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 .
Note from Examiner
The art unit location of your Application at the USPTO has changed. To aide in correlating any papers for this application, all further correspondence regarding this application should be directed to Examiner Judith Kamm in Art Unit 1611.
Election/Restrictions
Applicant’s election of the invention of Group I, drawn to an extract, and emulsion, and a food/beverage in the reply filed on 01/05/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
In a telephone interview with Atty. Floyd Trillis, the Examiner clarified that the species election requirement mailed 08/06/2025 required an election of a single species from one species group, while the reply filed 01/05/2026 set forth an election of a species from each of the four groups. In a return call on 07/21/2026, Atty. Trillis confirmed the election of a single species of the microalgae Chlorella. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 25 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 01/05/2026.
Claims 3 and 5-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/05/2026 and the subsequent telephone call on 07/21/2026 .
Claims 19-20, 22, and 26-27 are cancelled.
Claims 1-2, 4, 7-18, 21, 23-24, and 28-34 are under current examination. The claims were read in view of the species election detailed above.
Priority
This application is a national stage entry of PCT/EP2021/078232, filed 10/12/2021. Foreign priority has been claimed to GB 2016236.8, filed 10/13/2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/13/2023 and 01/14/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the Examiner.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: Compositions Comprising Extracts Rich in Polar Lipids.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is fewer than 50 words and contains the implied phrase “The present invention is related to”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 is objected to because of the following informalities: it is suggested that the Markush language “Extract rich in polar lipids obtained from microalgae,… photosynthetic organ(s) and/or tissue(s) of a plant and combinations thereof” should read “Extract rich in polar lipids obtained from microalgae,… photosynthetic organ(s) and/or tissue(s) of a plant or combinations thereof”. See MPEP 2117 I.
Claim 4 is objected to because of the following informalities: it is suggested that the word “and” should be inserted between “Ellipsoidion,” and “Pseudocharaciopsis” in lines 7-8.
Claim 7 is objected to because of the following informalities: it is suggested that the Markush language “the extract is selected from methyltetrahydrofuran extracts… ethanol or hydroethanolic extracts or mixtures thereof” should read “the extract is selected from methyltetrahydrofuran extracts… ethanol or hydroethanolic extracts and mixtures thereof”. See MPEP 2117 I.
Claim 9 is objected to because of the following informalities: it is suggested that “Crude” and “Purified” in line 2, respectively, should be recited in lowercase as “crude” and “purified”.
Claim 10 is objected to because of the following informalities: it is suggested that “Extract” in line 1 should be recited in lowercase as “extract”.
Claim 11 is objected to because of the following informalities: it is suggested that the word “in” of “polar lipids in based” in line 6 should be omitted.
Claim 15 is objected to because of the following informalities: it is believed that “betain” in line 7 is a misspelling of “betaine”.
Claim 18 is objected to because of the following informalities: it is suggested that “Purified” in line 2 should be recited in lowercase as “purified”; it is further suggested that the “extract contain” in line 2 should recite the “extract contains”.
Claim 21 is objected to because of the following informalities: it is suggested that “Extract” in line 1 should be recited in lowercase as “extract”.
Claim 30 is objected to because of the following informalities: it is suggested that “the droplets size” in line 2 should recite “the droplet size” with droplet in the singular.
Claim 34 is objected to because of the following informalities: it is suggested that the Markush language “selected from sauces, mayonnaises… spreads or margarines” should read “selected from sauces, mayonnaises… spreads and margarines”. See MPEP 2117 I.
Appropriate correction is required.
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 1-2, 4, 7-13, 15-18, 21, 23-24, and 28-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
In accordance with MPEP § 2106, claims found to recite statutory subject matter (in the present claim, a composition of matter; Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature, or natural phenomenon (Step 2A, Prong One). The instant claims recite a crude or purified extract rich in polar lipids obtained from microalgae, macroalgae, photosynthetic bacteria and/or photosynthetic organ(s) and/or tissue(s) of a plant and combinations thereof, wherein the microalgae is selected from one or more including the elected species of Chlorella; the claims further recite amounts and identities of the polar lipids, and that the extract has a light color. The claims further recite an emulsion comprising the extract as an emulsifying agent, and a food or beverage product for humans or animals, a nutritional supplement, a nutraceutical formulation, a fragrance or flavoring, a pharmaceutical formulation, an oenological or cosmetic formulation comprising the emulsion.
The claims are directed to a judicial exception such as a natural phenomenon (e.g., product of
nature) as the only compositional requirements set forth in the instant claims are an extract of a naturally occurring product and an emulsion comprising a combination of naturally occurring ingredients. Extraction of the naturally occurring Chlorella microalgae merely separates naturally occurring components, and an emulsion comprises water and oil, both naturally occurring components.
There is no indication of record that the extraction or the incorporation into an emulsion, food or beverage product, nutritional supplement, etc., has structurally or functionally changed the extract from its naturally occurring counterpart, or has imparted a markedly different characteristic. As evidenced by Ru et al. (“Chlorella vulgaris: a perspective on its potential for combining high biomass with high value bioproducts” Applied Phycology 2020, 1(1), 2-11), the microalgae Chlorella vulgaris can be consumed as a food supplement and is used as an emulsifier (see particularly abstract and “Food industry applications” at pg. 5-6). Neither the claim nor the instant Specification define “a light colour”, and there is no evidence of record that the color of the claimed extract is markedly different than naturally occurring Chlorella. Consequently, the claims are directed to a product of nature exception (Step 2A, Prong 1: YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to
determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). Here, the judicial exception is not integrated into a practical application because, as noted above, there is no indication that extraction has caused the nature-based product to have any characteristics (i.e., structural and/or functional) that are different from the naturally occurring product. Further, the claims do not include additional structural elements beyond the judicial exception. From MPEP 2106.04(d): “Because a judicial exception alone is not eligible subject matter, if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application.” (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B).
As noted above, there are no specific structural limitations recited in the claim beyond the judicial exception, and a judicial exception alone is not eligible subject matter. The claims do not recite anything else, compositionally or structurally, which provides an inventive concept that departs from merely reciting an extract and composition containing all naturally occurring components, the extract and composition having properties that are consistent with the naturally occurring counterparts of the components of the composition. Merely adjusting the amounts of polar lipids in the extract and the amount of extract used in an emulsion does not rise to the level of an inventive concept that provides significantly more than the judicial exception (Step 2B: NO).
Therefore, the claims are not patent eligible subject matter under 35 USC § 101.
Claim Rejections - 35 USC § 112(b)
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.
Claims 4, 10, 13, 15-18, 23, 31, and 33 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding instant claim 4, the phrase "such as" in parentheses at lines 4-5 (“Dunaliella (such as Dunaliella salina”) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding instant claim 10, the phrase "such as" at line 3 (“such as at least 60% of polar lipids”) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 13 recites a purified extract “having improved organoleptic properties including a neutral odour, a light colour and/or absence of off-taste”. The claim does not recite a baseline from which the organoleptic properties must be improved in order to satisfy this limitation. Further, neither the claim nor the instant specification define what characteristics a color must have to satisfy being “light”. Further, odor and taste are subjective, and neither the claim nor the instant specification define the terms “neutral odour” or “off-taste”. One of ordinary skill in the art would not be reasonably apprised of the scope of extracts that satisfy the limitation of “having improved organoleptic properties including a neutral odour, a light colour and/or absence of off-taste”, and the metes and bounds of the claim are uncertain.
Claim 15 recites the limitation "the polar lipids phase" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim as claim 1, from which claim 15 depends, recites an “[e]xtract rich in polar lipids”, but does not recite a polar lipids phase. It is unclear if claim 15 requires the presence of multiple phases or not.
Claim 16 recites the limitation "the polar lipid phase" in lines 1-2 and line 4. There is insufficient antecedent basis for this limitation in the claim as claim 1, from which claim 16 depends, recites an “[e]xtract rich in polar lipids”, but does not recite a polar lipid phase. It is unclear if claim 16 requires the presence of multiple phases or not.
Claim 17 recites the limitation "the polar lipid phase" in lines 1-2 and “the polar lipid fraction” in lines 5-6. There is insufficient antecedent basis for these limitations in the claim as claim 1, from which claim 17 depends, recites an “[e]xtract rich in polar lipids”, but does not recite a polar lipid phase or a polar lipid fraction. It is unclear if claim 17 requires the presence of multiple phases and/or multiple fractions or not.
Claim 18 recites the limitation "wherein the Purified extract contain less than 10% of sugars, proteins, peptides, chlorophylls and/or waxes". No units are associated with the recited % (wt., vol., mol, etc.), and the metes and bounds of the claim are uncertain. Further, it is unclear if the claim requires less than 10% of each component individually (i.e., less than 10% of sugars, less than 10% of proteins, etc.) or less than 10% of the combination of all sugars, proteins, peptides, chlorophylls, and waxes present in the extract.
Claim 23 recites the limitation "the emulsifying agent" in line 1. There is insufficient antecedent basis for this limitation in the claim as claim 21, from which claim 23 depends, recites both “at least one Extract according to claim 1 as an emulsifying agent” and “other emulsifying agents” (optionally included or not). It is unclear if “the emulsifying agent” recited in claim 23 refers to the extract as an emulsifying agent, the other emulsifying agents, or a combination thereof. For purposes of examination and applying prior art, it is interpreted that claim 23 requires that the at least one extract according to claim 1 is present from about 0.1 to about 10 wt.%.
Claim 31 recites the limitation “(25 °C)” in parentheses, rendering the claim indefinite as to whether this limitation is a required feature of the claim. If Applicant intends for this to be a required limitation, it is recommended that the claim recite “storage at 25 °C”.
Claim 33 recites the limitation "at least one emulsifying extract according to claim 1" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim as claim 1 does not recite that the extract is emulsifying. It is suggested the Applicant omit the word “emulsifying” from the claim.
Claim Interpretation
The instant specification defines that “"rich in polar lipids" in the present invention and in the specific context of crude extracts, means that the crude extract of the invention comprises at least 5 wt%, at least 10 wt%, at least 11 wt%, at least 12 wt%, at least 13 wt%, at least 14 wt%, at least 15 wt%, at least 16 wt%, at least 17 wt%, at least 18 wt%, at least 19 wt%, at least 20 wt%, at least 25 wt%, at least 30 wt%, at least 35 wt%, at least 40 wt%, at least 45 wt%, at least 50 wt% of polar lipids in relation to the total extract” (pg. 7, lines 29-34).” Thus, the Examiner interprets that an extract comprising at least 5 wt% of polar lipids relative to the total weight of the extract satisfies the limitation “rich in polar lipids”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4, and 7-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by White et al. (“Modulation of Polar Lipid Profiles in Chlorella sp. in Response to Nutrient Limitation” Metabolites 2019, 9, 39), hereafter “White”, as evidenced by Kose et al. (“Investigation of in vitro digestibility of dietary microalga Chlorella vulgaris and cyanobacterium Spirulina platensis as a nutritional supplement” Biotech 2017 7:170), hereafter “Kose”.
Regarding instant claims 1 and 4, White discloses the effects of nutrient limitation on cellular composition of polar lipid classes/species in Chlorella sp. using LC-MS/MS (see entire document, particularly “Abstract”). White discloses lipid extraction of Chlorella sp. culture samples (“2.1 Microalgal Strain and Culture Conditions” at pg. 3 and “2.5 Lipid Extraction” at pgs. 3-4) and the analysis of polar lipids in the lipid extracts (“2.6. Polar Lipid Analyses (Liquid Chromatography–Electrospray Ionisation Mass Spectrometry (LC-ESI-MS/MS)” at pg. 4). White discloses that polar lipids include glycolipids (monogalactosyldiacylglycerol (MGDG); digalactosyldiacylglycerol (DGDG); sulfoquinovosyldiacylglycerol (SQDG)), phospholipids (phosphatidylcholine (PC), phosphatidylglycerol (PG), phosphatidylethanolamine (PE)), and betaine lipids (e.g., diacylglyceryl trimethyl homoserine (DGTS)) (“1. Introduction”, paragraph 2). White discloses that the lipid extracts comprise greater than 5 wt% polar lipid, normalized for carbon; as one example, MGDG mean levels were 0.5 ± 0.22 mg/mg C in biomass grown in high nutrient media pg. 8, paragraph 2 and Figure 3 at pg. 9), and thus meet the limitation of “rich in polar lipids”.
Regarding instant claim 2, as noted above, White discloses extracts of Chlorella sp. rich in polar lipids. As evidenced by Kose, Chlorella species have been approved as Generally Recognized as Safe (GRAS) categorized single cell protein nutritional supplement (pg. 2, column 1, paragraph 2).
Regarding instant 7, White discloses that the extracts were generated using chloroform and methanol (“2.5 Lipid Extraction” at pgs. 3-4).
Regarding instant claim 8, the instant specification defines “raw material” as a material that was not used before for other extraction processes (pg. 5, lines 1-3). White discloses that the lipid extracts were generated from filtered culture samples (“2.5 Lipid Extraction” at pgs. 3-4), meeting the limitation of a raw material.
Regarding instant claim 9, White discloses that lipid extracts were generated using chloroform/methanol (2:1) and sonication to disrupt cellular material; samples were further extracted with 100% chloroform to ensure complete lipid extraction. Lipid-containing layers were pooled, dried under vacuum, and stored (“2.5 Lipid Extraction” at pgs. 3-4). As White does not disclose purification of the lipid extract, the extract is interpreted as a crude extract.
Regarding instant claim 10, as noted above, White discloses that the lipid extracts comprise greater than 5 wt% polar lipid, normalized for carbon; as one example, MGDG mean levels were 0.5 ± 0.22 mg/mg C in biomass grown in high nutrient media (pg. 8, paragraph 2 and Figure 3 at pg. 9).
Regarding instant claim 15, White discloses that lipid extracts comprise the galactosyl acylglycerols monogalactosyldiacylglycerol (MGDG) and digalactosyldiacylglycerol (DGDG), the phospholipids phosphatidylglycerol (PG), phosphatidylethanolamine (PE), and phosphatidylcholine (PC), the sulfur lipid sulfoquinovosyldiacylglycerol (SQDG), and the betaine lipid diacylglyceryl trimethyl homoserine (DGTS) (“1. Introduction”, paragraph 2; pg. 8, paragraph 2; and Figure 3 at pg. 9).
Regarding instant claim 16, White discloses that the monogalactosyldiacylglycerol (MGDG) mean levels were 0.5 ± 0.22 mg/mg C in biomass grown in high nutrient media, or greater than 5% by weight; concentrations of digalactosyldiacylglycerol (DGDG) reached a maximum of 0.15 ± 0.06 mg/mg C in cultures grown in high nutrient media with a 6-10% contribution to the total polar lipid (pg. 8, paragraph 2 and Figure 3 at pg. 9).
Regarding instant claim 17, White discloses that concentrations of the sulfur lipid sulfoquinovosyldiacylglycerol (SQDG)) reached a maximum of 0.4 ± 0.1 mg/mg and accounted for 11–31% of the total polar lipids in high nutrient cultures (pg. 8, paragraph 2 and Figure 3 at pg. 9).
Instant claims 11-14 and 18 depend from instant claim 9 which recites a crude extract rich in polar lipids or a purified extract rich in polar lipids, and provide further limitations on the optional purified extract. As set forth above, White meets the limitation of a crude extract rich in polar lipids consistent with instant claim 9.
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, 7-18, 21, 23-24, 28, and 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over White et al. (“Modulation of Polar Lipid Profiles in Chlorella sp. in Response to Nutrient Limitation” Metabolites 2019, 9, 39), hereafter “White”, as evidenced by Kose et al. (“Investigation of in vitro digestibility of dietary microalga Chlorella vulgaris and cyanobacterium Spirulina platensis as a nutritional supplement” Biotech 2017 7:170), hereafter “Kose”, in view of Kale (US 2012/0053357 A1, published March 1st, 2012, included on IDS submitted 04/13/2023) and Calleja et al. (US 2020/0037649 A1, published February 6th, 2020; included on IDS submitted 04/13/2023), hereafter “Calleja”.
Regarding instant claims 1 and 4, White teaches the effects of nutrient limitation on cellular composition of polar lipid classes/species in Chlorella sp. using LC-MS/MS (see entire document, particularly “Abstract”). White teaches that there is interest in applications of polar lipid from algae for use in a range of biotechnological industries, and that the application of phospholipids is well recognized in nutraceutical industries which take advantage of their amphiphilic nature (pg. 2, paragraph 2). White teaches lipid extraction of Chlorella sp. culture samples (“2.1 Microalgal Strain and Culture Conditions” at pg. 3 and “2.5 Lipid Extraction” at pgs. 3-4) and the analysis of polar lipids in the lipid extracts (“2.6. Polar Lipid Analyses (Liquid Chromatography–Electrospray Ionisation Mass Spectrometry (LC-ESI-MS/MS)” at pg. 4). White teaches that polar lipids include glycolipids (monogalactosyldiacylglycerol (MGDG); digalactosyldiacylglycerol (DGDG); sulfoquinovosyldiacylglycerol (SQDG)), phospholipids (phosphatidylcholine (PC), phosphatidylglycerol (PG), phosphatidylethanolamine (PE)), and betaine lipids (e.g., diacylglyceryl trimethyl homoserine (DGTS)) (“1. Introduction”, paragraph 2). White teaches that the lipid extracts comprise greater than 5 wt% polar lipid, normalized for carbon; as one example, MGDG mean levels were 0.5 ± 0.22 mg/mg C in biomass grown in high nutrient media (pg. 8, paragraph 2 and Figure 3 at pg. 9), and thus meet the limitation of “rich in polar lipids”.
Regarding instant claim 2, as noted above, White teaches extracts of Chlorella sp. rich in polar lipids. As evidenced by Kose, Chlorella species have been approved as Generally Recognized as Safe (GRAS) categorized single cell protein nutritional supplement (pg. 2, column 1, paragraph 2).
Regarding instant 7, White teaches that the extracts were generated using chloroform and methanol (“2.5 Lipid Extraction” at pgs. 3-4).
Regarding instant claim 8, the instant specification defines “raw material” as a material that was not used before for other extraction processes (pg. 5, lines 1-3). White teaches that the lipid extracts were generated from filtered culture samples (“2.5 Lipid Extraction” at pgs. 3-4), meeting the limitation of a raw material.
Regarding instant claim 9, White teaches that lipid extracts were generated using chloroform/methanol (2:1) and sonication to disrupt cellular material; samples were further extracted with 100% chloroform to ensure complete lipid extraction. Lipid-containing layers were pooled, dried under vacuum, and stored (“2.5 Lipid Extraction” at pgs. 3-4). As White does not disclose purification of the lipid extract, the extract of White is interpreted as a crude extract.
Regarding instant claim 10, as noted above, White teaches that the lipid extracts comprise greater than 5 wt% polar lipid, normalized for carbon; as one example, MGDG mean levels were 0.5 ± 0.22 mg/mg C in biomass grown in high nutrient media (pg. 8, paragraph 2 and Figure 3 at pg. 9).
Regarding instant claim 15, White teaches that lipid extracts comprise the galactosyl acylglycerols monogalactosyldiacylglycerol (MGDG) and digalactosyldiacylglycerol (DGDG), the phospholipids phosphatidylglycerol (PG), phosphatidylethanolamine (PE), and phosphatidylcholine (PC), the sulfur lipid sulfoquinovosyldiacylglycerol (SQDG), and the betaine lipid diacylglyceryl trimethyl homoserine (DGTS) (“1. Introduction”, paragraph 2; pg. 8, paragraph 2; and Figure 3 at pg. 9).
Regarding instant claim 16, White teaches that the monogalactosyldiacylglycerol (MGDG) mean levels were 0.5 ± 0.22 mg/mg C in biomass grown in high nutrient media, or greater than 5% by weight; concentrations of digalactosyldiacylglycerol (DGDG) reached a maximum of 0.15 ± 0.06 mg/mg C in cultures grown in high nutrient media with a 6-10% contribution to the total polar lipid (pg. 8, paragraph 2 and Figure 3 at pg. 9).
Regarding instant claim 17, White teaches that concentrations of the sulfur lipid sulfoquinovosyldiacylglycerol (SQDG)) reached a maximum of 0.4 ± 0.1 mg/mg C and accounted for 11–31% of the total polar lipids in high nutrient cultures (pg. 8, paragraph 2 and Figure 3 at pg. 9).
Instant claims 11-14 and 18 depend from instant claim 9 which recites a crude extract rich in polar lipids or a purified extract rich in polar lipids, and provide further limitations on the optional purified extract. As set forth above, White meets the limitation of a crude extract rich in polar lipids consistent with instant claim 9.
White does not teach an emulsion comprising the extract as an emulsifying agent (instant claim 21) present in a concentration of from about 0.1 to about 10 wt% (instant claim 23) which is a water-in-oil or an oil-in-water emulsion (instant claim 24) wherein the emulsion is free of synthetic or artificial emulsifiers and/or structuring agents (instant claim 28). White further does not teach a food or beverage product for humans or animals, a nutritional supplement, a nutraceutical formulation, a fragrance or flavouring, a pharmaceutical or veterinary formulation, an oenological or cosmetic formulation comprising an extract or emulsion (instant claims 32-33) or that the food or beverage is selected from sauces, mayonnaises, snacks, ice creams and desserts, dairy products, beverages, sausages and condiments, process products, meat analogues, coffee creamers, baked goods, spreads or margarines (instant claim 34).
Kale teaches the separation of polar lipids from algal cells, including Chlorella microalgae, and that polar lipids are high value products which can be used as surfactants, detergents, and food additives (see entire document, particularly Abstract and paragraphs [0107]-[0108] and [0120]). Kale teaches that polar lipids enhance the emulsification of neutral lipids (paragraphs [0009], [0119]). Polar lipids include phospholipids and glycolipids (paragraphs [0075] and [0113]), and phospholipids derived from algae are used as food additives (paragraph [0084]).
Calleja teaches a product of a food or drink for human or animal consumption comprising between 0.2 and 50% by weight of an extract of microalgae (see entire document, particularly Abstract), which may contain extract of microalgae of the genus Chlorella (paragraph [0069]). The lipid extract preferably contains polar lipids, in particular glycolipids and phospholipids (paragraphs [0040]-[0042]). The product may be a food intended for human consumption such a bakery product, a condiment, a dairy product, etc. (paragraph [0019]). Calleja exemplifies a salad dressing (a condiment which is an oil-in-water emulsion) comprising a stable emulsion of lipid extract of Odontella and Chlorella comprising phospholipids (Example 3, paragraphs [0077]-[0079]). The products and emulsions of Calleja are not taught to comprise synthetic or artificial emulsifiers or structuring agents.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the Chlorella extracts rich in polar lipids of White as an emulsifying agent in an emulsion and food product in an amount from 0.2 to 50% by weight, overlapping the claimed range, as suggested by Kale and Calleja.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to formulate a food product that has both emulsion stability imparted from the polar glycolipids and phospholipids, (see particularly Kale, paragraphs [0009], [0119]and Calleja Example 3, paragraphs [0077]-[0079]) and which can act as a controlled source of quality nutrients from microalgae cultures (see Calleja paragraph [0003]-[0004]). There is a reasonable expectation of success as the extracts of White comprise polar lipids including phospholipids, and White further teaches that the application of phospholipids is well recognized in nutraceutical industries which take advantage of their amphiphilic nature (pg. 2, paragraph 2). Further, regarding the claimed amounts extract, per MPEP 2144.05 I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over White, as evidence by Kose, in view of Kale and Calleja as applied to claims 1-2, 4, 7-18, 21, 23-24, 28, and 32-34 above, and further in view of Caporgno et al. (“Cultivation of Chlorella protothecoides under different growth modes and its utilisation in oil/water emulsions” Bioresource Technology 2019, 288, 121476), hereafter “Caporgno”.
The teachings of the modified White are set forth above.
The combination of White, Kale, and Calleja do not teach that the emulsion has a pH from about 2 to 10, as required by instant claim 29.
Caporgno teaches that microalgae such as Chlorella can be incorporated in different bio-based products, and microalgae and some purified fractions have been suggested as ingredients for oil in water (O/W) emulsions such as mayonnaise-like emulsions and salad dressing (see entire document, particularly Abstract and “1. Introduction” paragraphs 2-3). Caporgno teaches O/W emulsions with a fat content similar to salad dressing which incorporate suspensions prepared from Chlorella cultures (see “2.1 Microalgae cultivation”, “2.4. Microalgae suspensions with disrupted cells”, and “2.5. Emulsions”). Caporgno teaches that emulsions such as mayonnaise and salad dressings are characterized by a low pH and are clear examples of low-pH products in which microalgae could be incorporated; Caporgno further teaches that emulsions prepared from suspensions below pH 4 can result in phase separation (pg. 7, column 2, paragraph 2). Caporgno further teaches that pH affects the ζ-potential of microalgae, and at strong negative ζ-potentials, no aggregates are expected in suspensions (see paragraph bridging pg. 6-7 and Figure 4).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to adjust the pH of the Chlorella emulsion-containing condiments of the modified White to be at or above a pH of 4, overlapping the claimed range, as suggested by Caporgno. One of ordinary skill in the art would have been motivated to routinely optimize the pH within this range in order to achieve a pH that is suitable for use in low-pH emulsion applications, such as salad dressings, but which maintains a desired phase stability and ζ-potential, as suggested by Caporgno. Per MPEP 2144.05 II. A., “"[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)”. There is a reasonable expectation of success as the teachings of the modified White arrive at a salad dressing comprising a stable emulsion comprising a Chlorella extract.
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over White, as evidence by Kose, in view of Kale and Calleja as applied to claims 1-2, 4, 7-18, 21, 23-24, 28, and 32-34 above, and further in view of Grossman et al. (“Formation and Stability of Emulsions Prepared with a Water-Soluble Extract from the Microalga Chlorella protothecoides” J. Agric. Food Chem. 2019, 67, 6551-6558), hereafter “Grossman”.
The teachings of the modified White are set forth above. Further, Calleja teaches that food products can comprise hydrophilic extracts from microalgae containing proteins (paragraphs [0048]-[0050]).
The combination of White, Kale, and Calleja do not teach that the emulsion has a droplet size comprised between 0.05 and 50 micrometers (instant claim 30) or that the droplet size remains stable for at least one day of storage at ambient temperature (instant claim 31).
Grossman teaches that proteins from unicellular microalgae are potentially useful as emulsifiers, and exemplifies O/W emulsions prepared with protein from Chlorella protothecoides, resulting in emulsions having a volume-based mean droplet diameter of d43 ≤ 1 μm and being stable for at least 7 days with no significant increase in particle size during the 7 day storage period (see entire document, particularly Abstract and pg. 6554, column 2, paragraph 2). Grossman suggests storage at room temperature (“2.2. Fabrication of Water-Soluble Protein Extracts” at pg. 6552). Grossman teaches that the observed interfacial adsorption behavior of the proteins might enable the formulation of stable food emulsions (“3.3. Emulsifying Properties of Water-Soluble Proteins of Chlorella protothecoides”, paragraph 1 at pg. 6554), and show improved stability compared to common food proteins such as casein under conditions relevant to food-based applications such as variable pH and high salt contents (see “3.4. Stability of O/W Emulsion (Stress Test I): pH Shift” and “3.5. Stability of O/W Emulsion (Stress Test II): Ionic Strength”, particularly final paragraph at pg. 6557).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the emulsions of the modified White to comprise Chlorella proteins and achieve a droplet size of ≤ 1 μm, overlapping the claimed range, which remains size stable for at least 7 days, as suggested by Grossman. One of ordinary skill in the art would have been motivated to do so to achieve an emulsion with desirable properties for food-based applications, such as stability in different pHs and ionic strengths, as suggested by Grossman. There is a reasonable expectation of success as the teachings of the modified White arrive at a salad dressing comprising a stable emulsion comprising a Chlorella extract, and Calleja suggests the inclusion of proteins extracted from microalgae (paragraphs [0048]-[0050]). Further, regarding the claimed droplet size, per MPEP 2144.05 I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Conclusion
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/J.M.K./Examiner, Art Unit 1611
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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