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 .
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed July 7, 2025 is acknowledged.
Applicant has overcome the following by virtue of amendment of the claims: (1) the objections to the claims have been withdrawn; (2) the 112(b) rejection of claim 34 has been withdrawn.
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
1, 9-11, 20, 23, 25, 28-29, 31, 36-38, 44-49, 54, 58, 61, 63, 65-71
Withdrawn claims:
None
Previously canceled claims:
2-8, 12-18, 21, 24, 27, 30, 32-33, 39-43, 50-53, 55-57, 59-60, 64
Newly canceled claims:
19, 22, 26, 34-35, 62
Amended claims:
1, 31, 38, 45, 54, 61
New claims:
66-71
Claims currently under consideration:
1, 9-11, 20, 23, 25, 28-29, 31, 36-38, 44-49, 54, 58, 61, 63, 65-71
Currently rejected claims:
1, 9-11, 20, 23, 25, 28-29, 31, 36-38, 44-49, 54, 58, 61, 63, 65-71
Allowed claims:
None
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 9-11, 20, 23, 25, 28-29, 31, 37, 38, 44-49, 54, 58, 61, 63, 65-71 are rejected under 35 U.S.C. 103 as being unpatentable over Franklin (US 2012/0119862) in view of Bailey (2010/0305341 A1)(IDS Reference filed 01/25/2024).
Claim 1 is a product-by-process claim. MPEP §2113 states “even 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.” “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product.”
Claim 1 is directed to a microbial oil composition produced by an oleaginous yeast. Although claim 1 includes the process of producing the microbial oil (oleaginous yeast), the determination of patentability will depend on the product itself. The structure imparted by the process of claim 1 is a microbial oil with the composition of an oil made by an oleaginous yeast.
Franklin teaches an oil produced from oleaginous yeast ([0293]). Franklin also teaches a saturated fatty acid composition of at least 10% (the sum of saturated fatty acids (X:0) (p. 45, Table 20, row 2) is 33.95%, which lies within the claimed range of “at least 10%”). Franklin also teaches an unsaturated fatty acid composition of at least 30% (the sum of unsaturated fatty acids (X:1 and X:2) (p. 45 Table 20, row 2) is 60.51%, which lies within the claimed range of “at least 30%”). Franklin also teaches the composition comprising less than about 30% total polyunsaturated fatty acids (the sum of polyunsaturated fatty acids (X:2 or more) (Table 20, p. 45) is 3.37%, which falls within the claimed range of “less than about 30%”).
Franklin does not teach the composition comprising a sterol that is not a phytosterol.
However, in the same field of endeavor, Bailey teaches a method of producing oil and sterols, including ergosterol, from oleaginous yeast having one or more sterologenic modifications ([0007], [0079], [0092], [0195]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have used the oleaginous yeast that has had one or more sterologenic modifications of Bailey as the yeast used to make the oil of Franklin. One of ordinary skill would be motivated to make this modification because, as taught by Bailey, oleaginous yeast with sterologenic modifications produce sterols, including ergosterol, that are known to provide nutritional benefits ([0089]).
Regarding claim 9, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches a composition comprising 27.44% C16:0 (saturated) fatty acid (p. 45, Table 20, row 2), where 27.44% falls within the claimed range of “10-45% C16 saturated fatty acid”.
Regarding claim 10, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches a composition comprising 59.44% C18:1 and 3.37% C18:2 (unsaturated) fatty acids (p. 45, Table 20, row 2), where the sum of 62.81% falls within the claimed range of “10-70% C18 unsaturated fatty acid”.
Regarding claim 11, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches a composition comprising 5.6% C18:0 (saturated) fatty acid (p. 45, Table 20, row 2), where 5.6% falls within the claimed range of “3-30% C18 saturated fatty acid”.
Regarding claim 20, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches a saturated fatty acid content of at most 70% (the sum of saturated fatty acids (X:0) (p. 45, Table 20, row 2) is 33.95%, which lies within the claimed range of “at most 70%”).
Regarding claim 23, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches an unsaturated fatty acid composition of at most 70% (the sum of unsaturated fatty acids (X:1 and X:2) (p. 45, Table 20, row 2) is 60.51%, which lies within the claimed range of “at most 70%”).
Regarding claim 25, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches a composition of about 5-60% mono-unsaturated fatty acids as a percentage of overall fatty acids of Rhodotorula glutinous (the sum of mono-unsaturated fatty acids (X:1) (p. 45, Table 20, row 3) is 45.10%, which falls within the claimed range of “about 5-60% mono-unsaturated fatty acids”).
Regarding claim 28, Franklin in view of Bailey teaches all of the elements of claim 1 as described above. Although Franklin does not explicitly teach the triglyceride content recited in claim 28, the microbial oil of Franklin is made by the same process as the microbial oil of claim 1, upon which claim 28 depends. Therefore, the microbial oil of Franklin would inherently have the triglyceride content recited in claim 28. Furthermore, the instant specification provides evidence that a microbial oil would comprise a triglyceride content of 90-98% as a percentage of over glycerides. [147] teaches that the microbial produced oil comprises a triglyceride content of 90-98%.
Regarding claim 29, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches where the microbial oil-based product is a dielectric fluid ([0015]), and where the dielectric fluid of the invention contains less than 0.25% campesterol, stigmasterol, or beta-sitosterol, which are all known phytosterols ([0020]). Because there is no lower limit to “less than 0.25%”, it logically follows that there is an embodiment of the invention where the microbial oil does not contain any of the phytosterols listed.
Regarding claim 31, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches where the microbial oil-based product is a dielectric fluid ([0015]), and where the dielectric fluid of the invention contains less than 0.25% campesterol, stigmasterol, or beta-sitosterol, which are all known phytosterols ([0020]). Because there is no lower limit to “less than 0.25%”, it logically follows that there is an embodiment of the invention where the microbial oil does not contain any of the phytosterols listed.
Regarding claim 37, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches where the microbial oil-based product is a dielectric fluid containing less than 0.02 mg of chlorophyll per kilogram of oil ([0015]). Because there is no lower limit to “less than 0.02mg of chlorophyll per kilogram of oil”, it logically follows that there is an embodiment of the invention where the microbial oil does not contain chlorophyll.
Regarding claim 38, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches wherein the microbial oil composition contains beta carotene ([0015]).
Regarding claim 44, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches the use of recombinant oleaginous microbes ([0205], where yeast is a well-known microbe in the art).
Regarding claim 45, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches that suitable genera of yeast include Yarrowia, Candida, Rhodotorula, Rhodosporidium, Cryptococcus, Trichosporon, or Lipomyces ([0174]).
Regarding claim 46, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches using Rhodosporidium yeast ([0174]).
Regarding claim 47, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches using Rhodosporidium toruloides ([0174]).
Regarding claim 48, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches the composition being fractionable ([0296]).
Regarding claim 49, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches the composition is fractional and the fractions comprising a stearin fraction and olein fraction ([0296]).
Regarding claim 54, Franklin in view of Bailey teaches all elements of claim 1 as described above. Although Franklin does not explicitly teach the triglyceride profile recited in claim 54, the microbial oil of Franklin is made by the same process as the microbial oil of claim 1, upon which claim 54 depends. Therefore, the microbial oil of Franklin would inherently have the triglyceride profile recited in claim 54. Furthermore, the instant specification provides evidence that the microbial produced palm oil would necessarily comprise less than 10% sat-sat-sat triglycerides, greater than 15% sat-sat-unsat triglycerides, and greater than 15% sat-unsat-unsat triglycerides. Table 7 and [193] teaches that microbial produced oil comprises approximately 1.2 % w/w palmitic-palmitic-palmitic triglycerides, approximately 22.53% w/w palmitic-palmitic-oleic triglycerides, and approximately 20.78% w/w palmitic-oleic-oleic triglycerides. The instant specification also provides evidence that palmitic acid is C16:0 (i.e., saturated) and oleic acid is C18:1 (i.e., unsaturated) ([127]).
Regarding claim 58, Franklin in view of Bailey teaches all elements of claim 1 as described above. Although Franklin does not explicitly teach the triglyceride profile recited in claim 58, the microbial oil of Franklin is made by the same process as the microbial oil of claim 1, upon which claim 58 depends. Therefore, the microbial oil of Franklin would inherently have the triglyceride profile recited in claim 58. Furthermore, the instant specification provides evidence that the microbial produced palm oil would necessarily comprise a stearic-stearic-oleic triglyceride content of less than 10% and a stearic-oleic-oleic triglyceride content of less than 10%. [193] teaches that the microbial produced oil comprises 1.53% w/w stearic-stearic-oleic triglycerides and 4.29% w/w stearic-oleic-oleic triglycerides.
Regarding claim 61, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches wherein greater than 40% of triglycerides in the composition have one unsaturated side chain (the sum of mono-unsaturated fatty acids (X:1) (Table 20, p. 45) is 60.14%, which falls within the claimed range of “more than 40%”).
Regarding claim 63, Franklin in view of Bailey teaches all elements of claim 1 as described above. Although Franklin does not explicitly teach the triglyceride content recited in claim 63, the microbial oil of Franklin is made by the same process as the microbial oil of claim 1, upon which claim 63 depends. Therefore, the microbial oil of Franklin would inherently have the triglyceride content recited in claim 63. Furthermore, the instant specification provides evidence that between 10% and 15% of palmitic and/or stearic fatty acids are located at the sn-2 position of triglyceride molecules. Table 8 teaches that the microbial oil comprised 12% palmitic acid at sn-2 position.
Regarding claim 65, Franklin teaches culturing oleaginous yeast in media containing a fixed carbon source that results in the accumulation of oil ([0177]).
Regarding claim 66, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches a saturated fatty acid content of 33.95% (the sum of saturated fatty acids (X:0) (p. 45, Table 20, row 2), which lies within the claimed range of “at least about 20 % w/w”.
Regarding claim 67, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches a C18:1 concentration of 44.68% (p. 45, Table 20, row 2), which falls within the claimed range of “40-50% w/w”.
Regarding claim 68, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin also teaches a composition comprising 5.6% C18:0 (saturated) fatty acid (p. 45, Table 20, row 2), where 5.6% falls within the claimed range of “5-15% C18 saturated fatty acid”.
Claim 69 is a product-by-process claim. MPEP §2113 states “even 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.” “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product.”
Claim 69 is directed to a refined, bleached, and/or deodorized microbial oil composition produced by an oleaginous yeast. Although claim 1 includes the process of producing the microbial oil (oleaginous yeast), the determination of patentability will depend on the product itself. The structure imparted by the process of claim 1 is a microbial oil with the composition of an oil made by an oleaginous yeast.
Franklin teaches a refined, bleached, and/or deodorized (RBD) oil produced from oleaginous yeast ([0293]).
Regarding claim 70, Franklin in view of Bailey teaches all elements of claim 1 as described above.
Franklin does not teach the composition comprising a sterol that is selected from ergosterol, 3,5- Cycloergosta-6,8(14),22-triene, anthraergostatetraenol p-chlorobenzoate, ergosta- 5,7,9(11),22-tetraen-3β-ol, ergosta-7,22-dien-3-ol, 1'-Methyl-l'H-5α-cholest-3-eno[3,4- b]indole, 5χ-ergost-7-en-3β-ol, anthraergostatetraenol hexahydrobenzoate, 4,4- dimethylcholesta-8,24-dien-3-ol, and 9,19-cyclolanost-24-en-3-ol.
However, in the same field of endeavor, Bailey teaches a method of producing oil and sterols, including ergosterol, from oleaginous yeast having one or more sterologenic modifications ([0007], [0079], [0092], [0195]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have used the oleaginous yeast that has had one or more sterologenic modifications of Bailey as the yeast used to make the oil of Franklin. One of ordinary skill would be motivated to make this modification because, as taught by Bailey, oleaginous yeast with sterologenic modifications produce sterols, including ergosterol, that are known to provide nutritional benefits ([0089]).
Regarding claim 71, Franklin in view of Bailey teaches all elements of claim 1 as described above.
Franklin does not teach wherein the composition comprises at least 50 ppm of the sterol that is not a phytosterol.
However, in the same field of endeavor, Bailey teaches a method of producing oil and sterols, including ergosterol, from oleaginous yeast having one or more sterologenic modifications ([0007], [0079], [0092], [0195] Bailey teaches a method of producing sterols from oleaginous yeast (Abstract), where sterols are added to a final product in an amount of 0.01% (equivalent to 100 ppm; [0238]), which falls within the claimed range of “at least 50 ppm”.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Franklin (US 2012/0119862) in view of Bailey (2010/0305341 A1)(IDS Reference filed 01/25/2024) as evidenced by Doing (“Bleaching process of palm oil”, Doing, published March 30, 2019 [accessed online December 13, 2024] from https://www.palmoilrefineryplant.com/FAQ/bleaching_process_of_palm_oil_79.html).
Regarding claim 36, Franklin in view of Bailey teaches all elements of claim 1 as described above. Franklin teach the microbial oil is bleached ([0293]), the reference does not specifically teach the oil is free of pigments.
As evidenced by Doing in the bleaching step of oil processing, pigments are removed (p. 2, line 6). Therefore, the bleached oil of Franklin would contain no pigment.
Response to Arguments
Claim Objections: Applicant has overcome the objections to the claims based on amendments in the Claims. Accordingly, the objections have been withdrawn.
Claim Rejections - 35 U.S.C. §112(b): Applicant has overcome the 35 U.S.C. § 112(b) rejections of claim 34 based on amendments to the claims and/or cancelation. Accordingly, the 35 U.S.C. § 112(b) rejections have been withdrawn.
Claim Rejections – 35 U.S.C. §102 of claim 1, 9-11, 19, 20, 22, 23, 25, 26, 28, 29, 31, 37, 38, 44-49, 54, 58, 61-63, and 65 over Franklin: Applicant' s arguments have been fully considered and are persuasive to the extent that the claims as presently amended would not be anticipated by Franklin or Franklin as evidenced by Doing. However, upon further consideration, new grounds of rejection are made over Franklin in view of Bailey.
Claim Rejections – 35 U.S.C. §103 of claims 34 and 35 over Franklin in view of Bailey: Applicant’s arguments filed 07/07/2025 have been fully considered but they are not persuasive.
Applicant argued that neither Franklin nor Bailey discloses a microbial oil having each of the claimed features and that a skilled person would not have been motivated to arrive at the oils in view of Franklin’s teachings of low pour point oils with very low saturated fatty acid content, nor would they have had a reasonable expectation of success. Applicant further argued that a person having ordinary skill would not have been motivated by the disclosure of Franklin to obtain a microbial oil having at least about 10% w/w saturated fatty acids and to combine with the modifications of Bailey (Remarks, p. 10, ¶ 4- p. 11, ¶ 4).
This argument has been considered. However, as stated above, Franklin teaches an oil produced from oleaginous yeast ([0293]). Franklin also teaches a saturated fatty acid composition of at least 10% (the sum of saturated fatty acids (X:0) (p. 45, Table 20, row 2) is 33.95%, which lies within the claimed range of “at least 10%”). Therefore, no modification is required to be made to the process of Franklin to obtain an oil comprising at least about 10% w/w saturated fatty acids. Regarding the modification of Franklin in view of Bailey, the Examiner maintains that one of ordinary skill would have found it obvious to use a strain of oleaginous yeast with modifications as taught by Bailey to obtain a microbial oil that contains ergosterol because ergosterol has known health benefits (see the above rejection of Claim 1).
Applicant further argued that Bailey’s modifications are carried out with oleaginous yeast. Meanwhile, Franklin teaches oil production with a microalgae, and that because of this a skilled person would not have a reasonable expectation of success (Remarks, p. 11, ¶ 5- p. 12, ¶ 1).
This argument has been considered. However, the portions of Franklin that are relied upon in the present rejection are directed to oleaginous yeast as the oleaginous microbe used ([0019]; p. 45, Table 2). Thus one of ordinary skill would have had reasonable expectation of success because the disclosure of Franklin and Bailey are both directed to an oil produced using oleaginous yeast.
Applicant also argued that the cells of Franklin’s work would be expected to have at least one or more of the sterols that are claimed to not be present in the composition (Remarks, p. 12, ¶ 2).
This argument has been considered. However, as stated in the above rejection of claims 29 and 31, the Examiner maintains that Franklin also teaches where the microbial oil-based product is a dielectric fluid ([0015]), and where the dielectric fluid of the invention contains less than 0.25% campesterol, stigmasterol, or beta-sitosterol, which are all known phytosterols ([0020]). Because there is no lower limit to “less than 0.25%”, it logically follows that there is an embodiment of the invention where the microbial oil does not contain any of the phytosterols listed.
Applicant further argued that the present application teaches microbial oils as palm oil substituted, having a more balanced saturated/unsaturated fatty acid profile and containing non-phytosterol sterols (Remarks, p. 12, ¶ 3- p. 13, ¶ 2).
This argument has been considered. Although the invention of Franklin is directed to a lower saturated fatty acid content, the disclosure of Franklin still teaches the saturated fatty acid content of claim 1 as described above. MPEP §2123(I) states “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments.” Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989) and “The court held that the prior art anticipated the claims even though it taught away from the claimed invention. ‘The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.’” Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998).
Furthermore, in response to applicant's argument that the present application teaches a microbial oil as a palm oil substitute, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Thus, the oil of Franklin in view of Bailey would also be useful as a palm oil substitute. Additionally, MPEP §2111.02(II) states if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020).
The rejections of claims 1, 9-11, 20, 23, 25, 28-29, 31, 36-38, 44-49, 54, 58, 61, 63, and 65 have been maintained herein.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.S.H./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793