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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 14th, 2026 has been entered.
All previous objections and rejections not reiterated herein were overcome by amendments to the claims and specifications, filed May 14th, 2026 have been fully considered and found persuasive. As such the objections and rejections not reiterated herein have been withdrawn.
Election/Restrictions
Claims 1 – 5, 7, 9, 12 – 22, and 24 – 36 are currently pending in the application. However, due to a restriction requirement dated April 4th, 2024, claims 18 – 21, 24 – 26, and 28 – 31 are withdrawn from further consideration. However, due to claim amendments submitted May 14th, 2026; claim 24 has been rejoined and will be examined on the merits. Nevertheless, the restriction requirement between Group I and Group II is maintained. Moreover, the election of species requirement for the composition is also maintained. Hence claims 1 –2, 4 – 12, 24, 29 – 33, and 38 – 39 are being examined on the merits.
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.
Claims 1 – 5, 7, 9, 12 – 17, 22, 24, 27, and 32 – 36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claims recite an enriched composition comprising a fatty acid mixture and at least one additive, wherein the fatty acid mixture of the enriched, purified composition comprises 0.1-15 mg/g cholesterol, wherein the fatty acid mixture comprises at least 4.0 % by weight of very long chain monounsaturated fatty acids and at least 1.0 % by weight of very long chain polyunsaturated fatty acids, wherein the very long chain monounsaturated fatty acids and the very long chain polyunsaturated fatty acids have a chain length of 24 carbon atoms or more, and the fatty acid mixture comprises at least 1% by weight of very long chain monounsaturated fatty acids with chain length of 26 carbon atoms or more, wherein the fatty acids are derived from natural oils. Moreover the claims further recite that the at least one additive is selected from the group of solvents, carriers, viscosity modifiers, diluents, binders, sweeteners, aromas, pH modifiers, antioxidants, extenders, humectants, disintegrating agents, solution-retarding agents, absorption accelerators, wetting agents, absorbents, lubricants, coloring agents, pigments, thickeners, stabilizers, glossing agents, gelling agents, dispersing agents, salts, oils, waxes, polymers, silicone compounds, biogenic agents, film formers, tonicity agents, emulsifiers, surfactants, buffers, inorganic and organic sunscreens, anti-inflammatory agents, free radical scavengers, moisturizers, vitamins, enzymes, and preservatives.
However, as stated in the instant specification solvents and carriers includes water and ethanol (instant specification page 19 line 7). Additionally, the instant specification fails to limit, the at least one additive, to none natural forms. Each of these elements exists in nature, for example, the instant specification teach VLCPUFAs and VLCMUFAs are occur naturally in the bodies of mammals (page 2 lines 26 – 34) natural product versions can be selected. Additionally, the state of the art of Murphy et. al. ((1988), Biosynthesis of very long chain monounsaturated fatty acids by subcellular fractions of developing seeds, FEBS Letters, 230, 101-104; cited in the office action dated February 14th, 2025) teach that very long chain monounsaturated fatty acids, nervonic and cis-tetracosenoic acid (24: 1), are major constituents of certain seed oils (page 101 column 1 paragraph 1). Moreover, the state of the art of Carmona-Antonanzas et.al. ((2011), Biosynthesis of very long-chain fatty acids (C > 24) in Atlantic salmon: Cloning, functional characterisation, and tissue distribution of an Elovl4 elongase, Comparative Biochemistry and Physiology, Part B, 159, 122-129; cited in the office action dated February 14th, 2025) teach that very long-chain fatty acids (VLC-FA) are found in most animals and constitute a group of fatty acids (FA) with chain numbers normally ranging from C26 to C40 that can be saturated, monounsaturated or polyunsaturated (page 122 column 1 paragraph 1). Furthermore, Carmona-Antonanzas et.al. teach that the relative low abundance of VLC-FA compared to shorter chain FA (≤C24) and the difficulty of their analysis has hindered investigation of the functions and metabolism of VLC-FA (page 122 column 1 paragraph 1). Moreover, the state of the art of Nes ((2011), Biosynthesis of Cholesterol and Other Sterols, Chem. Rev., 111, 6423 – 6451), teaches that Cholesterol and its relatives possessing the 1,2-cyclopenta noperhydrophenanthrene ring system (Figure 1) form the sterolome, which comprises a chemical library of more than 1000 natural products found in all forms of eukaryotes and some prokaryotes that serve a myriad of biological functions (page 6423 column 1 paragraph 1).
Moreover, there is no indication in the specification that the claimed components within the composition have any characteristics (structural, functional, or otherwise) that are different from the naturally occurring components. Thus, the elements in the composition do not have markedly different characteristics from their natural counterparts in their natural state, and are “product of nature” exceptions. Accordingly, the claim is directed to a judicial exception.
This judicial exception is not integrated into a practical application because the claims by nature do not recite any elements in addition to the naturally occurring products. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the prior art teach both VLCPUFAs, VLCMUFAs, and cholesterol as naturally products. Hence, the claims do not amount to significantly more because they do not recite any elements in addition to the naturally occurring products. The applicant is advised that in order to overcome the rejection, applicant could and demonstrate that the combination of VLCPUFAs, VLCMUFAs, and cholesterol as claimed has some characteristic that makes it markedly different from the natural counterparts.
Response to Arguments
Applicant's arguments and claim amendments filed May 14th, 2026, see applicants remark’s page 8, have been fully considered but they are not persuasive.
Applicants has amended the claims to include the recitation of, “wherein the fatty acid mixture of the enriched, purified composition comprises 0.1 – 15 mg/g cholesterol.” See claim 1. Moreover applicant argues that the inclusion of the range of 0.1 – 15 mg/g is substantially higher then what is found natural in natural marine oils. Thus the applicant believes that the claims that the claims should np longer be rejected under 35 USC § 101. See applicant’s remarks page 8 paragraph 1. Additionally, applicants argues that the enriched purified compositions produces markedly different physical, chemical, and safety characteristics compared to any naturally occurring marine oil. See applicant’s remarks page 8 paragraph 2. Moreover, applicants argues that the enriched purified compositions produces markedly different oxidative characteristics compared to any naturally occurring marine oil. See applicant’s remarks page 8 paragraph 3.
The examiner contends that the standard for markedly different characteristics is not the amount of a single component present but whether the natural-based composition as a whole has markedly different characteristic. See MPEP 2106.04(c)I.A. Moreover, this composition is compared to the its naturally occurring counterpart in its natural state to see if there is difference in the claimed composition’s structure, function, and/or other properties. See MPEP 2106.04(c)II.
The examiner continues to contend that the markedly different characteristics of appearance, low oxidation parameters/enhanced stability, low cholesterol content, low environmental pollutants, and reduced order profile are the result of the method of preparation (withdrawn instant claims 28 – 31) and not of the composition itself. Moreover, page 16 of the instant specification discusses embodiments of the instant composition where the cholesterol levels are removed in a method step. See instant specification page 16 lines 3 – 10. Specifically, the instant specification states that in one embodiment, the oil material is an oil from a natural source which has been processed, i.e. it may have already gone through steps as disclosed in the above paragraphs, e. g. purification steps to remove impurities or unwanted components, steps to increase stability and/or increase concentration, and/or chemical reaction steps. See instant specification page 16 lines 29 – 32. Thus the instant specification discloses that the markedly different characteristics argues by the applicant is not a characteristic of the composition but how the compositions was processed.
Additionally, as stated in the rejection, claim 1 has been amended to include the “0.1 – 15 mg/g cholesterol;” however, cholesterol is still a natural product with no apparent difference. Thus the claimed very long chain fatty acids in combination with cholesterol does not have markedly different characteristics from what occurs in nature, and thus is a “product of nature” exception. Accordingly, the claim is directed to an exception (Step 2A: YES). Because the claim does not include any additional features that could add significantly more to the exception (Step 2B: NO), the claim does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Conclusion
Claims 1 – 5, 7, 9, 12 – 17, 22, 24, 27, and 32 – 36 are rejected.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
/JULIET C SWITZER/Primary Examiner, Art Unit 1682
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