Prosecution Insights
Last updated: April 19, 2026
Application No. 17/825,217

System, Emanation Generator, and Process for Production of High-Purity Therapeutic Radioisotopes

Final Rejection §102§112§DP
Filed
May 26, 2022
Examiner
DICKINSON, PAUL W
Art Unit
1618
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
BATTELLE MEMORIAL INSTITUTE
OA Round
4 (Final)
63%
Grant Probability
Moderate
5-6
OA Rounds
3y 4m
To Grant
72%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allow Rate
646 granted / 1025 resolved
+3.0% vs TC avg
Moderate +10% lift
Without
With
+9.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
43 currently pending
Career history
1068
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
42.0%
+2.0% vs TC avg
§102
20.0%
-20.0% vs TC avg
§112
25.2%
-14.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1025 resolved cases

Office Action

§102 §112 §DP
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 . DETAILED ACTION Applicant’s arguments, filed 8/4/2025, have been fully considered but they are not deemed to be fully persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. New Grounds of Rejection 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 31 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. Claim 31 recites “[t]he system of claim 21, wherein the radioactive product isotopes are selected from… and/or daughter isotopes thereof.” However, claim 21 recites “radioactive product isotopes… wherein the product isotopes comprise one or more of Lead or Bismuth isotopes,” and is not open to the radioactive product isotopes being daughters of Lead and/or Bismuth isotopes, as is recited in claim 31. As claim 31 is broader than claim 21, it’s unclear how claim 31 can limit claim 21. 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. 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 21 and 23-31 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 20090162278 to Ravn. Ravn discloses an emanation system for production of radioisotopes, comprising: an emanation device having an emanation source comprising a material having source isotope bound therein that emanates a radioactive daughter isotope gas therefrom; anda collection device configured to collect the radioactive daughter isotope gas, retaining same for a time sufficient to yield one or more radioactive daughter isotopes therein (abstract; Figures 1A-C; paragraphs 1 and 14-38; claim 45). Ravn teaches a method of producing isotopes, comprising the steps of emanating a radioactive gas generated in a source material comprising a source isotope to separate the radioactive gas as a pure product therefrom; and collecting the separated radioactive gas and retaining same for a time sufficient to decay the radioactive gas to yield one or more radioactive daughter isotopes therefrom (abstract; Figures 1A-C; paragraphs 1 and 14-38; claims 1-44). The emanation generator may comprise a radium source (a radioactive noble gas) (paragraphs 70, 306, 309, 312-313, 318-328, 344-345, and 351). The source isotope may be Thorium-228, Radium-223, Radium-224, Radium-226, and/or Radon-220 (claim 2). The daughter isotopes may be Pb-211, Pb-212, Bi-212, and/or Bi-213 (paragraphs 71 and 213). This is an emanation system for production of radioisotopes, comprising: an emanation device having an emanation source comprising a material having a Rn source isotope bound therein that emanates a radioactive isotope gas therefrom, wherein the Rn source isotope comprises one or more of Uranium, Thorium, and/or Radium; and a collection device configured to collect the radioactive isotope gas, retaining same for a time sufficient to yield one or more radioactive product isotopes therein, wherein the product isotopes comprise one or both of Lead or Bismuth isotopes. The source isotope may be disposed on a particle surface (paragraph 16). The source isotope is disposed on a porous matrix (a gas-permeable support) (paragraph 321). The collection device includes a cooling device configured to cool the radioactive gas emanated from the emanation device (the collecting step includes cooling the emanated radioactive gas with a cooling device to condense or deposit the emanated radioactive gas) (paragraphs 16, 321 and 324; Figures 1A-C). The collection device includes a soluble salt configured as a thin film (paragraph 378, 381, and 414). The system further includes an eluent delivery device or system configured to deliver a fluid to recover the radioactive daughter isotopes from the collection device (paragraphs 143 and 281). The method further includes the step of recovering the radioactive daughter isotopes in a fluid such as a biologically-compatible aqueous solution (paragraph 281). Applicant has provided no arguments on the merits of the rejection, and the rejection is deemed proper for the reasons given above. Double Patenting A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957). A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101. 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. Claims 21 and 23-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 15675529. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to a method of producing radioisotopes, the method comprising: preparing a composition comprising an Ra source isotope and sorbent particles; loading the composition onto a solid support material to form a mixture comprising the Ra source isotope, the sorbent particles, and the solid sorbent material; while within the mixture, decaying at least some of the Ra source isotope to yield one or more radioactive Rn daughter isotopes in a gaseous state; separating the gaseous Rn daughter isotopes from the mixture; and collecting the separated Rn daughter isotopes (patent claim 1), wherein the source isotope comprises one or more of Radium-224, Radium-223, and/or Radium-226 (patent claim 2), wherein the radioactive gas comprises one or more of Radon-220, Radon-219, and/or Radon-222 (patent claim 3), further comprising forming decay products of the collected Rn daughter isotopes (patent claim 4), wherein the decay products comprise one or more of Pb-212, Bi-212; Pb-211, Bi-211, Pb-214, and/or Bi-214 (patent claim 5), wherein the sorbent particles comprise magnetic and/or paramagnetic metal oxide particles (patent claim 6), wherein the solid sorbent material is gas-permeable (patent claim 7), wherein the collecting the separated Rn daughter isotopes further comprises cooling the daughter isotopes (patent claim 8), wherein the collecting the separated Rn daughter isotopes further comprises binding the daughter isotopes to a support having an affinity for the daughter isotope in gaseous form (patent claim 9), wherein the support comprises a soluble salt configured as a thin film or a packed salt (patent claim 10), wherein the support comprises a lipophilic liquid configured as a thin film (patent claim 11), wherein the support comprises a thin film coating on a solid support (patent claim 12), wherein the collecting the separated Rn daughter isotopes comprises collecting the daughter isotopes in a liquid solution (patent claim 13). This anticipates present claims 21 and 23-31. Applicant has provided no arguments on the merits of the rejection, and the rejection is deemed proper for the reasons given above. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /PAUL W DICKINSON/Primary Examiner, Art Unit 1618 October 25, 2025
Read full office action

Prosecution Timeline

May 26, 2022
Application Filed
Oct 07, 2023
Non-Final Rejection — §102, §112, §DP
Apr 15, 2024
Response Filed
Jul 09, 2024
Final Rejection — §102, §112, §DP
Jan 14, 2025
Request for Continued Examination
Jan 16, 2025
Response after Non-Final Action
Jan 30, 2025
Non-Final Rejection — §102, §112, §DP
Aug 04, 2025
Response Filed
Oct 25, 2025
Final Rejection — §102, §112, §DP
Apr 09, 2026
Interview Requested

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

5-6
Expected OA Rounds
63%
Grant Probability
72%
With Interview (+9.5%)
3y 4m
Median Time to Grant
High
PTA Risk
Based on 1025 resolved cases by this examiner. Grant probability derived from career allow rate.

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