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 .
Response to Arguments
Applicant's arguments filed 1 May 2026 have been fully considered but they are not persuasive. Applicant’s arguments have been fully considered but are not persuasive to overcome the rejections under 35 U.S.C. § 112(a). The amendments overcome certain discrete indefiniteness issues, as explained below, but do not cure the written-description and enablement deficiencies arising from the breadth of the claimed biomolecule, biomass, solvent, and operating-condition genera
(Old)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.
Applicant first argues that the rejected subject matter appeared in the application as originally filed and therefore enjoys a strong presumption of compliance with the written-description requirement. This argument is acknowledged but is not persuasive. Although originally filed claims are part of the disclosure and the Office bears the initial burden of explaining why the disclosure is inadequate, the presence of subject matter in an original claim does not automatically establish adequate written-description support. The specification must still reasonably convey that the inventors possessed the invention throughout the scope claimed. MPEP § 2163 expressly states that not all originally filed claims necessarily have adequate written-description support and that an original claim may be rejected when an aspect of the claimed invention has not been described with sufficient particularity.
The Office has met its initial burden by identifying the disparity between the breadth of the claims and the limited technical disclosure. Claims 1 and 10 broadly encompass extraction of unspecified “biomolecules” from unspecified “biomass,” while claims 6 and 8 expressly include chemically and structurally diverse carotenoids, alkaloids, volatile terpenoids, flowers, algae, fungi, citrus materials, and aromatic plants. The Office explained that these materials differ substantially in polarity, solvent affinity, thermal stability, ultrasonic stability, cellular structure, moisture content, and extractability. Applicant has not identified a disclosure establishing that the claimed process operates according to a common set of technical characteristics across this full scope.
Applicant next argues that possession is demonstrated because the specification describes the claimed sequence of multiple extraction stages alternating with ultrasonic cavitation stages. This argument does not address the full scope of the claims. The rejection does not dispute that the specification describes a three-extractor arrangement and the sequence of transferring biomass between the extractors. Rather, the deficiency is that the claims are not limited to that physical arrangement in the abstract. The claims require that extraction solvents dissolve broadly claimed biomolecules from broadly claimed biomass materials and that the process produce extracted biomolecules using the recited sequence. Successful performance of those functions depends on the particular target, biomass matrix, solvent system, co-solvent, pressure, temperature, residence time, and ultrasonic treatment.
A written description of one process arrangement does not, without more, establish possession of every functionally defined process embodiment falling within the claim. For a genus encompassing substantial variation, the disclosure must provide either a representative variety of species or identifying characteristics, such as a disclosed or art-recognized correlation, sufficient to show possession of the genus. A representative number of species must reflect the variation within the claimed genus, not merely provide isolated examples from a small portion of its scope.
Applicant argues that Example 1 is representative of the claims. This argument is not persuasive. Example 1 describes extraction of lutein from marigold and provides certain operating parameters, including feed rate, residence time, ultrasonic frequency, treatment duration, temperature, and pressure. The example does not identify the extraction solvent, co-solvent, relative quantities, solvent-to-biomass ratio, solvent flow rate, or recycle ratio. The example therefore does not identify the chemical characteristics or solvent-selection principles that would make lutein extraction representative of extraction of materially different alkaloids, volatile terpenoids, flavors, fragrances, or any other substance encompassed by the unrestricted term “biomolecules.”
The statements that the “same setup” was used to extract astaxanthin and colchicine do not cure the deficiency. The specification reports extraction results but does not disclose the solvents, co-solvents, ultrasonic conditions, temperatures, pressures, residence times, or other process parameters used for those extractions. Likewise, the specification identifies plants associated with citral and citronellal, but does not provide an extraction procedure or experimental result for either compound. Merely naming additional targets and biomass sources does not establish that the disclosed embodiments are representative of the full variety encompassed by the claims.
Applicant also argues that ultrasonic cavitation mechanically disrupts plant tissue and therefore operates independently of the chemical identity of the target biomolecule or biomass. This argument is not persuasive because mechanical disruption is only one aspect of the claimed process. Cavitation may assist in breaking a cellular structure, but the claims further require the extraction solvent to dissolve the target biomolecule, the resulting product and solvent to be separated, and the solvent to be condensed and recycled. The specification itself recognizes that different extraction solvents and co-solvents must be selected depending on the target biomolecule and biomass. Applicant expressly states that solvent selection “entirely depends” on the particular biomolecule and biomass combination. Thus, the asserted non-specificity of cavitation does not establish a common technical characteristic sufficient to demonstrate possession of every claimed extraction embodiment.
Applicant argues that there is no requirement to claim flow rates, solvent ratios, ultrasonic frequencies, or residence times. This argument does not address the rejection. The rejection does not require that all such parameters be placed in the claims. The issue is whether the specification provides sufficient descriptive support for the broad process that was claimed. The absence of meaningful solvent-selection criteria, process correlations, or representative operating examples demonstrates that the disclosure does not reasonably convey possession of the entire genus, irrespective of whether those parameters must be expressly recited in the claims.
Applicant’s reliance on the ordinary skill in the art is also unpersuasive. Applicant has not identified evidence establishing that an artisan would recognize a common extraction principle applicable to the complete claimed scope. A statement that an artisan could determine an appropriate solvent does not demonstrate that the inventors themselves possessed all process embodiments defined only by successful extraction. Written description is separate from enablement, and a showing that an embodiment might have been obvious or discoverable through routine work does not necessarily demonstrate that the embodiment was described as part of the inventor’s invention.
Accordingly, the written-description rejection of claims 1–10 is maintained. Claims 2–9 depend directly or indirectly from claim 1 and do not cure the unsupported breadth of the underlying biomolecule, biomass, solvent, and co-solvent genera. Claim 10 is expressly directed to an apparatus configured to perform the process of claim 1 and therefore retains the same unsupported functional scope.
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. .
Applicant relies on In re Marzocchi, In re Dinh-Nguyen, and In re Bowen for the proposition that the Office must provide acceptable evidence or reasoning sufficient to question the accuracy of an enabling disclosure. The cited principle is acknowledged, but it does not require withdrawal of the rejection. The Office need not establish actual inoperability of every undisclosed embodiment. The Office must provide a reasonable explanation why the disclosure does not enable the claimed scope, after which applicant must substantively address the identified deficiencies. MPEP § 2164 states that the examiner’s initial burden is satisfied by establishing a reasonable basis to question whether the protection provided by the claim is adequately enabled.)
That burden was met here. The Office identified the breadth of the claimed biomolecule and biomass genera, the unpredictable dependence of extraction on compound chemistry and matrix structure, the absence of specific solvent systems and co-solvents, the limited operating guidance, the absence of representative detailed examples, and the resulting need for target-by-target experimentation. These are specific technical reasons, rather than a mere unsupported conclusion that the disclosure is inadequate.
Applicant states that the first two Wands factors—the breadth of the claims and the nature of the invention—are not substantive. This position is inconsistent with controlling enablement practice. The breadth of the claims and the nature of the invention are expressly identified Wands factors and must be considered with the state and predictability of the art, the amount of direction, the working examples, and the quantity of experimentation.
The breadth of the claims weighs strongly against enablement. Claim 1 is not limited to a defined biomolecule class, biomass source, solvent, co-solvent, solvent ratio, ultrasonic energy level, or residence time. Claims 6 and 8 remain open-ended through the language “selected from but not limited to.” Claims 4 and 5 additionally require extraction efficiencies of 95–100% and product purities of 90–95% across the broad scope inherited from claim 1. The more broadly an applicant claims an entire class of processes, the more the specification must enable throughout that class.)
Applicant argues that it is unnecessary to recite specific solvents and operating parameters because those details can be selected by a person of ordinary skill. Again, the rejection does not require that every process variable appear in the claims. The enablement inquiry concerns whether the specification teaches the artisan how to select and use those variables throughout the claimed scope without undue experimentation. The disclosure provides no selection rule correlating the polarity, molecular structure, thermal stability, or matrix location of a target biomolecule with a suitable solvent, co-solvent, pressure, ultrasonic intensity, or residence time.
Applicant’s assertion that solvent and co-solvent selection is routine is not sufficient to rebut the rejection. Applicant concedes that solvent selection depends on the particular biomolecule and biomass combination but does not explain how an artisan would make that selection, how many alternatives would require testing, which failures would be expected, or whether the same solvent may be recycled through all three extractors without degrading selectivity or recovery. No declaration, technical literature, comparative data, or defined screening protocol was submitted to show that the required experimentation would be predictable and limited.
Applicant again relies on Example 1 as representative of the full claims. Example 1 does not provide sufficient direction for this purpose. Although it identifies selected mechanical and operating parameters, it omits the identity and quantity of the extraction solvent and co-solvent—the materials that perform the claimed dissolving and interstage-treatment functions. An artisan seeking to reproduce even the disclosed lutein embodiment would therefore have to independently determine essential chemical aspects of the process.
The reported astaxanthin and colchicine results do not supply the missing guidance. They do not state whether the same solvent, co-solvent, temperatures, pressures, residence times, ultrasonic frequencies, or solvent ratios were used. A statement that the same “setup” was employed establishes, at most, that the same general equipment configuration was used. It does not teach the process conditions that produced the reported results.
Applicant’s mechanical-cavitation argument likewise does not establish enablement. Even assuming cavitation disrupts biomass non-selectively, the artisan must still determine whether and under what conditions the target dissolves, survives ultrasonic and thermal exposure, separates from the solvent, and achieves the claimed recovery and purity. The physical disruption of cell walls does not make the solvent-extraction and product-recovery behavior of chemically unrelated compounds predictable.
Applicant argues that the claimed sequence is new and therefore should be protected regardless of the particular target or operating conditions. Novelty is not a substitute for enablement. Section 112(a) requires the disclosure to enable the scope sought, even where the general process architecture may be novel. A specification may leave an artisan to perform reasonable adaptation or testing, but it may not leave the artisan with a research assignment requiring trial-and-error identification of the embodiments that work.
Applicant’s response concerning the quantity of experimentation merely repeats that the necessary selections are routine. It does not rebut the Office’s finding that multiple variables would have to be optimized for each biomolecule/biomass combination. The claims encompass variation in target chemistry, biomass morphology, solvent identity, co-solvent identity, solvent ratio, ultrasonic conditions, temperature, pressure, residence time, and recycle operation. The specification supplies no general rule that permits these variables to be selected reliably. The required work is therefore not merely verification of known operating conditions; it is the development of those conditions.
The enablement rejection is consequently maintained against claims 1–10. Claim 7 limits the target to lutein but remains dependent from a claim covering lutein extraction from unrestricted biomass using unspecified solvents and co-solvents. Claim 9 limits the biomass to marigold but does not limit which biomolecule is extracted. Claim 10 requires an apparatus configured to perform the broad process of claim 1 and therefore incorporates the nonenabled functional scope of that process.
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.
Applicant’s amendments and arguments have overcome certain individual grounds, but not the rejection in its entirety.
Applicant has not, however, overcome the rejection of claim 10 concerning the phase separators. Claim 10 continues to recite phase separators “to provide a required latent heat of evaporation to separate the solvent from extracted products.” Applicant’s statement that phase separators using latent heat are known does not clarify whether the claimed separator supplies heat, functions as an evaporator, produces evaporation through pressure reduction, or merely receives a stream that has already been heated. The specification separately identifies heating jackets as supplying sensible heat, further leaving uncertain what structure or operation permits the phase separator itself to “provide” latent heat. The rejection of claim 10 on this basis is maintained.
The prior rejection based on the term “continuous process” is withdrawn. The specification defines a continuous process as one in which product is discharged without interruption and not in groups, and also identifies rotary valves and continuous countercurrent extraction units as providing continuous operation.
Amended claim 10 nevertheless presents an additional indefiniteness issue. The claim now states that the apparatus contains three repeating units, “each of the repeating units” comprising specified components “configured to perform the continuous process described in claim 1.” It is unclear whether each individual repeating unit must be capable of performing the entire three-extractor process of claim 1, or whether the three units collectively perform that process. Because one repeating unit contains only one extractor, the former interpretation is inconsistent with claim 1, while the latter interpretation is not clearly expressed. Claim 10 therefore fails to define the relationship between the repeating units and the incorporated process with reasonable certainty.
The § 112(b) grounds based on “valuable,” “biomolecules,” “co-solvent,” extractor/reactor terminology, and “continuous process” are withdrawn. The § 112(b) rejection of claim 10 concerning the phase separators providing latent heat is maintained, and claim 10 is additionally rejected because it is unclear whether each repeating unit or the complete apparatus is configured to perform the process of claim 1.
(New)Claim Rejections - 35 USC § 112
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.
Claim 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.
Claim 10 recites, in pertinent part, that “the extraction apparatus comprises three repeating units, each of the repeating units comprising an extractor, a phase separator, an interstage processing vessel with cavitation probe and a condenser, configured to perform the continuous process described in claim 1.” It is unclear whether the phrase “configured to perform the continuous process described in claim 1” modifies each individual repeating unit or the extraction apparatus comprising the three repeating units collectively.
Under the first reasonable interpretation, each individual repeating unit must be configured to perform the entire process of claim 1. However, each repeating unit is recited as containing only one extractor, one phase separator, one interstage processing vessel with a cavitation probe, and one condenser, whereas claim 1 requires a process involving first, second, and third extractors, multiple phase-separation operations, and sequential interstage ultrasonic-cavitation treatments. Thus, a single repeating unit does not contain the components necessary to perform the entire process of claim 1. Under the second reasonable interpretation, the three repeating units collectively are configured to perform the process of claim 1; however, claim 10 does not expressly state that the units are collectively configured or interconnected to perform that process.
Accordingly, one of ordinary skill in the art cannot determine with reasonable certainty whether claim 10 requires each repeating unit individually to perform the process of claim 1 or requires the three repeating units collectively to perform the process. Because the claim is reasonably susceptible to more than one interpretation and the interpretations impose materially different structural and functional requirements, the metes and bounds of claim 10 are unclear. During examination, a rejection under § 112(b) is appropriate when claim language, under its broadest reasonable interpretation, is subject to more than one reasonable interpretation. MPEP §§ 2173.01 and 2173.02.
Applicant may clarify the intended scope by amending the limitation, for example, to recite that “the three repeating units are interconnected and collectively configured to perform the continuous process of claim 1.”
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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