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
Applicant’s election without traverse of Group I, claims 1 - 8 in the reply filed on July 13, 2026 is acknowledged.
Claims 9 – 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 13, 2026.
Status of Claims
Claims 1 – 16 are pending.
Claims 1 – 8 are rejected.
Claims 9 – 16 are withdrawn.
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 – 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kleiber et al. (US 2015/0344397), Universidade Do Porto (WO2019/138338) (Unoversidade), Kearnety et al. (US 5,102,553), and further in view of Amalgamated Research, Inc. (WO2021/26072) (Amalgamated).
Rejected claims cover, inter alai, a process for purifying an organic acid comprising: separating an organic acid from a fermentation broth (FB) by adding an acid to the FB to form protonated organic acid; creating a solution of dissolved solids from the protonated organic acid; processing the solution of dissolved solids by using it as feedstock in a simulated moving bed (SMB) chromatography system that uses a dilute acid as an eluent and a strong acid cation (SAC) exchange resin; and wherein each step of the SMB chromatography system is divided into two sub-periods wherein a first sub-period encompasses a span of time where the feedstock and the eluent are injected into distinct columns within a recirculation loop and, concurrently, extract and raffinate fractions are also withdrawn from the SMB chromatography system at defined points and during a second sub-period an internal solids profile is recirculated within the SMB chromatography system without any additional material added or removed.
Dependent claim 2 further limits the FB. Dependent claim 3 further limits the organic acid to be purified. Dependent claims 4 and 5 further limits process. Dependent claims 6 – 8 further limit the eluent.
However, Kleiber discloses a method for purifying carboxylic acids from fermentation broths, which cannot be separated by distillation or only with difficulty, proves to be very complex. ([003]). The process comprising: separation of the biomass from the fermentation broth by filtration ( [0023], [0032, claim 16, step (a)); acidification with concentrated sulfuric acid of the filtered broth ([0024], claim 16, step (b1) first part; [0035]), thereby producing a solution of dissolved solids (ammonium salts); purification by simulated bed chromatography (SMB) of the solution (0024], claim 16, step
(b2) second part; [0036]).
For the SMB purification step, strong cation exchangers are preferred as stationary phase (see examples 1 and 2), and the eluent is demineralized water or the permeate obtained from the reverse osmosis (filtration step (a)) ( [0036-0037], claim 20).
The difference between the instantly claimed invention and Kleiber is as follows: the eluent used in the SMB purification step is a dilute acid (claim 1); each step of the SMB chromatography system is divided into two subperiods wherein a first sub-period encompasses a span of time where the feedstock and the eluent are injected into distinct columns within a recirculation loop; concurrently, extract and raffinate fractions are also withdrawn from the SMB chromatography system at defined points and during a second sub-period an internal solids profile is recirculated within the SMB chromatography system without any additional material added or removed (claim 1); adding an acid to the FB to lower the pH of he FB to be substantially between 1.0 – 2.0 (claim 4); the eluent used in the SMB chromatography system comprises acidified water and the acid is mineral acid (claims 6 – 7); and adjusting the pH of the acidified water to be substantially between 1.0 – 2.0 (claim 8).
However, regarding the eluent used in the SMB purification step is a dilute acid (claim 1), the Examiner turns to the teaching of Universidade. The prior art of Universidade discloses a method of purifying glycerol derivatives, herein include dihydroxyacetone (DHA), hydroxypyruvic acid (HPA), glycolic acid (GCO), oxalic acid (OXA), mesoxalic acid (MEO), tartronic acid (TTA), glyceric acid (GCA), glyceraldehyde (GLA), glyoxalic acid (GOX) and unreacted glycerol. The presently disclosed method may be used with any simulated moving bed chromatographic apparatus, including but not limited to moving port and moving column systems. (Abstract & claim 4). The method encompasses the use of a strong cation exchanger and acidified water as a mobile phase, the latter comprising most preferably sulfuric acid (pp. 26, Example 1, applied to the separation of glyceric acid and tartronic acid i.e. acids that can be produced by fermentation.
It follows that in view of Universidad, the use of a dilute acid as an eluent in a SMB separation using a strong cation exchanger for the purification of an organic acid, is an obvious alternative to demineralized water. This limitation is deemed to be obvious absent a showing of unexpected results.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35USC 103.
Regarding each step of the SMB chromatography system is divided into two subperiods wherein a first sub-period encompasses a span of time where the feedstock and the eluent are injected into distinct columns within a recirculation loop; concurrently, extract and raffinate fractions are also withdrawn from the SMB chromatography system at defined points and during a second sub-period an internal solids profile is recirculated within the SMB chromatography system without any additional material added or removed (claim 1); the Examiner turns to the teaching of Kearney. The prior art of Kearney discloses a time variable simulated moving bed process wherein the flow rates through the individual compartments of the sorbent bed of the SMB are controlled. (Abstract). The Examiner notes that Applicant fails to provide a reason for the SMB process being comprised of the two sub-periods. Kearney’s modified SMB separation discloses two sub-periods. (Examples I and II, claim 1). Wherein a first sub-period encompasses a span of time where the feedstock and the eluent are injected into distinct columns within a recirculation loop and, concurrently, extract and raffinate fractions are also withdrawn from the SMB chromatography system at defined points and during a second sub-period an internal solids profile is recirculated within the SMB chromatography system without any additional material added or removed. This modified SMB separation has also already been successfully used by the Applicant himself for the separation of sugars (see WO2021/226071, example 1). It follows that in order to solve the above-mentioned technical problem, a skilled person would consult Kearney and combine it with Kleiber. As such, this limitation is deemed obvious.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instantly claimed invention to combine the teachings of Kleiber with Kearney when seeking to devise a method for the purification of organic acids form fermentation broth. Motivation for the combination of the modified system is found in the teachings of WO2021/26072 (Amalgamated), wherein the modified SMB separation has also already been successfully used to separate sugars.
Therefore, 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 before the effective filing date of the instantly claimed invention. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (U.S. 2007).
Regarding adding an acid to the FB to lower the pH of the FB to be substantially between 1.0 – 2.0 (claim 4); the Examiner turns to the teaching of Kleiber. The prior art of Kleiber discloses decreasing said pH to 1.0-2.0 as described in the claim. ([0035]). The is considered a process measure that a person of ordinary skill in the art can easily select. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regard to the eluent used in the SMB chromatography system comprises acidified water and the acid is mineral acid (claims 6 – 7); the Examiner turns to the teaching of Unoversidade. Example 1 of Unoversidde discloses the use of acidified water as the eluent, wherein the acid is sulfuric acid. (pp. 26, & pp. 20 2nd full para.). These limitations are deemed to be obvious absent a showing of unexpected results.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35USC 103.
Regarding adjusting the pH of the acidified water to be substantially between 1.0 – 2.0 (claim 8), the Examiner turns to the teaching of Unoversidade page 20 second full paragraph. This limitation is deemed to be obvious absent a showing of unexpected results.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35USC 103.
Regarding claim 3, Kleiber discloses that organic acids to be separated by their process. Specifically, selected from the group comprising malic acid, glycolic acid, isocitric acid, mandelic acid, lactic acid, tartronic acid, tartaric acid, citric acid, β-hydroxybutyric acid, mevalonic acid, salicylic acid, oxalic acid, maleic acid, succinic acid, glutaric acid, adipic acid, pimelic acid, suberic acid, fumaric acid and itaconic acids. ([0052] & claim 32). This limitation is deemed to be obvious absent a showing of unexpected results.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35USC 103.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YATE' K. CUTLIFF whose telephone number is (571)272-9067. The examiner can normally be reached Monday-Friday (8:30 - 5:30).
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/YATE' K CUTLIFF/Primary Examiner, Art Unit 1692
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