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 .
Continued Examination Under 37 CFR 1.114
Receipt is acknowledged of a request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e) and a submission, filed on May 5, 2026.
Response to Arguments
Applicant's amendments and arguments filed May 5, 2026 have been fully considered.
The indefiniteness rejection(s) have been partially withdrawn and partially maintained and new grounds of indefiniteness are herein presented
The obviousness rejection(s) have been withdrawn.
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 11-13 and 16-24 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 11 recites “a first chromatography column” and “a second set of chromatography columns”. Claim 11 is deemed indefinite because it is unclear how there is “a second” set of columns when there is only a first single column. For the sake of compact prosecution, claim 11 is understood as “b) capturing a desired group of metal ions in a first chromatography column” and “a [[second]] subsequent set of chromatography columns”. Claims 17 and 22-24 are deemed indefinite for similar reasoning.
Claims 12, 13 and 16-24 are also rejected by virtue of the claim dependency.
Claim 22 recites “the metal ions”. The claim is deemed indefinite because it is unclear if the “metal ions” are the same as or separate and distinct as the “the desired group of metal ions”. For the sake of compact prosecution, claim 22 is understood as “wherein the first set of chromatography columns used to capture the desired group of metal ions is packed with strong-acid cation exchange resins; wherein the first ligand is configured to elute the desired group of metal ions and form at least one complex with metal ions with different equilibrium constants or stability constants”.
Claim 22 recites “the first set of chromatography columns”. There is insufficient antecedent basis for this limitation in the claim. For the sake of compact prosecution, claim 22 is understood as “the first chromatography column”.
Election/Restrictions
This application is in condition for allowance except for the presence of claims 1-10 directed to an invention nonelected without traverse. Accordingly, claims 1-10 should be canceled.
The restriction of claim 14, directed towards a non-elected species, will be rejoined.
Allowable Subject Matter
Claims 11-13 and 16-24 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance:
The prior art of record, alone or in combination, does not disclose, teach, suggest or render obvious claimed method for separating a mixture of metals, as recited in independent claim 11. The presently claimed method comprises the steps: a) dissolving a mixture of metals in a strong acid to result in a dissolved mixture; b) capturing a desired group of metal ions in a first chromatography column, the first chromatography column is washed in a salt solution to remove nonadsorbing species, resulting in the desired group of metal ions, wherein the salt solution is a sodium salt solution or an ammonium salt solution; c) co-eluting the desired group of metal ions with a first ligand solution to result in a further washed solution; d) loading the further washed solution onto a second set of chromatography columns, said second set of chromatography columns comprising chelating resins with functional groups of iminodiacetic acid; and e) co-eluting the desired group of metal ions with a second ligand solution. A feature of the presently claimed method is performed by a single chromatography column, that undergoes the capturing step (step b), the washing with a salt solution step (step b), and the co-eluting the desired group of metal ions (step c) followed by using a second set of chromatography columns to perform the steps of loading the further washed solution (step d) and then co-eluting the desired group of metal ions (step e). The interaction of a single first chromatography column to perform specific steps followed by the use of a set of chromatography columns to perform the remaining steps is an unobvious and novel limitation of the claimed method.
The closest prior art, US 20140294700 A1 (hereinafter US 700), as presented in the November 5, 2025 Office Action, discloses that the method and system comprises a first set of chromatography columns and a second set of chromatography columns. US 700 discourages a method and system comprising a single first chromatography column in combination with a second set of chromatography columns, as recited in independent claim 11, because US 700 discloses that the advantage of the method and system “resides in that with two pairs of columns respectively connected consecutively in a process direction, one pre-column and one separation column each are provided” (see US 700 paragraph 0055). US 700 discloses that the pairs of columns achieve a “twofold purified 177Lu eluate … and is still liberated of further traces of metal” (see US 700 paragraph 0055). US 700 discloses that “the concept of pre-columns/separation columns also has the advantage that a column application of acidic and acidified solutions, respectively, which in and for themselves would merely be partly suited for separation, is thereby made possible. The actual sharp separation is performed only in the separation column” (see US 700 paragraph 0055). Also, US 700 discloses that the pre-columns/separation columns achieve a reduction in process time (see US 700 paragraph 0055).
In view of the disclosure of US 700, one of ordinary skill in the art would not have been motivated to achieve the claimed single first chromatography column to perform the claimed steps in the claimed order followed by the use of the claimed set of chromatography columns to perform the claimed remaining steps in the claimed order, as recited in independent claim 11. Therefore, claims 11-13, 16-24 are allowable over the prior art in record.
As noted above, claim 14 will be rejoined. Hence, claims 11-14 and 16-24 are deemed to recite allowable subject matter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BERNADETTE K MCGANN whose telephone number is (571)272-5367. The examiner can normally be reached M-F 7:00 am -3:30 pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ben Lebron can be reached on 571-272-0475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BERNADETTE KAREN MCGANN/Examiner, Art Unit 1773
/BENJAMIN L LEBRON/Supervisory Patent Examiner, Art Unit 1773
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