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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/11/2026 has been entered.
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.
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.
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.
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.
Claim(s) 1-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miejer et al. (WO 2016/083597), cited IDS in view of Rashad et al. “Impregnated activated carbon for the adsorption of Gd(III) radionuclides from aqueous solutions”, Particulate Science and Technology, 36(5), 609–617, 2018, in view of Dwivedi et al. “Column performance of granular activated carbon packed bed for Pb(II) removal”, Journal of Hazardous Materials, Volume 156, Issues 1–3, 15 August 2008, Pages 596-603.
Meijer teaches methods of making metal chelates including DOTA-Gd meglumine (gadoterate meglumine meeting claims 5-7) in which an excess of Gd was used in the complexation step 1, then excess lanthanide was removed with a solid filter, to yield a second solution which comprises the metal complex free from excess gadolinium. See entire disclosure, especially abstract, examples and claims. Regarding claim 2 which recites the amount of free Gd in the second solution, Meijer is silent with respect to specific amounts remaining however the reference teaches the amount of excess lanthanide used in the complexation step is 0.001 to 5 mol/mol%. Depending on how much chelate complex is being made the amount of Gd in mM could be within the range claimed and is dependent on the amount used in the complexation step. The preparation of metal-chelate product produced from a variable amount of excess lanthanide is within the level of skill of one having ordinary skill in the art at the time of the invention. It has also been held that the mere selection of proportions and ranges is not patentable absent a showing of criticality. See In re Russell, 439 F.2d 1228 169 USPQ 426 (CCPA 1971). Regarding claim 8, the amount of excess lanthanide used in the complexation step of Meijer is 0.001 to 5 mol/mol%. See claim 2. Regarding claims 9-10, the pH of the GD-chelate solution of Meijer was adjusted with meglumine to between 4.5-5.5. See page 13 lines 19-24. Regarding claim 15, the separation step of Meijer appears to have been carried out at ambient temperature. See examples. Regarding claims 16-19, excess chelator free of coordinated metal in amounts of 0.025-0.25 was added in uncomplexed form after separation. See page 5 line 13-page 6 line 12 and claims 1,3. Regarding claims 20-21, Meijer teaches dispensing the finished composition in containers or syringes and carrying out terminal sterilization at each step. See claims 17-18.
Meijer while teaching the same complex formation and removing excess lanthanide is silent on performing the filtering step with activated carbon in a column or cartridge (claim 14) and instead uses resin.
Rashad is used primarily for its disclosure that activated carbon was well known to absorb Gd(III) and remove it from solution (R%>95%). See entire disclosure, especially abstract and conclusions page 8. Dwivedi is used only for the disclosure within that activated carbon was well known to be packed in columns and used for filtering. See entire disclosure, especially abstract.
Since Rashad teaches how to remove Gd from solution by absorbing unto activated carbon one of ordinary skill in the art would have a very high expectation of success in using the activated carbon alone or with the resin of Meijer to absorb and remove free Gd from the metal-chelate complex in high amounts of greater than 95% with a very high expectation of success and predictable results. It would also be obvious that the activated carbon could be used in a column as this was a well-known filtration method using activated carbon as taught by Dwivedi. An “obvious to try” rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. Obviousness stems from the notion that the combination of art known elements that, when combined, do no more than serve their art-recognized functions is obvious. Thus the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.“ [A] person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. KSRInternational Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1397 (2007).
Response to Arguments
Applicant's arguments filed 3/11/2026 have been fully considered but they are not persuasive.
While the examiner has removed the secondary reference Krause some of applicant’s arguments are still pertinent to the rejection above.
Applicants assert Miejer is silent with respect to removing Gd with activated carbon and instead uses scavenger resin.
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). Clearly as noted in previous actions Midjer is silent with respect to using activated carbon to remove free Gd, which is the reason it was combined with the secondary references which pick up this limitation.
Applicants assert there is no articulated reason to substitute activated carbon sorbent for Meijers specialized procedure which uses scavenger resin.
As noted in the rejection above replacing the scavenger resin is not necessary as the two absorbents could be combined with an expected additive effect of absorbing gadolinium. Regardless the examiner has provided a rationale for using the activated carbon including removing free Gd from the metal-chelate complex in high amounts of greater than 95%. Additionally, obviousness stems from the notion that the combination of art known elements that, when combined, do no more than serve their art-recognized functions is obvious. Clearly Meijer teaches all that is claimed expect for the use of activated carbon which was well known at the time of the claimed invention to be useful in removing gadolinium in high percentages. The examiner is only taking in to consideration what was known in the prior art at the time of the claimed inventio. One of ordinary skill could use activated carbon with a high expectation of success for its known use of removing gadolinium by absorption.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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/JAMES W ROGERS/Primary Examiner, Art Unit 1618