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
Claims 2-5, 10-12, 14-16, 20-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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.
Claims 1, 6-9, 17-19 are 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 1 recites the limitation "the required at least two separations" in v). There is insufficient antecedent basis for this limitation in the claim. Claims 6-9, 17-19 are rejected for their dependence on Claim 1 and for further failing to remedy this indefiniteness. For purposes of examination, the examiner will interpret the limitation as referring to the limitations of Claim 1 iv), which requires repeating steps i) and ii) at least once, resulting in two total separation steps.
Claim 8 recites the limitation "said Ra2+". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the examiner will interpret the limitation as referring to the mother radionuclide referred to in Claim 7.
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 (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.
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.
Claim(s) 1, 6-8, 13, 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nagatsu et al. (Cyclotron production of 225Ac from an electroplated 226Ra target, EJNMMI, 2021), hereinafter ‘Nagatsu’.
Regarding Claim 1, Nagatsu discloses a method for enhancing the radionuclide activity of a desired daughter radionuclide-containing aqueous eluate (Separation of 225Ac from the target matrix) that comprises the steps of
i) contacting a separation medium with an aqueous solution containing a mixture of mother radionuclide and desired daughter radionuclide, wherein said desired daughter radionuclide has a high affinity for and binds to said separation medium and said mother radionuclide has a low affinity for and does not bind to said separation medium to form a dispersion containing at least water, separation medium, desired daughter radionuclide, separation medium-bound to said desired daughter radionuclide, and unbound mother radionuclide (Separation of 225Ac from the target matrix: the activated target, which comprises 225Ac as a desired daughter radionuclide and 225Ra as a mother radionuclide, was dissolved in 3 mL of 0.7 M HNO3, thereby forming an aqueous solution of the same, and the solution was loaded slowly into a DGA cartridge (N,N,N′,N′-tetra-n-octyldiglycolamide), a separation medium. As shown in Fig. 3, the Ra mother radionuclides are eluted through the cartridge, having low affinity for and not binding to said separation medium, while the Ac daughter radionuclide is bound to the DGA resin – this process creates a dispersion containing at least water, separation medium, desired daughter radionuclide, separation medium-bound to said desired daughter radionuclide, and unbound mother radionuclide);
ii) maintaining that contact for a time period sufficient for unbound desired daughter radionuclide to bind to the separation medium (as discussed above, Ac-225 is sorbed to the DGA resin – therefore, the contact between the aqueous solution and the resin is maintained for a period of time sufficient for unbound desired daughter radionuclide to bind to the separation medium);
iii) separating said unbound mother radionuclide from the desired daughter radionuclide-bound separation medium formed in step ii) using a washing solution (Separation of 225Ac from the target matrix: The DGA cartridge was washed with 20 mL of 0.7 M HNO3 to remove residual 226Ra);
iv) repeating steps i) and ii) at least once and up to the binding limit of the desired daughter radionuclide to the separation medium used (Separation of 225Ac from the target matrix: to increase the leftover recovery of Ac/Ra, another 3 mL of 0.7 M HNO3 was introduced into the target cavity and the rinsing fraction was loaded into the same DGA cartridge. This step was repeated twice); and
v) stripping the bound desired daughter radionuclide from the separation medium using a volume of stripping solution less than that used if only steps i), ii), and iii) were used for each of the recited at least two separations to form an aqueous eluate solution having enhanced desired daughter radionuclide activity (Separation of 225Ac from the target matrix: 5 mM HNO3 (10 mL) was loaded into the DGA to elute 225Ac – given that the at least two separations as required by the claim are performed by Nagatsu, it logically flows that the volume of stripping solution used therein would be less than that used if only steps i), ii), and iii) were used for each of the recited at least two separations).
Regarding Claim 6, Nagatsu discloses the desired daughter radionuclide is Ac225 present as Ac3+ (Separation of 225Ac from the target matrix: the final product had the chemical form of AcCl3, implying Ac has an oxidation state of 3+ as claimed).
Regarding Claim 7, Nagatsu discloses said mother radionuclide of said desired daughter radionuclide Ac225 is present as Ra+2 (Ra liberation from legacy needles: Ra2+ is shown as present in the matrix separated to yield 225-Ac).
Regarding Claim 8, Nagatsu discloses said Ra+2 is one or both of Ra225 and Ra226 (Separation of 225Ac from the target matrix: The DGA cartridge was washed with 20 mL of 0.7 M HNO3 to remove residual 226Ra).
Regarding Claim 13, Nagatsu discloses a method for enhancing the radionuclide activity of a desired daughter radionuclide-containing aqueous eluate separated from an aqueous composition containing a mother radionuclide and a daughter radionuclide in which said aqueous composition is
1) contacted with a separation medium in which said desired daughter radionuclide has a high affinity for and binds to said separation medium and said mother radionuclide has a low affinity for and does not bind to said separation medium to form a dispersion containing at least water, separation medium, desired daughter radionuclide, separation medium-bound to said desired daughter radionuclide, and unbound mother radionuclide (Separation of 225Ac from the target matrix: the activated target, which comprises 225Ac as a desired daughter radionuclide and 225Ra as a mother radionuclide, was dissolved in 3 mL of 0.7 M HNO3, thereby forming an aqueous solution of the same, and the solution was loaded slowly into a DGA cartridge (N,N,N′,N′-tetra-n-octyldiglycolamide), a separation medium. As shown in Fig. 3, the Ra mother radionuclides are eluted through the cartridge, having low affinity for and not binding to said separation medium, while the Ac daughter radionuclide is bound to the DGA resin – this process creates a dispersion containing at least water, separation medium, desired daughter radionuclide, separation medium-bound to said desired daughter radionuclide, and unbound mother radionuclide),
2) that contact is maintained for a time period sufficient for unbound desired daughter radionuclide to bind to the separation medium (as discussed above, Ac-225 is sorbed to the DGA resin – therefore, the contact between the aqueous solution and the resin is maintained for a period of time sufficient for unbound desired daughter radionuclide to bind to the separation medium),
3) the unbound mother radionuclide is separated from the desired daughter radionuclide-bound separation medium formed in step 2) using a washing solution (Separation of 225Ac from the target matrix: The DGA cartridge was washed with 20 mL of 0.7 M HNO3 to remove residual 226Ra), and
4) the bound desired daughter radionuclide is stripped from the separation medium using a volume of stripping solution to form an aqueous eluate, the improvement comprising repeating steps 1), 2), and 3) at least once thereby forming an aqueous eluate solution containing enhanced desired daughter radionuclide activity in a stripping solution eluate volume that is less than that used if only steps 1), 2), 3) and 4) were used for each of the recited at least two separations (Separation of 225Ac from the target matrix: to increase the leftover recovery of Ac/Ra, another 3 mL of 0.7 M HNO3 was introduced into the target cavity and the rinsing fraction was loaded into the same DGA cartridge. This step was repeated twice. Further, 5 mM HNO3 (10 mL) was loaded into the DGA to elute 225Ac – given that the at least two separations as required by the claim are performed by Nagatsu, it logically flows that the volume of stripping solution used therein would be less than that used if only steps i), ii), and iii) were used for each of the recited at least two separations).
Regarding Claim 17, Nagatsu discloses the desired daughter radionuclide is Ac225 present as Ac3+ (Separation of 225Ac from the target matrix: the final product had the chemical form of AcCl3, implying Ac has an oxidation state of 3+ as claimed).
Regarding Claim 18, Nagatsu discloses said mother radionuclide of said desired daughter radionuclide Ac225 is present as Ra+2 (Ra liberation from legacy needles: Ra2+ is shown as present in the matrix separated to yield 225-Ac).
Regarding Claim 19, Nagatsu discloses said Ra+2 is one or both of Ra225 and Ra226 (Separation of 225Ac from the target matrix: The DGA cartridge was washed with 20 mL of 0.7 M HNO3 to remove residual 226Ra).
Claim(s) 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nagatsu et al. (Cyclotron production of 225Ac from an electroplated 226Ra target, EJNMMI, 2021), hereinafter ‘Nagatsu’, as evidenced by Eichrom Technologies Product Catalog (2014).
Regarding Claim 9, Nagatsu discloses said separation particles comprise a diglycolamide extractant corresponding in structure to Formula I dispersed onto a porous inert resin or silica support (Nagatsu discloses the use of an Eichrom DGA resin cartridge comprising N,N,N′,N′-tetra-n-octyldiglycolamide, which meets the formula of Claim 9, where R1-R4 are each n-octyl hydrocarbyl groups and wherein the sum of R1-R4 is 32 – these cartridges comprise an inert support that consists of porous silica or an organic polymer, see Page 5 of Eichrom Technologies Product Catalog).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LOGAN LACLAIR whose telephone number is (571)272-1815. The examiner can normally be reached M-F, 9:30-5:30 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anthony Zimmer can be reached at (571) 270-3591. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LOGAN LACLAIR
Examiner
Art Unit 1736
/L.E.L./Examiner, Art Unit 1736
/ANTHONY J ZIMMER/Supervisory Patent Examiner, Art Unit 1736
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