DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending in the instant application.
Priority
This application claims priority from U.S. Provisional Patent Application No. 63/348613 filed on June 3, 2022.
Information Disclosure Statements
Applicants’ Information Disclosure Statement, filed on 10/28/2025, has been considered. Please refer to Applicant’s copy of the PTO-1449 submitted herewith.
Response to Restriction Requirement
Applicant’s election with traverse of Group I (i.e. claims 1-17) in the reply filed by Applicant’s representative Susan S. Jackson on 02/25/2026 is acknowledged. Applicant traversed the restriction requirement on the ground that a search of the present claims would not be unduly burdensome upon the Examiner. Applicant’s argument has been fully considered, but is found not persuasive. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the product of Molybdenum/Technetium 99-m generator as claimed could be used in a materially different process of using that product of device for treating a disorder associated with different clinic applications such as treating different cancers, or a method of using different alumina by introducing said material into the claimed Molybdenum/Technetium 99-m generator of Group I in a guard filter. Therefore, Groups I and II are drawn to different inventions, which requires searching at different criteria at different commercial databases. It would be burden for the Examiner if the application were not restricted. Therefore, the restriction requirement is indeed appropriate, maintained, and made FINAL. However, Group II would be subject to rejoinder with Group I if Group I is found allowable and the method of Group II is commensurate in scope with an allowable product claim.
Status of the Claims
Claims 18-20 are withdrawn from further consideration by Examiner as being drawn to non-elected inventions under 37 CFR 1.142(b) due to the restriction requirement. Claims 1-17 are under examination on the merits.
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.
Claims 1-2, 4, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP2018038934A (“the `934 publication”) to Suzuki et al.
Applicant’s claim 1 is drawn to a Molybdenum/Technetium 99-m generator comprising: a metal-molybdate (Mo) containing powder; and a guard filter comprising an alumina.
The `934 publication [0001-0002, 0008, 0018, 0025 and Table 1] disclosed Gibbsite-based alumina molybdenum adsorbent and 99Mo/99mTc generator using the Gibbsite-based alumina molybdenum adsorbent. The Gibbsite-based alumina molybdenum adsorbent has a higher molybdenum (Mo) adsorption capacity than currently used medical alumina. Said Gibbsite-based alumina molybdenum adsorbent has a x-Al2O3 (chi-phrase) and γ-Al2O3 (gamma-phrase) multiphase when calcinated at a range 500-800 °C, and which allows for the recovery of adsorbed Mo. Therefore, the `934 publication anticipates claims 1-2, 4, and 11.
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.
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.
Claims 3, 5-10, and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over the `934 publication in view of US2021/0327602 (“the `602 publication”) to Brown et al.
The `934 publication [0001-0002, 0008, 0018, 0025 and Table 1] disclosed Gibbsite-based alumina molybdenum adsorbent and 99Mo/99mTc generator using the Gibbsite-based alumina molybdenum adsorbent. The Gibbsite-based alumina molybdenum adsorbent has a higher molybdenum (Mo) adsorption capacity than currently used medical alumina. Said Gibbsite-based alumina molybdenum adsorbent has a x-Al2O3 (chi-phrase) and γ-Al2O3 (gamma-phrase) multiphase when calcinated at a range 500-800 °C (Table 1), and which allows for the recovery of adsorbed Mo. In addition, the `934 publication [0025 and Table 1] demonstrates that D-201(calcinated at 500 °C) contains both x-Al2O3 (chi-phrase) and γ-Al2O3 (gamma-phrase) with the highest Mo absorption capacity of 92.8 mg/g at 90 °C.
The `602 publication (claim 20) discloses a system for separating a daughter isotope from a parent isotope in irradiated targets, the system comprising: a) an alkaline treatment for dissolving the irradiated target; b) a treatment to form a first solid phase of the parent isotope and a first liquid phase of the daughter isotope; c) a guard column to elute the first liquid phase and capture parent isotope that was not precipitated; d) a concentration column to adsorb the daughter isotope contained in the eluted first liquid phase; and e) a chemical cocktail to elute the adsorbed daughter isotope from the concentration column in a low-volume, pharmaceutically suitable matrix, wherein the parent isotope is molybdenum 99, and the daughter isotope is technetium 99. The `602 publication (claims 16-17) discloses the guard column comprises a resin selected from the group consisting of alumina, titania, zirconia, diphonix, di(2-ethylhexyl phosphoric acid), Ln-resin, or ganophosphoric acid-based chromatography, and combinations thereof; and the concentration column is an adsorbent selected from the group consisting of activated carbon, anion exchange resins, or anion-exchange membranes, and combinations thereof.
In terms of claim 3, the `934 publication does not teach the guard filter further comprises a material selected from the group consisting of MSU-X mesoporous alumina, Polymeric Titania Compound (PTC), Polymer Embedded Nanocrystalline Titania, Polymeric Zirconia Compound (PZC), Tetragonal Nano Zirconia, chitosan-based products, iron, activated carbon, and a combination thereof. However, the `602 publication (claims 16-17) discloses the guard column comprises a resin selected from the group consisting of alumina, titania, zirconia, diphonix, di(2-ethylhexyl phosphoric acid), Ln-resin, organo-phosphoric acid-based chromatography, and combinations thereof; and the concentration column is an adsorbent selected from the group consisting of activated carbon, anion exchange resins, or anion-exchange membranes, and combinations thereof.
In terms of claim 5 wherein the Molybdenum/Technetium 99-m generator comprises a column, the `602 publication (claim 16) discloses the guard column comprises a resin selected from the group consisting of alumina, titania, zirconia, diphonix, di(2-ethylhexyl phosphoric acid), Ln-resin, organo-phosphoric acid-based chromatography, and combinations thereof.
In terms of claim 6 wherein the column comprises a Mo powder bed containing the metal-molybdate containing powder, the `934 publication [Table 4] disclosed the column comprises a Mo powder bed containing the metal-molybdate containing powder. In addition, the `602 publication (Figure 1) discloses the column comprises a Mo powder bed (17) containing the metal-molybdate containing powder.
In terms of claim 7 wherein the column comprises a guard filter bed containing the gamma-phase aluminum oxide (γ-Al2O3), the `602 publication (claim 16) discloses the guard column comprises a resin selected from the group consisting of alumina, and the `934 publication [Table 4] discloses the column comprises a Mo powder bed containing the metal-molybdate containing powder, and the `934 publication [0025 and Table 1] demonstrates that D-201(calcinated at 500 °C) contains both x-Al2O3 (chi-phrase) and γ-Al2O3 (gamma-phrase) with the highest Mo absorption capacity of 92.8 mg/g at 90 °C.
In terms of claim 8 wherein the guard filter bed further comprises a material selected from the group consisting of MSU-X mesoporous alumina, Polymeric Titania Compound (PTC), Polymer Embedded Nanocrystalline Titania, Polymeric Zirconia Compound (PZC), Tetragonal Nano Zirconia, chitosan-based products, iron, activated carbon, and a combination thereof, the `602 publication (claims 16-17) discloses the guard column comprises a resin selected from the group consisting of alumina, titania, zirconia, diphonix, di(2-ethylhexyl phosphoric acid), Ln-resin, organo-phosphoric acid-based chromatography, and combinations thereof; and the concentration column is an adsorbent selected from the group consisting of activated carbon, anion exchange resins, or anion-exchange membranes, and combinations thereof.
In terms of claim 9 wherein the guard filter bed has a bed height (Length) and a column inner diameter (D) in a ratio of L/D in a range of 0.25 to 10, the `602 publication (Figure 1) discloses a guard filter column (20), but does not specify the bed height (Length) and a column inner diameter (D) in a ratio of L/D in a range of 0.25 to 10. However, one ordinary skilled in eth art would have known that the guard filter column (20) meets the bed height (Length) and a column inner diameter (D) in a ratio of L/D in a range of 0.25 to 10 according to Figure 1 of the `602 publication, or it would be an routine optimization to get a guard filter bed having a bed height (Length) and a column inner diameter (D) in a ratio of L/D in a range of 0.25 to 10 based on the disclosure of Figure 1 of the `602 publication.
In terms of claim 10 wherein a mass ratio of the gamma-phase aluminum oxide to the metal-molybdate powder (A1:P) is in a range of 0.025:1 to 5:1, the `934 publication does not specifically teach the mass ratio of the gamma-phase aluminum oxide to the metal-molybdate powder. Instead, the `934 publication [0036] teaches using gibbsite alumina adsorbed with 50-70mg (Mo)/g (alumina) of Mo. In addition, the `934 publication [0018] teaches Said Gibbsite-based alumina molybdenum adsorbent has a x-Al2O3 (chi-phrase) and γ-Al2O3 (gamma-phrase) multiphase when calcinated at a range 500-800 °C (Table 1), and which allows for the recovery of adsorbed Mo. In addition, the `934 publication [0025 and Table 1] demonstrates that D-201(500 °C) contains both x-Al2O3 (chi-phrase) and γ-Al2O3 (gamma-phrase) with the highest Mo absorption capacity of 92.8 mg/g at 90 °C, which reads on the mass ratio of the aluminum oxide to the metal-molybdate powder (A1:P) is in a range of 0.025:1 to 5:1. By calcinating Gibbsite-based alumina at temperature at a range 500-800 °C (Table 1), one ordinary skilled in the art would have optimized the Gibbsite-based alumina to gamma-phase aluminum oxide in light of the disclosure by the `934 publication as a routine optimization.
In terms of claim 12 wherein the Molybdenum/Technetium 99-m generator comprises a column, the `602 publication (claim 16) discloses the guard column comprises a resin selected from the group consisting of alumina, and the `934 publication [Table 4] discloses the column comprises a Mo powder bed containing the metal-molybdate containing powder.
In terms of claim 13 wherein the column comprises a Mo powder bed containing the metal-molybdate containing powder, the `602 publication (claim 20) discloses a system for separating a daughter isotope from a parent isotope in irradiated targets, the system comprising: a) an alkaline treatment for dissolving the irradiated target; b) a treatment to form a first solid phase of the parent isotope and a first liquid phase of the daughter isotope; c) a guard column to elute the first liquid phase and capture parent isotope that was not precipitated; d) a concentration column to adsorb the daughter isotope contained in the eluted first liquid phase; and e) a chemical cocktail to elute the adsorbed daughter isotope from the concentration column in a low-volume, pharmaceutically suitable matrix, wherein the parent isotope is molybdenum 99, and the daughter isotope is technetium 99.
In terms of claim 14 wherein the column comprises a guard filter bed containing the chi-phase aluminum oxide (x-Al2O3), the `934 publication [0018] teaches Said Gibbsite-based alumina molybdenum adsorbent has a x-Al2O3 (chi-phrase) and γ-Al2O3 (gamma-phrase) multiphase when calcinated at a range 500-800 °C (Table 1), and which allows for the recovery of adsorbed Mo.
In terms of claim 15 wherein the guard filter bed further comprises a material selected from the group consisting of MSU- X mesoporous alumina, Polymeric Titania Compound (PTC), Polymer Embedded Nanocrystalline Titania, Polymeric Zirconia Compound (PZC), Tetragonal Nano Zirconia, chitosan-based products, iron, activated carbon, and a combination thereof, the `602 publication (claims 16-17) discloses the guard column comprises a resin selected from the group consisting of alumina, titania, zirconia, diphonix, di(2-ethylhexyl phosphoric acid), Ln-resin, organo-phosphoric acid-based chromatography, and combinations thereof; and the concentration column is an adsorbent selected from the group consisting of activated carbon, anion exchange resins, or anion-exchange membranes, and combinations thereof.
In terms of claim 16 wherein the guard filter bed has a bed height (Length) and a column inner diameter (D) in a ratio of L/D in a range of 0.25 to 10, the `602 publication (Figure 1) discloses a guard filter column (20), but does not specify the bed height (Length) and a column inner diameter (D) in a ratio of L/D in a range of 0.25 to 10. However, one ordinary skilled in eth art would have known that the guard filter column (20) meets the bed height (Length) and a column inner diameter (D) in a ratio of L/D in a range of 0.25 to 10 according to Figure 1 of the `602 publication, or it would be an routine optimization to get a guard filter bed having a bed height (Length) and a column inner diameter (D) in a ratio of L/D in a range of 0.25 to 10 based on the disclosure of Figure 1 of the `602 publication.
In terms of claim 17 wherein a mass ratio of the chi-phase aluminum oxide to the metal-molybdate powder (AL:P) is in a range of 0.025:1 to 5:1, the `934 publication does not specifically teach the mass ratio of the chi-phase aluminum oxide to the metal-molybdate powder. Instead, the `934 publication [0036] teaches using gibbsite alumina adsorbed with 50-70mg (Mo)/g (alumina) of Mo. In addition, the `934 publication [0018] teaches Said Gibbsite-based alumina molybdenum adsorbent has a x-Al2O3 (chi-phrase) and γ-Al2O3 (gamma-phrase) multiphase when calcinated at a range 500-800 °C (Table 1), and which allows for the recovery of adsorbed Mo. In addition, the `934 publication [0025 and Table 1] demonstrates that D-201(500 °C) contains both x-Al2O3 (chi-phrase) and γ-Al2O3 (gamma-phrase) with the highest Mo absorption capacity of 92.8 mg/g at 90 °C, which reads on the mass ratio of the aluminum oxide to the metal-molybdate powder (A1:P) is in a range of 0.025:1 to 5:1. By calcinating Gibbsite-based alumina at temperature at a range 500-800 °C (Table 1), one ordinary skilled in the art would have optimized the Gibbsite-based alumina to x-Al2O3 (chi-phrase) aluminum oxide in light of the disclosure by the `934 publication as a routine optimization.
Conclusions
Claims 1-17 are rejected.
Claims 18-20 are withdrawn.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong L. Chu, whose telephone number is (571)272-5759. The examiner can normally be reached on M-F 8:30am-5:00pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amber R. Orlando can be reached on 571-270-3149. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
/YONG L CHU/Primary Examiner, Art Unit 1731
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