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 and Claim Status
1. Applicant’s election without traverse of Invention II, claims 17-21 in the reply filed on 03/24/26 is acknowledged.
2. Claims 17-35 are pending and examined herein.
Allowable Subject Matter
2. Claims 17-35 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
3. The following is a statement of reasons for the indication of allowable subject matter: The closest prior art (cited on attached PTO-892) does not fairly suggest irradiating 176Yb in a “sealed tube” and sublimating unreacted 176Yb from produced 177Lu in the same sealed tube, followed by separating the sealed tube into a portion containing the product and a portion containing sublimed 176Yb. Panteleev irradiates and sublimes in the same container. Sisson teaches the sublimation steps and post-processing to separate 176Yb from 177Lu. Neither disclose or suggest the breaching step.
Claim Rejections - 35 USC § 112
4. 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.
5. Claims 17-35 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 pre-AIA the applicant regards as the invention.
6. Claims 17-35 are replete with terms lacking or having unclear antecedent basis. The following list is exemplary, not exhaustive:
In claim 17: “the 177Lu product material” and “the tube sealing” lack antecedent basis because they were not previously introduced.
In claim 18: “the concentrated 177Lu product material” was not previously introduced.
In claims 19 and 20: “the irradiation and the sublimation” should refer to the irradiating and subliming steps previously introduced. Further in claim 20, “the source material” lacks antecedent basis.
In claim 21: “the sublimed 176Yb” was not previously introduced. Further, no crucible was previously introduced, so the recitation “another crucible” lacks antecedent basis.
In claim 23: “the sublimed 176Yb” was not previously introduced. Further, “the irradiation and the sublimation” and “the irradiated source material” lack antecedent basis.
In claim 24: “the concentrated product material” and “the sublimed source material” lack antecedent basis.
In claim 25: “the concentrated product material,” “the further concentration,” and “the sublimed source material” lack antecedent basis.
In claim 26: “the sublimed source material” and “the source material” lack antecedent basis.
In claims 27-29: “the respective source material and sublimed material” lack antecedent basis.
In claim 30: “the concentrated 177Lu” lacks antecedent basis. It is further unclear as to what the recitation “the 177Lu” refers.
In claim 32: “the irradiated source material” and “the remaining concentrated 177Lu” lack antecedent basis.
In claim 34: “the sublimed 176Yb,” “the irradiation” and “the sublimation” lack antecedent basis.
In claim 35: is the tube recited the same sealed tube previously introduced?
7. Regarding claim 22, the recitation “and consecutively” does not adequately define which of the recited steps are consecutive. A suggested amendment is provided below.
8. Further regarding claims 27-29, a wherein clause in a method claim should give “meaning and purpose to the manipulative steps.” (MPEP 2111.04(1)). The recitations do not clearly denote how a previously recited method step is performed, nor do they clearly introduce a further process step. Accordingly, the claims do not clearly define the metes and bounds of the claimed method. Suggested amendments are provided below.
9. Regarding claims 31-32, the limitations do not clearly specify a further limitation of previously recited method steps. They appear to be statements of the results desired or obtained by performing process steps. Suggested amendments are provided below.
10. Regarding claim 34, it is unclear how irradiating the sublimed 176Yb and performing the subliming step on the irradiated sublimed 176Yb would provide a result of further concentrating the 177Lu. Wouldn’t this repetition simply produce more 177Lu?
11. Any claim not specifically addressed above is rejected under 35 U.S.C. §112 because it depends on a rejected claim.
12. The examiner suggests the following amendments as a starting point for Applicant to correct all claims:
13. Claim 17 should be amended to provide proper antecedent basis for the recitations in the dependent claims. The dependent claims should be amended correspondingly to refer to the terms introduced in claim 17.
A method of producing 177Lu, the method comprising:
irradiating with neutrons a source material comprising 176Yb in a sealed tube and producing an irradiated source material comprising the 176Yb and the 177Lu, the sealed tube comprising a top section, a bottom section, and a tube sealing;
subliming, in the sealed tube, the 176Yb from the irradiated source material and producing sublimed 176Yb in the top section of the sealed tube and concentrated 177Lu in the bottom section of the sealed tube; and
breaching the tube sealing and separating the top section of the sealed tube having the sublimed 176Yb therein from the bottom section of the tube having the concentrated 177Lu therein.
14. Claim 18 should be amended to provide antecedent basis for the final 177Lu product.
…further comprising post-processing the concentrated 177Lu and producing purified 177Lu.
15. Claim 22 should be amended to clearly recite that the additional steps are that of producing the sealed tube. Claim 35 should be amended in a similar manner. In fact, the only additional limitation claim 35 recites is the material of the tube, so claim 35 could be made dependent on claim 22 and amended to only recite the additional limitation.
…further comprising: prior to the irradiating, producing the sealed tube by consecutively:
depositing the source material in the bottom section;
attaching the top section to the bottom section;
heating and generating a vacuum in the top section and bottom section; and
forming the tube sealing.
16. Claims 25-29 and 34-35 should be amended to clearly recite the additional process steps and to clearly refer to previously introduced process steps and limitations.
17. Claim 31 and 32 should be amended to positively recite the additional limitations of the post-processing/subliming steps:
…wherein the post-processing step provides the purified 177Lu at a yield of above 60% with a total purification coefficient of at least a million.
…wherein the subliming step sublimed at least 99 wt% of the 176Yb from the irradiated source material, providing the concentrated 177Lu with at most 1 wt% 176Yb.
Claim Objections
18. Claims 23 and 34 objected to because of the following informalities: improper punctuation. Appropriate correction is required.
Interviews
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARON M DAVIS whose telephone number is (571)272-6882. The examiner can normally be reached Monday - Thursday, 7:00 - 5:00 pm ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jack Keith can be reached at 571-272-6878. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHARON M DAVIS/Primary Examiner, Art Unit 3646
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