DETAILED CORRESPONDENCE
Application Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s amendment to the claims filed on 02/23/2026 in response to the Non-Final Rejection mailed on 10/21/2025 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
3. Claim 3 is cancelled.
4. Claims 13, 15-16, 19-22, and 24-29 are pending.
5. Applicant’s remarks filed on 02/23/2026 in response to the Non-Final Rejection mailed on 10/21/2025 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Information Disclosure Statement
6. The IDS filed on 02/23/2026 has been considered by the examiner and a copy of the Form PTO/SB/08 is attached to the office action.
Claim Rejections - 35 USC § 103
7. The rejection of claim 23 under 35 U.S.C. 103 as being unpatentable over Hong et al. (US Patent Application Publication 2010/0317072 A1; cited on IDS filed on 12/05/2023) in view of Chi et al. (US Patent Application Publication 2009/0209014 A1; cited on IDS filed on 12/05/2023) and Sakaguchi et al. (US Patent Application Publication 2016/0289689 A1; cited on PTO-892 mailed on 11/01/2024) is withdrawn in view of applicants’ amendment to the claims to cancel claim 23.
8. The rejection of claims 13, 15-16, 19-22 and 24-29 under 35 U.S.C. 103 as being unpatentable over Hong et al. (US Patent Application Publication 2010/0317072 A1; cited on IDS filed on 12/05/2023) in view of Chi et al. (US Patent Application Publication 2009/0209014 A1; cited on IDS filed on 12/05/2023) and Sakaguchi et al. (US Patent Application Publication 2016/0289689 A1; cited on PTO-892 mailed on 11/01/2024) is maintained for the reasons of record and the reasons set forth below.
9. With respect to claim 13, Hong et al. teach a method for producing a microbial oil/lipid comprising preparing a microorganism having an ability to produce both eicosapentaenoic acid and docosahexaenoic acid; culturing the prepared microorganism in a medium containing glycerol under an aerated environment and obtaining a microbial oil/lipid from biomass, wherein the microbial oil/lipid comprises eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), a content of greater than 50% weight percent of eicosapentaenoic acid measured as a weight percent of total fatty acids and having at least one fatty acid ratio of eicosapentaenoic acid to content of docosahexaenoic acid of 1.7 or higher [see Abstract; paragraphs 0043-044; 0200-0204; 0222; Examples] (Hong et al. discloses strains having less than 0.5% docosahexaenoic acid [see paragraph 0204], which is interpreted as a ratio of 1.7 or higher).
With respect to claims 14-15 and 18, Hong et al. teach a method for producing a microbial oil/lipid comprising preparing a microorganism having an ability to produce both eicosapentaenoic acid and docosahexaenoic acid; culturing the prepared microorganism in a medium containing glycerol under an aerated environment and obtaining a microbial oil/lipid from biomass, wherein the microbial oil/lipid comprises eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), a content of greater than 50% weight percent of eicosapentaenoic acid measured as a weight percent of total fatty acids and having at least one fatty acid ratio of eicosapentaenoic acid to content of docosahexaenoic acid of 1.7 or higher [see Abstract; paragraphs 0043-044; 0200-0204; 0222; Examples] (Hong et al. discloses strains having less than 0.5% docosahexaenoic acid [see paragraph 0204], which is interpreted as a ratio of 1.7 or higher)
With respect to claim 16, Hong et al. teach the method wherein the culture is left at 30oC [see Examples].
With respect to claim 20, Hong et al. teach the method wherein the content of saturated fatty acids is less than about 8% [see paragraph 0204].
With respect to claim 23, Hong et al. teach the method wherein the microbial oil/lipid from strains of oleaginous yeast Yarrowia lipolytica comprising eicosapentaenoic acid and docosahexaenoic acid, a content of greater than 50% weight percent of eicosapentaenoic acid measured as a weight percent of total fatty acids and having eicosapentaenoic acid content greater than docosahexaenoic acid [see Abstract; paragraphs 0043-044; 0200-0204].
With respect to claim 24, Hong et al. teach the method wherein the microbial oil/lipid wherein the content of docosahexaenoic acid is 0.5% base on the total fatty acids [see paragraphs 0204].
With respect to claim 29, Hong et al. teach the method wherein the microbial oil/lipid is from a strain of Yarrowia lipolytica (interpreted as crude oil) [see Abstract; paragraphs 0043-044; 0200-0204].
With respect to claims 16, 19, 21-22, and 25-28, Hong et al. teach a microbial oil/lipid from strains of oleaginous yeast Yarrowia lipolytica comprising eicosapentaenoic acid and docosahexaenoic acid, a content of greater than 50% weight percent of eicosapentaenoic acid measured as a weight percent of total fatty acids and having at least one fatty acid ratio of eicosapentaenoic acid to content of docosahexaenoic acid of 1.7 or higher [see Abstract; paragraphs 0043-044; 0200-0204] (Hong et al. discloses strains having less than 0.5% docosahexaenoic acid [see paragraph 0204], which is interpreted as a ratio of 1.7 or higher). Hong et al. also teach wherein the microbial oil comprises additional fatty acids such as arachidonic acid, n-6 docosapentaenoic acid, n-3 docosapentaenoic acid, C18 carbon atoms, eicosatetraenoic acid and triglycerides [see Table 2; paragraphs 0080-0081, 0137-0138, 0175].
However, Hong et al. does not teach the method of claims 13, wherein the microorganism is a Thraustochytrid and the method claims 13 and 15, wherein the microorganism does not grow or can produce more DHA than EPA in a medium containing glucose.
Chi et al. teach methods of culturing microorganisms belonging to Stramenopiles cultured on crude glycerol from the production of omega-3 fatty acids wherein the Stramenopiles, such as Thraustochytrids, produce more DHA than EPA when in a medium containing glucose [see Abstract; paragraphs 0011, 0019-0022].
Sakaguchi et al. teach methods of culturing microorganisms belonging to Stramenopiles, such as Thraustochytrids, comprising the inhibition of expression of a gene encoding a C20 elongase that results in an increase in production of arachidonic acid and eicospentaenoic acid and reduction of DHA [see Abstract; paragraphs 0040-0050; Examples 5-9]. Sakaguchi et al. further teach that the cell culture conditions (including medium, culture temperature and aeration conditions) may be appropriately set according to factors as the type of cell and the type and amount of the unsaturated fatty acid to be produced [see paragraph 0221].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Hong et al., Chi et al., and Sakaguchi et al. in order to produce EPA in a Stramenopile organism because Hong et al. teach methods for production of EPA from microbial culturing using glycerol as a carbon source. Chi et al. teach that crude glycerol can be used a carbon source for culturing Stramenopiles for the production of omega-3 fatty acids. Sakaguchi et al. teach that omega-3 fatty acids of shorter chain lengths such as arachidonic acid and EPA can be produced in Stramenopiles by deletion of a C20 elongase. One of ordinary skill in the art desiring to produce EPA would have a reasonable expectation of success, a reasonable level of predictability, and would be motivated to combine the teachings of Hong et al., Chi et al., and Sakaguchi et al. because Chi et al. acknowledges that crude glycerol can be used a carbon source for culturing Stramenopiles for the production of omega-3 fatty acids and Sakaguchi et al. acknowledges that deletion of a C20 elongase in Stramenopiles results in increased omega-3 fatty acids of shorter chain lengths. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Although the combination of Hong et al., Chi et al., and Sakaguchi et al. does not specifically teach the method of claims 13 and 15, aerated environment of 30 mL/min or more and 1500 mL/min or less; the method of claim 16, culture environment equivalent to a water evaporation amount of 0.5 mL when the culture is left for 10 days; or the specific % of fatty acids of claims 19, 21-22, and 25-28, Hong et al. does teach that one of skill in the art of processing and formulation will be familiar with processes to maintain and grow cultures and concentrate the oils produced from the Yarrowia cells such that it comprises the desired amount of eicosapentaenoic acid and means to blend the oils with other fatty acids such as arachidonic acid, n-6 docosapentaenoic acid, n-3 docosapentaenoic acid, C18 carbon atoms, eicosatetraenoic acid and triglycerides are well known to one of skill in the art, and that these techniques readily permit the creation of an oil comprising uniquely tailored fatty acid profiles. Sakaguchi et al. further teach that the cell culture conditions (including medium, culture temperature and aeration conditions) may be appropriately set according to factors as the type of cell and the type and amount of the unsaturated fatty acid to be produced [see paragraph 0221]. To this end, MPEP 2144.05.II.A states “[g]enerally, 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the culture environment in order to maximize oil production and blend the oils using the teachings of Hong et al., Chi et al., and Sakaguchi et al. to meet any desired tailored fatty acid profile, and it would require only routine skill in the art to do so. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
RESPONSE TO REMARKS: Applicants' remarks filed on 10/10/2025 have been fully considered by the examiner; however, they are found to be not persuasive for the reasons of record and the reasons set forth below. Regarding applicants' remarks that the Office has not stated any rationale why a skilled artisan would have been directed to modify Hong's methods with a microorganism belonging to Stramenopiles such as Thraustochytrids, this argument is found to be not persuasive because both Chi et al. and Sakaguchi et al. acknowledge that Stramenopiles, such as Thraustochytrids, are great organisms for the production of polyunsaturated and unsaturated fatty acids. Sakaguchi et al. also teach the production arachidonic acid and eicospentaenoic acid and reduction of DHA in Stramenopiles [see rejection above].
Regarding applicants’ remarks that Sakaguchi does not teach or suggest achieving EPA dominance solely adjusting culture conditions and the routine optimization rationale does not provide a recognizable direction for optimization in the cited references, this argument is found to be not persuasive because it is noted that the features upon which applicant relies (i.e., solely adjusting culture conditions) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims are generic to the type of Thraustochytrid for preparing the EPA and is not exclusive of the genetically modified microorganisms taught by Sakaguchi et al. Furthermore, Sakaguchi et al. explicitly teach that factors or cell culture conditions (including medium, culture temperature, and aeration conditions) may be appropriately set according to such factors as the type of the cell and type and amount of unsaturated fatty acids to be produced [see paragraph 0221]. As such, Sakaguchi et al. establishes the direction for optimization of conditions for the microorganism growth depending on the desired fatty acid.
Regarding applicants arguments that there is no evidence that the combination of (glycerol + low aeration rate) would have necessarily altered the PUFA composition ratio, these arguments are found to be not persuasive for the reasons already of record regarding Sakaguchi et al. above.
Conclusion
10. Status of the claims:
Claims 13, 15-16, 19-22, and 24-29 are pending.
Claims 13, 15-16, 19-22, and 24-29 are rejected.
No claims are in condition for an allowance.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAUL J HOLLAND/Primary Examiner, Art Unit 1656