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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 29 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 1-11 and 13-16 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, 6-9 and 13-15, Bruse teaches a process for reducing hydrocarbon impurities in lauric vegetable oil such as coconut oil comprising subjecting the vegetable oil to short path evaporation (SPE) to obtain a retentate and a distillate under the following conditions:
Pressure: < 0.001 mbar [0032]
Temperature: 100°-300° C [0034]
Coconut oil has a fatty acid content as recited in claim 1. Bruse is silent regarding removing mineral oil saturated hydrocarbons (MOSH)
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):
PNG
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77
371
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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 yields and functional limitations recited in claims 1 and 13-15 merely reflect 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 6-8. 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, 6 and 9 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, 6-9 and 13-15 merely reflect the employment of a known technique for lipid processing to remove known contaminants and yield a predictable result. Therefore, claims 1, 2, 6-9 and 13-15 are rendered obvious by the modification of Bruse.
Regarding claims 3 and 4, Bruse teaches degumming, bleaching and deodorization. [0017, 0045, 0043]
Regarding claims 5 and 16, Bruse teaches sparging with steam at a temperature of 180°-230° C at a flow rate of 0.7-2.5 wt%. [0024-0031,0056]
Regarding claims 10 and 11, Bruse teaches the same starting material as claimed and disclosed by applicant, namely coconut oil, and therefore it logically follows such material would have a MOSH and MOAH content as recited in claims 10 and 11. Additionally, there is not criticality to the levels of contaminants recited and therefore this limitation does not provide a patentable distinction over the prior art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8, 11 and 12 of copending Application No. 18/558482 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application anticipate or render obvious at least present claims 1-6.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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