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 1-10 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 are directed to a continuous extraction process and apparatus for extracting “biomolecules” from “biomass,” wherein the biomolecules are broadly recited as including, but not limited to, lutein, astaxanthin, colchicines, citral, and citronella (claim 6), and the biomass is broadly recited as including, but not limited to, marigold, maize, glory lily, microalgae, fungi, citrus plants, and various aromatic plants (claim 8).
These recited biomolecules belong to chemically and physically distinct classes of compounds, including carotenoids, alkaloids, and volatile terpenoids, which differ substantially in polarity, thermal stability, solvent affinity, and susceptibility to ultrasonic degradation. Likewise, the listed biomass sources differ substantially in cellular structure, oil content, moisture content, and extractability.
The specification does not reasonably convey possession of a single extraction process and apparatus that is applicable to this full scope of chemically diverse biomolecules and structurally diverse biomass types. The disclosure does not provide representative species, working examples, or common technical principles demonstrating that the same extraction solvents, co-solvents, ultrasonic conditions, pressures, and temperatures are suitable across the full breadth of compounds and biomass recited in the claims.
Instead, the claims rely on functional language (“valuable biomolecules,” “biomolecules selected from but not limited to…”) without identifying structural features, solvent systems, or operating conditions that would demonstrate possession of the full claimed genus. The absence of disclosure establishing that the inventors had possession of a broadly applicable extraction system for all recited biomolecules and biomass types renders the scope of the claims unsupported.
Accordingly, the specification does not reasonably convey to a person of ordinary skill in the art that the inventors were in possession of the claimed subject matter at the time of filing.
Claims 1-10 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. .
The claims require a continuous multi-stage extraction system using three extractors, phase separators, solvent recycling, interstage processing vessels, and ultrasonic cavitation, and purport to be applicable to a wide range of biomolecules and biomass sources.
Applying the factors set forth in In re Wands, 858 F.2d 731 (Fed. Cir. 1988):
1. Breadth of the claims
The claims encompass extraction of chemically unrelated biomolecules (carotenoids, alkaloids, and volatile terpenoids) from structurally diverse biomass sources, using broadly recited extraction solvents and co-solvents, without limitation to specific solvent systems or operating regimes.
2. Nature of the invention
Extraction efficiency, compound stability, and selectivity are highly dependent on compound chemistry, solvent polarity, temperature, pressure, and ultrasonic energy. Extraction behavior is therefore unpredictable across different compound classes and biomass matrices.
3. State of the prior art
The prior art recognizes that extraction conditions must be tailored to specific compound classes and plant or microbial matrices. There is no general, universally applicable ultrasonic multi-stage extraction process that functions across all claimed biomolecules and biomass types.
4. Level of skill in the art
A person of ordinary skill would understand that extensive optimization would be required to determine appropriate solvents, co-solvents, ultrasonic parameters, pressures, and temperatures for each biomolecule and biomass combination.
5. Amount of direction provided in the specification
The specification provides only broad ranges of temperature and pressure and does not identify suitable solvent systems, co-solvents, solvent recycling ratios, ultrasonic intensities, residence times, or compound-specific operating conditions necessary to successfully extract each class of biomolecules.
6. Presence or absence of working examples
The specification does not provide representative working examples covering the breadth of claimed biomolecules and biomass types, nor does it demonstrate successful extraction of different chemical classes under the same process conditions.
7. Quantity of experimentation required
Practicing the full scope of the claims would require substantial trial-and-error experimentation to identify workable solvent systems and process parameters for each biomolecule and biomass combination.
In view of the breadth of the claims, the chemical unpredictability of extraction processes, and the lack of detailed guidance or representative examples, undue experimentation would be required to practice the full scope of the claimed invention.
Accordingly, the claims are not enabled.
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 1-10 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.
1. “biomolecules” and “valuable biomolecules”
Claims 1, 6, and 7 recite “biomolecules” and “valuable biomolecules” without structural, chemical, or functional boundaries that would permit a person of ordinary skill in the art to determine which compounds fall within the scope of the claims. The term “valuable” is subjective and does not define a technical characteristic of the extracted compounds.
2. “co-solvent”
Claims 1(c) and 1(f) recite treatment with a “co-solvent,” but do not specify whether the co-solvent must be miscible or immiscible with the extraction solvent, whether it differs chemically from the extraction solvent, or what functional role it serves in extraction. Without such boundaries, the scope of the term cannot be determined with reasonable certainty.
3. Functional inconsistency in phase separators
Claim 10(b) recites that phase separators provide “latent heat of evaporation to separate the solvent from extracted products.” Phase separators are not typically heat-providing devices, and the claim does not clarify whether the phase separator also functions as an evaporator or whether additional heating components are required. This creates uncertainty as to the structure and operation of the claimed apparatus.
4. Inconsistent terminology: extractor vs reactor
Claim 10(a) recites a “first extractor, a second reactor and a third reactor,” while claim 1 consistently refers to extractors. The claims do not clarify whether the reactors are chemically reactive vessels or merely extraction vessels, rendering the scope of the apparatus unclear.
5. “continuous process” without operational boundaries
Claim 1 recites a “continuous process” but does not specify operational features that distinguish continuous from batch or semi-batch operation, such as continuous feed and discharge mechanisms or residence time relationships. As a result, it is unclear what operational modes are encompassed by the claims.
Because the claims contain multiple terms and structural inconsistencies that fail to provide reasonably certain boundaries of the claimed subject matter, the scope of the invention cannot be determined with reasonable certainty.
Claims which depend from an indefinite claim are also indefinite. Ex parte Cordova, 10 U.S.P.Q.2d 1949, 1952 (P.T.O. Bd. App. 1989).
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