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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 & 3-20 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 1 recites a method for extracting fatty acids from a “lipid-rich marine organism” comprising exposing the starting material to a “supercritical fluid” at a defined temperature and pressure and collecting an extract containing the fatty acids. Claim 1 does not limit the supercritical fluid to carbon dioxide. Claim 2, in contrast, expressly limits the supercritical fluid to supercritical carbon dioxide. Claims 3–20 depend, directly or indirectly, from claim 1 without incorporating the carbon-dioxide limitation of claim 2 and therefore continue to encompass the full genus of supercritical fluids recited by claim 1.
The specification identifies carbon dioxide as a preferred supercritical fluid and explains that supercritical CO₂ is capable of extracting fatty acids, including PUFAs. However, the specification additionally states that alternative supercritical fluids may include hydrogen, nitrogen, methane, and ethane, and does not limit the generic “supercritical fluid” genus to those expressly identified species. Thus, the claims encompass supercritical fluids having materially different critical temperatures, critical pressures, densities, polarities, solvent strengths, chemical properties, and interactions with the biological starting materials.
The working disclosure, however, is substantially narrower than that claim scope. The experimental work employs liquid carbon dioxide as the solvent for supercritical-fluid extraction, and the disclosed extraction apparatus and experimental procedure employ supercritical CO₂ with Cucumaria frondosa viscera. The optimization experiments similarly concern supercritical-CO₂ extraction of Cucumaria frondosa viscera and investigate temperature, pressure, extraction time, and ethanol co-solvent concentration for that particular extraction system. No working example has been identified employing supercritical hydrogen, nitrogen, methane, ethane, or another materially different supercritical fluid to extract the claimed fatty acids from the recited marine organisms.
The specification itself establishes that the effectiveness of the extraction is dependent upon the physical and chemical properties of the extraction system. It states that temperature and pressure may have to be optimized when different starting materials and different amounts of starting material are used. The disclosed experimental results further explain that solubility of the target compounds depends upon the density of the supercritical fluid, which is a function of temperature and pressure, as well as upon the polarity of the extraction solvent. Consequently, the specification does not establish that the conditions shown to produce fatty-acid extraction with supercritical CO₂ would reasonably be expected to provide the claimed extraction when substantially different supercritical fluids are substituted.
In determining whether the disclosure enables the claimed invention without undue experimentation, the factors set forth in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), have been considered. The factors include: (1) the breadth of the claims; (2) the nature of the invention; (3) the state of the prior art; (4) the level of ordinary skill in the art; (5) the predictability or unpredictability of the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
As to the breadth of the claims, claim 1 encompasses the use of an unrestricted genus of supercritical fluids with an equally broad class of lipid-rich marine-organism starting materials. The specification identifies exemplary marine materials extending beyond sea cucumber to plankton, copepods, krill, sardines, anchovy, tuna, sea bass, herring, marine-processing waste, tissues from rays and sharks, whale and seal blubber, and fish roe. The breadth is therefore considerably greater than the experimentally demonstrated CO₂/C. frondosa system.
As to the nature of the invention and predictability of the art, supercritical-fluid extraction is dependent upon solvent density, solvent polarity, temperature, pressure, substrate composition, moisture content, extraction time, and interaction between those variables. The specification's own response-surface experiments evaluate several of these variables to determine suitable conditions for the specific CO₂/C. frondosa system. The disclosed results therefore demonstrate that the extraction cannot reasonably be treated as invariant with respect to the identity of the supercritical fluid.
As to the amount of guidance and working examples, substantial guidance is provided for carbon dioxide, particularly supercritical carbon dioxide used with C. frondosa. The disclosure provides preferred CO₂ pressures of approximately 20–50 MPa and temperatures of approximately 35–75°C, and states that those parameters may require optimization for different starting materials. In contrast, the specification provides no corresponding operative conditions or working examples demonstrating extraction using the expressly identified alternative supercritical fluids.
As to the quantity of experimentation required, practicing the full claimed scope would require the ordinarily skilled artisan to determine, for each materially different supercritical fluid and marine starting material, whether the fluid is capable of extracting the claimed fatty acids and, if so, to identify suitable critical conditions, operating pressure, temperature, extraction time, flow rate, and potentially co-solvent conditions. Such work constitutes more than the routine application of disclosed conditions because the specification indicates that extraction behavior is dependent upon the fluid's density and polarity and upon interaction among process variables.
Accordingly, when the Wands factors are considered collectively, the amount of experimentation required to practice the full scope of claim 1 and claims 3–20 would be undue. The disclosure teaches how to practice a substantial subset of the claimed subject matter, particularly supercritical-CO₂ extraction, but does not provide a teaching reasonably commensurate with the entire claimed genus. The enablement requirement applies to the invention defined by the claims, and where an entire class is claimed, the disclosure must enable the skilled artisan to make and use the claimed class without undue or unreasonable experimentation. MPEP §§ 2164 and 2164.01.
NOTE: Claim 2 is not included in this rejection because claim 2 expressly requires supercritical carbon dioxide, for which the specification provides detailed operating conditions, experimental procedures, and working examples.
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 1-20 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.
Independent claim 1 recites a “lipid-rich marine organism starting material.” Each of claims 2–20 depends directly or indirectly from claim 1 and therefore incorporates this limitation.
The term “lipid-rich” is a relative term or term of degree. Although the mere use of a relative term or term of degree does not render a claim indefinite, the specification must provide a standard permitting one of ordinary skill in the art to determine the scope of the term with reasonable clarity.
Here, the specification states generally that the invention concerns extraction of fatty acids from “lipid-rich marine organisms,” but does not provide an objective threshold, quantitative concentration, test, comparative standard, or other criterion establishing when a marine organism is sufficiently rich in lipid to fall within the limitation. Instead, the disclosure identifies a heterogeneous collection of organisms and materials as potential starting materials, including plankton, copepods, krill, several species of fish, marine-processing waste, ray and shark tissue, whale and seal blubber, fish roe, and sea cucumbers.
Moreover, the specification reports substantially different lipid contents for materials encompassed by the disclosure. For example, fresh Cucumaria frondosa is reported as containing approximately 0.70% lipid, while fresh C. frondosa viscera is reported as containing approximately 4.68% lipid, and dried viscera is reported as having substantially higher lipid contents on a dry-weight basis. The disclosure does not state which, if any, of these values represents the lower boundary of “lipid-rich,” nor does it establish a comparison population or reference value by which the term is to be evaluated.
Therefore, one of ordinary skill in the art would be unable to determine with reasonable certainty whether a particular marine organism containing, for example, a relatively low but extractable amount of lipid satisfies the “lipid-rich” limitation. More than one reasonable interpretation of the scope is possible, and the metes and bounds of claims 1–20 are consequently unclear.
Additional rejection claims 3, 4, 7, and 9–11 — “about”
Claim 3 recites a temperature of “about 35°C to about 75°C”; claim 4 recites a pressure of “about 20 MPa to about 50 MPa”; and claim 7 recites a co-solvent-to-starting-material ratio of “about 1:1 to about 5:1 by weight.” Claims 9–11 respectively recite a supercritical-fluid flow rate of “about 10 ml/min,” a dynamic-extraction time of “about 30 minutes,” and a static-extraction time of “about 20 minutes.”
The specification expressly defines “about,” but provides several materially different alternatives. Specifically, the specification states that “about” can mean a range considered reasonably similar to the stated value by a person of ordinary skill; can mean values within a standard deviation using measurements generally acceptable in the art; can mean ±10% of the specified value; or can mean ±1 unit of the specified value.
These alternative definitions establish different claim boundaries. For example, under the ±10% definition, “about 30 minutes” potentially encompasses approximately 27–33 minutes, whereas under the ±1-unit definition it potentially encompasses approximately 29–31 minutes. Similarly, “about 75°C” would encompass approximately 67.5–82.5°C under a ±10% construction but approximately 74–76°C under the ±1-unit construction. The alternative “standard deviation” construction introduces still another boundary dependent upon an unidentified population or measurement set, while the “reasonably similar” construction provides no specified objective criterion for selecting among the alternative definitions.
The issue is therefore not merely that the claims employ the term “about.” Terms of degree may be definite where the specification provides sufficient guidance regarding their scope. Rather, applicant's own express definitions provide multiple non-equivalent constructions without identifying which construction governs a particular claim limitation. MPEP § 2173.05(b) recognizes that terms of degree are acceptable only where one of ordinary skill would understand what is claimed in light of the specification.
Accordingly, a person of ordinary skill cannot determine which of the several expressly disclosed definitions establishes the metes and bounds of the temperature, pressure, ratio, flow-rate, and time limitations.
Claim Rejections - 35 USC § 102
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 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 1–4, 12, and 17–20 are rejected under 35 U.S.C. §102(a)(1) as being anticipated by CN 101530127 A (“CN ’127”).
Regarding claim 1, CN ’127 discloses using sea cucumber and sea-cucumber internal organs as raw material, freeze drying the material, pulverizing it, placing the pulverized sea cucumber into an extraction vessel, and carrying out supercritical carbon-dioxide extraction to obtain a sea-cucumber oil containing fatty acids. The reference specifically states that the resulting oil contains monounsaturated fatty acids and polyunsaturated fatty acids. See CN ’127, Abstract; Description, technical scheme, corresponding to translated text at lines 163–171. Thus, CN ’127 discloses a method in which a lipid-rich marine-organism starting material is exposed to a supercritical fluid at a defined temperature and pressure and the resulting fatty-acid-containing extract is collected.
Regarding claim 2, CN ’127 expressly identifies the supercritical fluid as carbon dioxide. See CN ’127, Description, extraction step 4; claim 2.
Regarding claims 3 and 4, CN ’127 expressly teaches supercritical CO₂ extraction over 30–70°C and 25–35 MPa. More particularly, Example 4 performs the extraction at 60°C and 32 MPa; Example 5 performs it at 70°C and 35 MPa; and Example 6 performs it at 55°C and 28 MPa. Each of those examples therefore contains a temperature within the claimed approximately 35–75°C range and a pressure within the claimed approximately 20–50 MPa range. See CN ’127, Examples 4–6; claims 2 and 5. Under MPEP §2131.03, disclosure of a specific point within a claimed range anticipates the range.
Regarding claim 12, CN ’127 expressly requires freeze drying the cleaned sea cucumber before extraction. See CN ’127, Description, steps 1–4; claims 2 and 6; Examples 4–6. Because claim 12 is written in the alternative as “freeze-dried or air-dried,” disclosure of freeze drying satisfies the claim.
Regarding claim 17, CN ’127 expressly pulverizes the dried sea cucumber before introducing it into the extraction vessel. The general process specifies a particle size of 20–120 mesh, and Examples 4–6 use pulverized material of approximately 80, 120, and 40 mesh, respectively. See CN ’127, Description, step 3; Examples 4–6; claims 2, 4 and 6.
Regarding claim 18, the starting material of CN ’127 is expressly a sea cucumber or its internal organs. See CN ’127, Abstract and claims 1–2.
Regarding claim 19, CN ’127 specifically identifies Cucumaria frondosa and its internal organs as suitable sea-cucumber raw material. Example 4 uses C. frondosa body wall, Example 5 uses C. frondosa body wall and internal organs, and Example 6 uses its internal organs. See CN ’127, Description; Examples 4–6; claim 7.
Regarding claim 20, CN ’127 expressly characterizes the extracted sea-cucumber oil as containing polyunsaturated fatty acids. Further, the fatty-acid analysis reported for Example 6 identifies C20:5 EPA at approximately 10.58% of the total fatty-acid material. See CN ’127, claim 1 and Example 6. Because claim 20 recites the listed fatty acids in the alternative, disclosure of PUFAs and EPA satisfies the limitation.
Claims 1–3, 5, 6, 8, 9, 12–14, and 20 are rejected under 35 U.S.C. §102(a)(1) as being anticipated by Tanaka et al. (“Tanaka”).
Regarding claims 1 and 2, Tanaka uses tuna shavings, a marine-organism starting material containing lipids and DHA-containing phospholipids, and extracts lipids from those shavings using supercritical carbon dioxide. The extracted material is characterized by fatty-acid analysis and includes DHA. See Tanaka, p. 569, Abstract; p. 570, §§1 and 2.1. The Abstract specifically describes SC-CO₂/ethanol extraction of tuna shavings and recovery of DHA-containing phospholipid.
Regarding claim 3, Tanaka reports extraction experiments on ethanol-soaked tuna shavings at temperatures including 40°C and 60°C, both within the claimed approximately 35–75°C range. See Tanaka, p. 573, §3.3 and Fig. 3.
Regarding claims 5 and 6, Tanaka expressly teaches soaking the freeze-dried tuna shavings in ethanol before exposure to supercritical CO₂. In particular, §2.4 states that the freeze-dried tuna shavings were soaked in the same amount of ethanol for approximately twelve hours before the soaked shavings were loaded into the extraction reactor and contacted with supercritical CO₂. See Tanaka, p. 571, §2.4. The Abstract likewise states that the tuna shavings were soaked in ethanol before SC-CO₂ extraction. Thus, ethanol—the disclosed entrainer/co-solvent—is included with the starting material before exposure to the supercritical fluid.
Regarding claims 8 and 9, Tanaka's 300-mL scale procedure loads 100 g of the ethanol-soaked tuna shavings and extracts that material with SC-CO₂ flowing at 10 mL/min. See Tanaka, p. 571, §2.5, first paragraph. Operation of the charged extraction reactor at a stated SC-CO₂ flow rate necessarily causes the supercritical fluid to flow over/through the starting material during extraction and therefore constitutes the claimed dynamic extraction. The disclosed 10 mL/min rate is the rate recited in claim 9.
Regarding claim 12, Tanaka expressly states that the dried tuna shavings were freeze-dried before extraction. See Tanaka, p. 570, §2.1, first paragraph.
Regarding claims 13 and 14, Tanaka expressly soaks the marine-organism material in an organic solvent before SC-CO₂ extraction, and expressly identifies that solvent as ethanol. See Tanaka, p. 571, §2.4.
Regarding claim 20, Tanaka expressly identifies the target compounds as DHA-containing phospholipids and discusses SC-CO₂ extraction of marine-material lipids containing PUFAs. The fatty-acid analysis of the tuna material identifies C20:5 and C22:6, with DHA constituting approximately 26% of the phospholipid fatty-acid profile. See Tanaka, pp. 569–571, Abstract, §1, §3.1 and Table 1.
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.
Claims 7 & 10 is/are rejected under 35 U.S.C. §103 as being unpatentable over Tanaka in view of Yang et al. (“Yang”).
Tanaka teaches the method of claim 5, including ethanol-soaking the marine starting material before SC-CO₂ extraction, but does not expressly state the ethanol-to-starting-material ratio on the weight/weight basis required by claim 7.
Yang expressly identifies ethanol-to-biomass ratio as an extraction variable in supercritical-CO₂ recovery of fatty acids. Yang tests ratios of 0.5:1, 1:1, 2:1, 3:1 and 4:1 v/w and reports that introduction of ethanol substantially increases recovery of total lipids, total fatty acids and GLA; Yang further concludes that a 3:1 ratio is sufficient from an economic standpoint. See Yang, §2.3 and §3.2.4; Fig. 3. Thus, Yang does considerably more than merely list possible ethanol amounts: it expressly establishes the ethanol-to-biomass ratio as a result-effective variable affecting fatty-acid extraction.
Expressed on a mass basis, Yang's disclosed ratios overlap the claimed range. The accepted density of ethanol at about 20°C is approximately 0.7893 g/cm³. Thus, for example, Yang's 2:1, 3:1 and 4:1 mL/g ratios correspond approximately to 1.58:1, 2.37:1 and 3.16:1 g/g, respectively, each falling within claim 7's approximately 1:1–5:1 weight ratio.
One of ordinary skill, starting from Tanaka's ethanol-soaked marine material, would have had reason to select the amount of ethanol according to Yang's expressly identified ethanol/biomass ratio because both references use ethanol in the extraction of fatty-acid-containing lipids from biological biomass and both address extraction efficiency and solvent consumption. Tanaka itself identifies reduction in ethanol consumption as an industrial consideration, while Yang expressly identifies the ratio that provides high fatty-acid recovery without unnecessary ethanol. The skilled artisan would have reasonably expected success because Yang experimentally demonstrates the effect of the ratio on lipid and fatty-acid recovery. This is therefore an application of a known result-effective extraction variable rather than an unsupported assertion of “routine optimization.”
As discussed above, Tanaka teaches the underlying dynamic SC-CO₂ extraction of marine-organism material. Tanaka does not disclose the approximately 30-minute dynamic extraction time required by claim 10.
Yang teaches SC-CO₂ extraction of fatty-acid-containing algal biomass and expressly employs a 30-minute dynamic extraction phase. In the conditions reported for Figures 3 and 4, Yang uses a 60-minute extraction consisting of a 30-minute static extraction followed by a 30-minute dynamic extraction. Yang also treats extraction time as an experimental process variable. See Yang, §3.2.4 and Figs. 3–4.
It would have been obvious to use Yang's 30-minute dynamic period in Tanaka's dynamic SC-CO₂ extraction because both references concern recovery of fatty-acid-containing lipids from biological biomass with supercritical CO₂, and Yang directly demonstrates that a 30-minute dynamic phase performs the extraction. The modification merely uses an experimentally established SFE phase duration for the same type of mass-transfer operation. The experimental success reported by Yang supplies the requisite reasonable expectation of success.
Claim 11 is rejected under 35 U.S.C. §103 as being unpatentable over Tanaka in view of Mehariya et al. (“Mehariya”),
Tanaka teaches the underlying SC-CO₂ extraction of lipid/fatty-acid-containing biomass but does not teach a 20-minute static phase.
Mehariya expressly teaches supercritical-CO₂ extraction of microalgal biomass and evaluates recovery of lipids and fatty acids. Section 3.4 states that extraction was conducted in cycles and that “each cycle has a static extraction time of 20 min.” See Mehariya, §3.4, p. 11 of 15.
One of ordinary skill would have had reason to incorporate the known 20-minute static contact period into Tanaka's SC-CO₂ process before commencing dynamic flow because a static period allows the supercritical solvent to contact and penetrate the biomass before the extract is swept from the vessel. Mehariya demonstrates that the precise 20-minute static period was actually used in an SFE process involving recovery of lipids and fatty acids from biomass. The proposed modification therefore does not depend upon arbitrarily selecting “20 minutes”; the precise claimed duration was already a known SFE operating condition in closely related biomass extraction, providing a reasonable expectation of successful extraction.
Claim 15 is rejected under 35 U.S.C. §103 as being unpatentable over Tanaka in view of Kermanshahi-pour et al. (“Kermanshahi-pour”).
Tanaka teaches soaking marine-organism material in ethanol before supercritical-CO₂ extraction, thereby teaching the limitations incorporated through claim 13, but Tanaka uses freeze-dried tuna material rather than the fresh/non-dried starting material recited in claim 15.
Kermanshahi-pour concerns recovery of PUFAs from a marine thraustochytrid and expressly compares freeze-dried biomass, wet biomass, and ethanol-treated wet biomass. Most importantly, Kermanshahi-pour reports that processing ethanol-treated wet biomass resulted in PUFA recovery and purity comparable to that obtained with freeze-dried biomass. See Kermanshahi-pour, Abstract and Conclusions. The reference identifies thraustochytrids as marine protists and specifically targets omega-3 PUFAs including DHA.
Accordingly, a person of ordinary skill seeking to simplify Tanaka's process would have had an express reason to apply Tanaka's ethanol treatment directly to non-dried/wet marine starting material rather than first freeze drying it: Kermanshahi-pour specifically demonstrates that ethanol treatment of wet marine biomass can produce PUFA recovery and purity comparable to freeze drying. The expected benefit is elimination of the drying operation while retaining effective fatty-acid recovery. Because Kermanshahi-pour experimentally demonstrates successful treatment of wet marine biomass with ethanol, there would have been a reasonable expectation that ethanol pretreatment could likewise be applied to Tanaka's non-dried marine material before extraction.
This rejection assumes that “fresh” in claim 15 is given its broadest reasonable meaning consistent with the specification as non-dried starting marine material. If applicant has supplied a narrower express definition of “fresh,” that definition should be applied before entering this rejection.
Claim 16 is rejected under 35 U.S.C. §103 as being unpatentable over Tanaka in view of Bruheim et al, US. Publication 2008/0274203 (“Aker”).
Tanaka teaches soaking marine tuna material with ethanol before supercritical-CO₂ extraction. See Tanaka, p. 571, §2.4. Tanaka also independently teaches that adding ethanol as an entrainer to SC-CO₂ substantially increases extraction yield; 5–20% ethanol is evaluated, and 5% ethanol produces about an 85% extraction yield. See Tanaka, p. 572, §3.2. Tanaka, however, describes the solvent-soaked sample as subsequently contacted with “neat” SC-CO₂ and therefore does not state as explicitly as claim 16 that the pre-soaking solvent is used as the co-solvent during the supercritical-fluid extraction.
Aker removes that distinction. Aker expressly teaches extraction of marine krill biomass by supercritical-fluid extraction with ethanol as a co-solvent. Example 7, paragraph [0103], extracts krill meal at 300 bar and 333 K using 5% ethanol with CO₂ for 60 minutes and then raises the ethanol content to 23%. The resulting oil contains EPA, DHA and total omega-3 fatty acids. See Aker, Example 7, ¶[0103], U.S. publication p. 18 and Table 21. Aker elsewhere expressly characterizes ethanol as the polar entrainer added to the SC-CO₂ extraction medium.
It would have been obvious to use the ethanol already employed in Tanaka's marine-biomass soaking step as the ethanol co-solvent during the subsequent SC-CO₂ extraction, as expressly taught by Aker. Both references teach ethanol-assisted SC-CO₂ extraction of marine lipid material, and both establish that ethanol improves recovery of the more polar lipid fraction. The modification would avoid an unnecessary solvent-removal/readdition operation and would retain ethanol in precisely the extraction environment in which Aker demonstrates successful recovery of EPA- and DHA-containing marine lipids. A person of ordinary skill therefore would have had both an articulated reason to make the modification and a reasonable expectation of success.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH D CARR whose telephone number is (571)272-0637. The examiner can normally be reached Monday-Friday (10:30 am -6:30 pm).
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/DEBORAH D CARR/ Primary Examiner, Art Unit 1691
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