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 .
Priority
The instant application claims benefit to US Application No. 16/470,376 filed 17 June 2019, 17/580,169 filed 20 Jan 2022, PCT/US17/67112 filed on 18 December 2017, and US Provisional Application No. 62437340 filed 21 December 2016 and is acknowledged. The instant claims herein are examined using the effective filing date of 21 December 2016 for the basis of any prior art rejections.
Drawings
The drawings are objected to because Fig. 8 of the drawings discloses sequences not identified by a sequence identifier number (SEQ ID NO). The sequences must be disclosed in a sequence listing and identified by a specific SEQ ID NO (see MPEP 2421.02). The sequence rules embrace all unbranched nucleotide sequences with ten or more nucleotide bases and all unbranched, non-D amino acid sequences with four or more amino acids, provided that there are at least 10 "specifically defined" nucleotides or 4 "specifically defined" nucleotides or amino acids. The rules apply to all sequences in a given application, whether claimed or not. 37 CFR 1.821(d) requires the use of the assigned sequence identifier number in all instances where the description or claims of a patent application discusses sequences, regardless of whether a given sequence is also embedded in the text of the description or claims of an application. 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 specification refers to the drawings as “Figure” instead of “FIG”.
Appropriate correction is required.
The abstract of the disclosure is objected to because the abstract does not sufficiently describe the claimed invention. Correction is required. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites, inter alia, “a thermostable serine protease comprising at least 94% sequence identity to SEQ ID NOs: 2 or3;” (emphasis added). It is suggested to Applicant to amend the claim so that it reads a thermostable serine protease comprising at least 94% sequence identity to SEQ ID NOs: 2 or 3;”. Appropriate correction is required.
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.
Claims 1-17 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 recites the limitation “the product produced in step (c)” in line 7. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of any product produced in step (c) earlier in the claim. Thus, the claim is indefinite as it is unclear what “product produced in step (c)” is being referred to. Claim 28 also recites “wherein the fermentation product is an alcohol or an organic acid” in the last line. There is also insufficient antecedent basis for this limitation in the claim. There is no recitation of any fermentation product earlier in the claim. Thus, the claim is indefinite as it is unclear what “fermentation product” is being referred to. Please note that the dependent claims are also indefinite due to dependency on claim 1.
Claim 3 recites, inter alia, “wherein addition of a nitrogen source is eliminated or reduced by at least 60% by using 1-20 g thermostable serine protease/MT starch-containing material comprising at least 94% sequence identity to SEQ ID NOs: 2 or 3”. This limitation is indefinite as it is unclear what “addition of a nitrogen source” is being referred to, as there is no recitation of a nitrogen addition step in claim 1. Furthermore, it is unclear what the elimination or reduction of addition of a nitrogen source by at least 60% is being compared to. For the purposes of compact patent prosecution, the examiner has interpreted the limitation of “addition of a nitrogen source is eliminated or reduced by at least 60% by using 1-20 g thermostable serine protease/MT starch-containing material comprising at least 94% sequence identity to SEQ ID NOs: 2 or 3” to be a property/inherent result of the recited method. Please note that claim 4 is also indefinite due to dependency on claim 3.
Claim 4 recites, inter alia, “wherein when the fermentation product is ethanol then no acid proteolytic enzyme is needed in step (c) when using 1-20 g thermostable serine protease/MT starch-containing material comprising at least 94% sequence identity to SEQ ID NOs: 2 or 3” (emphasis added). This limitation is indefinite as it is unclear what “acid proteolytic enzyme” is being referred to, as there is no recitation of any acid proteolytic enzyme used anywhere in claim 1. For the purposes of compact patent prosecution, the examiner has interpreted the limitation of “no acid proteolytic enzyme is needed in step (c)” to be a property/inherent result of the recited method.
Claim 7 recites the limitation “the starch gelatinization temperature” in line 3. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of any starch gelatinization temperature earlier in the claim, or in claim 1 from which this claim depends. Thus, the claim is indefinite.
Claim 9 recites the limitation “the product of step (a)” in line 3. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of any product of step (a) earlier in the claim, or in claim 28 from which this claim depends. Thus, the claim is indefinite as it is unclear what “product of step (a)” is being referred to. Claim 9 also recites that “the need for adding a nitrogen source during the saccharification process is reduced by at least about 30% compared to a process where starch-containing material is not liquefied with the enzyme cocktail comprising a thermostable serine protease at least 94% sequence identity to SEQ ID NOs: 2 or 3” (emphasis added). This limitation is indefinite as it is unclear what “need for adding a nitrogen source” is being referred to, as there is no recitation of a need for nitrogen addition during saccharification recited in claim 1 and the phrase “at least about” renders the claim indefinite as the term “at least” sets a lower limit but “about” does not set an upper limit. For the purposes of compact patent prosecution, the examiner has interpreted the limitation of “the need for adding a nitrogen source during the saccharification process is reduced by at least about 30% compared to a process where starch-containing material is not liquefied with the enzyme cocktail comprising a thermostable serine protease at least 94% sequence identity to SEQ ID NOs: 2 or 3” to be a property/inherent result of the recited method.
Claim 12 recites, inter alia, the limitation “wherein glycerol levels from materials obtained at the end of the fermentation are decreased, when compared to materials obtained at the end of a control fermentation not comprising said thermostable serine protease comprising at least 94% sequence identity to SEQ ID NOs: 2 or 3” (emphasis added). This limitation is indefinite as it is unclear what “glycerol levels from materials obtained at the end of fermentation” is being referred to, as there is no recitation of any glycerol levels from any materials obtained at the end of fermentation recited in claim 1. For the purposes of compact patent prosecution, the examiner has interpreted the limitation of “wherein glycerol levels from materials obtained at the end of the fermentation are decreased, when compared to materials obtained at the end of a control fermentation not comprising said thermostable serine protease comprising at least 94% sequence identity to SEQ ID NOs: 2 or 3” to be a property/inherent result of the recited method.
It is noted any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office action.
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.
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 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kreel et al (US 10,035,973 B2; filed 20 June 2014), and further in view of Toth et al (UniProt KB Accession number A0A147KH40 serine protease from T. cellulosilytica TB100 published 06 June 2016; retrieved 10/05/2026 from https://www.uniprot.org/uniprotkb/A0A147KH40/history; hereinafter “Toth”).
Kreel teaches a process of extracting/recovering oil from liquefied material as well as thin stillage and/or syrup at the backend of a fermentation product production process based on starch-containing material (a method of producing fermentation products from starch containing material as in claim 1) by: (a) converting a starch-containing material into dextrins with an alpha-amylase; (b) saccharifying the dextrins using a carbohydrate source generating enzyme to form a sugar (saccharifying as in claim 1, step (b)); (c) fermenting the sugar in a fermentation medium into a fermentation product using a fermenting organism (fermenting as in claim 1, step (c)); (d) recovering the fermentation product to form a whole stillage (optionally recovering the product as in claim 1, step (d)); . . . wherein a bacterial or fungal protease is present and/or added during steps (d)-(e′) (col 2, lines 14-32; see claim 1 of Kreel). Kreel also teaches that step (a) is carried out as a liquefication step (liquefying the starch containing material as in claim 28, step (a)) (col 1, lines 17-21; col 2, lines 61-62). Kreel also teaches that the fermentation product can be alcohols and organic acids (as in claim 1) (col 11, lines 18-28). Kreel further teaches that one or more enzymes can be used in the process during step (a) or step (d)-(e’), including various thermostable yeast and bacterial proteases, and bacterial and fungal alpha-amylases (enzyme cocktail as in claim 1) (col 14, see lines 12-23; lines 52-57; col 16, lines 11-34). Kreel further teaches that the protease is a bacterial serine protease (see claim 14) and specifically that the protease is from Thermobifida fusca (see claim 17-18).
Kreel does not explicitly teach a thermostable serine protease comprising at least 94% sequence identity to SEQ ID NOs: 2 or 3.
However, Toth teaches a plant polysaccharide degrading enzyme of Thermobifida cellulosilytica TB100 (title). The protease of Toth has 100% sequence identity to both SEQ ID NOs 2 and 3 (see alignments below):
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1044
1428
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893
1220
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1486
555
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Toth does not explicitly teach that the protease is thermostable. However, according to MPEP 2112.01(II), "products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Given that the sequence of Toth has 100% identity to both SEQ ID NOs: 2 and 3 (i.e., they are exactly identical), the sequence of Toth is a thermostable serine protease.
Therefore, it would have been prima facie obvious to one of ordinary skill at the time of filing to modify the method of Kreel by utilizing the Thermobifida cellulosilytica TB100 serine protease as taught by Toth to arrive at the claimed invention. As the claimed invention relies on the fermentation of starch-containing materials using a serine protease from Thermobifida, one of ordinary skill would have been motivated to perform a simple substitution of one known element (the serine protease of Kreel) with another (the serine protease of Toth) with a reasonable expectation of success (using a protease to ferment starch-containing materials to produce fermentation products). One of ordinary skill would have been motivated to perform the substitution because Kreel teaches the advantageous process of fermenting starch-containing materials using thermostable bacterial serine proteases from Thermobifida, and Toth teaches a plant polysaccharide degrading protease from Thermobifida cellulosilytica. Thus, the combination of Kreel and Toth renders prima facie obvious claim 28.
Regarding claim 2, Kreel teaches that steps (b) and (c) may be carried out simultaneously (col 2, lines 40-41; see claim 14).
Regarding claim 3, neither Kreel nor Toth explicitly teach that the “addition of a nitrogen source is eliminated or reduced by at least 60% by using 1-20 g thermostable serine protease/MT starch-containing material comprising at least 94% sequence identity to SEQ ID NOs: 2 or 3”. However, the examiner has interpreted the limitation of to be a property/inherent result of the recited method. As Kreel and Toth (in combination) teach the required steps of step (a)-(d), anything beyond the recited steps is, absent evidence to the contrary, an inherent result of practicing the claimed method. Thus, Kreel and Toth teach that addition of a nitrogen source is eliminated or reduced by at least 60% when using the serine protease of Toth.
Regarding claim 4, neither Kreel nor Toth explicitly teach “wherein when the fermentation product is ethanol then no acid proteolytic enzyme is needed in step (c). . .”. However, the examiner has interpreted this limitation to be a property/inherent result of the recited method. As Kreel and Toth (in combination) teach the required steps of step (a)-(d), anything beyond the recited steps is, absent evidence to the contrary, an inherent result of practicing the claimed method. Thus, Kreel and Toth teach that when the fermentation product is ethanol then no acid proteolytic enzyme is needed when using the serine protease of Toth.
Regarding claim 5-6, Kreel teaches that the starch-containing material can be corn, wheat, barley, cassava, sorghum, rye, potato, beans, milo, peas, rice, sago, sweet potatoes, tapioca, or any combination thereof (col 11, lines 13-17).
Regarding claim 7, Kreel teaches that before step (a), a slurry is formed using the starch containing material and water (col 9, lines, 21-26), and that the temperature of step (a) is carried out at or above the gelatinization temperature between 80-90 deg C at a pH from 4-7, preferably 4.5-6 (col 9, lines 11-16; see claim 3). Kreel also teaches that the stillage from dry grind corn was heated to 85 deg C at pH of 4 in a water bath for two hours (see Example 4). The pH (4.0-6.5) and time (about 2 minutes to about 8 hours) as claimed overlap/lie inside the ranges of Kreel, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (see MPEP 2144.05(I)).
Regarding claim 8 and 10, Kreel teaches using alpha-amylase (col 14, see lines 12-23; lines 52-57; col 16, lines 11-34) and that the material is saccharified to a sugar by treating the starch-containing material with an alpha-amylase (as in claim 8) and a glucoamylase (i.e., a glycosidase as in claim 10) (col 10, lines 23-27).
Regarding claim 9, Kreel teaches that saccharification is carried out at a temperature from 20-75 deg C, preferably 40-70 deg, and at a pH between 4 and 5 (col 10, lines 4-6). The temperature (30-65 deg) and pH (about 3.0 to about 5.0) as claimed overlap/lie inside the ranges of Kreel. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (see MPEP 2144.05(I)). Furthermore, neither Kreel nor Toth explicitly teach “the need for adding a nitrogen source during the saccharification process is reduced by at least about 30%. . .”. However, the examiner has interpreted the limitation to be a property/inherent result of the recited method. As Kreel and Toth (in combination) teach the required steps of step (a)-(d), anything beyond the recited steps is, absent evidence to the contrary, an inherent result of practicing the claimed method. Thus, Kreel and Toth teach that the need for adding a nitrogen source during the saccharification process is reduced by at least about 30%, when using the serine protease of Toth.
Regarding claim 11, Kreel teaches that the microorganism can be Saccharomyces cerevisiae (col 13, lines 17-22).
Regarding claim 12, Kreel teaches fermentation carried out at temperatures from 25-40 deg C for 6 to 120 hours and the pH may be from 4-7, preferably 4.5-6.0 (col 10, lines 7-16; col 10, lines 53-56). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (see MPEP 2144.05(I)). Furthermore, neither Kreel nor Toth explicitly teach “wherein glycerol levels from materials obtained at the end of the fermentation are decreased, when compared to materials obtained at the end of a control fermentation not comprising said thermostable serine protease comprising at least 94% sequence identity to SEQ ID NOs: 2 or 3”. However, the examiner has interpreted this limitation to be a property/inherent result of the recited method. As Kreel and Toth (in combination) teach the required steps of step (a)-(d), anything beyond the recited steps is, absent evidence to the contrary, an inherent result of practicing the claimed method. Thus, Kreel and Toth teach that the glycerol levels from materials obtained at the end of fermentation are decreased, when using the serine protease of Toth.
Regarding claim 13-14, Kreel teaches that the fermentation product can be an alcohol (as in claim 40), specifically ethanol, methanol, and butanol (as in claim 41) (col 11, lines 18-28).
Regarding claim 15, Kreel teaches that the recovery of the fermentation product via distillation (col 11, lines 29-30).
Regarding claim 16-17, Kreel teaches that the product can be an organic acid (as in claim 43), specifically citric acid, acetic acid, itaconic acid, lactic acid, gluconic acid, and succinic acid (as in claim 44).
Accordingly, the invention was prima facie obvious at the time of filing, especially in absence of evidence to the contrary.
Conclusion
NO CLAIMS ALLOWED.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Bertrand, E., Vandenberghe, L.P.S., Soccol, C.R., Sigoillot, JC., Faulds, C. (2016). First Generation Bioethanol. In: Soccol, C., Brar, S., Faulds, C., Ramos, L. (eds) Green Fuels Technology. Green Energy and Technology. Springer, Cham.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGIANA C REGLAS whose telephone number is (571)270-0995. The examiner can normally be reached M-Th: 8:00am-2:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.C.R./Examiner, Art Unit 1651
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
