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
This application claims benefit of priority to PCTCN2020074593 filed on 02/10/2020 and PCTCN2020113457 filed on 09/04/2020. This application is also a 371 of PCT/US2021/017219 filed on 02/02/2021.
Information Disclosure Statement
The Information Disclosure Statement filed on 04/15/2025 has been acknowledged and is considered.
Drawings
The Drawings filed on 08/08/2022 are accepted by the Examiner.
Election/Restriction Requirement – Response to Arguments
Applicant argued there would not be a serious search burden on the Examiner to search all sequences.
The burden of search is not a criteria for 371 applications. The burden of search applies to US practice applications only. Any prior statements made regarding the burden of search were inadvertent and the Examiner apologizes for any inconvenience caused.
Amendments and Claim Status
Claims 5 – 19 are currently pending.
Claims 6 – 13 are withdrawn.
Claims 5 and 14 – 19 are under examination.
Withdrawn Objections
Objections – Response to Arguments
Applicant’s arguments regarding the abstract are persuasive. Thus, the objection is withdrawn.
Maintenance of Rejections
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 5, 14, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Allain et al. (WO2005069840A2, 08/04/2005) (IDS Reference) and Morlon-Guyot et al. (DNA Sequence, 07/11/2009).
Regarding claim 5, Allain et al. disclose a process for producing a fermentation product from milled starch-containing material comprising: (a) saccharifying milled starch-containing material with a glucoamylase having an amino acid sequence shown in SEQ ID NO:2, or a glucoamylase being at least 70% identical thereto, at a temperature below the initial gelatinization temperature of said starch-containing material, (b) fermenting using a fermenting organism (Claim 1). The process of any of claims 1-3, wherein an acid alpha-amylase is present (Claim 14). The starch-containing material is obtained from corn, cobs, wheat, barley, rye, milo, sago, cassava, manioc, tapioca, sorghum, rice or potatoes (Claim 31). The instant Specification notes any raw starch starting material can be used, including whole grains, corn, wheat, barley, rye, milo, sago, cassava, tapioca, sorghum, rice, peas, beans, or sweet potatoes, or mixtures thereof or starches derived there from, or cereals (Specification, Page 17, Lines 33-37). As such, the disclosure of claim 31 reads on a raw starch material.
Allain et al. does not disclose wherein the alpha-amylase has at least 85% sequence identity to the polypeptide of SEQ ID NO:14 or SEQ ID NO: 15.
However, Morlon-Guyot et al. disclose detection of an α-amylase gene in L. manihotivorans strain LMG 18010T that had more than 98% nucleotide sequence identities with L. amylovorous and L. plantarum α-amylase genes (Abstract). The α-amylase gene in L. manihotivorans strain LMG 18010T detected by Morlon-Guyot et al. shares 92.9% sequence identity with instant SEQ ID NO: 15. The sequence alignment between the α-amylase gene in L. manihotivorans strain LMG 18010T and instant SEQ ID NO: 15 is shown below.
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Exemplary rationales that may support a conclusion of obviousness include simple substitution of one known element for another to obtain predictable results. See MPEP 2143(I)(B). As such, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized an alpha-amylase with at least 85% sequence identity to the polypeptide of SEQ ID NO:15, including the strain disclosed by Morlon-Guyot et al., in the method of Allain et al. as it amounts to simple substitution of one known alpha-amylase for another to obtain predictable results.
Regarding claim 14, Allain et al. disclose in a preferred embodiment saccharification and fermentation are carried out simultaneously (Page 3, Paragraph 1).
Regarding claim 17, Allain et al. disclose fermenting organisms include fungal organisms, such as yeast (Page 7, Paragraph 1).
Regarding claim 18, Allain et al. disclose wherein the fermentation product is an alcohol, preferably ethanol (Claim 28).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Allain et al. (WO2005069840A2, 08/04/2005) (IDS Reference) and Morlon-Guyot et al. (DNA Sequence, 07/11/2009) as applied to claim 5 above, and further in view of Olsen et al. (US20040115779A1, 06/17/2004).
The teachings of Allain et al. and Morlon-Guyot et al. are discussed above.
Regarding claims 15 and 16, neither Allain et al. nor Morlon-Guyot et al. disclose wherein the fermenting organism expresses the alpha-amylase or the glucoamylase in situ during fermentation.
However, Olsen et al. disclose a process for producing a fermentation product, comprising a fermentation step, wherein the fermentation step is carried out in the presence of all of the following enzyme activities: carbohydrate-source generating enzyme activity, alpha-amylase activity, protease activity and debranching enzyme activity (Paragraph [0009]), reading on the fermenting organism expressing the alpha-amylase and glucoamylase in situ during fermentation. Further, the term “carbohydrate-source generating enzyme” includes glucoamylases (being a glucose generator) (Paragraph [0015]). Performing the fermentation step in the presence of all of the activities of the invention have been shown to result in increased fermentation rate and ethanol yield (Paragraph [0011]).
Exemplary rationales that may support a conclusion of obviousness include combining prior art elements according to known methods to yield predictable results and use of known technique to improve similar devices (methods, or products) in the same way. See MPEP 2143(I)(A)(C). As such, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention for the fermenting organism to express the alpha-amylase and glucoamylase during the fermentation step, reading on in situ during fermentation, in the method of Allain et al. motivated by the desire to increase the fermentation rate and ethanol yield as taught by Olsen et al. as it amounts to combining prior art elements according to known methods to yield predictable results and to improve upon a known technique to improve the method.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Allain et al. (WO2005069840A2, 08/04/2005) (IDS Reference) and Morlon-Guyot et al. (DNA Sequence, 07/11/2009) as applied to claim 5 above, and further in view of Vind et al. (WO2014177541A2, 11/06/2014).
The teachings of Allain et al. and Morlon-Guyot et al. are discussed above.
Regarding claim 19, neither Allain et al. nor Morlon-Guyot et al. disclose wherein the glucoamylase comprises the amino acid sequence of SEQ ID NO: 18, or has an amino acid sequence that is at least 85% identical to SEQ ID NO:18.
However, Vind et al. disclose a glucoamylase variant with glucoamylase activity represented by SEQ ID NO: 3 that shares 100% sequence identity to instant SEQ ID NO: 18.
Exemplary rationales that may support a conclusion of obviousness include simple substitution of one known element for another to obtain predictable results. See MPEP 2143(I)(B). As such, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized a glucoamylase with at least 85% sequence identity to the amino acid sequence of SEQ ID NO: 18, including the glucoamylase variant disclosed by Vind et al., in the combined method of Allain et al. and Morlon-Guyot et al. as it amounts to simple substitution of one known glucoamylase for another to obtain predictable results.
103 Rejection - Response to Arguments
Applicant’s arguments filed on 07/14/2025 have been fully considered but they are not persuasive.
Applicant argued the relationship between instant SEQ ID NO. 15 and the sequence of Morlon-Guyot et al. is alleged because a sequence was not presented.
A sequence alignment has been added to the rejection above to prove the sequence identity between instant SEQ ID NO. 15 and the sequence of Morlon-Guyot et al.
Applicant further argued they are unclear “how a gene which is comprised of DNA can have any homology to a polypeptide that has amino acids.”
The Examiner is unclear what Applicant is referring to with this statement. The DNA sequence of a gene can be converted to an amino acid sequence easily. Additionally, the elected sequence, SEQ ID NO. 15, is represented with an amino acid sequence, as is the sequence of Morlon-Guyot et al. The Examiner made no mention of a DNA sequence, other than to cite the publisher of the non-patent literature authored by Morlon-Guyot et al. The Examiner has not compared a DNA sequence to an amino acid sequence anywhere in the rejection.
Applicant argued the rejection over claims 14 – 19 should be withdraw because those claims are dependent upon independent claim 5, and a prima facie case of obviousness over claim 5 has not been established.
Applicant’s arguments have been full considered but are not persuasive. As mentioned above, the rejection over Allain et al. and Morlon-Guyot still stands, and a sequence alignment has been provided.
Double Patenting
Non-Statutory 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.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 14 of U.S. Patent No. US 9879241 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both encompass a process for producing a fermentation product with a starch material using a glucoamylase, an alpha-amylase and a fermenting organism. Claims 13 and 14 of ‘241 are drawn to a process for producing a fermentation product corresponding to instant claim 5.
Claims 5, 14 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 13, 28, 30 and 31 of U.S. Patent No. US 7618795 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both encompass a starch hydrolysis process comprising subjecting the material to a temperature below the initial gelatinization temperature in the presence of a glucoamylase and an alpha-amylase. Claims 1, 6 and 13 of ‘795 are drawn to a starch hydrolysis process utilizing a glucoamylase and an-alpha amylase corresponding to instant claim 5. Claim 28 of ‘795 is drawn to a process of a fermentation product corresponding to instant claim 5. Claim 30 of ‘795 is drawn to a process for the production of fuel ethanol corresponding to instant claim 18. Claim 31 of ‘795 indicates the fermentation and hydrolysis occur simultaneously, corresponding to instant claim 14.
Claims 5, 14 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14 and 18 of U.S. Patent No. US 8105801 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both encompass a starch hydrolysis process comprising subjecting the material to a temperature below the initial gelatinization temperature in the presence of a glucoamylase and/or an alpha-amylase. Claim 1 of ‘801 is drawn to a starch hydrolysis process utilizing an alpha-amylase or a glucoamylase corresponding to instant claim 5. Claim 15 of ‘801 is drawn to a process for production of a fermentation product corresponding to instant claim 5. Claim 17 of ‘801 is drawn to a process for production of fuel ethanol corresponding to instant claim 18. Claim 18 of ‘801 indicates the fermentation and hydrolysis occur simultaneously, corresponding to instant claim 14.
Double Patenting – Response to Arguments
Applicant argued double patenting rejections are premature and would not make any considerations regarding double patenting until a potential allowance.
As such, the double patenting rejections remain.
Conclusion
Claims 5 and 14 – 19 are rejected.
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653