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 .
Claim Objections
Claim 8 is objected to because of the following informalities:
Claim 8 states: The method for synthesizing DAG according to claim 1, wherein the hydrolyzate is an oil phase obtained by layering a reaction system after the hydrolysis reaction is completed.
The underlined “a reaction system” can only reasonably mean the “a hydrolysis reaction” as recited in claim 1. As such, the claim should be so clarified that the reaction system undergoing layer is “the hydrolysis reaction.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 2, 3, and 7, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In claims 2, 3 and 7, it is not clear if the claim features following “preferably” are required features of the claim such than an ordinarily skilled artisan cannot determine how to avoid infringement.
Claim 1 recites a lipase being “MAS1-H108A.” The specification describes that MAS1 is a TAG lipase from Streptomycetes sp. W007, which is considered to be sufficient to identify the lipase genus under discussion. However, there is no universally recognized number scheme for lipases from Streptomycetes sp. W007. The meaning of “H108A” is not defined in the specification but is nevertheless understood as nomenclature indicating a point substitution of an amino acid. However, in the absence of any universally recognized number scheme for lipases from Streptomycetes sp. W007 or a reference sequence defining the meaning of position “H108,” an ordinarily skilled artisan is unable to determine if any particular lipase from Streptomycetes sp. W007 has or does not have a H108A substitution such that an ordinarily skilled artisan cannot determine how to avoid infringement.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 recites a product by process and does not require the performance of any of the method steps of claim 1 from which claim 10 depends. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." MPEP 2113(I). As such, claim 10 encompassed DAG prepared by any method including DAG that is found naturally in oils such that claim 10 can be infringed without infringing claim 1. As such, claim 10 fails to include all the limitations of claim 1 from which claim 10 depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sasue et al. (Synthesis of palm oil high in diacylglycerol through direct esterification, Malaysian J. Analytical Sci. 19, 2015, 222-29).
The rejection under 35 U.S.C. 112(d) set forth above is incorporated herein by reference.
“Palm oil is produced from a part of palm fruit (Elaeis guineensis) known as mesocarp. The hybrid of Dura and Pisifera known as Tenera is the type of palm fruit cultivated abundantly in Malaysia. Palm oil can be classified either as saturated or unsaturated fat due to the equal amount of saturated and unsaturated fat found in the oil. Saturated fatty acid in the palm oil consist of 44% palmitic acid, and 5% oleic acid. While unsaturated fatty acid are in the form of 39% oleic acid (mono-unsaturated fatty acid) and 10% linoleic acid (polyunsaturated fatty acid). Triacylglycerol (TAG) is the main component in the palm oil followed by diacylglycerol (DAG) around 6-8% and monoacylglycerol (MAG) with quantity less than 1%.”
DAG as encompassed by claim 10 has the same structure regardless of how it is produced. As such DAG as found in palm oil meets the features of claim 10.
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.
Claim(s) 1-3, 5-8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sasue et al. (Synthesis of palm oil high in diacylglycerol through direct esterification, Malaysian J. Analytical Sci. 19, 2015, 222-29) further in view of CN 103952385 A (published 2014) (CN’385) (see IDS). A machine translation of CN’385 is provided and cited herein.
Sasue, abstract, teaches:
Palm oil (PO) mainly constitutes of 90-98% of triacylglycerol, 2-6% of diacylglycerol (DAG) and 2-5% of monoacylglycerol. This study was carried out to produce PO that is high in DAG through direct esterification using 1, 3 positional specific lipase from Rhizomucor miehei (RM IM) and Thermomyces lanuginose (TL IM) as catalysts. Palm olein oil has been hydrolysed by water and 4% enzyme in a controlled water bath at 300 rpm for 48 hours at a temperature of 60±2[Symbol font/0xB0]C while the esterification process was carried out in a same condition except it was run for 24 hours only. Samples DAG A1 and DAG B1 were synthesized products of the first replication using 10% enzyme TL IM and 10% enzyme RM IM respectively while samples DAG A2 and DAG B2 were synthesized products of second replication. DAG spots found on the thin layer chromatography (TLC) plates of samples DAG A1, A2, B1 and B2 bigger than the spot of the control sample. Based on high performance liquid chromatography chromatogram peak area, the total DAG accumulation showed significant differences (p< 0.05) between the usage of enzymes TL IM and RM IM which were 34.28% and 45.67% respectively. The esterification method has clearly increased the DAG content of the control sample which was only 3.17%. Significant differences (p< 0.05) also existed in the iodine value (IV), melting and crystallization temperature of all the samples. IV of control sample, DAG A and B were respectively 56.00, 35.00 and 30.50. Differential scanning calorimetry curves showed the melting and crystallization temperature were respectively-3.73oC and-5.72[Symbol font/0xB0]C for samples using TL IM while-4.92 and-6.56 respectively for RM IM. The results concluded that the usage of enzyme RM IM is more effective in the production of PO high in DAG and efficiency of direct esterification process has been proved.
From pages 223-24 of Sasue:
Palm olein cooking oil (Seri Murni) purchased from the market has been used for this study. The two catalysts that were used for this study 1,3 positional specific lipase from Rhizomucor miehei (RM IM) and Thermomyces lanuginose (TL IM) were supplied by Novozymes Malaysia Sdn Bhd. All other solvents and reagents were analytical or chromatographic grades.
A total of 150 g of palm oil was transferred into a 250 ml conical cone and followed by the addition of 60% water and 4% enzyme TL (based on the quantity of oil). The mixture has been placed on a vortex for uniform distribution of the enzyme. The mixed sample, then was transferred into the test tubes and was left it in the water bath with temperature 60±2ºC for 48 hours at the speed of 300 rpm. The samples were strained out to separate the enzyme and the glycerol. The resultant from this process was known as hydrolysate. Finally glycerol was added to the hydrolysate. The steps were repeated with enzyme RM.
Direct esterification was a solvent free process. In this study, 2 replicates of direct esterification of hydrolysate with glycerol were conducted. The results obtained through this process were labelled as DAG A1 and DAG A2 respectively. A total of 100 ml of hydrolysate compose of 1.33 mol free fatty acid and 0.22 mol glycerol in the stoichiometric ratio 2:1 (free fatty acid : glycerol) were added in 250 ml conical cone followed by the addition of 10% enzyme Thermomyces lanuginosa (weight/ substrate weight). The mixture was placed in the water bath with temperature of 60±2ºC at the speed of 300 rpm. After 24 hours, palm oil that is high in DAG content was obtained. The steps were repeated with enzyme Rhizomucor miehei that were labelled as DAG B1 and DAG B2. Finally, Thin Layer Chromatography (TLC) and High Performance Liquid Chromatography (HPLC) analysis were conducted on this oil to determine the extraction efficiency of the two lipases.
From pages 224-25 of Sasue:
Enzymatic hydrolysis was the main step involve in the production of palm oil high in DAG whereby it break down the complete triglyceride structure into FFA and glycerol. In this study, the efficiency of breaking the triglyceride bond was observed by the usage of 1,3 positional specific lipase from Rhizomucor miehei (RM IM) and Thermomyces lanuginose (TL IM). Figure 1 obviously showed that enzyme TLIM produce more FFA which was about 35%/24 hours compare to less than 5%/24 hours by enzyme RMIM.”
Due to TL IM producing more free fatty acid, Sasue teaches the method in Schemes 1 and 2 of Sasue wherein TAG (triacylglycerol) is hydrolyzed with the TL IM enzyme and then direct esterification of the produced hydrolysate with either TL IM or RM IM to produce a DAG-enriched oil. The esterification performed with RM IM is the DAG B1 and DAG B2 enriched palm oil having the composition shown in Table 1 of Sasue with 45.67% DAG. The 1,3 positional specific lipase from Rhizomucor miehei (RM IM) is understood to be a “partial glyceride lipase,” i.e. a lipase that does not have specification for all three acyl positions of a TAG.
The above is a description of the following method:
A method for synthesizing diacylglycerol (DAG), comprising the following steps: step (1), mixing an oil, a lipase and a solvent (60% water), and performing a hydrolysis reaction at a temperature of 60±2ºC to obtain a hydrolyzate; and step (2), under the action of a partial glyceride lipase, performing an esterification reaction on the hydrolyzate obtained in step (1) with glycerol.
However, Sasue does not teach that a lipase used for enzymatic hydrolysis is lipase MAS1 as recited.
CN’385, abstract, states:
The invention claims a thermally stable lipase derived from a marine actinomycete and application thereof, wherein the amino acid sequence is shown as SEQ ID NO: 2, the thermally stable lipase gene sequence shown as SEQ ID NO: 1. The invention obtains neutral lipase, has optimal enzyme activity at pH7.0, the olive oil in the hydrolysis reaction, the optimum temperature is 70 ℃, the soybean lecithin is the hydrolysis of substrate, the preferable reaction temperature is 40 ℃. and also has excellent thermal stability of the lipase, 60 ℃ processing for half an hour with 95% of enzyme activity remaining. with strong tolerance to organic solvent. The lipases of the invention can be applied in high temperature catalytic vegetable oil to ester hydrolysis and generating diacylglycerol. using the method to obtain the recombinant lipase, has high catalytic activity and thermal stability.
The lipase described by CN’385 is identified as MAS1. CN’385, para. [0031].
Substitution of known elements is obvious upon a finding of:
(1) a finding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components;
(2) a finding that the substituted components and their functions were known in the art;
(3) a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable; and
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness. (MPEP 2143(I)(B)).
Here, CN’385 teaches a lipase for hydrolysis of vegetable oils specifically for the purpose of producing DAG. That is, the function of MAS1 lipase is known in the prior art. One having ordinarily skill in the art at time of filing could have substituted TL IM lipase as used for oil hydrolysis in the methods of Sasue with predictable results. In particular, as shown in Fig. 13A of CN’385 shows that the MAS1 lipase has activity to convert a starting oil with TAG to several products including 1,3- and 1,2-DAG wherein FFA is the largest product produced (in addition to unhydrolyzed TAG). CN’385, para. [0097]. Although MAS1 is taught by Sasue to directly produce DAG as a hydrolysis product, as shown in Fig. 13 FFA is the largest product produced. As such, wherein MAS1 is substituted for TL IM within the methods of Sasue, an ordinarily skilled artisan at the time of filing would have been further motivated to perform the esterification reaction with RM IL as discussed above in order to achieve the benefit of converting FFA to DAG as shown in Scheme 2 of Sasue. As such, one of ordinary skill in the art could have substituted MAS1 lipase within the hydrolysis of reaction of Sasue and the results of the substitution would have been predictable being production of an oil with enriched DAG content. No additional findings based on the Graham factual inquiries is apparent in order to explain a conclusion of obviousness. As such, based upon the guidance MPEP 2143(I)(B) an ordinarily skilled artisan at time of filing would have been motivated to substitution MAS1 lipase as taught by CN’385 in replacement of TL IM within the methods of Sasue in view of the guidance of MPEP 2143(I)(B) to meet the features of at least claims 1, 5 and 10.
Regarding claim 6, CN’385, para. [0058], reports “temperature influence of lipase enzyme activity to MAS1 at different temperature (20 degrees centigrade to -75 degrees centigrade). . . . result shows that the optimum reaction temperature of MAS1 is 40 degrees centigrade, at 60 degrees centigrade reaches 90% relative enzyme activity.” When employing MAS1 in any hydrolysis reaction of an oil, an ordinarily skilled artisan at time of filing would have been motivated to employ temperatures taught by CN’385 to be appropriate for such enzyme including 40[Symbol font/0xB0]C.
Regarding claim 7, Sause as discussed teaches “150 g of palm oil was transferred into a 250 ml conical cone and followed by the addition of 60% water and 4% enzyme TL (based on the quantity of oil).” This is understood as 150 g oil, 90 g water and 6 g enzyme in a hydrolysis reaction mixture, which is a ration of oil to water solvent of 1:0.6 falling within the first range of oil to solvent mass ratio recited in claim 7. When employing the MAS1 lipase as discussed above, an ordinarily skilled artisan at time of filing would have nevertheless been motivated to employ the same amounts of oil and water as otherwise taught by Sause.
Regarding claims 2 and 3, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." MPEP 2144.05(II)(A).
Sasue Fig. 1 shows hydrolysis of oil with TL IM producing over 40% FFA. CN’385, Fig. 3A, shows over 20% FFA produced by MAS1 by hydrolysis of oil. An ordinarily skilled artisan at time of filing would have readily understood that the extent of hydrolysis of TAG in an oil to products, wherein FFA is the dominant product as shown in Fig. 13A of CN’385, can be increased by increasing an amount of lipase enzyme applied in the hydrolysis reaction. As such, wherein the general conditions of a MAS1 lipase hydrolyzing an oil to FFA is disclosed in the prior art, it is not inventive to discover workable conditions including an amount of MAS1 lipase to result in FFA production of greater than 45 wt% as recited in claim 2 nor for residual TAG to be less than 22 wt% as recited in claim 3. It is noted that Table 1 of Sasue shows that DAB B enriched oil has 15.25% TAG. Since TAG concentration is not reduced by an esterification reaction, the same implies or suggests that TAG is less than 22 wt% after performance of hydrolysis prior to esterification.
Regarding claim 8, “Direct esterification was a solvent free process. In this study, 2 replicates of direct esterification of hydrolysate with glycerol were conducted. The results obtained through this process were labelled as DAG A1 and DAG A2 respectively. A total of 100 ml of hydrolysate compose of 1.33 mol free fatty acid and 0.22 mol glycerol in the stoichiometric ratio 2:1 (free fatty acid : glycerol) were added in 250 ml conical cone followed by the addition of 10% enzyme Thermomyces Lanuginosa (weight/ substrate weight).” Sasue, page 224. As discussed, Sasue teaches the addition of water/solvent for the preceding hydrolysis reaction. Sasue does not appear to directly describe how water is removed to generate solvent-free “100 ml of hydrolysate.” However, as explained by CN’385, hydrolysis of a TAG-containing oil with a lipase produces an oil layer and a water layer. “[C]entrifuging for 5 min at 10 rpm, removing the water phase on the lower layer, the upper layer of organic phase by 0.45 microns of organic phase filter film, taking 10 mu L for HPLC analysis.” CN’385, para. [0096]. That is, CN’385 teach that the hydrolysis products of an oil hydrolyzed with a lipase can be recovered by centrifuging the reaction to generate a lower water layer and removing an upper layer containing the hydrolysis products including FFA. Again, Sasue teach performing an esterification reaction as a “solvent free process” with “100 mL hydrolysate.” In view of CN’385, an ordinarily skilled artisan at time of filing would have readily understood that it is advantageous to remove any water by centrifugation to separate a water layer that is then removed and taken all or a portion of the upper layer containing (oil layer) FFA and other lipid products for the esterification reaction as a “hydrolysate,” since 1) Sasue teaches that esterification is a “solvent free process” and CN’385 demonstrates how solvent (i.e. water) can be removed from a hydrolysis reaction of an oil with a lipase. Doing the same is understood to fall within the broadest reasonable interpretation of “the hydrolysate is an oil obtained by layering a reaction system (i.e. separating the hydrolysis reaction after completion into a water phase and an oil phase by centrifugation or otherwise) after the hydrolysis reaction is complete.”
Claim(s) 1-3 and 5-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sasue et al. (Synthesis of palm oil high in diacylglycerol through direct esterification, Malaysian J. Analytical Sci. 19, 2015, 222-29) and CN 103952385 A (published 2014) (CN’385) as applied to claims 1-3, 5-8 and 10 above, and further in view of CN 102965404 A (CN’404). Machine translations of CN’385 and CN’404 are provided and cited herein.
Regarding claim 9, CN’404, abstract, teaches:
The invention discloses a method for preparing high-purity diglycerides, which comprises the following steps: 1) using partial glyceride lipase to catalyze the reaction of fatty acid donors and glycerol to synthesize a mixture containing diglycerides and monoglycerides, and subjecting the mixture to Centrifuge and recover the upper oil phase; 2) use monoglyceride lipase to catalyze the monoglycerides in the oil phase obtained in step 1) to react with hydroxyl donors to convert them into non-glycerides; 3) convert the mixture obtained in step 2) The non-glyceride components are separated from diglyceride to obtain high-purity diglyceride. In the present invention, the monoglyceride in the mixture is selectively removed by an enzymatic method, which simplifies the separation process, reduces the energy consumption of the separation process, and well solves the problem of MAG separation in the mixture. The content of diglyceride in the product prepared at the same time is as high as more than 98%.
Technical scheme of the present invention is as follows:
A preparation method of high-purity diglycerides, comprising the following steps:
1) Using partial glyceride lipase to catalyze the reaction of fatty acid donors and glycerol to synthesize a mixture containing diglyceride and monoglyceride, the above mixture is centrifuged, and the upper oil phase is recovered;
2) Using monoglyceride lipase to catalyze the monoglyceride in the oil phase obtained in step 1) to react with a hydroxyl donor to convert it into a non-glyceride;
3) Separating non-glyceride components in the mixture obtained in step 2) from diglyceride to obtain high-purity diglyceride. After the above reaction, the reaction product includes diglyceride, fatty acid or low-carbon alkyl ester of fatty acid. For this product system, molecular distillation or short-path distillation is generally used to separate the above components according to the boiling point of the material. Separation to obtain a high-temperature fraction with diglyceride as the main component, which is the target product.
After production of a DAG enriched oil, Sasue does not teach any additional purification to separate components such oil to have increased DAG. However, CN’404 teaches that it is desirable to obtain high purity DAG that can be obtained by performance of molecular distillation. As such, at the time of filing an ordinarily skilled artisan would have been motivated to perform molecular distillation upon any oil having a significant DAG content including any oil produced in accordance with the teachings of Sasue in order to achieve the benefit of high purity DAG as taught by CN’404.
Claim(s) 1-8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sasue et al. (Synthesis of palm oil high in diacylglycerol through direct esterification, Malaysian J. Analytical Sci. 19, 2015, 222-29) further in view of CN 103952385 A (published 2014) (CN’385) as applied to claims 1-3, 5-8 and 10 above, and further in view of CN 110951796 A (published 04/03/2020) (CN’796) and CN 102965404 A (CN’404). Machine translations of CN’796 and CN’404 are provided and cited herein.
Regarding claim 4, CN’796, abstract, teaches:
The invention discloses a method for converting fatty acid ethyl ester into diglyceride, which comprises the following steps: (1) mixing fatty acid ethyl ester with glycerol, and carrying out glycerolysis reaction by using lipase as a catalyst and vacuumizing; (2) and (2) centrifuging the reaction product obtained in the step (1), and performing molecular distillation to obtain the purified diglyceride. The invention uses lipase as a catalyst to generate diglyceride under vacuum state, has mild and simple reaction conditions, and solves the problems that the prior oil purification process has high fatty acid content and cannot completely remove the diglyceride. Has high application value for producing pure diglyceride oil products.
In order to achieve the above purpose, the steps of the invention are as follows:
a process for the conversion of fatty acid ethyl esters to diglycerides, comprising the steps of:
(1) mixing fatty acid ethyl ester with glycerol, and carrying out glycerolysis reaction by using lipase as a catalyst and vacuumizing; the Lipase is one or the mixture of more than two of Lipase MGMDL2, Lipase SMG1, Lipase AOL, Lipase PCL, monoglyceride Lipase GMGL and monoglyceride Lipase MGLP;
(2) and (2) centrifuging the reaction product obtained in the step (1), and performing molecular distillation to obtain the purified diglyceride. CN’796, page 2.
CN’796 teach the production of DAG from reactants being glycerol and a fatty acid ethyl ether. However, the taught lipases are of a nature known to further produce DAG from a combination of glycerol and a free fatty acid (FFA). For example, CN’404, abstract, teaches:
The invention discloses a method for preparing high-purity diglycerides, which comprises the following steps: 1) using partial glyceride lipase to catalyze the reaction of fatty acid donors and glycerol to synthesize a mixture containing diglycerides and monoglycerides, and subjecting the mixture to Centrifuge and recover the upper oil phase.
“Preferably, the partial glyceride lipase described in step 1) is one or both of Lipase SMG1 and LipaseG50.” “Preferably, the fatty acid donor described in step 1) is fatty acid, lower-carbon alkyl ester of fatty acid, or one or a mixture of two or more of the raw materials containing fatty acid and lower-carbon alkyl ester of fatty acid.” CN’404, page 2.
As such, an ordinarily skilled artisan at time of filing would understand that the described lipases, including but not limited to SMG1, are capable of producing DAG from glycerol and either of fatty acid or an ester thereof such as an ethyl ester.
Substitution of known elements is obvious upon a finding of:
(1) a finding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components;
(2) a finding that the substituted components and their functions were known in the art;
(3) a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable; and
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness. (MPEP 2143(I)(B)).
As discussed above, Sasue teaches the use of RM IM lipase for performance of an esterification reaction to produce DAG and otherwise teaches the features of the claims except for the identity of specific lipases. However, the prior art teaches that other known lipases are taught in the prior art to produce DAG by esterification of TAG and specifically including combinations of two or more of Lipase SMG1, Lipase AOL, Lipase PCL as taught by CN’796. CN’404 sets an expectation that lipases in general can utilize either free fatty acid (FFA) or an ester thereof (e.g. ethyl ester) for catalyzing an esterification reaction of glycerol. As such, an ordinarily skilled artisan at time of filing could have substituted the RM IM lipase taught by Sasue with a combination of two or more Lipase SMG1, Lipase AOL, Lipase PCL within the methods of Sasue with an expectation of producing a DAG-enriched oil. No other findings are deemed to be particularly necessary to explain a conclusion of obviousness. As such, in view of the guidance of MPEP 2143(I)(B) an ordinarily skilled artisan at time of filing would have been motivated to substitute a combination of two or more Lipase SMG1, Lipase AOL, Lipase PCL within the methods of Sasue in replacement of the RM IM lipase.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon without significantly more. The claim(s) recite(s) a diacylglycerol that is a product of nature. This judicial exception is not integrated into a practical application because the claims recite no features that can be considered to be a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite additional elements.
“If the claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim recites a "product of nature" exception, and requires further analysis in Step 2A Prong Two to determine whether the claim as a whole integrates the exception into a practical application.” MPEP 2106.04(c). “It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart.” MPEP 2106.04(b)(II).
“The markedly different characteristics analysis is part of Step 2A Prong One, because the courts use this analysis to identify product of nature exceptions.” MPEP 2106.04(c). “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception.” MPEP 2106.04(c)(II).
Examiners should keep in mind that if the nature-based product limitation is naturally occurring, there is no need to perform the markedly different characteristics analysis because the limitation is by definition directed to a naturally occurring product and thus falls under the product of nature exception.” MPEP 2106.04(c)(I).
Here, claim 10 is directed towards a composition of matter such that step 1 is yes. The rejections under 35 U.S.C. 112(d) and 102(a)(1) above are incorporated herein by reference. As set forth above, diacylglycerol that meets the limitations of claim 10 is a natural-product found in palm oil. Claim 10 does not require DAG to be purified nor isolated such that naturally-occurring palm oil meets the limitations of claim 10. Since the natural product (e.g. DAG) recited in the claim is naturally-occurring, for step 2A, prong 1, “there is no need to perform the markedly different characteristics analysis because the limitation is by definition directed to a naturally occurring product and thus falls under the product of nature exception.”
Regarding, step 2A, prong 2, “Prong Two asks does the claim recite additional elements that integrate the judicial exception into a practical application? In Prong Two, examiners evaluate whether the claim as a whole integrates the exception into a practical application of that exception.” MPEP 2106(II)(A)(2). Regarding Step 2B for the claims, “Step 2B asks: Does the claim recite additional elements that amount to significantly more than the judicial exception”? MPEP 2106.05(II).
For step 2A, prong 2, and step 2B, claim 10 does not recite any additional features other than DAG. As such, the claim does not recite any features that integrates the product of nature (DAG) into a practical application nor recites additional elements that amount to significantly more than the judicial exception.
For these reasons, claim 10 is directed towards ineligible subject matter.
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 and 5-10 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-10 and 12 of copending Application No. 17/639,703 in view of Sasue et al. (Synthesis of palm oil high in diacylglycerol through direct esterification, Malaysian J. Analytical Sci. 19, 2015, 222-29), CN 103952385 A (published 2014) (CN’385), and CN 102965404 A (CN’404).
The rejections under 35 U.S.C. 103 above over Sasue and CN’385 and Sasue, CN’385 and CN’404 are incorporated herein by reference.
Copending claim 1 states:
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Copending claim 1 meets the features of claim 1, step (2), wherein a partial glyceride lipase performs an esterification reaction to produce DAG from glycerol and a fatty acid except for setting forth that such fatty acid is from a hydrolysis reaction as recited in step (1) of claim 1. Copending claim 6 sets forth that the recited fatty acid donor can be a fatty acid.
However, as discussed above, Sasue teaches a method for synthesizing diacylglycerol (DAG), comprising the following steps: step (1), mixing an oil, a lipase and a solvent (60% water), and performing a hydrolysis reaction at a temperature of 60±2ºC to obtain a hydrolyzate; and step (2), under the action of a partial glyceride lipase, performing an esterification reaction on the hydrolyzate obtained in step (1) with glycerol. That is, Sasue teach that the fatty acid for performing an esterification reaction with a partial lipase to produce DAG as recited in the copending claims can be advantageously obtained for hydrolyzing an oil as recited in step (1) of claim 1: mixing an oil, a lipase and a solvent/water to produce a hydrolysate with fatty acids. As such, at the time of filing an ordinarily skilled artisan would have been motivated to modify embodiments of the copending claims such that a fatty acid donor is provided as taught to be advantageous by Sasue by mixing an oil, a lipase and a solvent/water to produce a hydrolysate with fatty acids, wherein the hydrolysate containing fatty acids is combined with glycerol and a partial glyceride lipase to produce DAG as recited in the copending claims. CN’385 teaches why and ordinarily skilled artisan at the time of filing would have been motivated to apply MAS1 as a lipase in such a hydrolysis reaction. The combined teaches of Sasue, CN’385 and CN’404 teach the remaining features of claims 1-3 and 5-10 are advantageous and therefore suggested to be performed by an ordinarily skilled artisan at time of filing for the same reasons as set forth above.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/TODD M EPSTEIN/Primary Examiner, Art Unit 1652
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