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
Applicant’s election without traverse of claims 1-5 and 7-9 in the reply filed on 05/18/2026 is acknowledged. Claims 10–12, 14–16, and 18–19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/18/2026.
Status of Claims
Claims 1–5 and 7–9 are under examination.
This application has been transferred to a different Examiner.
Allowable Subject Matter
Claim 7 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. (And if the indefiniteness rejections of the other pending claims are resolved.)
The following is a statement of reasons for the indication of allowable subject matter: Allen with Thiel teaches the entirety of claim 1, but Examiner does not find that the skilled artisan would take the enriched enclosure of Allen/Thiel and modify it to also be an alloy, without improper hindsight of Applicant’s invention. Allen discloses that “assembly 122 a may be fabricated of zirconium alloy, stainless steel, aluminum, nickel alloy, silicon, graphite, and/or Inconel, etc.,” ¶ 46, but Examiner does not find this reasonably combinable with said enclosure also being enriched in one of the three isotopes recited in claim 1.
If Applicant would like the method claims to be rejoined in a future allowance,
Examiner asks that the method claims be amended to explicitly depend upon the allowed independent claim, e.g., claim 16 “A method for producing pharmaceutical radioisotopes with the enclosure of claim 1, the method comprising …” Examiner is unsure if claim 10 can be rejoined but is open to an interview for discussion to avoid unnecessary continuations.
Election/Restrictions
Applicant’s election without traverse of claims 1-5 and 7-9 in the reply filed on 05/18/2026 is acknowledged. Claims 10-12, 14-16, and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/18/2026.
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 2, 3, 5, and 9 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.
Claims 2 and 3 recite that the enriched material/enclosure has “a short half-life upon exposure to neutron flux.” This limitation is unclear because the enriched material/enclosure was defined in parent claim 1 as comprising “at least one of Nickel-64, Copper-63, or Copper-65.” Upon exposure to neutron flux, obviously these isotopes would change to different isotopes. For example, it is unclear if claims 2 and 3 are referring to Copper-63 having a short half-life, or to Copper-64 (after it absorbs a neutron) having a short half-life. For the purpose of examination, Examiner assumes Applicant means not the enriched material/enclosure isotope, but rather the isotope it becomes upon exposure to neutron flux.
Similarly, claim 5 recites that “the enriched material comprises a precursor to a beta emitter.” Taking Copper-63 as an example, it is unclear in what manner the claim intends Copper-63 to be a precursor to a beta emitter. The nuclear reaction must be included in order to know if Copper-63 will lead to something that is a beta emitter. If protons or gamma rays or neutrons are incident on a Copper-63 target, the resultant element may or may not be a beta emitter. Examiner suggests including the neutron flux reaction in a parent claim to claim 5 so that it is clear that Copper-63, upon absorbing a neutron and becoming Copper-64, is then a beta emitter (Copper-64 is a beta emitter1). For the purpose of examination, Examiner assumes Applicant means that, upon absorbing a neutron the recited species in claim 1 leads to a secondary radioisotope that is a beta emitter.
Claim 9 recites that “the enclosure comprises an outer wall comprised of the enriched material.” Examiner is unclear if the enclosure itself is the “outer wall,” or if the enclosure is a first wall, and the recited “outer wall” is a distinct wall radially external to the enclosure wall. Similarly, in light of claim 8’s recitation that the enclosure comprises a “number of layers,” is the “outer wall” of claim 9 considered by Applicant to be equivalent to an external layer? For example, if the enclosure is a first wall, and it has a coating radially externally applied to its surface, is said coating reasonably a “layer” per claim 8 as well as an “outer wall” per claim 9? In other words, (1) is the claimed enclosure separate from the “outer wall” of claim 9 and the “layers” of claim 8, or part of either/both, and (2) is a wall = a coating = a layer? For the purposes of examination, Examiner assumes that claim 9’s outer wall may be equivalent to the enriched material, as long as said wall is radially external to something internal (already covered by claim 1’s recitation that the enclosure defines cavity having a target inside it).
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 § 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 1–5, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Allen (US 2013/0336436) in view of Thiel (US 2024/0161939).
Regarding claim 1, Allen discloses (Fig. 9) an enclosure (122b) for producing a radioisotope from an irradiation target material (130) in a thimble guide tube of a nuclear reactor core (the cited radioisotope enclosure is capable of being inserted into a reactor core guide tube, e.g., see tubing 200 and “instrumentation tube,” ¶ 8 and see also ¶ 44), wherein the enclosure (122b) is comprised of an enriched material (“Copper-63,” table 1 or claim 6), wherein the enriched material comprises at least one of Nickel-64, Copper-63, or Copper-65 (“Copper-63,” table 1 or claim 6), wherein the enclosure defines a cavity therein (see Fig. 9), and wherein the cavity of the enclosure is configured to house the irradiation target material (130).
Allen states that the enclosure 122b may be comprised of the “target material itself,” ¶ 54, which may be “Copper-63,” table 1 or claim 6. It is likely that Allen’s Copper-63 is copper enriched in the isotope 63Cu because otherwise Allen would likely simply say “copper.” However, because Allen does not explicitly state that the Copper-63 is copper enriched in the isotope 63Cu, Thiel is cited.
Thiel is in the same art area of radioisotope production (abstract) and teaches using an enriched target material (as a single example of many, targets “with 99% enriched 60Ni or 61Ni can be used,” ¶ 601).
A purpose for this teaching is, as described by Thiel (¶ 601), to “improve the yield and purity of the [] product.”
Similarly, Allen points out that “An irradiation target is a target that is irradiated for the purpose of generating radioisotopes,” ¶ 57, and that “lengthy isotopic and/or chemical extraction processes” are desirably avoided. Both of these statements imply that natural copper is not desirable, because the desired radioisotope produced is 64Cu (table 1, to study “Wilson’s & Menke’s diseases”), which is most efficiently produced by copper enriched in the isotope 63Cu, and also because avoiding “lengthy isotopic” separation processes clearly indicates that a purified parent material is preferred.
The combination of the explicit enrichment of Thiel with the Copper-63 enclosure of Allen would have produced a radioisotope target within an enclosure enriched in the 63Cu isotope, i.e., Applicant's claimed invention.
This combination would have been obvious to one having ordinary skill in the art before the effective filing date of the invention, as it produces no unexpected results. In view of the prior art teachings of Allen, a person of ordinary skill would have predicted that combining Thiel’s explicit enrichment with Allen's 63Cu enclosure would have produced Applicant's claimed invention of a radioisotope target within an enclosure enriched in the 63Cu isotope. The skilled person’s motivation for the combination would have been the expectation of, as described by Thiel (¶ 601), to “improve the yield and purity of the [] product … Using these targets, the extrapolated purity of [the desired radioisotope] will be higher” because there will be less “impurity.”
Regarding claim 2, the above-described combination of Allen with Thiel teaches all the elements of the parent claim, and Allen further discloses wherein the enriched material has a short2 half-life (64Cu has a half-life of 13 hours) upon being exposed to a neutron flux (“expose irradiation targets to neutron flux,” ¶ 8).
Regarding claim 3, the above-described combination of Allen with Thiel teaches all the elements of the parent claim, and Allen further discloses wherein the enclosure has a short3 half-life (64Cu has a half-life of 13 hours) upon exposure to a neutron flux (“expose irradiation targets to neutron flux,” ¶ 8).
Regarding claim 4, the above-described combination of Allen with Thiel teaches all the elements of the parent claim, and Thiel further discloses wherein the enriched material is isotopically pure (targets “with 99% enriched 60Ni or 61Ni can be used,” ¶ 601). The skilled artisan would have been motivated, prior to the effective filing date of the invention, to have utilized an isotopically pure material for the reasons already described above in response to claim 1.
Regarding claim 5, the above-described combination of Allen with Thiel teaches all the elements of the parent claim, and Allen further discloses wherein the enriched material comprises a precursor to a beta emitter (see the above indefiniteness rejection—following absorption of a neutron, 63Cu becomes 64 Cu, and Copper-64 is a beta emitter4).
Regarding claim 8, the above-described combination of Allen with Thiel teaches all the elements of the parent claim, and Allen further discloses wherein the enclosure is comprised of a number of layers (e.g., Fig. 8, 122a + outer layer 139). The skilled artisan would have been motivated, prior to the effective filing date of the invention, to have utilize the adhesive tape layer of Allen in order to “further flexibly hold example assemblies 122 a together,” Allen, ¶ 50.
Regarding claim 9, the above-described combination of Allen with Thiel teaches all the elements of the parent claim, and Allen further discloses wherein the enclosure comprises an outer wall comprised of the enriched material (as shown in at least Fig. 9, the enclosure 122b comprises an outer wall relative to internal targets 130).
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.
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, 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.
Please be aware that, as of October 1, 2025, the PTO has implemented a policy of one interview per round of examination. Additional interviews require managerial approval.
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 https://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.
LILY CRABTREE GARNER
Primary Examiner
Art Unit 3646
/LILY C GARNER/Primary Examiner, Art Unit 3646
1 https://periodictable.com/Isotopes/029.64/index.full.html
2 interpreted as defined in the published application at ¶ 18 as “on the order of days”
3 interpreted as defined in the published application at ¶ 18 as “on the order of days”
4 https://periodictable.com/Isotopes/029.64/index.full.html
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