DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
2. Claims 1-19 are under examination.
Response to Amendment
3. Applicant’s arguments, dated 6/18/2025, were persuasive and new prior art rejections are made. Therefore, this action is being made Non-Final.
Claim Objections
Claim 18 is objected to because of the following informalities: “Lutetium 177” should be written as “Lutetium-177”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
4. Claim 3 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 states that, “the enclosure is comprised of an enriched material”, therefore the “enclosure” is the “enriched material”. Claim 2 states that, “the enriched material has a short half-life upon being exposed to a neutron flux” and claim 3 states that, “the enclosure has a short half-life upon exposure to a neutron flux.” Since the “enclosure” is the “enriched material”, claim 3 fails to further limit the subject matter of claim 2. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
5. Claims 16 - 19 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.
6. Claim 16 recites “the target assembly comprising…at least one irradiation target material…removing the irradiated target assembly...to produce one or more pharmaceutical radioisotopes.” Specifically, claim 16 calls the initial (i.e., not yet irradiated) target material “irradiation target material.” However, then claim 18 recites “the irradiation target material of the irradiated target assembly comprises Lutetium 177 and/or Actinium-225.” Therefore, claim 18’s “irradiation target material” is post irradiation. As such, it is unclear if the recited “Lutetium 177 and/or Actinium-225” are referring to the initial irradiation target material, as implied by claim 16, or the post-irradiation target material, as implied by claim 18.
7. Claim 19 recites “each of the irradiation target material and the enclosure of the irradiated target assembly are comprised of a pharmaceutical radioisotope.” It is unclear if this claim requires the irradiation target material and the enclosure to be comprised of the same radioisotope, or if, for example, the irradiation target material may be Co-59 and the enclosure Mo-98.
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
Claim Rejections - 35 USC § 103
8. 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 (i.e., changing from AIA to pre-AIA ) 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.
9. 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.
10. 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.
11. 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 (i.e., changing from AIA to pre-AIA ) 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.
12. 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.
13. 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.
14. The factual inquiries 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.
15. 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.
16. Claim(s) 10-12 and 15 are rejected under 35 U.S.C. 102(a(1)) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Clayton (Patent US 10242760 B2).
17. Regarding claim 10, Clayton discloses (Figure 1) a system for generating 99mTc from 98Mo from a target (24) within a target assembly (26). Clayton states that the multilayer target (100) of Fig. 4 may be used as the target material (24) shown in Fig. 1 [Column 6, Lines 19-25]. Clayton discloses a target assembly (100) for producing synthetic radioisotopes, the target assembly comprising: an enclosure (104) defining a cavity therein (106), wherein the enclosure comprises an outer wall (104) comprised of an enriched material (e.g., 98Mo, (Column 8, Lines 8-9]); and an irradiation target (102) material positioned within the cavity of the enclosure, wherein the irradiation target material comprises a precursor [e.g., 100Mo, Column 8, Lines 7-8] to a first radioisotope1.
18. Examiner notes that Clayton uses the term “enhanced” instead of “enriched” when referring to 98Mo in [Column 4, Lines 31-35]: “enhanced 98Mo, having a concentration of over 99%...the concentration of the enhanced 98Mo may be 99.9% or more…commercially available from Urenco.” It appears that Clayton uses these terms interchangeably, as evidenced by his suggestion of using 98Mo supplied by Urenco, whose website describes enrichment in terms of concentration2 exceeding 99%3. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to use enriched 98Mo over natural Mo in the area of medical radioisotope production, for the purpose of dramatically increasing the yield and specific activity of the resulting Molybdenum-99, which is a desirable radioisotope for its 99mTc daughter, “used in the medical imaging of bone, liver, lung, brain, kidney, and other organs to diagnose medical conditions, including cancer and cardiac conditions,” as explained by Clayton in col. 1, lines 23-26.
19. Regarding claim 11,Clayton teaches all the elements of the parent claim. Clayton additionally teaches wherein the enriched material (e.g., 98Mo, [Column 1, Lines 50-62] and [Column 2, Lines 7-14]) comprises a precursor to a second radioisotope (99Mo or 99mTc), wherein the second radioisotope is a short lived radioisotope4.
20. Regarding claim 12,Clayton teaches all the elements of the parent claim. Clayton additionally teaches wherein the enriched material comprises an isotopically pure metallic metal: "The concentration of the enhanced 98Mo may be 99.9% or more” (e.g., 98Mo, [Column 4, Lines 31-32]).
21. Regarding claim 15, Clayton teaches all the elements of the parent claim. Clayton teaches a layer of inert material (108) (Fig.4) positioned between the enriched material and the cavity.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code 103 not included here can be found above.
22. Claims 1-5, 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Clayton (Patent US 10242760 B2) in view of Heibel (WO2021076673A1).
23. Regarding claim 1, Clayton discloses (Figure 4) an enclosure (100) for producing a radioisotope from an irradiation target material wherein the enclosure (104) is comprised of an enriched material (e.g.,98Mo, [Column 4, Lines 31-32]), (Examiner notes that Clayton uses the term “enhanced” instead of “enriched” when referring to 98Mo in [Column 4, Lines 31-35]: “enhanced 98Mo, having a concentration of over 99%...the concentration of the enhanced 98Mo may be 99.9% or more…commercially available from Urenco.” It appears that Clayton uses these terms interchangeably, as evidenced by his suggestion of using 98Mo supplied by Urenco, whose website describes enrichment in terms of concentration5,6 exceeding 99) wherein the enclosure defines a cavity therein (106), and wherein the cavity of the enclosure is configured to house the irradiation target material (102). Clayton does not teach producing a radioisotope from an irradiation target material in a thimble guide tube of a nuclear reactor core. Heibel does teach this. Heibel teaches a radioisotope production capsule (100)[0029](Figure 4) used to generate the maximum account of desired radioisotope from irradiation targets (120) designed to fit into the guide thimbles (30) present in conventional reactors [0010]. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to use the enriched isotope production enclosure of Clayton with the thimble guide tube as described by Heibel, for the purpose of increasing the neutron moderator and coolant flow among the fuel rods, while simultaneously producing desirable radioisotopes during reactor operation [0029].
24. Regarding claim 2, Clayton and Heibel teach all the elements of the parent claim. Clayton discloses wherein the enriched material has a short half-life7,8 upon being exposed to a neutron flux [Column 1, Lines 53-55].
25. Regarding claim 3, Clayton and Heibel teach all the elements of the parent claim. Clayton further discloses wherein the enclosure (104) has a short half-life9 upon exposure to a neutron flux [Column 1, Lines 53-55].
26. Regarding claim 4, Clayton and Heibel teach all the elements of the parent claim. Clayton further teaches, in the embodiment of Fig. 4, an enriched material that is isotopically pure. "The concentration of the enhanced 98Mo may be 99.9% or more." [Column 4, Lines 32-33].
27. Regarding claim 5, Clayton and Heibel teach all the elements of the parent claim. Clayton further teaches the enriched material comprises a precursor to a beta emitter. Neutrons with enough energy to pass through the hydrogenous material enter the outer target layer (104) and may be captured by atoms of 98Mo, forming 99mTc via 99Mo. [Column 8, Lines 12-14]. 99Mo is a beta emitter.
28. Regarding claim 8, Clayton and Heibel teach all the elements of the parent claim. Clayton additionally teaches the enclosure is comprised of a number of layers (Figure 4, [Column 3, Lines 25-26]).
29. Regarding claim 9, Clayton and Heibel teach all the elements of the parent claim. Clayton additionally teaches the enclosure comprises an outer wall (104) comprised of the enriched material (Figure 4, [Column 4, Lines 31-32]).
30. Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over Clayton (Patent US 10242760 B2) and Heibel (WO2021076673A1) in view of Pipes (US20220064015A1).
31. Regarding claim 6, Clayton and Heibel teach all the elements of the parent claim. Additionally, Clayton teaches the use of the enriched material, as cited, above in response to claim 1, but the above described by Clayton does not explicitly teach the use of Nickel-64, Copper-63, or Copper-65. Pipes does teach this. Pipes is the same art of medical isotope production and teaches using at least one Nickel-64, Copper-63, or Copper-65 ("isotopically enriched nickel-64 (64Ni) targets," [0006]). One of ordinary skill in the art before the effective filing date of the invention would have been motivated to use enriched nickel-64 in the enclosure material in order to produce 64Cu because, as explained by Pipes [0005], "Copper-64 (64Cu) is a 'non-standard' isotope that can be used in diagnostic nuclear medicine with its excellent characteristics for PET imaging [0006].
32. Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Clayton (Patent US 10242760 B2) in view of Pipes (US 20220064015A1).
33. Regarding claim 13, Clayton teaches all the elements of the parent claim. Clayton does not explicitly teach the use of Nickel-64, Copper-63, or Copper-65. Pipes does teach this. Pipes is the same art area of medical isotope production and teaches using an isotopically pure metallic material comprising at least one Nickel-64, Copper-63, or Copper-65 ("isotopically enriched nickel-64 (64Ni) targets," [0006]). One of ordinary skill in the art before the effective filing date of the invention would have been motivated to use enriched nickel-64 in the enclosure in order to produce 64Cu because, as explained by Pipes [0005], "Copper-64 (64Cu) is a 'non-standard' isotope that can be used in diagnostic nuclear medicine with its excellent characteristics for PET imaging [0006].
34. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Clayton (Patent US 10242760 B2) and Heibel (WO 2021076673A1) as applied to claim 1 above, and in further view of Russell II (Publication US 20180244535 A1).
35. Regarding claim 7, Clayton and Heibel teach all the elements of the parent claim. Clayton additionally teaches the use of an enriched material for the enclosure, as cited above in response to claim 1, but is silent to the chemical form of the target material and does not explicitly suggest an alloy. Russell II does.
36. Russell II is in the same art area of molybdenum-based materials suitable for use in radioisotope production and describes irradiating a molybdenum capsule [0006] wherein the molybdenum material may comprise an alloy (“Non-limiting examples of a metal molybdenum material include, but are not limited to…Mo alloys,” [0024]). One of ordinary skill in the art before the effective filing date of the invention would have been motivated to use an alloyed molybdenum such as Russell’s for the molybdenum of Clayton’s because, as is known in the art, alloyed metals have thermal properties that allow them to withstand the high temperatures and radiation inside a nuclear reactor. The ordinary skilled artisan would have been motivated to utilize a molybdenum alloy in order to provide better corrosion resistance and physical sturdiness within the environment of a nuclear reactor, and further to mitigate the cost of a pure-molybdenum target.
37. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.) MPEP 2144.07.
38. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Clayton (Patent US 10242760 B2) and in view of Russell II (Publication US 20180244535 A1).
39. Regarding claim 14, Clayton and Heibel teach all the elements of the parent claim. Clayton additionally teaches the use of an enriched material for the enclosure, as cited above in response to claim 1, but is silent to the chemical form of the target material and does not explicitly suggest an alloy. Russell II does.
40. Russell II is in the same art area of molybdenum-based materials suitable for use in radioisotope production and describes irradiating a molybdenum capsule [0006] wherein the molybdenum material may comprise an alloy (“Non-limiting examples of a metal molybdenum material include, but are not limited to…Mo alloys,” [0024]). One of ordinary skill in the art before the effective filing date of the invention would have been motivated to use an alloyed molybdenum such as Russell’s for the molybdenum of Clayton’s because, as is known in the art, alloyed metals have thermal properties that allow them to withstand the high temperatures and radiation inside a nuclear reactor. The ordinary skilled artisan would have been motivated to utilize a molybdenum alloy in order to provide better corrosion resistance and physical sturdiness within the environment of a nuclear reactor, and further to mitigate the cost of a pure-molybdenum target..
41. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.) MPEP 2144.07.
42. Claims 16, 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Heibel (Publication WO2021076673) in view of Clayton (Patent US 10242760 B2).
43. Regarding claim 16, Heibel discloses a method for producing pharmaceutical radioisotopes with a target assembly (10) (Fig. 3) the method comprising: inserting the target assembly into a thimble guide tube [0010], the target assembly comprising an enclosure (18) and at least one irradiation target material (12) positioned within the enclosure, irradiating the target assembly with a neutron flux [0049] (Examiner additionally notes that nuclear reactions within a nuclear reactor liberate neutrons, thus creating a “neutron flux”. A material or object placed within an operating nuclear reactor will be subject to neutron irradiation by the neutron flux), and removing the irradiated target assembly, (“removing the capsule from the insert component,” 0015]) from the thimble guide tube to produce one or more pharmaceutical radioisotopes [0010]. Heibel does not disclose that the enclosure is comprised of an enriched material. Clayton does.
44. Clayton discloses (Figure 4) enclosure for producing a radioisotope from an irradiation target material wherein the enclosure (104) is comprised of an enriched material (e.g.,98Mo, [Column 4, Lines 31-32]). (Examiner notes that Clayton uses the term “enhanced” instead of “enriched” when referring to 98Mo in [Column 4, Lines 31-35]: “enhanced 98Mo, having a concentration of over 99%...the concentration of the enhanced 98Mo may be 99.9% or more…commercially available from Urenco.” It appears that Clayton uses these terms interchangeably, as evidenced by his suggestion of using 98Mo supplied by Urenco, whose website describes enrichment in terms of concentration10 exceeding 99%11.) One of ordinary skill in the art before the effective filing date of the invention would have been motivated to use enriched 98Mo over natural Mo in the area of medical radioisotope production, for the purpose of dramatically increasing the yield and specific activity of the resulting Molybdenum-99, which is a desirable radioisotope for its 99mTc daughter, “used in the medical imaging of bone, liver, lung, brain, kidney, and other organs to diagnose medical conditions, including cancer and cardiac conditions,” as explained by Clayton in col. 1, lines 23-26.
45. Regarding claim 18, Heibel and Clayton teach all the elements of the parent claim. Heibel further discloses wherein the irradiation target material (12) of the irradiated target assembly comprises Actinium-225 [0036 and 0037].
46. Regarding claim 19. Heibel and Clayton teach all the elements of the parent claim. As combined above in response to claim 16, Heibel in view of Clayton teaches wherein each of the irradiation target material (Heibel, (12), Fig. 3, Ac-225 or Co-60, [0037]) and the enclosure (Heibel enclosure 18 modified by Clayton to be enriched Mo-98, as described above) of the irradiated target assembly are comprised of a pharmaceutical radioisotope (Mo-98, Ac-225, and Co-60 are all pharmaceutical radioisotopes).
47. Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Heibel (Publication WO2021076673) in view of Clayton (Patent US 10242760 B2) in further view of Pipes (US20220064015A1).
48. Regarding claim 17, Heibel in view of Clayton teaches all the elements of the parent claim. Heibel in view of Clayton does not disclose the enriched material comprises Nickel-64, Copper-63, and/or Copper-65. Pipes does. Pipes teaches Copper-64 chloride has been produced from isotopically enriched nickel-64 targets [0006]. The skilled artisan would have been motivated, before the effective filing date of the invention to use an enriched nickel-64 material to produce a pharmaceutical radioisotope in the method described by Heibel for the benefit of the high specific activity and radionuclidic purity of Ni-64 for patient safety from trace contaminants in radioactive precursor used in radiolabeled pharmaceutical diagnostics [0008].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIMBERLY D GAMBONE RODRIGUEZ whose telephone number is (571)272-5108. The examiner can normally be reached 8:00am-4pm.
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.
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/K.D.G./Examiner, Art Unit 3646
/JACK W KEITH/Supervisory Patent Examiner, Art Unit 3646
1 99Mo can be generated by subjecting target material comprising enriched molybdenum-100 to a strong source of X-rays to generate 99Mo via the (γ,n) process, which then decays in 6.01 hours to form 99mTc.
2 https://urencoisotopes.com/isotopes/molybdenum
3 https://urencoisotopes.com/isotopes , “Using the most advanced centrifuge technology available in the world today, we can enrich materials to exceed 99% or deplete below 1%.”
4 Examiner notes that, Mo-98 can become Mo-99 (first radioisotope) upon exposure to a neutron flux. Mo-99 has a half-life of 2.74 days. Mo-99 decays via beta decay to form 99mTc (second radioisotope). 99mTc has a half-life of 6.01 hours. (Nuclides and Isotopes, 15th Edition, Chart of the Nuclides, General Electric Co. and KAPL, Inc., 1996.)
5 https://urencoisotopes.com/isotopes/molybdenum
6 https://urencoisotopes.com/isotopes , “Using the most advanced centrifuge technology available in the world today, we can enrich materials to exceed 99% or deplete below 1%.
7 This term is interpreted as defined in the specification at [0018] to mean "less than one week, or less than 5 days, or less than 1 day."
8 Examiner notes that bombarding a target material comprising molybdenum-98 by accelerated deuterons can generate molybdenum-99. Mo-99 has a half-life of 2.74 days. Mo-99 decays via beta decay to form 99mTc (second radioisotope). 99mTc has a half-life of 6.01 hours. (Nuclides and Isotopes, 15th Edition, Chart of the Nuclides, General Electric Co. and KAPL, Inc., 1996.)
9 Mo-99 has a half-life of 2.74 days. Mo-99 decays via beta decay to form 99mTc (second radioisotope). 99mTc has a half-life of 6.01 hours. (Nuclides and Isotopes, 15th Edition, Chart of the Nuclides, General Electric Co. and KAPL, Inc., 1996.)
10 https://urencoisotopes.com/isotopes/molybdenum
11 https://urencoisotopes.com/isotopes , “Using the most advanced centrifuge technology available in the world today, we can enrich materials to exceed 99% or deplete below 1%.”