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 Objections
The claims are objected to because of the following informalities:
Claim 1 recites “a plurality of targets that generates.” The verb should be pluralized to match the subject: a plurality of targets that generate. See also “the plurality … is” in line 9.
Claim 5 recites “the control apparatus … predict.” The term “predict” should be correct to “predicts.”
Appropriate correction is required.
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.
Claims 1–11 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites the limitation "the targets" in line 8. There is insufficient antecedent basis for this limitation in the claim. Specifically, it is unclear if this is the exact same feature as the previously recited “a plurality of targets,” or if “the targets” in line 8 is intended to be a subset of the recited plurality.
In claim 1, lines 9-14, it is recited that the plurality of targets is divided into two groups: an irradiation group for generating the radionuclide, and a refinement group for separation treatment. This limitation conflicts with the recitation in lines 5-6 that the targets generate the radionuclide by irradiation and with the recitation in lines 7-8 that the radionuclide is separated and refined from the targets. In other words, lines 5-8 recite that the targets are both irradiated to generate radionuclides and these radionuclides are separated out and refined. Therefore, it is unclear how the targets/radionuclides can be separated into two (distinct?) groups based on being irradiated versus being separated, when said targets/radionuclides have already gone through both of these processes. Alternatively, if the claim intends to recite that these two groups have overlapping targets or that the groups exchange/share targets, then the claim should be amended to make this clear. This same rejection applies to claim 11 for its substantially similar language.
The limitation “wherein the plurality of targets is divided … [into two groups]” is indefinite because it is unclear if this division is a physical division or a division performed in the human mind, e.g., an operator mentally separates the targets into two groups depending upon their behavior, interactions, or other observations. Alternatively, if the claim intends to recite that the groups share targets, e.g., if first the targets are in the irradiation group and then they move to the second, refinement group, then the claim should be amended to make this clear. This same rejection applies to claim 11 for its substantially similar language.
Claim 1 recites “the irradiation target group and the refinement target group are processed in parallel.” It is unclear if this means the two groups are capable of being processed simultaneously by the system, or if it means the system is structured such that the two groups are side-by-side, or that they move/flow in the same direction. This same rejection applies to claim 11 for its substantially similar language.
The term “raw” in claim 3 is a relative term which renders the claim indefinite. The term “raw” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Additionally, the term “raw include” introduced in claim 3 has insufficient antecedent basis.
Claim 3 recites the limitation "a measurement result" in line 4. There is insufficient antecedent basis for this limitation in the claim. Specifically, no measurement has yet been positively recited, and therefore the result of such a measurement does not have antecedent basis in the claim.
Claims 2, 4, and 10 recite the limitation "the number of targets”. There is insufficient antecedent basis for this limitation in the claims.
Claims 1, 2, 3, 4, 5, 6, 7, and 9 are each individually indefinite because they are system claims that recite steps, e.g., “the control apparatus refers … and selects,” claim 3 and “the plurality of targets is divided,” claim 1. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b). See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). See MPEP 2173.05(p)(II).
Claim 5 recites that the control apparatus “predict[s] an amount of radionuclide to be separated and refined.” The term “predicts” here does not make sense. The control system making a prediction would imply that the parameter being predicted was not under the control of the control system, e.g., a meteorologist predicts the next day’s weather but does not have control over it. This is not the case here. Here, the control system is not predicting an amount of radionuclide to be separated and refined, but rather it is selecting this value. The above rejection holds also for claim 7 because of its substantially similar language.
Claim 7 recites, in the final clause, that the control apparatus “determines that there is the abnormality … when a difference between […] and […] is a threshold or more.” The claim appears to be incomplete. What is the threshold? Is it a numerical value? How can one have “more” of “a threshold”? One can exceed a numerical value, but it is unclear how one can have “more” or less of a threshold.
Any claim not specifically addressed in this section that depends from a rejected claim is also rejected under 35 U.S.C. 112(b) for its dependency upon an above–rejected claim and for the same reasons.
Claim Rejections - 35 USC § 102
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 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.
For Applicant’s benefit, portions of the cited reference(s) have been cited to aid in the review of the rejection(s). While every attempt has been made to be thorough and consistent within the rejection, it is noted that the prior art must be considered in its entirety, including disclosures that teach away from the claims. See MPEP 2141.02 VI.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6, and 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2020225951A1 (English version US20220199277A1 “Tadokoro” cited herein for convenience).
Regarding claim 1, Tadokoro discloses (fig. 5) a radionuclide production system for generating, separating, and refining a radionuclide, comprising: a particle beam irradiation apparatus (50) that generates a particle beam (10, 12); a plurality of targets (11, 23, 20) that generate[] the radionuclide (“desired radionuclide,” ¶ 87) by irradiation with the particle beam; and a separation refinement apparatus (30) that separates and refines the radionuclide from the targets, wherein the plurality of targets is divided into an irradiation target group (11, 23) subjected to an irradiation treatment of generating the radionuclide by the irradiation with the particle beam and a refinement target group (20) subjected to a separation refinement treatment of separating and refining the radionuclide from the targets, and the irradiation target group (11, 23) and the refinement target group (20) are processed in parallel (irradiation of 11, 23 may occur simultaneously as separation of the radionuclide from the fluid 20 via device 30, fig. 5).
Regarding claim 2, Tadokoro anticipates all the elements of the parent claim and additionally discloses (fig. 5) a control apparatus (60) that selects a target condition in the irradiation treatment and the separation refinement treatment or a condition for the irradiation with the particle beam (the control apparatus may select a desired target temperature or flow rate, ¶¶ 91-91), wherein the target condition is one or more of the number of targets of the irradiation target group, the number of targets of the refinement target group, a configuration of each target of the irradiation target group, a configuration of each target of the refinement target group, and arrangement of the targets of the irradiation target group (“the control unit 60 may adjust the flow rate of the pump 22 according to an amount of the radionuclide desired to be taken out from the separation device 30. That is, when it is desired to reduce the amount of the radionuclide to be taken out from the separation device 30, the control unit 60 reduces the flow rate of the pump 22. Thus, the production amount can be controlled by adjusting the flow rate of the pump 22,” ¶ 92), and the control apparatus (60) selects the target condition or the irradiation condition based on a measured amount of radionuclide separated and refined from each target of the refinement target group (“the control unit 60 may adjust the flow rate of the pump 22 according to an amount of the radionuclide desired to be taken out from the separation device 30. That is, when it is desired to reduce the amount of the radionuclide to be taken out from the separation device 30, the control unit 60 reduces the flow rate of the pump 22. Thus, the production amount can be controlled by adjusting the flow rate of the pump 22,” ¶ 92).
Regarding claim 3, Tadokoro anticipates all the elements of the parent claim and additionally discloses (fig. 5) wherein the control apparatus (60) refers to a measurement result of an amount of raw nuclide included in each target or an amount of radionuclide generated by nuclear transformation of the raw nuclide (“the control unit 60 may adjust the flow rate of the pump 22 according to an amount of the radionuclide desired to be taken out from the separation device 30. That is, when it is desired to reduce the amount of the radionuclide to be taken out from the separation device 30, the control unit 60 reduces the flow rate of the pump 22. Thus, the production amount can be controlled by adjusting the flow rate of the pump 22,” ¶ 92), and selects the target condition or the irradiation condition such that the measured amount of radionuclide separated and refined from each target of the refinement target group reaches a preset desired radionuclide production (“the control unit 60 may adjust the flow rate of the pump 22 according to an amount of the radionuclide desired to be taken out from the separation device 30,” ¶ 92).
Regarding claim 4, Tadokoro anticipates all the elements of the parent claim and additionally discloses (fig. 5) a control apparatus (60) that selects a target condition in the irradiation treatment and the separation refinement treatment or a condition for the irradiation with the particle beam (the control apparatus may select a desired target temperature or flow rate, ¶¶ 91-91), wherein the target condition is one or more of the number of targets of the irradiation target group, the number of targets of the refinement target group, a configuration of each target of the irradiation target group, a configuration of each target of the refinement target group, and arrangement of the targets of the irradiation target group (“the control unit 60 may adjust the flow rate of the pump 22 according to an amount of the radionuclide desired to be taken out from the separation device 30. That is, when it is desired to reduce the amount of the radionuclide to be taken out from the separation device 30, the control unit 60 reduces the flow rate of the pump 22. Thus, the production amount can be controlled by adjusting the flow rate of the pump 22,” ¶ 92), and the control apparatus selects the target condition or the irradiation condition based on a history of the irradiation treatment and the separation refinement treatment to which the targets are subjected (the control apparatus may increase or decrease a condition, e.g., a flow rate or temperature, of the target based on a history of treatment, e.g., the previous flow rate or temperature, and the separation refinement treatment to which the targets are subjected, e.g., the take-out portion 31 leaving separation device 30 relative to the amount 20 flowing in the loop 21).
Regarding claim 6, Tadokoro anticipates all the elements of the parent claim and additionally discloses (fig. 5) a control apparatus (60) that detects an abnormality (e.g., the condition wherein not enough radionuclide is present in the loop 21) in the irradiation treatment or the separation refinement treatment, wherein the control apparatus (60) detects the abnormality in the irradiation treatment or the separation refinement treatment based on a history of the irradiation treatment and the separation refinement treatment to which the targets are subjected and a measured amount of radionuclide separated and refined from each target of the refinement target group (if the control apparatus 60 determines, based on radionuclide amount history, that too much radionuclide is being taken out from the separation device 30, it reduces the flow rate of the pump 22, ¶ 92).
Regarding claim 8, Tadokoro anticipates all the elements of the parent claim and additionally discloses (fig. 5) wherein the particle beam irradiation apparatus is an electron linear accelerator (1).
Regarding claim 9, Tadokoro anticipates all the elements of the parent claim and additionally discloses (fig. 5) wherein the radionuclide production system produces actinium 225 (Ac-225) (“Ra-225,” ¶ 87, which decays to 225Ac).
Regarding claim 10, Tadokoro anticipates all the elements of the parent claim and additionally discloses (fig. 5) wherein the number of targets (11, 23, 20) is 10 or less (3 < 10).
Regarding claim 11, Tadokoro discloses (fig. 5) a radionuclide production method for generating, separating, and refining a radionuclide, comprising: an irradiation treatment (via 50) of generating the radionuclide (“Ra-225,” ¶ 87) in a target (11, 23, 20) by irradiation with a particle beam (10, 12); and a separation refinement treatment (via 30) of separating and refining the radionuclide from the target, wherein the target (11, 23, 20) includes a plurality of targets divided into an irradiation target group subjected to the irradiation treatment and a refinement target group subjected to the separation refinement treatment, and the irradiation target group (11, 23) and the refinement target group (20) are processed in parallel to produce the radionuclide (irradiation of 11, 23 may occur simultaneously as separation of the radionuclide from the fluid 20 via device 30, fig. 5).
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 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.
For Applicant’s benefit, portions of the cited reference(s) have been cited to aid in the review of the rejection(s). While every attempt has been made to be thorough and consistent within the rejection, it is noted that the prior art must be considered in its entirety, including disclosures that teach away from the claims. See MPEP 2141.02 VI.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Tadokoro, Figure 8 embodiment.
Regarding claim 5, Tadokoro anticipates all the elements of the parent claim and additionally discloses (fig. 5) the control apparatus (60) but does not explicitly disclose the claimed estimation.
Tadokoro does teach this in the embodiment shown in Figure 8. Tadokoro (fig. 8) teaches a control system (“a timing at which the radionuclide is taken out can be controlled,” ¶ 99) that estimates an amount of raw nuclide (“Ra-226 which is the raw material,” ¶ 100) included in each target (in 20) or an amount of radionuclide (“Ac-225,” ¶ 100) generated by nuclear transformation of the raw nuclide based on the history of the irradiation treatment and the separation refinement treatment to which the targets are subjected, predict[s] an amount of radionuclide (“Ac-225,” ¶ 100) to be separated and refined (via 30) from each target of the refinement target group (20) based on the estimated raw nuclide amount or the estimated radionuclide amount (the system predicts that at “about 428 hours,” the radionuclide Ac-225 is at its “maximum amount,” ¶ 100), and selects the target condition or the irradiation condition such that the predicted amount of radionuclide to be separated and refined from each target of the refinement target group reaches a preset desired radionuclide production amount (the irradiation condition, e.g., whether or not the targets in 20 continue to circulate in loop 21 and be irradiated, is selected such that the predicted amount of Ac-225 to be separated and refined from each target of the refinement target group 20 reaches its maximum prior to the opening of switch 27, at which time, the targets in 20 may “pass through the separation device 30,” ¶ 101 to be removed from the loop 21 and therefore the condition of continuing to be irradiated or not).
The skilled artisan would have been motivated to utilize the estimation and target condition selection as taught by Tadokoro in Figure 8 in order to obtain the “maximum amount” of the desired radionuclide of Ac-225 before it starts to dwindle, as described in ¶ 100.
Regarding claim 7, Examiner notes that the third clause (“…determines…”) is a conditional limitation, and because this is an apparatus claim, the apparatus must simply be capable of making the claimed determination if that situation were to occur (the difference being equal to or greater than a threshold). Tadokoro anticipates all the elements of the parent claim and additionally discloses (fig. 5) wherein the control apparatus (60) determines that there is the abnormality in the irradiation treatment or the separation refinement treatment (e.g., the condition wherein not enough radionuclide is present in the loop 21) when a difference between the predicted amount of radionuclide to be separated and refined from each target of the refinement target group (20) and the measured amount of radionuclide separated and refined from each target of the refinement target group (20) is a threshold or more (if the control apparatus 60 determines that more radionuclide is being taken out from the separation device 30 than intended, it reduces the flow rate of the pump 22, ¶ 92).
Tadokoro does not explicitly disclose the claimed estimation.
Tadokoro does teach this in the embodiment shown in Figure 8. Tadokoro (fig. 8) teaches a control system (“a timing at which the radionuclide is taken out can be controlled,” ¶ 99) that estimates an amount of raw nuclide (“Ra-226 which is the raw material,” ¶ 100) included in each target (in 20) or an amount of radionuclide (“Ac-225,” ¶ 100) generated by nuclear transformation of the raw nuclide based on the history of the irradiation treatment and the separation refinement treatment to which the targets are subjected, predicts an amount of radionuclide (“Ac-225,” ¶ 100) to be separated and refined (via 30) from each target of the refinement target group (20) based on the estimated raw nuclide amount or the estimated radionuclide amount (the system predicts that at “about 428 hours,” the radionuclide Ac-225 is at its “maximum amount,” ¶ 100).
The skilled artisan would have been motivated to utilize the estimation and prediction as taught by Tadokoro in Figure 8 in order to obtain the “maximum amount” of the desired radionuclide of Ac-225 before it starts to dwindle, as described in ¶ 100.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LILY C GARNER whose telephone number is (571)272-9587. The examiner can normally be reached 9-5 CT.
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LILY CRABTREE GARNER
Primary Examiner
Art Unit 3646
/LILY C GARNER/Primary Examiner, Art Unit 3646