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 .
This office action is in regard to the application filed on May 26, 2022 and in response to a Request for Continued Examination filed on August 18, 2025.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 18, 2025 has been entered.
Status of Application
The amendment filed July 17, 2025 has previously been entered. Claims 11 and 12 are not included in the claim listing and are thereby considered to be canceled. As per MPEP 714.II.C., each amended claim document that includes a change to an existing claim must include a complete listing of all claims ever presented, followed by a status identifier (e.g., “canceled”).
Claims 1, 2, and 6-10 are currently pending in the application; claims 3-5, 11, and 12 are canceled. Claims 1, 6, and 7 have been amended. Claims 1, 2, and 6-10 are hereby examined on the merits.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 2, and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Bijl et al. (WO 97/37032), herein after referred to as Bijl.
Regarding claims 1, 2, and 5, Bijl teaches a microbial polyunsaturated fatty acid-containing oil (i.e., a microorganism oil composition enriched with polyunsaturated fatty acids) (Abstract), wherein the oil composition comprises:
no saturated fatty acid content,
a docosahexaenoic acid (DHA) (i.e., an omega-3 polyunsaturated fatty acid) content of 32.6% (equivalent to 326 mg/g of composition),
and in that it comprises, with respect to the total quantity of monoglycerides, diglycerides, triglycerides, and fatty acid ethyl esters:
a quantity of triglycerides of 67%, and
a quantity of diglycerides of 12% (Example 19, p. 42).
Bijl also teaches that the quantity of monoglycerides can be 2% (Example 16, Table 3, pp. 39-40).
Bijl teaches an amount of omega-3 polyunsaturated fatty acid that is less than the claimed amount of 600 mg/g (Example 19, p. 42). However, differences in the concentration will not generally support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. Where 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).
Concentration of a component in a composition is a known variable that affects various properties of a resulting product, and therefore, concentration is a result effective variable. As such, one of ordinary skill in the art would have a reasonable expectation of success to formulate the claimed range through routine optimization. It is well known within the art that a change in concentration of a polyunsaturated fatty acid, particularly in an oil composition, will affect the overall profile and properties of the final product, in this case a microorganism oil composition. It would have been obvious to one of ordinary skill in the art to have adjusted the concentration levels through routine optimization until the desired end product was achieved.
The amounts of triglycerides and diglycerides that Bijl teaches (Example 19, p. 42), with respect to the total quantity of monoglycerides, diglycerides, triglycerides, and fatty acid esters, are outside of the claimed ranges of 55-65% for triglycerides and 25-35% for diglycerides.
However, differences in the concentration will not generally support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. Where 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).
Concentration of a component in a composition is a known variable that affects various properties of a resulting product, and therefore, concentration is a result effective variable. As such, one of ordinary skill in the art would have a reasonable expectation of success to formulate the claimed range through routine optimization. It is well known within the art that a change in concentration of one or multiple glycerides, particularly in an oil composition, will affect the overall profile and properties of the final product, in this case a microorganism oil composition. It would have been obvious to one of ordinary skill in the art to have adjusted the concentration levels through routine optimization until the desired end product was achieved.
Additionally, Bijl teaches that the oil composition, with respect to the total amount of triglycerides, diglycerides, and monoglycerides, comprises the most amount of triglycerides (p. 4 lines 24-25), a smaller amount of diglycerides, and the least amount of monoglycerides (p. 5 lines 14-16), which corresponds to the amounts in the instant claims wherein there is the most triglycerides, a smaller amount of diglycerides, and the least amount of monoglycerides.
Regarding claim 6, Bijl teaches that the omega-3 polyunsaturated fatty acid is docosahexaenoic acid (DHA) (Example 19, p. 42).
Regarding claim 7, Bijl teaches that DHA and eicosapentaenoic acid (EPA) are suitable alternative omega-3 polyunsaturated fatty acids for use in the invention (p. 4, lines 9-10). Thus, it would have been obvious to one of ordinary skill in the art to select and use EPA in place of DHA in the composition of Bijl, as both of DHA and EPA are taught as interchangeable.
Regarding claim 8, Bijl teaches that the microbial oil (i.e., microorganism oil) composition can comprise of more than one polyunsaturated fatty acids (p. 5 lines 27-29), and that one polyunsaturated fatty acid is a C20 omega-3 polyunsaturated fatty acid (p. 4 lines 5-7), which is omega-3 eicosatetraenoic acid.
Bijl also teaches 32.6% (equivalent to 326 mg/g of composition) of DHA in the oil composition (Example 19, p. 42), which meets the claim limitation of at least 4 mg/g/ of composition. Since Bijl teaches that DHA and omega-3 eicosatetraenoic acid are suitable alternative omega-3 polyunsaturated fatty acids for use in the invention (p. 4, lines 9-10), it would have been obvious to one of ordinary skill in the art to select and use omega-3 eicosatetraenoic acid in place of DHA in the composition of Bijl, as both of DHA and omega-3 eicosatetraenoic acid are taught as interchangeable. Therefore, Bijl is considered to teach the instant claim limitations.
Regarding claim 9, Bijl teaches that the microbial oil composition can comprise of more than one polyunsaturated fatty acids (p. 5 lines 27-29), and that one polyunsaturated fatty acid is a C22 omega-6 polyunsaturated fatty acid (p. 4 lines 5-7), which is omega-6 docosapentaenoic acid. Bijl also teaches a microbial oil composition that does not contain any omega-6 docosapentaenoic acid (Example 19, p. 42), thereby reading on the claimed limitation of a content less than or equal to 140 mg/g of composition.
Regarding claim 10, Bijl teaches that the microbial oil composition is a food composition or nutritional supplement (p. 4 lines 13-15).
Response to Arguments
Applicant's arguments filed July 17, 2025 have been fully considered but they are not persuasive.
Applicant argues that the oil of Bijl is a natural oil obtained from a microalgal biomass, while the instant invention is a synthetic oil (Remarks, p. 4-6).
This argument is not persuasive. Nowhere do the instant claims require that the oil is a synthetic oil, the claims only require that the oil is a microorganism oil composition. Not only do the claims not require a synthetic oil, but nowhere in the specification does applicant state that the oil is a synthetic oil. Even if a synthetic oil was specifically stated in the specification, per MPEP 2145.VI., although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that the instant invention is not an oil directly extracted from microalgal biomass, and that the processes to obtain the oil of Bijl and the oil of the instant invention are different (Remarks, p. 4-6).
This argument is not persuasive. First, the oil of the instant invention is in fact obtained from a microalgal biomass, as can be seen in the instant specification on page 2 lines 4-12, page 4 lines 1-6, and Example 1 on page 8. Second, the claimed invention is that of a composition, not of a method. The process to obtain the claimed composition (e.g., transesterification) holds no patentable weight where the claims are directed to a product. It does not matter how a composition of the prior art is obtained, so long as the composition itself is the same, or obvious to, the claimed composition.
Applicant argues that the components of glycerides in the oil of Bijl are outside of those of the claimed ranges (Remarks, p. 5-6).
This argument is not persuasive. The oil composition of Bijl comprises amounts of glycerides that would have been obvious to one of ordinary skill in the art to have adjusted through no more than routine optimization, with a reasonable expectation of success to formulate the claimed ranges, as set forth above in the rejection.
In the absence of any further arguments with regard to the rejections of the additional dependent claims, the rejections of these dependent claims are maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURA E SWEENEY whose telephone number is (571)272-0244. The examiner can normally be reached M-F 8:00-5:00 EST.
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/M.E.S./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791