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 .
DETAILED ACTION
The amendment filed 05/01/2026 has been entered. Claims 2, 10, 20, 21, 23, 24, and 26-28 are cancelled. Claims 1, 3-9, 11-13, 14-19, 22, and 25 are pending.
Election/Restrictions
Applicant's election with traverse of claims 1-9 and 11-13 in the reply filed on 05/01/2026 is acknowledged. The traversal is on the grounds that claim 1, as amended, does make a contribution over the prior art. This is not found persuasive because the restriction was based on the claims as they were originally presented.
The requirement is still deemed proper and is therefore made FINAL.
Claims 14-19, 22, and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/01/2026.
Claims 1, 3-9, and 11-13 are under examination.
Claim Objections
Claims 1 and 5-7 are objected to because of the following informalities:
Claims 1 and 7 contain grammatical errors and convoluted language. Applicant may consider following amendment:
Claim 1. A process for extracting a metabolite from a raw material comprising the steps of: (a) contacting the raw material with a first extraction composition; (b) separating the first extraction composition containing the metabolite from the raw material, and (c) contacting the composition from step (b) with a second extraction composition,
wherein the raw material is not destroyed after extraction,
wherein the raw material is a microbial cell culture.
Claim 7. The process of claim 1, wherein the second extraction composition comprises a silica-based solid phase.
Claims 5 and 6 are each missing a period at the end of the sentence.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 3-5, 8, 9, and 12 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 3, which depends from claim 1, recites that the raw material is selected from the group consisting of a cell culture comprising bacteria, yeasts, plant cell culture and small cells filamentous microbes, and algae. However, claim 1 recites that the raw material is a microbial cell culture. Therefore, it is unclear if the claim means that the microbial cell culture of claim 1 may also contain plant cells, or if the raw material may only include plant cells. Moreover, it is also unclear what “small cells filamentous microbes” means, as the phrase is not an art recognized phrase and is not defined in the instant specification. One of ordinary skill in the art would not be able to ascertain the in the raw material comprises.
Claims 4 and 5 are also rejected as they depend from claim 3.
Claim 8 recites: wherein the first extraction composition comprises a solvent that is a substituted (with Fl, Cl, Br or I) hydrocarbon. It is unclear if the elements in parentheses are required or optional, and thus not required, by the instant claim.
A broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation of a “perfluorocarbon”, and the claim also recites “optionally, wherein the perfluorocarbon is selected from the group consisting of FC-3283, FC 40, FC 770 and FC 3284”, which is the narrower statement of the limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
Claim 9 also contains the trademark/trade names FC-3283, FC 40, FC 770, and FC 3284. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe perfluorocarbons and, accordingly, the identification/description is indefinite.
Claim 12 contains a Markush group, but recites “or” instead of “and” at the end of the list of alternatives. Therefore, the list is open-ended and it is unclear what other alternatives are intended to be encompassed by the group.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 4, 6, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Oudshoorn et al., (EP 3766982 A1; cited in the IDS filed 03/20/2024).
Regarding claim 1, Oudshoorn teaches a method for recovering a biocatalytically produced organic substance, i.e., a metabolite, from a reaction mixture (para. [0023]). Oudshoorn teaches that the biocatalyst usually is, or originates from, a microorganism (para. [0081]), which suggests a microbial cell culture raw material. Oudshoorn teaches that the method comprises a first extraction wherein the organic substance is extracted from the reaction medium, a separation of the liquid product recovery phase, containing the organic substance, from the reaction mixture, and a second extraction of the organic substance from the product recovery phase, called a back-extraction (claim 17). Although Oudshoorn does not explicitly teach that the reaction mixture, i.e., cell culture raw material, is not destroyed, Oudshoorn does not teach a step of destroying the reaction mixture after extraction, therefore, it would be obvious to one of ordinary skill in the art that the method of Oudshoorn does not require a step of destroying the raw material after metabolite extraction.
Regarding claim 3 and 4, Oudshoorn teaches that the biocatalyst may be algae (para. [0081]), which suggests that the reaction mixture may be an algal cell culture.
Regarding claim 6, Oudshoorn teaches that ethanol may be used as the solvent for the second extraction (para. [0129]).
Regarding claim 11, Oudshoorn teaches that a preferred organic substance produced/recovered in accordance with the invention is an isoprenoid (para. [0089]).
Regarding claim 12, Oudshoorn teaches that the isoprenoid may be patchoulol (para. [0090]).
Regarding claim 13, although Oudshoorn teaches that the biocatalyst may be plant cells, Oudshoorn also teaches that the biocatalyst may be algae, fungi, or prokaryotic microorganisms. Therefore, it would be obvious to one of ordinary skill in the art that a raw material cell culture that does not contain plant material may be used in the process of Oudshoorn.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Oudshoorn et al., (EP 3766982 A1) as applied to claim 4 above, and further in view of Heaps et al., (US 2012/0058535 Al).
See discussion of Oudshoorn above, which is incorporated into this rejection as well.
Oudshoorn does not teach that the algae may be a Chlamydomonas reinhardtii strain.
However, Heaps teaches a method for the production of terpenes and terpenoids (Abstract) using microorganisms that may include Chlamydomonas reinhardtii (p. 7, col. 1, para. [0016]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to specifically use Chlamydomonas reinhardtii as taught by Heaps, as the biocatalyst to produce an organic substance as taught by Oudshoorn. One of ordinary skill in the art would have been motivated to do so because Heaps teaches that Chlamydomonas reinhardtii may be transformed with vectors for the production of terpenes and terpenoids, i.e., metabolites. One of ordinary skill in the art would have had a reasonable expectation of success because Oudshoorn and Heaps are in the same field of endeavor of microorganism metabolite production.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Oudshoorn et al., (EP 3766982 A1) as applied to claim 1 above, and further in view of Betton et al., (WO 2008/071985 A2; IDS filed 03/20/2024).
See discussion of Oudshoorn above, which is incorporated into this rejection as well. Oudshoorn does not teach that the second extraction step utilizes a silica-based solid phase extraction method or that the first extraction step comprises a solvent that is a substituted hydrocarbon or a perfluorocarbon.
However, regarding claim 7, Betton (Abstract) teaches a process for extracting a compound from a raw material comprising a first extraction step, a separation step, and a purification step, which is considered a second extraction step. Betton (Abstract) teaches that the purification step comprises contacting the crude product with a solid adsorbent, which is the same as solid phase extraction. Betton teaches that suitable adsorbents include silica gel (p. 13, line 5). Therefore, it is considered that the purification process of Betton uses silica-based solid phase extraction.
Regarding claim 8, Betton teaches contacting the raw material with an extraction solvent comprising at least one fluorocarbon (Abstract), i.e., a substituted hydrocarbon.
Regarding claim 9, Betton teaches that a suitable fluorocarbon may be perfluoroethane or perfluoropropane (p. 17, line 16), which are perfluorocarbons. Betton teaches that the fluorocarbon is in a solvent which suggests that the perfluorocarbon may be in liquid form.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to specifically use a substituted hydrocarbon solvent, a perfluorocarbon, and silica-based solid phase extraction, as taught by Betton, to extract/purify the biocatalyically produced organic substance, i.e., a metabolite, as taught by Oudshoorn. One of ordinary skill in the art would have been motivated to do so because Dee teaches that fluorocarbon solvents can be more easily removed from extracted material (p. 2, para. 1) and teaches that the extraction process of the invention may be used to extract a biologically active compound from a cell culture or fermentation broth (p. 6, lines 27-30). One of ordinary skill in the art would have had a reasonable expectation of success because Oudshoorn and Dee are in the same field of endeavor of metabolite extraction processes.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL EMILY MARTIN whose telephone number is (703)756-1416. The examiner can normally be reached M-Th 8:30-16:00, F 8:30-10:00 EST.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/RACHEL EMILY MARTIN/Examiner, Art Unit 1657
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