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 .
All previous objections and rejections not reiterated herein were overcome by amendments to the claims and specifications, filed January 20th, 2026 have been fully considered and found persuasive. As such the objections and rejections not reiterated herein have been withdrawn.
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, 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 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, colouring agents, pigments, thickeners, stabilisers, 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, 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 and VLCMUFAs 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 and VLCMUFAs as claimed has some characteristic that makes it markedly different from the natural counterparts.
Response to Arguments
Applicant's arguments and claim amendments filed January 20th, 2026, see applicants remark’s pages 7 – 9, have been fully considered but they are not persuasive.
Applicants has amended the claims to include the recitation of, “and at least one additive,” and the applicant has stated that, “and at least one additive,” was included to clarify that the claimed composition as not naturally occurring (see applicant’s remarks page 7 paragraph 2). Additionally, the applicants argues that the enriched purified compositions exhibited at least five markedly different characteristics which include appearance, low oxidation parameters/enhanced stability, low cholesterol content, low environmental pollutants, and reduced order profile that distinguished it from any natural oil (see applicant’s remarks pages 8 paragraph 2).
The examiner continues to contends 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.
Additionally, as stated in the rejection, claim 1 has been amended to include the “at least one additive;” however, as defined in the specification the recitation can still include naturally derived additives such as ethanol and water. Likewise aloe vera gel/ or marshmallow root which are both natural products that are lubricants which are not excluded. Thus the limitation of “at least one additive” fails to overcome the 101 rejection of the instant claims. Thus there is no difference between the claimed and naturally occurring very long chain fatty acids, the claimed very long chain fatty acids 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, 27, and 32 – 36 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
/JULIET C SWITZER/Primary Examiner, Art Unit 1682