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 4 and 19 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims recite a fatty acid desaturase comprising “group 3y cyanobacteria.” The specification does not reasonably convey that the inventors were in possession of the claimed subject matter as of the filing date. Specifically, the specification does not:
define “group 3y cyanobacteria,” identify representative species or strains, correlate the group to a recognized taxonomic or phylogenetic classification, or describe common structural, genetic, or functional characteristics sufficient to delineate the claimed group.
A claim directed to a biological genus requires disclosure of either representative species falling within the scope of the genus or defining characteristics sufficient to delineate the scope of the genus. The specification provides neither. Accordingly, claims 4 and 19 lack adequate written description and are rejected under 35 U.S.C. §112(a).
Claims 23-24 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.
Claims 23 and 24 require producing biodiesel from cocoa butter having a cloud point reduced to as low as −61°F, or within a range extending to −61°F. While the specification describes desaturation and urea clathration processes generally, it does not provide sufficient guidance to enable a person of ordinary skill in the art to reliably achieve the claimed extreme cloud point across the full scope of the claims.
In determining whether undue experimentation would be required, the following Wands factors are considered:
1. Breadth of the claims:
The claims encompass biodiesel compositions achieving extremely low cloud points down to −61°F.
2. Nature of the invention:
Cold-flow properties of biodiesel are highly sensitive to fatty acid composition, feedstock variability, and processing conditions, making the art unpredictable at extreme low-temperature performance limits.
3. State of the prior art:
The prior art generally teaches more modest cloud point reductions and does not establish routine achievement of cloud points approaching −61°F for biodiesel derived from cocoa butter.
4. Level of guidance in the specification:
The specification does not disclose specific process parameters, compositional targets, or control variables necessary to achieve the claimed lower endpoint.
5. Presence or absence of working examples:
The specification does not include working examples demonstrating biodiesel compositions having cloud points at or near −61°F.
6. Amount of experimentation required:
Absent guidance, a skilled artisan would be required to engage in extensive trial-and-error experimentation to determine whether and how the claimed cloud point can be achieved.
7. Predictability of the art:
Biodiesel cold-flow behavior at extreme low temperatures is unpredictable.
Considering these factors as a whole, the specification does not enable the full scope of claims 23 and 24 without undue experimentation. Accordingly, claims 23 and 24 are rejected under 35 U.S.C. §112(a) for lack of enablement.
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 4-5, 14, 17, 19-20, 22-24 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.
Claims 5, 17, 20, 22, and 23 recite that “at least a portion” of saturated fatty acids is converted or separated. The phrase “at least a portion” fails to set forth any objective minimum amount, percentage, or measurable threshold required to satisfy the limitation. As written, the claims encompass an indeterminate range extending from a de minimis amount to substantially complete conversion or separation, such that the scope of the claims cannot be determined with reasonable certainty.
Accordingly, claims 5, 17, 20, 22, and 23 are indefinite.
Claims 4 and 19 recite a “group 3y cyanobacteria” fatty acid desaturase. The term “group 3y cyanobacteria” does not have a clear, well-established meaning in the art, and the claims do not define the term or otherwise provide objective boundaries for determining which organisms are encompassed by the limitation. As a result, one of ordinary skill in the art cannot determine the scope of the claims with reasonable certainty.
Accordingly, claims 4 and 19 are indefinite.
Claim 14 recites “centrifuge filtering the clathrates from the biodiesel.” It is unclear whether this limitation refers to centrifugation, filtration, a sequential combination of centrifugation and filtration, or a specific hybrid separation process. Because the mechanism by which separation is achieved is ambiguous, the scope of the claimed process step cannot be reasonably ascertained.
Accordingly, claim 14 is indefinite.
Claim 10 recites that the catalyst comprises “potassium hydroxide sodium hydroxide.” As written, the claim is ambiguous as to whether the catalyst comprises both potassium hydroxide and sodium hydroxide, or either potassium hydroxide or sodium hydroxide. The claim does not include a conjunction (e.g., “and” or “or”) sufficient to clarify the intended scope of the catalyst limitation.
Accordingly, the scope of claim 10 cannot be determined with reasonable certainty.
Claims 23 and 24 recite that the cloud point of the biodiesel is reduced “to as low as −61°F.” The phrase “as low as” is open-ended and fails to define a clear lower bound for the claimed limitation. As written, the claims encompass an indeterminate range extending below −61°F, such that the metes and bounds of the claims cannot be determined with reasonable certainty.
Accordingly, claims 23 and 24 are indefinite.
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.
Claim(s) 1-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2007/071046 (hereafter WO’046) in view of Heilmann et al. (US 7,655,833, hereafter US’833).
WO’046 discloses a process for preparing biodiesel (fatty alkyl esters) from triglyceride oils by transesterification, followed by phase separation and downstream processing (see Abstract; Summary; Detailed Description). WO’046 teaches that suitable feedstocks include vegetable oils and animal fats, and expressly lists cocoa butter oil among suitable oils for biodiesel production (see Detailed Description, list of suitable oils).
WO’046 further teaches: transesterifying triglyceride oils to produce fatty alkyl esters (biodiesel); separating biodiesel from glycerin-containing phases; and
post-transesterification processing directed to improving biodiesel handling and properties.
WO’046 does not disclose enzymatic desaturation of triglycerides prior to transesterification.
US’833 discloses fatty acid desaturase (ADS) polypeptides capable of desaturating saturated fatty acids, including C14–C18 fatty acids (col. 2, ll. 63–67). US’833 further teaches that the activity of ADS results in a decrease in saturated fatty acids and an increase in unsaturated fatty acids in lipid substrates (col. 2, ll. 68–74).
US’833 additionally discloses: methods for decreasing saturated fatty acid content in oils using ADS enzymes (col. 3, ll. 40–45); nucleic acid sequences and expression constructs encoding functional ADS enzymes (col. 3, ll. 10–20; ll. 25–34); and implementation of ADS systems to alter fatty acid composition in glycerolipid-based substrates, such as triglyceride oils (col. 2, ll. 68–74; col. 3, ll. 40–55).
Thus, US’833 teaches a known enzymatic technique for reducing saturated fatty acid content in triglyceride feedstocks.
Claim 1 recites, in substance:
producing biodiesel from cocoa butter;
desaturating cocoa butter using a fatty acid desaturase;
transesterifying the desaturated cocoa butter to produce biodiesel;
and separating biodiesel from other components.
WO’046 teaches producing biodiesel from triglyceride oils, expressly including cocoa butter oil, by transesterification and separation steps. US’833 teaches enzymatic desaturation of saturated fatty acids in triglyceride substrates using fatty acid desaturases (col. 2, ll. 63–74; col. 3, ll. 40–45). Accordingly, WO’046 discloses all limitations of claim 1 except enzymatic desaturation, which is taught by US’833.
Claims 2–9 further limit the desaturating step to enzyme fatty acid desaturases, including cytochrome b5–dependent desaturase systems. US’833 discloses ADS enzymes and associated desaturase systems suitable for desaturating saturated fatty acids in lipid substrates (col. 2, ll. 63–74; col. 3, ll. 10–20; ll. 25–34), thereby meeting the additional limitations of claims 2–9.
Claim 10 further specifies that the transesterification is carried out using alkali metal hydroxide catalysts and methanol or ethanol. WO’046 teaches transesterification of triglyceride oils using alkali catalysts, including sodium- and potassium-based hydroxides, in combination with lower alcohols such as methanol and ethanol, which are conventional reagents in biodiesel production. Selection of potassium hydroxide or sodium hydroxide as the catalyst, and methanol or ethanol as the alcohol, represents a routine and predictable choice of known reagents, and therefore does not impart patentable distinction.
Claim 11 further specifies separating glycerol by gravity draining. WO’046 teaches density-based phase separation of biodiesel and glycerol, including settling and draining of the glycerol layer. Gravity draining of glycerol from biodiesel is a conventional and predictable separation technique routinely employed in biodiesel processes. Accordingly, claim 11 does not add a patentable distinction.
Claims 12–16 recite additional biodiesel processing and separation steps. WO’046 teaches post-transesterification separation and purification steps directed to improving biodiesel handling and quality (see Detailed Description) . Applying known biodiesel purification techniques to the biodiesel produced by the combined process would have been an obvious matter of routine optimization.
Claims 17–22 recite preparing cocoa butter for conversion to biodiesel by reducing saturated fatty acids, including via enzymatic desaturation. WO’046 teaches cocoa butter oil as a biodiesel feedstock, and US’833 teaches enzymatic desaturation of saturated fatty acids in triglyceride oils (col. 2, ll. 63–74; col. 3, ll. 40–45). The combination therefore teaches preparing cocoa butter for biodiesel conversion by enzymatic desaturation prior to transesterification.
Claim 23 further recites that the biodiesel produced from cocoa butter has a cloud point reduced to as low as −61°F.
WO’046 teaches improving biodiesel properties through processing and modification of feedstock composition, including removal or reduction of saturated fatty acid components, which are known to adversely affect cold-flow properties. US’833 teaches enzymatic desaturation as a means of reducing saturated fatty acid content in triglyceride feedstocks. It was well known in the art that reducing saturated fatty acids lowers biodiesel cloud point.
Achieving a particular cloud point value, including an extreme low value such as −61°F, represents an optimization of a result-effective variable (cold-flow temperature) through the combined application of known techniques—enzymatic desaturation and downstream processing/fractionation. Absent a showing of criticality or unexpected results at −61°F, selection of a specific cloud point within the predictable results of reducing saturated fatty acids would have been an obvious matter of routine optimization.
Accordingly, claim 23 does not add a patentable distinction over the combined teachings of WO’046 and US’833.
Claim 24 recites a cocoa butter-derived biodiesel produced by desaturation, transesterification, and downstream processing. The combined teachings of WO’046 and US’833 disclose the recited process steps and resulting biodiesel.
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine WO’046 with US’833 because:
WO’046 recognizes that feedstock composition affects biodiesel properties and processing behavior.
It was well known that reducing saturated fatty acid content improves biodiesel cold-flow and handling characteristics.
US’833 teaches enzymatic desaturation as a known and predictable technique for reducing saturated fatty acids in triglyceride feedstocks (col. 2, ll. 63–74; col. 3, ll. 40–45).
Applying enzymatic desaturation prior to transesterification in the WO’046 process would have predictably improved biodiesel properties without altering the fundamental biodiesel production steps.
The combination represents the use of a known technique to improve a similar process for the same purpose, yielding predictable results, consistent with KSR Int’l Co. v. Teleflex Inc.
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