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 .
Status of Claims
Claims 1-6 and new claims 19-27 are under examination.
Response to Amendment
Applicant has made no amendments to claims 1-6. The rejection to claims 1-6 is held.
Response to Arguments
Applicant's arguments filed August 21, 2025 have been fully considered but they are not persuasive. The applicant’s argument is that Clayton teaches to bombard a tungsten target material 202 of a multilayer target 200 with electrons from an accelerator and that the impact of the electrons with the tungsten target material produces X-rays which impact the second target material which may be 100Mo. Applicant continues further, that if the tungsten target material 202 of Clayton were replaced with Cobalt-59, as suggested by examiner, the Cobalt-59 would merely be bombarded with electrons as taught by Clayton and that “Bombarding Cobalt-59 with electrons will not produce Cobalt-60.”
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The Examiner presents the prior art of Clayton (paragraph [0045]-[0046]), where accelerated electrons cause generation of X-rays, which are emitted in all directions, and subsequently cause generation of 99Mo, taught in paragraphs [0041]-[0043]. The process taught is that 99Mo is generated by subjecting the target (202) material comprising enriched 100Mo to a strong source of X-rays, to generate 99Mo via the 100Mo(γ,n)99Mo process (i.e., 100Mo + γ [Wingdings font/0xE0] 99Mo + n).
In Clayton’s embodiment using the tungsten target material, the process of Clayton is a multi-interaction process. First, the incoming electron beam causes generation of X-rays by interacting with the tungsten target (202), which are emitted in all directions. Then, some of those X-rays will interact with the enclosure (204) 100Mo to cause the 100Mo(γ,n)99Mo reaction, as taught in paragraph [0041]. Then, neutrons which escaped the material may be captured by 100Mo to generate 99Mo and 99mTc [paragraph 0043].
By modifying the tungsten target material of Clayton with the Cobalt-59 (59Co) material of Smith, some of the electrons in the electron beam will interact with the 59Co target material. The examiner agrees with the applicant that this interaction does not produce Cobalt-60; however, some of the other electrons will interact with the enclosure (204) 100Mo material and produce X-rays, which are emitted in all directions and cause the subsequent reaction 100Mo(γ,n)99Mo. The generated neutrons from the 100Mo(γ,n)99Mo reaction may then be absorbed by Smith’s 59Co to produce 60Co.
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 (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.
For applicant's benefit, the portions of the reference(s) relied upon in the below rejections have been cited to aid in the review of the rejections. While every attempt has been made to be thorough and consistent within the rejection, it is noted that 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, 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.
Claim(s) 1-3, 5-6, 19-23, and 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clayton (Publication US20160078971A1) in view of Smith (Publication US20110013739A1).
Regarding Claim 1, Clayton discloses (Fig. 5) a target assembly (200) for producing synthetic radioisotopes, the target assembly comprising: an enclosure (204) comprised of an enriched material [e.g., 100Mo, 0045-0046], wherein the enriched material is configured to have a short half-life1 upon being exposed to a neutron flux2, and wherein the enclosure defines a cavity therein (106); and an irradiation target (202), wherein the irradiation target material is configured to be housed within the cavity of the enclosure.
Clayton does not disclose a precursor to Cobalt-60. Smith does.
Smith teaches (e.g., Fig. 3 and 4) a target assembly (100) for producing synthetic radioisotopes of Cobalt [0028] and an irradiation target material (110) comprised of a precursor to Cobalt-60. [0028]
One of ordinary skill in the art before the effective filing date of the invention would have been motivated to combine Smith’s Cobalt-60 precursor target material with Clayton’s target assembly with for the predictable advantage that this daughter isotope has desirable characteristics, such as being particularly long-lived. The initial irradiation target amount may be chosen and/or example irradiation target products may have sufficiently long half-lives such that a useful amount of product remain undecayed at a time when the product is available for harvesting. (Smith, [0028]).
Regarding Claim 2, Clayton in view of Smith teaches all the elements of the parent claim. Additionally, Smith teaches wherein the irradiation target material comprises Cobalt-59 ([0028]). The skilled artisan would have been motivated to utilize the Co-59 of Smith for the reasons described above in response to claim 1.
Regarding Claim 3, Clayton in view of Smith teaches all the elements of the parent claim. Clayton teaches, in another embodiment, an enriched material that is isotopically pure: “The 100Mo target may be enriched to a least 99%.” [0041]
One of ordinary skill in the art before the effective filing date of the invention would have been motivated to use isotopically enriched 100Mo for the reason that technetium-99 (99mTc) is used in the medical imaging of bone, liver, lung, brain, kidney, and other organs to diagnose medical conditions. [0003] 99mTc is commonly obtained by producing 99Mo which decays into 99mTc. 99Mo is generated by subjecting enriched molybdenum-100 to the (γ,n) process, which decays to 99mTc. [0041] By subjecting isotopically pure 100Mo to the (γ,n) process, more 99mTc will be produced, as would have been understood by the ordinary skilled artisan in light of Clayton’s teachings regarding 99mTc as cited in [0003] above.
Regarding Claim 5, Clayton in view of Smith teaches all the elements of the parent claim. Additionally, Clayton in view of Smith teaches the enriched material of claim 1, taught by Clayton, is a metal (e.g., 100Mo; [Clayton, 0045-0046]).
Regarding Claim 6, Clayton in view of Smith teaches 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 does not explicitly suggest an alloy. Smith does. Smith teaches an enclosure (100, Fig 4) made of a material that comprises an alloy (“zirconium and alloys thereof, corrosion resistant stainless steel, aluminum, etc.,” [0040]). The skilled artisan would have been motivated, before the effective filing date of the invention, to use an alloy material for the purpose of “corrosion resistance” or to maintain its mechanical and neutronic properties in an operating nuclear reactor environment while providing adequate containment to the irradiation target housed therein. [Smith, 0040].
Regarding Claim 19, Clayton in view of Smith teaches all the elements of claim 1. Clayton does not teach wherein the irradiation target material is configured to produce Cobalt-60 upon being exposed to a neutron flux. Smith teaches this.
Smith teaches (e.g., Fig. 3 and 4) a target assembly (100) for producing synthetic radioisotopes of Cobalt [0028] and an irradiation target material (110) comprised of a precursor to Cobalt-60. [0028]
One of ordinary skill in the art before the effective filing date of the invention would have been motivated to combine Smith’s Cobalt-60 precursor target material with Clayton’s target assembly for the predictable advantage that this daughter isotope has desirable characteristics, such as being particularly long-lived. The initial irradiation target amount may be chosen and/or example irradiation target products may have sufficiently long half-lives such that a useful amount of product remain undecayed at a time when the product is available for harvesting. (Smith, [0028]).
Regarding Claim 20, Clayton discloses (Fig. 5) a target assembly (200) for producing radioisotopes, the target assembly comprising: an enclosure (204) comprised of an enriched material [e.g., 100Mo, 0045-0046], wherein the enclosure defines a cavity (106) therein, wherein the enriched material comprises a precursor to a first radioisotope, wherein the enriched material is configured to produce the first radioisotope upon being exposed to a neutron flux3, wherein the first radioisotope has a first half-life; and an irradiation target material (202), wherein the irradiation target material is configured to be housed within the cavity of the enclosure.
Clayton does not teach an irradiation target material comprising a precursor to a second radioisotope wherein the irradiation target material is configured to produce the second radioisotope upon being exposed a neutron flux, and wherein the second radioisotope has a second half-life that is greater than the first half-life. Smith teaches this.
Smith teaches (e.g., Fig. 3 and 4) a target assembly (100) for producing radioisotopes of Cobalt [0028] upon exposure to a neutron flux. Smith cites a target material of Co-59 because it readily converts to Co-604 in the presence of a neutron flux [0028].
One of ordinary skill in the art before the effective filing date of the invention would have been motivated to modify Clayton’s target assembly with Smith’s Cobalt-60 precursor target material for the predictable advantage that this daughter isotope has desirable characteristics, such as being particularly long lived. The initial irradiation target amount may be chosen and/or example irradiation target produces may have sufficiently long half-lives such that a useful amount of product remain undecayed at a time when the product is available for harvesting. (Smith, [0028]) The result of the modification to Clayton would have been predictable to the skilled artisan.
Regarding Claim 21, Clayton in view of Smith teaches all the elements of the parent claim. Clayton does not disclose wherein the second radioisotope is Cobalt-60. Smith teaches this.
Smith teaches wherein the second radioisotope is Cobalt-60 [0028]. One of ordinary skill in the art at the time of filing would have been motivated to use the Cobalt-60 precursor target material of Smith in Clayton’s target assembly for the reasons stated above.
Regarding Claim 22, Clayton in view of Smith teaches all the elements of the parent claim. Clayton does not disclose wherein the irradiation target material comprises Cobalt-59. Smith teaches this.
Smith teaches wherein the irradiation target material comprises Cobalt-59 [0028]. One of ordinary skill in the art at the time of filing would have been motivated to use the Cobalt-59 irradiation target material of Smith in Clayton’s target assembly for the reasons stated above.
Regarding Claim 23, Clayton in view of Smith teaches all the elements of the parent claim. Clayton teaches, in another embodiment, an enriched material that is isotopically pure: “The 100Mo target may be enriched to a least 99%.” [0041]
One of ordinary skill in the art before the effective filing date of the invention would have been motivated to use isotopically enriched 100Mo for the reason that technetium-99 (99mTc) is used in the medical imaging of bone, liver, lung, brain, kidney, and other organs to diagnose medical conditions. [0003] 99mTc is commonly obtained by producing 99Mo which decays into 99mTc. 99Mo is generated by subjecting enriched molybdenum-100 to the (γ,n) process, which decays to 99mTc. [0041] By subjecting isotopically pure 100Mo to the (γ,n) process, more 99mTc will be produced, as would have been understood by the ordinary skilled artisan in light of Clayton’s teachings regarding 99mTc as cited in [0003] above.
Regarding Claim 25, Clayton in view of Smith teaches all the elements of the parent claim. Additionally, Clayton in view of Smith teaches the enriched material of claim 1, taught by Clayton, is a metal (e.g., 100Mo; [Clayton, 0045-0046]).
Regarding Claim 26, Clayton in view of Smith teaches 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 20, but does not explicitly suggest an alloy. Smith does. Smith teaches an enclosure (100, Fig 4) made of a material that comprises an alloy (“zirconium and alloys thereof, corrosion resistant stainless steel, aluminum, etc.,” [0040]). The skilled artisan would have been motivated, before the effective filing date of the invention, to use an alloy material for the purpose of “corrosion resistance” or to maintain its mechanical and neutronic properties in an operating nuclear reactor environment while providing adequate containment to the irradiation target housed therein. [Smith, 0040].
Regarding Claim 27, Clayton discloses (Fig. 5) a target assembly (200) for producing synthetic radioisotopes of Cobalt, the target assembly comprising: an enclosure (204) comprised of an enriched material [e.g., 100Mo, 0045-0046], wherein the enriched material is configured to have a first half-life5 upon being exposed to a neutron flux, and wherein the enclosure defines a cavity (106) therein; and
an irradiation target material (202), wherein the irradiation target material is configured to be housed within the cavity of the enclosure. Clayton does not disclose the irradiation target material is comprised of a precursor to Cobalt-60, wherein the irradiation target material is configured to produce Cobalt-60 when exposed to a neutron flux. Clayton does not teach an irradiation target material comprised of a precursor to Cobalt-60 wherein the irradiation target material is configured to produce Cobalt-60 when exposed to a neutron flux. Smith teaches this.
Smith teaches (e.g., Fig. 3 and 4) a target assembly (100) for producing radioisotopes of Cobalt [0028] upon exposure to a neutron flux. Smith cites a target material of Co-59 because it readily converts to Co-606 in the presence of a neutron flux [0028].
One of ordinary skill in the art before the effective filing date of the invention would have been motivated to modify Clayton’s target material with Smith’s Cobalt-60 precursor target material for the predictable advantage that this daughter isotope has desirable characteristics, such as being particularly long lived. The initial irradiation target amount may be chosen and/or example irradiation target produces may have sufficiently long half-lives such that a useful amount of product remain undecayed at a time when the product is available for harvesting. (Smith, [0028]) The result of the modification to Clayton would have been predictable to the skilled artisan.
Claim 4 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clayton (Publication US20160078971A1) and Smith (Publication US20110013739A1) in further view of Pipes (US 20220064015 A1).
Regarding Claim 4, Clayton in view of Smith teaches 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 combination of Clayton with Smith 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 enclosure enriched in 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].”
Regarding Claim 24, Clayton in view of Smith teaches all the elements of the parent claim. Additionally, Clayton teaches the use of the enriched material, as cited above in response to claim 20, but the above-described combination of Clayton with Smith 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 enclosure enriched in 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].”
Conclusion
THIS ACTION IS MADE FINAL. 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 KIMBERLY D GAMBONE RODRIGUEZ whose telephone number is (571)272-5108. The examiner can normally be reached 8:30am-5pm.
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
/PETER M POON/ Supervisory Patent Examiner, Art Unit 3643
1 This term is interpreted as defined in the Specification at [0025] to mean “less than one week, or less than 5 days, or less than 1 day.”
2 Examiner notes that Mo-100 becomes Mo-101 upon exposure to a neutron flux. Mo-101 has a half-life of 14.6 minutes.
3 Examiner notes that Mo-100 becomes Mo-101 upon exposure to a neutron flux. Mo-101 has a half-life of 14.6 minutes.
4 Examiner notes that Co-59 becomes Co-60 upon exposure to a neutron flux. Co-60 has a half-life of 5.2 years.
5 Examiner notes that Mo-100 becomes Mo-101 upon exposure to a neutron flux. Mo-101 has a half-life of 14.6 minutes.
6 Examiner notes that Co-50 becomes Co-60 upon exposure to a neutron flux. Co-60 has a half-life of 5.2 years.
Prosecution Insights