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 .
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 14 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 recitation regarding the reduced pressure is recited as “1x10-3”. However there are no units recited for this pressure. This limitation is interpreted as torr as the unit of pressure to be consistent with the pressures mentioned throughout the application (see Spec Para [0022] for example).
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.
Claim(s) 1-7 and 9-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shine WO 2021202914.
Regarding Claim 1, Shine discloses a method (abstract, A method) comprising: sublimating or distilling an ytterbium composition from an initial solid composition comprising ytterbium and lutetium in an inert or reduced pressure environment and at a first average temperature in a range of from 400 °C to 2000 °C for a first sublimation/distillation period to leave a lutetium composition comprising a higher weight percentage of lutetium than was present in the initial solid composition (Para. [0002], providing a solid composition having ytterbium and lutetium therein, and subliming or distilling the ytterbium from the solid composition at a reduced pressure and at a temperature of about 400°C to about 3000°C to leave a lutetium composition comprising a higher weight percentage of lutetium than was present in the solid composition (i.e. a lutetium-enriched composition-or sample) ... the solid composition may include Yb-176 and Lu-177; Para. [0021], In some embodiments, temperature ramp rates over a period of 10 minutes to 2 hours may be employed to ensure no blistering or uneven heating of the subject Yb sample containing the lutetium; (See points in Para. [0060]), 8. Under an inert atmosphere (e.g. He, N2, Ar, etc.), the chamber is evacuated until a stable pressure of approximately 1x10^-6 torr is obtained. 9. The crucible is then heated by radiofrequency (RF) induction heating to approximately 470°C. 11. Following completion of sublimation, the crucible is heated further, to approximately 600°C for 10 minutes.), collecting the ytterbium composition (Para. [0016], The vaporized fraction can then be recovered downstream after the vapor is condensed. In this case, the ytterbium is vaporized (and it may be collected downstream for later use) leaving behind a material that is enriched in lutetium. This may be conducted on larger scale, therefore increasing the amount of lutetium available. It is noted that the Yb that is collected is available for recycling to the reactor to produce further Lu in subsequent runs of the process.; Para. [0060], As the Yb metal sublimates from the heated crucible it is selectively deposited on to a cold finger which is actively cooled for collection and re-use at step 1 ); retaining the ytterbium composition for a waiting period to form a decayed ytterbium composition, wherein the waiting period is longer than the first sublimation/distillation period (Para. [0022], The time period required for the subliming and/or distilling steps may vary widely and is dependent upon the amount of material in the sample, the temperature, and the pressure. It may vary from about 1 second to about 1 week; Para. [0018], The sealed overpack is placed within the reactor and irradiated for several hours to several days, i.e., a waiting period to form a decayed ytterbium composition, (dependent on flux and batch requirements) to generate Lu-177 within the Yb-176 target.; Para. [0061], A quartz vial is loaded with 176Yb metal (10 g) and irradiated for 6 days thereby converting some of the 176Yb to 177Lu. The mixed 176Yb/177Lu sample is then transferred to a crucible and loaded into a vacuum chamber. The crucible is then heated to 1000°C, at an external pressure of 1e-6 torr, for approximately 24 hours); and subsequent to the waiting period (Para. [0061], The crucible is then heated to 1000 °C, at an external pressure of 1 e-6 torr, for approximately 24 hours, during which time a portion of the 176Yb sublimes within the crucible onto a cold finger within the vacuum chamber and the 177Lu remains in the crucible. The 176Yb may then be recycled for further irradiation).
The difference between Shine and that of claim 1 is that claim 1 requires subsequent to the waiting period, sublimating or distilling a refined ytterbium composition from the decayed ytterbium composition in an inert or reduced pressure environment and at a second average temperature in a range of from 400 °C to 2000 °C for a second sublimation/distillation period to leave a waste composition.
In secondary embodiments, Shine teaches a quartz vial is loaded with 176Yb metal (10 g) and irradiated for 6 days thereby converting some of the 176Yb to 177Lu. The mixed 176Yb/177Lu sample is then transferred to a crucible and loaded into a vacuum chamber. The crucible is then heated to 1000 °C, at an external pressure of 1 e-6 torr, for approximately 24 hours, during which time a portion of the 176Yb sublimes within the crucible onto a cold finger within the vacuum chamber and the 177Lu remains in the crucible. The 176Yb may then be recycled for further irradiation (Para. [0061]), the ytterbium that is sublimed/distilled from the solid composition may be recycled as additional target material for irradiation (Para. [0019]), in the described process, the Yb metal that is collected from the distillation/sublimation process is available for reuse (i.e. recycled for irradiation) almost immediately (Para. [0053]), as the Yb metal sublimates from the heated crucible it is selectively deposited on to a cold finger which is actively cooled for collection and re-use at step 1 (Para. [0060]) according to various embodiments, the temperature for sublimation and/or distillation may be from about 450°C to about 1500°C, or from about 450°C to about 1200°C. Also, according to various embodiments, the pressure may be from about 1x10-118 to about 1520 torr (Para. [0020]) and in other embodiments, the ytterbium that is collected from the sublimation/distillation is collected in an amount that is about 90 wt% to about 99.999 wt% of the ytterbium present in the solid composition. The purification steps are also conducted to remove other trace metals and contaminants, i.e., a waste composition comprising impurities including Lu-175. For example, materials such as metals, metal oxides, or metal ions of K, Na, Ca, Fe, Al, Si, Ni, Cu, Pb, La, Ce, Lu (non-radioactive), Eu, Sn, Er, and Tm may be removed (Shine: Para. [0023]).
Before the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize the processing steps of Shine (Paras. [0060]-[0061]) to include sublimating or distilling a refined ytterbium composition from the decayed ytterbium composition in an inert or reduced pressure environment and at a second average temperature in a range of from 400 °C to 2000 °C for a second sublimation/distillation period to leave a waste composition. One would be motivated to do so to isolate and purify lutetium for ytterbium irradiation target (Shine: abstract: Paras [0001]) by repeating the processing steps within conditions defined by Shine (Shine: Paras. [0060]-[0061]) to re-use the Yb irradiation target (Shine: Paras. [0019], [0053], [0060]-[0061]) to improve reusability of enriched Lu-177 suitable to be used for diagnostic testing in environmentally friendly process with recycling of input materials (Shine: Paras. [0011], [0053], [0060]).
Regarding Claim 2, Shine discloses the method of claim 1, further comprising collecting the refined ytterbium composition (Para. [0023], the ytterbium that is collected from the sublimation/distillation is collected in an amount that is about 90 wt% to about 99.999 wt% of the ytterbium present in the solid composition; Para. [0060], as the Yb metal sublimates from the heated crucible it is selectively deposited on to a cold finger which is actively cooled for collection and re-use at step 1).
Regarding Claim 3, Shine further discloses comprising forming the refined ytterbium composition into an ytterbium target (Para. [0019], the ytterbium that is sublimed/distilled from the solid composition may be recycled as additional target material for irradiation).
Regarding Claim 4, Shine further discloses comprising irradiating the ytterbium target with neutrons to form a recycled solid composition comprising ytterbium and lutetium (Para. [0013], The second production method for Lu-177 is a neutron capture reaction on ytterbium-176 (Yb-176) (Yb-176(n,y)Yb-177) to produce Yb-177. Yb-177 then rapidly (tin of 1.911 hours) beta-decays into Lu-177. An impurity ofYb-174 is typically present in the Yb-176, leading to a further impurity of Lu-175 in the final product. This process is considered to be a "no carrier added" process. The process may be carried out as ytterbium metal or ytterbium oxide.; Para. [0014], The present disclosure describes a process for the separation of Yb and Lu obtained from a no carrier added process.; claim 22, further comprising prior to subliming, contacting a solid comprising Yb-176 with a neutron source).
Regarding Claim 5, Shine does not disclose the method further comprising sublimating or distilling an ytterbium composition from the recycled solid composition in an inert or reduced pressure environment and at a third average temperature in a range of from 400 °C to 2000 °C for a third sublimation/distillation period to leave a subsequent lutetium composition comprising a higher weight percentage of lutetium than was present in the recycled solid composition.
Shine teaches a quartz vial is loaded with 176Yb metal (10 g) and irradiated for 6 days thereby converting some of the 176Yb to 177Lu. The mixed 176Yb/177Lu sample is then transferred to a crucible and loaded into a vacuum chamber. The crucible is then heated to 1000 °C, at an external pressure of 1 e-6 torr, for approximately 24 hours, during which time a portion of the 176Yb sublimes within the crucible onto a cold finger within the vacuum chamber and the 177Lu remains in the crucible. The 176Yb may then be recycled for further irradiation (Para. [0061]), the ytterbium that is sublimed/distilled from the solid composition may be recycled as additional target material for irradiation (Para. [0019]), in the described process, the Yb metal that is collected from the distillation/sublimation process is available for reuse (i.e. recycled for irradiation) almost immediately (Para. [0053]), as the Yb metal sublimates from the heated crucible it is selectively deposited on to a cold finger which is actively cooled for collection and re-use at step 1 (Para. [0060]) according to various embodiments, the temperature for sublimation and/or distillation may be from about 450°C to about 1500°C, or from about 450°C to about 1200°C. Also, according to various embodiments, the pressure may be from about 1x10^-8 to about 1520 torr (Para. [0020]).
Before the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize the processing steps of Shine (Paras. [0060]-[0061]) to further comprising sublimating or distilling an ytterbium composition from the recycled solid composition in an inert or reduced pressure environment and at a third average temperature in a range of from 400 °C to 2000 °C for a third sublimation/distillation period to leave a subsequent lutetium composition comprising a higher weight percentage of lutetium than was present in the recycled solid composition, since omission of an element and its function in a combination where the remaining elements perform the same function as before involves only routine skill in the art. One would be motivated to do so to isolate and purify lutetium for ytterbium irradiation target (Shine: abstract: Paras [0001]) by repeating the processing steps with the recycled Yb as many times as deemed necessary within conditions defined by Shine (Shine: Paras. [0060]-[0061]) to re-use the Yb irradiation target (Shine: Paras. [0019], [0053], [0060]-[0061]) to improve reusability of enriched Lu-177 suitable to be used for diagnostic testing in environmentally friendly process with recycling of input materials (Shine: Paras. [0011], [0053], [0060]).
Regarding Claim 6, Shine discloses the method of claim 1, wherein the refined ytterbium composition comprises 0.01 wt.% Lu-175 or less (Para. [0013], The second production method for Lu-177 is a neutron capture reaction on ytterbium-176 (Yb-176) (Yb-176(n,y)Yb-177) to produce Yb-177. Yb-177 then rapidly (tin of 1.911 hours) beta-decays into Lu-177. An impurity of Yb-174 is typically present in the Yb-176, leading to a further impurity of Lu-175 in the final product.; Para. [0023], the ytterbium that is collected from the sublimation/distillation is collected in an amount that is about 90 wt% to about 99.999 wt% of the ytterbium present in the solid composition. The purification steps are also conducted to remove other trace metals and contaminants, i.e., impurities including Lu-175 from 0.001 to 10 wt%).
Regarding Claim 7, Shine discloses the method of claim 1, wherein the waste composition comprises Lu-175 and at least one of one or more ytterbium oxides, one or more ytterbium silicates, lanthanum, iron, aluminum, nickel, copper, cerium, tin, erbium, cobalt, silicon, chromium, tantalum, titanium, molybdenum, manganese, and mixtures and alloys thereof (Para. [0061], The crucible is then heated to 1000°C, at an external pressure of 1 e-6 torr, for approximately 24 hours, during which time a portion of the 176Yb sublimes within the crucible onto a cold finger within the vacuum chamber and the 177Lu remains in the crucible. The 176Yb may then be recycled for further irradiation; Para. [0013], The second production method for Lu-177 is a neutron capture reaction on ytterbium-176 (Yb-176) (Yb-176(n,y) Yb-177) to produce Yb-177. Yb-177 then rapidly (tin of 1.911 hours) beta-decays into Lu-177. An impurity of Yb-174 is typically present in the Yb-176, leading to a further impurity of Lu-175 in the final product.; Para. [0023], In other embodiments, the ytterbium that is collected from the sublimation/distillation is collected in an amount that is about 90 wt% to about 99.999 wt% of the ytterbium present in the solid composition. The purification steps are also conducted to remove other trace metals and contaminants, i.e., a waste composition comprising impurities including Lu-175. For example, materials such as metals, metal oxides, or metal ions of K, Na, Ca, Fe, Al, Si, Ni, Cu, Pb, La, Ce, Lu (non-radioactive), Eu, Sn, Er, and Tm may be removed).
Regarding Claim 9, Shine discloses that the ytterbium composition comprises Yb-176 and Yb-175 (claim 22, solid comprising Yb-176a and inherently comprises other Yb isotopes including Yb-175; Para. [0013], The second production method for Lu-177 is a neutron capture reaction on ytterbium-176 (Yb-176) (Yb-176(n,y)Yb-177) to produce Yb-177. Yb-177 then rapidly (tin of 1.911 hours) beta-decays into Lu-177. An impurity ofYb-174 is typically present in the Yb-176, leading to a further impurity of Lu-175 in the final product) and during the waiting period the Yb-175 decays partially into Lu-175 to form the decayed ytterbium composition and sublimating or distilling the refined ytterbium composition from the decayed ytterbium composition separates Yb-176 and Lu-175 (claim 22, solid comprising Yb-176a and inherently comprises other Yb isotopes including Yb-175; Para. [0013], The second production method for Lu-177 is a neutron capture reaction on ytterbium-176 (Yb-176) (Yb-176(n,y)Yb-177) to produce Yb-177. Yb-177 then rapidly (tin of 1.911 hours) beta-decays into Lu-177. An impurity of Yb-174 is typically present in the Yb-176, leading to a further impurity of Lu-175 in the final product, i.e., during the waiting period the Yb-175 decays partially into Lu-175 to form the decayed ytterbium composition; Para. [0015], The separation of Yb and Lu may, at least partially, lake advantage of the difference in their vapor pressure at a particular temperature and pressure, i.e., separates Yb and Lu, thus separates Yb-176 and Lu-175).
Regarding Claim 10, Shine discloses the method of claim 9, wherein the refined ytterbium composition comprises Yb-176 and the waste composition comprises Lu-175 (Para. [0061], The crucible is then heated to 1000°C, at an external pressure of 1e-6 torr, for approximately 24 hours, during which time a portion of the 176Yb sublimes within the crucible onto a cold finger within the vacuum chamber and the 177Lu remains in the crucible. The 176Yb may then be recycled for further irradiation; Para. [0013], The second production method for Lu-177 is a neutron capture reaction on ytterbium-176 (Yb-176) (Yb-176(n,y)Yb-177) to produce Yb-177. Yb-177 then rapidly (tin of 1.911 hours) beta-decays into Lu-177. An impurity ofYb-174 is typically present in the Yb-176, leading to a further impurity of Lu-175 in the final product.; Para. [0023], In other embodiments, the ytterbium that is collected, i.e., the refined ytterbium composition comprises Yb-176, from the sublimation/distillation is collected in an amount that is about 90 wt% to about 99.999 wt% of the ytterbium present in the solid composition. The purification steps are also conducted to remove other trace metals and contaminants, i.e., a waste composition after purification comprising impurities including Lu-175. For example, materials such as metals, metal oxides, or metal ions of K, Na, Ca, Fe, Al, Si, Ni, Cu, Pb, La, Ce, Lu (non-radioactive), Eu, Sn, Er, and Tm may be removed).
Regarding Claim 11, Shine fails to disclose wherein the wailing period is at least 1 week in the same embodiment.
Shine teaches wherein the sealed overpack is placed within the reactor and irradiated for several hours to several days, i.e., a waiting period to form a decayed ytterbium composition, (dependent on flux and batch requirements) to generate Lu-177 within the Yb-176 target (Para. [0018]) and a quartz vial is loaded with 176Yb metal (10 g) and irradiated for 6 days (Para. [0061]).
Before the effective filling date of the claimed invention it would have been within the skill of a person of ordinary level of skill in the art to determine a suitable or optimal time waiting period for the decay. One would be motivated to decay an irradiation target for several hours to several days (Shine: Paras. [0001], [0018], [0061]) to achieve desired isotopes and isotope ratios based on their t1/2 values (Shine: para. [0013]). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." (MPEP §214405 IIA).
Regarding Claims 12 and 13, Shine fails to explicitly disclose wherein, during the waiting period, 90% or 99% or more of Yb-175 present in the ytterbium composition decays into Lu-175.
Shine teaches the second production method for Lu-177 is a neutron capture reaction on ytterbium-176 (Yb-176) (Yb-176(n,y)Yb-177) to produce Yb-177. Yb-177 then rapidly (tin of 1.911 hours) beta-decays into Lu-177. An impurity ofYb-174 is typically present in the Yb-176, leading to a further impurity of Lu-175 in the final product (Para. [0013]) similarly as the Applicant describes, See instant Specification, in Paras. [0040]-[0041], and the sealed overpack is placed within the reactor and irradiated for several hours to several days, i.e., a waiting period to form a decayed ytterbium composition, (dependent on flux and batch requirements) to generate Lu-177 within the Yb-176 target (Para. [0018]) and a quartz vial is loaded with 176Yb metal (10 g) and irradiated for 6 days (Para. [0061]).
Before the effective filing date of the claimed invention it would have been within the skill of a person of ordinary level of skill in the art to determine a suitable or optimal amount of Yb-175 that decays during the waiting period. The Shine reference teaches altering irradiation with the neutron source for a duration from several hours to several days and adjusting flux and batch requirements to provide conditions of decaying Yb-176 impurity Yb-174 into Lu-175 (Shine: Paras. [0013], [0018], [0061]; claim 22) to be further processed by processing steps (Shine: Para. [0060]) to remove from the composition as it is a known Lu isotope that is the most stable and non-radioactive, therefore not usable in radioactive isotope applications (Shine: Para. [0011]). Thus making the amount of Yb-175 that decays into Lu-175 is a result effective variable that can be optimized without undue experimentation.
Regarding Claim 14, Shine discloses that the reduced pressure is 1x10^-3 torr or less and the first average temperature is in a range of from 450 °C to 1500 °C (Para. [0020], According to various embodiments, the temperature for sublimation and/or distillation may be from about 450°C to: about 1500°C, or from about 450°C to about 1200°c. Also, according to various embodiments, the pressure may be from about 1x10"-8 to about 1520 torr.; (See points in Para. [0060]), 8. Under an inert atmosphere (e.g. He, N2, Ar, etc.), the chamber is evacuated until a stable pressure of approximately 1x10"-6 torr is obtained. 9. The crucible is then heated by radiofrequency (RF) induction heating to approximately 470°C ... 11. Following completion of sublimation, the crucible is heated further, to approximately 600°C for 10 minutes.).
Regarding Claim 15, Shine discloses that the first average temperature is less than 700 °c (Para. [0020], According to various embodiments, the temperature for sublimation and/or distillation may be from about 450 °C to about 1500 °C, or from about 450°C to about 1200°C.; Para. [0060], 9. The crucible is then heated by radiofrequency (RF) induction heating to approximately 470 °C ...11. Following completion of sublimation, the crucible is heated further, to approximately 600°C for 10 minutes.).
Regarding Claim 16, Shine fails to explicitly disclose wherein the first average temperature and the second average temperature are equal or differ by less than 100°C.
Shine teaches a quartz vial is loaded with 176Yb metal (10 g) and irradiated for 6 days thereby converting some of the 176Yb to 177Lu. The mixed 176Yb/177Lu sample is then transferred to a crucible and loaded into a vacuum chamber. The crucible is then heated to 1000 °C, at an external pressure of 1 e-6 torr, for approximately 24 hours, during which time a portion of the 176Yb sublimes within the crucible onto a cold finger within the vacuum chamber and the 177Lu remains in the crucible. The 176Yb may then be recycled for further irradiation (Para. (0061]), the ytterbium that is sublimed/distilled from the solid composition may be recycled as additional target material for irradiation (Para. [0019]), in the described process, the Yb metal that is collected from the distillation/sublimation process is available for reuse (i.e. recycled for irradiation) almost immediately (Para. [0053]), as the Yb metal sublimates from the heated crucible it is selectively deposited on to a cold finger which is actively cooled for collection and re-use at step 1 (Para. [0060]) according to various embodiments, the temperature for sublimation and/or distillation may be from about 450°C to about 1500°C, or from about 450°C to about 1200°c. Also, according to various embodiments, the pressure may be from about 1x10^-8 to about 1520 torr (Para. [0020]).
Before the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize the processing steps of Shine (Paras. [0060]-[0061]) to wherein the first average temperature and the second average temperature are equal or differ by less than 100 °C. One would be motivated to do so to isolate and purify lutetium for ytterbium irradiation target (Shine: abstract: Paras [0001]) by repeating the processing steps within conditions defined by Shine (Shine: Paras. [0060]-[0061]) to re-use the Yb irradiation target (Shine: Paras. [0019], [0053], [0060]-[0061]), thus repeated processing steps can be performed using the same conditions, to improve reusability of enriched Lu-177 suitable to be used for diagnostic testing in environmentally friendly process with recycling of input materials (Shine: Paras. [0011], [0053], [0060]).
Regarding Claim 17, Shine further discloses comprising subjecting the lutetium composition to chromatographic separation to further enrich the lutetium in the lutetium composition (Para. [0004], In any of the above methods, the method may further include subjecting the lutetium composition or the lutetium-enriched sample to chromatographic separation to further enrich the lutetium in the composition or sample. In any of the above embodiments, the chromatographic separation may include column chromatography, plate chromatography, thin cell chromatography, or high-performance liquid chromatography).
Regarding Claim 18, Shine discloses the method of claim 17, further comprising, dissolving the lutetium composition in an acid to form a dissolved lutetium solution, adding a chelator to the dissolved lutetium solution and neutralizing with a base to form a chelated lutetium solution comprising both chelated lutetium and ytterbium (Para. [0005], In any of the above methods, the method may further include dissolving the lutetium composition or lutetium-enriched sample in an acid to form a dissolved lutetium solution, adding a chelator to the dissolved lutetium solution and neutralizing with a base to form a chelated lutetium solution comprising both chelated lutetium and ytterbium), and subjecting the chelated lutetium solution to chromatographic separation, collecting a purified, chelated lutetium fraction, and de-chelating the lutetium to obtain purified lutetium (Para. [0005], subjecting the chelated lutetium solution to chromatographic separation, collecting a purified, chelated lutetium fraction, and de-chelating the lutetium to obtain purified lutetium).
Regarding Claim 19, Shine discloses that the initial solid composition is contained in a crucible of a sublimation/distillation apparatus and subliming or distilling ytterbium from the initial solid composition comprises heating the crucible such that the ytterbium composition sublimates, distills, or both sublimates and distills from the initial solid composition and collects on a collection substrate of the sublimation/distillation apparatus (Para. [0018], Generally, the process of the initial purification by distillation and/or sublimation proceeds as follows. An enriched Yb-176 metal target is packaged into a 1 cm diameter quartz tube with sealed ends. The quartz tube is then sealed in an inert overpack (e.g. aluminum) suitable for irradiation and impervious to water or air ingress. The sealed overpack is placed within the reactor and irradiated for several hours to several days (dependent on flux and batch requirements) to generate Lu-177 within the Yb-176 target. After irradiation, the irradiated Yb metal target is removed within an inert environment and placed inside a refractory metal crucible (e.g. molybdenum or tantalum), and placed in a vacuum chamber where the pressure is reduced. The crucible is then heated by radiofrequency (RF) induction. As the Yb metal sublimates from the heated crucible it is deposited onto the cold finger that is actively cooled for collection.).
Regarding Claim 20, Shine discloses the method of claim 1, wherein the refined ytterbium composition comprises a higher weight percentage of ytterbium than was present in the decayed ytterbium composition (Para. [0002], providing a solid composition having ytterbium and lutetium therein, and subliming or distilling the ytterbium from the solid composition at a reduced pressure and at a temperature of about 400°C to about 3000°C to leave a lutetium composition comprising a higher weight percentage of lutetium than was present in the solid composition; Para. [0013], The second production method for Lu-177 is a neutron capture reaction on ytterbium-176 (Yb-176) (Yb-176(n,y)Yb-177) to produce Yb-177. Yb-177 then rapidly (tin of 1.911 hours) beta-decays into Lu-177. An impurity of Yb-174 is typically present in the Yb-176, leading to a further impurity of Lu-175 in the final product.; Para. [0023], the ytterbium that is collected from the sublimation/distillation is collected in an amount that is about 90 wt% to about 99.999 wt% of the ytterbium present in the solid composition, i.e., the solid composition separated to enriched-Lu and collected in an amount that is about 90 wt% to about 99.999 wt% of the ytterbium present in the solid composition, thus the collected Yb has higher wt% of Yb than the irradiated and decayed solid composition).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shine WO 2021202914, in view of Shindo et al. US 2010/0260640.
Regarding Claim 8, Shine discloses that the waste composition comprises an ytterbium oxide (Paras. [0018], [0060], At this stage of the process, the generated lutetium or lutetium oxide, minute quantities of ytterbium or ytterbium oxide, and trace contaminants remain in the crucible; Para. [0023], In other embodiments, the ytterbium that is collected from the sublimation/distillation is collected in an amount that is about 90 wt% to about 99.999 wt% of the ytterbium present in the solid composition. The purification steps are also conducted to remove other trace metals and contaminants. For example, materials such as metals, metal oxides, or metal ions of K, Na, Ca, Fe, Al, Si, Ni, Cu, Pb, La, Ce, Lu (non-radioactive), Eu, Sn, Er, and Tm may be removed) and the method further comprises the ytterbium oxide and metallizing the ytterbium (claim 20, reducing ytterbium oxide to ytterbium metal, and irradiating the ytterbium metal to generate lutetium).
Shine fails to disclose wherein the waste composition comprises 10 mg or more of an ytterbium oxide and the method further comprises dissolving the ytterbium oxide to form a dissolved ytterbium oxide and metalizing the dissolved ytterbium.
Shine teaches the process may be carried out as ytterbium metal or ytterbium oxide (Para. [0013], starting with an impure source of lutetium (i.e. the irradiated ytterbium oxide target) (Para. [0030]), the time period required for the subliming and/or distilling steps may vary widely and is dependent upon the amount of material in the sample, the temperature, and the pressure (Para. [0022]) and at this stage of the process, the generated lutetium or lutetium oxide, minute quantities of ytterbium or ytterbium oxide, and trace contaminants remain in the crucible (Paras. [0018], [0061]).
Before the effective filling date of the claimed invention it would have been within the skill of a person of ordinary level of skill in the art to determine a suitable or optimal amount of ytterbium oxide to include. The amount of ytterbium oxide left is directly controlled by the number of re-use steps. The amount of ytterbium oxide remaining the sublimation or distillation steps would control the amount of ytterbium metal that can be reduced out. One would be motivated to use an amount which is sufficient to be irradiated and processed to generate lutetium 175 (Shine: paras. [0013], [0022]-[0023], [0060] and ; claim 20) and the motivation for doing so would be to improve efficiency of generating lutetium suitable to be used for diagnostic testing in environmentally friendly process with recycling of input materials (Shine: Paras. [0011], [0053], [0060]). Thus the making the oxide amount a result effective variable which can be optimized without undue experimentation.
Shindo relates to producing high purity ytterbium (Abstract) teaches (Para. [0024], a method of producing high purity ytterbium in which high purity ytterbium can be obtained by heating ytterbium oxide in a vacuum together with reducing metals, and reducing the product with reducing metals and simultaneously distilling the same) and a method further comprises dissolving the ytterbium oxide to form a dissolved ytterbium oxide and metalizing the dissolved ytterbium (Para. [0025], In the foregoing thermal reduction, the ytterbium oxide and the reducing metals may be mixed in advance, and then heated in order to perform the reduction and distillation of ytterbium, or the ytterbium oxide may be heated, and reducing metals may be placed therein and mixed in order to perform the reduction and distillation of ytterbium.; Para. [0055], Subsequently, this was mixed with lanthanum (La) as a metal of a reducing character, and thermally reduced in a vacuum at 1020° C. Pursuant to the advancement of reduction of the ytterbium oxide, ytterbium became distilled, i.e., dissolving ytterbium oxide, and the purity improved; Para. [0027], solidified, i.e., metalizing the dissolved ytterbium, under diminished pressure as need to obtain an ingot.).
Before the effective filing date of the claimed invention it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Shine to include a method further comprises dissolving the ytterbium oxide to form a dissolved ytterbium oxide and metalizing the dissolved ytterbium as taught by Shindo. One would be motivated to do so for the benefit of performing a method of purifying and further reducing ytterbium oxide to metallize ytterbium (Shine: abstract; Paras. [0018], [0023], [0060]) wherein ytterbium oxide is purified to produce a high purity ytterbium suitable for a sputtering target (Shindo: abstract; Paras. [0023]-[0024], [0027], [0055]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SYED TAHA IQBAL whose telephone number is (571)270-5857. The examiner can normally be reached M-F; 7-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anthony Zimmer can be reached at (571) 270-3591. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and 7https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SYED T IQBAL/ Examiner, Art Unit 1736
/ANTHONY J ZIMMER/ Supervisory Patent Examiner, Art Unit 1736