DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Preliminary Amendment filed on October 16, 2024, has been received and entered.
Claim Disposition
3. Claims 1-20 are pending and are under examination.
Information Disclosure Statement
4. The Information Disclosure Statement filed on October 16, 2024, has been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action. Note that some references have been lined through that have no date or an improper date citation.
Claim Objection
5. Claims 1-20 are objected to because of the following informalities:
For clarity and precision of claim language, it is suggested that claim 14 is amended to read, “ A process for producing free fatty acids, [[said process]] comprising:
The dependent claims hereto are also included.
For clarity it is suggested that claim 2 is amended to read, “The process of claim 1,[[wherein the process]] further [[comprises]] comprising….”.
For clarity and consistency it is suggested that claims 3-20 are amended to delete “according to” and instead recite “of”.
For clarity it is suggested that claim 6 is amended to delete “and/or’’ after ‘halophytes and before ‘animal fat’ (i.e. “…from halophytes, animal fat or any combination thereof”).
For clarity it is suggested that claim 11 is amended to italicize all the organism names (see candidum lipase, Hyphozyma etc.) and to delete reference to ‘homologs thereof and variants thereof’.
Appropriate correction is required.
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.
6. Claims 1-20 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.
Claim 1 and the dependent claims hereto are indefinite for the recitation of “water in an amount sufficient” because this limitation should be expressly recited as the ordinary skilled worker cannot guess what is sufficient and note that dependent claims recite a specific amount. See also the language of “effective to substantially complete” as this language is also vague and indefinite.
Claim 5 is indefinite for the recitation of “fat producing genetically manipulating microorganism” because the language is vague and an ordinary skill worker is not informed of the genetic manipulation this could mean a deletion of a gene, an amino acid or a metabolic change. This language does not clearly set forth what is happening in the microorganism.
Claim 7 lacks clear antecedent basis for the recitation of “..the temperature in step (a)” because the temperature is recited in step b.
Claim 15 lacks clear antecedent basis for the recitation of “..water in an continuous stirred tank reactor is added to one or more reactors”, the claim recites ‘reactor’ meaning one and does not expressly say water is added or the type of reactor.
Claim 16 lacks clear antecedent basis for “one or more CSTR reactors.
Claim 17 lacks clear antecedent basis for the recitation of “the amount of water added in the reactor”. See also claim 18 because it independent claim does not clearly set forth that water is added.
Claim 20 lacks clear antecedent basis for the recitation of “the split yield”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
7. Claim(s) 1, 3-4, 6-15, 17 and 20 is/are rejected under 35 U.S.C. 102(a)(1) and (a) (2) as being anticipated by EP 1006174 (of record in the application).
The claimed invention is directed to a process for producing free fatty acids.
EP 1006174 discloses a process for producing free fatty acids (here: carboxylic
acids) and glycerole (here: glycerine) in a continuous or batch process by (a) enzymatic pre-splitting, namely by hydrolysing a fatty acid feedstock such as e.g. palm oil or animal fat with a lipase and water at e.g. 45°C for 24 hours in a reactor and mixing said partially hydrolysed fatty acid feedstock in a thermal splitter (here: pressure splitter) at a temperature between 200-300°C at a pressure of 31-65.5 bar (450-950 psi). The
enzymatic hydrolysis is carried out preferably at a temperature below 70°C with lipases
derived from e.g. Candida cylindracea, Humicola lanuginosa or Pseudomonas sp.
ATCC 21808. According to example 2 the molar water : feedstock ratio is 0.24, i.e. within the claimed range. Example 3 discloses the use of 0.02 g Novo LIPOLASE TM 30T lipase per 200 g fatty acid feedstock which falls within the range of present claim 10. In order to use larger amounts of feedstock a tank reactor equipped with a side mounted agitator is described in example 5. Figure 3 demonstrates an improvement in free fatty acid yield by combining lipase pre-splitting and hydrolysis in a thermal splitter column to an acid value of 186 compared to a maximum value of 200, i.e. a split yield of 93% is achieved ([0008],[0018],[0021]-[0026];figure 3; examples 2,3,5). Therefore, the limitations of the claims are met by the reference.
8. Claim(s) 1-4, 6-12, 15 and 17 is/are rejected under 35 U.S.C. 102(a)(1) and (a) (2) as being anticipated by EP 0832183 (of record in the application).
EP 0832183 refers to a continuous process for producing free fatty acids
comprising (a) a step of hydrolysing a fatty acid feedstock such as oils and fats such as tallow in the presence of a lipase, e.g. Novo LIPOLASE™ 100T a lipase from Humicola lanuginosa, and a minor amount of water at elevated temperature, e.g. 60°C, in a reactor equipped with an agitator and (b) a step of processing said mixture of step (a) in a pressure splitter with elevated temperature (200°C to 300°C) and pressure (31
bar-65.5 bar (here: 3.10 to 6.55 MPa)) to obtain free fatty acids and glycerol. From the resulting glycerine-water stream the water is removed so that the free fatty acids are at least partially separated. Example 2 shows the use of Lipolaseᵀ in the range of present claim 10 (after calculated conversion: 48,851 mg enzyme/kg tallow). In example 1 the molar ratio of water: fatty acid feedstock is 0.89 ([0009]-[0010],[0012];examples 1,2). Therefore the limitations of the claims are met by the reference.
9. Claim(s) 1, 3, 4, 6-15 and 17 is/are rejected under 35 U.S.C. 102(a)(1) and (a) (2) as being anticipated by WO 98/27219 (of record in the application).
WO 98/27219 relates to a process for converting glycerides into free fatty acids and glycerol by hydrolysing a glyceride feedstock with a lipase such as Novo LIPOLASE™ 100T in the presence of water and calcium, magnesium or mixtures
thereof under agitation and at a temperature between 50-60°C to obtain a partially hydrolysed glyceride feedstock. Said feedstock is introduced into a thermal splitter column (here: pressure splitter) to hydrolyse the remaining glycerides at a temperature between 250-280°C and at a pressure between 37.9-65.5 bar (here: 550-950 psi). The feedstock may be fats as tallow or oils as palm oil, the enzyme is dosed at 75 mg/kg feedstock (recalculated values) and the enzymatic step may be carried out in batch or continuous mode for a duration of 24-48 hours. The reactor is a continuously stirred reactor and the molar water : feedstock ratio is 0.705. The maximum yield of free fatty acids that was achieved after the partial enzyme splitting was an acid value of 48.8
compared to a maximum of 200 for complete hydrolysis, no value is indicated for said yield after the claimed two-step procedure (page 9, line 15 - page 12, line 17; examples 1,2; table 1). Therefore the limitations of the claims are met by the reference.
Therefore, the limitations of the claims are met by the reference.
Conclusion
10. No claims are presently allowable.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652