious. Fawcett is silent as to the mass if its irradiation targets, suggesting that such a parameter is a matter of obvious design choice (see [0027]). Melville suggests that only “grams” of Ra-226 are needed for commercial production of Ac-225 (see the “Highlights” on the first page). Accordingly, one of ordinary skill in the art at the time of invention/filing would have found it obvious use an irradiation target assembly comprising at least 1g of Ra226 in the method of Fawcett as combined with Melville.
One of ordinary skill in the art at the time of invention/filing would have found it obvious to use the method of Fawcett to produce commercial quantities Ac-225 from Ra-226 in hours.
12. Regarding claim 16, the combination of Melville’s Ra-226 target with Fawcett’s radioisotope production method makes claim 15 obvious. Fawcett further discloses a method wherein irradiating the Ra-226 material with the neutron flux generated in the commercial nuclear reactor comprises irradiating the Ra-226 material with thermal neutrons and fast neutrons, and wherein a ratio of thermal neutrons to fast neutrons in the neutron flux is greater than 10:1 ([0019]2). Melville also establishes that such a condition is present in nuclear fission reactors (see Fig. 6; Section 2.4).
One of ordinary skill in the art at the time of invention/filing would have found it obvious to use the method of Fawcett to produce commercial quantities Ac-225 from Ra-226 in hours.
13. Regarding claim 17, the combination of Melville’s Ra-226 target with Fawcett’s radioisotope production method makes claim 16 obvious. Melville further teaches wherein the Ra-225 material is produced via a Ra-226 (n, 2n) reaction (section 1.2).
One of ordinary skill in the art at the time of invention/filing would have found it obvious to use the method of Fawcett to produce commercial quantities Ac-225 from Ra-226 in hours.
14. Regarding claim 18, the combination of Melville’s Ra-226 target with Fawcett’s radioisotope production method makes claim 17 obvious. Fawcett further suggests that irradiation targets can be inserted and removed from the reactor “at times other than a planned reload at a planned outage” to “produce isotope material for those isotopes having shorter half-lives.” Melville teaches that commercial quantities of Ra-226 can be produced in a matter of several hours in a nuclear reactor (Section 5). Accordingly, a step of “repeatedly inserting the irradiation target assembly into a core of the commercial nuclear reactor and retracting the target assembly from the core of the commercial reactor to produce and collect the Ac-225 material while continuously producing electricity using the commercial nuclear reactor for at least one year” would have been obvious to the skilled artisan at the time of the invention/filing. One would take Melville’s statement to mean that would irradiate a first set of Ra-226 targets in the reactor for several hours, remove them, retrieve the “commercial” quantities of Ra-226, and insert fresh targets into the reactor for several hours.
One of ordinary skill in the art at the time of invention/filing would have found it obvious to use the method of Fawcett to produce commercial quantities Ac-225 from Ra-226 in hours.
18. The method of Claim 17, further comprising repeatedly inserting the irradiation target assembly into a core of the commercial nuclear reactor and retracting the target assembly from the core of the commercial reactor to produce and collect the Ac-225 material while continuously producing electricity using the commercial nuclear reactor for at least one year.
19. Claims 7-11 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fawcett US 2007/0133731 in view of Melville "A theoretical model for the production of Ac-225 for cancer therapy by neutron capture transmutation of Ra-226" in further view of Allen et al., US 2013/0336436.
20. Regarding claim 7, the combination of Melville’s Ra-226 target with Fawcett’s radioisotope production method makes claim 1 obvious. Fawcett further discloses a method wherein the thermal nuclear reactor is a commercial pressurized water reactor (PWR) or a commercial boiling water reactor (BWR) ([0017]) and further suggests and wherein inserting the irradiation target assembly into the core of the thermal nuclear reactor comprises inserting the irradiation target assembly via a movable incore detector system (MIDS) or a traversing incore probe system (TIPS) ([0039]). Allen teaches a method of producing radioisotopes (Title; Abs.) wherein inserting the irradiation target assembly into the core of the thermal nuclear reactor comprises inserting the irradiation target assembly via a traversing incore probe system (TIPS) (see [0040]). One of ordinary skill in the art at the time of invention/filing would have found it obvious to employ the insertion methodology of Allen in the method of Fawcett because Fawcett expressly suggests such a modification and because Allen teaches that such a target insertion/removal process allows for the production of relatively short-lived radioisotopes, which can then be “quickly and simply harvested be removing the targets from the instrumentation tube…without shutting down the reactor” ([0008]).
21. Regarding claim 8, the combination of the combination of Melville’s Ra-226 target and Allen’s target insertion process with Fawcett’s radioisotope production method makes claim 7 obvious. Allen further teaches a method wherein the irradiation target assembly comprises (see Figs. 7-8): a target rabbit (112a) couplable to the TIPS ([0049]); and a target pin (130) housed within the target rabbit, wherein the target pin encases the target radioisotopes ([0047]), which in the combination of Melville with Fawcett would be the Ra-226.
One of ordinary skill in the art at the time of invention/filing would have found it obvious to employ the insertion methodology of Allen in the method of Fawcett for the reasons stated above.
22. Regarding claim 9, the combination of the combination of Melville’s Ra-226 target and Allen’s target insertion process with Fawcett’s radioisotope production method makes claim 8 obvious. Allen further teaches a method wherein the target rabbit comprises a shell (135) to house the target pin, and wherein the target rabbit defines a gap between the shell and the target pin (see Figs. 7 and 8).
One of ordinary skill in the art at the time of invention/filing would have found it obvious to employ the insertion methodology of Allen in the method of Fawcett for the reasons stated above.
23. Regarding claim 10, the combination of the combination of Melville’s Ra-226 target and Allen’s target insertion process with Fawcett’s radioisotope production method makes claim 9 obvious. Allen further teaches a method wherein the irradiation target assembly comprises a plurality of the target pins housed within the target rabbit (see Figs. 7 and 8).
One of ordinary skill in the art at the time of invention/filing would have found it obvious to employ the insertion methodology of Allen in the method of Fawcett for the reasons stated above.
24. Regarding claim 11, the combination of the combination of Melville’s Ra-226 target and Allen’s target insertion process with Fawcett’s radioisotope production method makes claim 9 obvious. Allen further teaches a method wherein the irradiation target assembly comprises a plurality of the irradiation target rabbits coupled together (see Fig. 8).
One of ordinary skill in the art at the time of invention/filing would have found it obvious to employ the insertion methodology of Allen in the method of Fawcett for the reasons stated above.
25. Regarding claim 19, the combination of Melville’s Ra-226 target with Fawcett’s radioisotope production method makes claim 18 obvious. Fawcett further suggests and wherein inserting the irradiation target assembly into the core of the thermal nuclear reactor comprises inserting the irradiation target assembly via a movable incore detector system (MIDS) or a traversing incore probe system (TIPS) ([0039]). Allen teaches a method of producing radioisotopes (Title; Abs.) wherein inserting the irradiation target assembly into the core of the commercial nuclear reactor comprises inserting the irradiation target assembly via a traversing incore probe system (TIPS) (see [0040]). One of ordinary skill in the art at the time of invention/filing would have found it obvious to employ the insertion methodology of Allen in the method of Fawcett because Fawcett expressly suggests such a modification and because Allen teaches that such a target insertion/removal process allows for the production of relatively short-lived radioisotopes, which can then be “quickly and simply harvested be removing the targets from the instrumentation tube…without shutting down the reactor” ([0008]).
26. Regarding claim 20, the combination of the combination of Melville’s Ra-226 target and Allen’s target insertion process with Fawcett’s radioisotope production method makes claim 19 obvious. Allen further teaches a method further comprising concurrently inserting a plurality of the irradiation target assemblies into the commercial nuclear reactor (see Figs 7 and 8).
One of ordinary skill in the art at the time of invention/filing would have found it obvious to employ the insertion methodology of Allen in the method of Fawcett for the reasons stated above.
Allowable Subject Matter
27. Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Objections
28. Claims 9 is objected to because of the following informalities: it lacks the word “wherein”. Appropriate correction is required.
Conclusion
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/SHARON M DAVIS/Primary Examiner, Art Unit 3646
1 See “Thermal Neutron” attached hereto.
2 See “Thermal Neutron” attached hereto.
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