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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1, 2, 4 and 7-18 in the reply filed on July 18, 2026 is acknowledged.
Claims 19-22 and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 18, 2026.
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 8, 13 and 14 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 claim 8, the recitation “where the first microbial oil has a ratio of DHA:DPA (n-3) of 0.2-0.7:1” renders the claim indefinite. Given claim 1 requires the first microbial oil have a DPA (n-3):DHA greater than 0.2, it is not clear how a ratio of DHA:DPA(n-3) could also be 0.2
Regarding claim 13, the recitation “wherein the second oil is a microorganism selected from the group consisting of . . .” renders the claim indefinite because there is no antecedent basis for “the second oil.”. Moreover, is not clear how the oil is a microorganism.
Regarding claim 15, the recitation “wherein the composition is a food product, cosmetic or pharmaceutical composition” renders the claim indefinite. It is not clear how the microbial oil can be, for example a pharmaceutical. Does Applicant intend to claim, for example, a food product comprising the composition of claim 1?
Claims 14 and 16-18 are rejected because it is dependent from a rejected base claim.
Claim Rejections - 35 USC § 103
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, 4, 7, 9-12 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Radakovits et al. (US 20160177255 – IDS filed May 24, 2024).
Regarding claims 1 and 2, Radakovits et al. disclose a microbial oil composition comprising long chain polyunsaturated fatty acids (LC-PUFAs -including omega-3-polyunsaturated fatty acids or omega-3 PUFAs –[0003]) wherein the PUFAs comprise docosahexaenoic acid (DHA) and docosapentaenoic acid (DPA n-3) ([0009]-[0015], [0040]). Radakovits et al. disclose wherein the ratio of DPA (n-3) to DHA in the microbial oil is 0.28 ([0009]-[0011]).
Regarding claim 4, Radakovits et al. disclose all of the claim limitations as set forth above. Radakovits et al. disclose wherein the percentage of fatty acids as DPA is less than 12% ([0009], [0015]).
Regarding claim 7, Radakovits et al. disclose all of the claim limitations as set forth above. Radakovits et al. disclose the microbial oil composition comprises a second oil wherein the second oil is a vegetable or fish oil (wherein the lipids are extracted into vegetable or fish oils -[0067]).
Regarding claim 9, Radakovits et al. disclose all of the claim limitations as set forth above. Given Radakovits et al. disclose a second oil wherein the second oil is a fish oil, inherently the oil would exhibit a ratio of DAH:DPA(n-3): EPA within the claimed range.
Regarding claim 10, Radakovits et al. disclose all of the claim limitations as set forth above. Radakovits et al. disclose wherein the microbial oil is obtained from a microorganism including an algal strain, a bacterial strain, or a fungal strain ([0019], [0087]).
Regarding claims 11 and 12, Radakovits et al. disclose all of the claim limitations as set forth above. While Radakovits et al. does not disclose the first microbial oil is obtained from a microorganism of the Ichthyosporea class, even though product-by-process claims are limited by the process, determination of patentability is based on the product itself. The patentability of the product does not depend on its method of production, i.e., where the ingredient is obtained from. 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).
Regarding claims 15-18, Radakovits et al. disclose all of the claim limitations as set forth above. Radakovits et al. disclose wherein the composition comprising the microbial oil composition is an infant formula, a therapeutic drink, a nutritional drink, a beverage ([0023]). Here, a nutritional drink or an infant formula is considered a dietary supplement.
Claims 1, 2, 4, 7, 9-12 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over APT et al. (US 2013/0190520 A1).
Regarding claims 1 and 2, APT et al. disclose a microbial oil comprising omega-3 polyunsaturated fatty acids (i.e., LC-PUFAs) where in the omega30 polyunsaturated fatty acids comprise docosahexaenoic acid, eicosapentaenoic acid and docosapentaenoic acid (Abstract, [0072], [0098]). APT et al. disclose wherein the omega-3 PUFAs comprise a ratio of DPA9n-3): DHA of 2.8 (wherein 1 gram of oil comprising 200 mg DHA and 55 mg of DPA(n-3)([0098]).
Regarding claim 4, APT et al. disclose all of the claim limitations as set forth above. APT et al. disclose the DPA (n-3) is in an amount up to 10% by weight of the omega-3 PUFAs ([0086]).
Regarding claim 7, APT et al. disclose all of the claim limitations as set forth above. APT et al. disclose diluting the microbial oil with sunflower oil (i.e., vegetable oil)([0070], [0225]/Example 5, [0235]/Example 8, [0236], [0238]).
Regarding claim 9, Radakovits et al. disclose all of the claim limitations as set forth above. Given Radakovits et al. disclose a second oil wherein the second oil is a vegetable oil, i.e., sunflower oil, inherently the oil would exhibit a ratio of DAH:DPA(n-3): EPA within the claimed range.
Regarding claim 10, APT et al. disclose all of the claim limitations as set forth above. APT et al. disclose wherein the microbial oil is obtained from microalgae ([0037]).
Regarding claims 11 and 12, APT et al. disclose all of the claim limitations as set forth above. While APT et al. does not disclose the first microbial oil is obtained from a microorganism of the Ichthyosporea class, even though product-by-process claims are limited by the process, determination of patentability is based on the product itself. The patentability of the product does not depend on its method of production, i.e., where the ingredient is obtained from. 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).
Regarding claims 15-18, APT et al. disclose all of the claim limitations as set forth above. APT et al. disclose a food product, cosmetic, or pharmaceutical composition comprising the microbial oil ([0025]). APT et al. disclose the food product can be an infant formula, a beverage, a therapeutic drink or a nutritional drink ([0025]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH A GWARTNEY whose telephone number is (571)270-3874. The examiner can normally be reached M-F: 9 a.m. - 5 p.m. EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at 571-272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ELIZABETH A. GWARTNEY
Primary Examiner
Art Unit 1759
/ELIZABETH GWARTNEY/ Primary Examiner, Art Unit 1759
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