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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 30 January 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.
Claims 1-8, 11-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Bruse USPGPub 20200056116, EFSA “Scientific Opinion on Mineral Oil Hydrocarbons in Food” EFSA Journal 2012;10(6):2704, Couper, James R. et al. (2012). Chemical Process Equipment - Selection and Design (3rd Edition) and Xu “Short-Path Distillation for Lipid Processing” in Healthful Lipids, C.C. Akoh ed., 2019.
Regarding claims 1, 2, 11 and 12, Bruse teaches a process for reducing hydrocarbon impurities in lauric vegetable oil such as coconut oil [0021] comprising subjecting the oil to short path evaporation (SPE) to obtain a retentate and a distillate under the following conditions:
Pressure: < 0.001 mbar [0032]
Temperature: 220°-260° C [0034]
After SPE, Bruse teaches the retentate oil is contacted adsorbent to obtain a bleached vegetable oil. [0045]
Finally, the oil is deodorized. [0020]
Coconut oil has a fatty acid content as recited in claim 1.
Bruse is silent regarding removing mineral oil saturated hydrocarbons (MOSH) and mineral oil aromatic hydrocarbons (MOAH).
EFSA teaches “The (predominantly applied) physical refining of edible oils (removal of free fatty acids in the deodorisation step) yields a condensate containing the free fatty acids, some valuable components like tocopherols, but also most of the MOH below about <C27 contaminating crude edible oils.” (Sec. 6.1.7.1)
EFSA further teaches “The MOAH content of MOH present in food are mostly around 20 %, but may in vegetable oil and oil seeds be up to 30 - 35 % of the MOH levels. The MOAH fraction could represent a carcinogenic risk. Therefore the CONTAM Panel considers the exposure to MOAH through food to be of potential concern.” (Sec. 8) EFSA also states “there is potential concern associated with the current background exposure to MOSH”. (Sec. 8) “The carbon-numbers of the MOSH to which humans are exposed via food range from C12 to C40 with centres ranging from C18 to C34 (Table 3). Evidence from analyses of the MOSH content of human tissues show an accumulation of MOSH with carbon numbers between n-C16 to n-C35 with centres around n-C23 to n-C24. The accumulating constituents appear to be unresolved MOSH mainly branched- and alkyl-substituted cycloalkanes.
Bruse and EFSA are both directed towards contaminants in refined oil products. It would have been obvious to one of ordinary skill in the art at the time the application was filed to have ensured the removal of MOSH and MOAH from the palm oil disclosed by Bruse since EFSA discloses these were known carcinogenic contaminants in food oils.
Bruse does not explicitly teach the SPE processing conditions recited.
Couper teaches that the rate of evaporation in molecular distillation processes (e.g. SPE) is predicted by the theoretical Langmuir equation (pg. 452):
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It is clear from this equation that the evaporation rate for a given analyte having a molecular weight M and partial pressure P0 is controlled by the temperature of evaporation. Higher temperatures clearly yield higher rates of evaporation.
Xu teaches that, as a milder separation technology, short path distillation has been used in the oil and fat industry for the separation of monoacylglycerols (MAG), polyunsaturated fatty acids (PUFA) from fish oil derivatives, carotenoids, and tocopherols.(Pg. 127) Xu states:
“Feeding rate and evaporator temperature are the most important factors as shown in the previous study (8). An increase in feeding rate will increase the productivity of the process, but will reduce the residence time of the fluids in the evaporator and affect the separation efficiency. The high volatility of the evaporation at a high feeding rate will increase the loss of heat. Therefore, the evaporator temperature and the efficiency of heat transfer of the evaporator are also related to the feeding rate. These factors interact with each other; however, too high an evaporation temperature will reduce the separation efficiency even though the volatility can be increased.”
Bruse, Couper and Xu are all directed to short path distillation. Couper and Xu are text book references that establish the level of ordinary skill in the short path distillation art recognized the result effective variables that were necessary to optimize in order to successfully remove a given target analyte from a lipid matrix. It would have been obvious to one of ordinary skill in the art at the time the application was filed to have optimized the flow rate of the process of Bruse depending on the molecular weight of the impurity being removed, the partial pressure of the impurity being removed and the temperature being used for SPE. It would have been obvious to one of ordinary skill in the art at the time the application was filed to have balanced the speed of impurity removal with the efficiency of the removal of a given impurity. Likewise, it would have been obvious to one of ordinary skill to employ the most stringent and hygienic laboratory standards to ensure the highest yield of purified oil balanced with the time and expense of the SPE process since this is the goal of all purification processes. Therefore the yield recited in claim 1 merely reflects the obvious optimization of known prior art processes.
The pressure and temperature of the SPE process of Bruse overlap or encompass the values recited in claims 1, 2 and 11. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) Given that MOSH removal and the relationship between pressure, temperature and evaporation rate were known in the art, the feed rate recited in claims 1 and 12 merely reflects the obvious optimization of the process of Bruse.
Bruse and EFSA illustrate that impurities including MOAH and MOSH were well known in the food oil processing arts to be carcinogenic contaminants. Bruse, Couper and Xu establish that one of ordinary skill in the art would readily recognize the utility of SPE for removal of contaminants and would have a reasonable expectation of success of removal of contaminants to sub-ppm levels based on their molecular weight/boiling point through optimization of SPE processing conditions. As such, the limitations of claims 1, 2, 11 and 12 merely reflect the employment of a known technique for lipid processing to remove known contaminants and yield a predictable result.
Regarding claims 3, 4 and 16, Bruse teaches degumming, bleaching and deodorization. [0017, 0045, 0043]
Regarding claim 5, Bruse teaches bleaching with acid-activated bleaching earth dosed at 0.8-5 wt% based upon the weight of the vegetable oil at a temperature ranging from 70-100°C. [0045-0048] It would have been obvious to one of ordinary skill in the art at the time the application was filed to have optimized the bleaching time depending on the amount of bleaching desired. Therefore, the limitations of claim 5 are rendered obvious by the modification of Bruse.
Regarding claims 6, 7 and 14, Bruse teaches deodorizing takes place at a temperature of less than 230°C. [0027]
Regarding claim 8, Bruse teaches deodorizing takes place using sparge steam in an amount of 0.7-2.5 wt%. [0031]
Regarding claim 13, Bruse teaches degumming prior to SPE [0049-0057], alkali neutralization [0044], bleaching with neutral bleaching earth dosed at 0.8-5 wt% based upon the weight of the vegetable oil at a temperature ranging from 70-100°C [0045-0048] and deodorizing at a temperature of less than 230°C and a deodorization time of 2hrs. [0027] (Table 1)
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Bruse USPGPub 20200056116, EFSA “Scientific Opinion on Mineral Oil Hydrocarbons in Food” EFSA Journal 2012;10(6):2704, Couper, James R. et al. (2012). Chemical Process Equipment - Selection and Design (3rd Edition) and Xu “Short-Path Distillation for Lipid Processing” in Healthful Lipids, C.C. Akoh ed., 2019 as applied to claim 1 above in further view of De Greyt, W. and Kellens, M. (2005). Deodorization. In Bailey's Industrial Oil and Fat Products, F. Shahidi (Ed.). https://doi.org/10.1002/047167849X.bio027
Regarding claims 9 and 10, Bruse teaches what has been recited above but is silent regarding using a packed stripping column for deodorization.
De Greyt is a technical reference that establishes the level of ordinary skill in the oil refining deodorization art. De Greyt teaches (Pg. 368-369):
“Another way to improve the stripping is to increase the contact surface between steam and oil. In edible oil deodorization, this is accomplished in so-called packed columns that can be filled with various types of surface-extending devices. Packed columns have already been applied in edible oil deodorization for decades. A very good contact between the vapor and the oil at low pressure is created by a continuous thin film of oil flowing over the packing material. Both random and structured packings are used, but the structured packing is most preferred for its lower pressure drop and higher vaporization efficiency. As a result of the fact that stripping steam is introduced into the column in a countercurrent way, packed columns require less steam than tray deodorizers, which work according to the cross- flow principle (4)”
De Greyt further states “Aside from a higher stripping efficiency, a packed column is also characterized by a very short holdup time.” (Pg. 370)
Bruse and De Greyt are both directed towards refinement of vegetable oils. It would have been obvious to one of ordinary skill in the art at the time the application was filed to have used a packed stripping column as disclosed by De Greyt in the method of Bruse given the improved stripping provided by the increase in contact surface between steam and oil provided by a packed column. While Bruse and De Greyt are silent regarding the specific packing surface area and oil loading recited in claims 9 and 10, it is clear from the teachings of De Greyt (pg. 341-382) that these parameters are merely result effective variables that are routinely optimized by those of ordinary skill in the art. "[W]here 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) As such, claims 9 and 10 do not provide a patentable distinction over the cited references.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Bruse USPGPub 20200056116, EFSA “Scientific Opinion on Mineral Oil Hydrocarbons in Food” EFSA Journal 2012;10(6):2704, Couper, James R. et al. (2012). Chemical Process Equipment - Selection and Design (3rd Edition) and Xu “Short-Path Distillation for Lipid Processing” in Healthful Lipids, C.C. Akoh ed., 2019 as applied to claim 1 above in further view of Pudel “3-MCPD- and glycidyl esters can be mitigated in vegetable oils by use of short path distillation” Eur. J. Lipid Sci. Technol. 2016, 118, 396–405.
Regarding claim 15, Bruse teaches what has been recited above. Bruse further teaches that the process disclosed can reduce the quantity of 3-MCPD and 3-MCPD fatty esters to less than 1 ppm. [0039]
Bruse is silent regarding explicitly disclosing the removal of glycidyl esters.
Pudel discloses that 3-MCPD and glycidyl esters are carcinogenic to humans. (Sec. 1) Pudel teaches removal of 3-MCPD and glycidyl esters from vegetable oils using short path distillation. (abstract) Pudel teaches “In all short path distilled palm oils treated with different settings of process variables (Table 3) 3-MCPD-FE were not detected (LOD >0.1 mg/kg), while the level for G-FE ranged between limit of detection and 0.7 mg/kg (0.7 ppm). Most of the samples were below 0.2 mg/kg (0.2 ppm) (19 from 25).” (Sec. 3.1)
Bruse and Pudel are both directed towards use of SPE to remove 3-MCPD. It would have been obvious to one of ordinary skill in the art at the time the application was filed to have performed SPE in Bruse to ensure removal of glycidyl esters to levels less than 0.2 ppm as disclosed by Pudel since this compound was known to be carcinogenic and could be removed concurrently with 3-MCPD. Therefore, the limitations of claim 15 are rendered obvious by the modification of Bruse with the cited references.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because they are not relevant to the combination of references in the new grounds of rejection presented above.
Conclusion
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/Michele L Jacobson/Primary Examiner, Art Unit 1793