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 .
Election/Restrictions
Applicant's election with traverse of group I, claims 1 – 10 in the reply filed on April 3, 2026 is acknowledged. The traversal is on the grounds that there is no undue burden to search all groups together. This is not found persuasive because the instant case is a 371 of PCT/EP2022/078032, which follows the unity of invention analysis (MPEP 823). As stated previously, the groups do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: Groups I and II lack unity of invention because the groups do not share the same or corresponding technical feature. The technical feature of group I is producing alcohol by culturing a microorganism with carbon substrate and support; while the technical feature of group II is a system comprising a reactor, support and mcans for monitoring microorganisms living therein. Even if the method uses a bioreactor as claimed in group II, the features of the system do not make a contribution over the prior art in view of WO 2020/064900 A1, cited by US 2021/0340480. Gonzalez Penas teaches a fermentation reactor comprising a solid support comprising a foam of polyurethane to which microorganisms are immobilized; and a means to measure fluid and gas from the culture (claims, 0074-0077, examples 3, 4).
Notwithstanding, the invention of group I may be classified in C12P 7/6 while the invention of group II may be classified in C12M 21/12; and other systems can be used to produce alcohol such as a pot, fermentation bucket, airlock and syphon.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1 – 13 are pending; claims 11 – 13 are withdrawn; claims 1 – 10 have been considered on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 19, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show labels or referenced numbered parts as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
The drawings are referenced in the specification however fail to include reference to the various numbered and lettered parts of therein.
Appropriate correction is required.
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 are 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.
Claims 1 – 10 are drawn to a process for producing alcohols with any sugary carbon based substrate and any microorganism. These claims are considered genus claims that encompass a wide array of alcohols, substrates and microorganisms. The specification fails to set forth a representative number of examples in order to reasonably verify possession of such a potentially enormous number of methods.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claims are broad generics, with respect to all microorganisms, all sugary carbon-based substrates and all alcohols that might result from a single fermentation method, let alone any and all of the various combinations of microorganisms and substrates that are encompassed by the claims. For example, various substrates might include glucose, fructose, sucrose and maltose as well as any fruit, plant material, honey; while the microorganisms that might ferment the various substrates vary based on whether they can metabolize the various sugar substrates, to include natural and genetically modified organisms. The possible combinations of microorganism, substrate and product produced are limitless with potentially thousands of substrates and products. The instant disclosure identifies a single microorganism, Clostridium beijerinckii DSM 6423; a single substrate GAPES medium; alludes to IBE (Isopropanol-Butanol-Ethanol) and ABE (Acetone-Butanol-Ethanol); and identifies only isopropanol production with the C. beijerinckii.
The purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by them. A patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention. Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." The specification lacks sufficient variety of species of substrates, microorganisms and alcohols to reflect this variance in the genus since the specification does not provide any examples of such a genus of these categories. Accordingly, the specification fails to provide adequate written description for the genus of “alcohol,” “sugary carbon-based substrate,” and “microorganism” and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed had possession of the entire scope of the claimed invention. Moreover, the specification neither describes the complete structure of a representative number of species, nor describes a representative number of species in terms of partial structure and relevant identifying characteristics. Absent of such teachings and guidance as to the structure and function of these identified parameters, the specification does not describe the claimed method in such full, clear, concise and exact terms so as to indicate that Applicant had possession of these processes at the time of filing of the present application.
Thus, the written description requirement has not been satisfied.
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 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 its dependents are drawn to a method for producing alcohol(s), however are rendered indefinite for not clearly stating what active steps the method requires to meet the limitations of the claims. Specifically, in claim 1, examples phrases "according to which," "in order to produce," is operated," "and in that" and "in order to control" do not express active steps but functional outcomes. In this regard, it is unclear what limitations are required active steps and what limitations are intended outcomes or functions only.
Claim 1 and its dependents are further indefinite for referring to labeled parts of a drawing that do not have labels.
In claim 1, the phrase "control the production" renders the claims indefinite as it is unclear what is being control and how, to what "the production" refers.
In claim 1, the phrase "is monitored without intervention" renders the claim and its dependents indefinite as it is unclear how the phrase intends to limit the method, what is required to be carried out and what is excluded from "without intervention." Moreover, the phrase appears to merely recite a mental step of monitoring (or observing) the method.
In claim 1, "on the basis of analysis" renders the claim indefinite as it is unclear what must be actively carried to meet the limitation. Clarification is required. For purposes of examination, the phrase is interpreted as mental steps only and no active steps are required to be performed.
In claim 1, "a sugary carbon based substrate" renders the claim and its dependents indefinite because the phrase is not adequately defined by the claim language or specification.
Claim 2 is indefinite as no active steps are required. Since measuring viability can occur by merely observation with the eye, it is unclear what active steps must be carried out to meet the limitations of the claim.
In claim 4, "the sample analysed" and "the stream of fermentation must" lack proper antecedent basis.
In claim 4, the term "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
In claim 5, it is unclear what active step must be performed as the method comprises a measurement (noun) rather than an active step. Clarification is required.
Claim 6 is replete with confusing, passive phrases that fail to accurately and clearly set forth the metes and bounds of the claimed method. It is unclear what active steps are required to carry out the claimed invention. The language recites intended outcomes and functions without clearly stating any active steps, e.g., the "analysis…determines," "the analysis…evaluates," and "an evaluation…is deduced." Clarification is required. For purposes of examination, the claim is interpreted as a mental step of forming an opinion about the concentration of microorganisms.
In claim 7, line 2 "the flow rate of sugary stream" lacks proper antecedent basis.
Claim 7 is rendered indefinite as no active steps are recited. While "is/are modulated" is recited, the phrase is not adequately defined by the claim language, specification or context clues such that one practicing the invention would know what is required to "modulate."
Claims 8 - 9 fail to set forth any active steps to be carried out rendering the claims indefinite. Please note that "is evaluated" fails to clearly set forth the metes and bounds of the claimed invention such that one practicing the invention would know what is included or excluded from the method.
In claim 9, the phrase "degree of saturation" renders the claim indefinite as it is unclear what is saturating the support. For example, the amount of liquid phase in the support; the number of hydrogen atoms in a particular molecule; or how much solute is dissolved in a solvent. Clarification is required.
In claim 10, the phrase "being derived from a strain" renders the claim indefinite as it is unclear what microorganism is required to meet the limitation of the claim. Clarification is required.
Claim Rejections - 35 USC § 102
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 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.
Claims 1 and 5 – 10 are rejected under 35 U.S.C. 102a1 as being anticipated by Coupard et al. (US 2019/0203162).
Regarding claim 1, Coupard teaches a process for producing alcohols (0001, 0035, claims 8 - 9), wherein a culture medium containing an aqueous solution of sugars is introduced into a bioreactor (reaction section) (0023, claim 13) comprising immobilized microorganisms (0023, 0033, 0054 - 0058, claim 18), whereby fermentation produces a mash containing alcohol (or must enriched in alcohol) (0020) and gas stream (fermentation gas) (abstract, claims); wherein the process is continuous in broth (liquid phase) (0037 - 0039, 0052); and wherein fermentation products are recovered, e.g., fermentation mash and gases (0011 - 0015, 0067), to avoid inhibiting effect on microorganisms (or wherein the quantity of microorganisms have been "monitored"). Since the limitations "analysis" and "monitored" are interpreted as mental steps that can be carried out by observing and thinking, the reference anticipates the claimed method.
Regarding claim 5, the method includes a gas stripping step, wherein fermentation gases are removed from the reactor at a flow rate measured at 0.5 - 2.5 L/L/min (0057 0067), or wherein the method comprises a measurement (analysis) of the flow rate at an outlet of the reactor (reaction section).
Regarding claims 6 and 7, Coupard teaches that fermentation mash and gasses are removed in order to limit effects on inhibiting microorganisms (0067), indicating that one is forming an opinion about the concentration of microorganisms, or evaluating the products to deduce the concentration; and modulating the quantity of the microorganisms on the support.
Regarding claims 8 - 9, in practicing the process of Coupard, a microorganism biofilm is inherently produced. Since monitoring and evaluating encompass mental steps of observing the process, the reference is interpreted to meet the limitations of monitoring and evaluating the microorganisms.
Regarding claim 10, the method produces isopropanol, butanol and ethanol (0001, examples, claims) and the microorganism is Clostridium (0004, examples, claims).
The reference anticipates the claimed subject matter.
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.
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 – 4 are rejected under 35 U.S.C. 103 as being unpatentable over Coupard et al. (US 2019/0203162) in view of Branska et al. (2018).
Regarding claim 1, Coupard teaches a process for producing alcohols (0001, 0035, claims 8 - 9), wherein a culture medium containing an aqueous solution of sugars is introduced into a bioreactor (reaction section) (0023, claim 13) comprising immobilized microorganisms (0023, 0033, 0054 - 0058, claim 18), whereby fermentation produces a mash containing alcohol (or must enriched in alcohol) (0020) and gas stream (fermentation gas) (abstract, claims); wherein the process is continuous in broth (liquid phase) (0037 - 0039, 0052); and wherein fermentation products are recovered, e.g., fermentation mash and gases (0011 - 0015, 0067), to avoid inhibiting effect on microorganisms (or wherein the quantity of microorganisms have been "monitored"). Since the limitations "analysis" and "monitored" are interpreted as mental steps that can be carried out by observing and thinking, the reference anticipates the claimed method.
Regarding claims 2 - 3, Coupard specifically teaches the fermentation products are recovered to avoid inhibiting effect on microorganisms. In this regard, it would have been obvious to one of ordinary skill in the art to measure viability of the microorganisms when practicing the methods of Coupard. While Coupard does not teach the method wherein flow cytometry is used on a sample of the liquid phase, flow cytometry was commonly used in processes of producing the claimed alcohols. In support, Branska teaches methods of quantifying clostridia (same genus as applicant) during processes of producing ABE (actetone-butanol-ethanol process as practiced by applicant) to determine viability (abstract, p.10-11). Branska teaches the process allows for a high throughput methodology with greater detailed insight on the microorganisms during the process (p.2, right col.) and quantification without additional treatment (p.11, left col.). Since Coupard teaches the method is intended to avoid inhibiting effects on microorganisms, one of ordinary skill in the art would have been motivated by Branska to measure viability of the microorganisms via flow cytometry with a reasonable expectation for successfully producing alcohols therefrom and for the advantages disclosed therein.
Regarding claim 4, Coupard teaches removing fermentation mash (liquid phase) from the bioreactor (reaction section) or outside the bioreactor (0015).
Thus, absent evidence of an unexpected result or advantage, the claims are rendered obvious in light of the cited references.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 – 2 and 6 – 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 2, 6 – 7, 15 – 16, 19 of U.S. Patent No. 12 618 086.
Regarding claims 1 – 2 and 10, the patent claims a process for producing Acetone-Butanol-Ethanol, Isopropanol-Butanol-Ethanol, or Isopropanol-Butanol-Ethanol-Acetone, according to which a sugary fluid is introduced into a reaction section comprising a support on which microorganisms of the genus Clostridium are immobilized, in order to produce, by fermentation, an alcohol-enriched must under the action of said microorganisms, characterized in that the process is carried out continuously, in that a portion of spent support is periodically replaced by a portion of new support, by a portion of regenerated support, or by a portion of a combination of new support and regenerated support characterized in that only a portion is replaced each time a replacement is made. This indicates that the microorganisms are monitored based on motion of the support (e.g. gases per specification under “The Solid Support”) and mash output, or viability (claims 1 - 2, 6 – 7, 15, 19).
Regarding claims 6 – 9, the claims are interpreted as mental steps that can be carried out by observation, making judgements or determinations based on those observations.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUTH A DAVIS/ Primary Examiner, Art Unit 1699
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