DETAILED ACTION
All objections and rejections raised in prior Office Actions are withdrawn unless restated below.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/10/2025 has been entered.
Claim Interpretation
The specification, pages 20-21, states:
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In view of the specification, altering fermentation parameters meets the claim limitation of claim 1 of “modifying the sophorolipid biosurfactant during cultivation. It is impossible to culture a microorganism with no fermentation parameters such that any and every possible set of fermentation parameter results in a “modification” of produced sophorolipid biosurfactant relative to another set of fermentation parameters. That is, claim 1 and the specification does not state to what base line fermentation parameters for culturing S. bombicola would be considered to be “not altered” or not modifying the sophorolipid biosurfactant during the cultivation. As such, since any set of fermentation parameters has some effect on sophorolipid produced, culturing S. bombicola under any set of fermentation parameters satisfies modifying the sophorolipid during the cultivation cycle.
A sophorolipid derived from esterifying the carboxylic acid group of a non-lactone sophorolipid is not considered to be an acidic sophorolipid since a carboxylic acid group is not long present after esterification.
In this office action, ASL is an abbreviation for acidic sophorolipid and LSL is an abbreviation for lactonic sophorolipid.
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.
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asmer et al. (Microbial Production, Structure Elucidation and Bioconversion of Sophorose Lipids, J. Am. Oil Chem. Soc. 65, 1988) further in view of Van Bogaert et al. (Microbial production and application of sophorolipids, Appl. Microbiol. Biotechnol. 76, 2007, 23-34) as evidenced by ATCC 22214, Product Sheet, 2025, and AmphiStar Biosurfactants, Products Website, amphistar.com/products, retrieved 03/31/2026 (AmphiStar).
Asmer, abstract, states:
Cultivation of Torulopsis bombicola ATCC 22214 [i.e. Starmerella bombicola] on a mixture of glucose and oleic acid (A) or oleic acid alone {B) produced large amounts of sophorose lipids. In the case of A, 38 g/l of crude product were finally isolated; fermentation B led to 77 g/l. After separation by MPLC and TLC, six glycolipids were obtained and identified by NMR and fast atom bombardment-mass spectrometry (FAB-MS}. In general, a 17-hydroxyocta- decanoic acid at the C-l'-position and acetate groups at the C-6'-and C-6"-positions of sophorose were found as substituents in the lactone and acidic forms of these lipids. The composition of product from A was as follows: 62% of sophorolipid l',4"-lactone 6',6"-diacetate {SL-1), 4% of sophorolipid l',4"-lactone 6"-monoacetate {SL- 2), 4% of sophorolipid l',4"-lactone (SL-3), 4% of sophorolipid l',6'-and l',6"-lactones (SL-4a,b}, 4% of so- phorolipid 6'-monoacetate acid {SL-5), 4% of sophorol- ipid acid {SL-6) and finally 17% of other lipids. In B, the principal lactone (40%) had a double bond in the fatty acid moiety; the other components were identical with the above products. Yields of 13% SL-2 and of 35% lipids containing no carbohydrate were significant. SL-1 was deacetylated to SL-3 (yield: 25- 30%) using acetyl-esterase in a two-phase system (cy- clohexane/water).
“Since 1961, it has been known that the yeast Torulopsis bombicola produces a mixture of sophorose lipids during growth on glucose, yeast extract and urea. Studies on the improvement of biosurfactant yield showed that the step-wise addition of long chain fatty acid esters or n-alkanes promoted the biosynthesis.” Asmer, page 1460, left col.
ATCC 22214, Product Sheet, evidences that T. bombicola ATCC 22214 is also known as Starmerella bombicola ATCC 22214.
More specifically, Asmer, Table 1, teaches cultivation of S. bombicola under the following conditions:
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At least soybean oil and stearic acid methylester are neutral oils.
A primary teaching of Asmer that variation of first and second carbon sources during cultivation of S. bombicola has large, significant effects on the composition of sophorolipids produced.
“Incubation temperatures between 23C and 30 C promoted growth and glycolipid produc-
tion. 4) Step-wise or continuous addition of the second carbon source of triglycerols, fatty acids, esters, alcohols and n-alkanes, after 24 hr to the basic medium enhanced the sophorolipid production. Lipophilic compounds containing a C-18 chain length (with or without a double bond) were particularly suitable. 5) A ratio of glucose/2nd carbon source of about 3/1 in the medium favored the overproduction of a single sophorolipid (SL-1). Lower ratios led to more hydrophilic sophorolipids.” Asmer, page 1463, left col.
As shown in Table 1, the predominate sophorolipid is a lactone (laconic) sophorolipid (LSL). However, it is understood that a minor amount of acid sophorolipid (ASL) as shown in Fig. 4B and Fig. 3 of Asmer is a component of all products including the ASL SL-5 discussed in the abstract of Asmer.
In view of the description of Asmer that selection of carbon sources for cultivation of S. bombicola affects the quality of sophorolipid produced particularly with respected to more or less hydrophilic sophorolipids, the same is “modifying the sophorolipid biosurfactant during the cultivation cycle” as a result of the carbon source present. That is, Asmer, page 1462, left col., teaches: “As such, Asmer discloses: Step-wise or continuous addition of the second carbon source of triglycerols, fatty acids, esters, alcohols and n-alkanes, after 24 hr to the basic medium enhanced the sophorolipid production,” wherein addition of a carbon source during cultivation that affects sophorolipid production is “modifying the sophorolipid biosurfactant during the cultivation cycle.
A method for producing a green biosurfactant composition, comprising:
performing a cultivation cycle of cultivating a Starmerella bombicola microorganism to produce a sophorolipid biosurfactant molecule and modifying the sophorolipid biosurfactant during the cultivation cycle, wherein the green surfactant composition comprises an acidic sophorolipid and lactonic sophorolipid.
Asmer does not discuss a sophorolipid (i.e. green surfactant) composition having a HLB value of 10 or greater.
“Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." MPEP 2112.01. “Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” MPEP 2112.01.
Asmer discloses the structure of the sophorolipids discussed therein. However, Asmer does not directly discuss the HLB values of such sophorolipids or crude preparations of mixtures thereof prepared by cultivation of S. bombicola.
However, the following sound basis is noted for believing that the sophorolipids described by Asmer have HLB values greater than 10.
Van Bogaert, abstract, teaches, Sophorolipids are surface-active compounds synthesized by a selected number of yeast species. They have been known for over 40 years, but because of growing environmental awareness, they recently regained attention as biosurfactants due to their biodegradability, low ecotoxicity, and production based on renewable resources.
“Asmer et al. (1988) were the first to shed light on this structural variation. They separated the sophorolipid mixture by medium pressure liquid chromatography and thin layer chromatography, and mainly based on the lactonization and acetylation pattern, they put forward 14 components. . . . When sophorolipids are solved in water, they lower the surface tension from 72.8 mN/m down to 40 to 30 mN/m, with a critical micelle concentration of 40 to 100 mg/l. The hydrophilic/lipophilic balance is 10 to 13, making sophorolipids useful as detergents or as stabilizers for oil-in-water emulsions.” Asmer, page 24, right col.
As such, Van Bogaert teaches an expectation that sophorolipid compositions as producible by S. bombicola are fully expected to have a HLB of greater than 10 and that in general the same is required for such sophorolipids to be useful for forming oil-in-water emulsions. Asmer discusses “For testing in various fields of technical application, such as oil pollution abatement at sea and in coastal waters, larger quantities of the most hydrophilic sophorolipid lactone SL-3 were necessary,” which is evidence that the sophorolipids taught therein are generally to be used in forming oil-in-water emulsions (i.e. water is in greater amount in the sea as compared to any oil therein). In view of the teachings of Ban Bogaert, it is not inventive to discover or culture S. bombicola as taught by Asmer to have a HBL of greater than 10 in view of Van Bogaert explicitly teaching that a HLB greater than 10 is expected for sophorolipid compositions and particular for oil-in-water emulsions wherein the discussion in Asmer of “oil pollution abatement at sea and in coastal waters” is suggestive of use in oil-in-water emulsions. As discussed above, Asmer discusses how to manipulate culture conditions to affect the presence of “more hydrophilic sophorolipids,” wherein more hydrophilic is associated with higher HLB value. Asmer, in Fig. 9 and related text, also discusses conversion of SL-1 to SL-3 (deacylated sophorolipid) as a means for producing more hydrophilic sophorolipids. Hydrophilic sophorolipids are associated with higher HLB values. See Specification, page 1, lines 15-20.
Further, AmphiStar describes an acetylated lactonic sophorolipid C18:1 with identical structure to SL-7 (Fig. 5) of Asmer with a HLB of 13.1, and a corresponding non-acetylated acid sophorolipid C18:1 (i.e. lactone ring opened and deacetylated as compared to SL-7 of Asmer) with a HLB of 11.0. The same provides a shows a sound basis for believing that the SL-1 sophorolipid of Asmer that is identical to SL-7 except for lack of a double bond also has a HLB greater than 10, and that crude mixtures of sophorolipids useful for forming oil-in-water emulsion having any of these sophorolipids as predominant components also have a HLB greater than 10.
“In certain circumstances, references cited to show a universal fact need not be available as prior art before the effective filing date of applicant’s claimed invention. In re Wilson, 311 F.2d 266, 135 USPQ 442 (CCPA 1962). Such facts include the characteristics and properties of a material or a scientific truism.” MPEP 2124. AmphiStar is cited for showing the characteristics and properties of a material.
Claim(s) 1 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asmer et al. (Microbial Production, Structure Elucidation and Bioconversion of Sophorose Lipids, J. Am. Oil Chem. Soc. 65, 1988) and Van Bogaert et al. (Microbial production and application of sophorolipids, Appl. Microbiol. Biotechnol. 76, 2007, 23-34) as evidenced by ATCC 22214, Product Sheet, 2025, and AmphiStar Biosurfactants, Products Website, amphistar.com/products, retrieved 03/31/2026 (AmphiStar) as applied to claim 1 above, and further in view of Hirata et al. (Natural Synergism of Acid and Lactone Type Mixed Sophorolipids in Interfacial Activities and Cytotoxicities, J. Oleo Sci. 58, 2009, 565-572).
Regarding claim 4, “Biochemical conversion of sophorolipid SL-1. For testing in various fields of technical application, such as oil pollution abatement at sea and in coastal waters, larger quantities of the most hydrophilic sophorolipid lactone SL-3 were necessary. Preliminary studies on alkaline hydrolysis of both acetate groups at C-6' and C-6" were unsuccessful as the lactone also was cleaved. Hence, hydrolyzing enzymes such as acetylcholine esterase (ACE), pig liver esterase (PLE) and acetylesterase (AE) were tested.” Asmer, page 1465, right col.
Regardless of reported “unsuccess,” alkaline hydrolysis (i.e. mixing an alkaline substance) was performed by Asmer and formed acidic and deacylated sophorolipid, which is modification of sophorolipid/biosurfactant molecule after production of biosurfactant by mixing an alkaline substance.
Hirata, abstract, states:
Sophorolipids (SLs) naturally produced from Candida bombicola are a mixture of lactonic (SL-lactone) and acidic (SL-acid) sophorosides of 17-L-hydroxydecanoic acid with an SL-lactone:SL-acid ratio of 72:28. SLs are biodegradable low-foaming surfactants with high detergency and hardness-tolerance properties. To analyze the effect of the SL-lactone:SL-acid ratio on these properties, SL-LXs containing X% SL-lactone, in which X varied from 0 to 100, were prepared and their interfacial activities and cytotoxicities examined. The minimum surface tension values for all SLs examined were comparable. The critical micelle concentration (CMC) was 680 mg/L for SL-L0 and 62-110 mg/L for the other SLs. Interestingly, natural SL (SL-L72) had the lowest surface tension and CMC among all of the SLs examined. The foaming ability and stability of the SLs were dependent on the SL-L content. SL-L0 and L17 had higher foaming values than the other SLs examined in 0-ppm hardness water. These values greatly reduced and became constant when the SL-L content increased over 55%. The detergencies of all of the SLs examined were comparable, except for those of SL-L0 and SL-L100, which were slightly lower than those of the other SLs. These results suggest that natural synergism between SLs creates a better balance for many interfacial activities. The cytotoxicity of SL-L72 was higher than that of SL-L0, but was comparable to that of surfactin, which is commercially available for cosmetic use. The low cytotoxicities and high interfacial properties of SLs increase their usefulness as biocompatible surface active agents for many applications.
“SLs with various SL–L100:SL–L0 ratios were prepared by the differences in the solubilities of SL–L100 and SL–L0 in pH–neutral aqueous solution. . . . SL–L0 was obtained by alkaline hydrolysis of SL.” Hirata, page 567, left col. As shown in Fig. 1 of Hirata, SL-L100 is LSL identical to the structure of SL-7 of Asmer, and SL-L0 is the corresponding ASL made by alkaline hydrolysis just as Asmer describes alkaline hydrolysis to form a ASL corresponding to a LSL.
As such, Hirata teaches that it is a known process and technique in the prior art to mix a purified LSL with its corresponding ASL formed by alkaline hydrolysis of the LSL at different ratios wherein “natural synergism between SLs creates a better balance for many interfacial activities.” “Therefore, it seems likely that natural SLs exhibit unusual properties due to synergistic effects of these two nonionic and anionic unique surfactants. However, their synergistic effects remain to be analyzed. We report here the effect of a SL–lactone:SL–acid ratio on the interfacial activities and cytotoxicities of SLs.” Hirata, page 565, right col. It is noted that Table 1 of Hirata shows data from specific mixtures of SL-L100 (LSL) and SL-L0 (ASL) and resulting properties including CMC and surface tension; Fig. 3 of Hirata shows foaming properties of such mixtures.
As discussed, Asmer explicitly teaches the actual practice of alkaline hydrolysis of LSL SL-1 taught therein to produce its corresponding deacylated ASL. In view of Hirata teaching that beneficial synergistic effects to optimize interfacial activities by mixing a LSL with its corresponding ASL, an ordinarily skilled artisan at the time of filing would have been motivated to mix SL-1 as taught by Asmer with the corresponding ASL produced by alkaline hydrolysis at different ratios to at least investigate synergistic interface properties as taught by Hirata. As noted above, AmphiStar evidences that a deacylated acidic 18:1 sophorolipid that would be formed by NaOH treatment of SL-7 of Asmer has a HLB of 11.0 wherein it would appear that the removal of the alkene group (to an alkane) would not have a large effect on HLB such that both LSL and ASL components of such a mixture would be expected to have a HLB value greater than zero.
Further, Asmer teaches the production of SL-7 that is identical to SL-L100 of Hirata, which AmphiStar evidences has an HLB of 13.1 in its acetylated form. Since Hirata teaches performing alkaline hydrolysis on this specific sophorolipid, an ordinarily skilled artisan would have been motivated to take SL-7 produced as described by Asmer that is identical to SL-L100 of Hirata and subject the same to alkaline hydrolysis to produce an ASL (i.e. SL-L0) and repeat the formation of sophorolipid mixtures of these ASL and LSL to repeat the experiments of Hirata, since Asmer teaches a means for producing SL-7 that is SL-L100 of Hirata. As discussed, Hirata teaches that alkaline hydrolysis of an acetylated LSL produces a deacylated ASL, wherein AmphiStar evidences that non-acetylated acidic sophorolipid C18:1 consistent with SL-L0 of Hirata has a HLB of 11.0. Both LSL and ASL as described as having a HLB greater than 10 provides a basis for any mixture having a HLB greater than 10.
Claim(s) 1 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asmer et al. (Microbial Production, Structure Elucidation and Bioconversion of Sophorose Lipids, J. Am. Oil Chem. Soc. 65, 1988) and Van Bogaert et al. (Microbial production and application of sophorolipids, Appl. Microbiol. Biotechnol. 76, 2007, 23-34) as evidenced by ATCC 22214, Product Sheet, 2025, and AmphiStar Biosurfactants, Products Website, amphistar.com/products, retrieved 03/31/2026 (AmphiStar) as applied to claim 1 above, and further in view of Noureddini (Densities of Vegetable Oils and Fatty Acids, Papers in Biomaterials, 1992, 14).
Regarding claim 3, Asmer as discussed teaches cultivation with 3.6% (i.e 36 g/L) of secondary carbon sources including soybean oil. Asmer does not provide a density for soybean oil as to determine its concentration in units of mL/L wherein soybean oil density may vary by source. Noureddini, Table 3, reports the density of soybean oil at 75[Symbol font/0xB0]F as about 0.92 g/mL, which is understood as a typical density for soybean oil. At a density of .92 g/mL, 36 g/L of soybean oil is about 39 mL/L that is well within the range of 25-75 mL/L of a soybean oil as recited in claim 3. For this reasons, Asmer is understood as fully suggesting the features of claim 3.
Claim(s) 1 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asmer et al. (Microbial Production, Structure Elucidation and Bioconversion of Sophorose Lipids, J. Am. Oil Chem. Soc. 65, 1988) and Van Bogaert et al. (Microbial production and application of sophorolipids, Appl. Microbiol. Biotechnol. 76, 2007, 23-34) as evidenced by ATCC 22214, Product Sheet, 2025, and AmphiStar Biosurfactants, Products Website, amphistar.com/products, retrieved 03/31/2026 (AmphiStar) as applied to claim 1 above, and further in view of De Rose (U.S. 2018/0237729 A1) (see IDS).
Regarding claim 19, while Asmer is focused on biosurfactant for use in oil remediation applications. The use of biosurfactants in laundry detergents in well-established in the prior art. De Rose teaches laundry detergents wherein Suitably, the composition comprises a biosurfactant which is a glycolipid (in other words, the biosurfactant comprises a carbohydrate). Suitable biosurfactants are as described herein and include rhamnolipid, sophorolipid, trehalolipid (trehalose lipids), and a mannosylerythritol lipid (MEL), and combinations thereof. De Rose, para. [0021]. The laundry detergent compositions of De Rose include preservatives and builders along with other common components of laundry detergent compositions. De Rose, para. [0150]. Since De Rose teach the use of any suitable biosurfactants within embodiments of the laundry detergent compositions taught therein, an ordinarily skilled artisan at the time of filing would have been motivated to employ the sophorolipids of Asmer as discussed above. That is, in laundry applications water is in large excess over any oil or hydrophobic compound to be dissolved/emulsified similar to the oil-in-water applications of Asmer. While Asmer is focused on biosurfactant for use in oil extraction applications, the same are nevertheless biosurfactants falling within the categories taught by De Rose having properties suitable for the same.
Claim(s) 1 and 18, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asmer et al. (Microbial Production, Structure Elucidation and Bioconversion of Sophorose Lipids, J. Am. Oil Chem. Soc. 65, 1988), Van Bogaert et al. (Microbial production and application of sophorolipids, Appl. Microbiol. Biotechnol. 76, 2007, 23-34) and De Rose (U.S. 2018/0237729 A1) as evidenced by ATCC 22214, Product Sheet, 2025, and AmphiStar Biosurfactants, Products Website, amphistar.com/products, retrieved 03/31/2026 (AmphiStar) as applied to claims 1 and 19 above, and further in view of Saika et al. (Tailor-made mannosylerythritol lipids: current state and perspectives, Appl. Microbiol. Biotechnol. 10, 2018, 6877-6884) (previously cited).
Regarding 18, as indicated above, De Rose teaches Suitable biosurfactants are as described herein and include rhamnolipid, sophorolipid, trehalolipid (trehalose lipids), and a mannosylerythritol lipid (MEL), and combinations thereof. De Rose, para. [0021]. As such, De Rose directly teaches and suggests that any combination of biosurfactants in these classes can be mixed and applied to the taught detergent compositions such that an ordinarily skilled artisan at the time of filing would have been motivated to do the same. Saika, Fig. 1, teaches that there are four mannosylerythritol lipid (MEL) generally known in the prior art including MEL-D having an HLB of 10.1. Since De Rose openly teaches that any combination of rhamnolipid, sophorolipid and MEL can be combined in the detergent compositions thereof, at the time of filing an ordinarily skilled artisan in addition to a combination sophorolipid and MEL, such an artisan would have been further motivated to add any known MEL biosurfactant including MEL-D in view of the explicit teachings of De Rose in addition to sophorolipids for forming oil-in-water emulsions as taught by Asmer.
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, 3, 4, 18 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,460,238 in view of Asmer et al. (Microbial Production, Structure Elucidation and Bioconversion of Sophorose Lipids, J. Am. Oil Chem. Soc. 65, 1988), Noureddini (Densities of Vegetable Oils and Fatty Acids, Papers in Biomaterials, 14), De Rose (U.S. 2018/0237729 A1) and Saika et al. (Tailor-made mannosylerythritol lipids: current state and perspectives, Appl. Microbiol. Biotechnol. 10, 2018, 6877-6884).
The teachings of Asmer, Noureddini, De Rose and Saika discussed above are incorporated herein by reference.
Patented claims recite:
1. A method for producing a sophorolipid composition with an HLB of 9 or greater [directly suggests that HLB can be 10 or greater, i.e. not limited to range of 9-10], the method comprising:
obtaining a yeast fermentation product comprising a mixture of hydrophilic SLP molecules comprising non-acetylated linear SLP, and hydrophobic SLP molecules comprising lactonic SLP and mono-and di-acetylated linear SLP, said mixture being produced by cultivating a SLP-producing microorganism [as in patented claim 3, performing a cultivation cycle of cultivating S. bombicola to produce a sophorolipid biosurfactant being a composition mixture of acidic and lactonic sophorolipids];
functionalizing the hydrophobic SLP molecules by converting them into hydrophilic molecules to produce a hydrophilic SLP fraction comprising only hydrophilic SLP molecules, wherein the hydrophobic SLP molecules are converted to hydrophilic SLP molecules by mixing the hydrophobic SLP molecules with a base [modifying the sophorolipid biosurfactant composition after the cultivation cycle is complete by mixing an alkaline/base substance as in current claim 4];
producing a purified hydrophobic SLP fraction; and
mixing the hydrophilic SLP fraction with the purified hydrophobic SLP fraction at a ratio of hydrophilic SLP molecules to purified hydrophobic SLP molecules between 60:40 to 75:25.
3. The method of claim 1, wherein the SLP-producing microorganism is Starmerella bombicola.
7. The method of claim 1, wherein the base facilitates alkali-mediated lactone bond breakage of lactonic SLP molecules and/or alkali-mediated deacetylation of lactonic and/or linear SLP molecules.
8. The method of claim 4, wherein the water solubility of the hydrophobic SLP fraction is increased by mixing the fraction with an organic amine selected from ethanolamine, triethanolamine, propylamine, and isopropylamine.
As annotated above, the patented claims appear to directly anticipate or suggest at least claims 1 and 4. Regarding claim 3, Asmer and Noureddini, as discussed above, teach that it is well established in the prior art to cultivate S. bombicola with an oil falling within the range of 25-75 mL/L to benefit the production of sophorolipids by S. bombicola such that an ordinarily skilled artisan at time of filing would have been motivated to modify embodiments of the patented claims to similarly cultivate in presence of an oil, which affects (i.e. tailors) the structure of the sophorolipids produced. Regarding claims 18 and 19, De Rose and Saika, as discussed above, teach that an ordinarily skilled artisan at time of filing would have been motivated to introduce sophorolipid compositions into a laundry detergent as recited in claim 19 and/or further include mannosylerythriol MEL-D as discussed above since De Rose and Saika teach incorporation of such compounds into a laundry detergent are beneficial.
Response to arguments
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S. bombicola is taught in the prior art to produce combination of lactonic and acid sophorolipids with HLB over 10. The claims do not require that the product be modified. Modifying the sophorolipid biosurfactant during the cultivation cycle requires only that S. bombicola be cultivated under some condition that produces sophorolipids that have a HLB value over 10. The HLB of a blend of sophorolipids is an average of the value of individual sophorolipid components. That is, a blend of a sophorolipid having an HLB of 11 and a sophorolipid having an HLB of 12 will be greater than 10. See Kunieda et al. (Evaluation of the Hydrophile-Lipophile Balance (HLB) of Nonionic Surfactants, J. Colloid Interface Sci. 107, 1985, 107-21), page 108, left col.:
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That is, the HLB of a mixture is at least approximated by a weight average of components.
It is noted that reference 38 of Koh (page 119, right col.) is Bisht as cited in the previous Office Action:
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35
370
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From Koh, page 109, right col.:
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63
381
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Conclusion
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/TODD M EPSTEIN/Primary Examiner, Art Unit 1652