DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election with traverse of Group III (Invention III) in the reply filed on 11/19/2025 is acknowledged. The arguments filed have been considered but are not found persuasive.
As previously stated Inventions 1-3 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: WO2014058896 (04/17/2014; IDS filed 10/04/2023) teaches an enzyme composition comprising 37% Aspergillus fumigatus Cel7 A cellobiohydrolase I, 10% Trichoderma reesei GH5 endoglucanase and 5% Aspergillus fumigatus beta-glucosidase wherein the composition has a RCBH1 of 0.88 (see Example 15); the said composition is used in methods for preparing sugar from cellulosic material and for preparing fermentation products such as alkane, alkene or organic acids by use of the sugars produced; and teaches the addition of further enzymes such as glucoamylase to the enzyme composition.
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. The requirement is still deemed proper and is therefore made FINAL.
Claims 10, 12-17 are pending and under consideration in this Office Action.
Title
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which
Claim Rejections - 35 USC § 112(b) or 35 U.S.C. 112 (pre-AIA ) 2nd Paragraph
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 10, 12-17 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 pre-AIA the applicant regards as the invention.
Claim 10 recites the phrases “the amino acid sequence of the mature polypeptide of SEQ ID NO: 2” and “the amino acid sequence of the mature polypeptide of SEQ ID NO: 4” which render the claim vague and indefinite because the specific amino acid sequence and structure of the mature polypeptide is not known and not recited in the claim. Dependent claims 12-17 are also rejected because they do not correct the defect.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 10, 12-17 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a broad genus of processes for producing any genus of fermentation products from any cellulosic material, which process comprises a) hydrolysing the cellulosic material with any genus of enzyme compositions to obtain any genus of sugars, b) fermenting the obtained sugar by contacting the obtained sugar with any genus of fermenting microorganisms to produce the fermentation product, and c) optionally, recovering the fermentation product, wherein the enzyme composition comprises any genus of glucoamylases comprising the amino acid sequence of any mature polypeptide of SEQ ID NO: 2, any genus of cellobiohydrolase I comprising the amino acid sequence of any mature polypeptide of SEQ ID NO: 4, and any genus of beta-glucosidase. According to MPEP 2163:
“For each claim drawn to a genus: The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014)…”
According to MPEP 2163.02:
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter." Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
The specification as originally filed does not disclose a representative number of species of the genus of fermentation products, genus of sugars, genus of enzyme compositions, genus of glucoamylase, genus of cellobiohydrolase I, genus of beta-glucosidase. The specification as originally filed does not provide a correlation between function and structure to enable one of ordinary skill in the art to predict which amino acid sequences and structures of the any any mature polypeptide of SEQ ID NO: 2 and mature polypeptide of SEQ ID NO: 4 correlate with glucoamylases activity and enzymatic activity epimerases can be genetically engineered and still retain enzymatic activity. Hence, the specification does not provide sufficient written description to inform one of ordinary skill in the art that applicants were in possession at the time the application was filed of the claimed genus of methods for preserving a fermentation broth of any genus of engineered strain of D- psicose-3-epimerases, comprising: adding any lysozyme into a fermentation broth of an engineered strain of D-psicose-3-epimerase, stirring to make the OD600 of the fermentation broth less than or equal to 1 to obtain an enzyme solution; and adjusting the enzyme solution to be weakly alkaline with an alkali liquor, and storing the weakly alkaline enzyme solution at room temperature.
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 of this title, 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.
Claims 10, 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over WO2014058896 (04/17/2014; IDS filed 10/04/2023) in view of US20180320155 (11/08/2018; PTO 892), US20190032037 (01/31/2019; PTO 892), Accession BBT35074 (26-FEB-2015; PTO 892), Accession BBT36221 (26-FEB-2015; PTO 892).
WO2014058896 (04/17/2014; IDS filed 10/04/2023) teaches an enzyme composition comprising 37% Aspergillus fumigatus Cel7 A cellobiohydrolase I, 10% Trichoderma reesei GH5 endoglucanase and 5% Aspergillus fumigatus beta-glucosidase wherein the composition has a RCBH1 of 0.88 (see Example 15); the said composition is used in methods for preparing sugar from cellulosic material and for preparing fermentation products such as alkane, alkene or organic acids by use of the sugars produced; and teaches the addition of further enzymes such as glucoamylase to the enzyme composition. See entire publication and claims especially claims 16-19 and Example 15.
The teachings of the reference differ from the claims in that the reference does not teach the claimed glucoamylase and cellobiohydrolase I in the enzyme composition.
US20180320155 teaches isolated polypeptides having cellulolytic enhancing activity and polynucleotides encoding the polypeptides, catalytic domains, cellulose binding domains and polynucleotides encoding the polypeptides, catalytic domains or cellulose binding domains, and processes for of fermenting a cellulosic material, comprising: fermenting the cellulosic material with one or more fermenting microorganisms, wherein the cellulosic material is saccharified prior to the fermenting with an enzyme composition comprising a GH61 polypeptide having cellulolytic enhancing activity (see entire publication and claims especially paragraphs [0009]-[0032] and Examples 1-6. US20180320155 teaches the following in the claims:
32. A process for degrading a cellulosic material, comprising: treating the cellulosic material with an enzyme composition comprising a GH61 polypeptide having cellulolytic enhancing activity, wherein the GH61 polypeptide having cellulolytic enhancing activity is selected from the group consisting of:
(a) a GH61 polypeptide having at least 95% sequence identity to the mature polypeptide of SEQ ID NO: 2;
(b) a GH61 polypeptide encoded by a polynucleotide having at least 98% sequence identity to the mature polypeptide coding sequence of SEQ ID NO: 1 or the cDNA sequence thereof; and
(c) a GH61 polypeptide comprising SEQ ID NO: 2, or the mature polypeptide of SEQ ID NO: 2.
39. A process for producing a fermentation product, comprising:
(a) saccharifying a cellulosic material with an enzyme composition comprising a GH61 polypeptide having cellulolytic enhancing activity, wherein the GH61 polypeptide having cellulolytic enhancing activity is selected from the group consisting of:
(i) a GH61 polypeptide having at least 95% sequence identity to the mature polypeptide of SEQ ID NO: 2;
(ii) a GH61 polypeptide encoded by a polynucleotide having at least 98% sequence identity to the mature polypeptide coding sequence of SEQ ID NO: 1 or the cDNA sequence thereof; and
(iii) a GH61 polypeptide comprising SEQ ID NO: 2, or the mature polypeptide of SEQ ID NO: 2;
(b) fermenting the saccharified cellulosic material with one or more fermenting microorganisms to produce the fermentation product; and
(c) recovering the fermentation product from the fermentation.
46. A process of fermenting a cellulosic material, comprising: fermenting the cellulosic material with one or more fermenting microorganisms, wherein the cellulosic material is saccharified prior to the fermenting with an enzyme composition comprising a GH61 polypeptide having cellulolytic enhancing activity, wherein the GH61 polypeptide having cellulolytic enhancing activity is selected from the group consisting of:
(a) a GH61 polypeptide having at least 95% sequence identity to the mature polypeptide of SEQ ID NO: 2;
(b) a GH61 polypeptide encoded by a polynucleotide having at least 98% sequence identity to the mature polypeptide coding sequence of SEQ ID NO: 1 or the cDNA sequence thereof; and
(c) a GH61 polypeptide comprising SEQ ID NO: 2, or the mature polypeptide of SEQ ID NO: 2.
US20190032037 teaches composition for biomass hydrolysis where the components of the composition may be obtained by biological or synthetic means (see entire publication and claims especially paragraphs [0027]-[0087]. US20190032037 teaches the following in the claims:
1. A composition for hydrolysis of biomass comprising;
a. Cellobiohydrolase I (GH7-CBM1) in the range of 50%-75%, beta-D-glucosideglucohydrolase (GH3) in the range of 1%-4%, xylanase (GH11-CBM1) in the range of 1%-6%, swollenin in the range of 7%-13%, GMF family protein in the range of 1%-5%, IgE-binding protein in the range 1%-3%, Hydrophobic surface binding protein A in the range 1%-3%, endoglucanse (GH5-CBM1) in the range of 2%-25%, LPMO (AA9) in the range of 1%-5%.
b. optionally, comprising, cellobiohydrolase II (GH6-CBM1) in the range of 25%-40%, endogluconase GH45 in the range of 0.50%-2.5%, alpha-L-arabinofuranosidase in the range of 2%-5%, acetyl xylan esterase (CE5-CBM1) in the range of (15%-30%),carbohydrate esterase (CE3-CBM1) in the range of 0.30%-2%, Glycoside Hydrolase family 18 protein (GH 18) in the range of 1%-4%, glucoamylase (GH15-CBM20) in the range of 8%-15%,
2. A composition as claimed in claim 1, wherein the components of the composition are obtained by biological or synthetic sources, preferably biological sources.
3. A composition as claimed in claim 1, wherein the components of the composition are obtained from Talaromyces spp, Acremonium spp, Penicillium spp, preferably, Penicillium spp, more preferably Penicillium funiculosum (NCIM1228).
Accession BBT35074 teaches Rasamsonia emersonii glucoamylase having an amino acid sequence that is 100% identical to SEQ ID NO: 2 (see attached record).
Accession BBT36221 teaches Rasamsonia emersonii cellobiohydrolase I having an amino acid sequence that is 100% identical to SEQ ID NO: 4 (see attached record).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify and/or combine the reference teachings to make the claimed invention by using the Rasamsonia emersonii glucoamylase of Accession BBT35074 and the Rasamsonia emersonii cellobiohydrolase I of Accession BBT36221 in the method of WO2014058896 and recovering the produced fermentation product including at least on C5 sugar. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do this in order to obtain a simple process for producing a fermentation product using an enzyme composition. It would have been obvious to adjust the amounts of the enzymes and proportions of the enzymes, to form the enzyme composition as a fermentation broth, use any fermenting microorganisms, and subject the cellulosic material to any of the stated pretreatment recited in the claims as routine optimization and/or as desired in view of the above teachings especially the teachings of US20190032037 and US20180320155. One of ordinary skill in the art before the effective filing date of the claimed invention would have a reasonable expectation of success in view of the reference teachings showing enzyme compositions used for producing a fermentation product from cellulosic material. Hence, the claimed invention as a whole is prima facie
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 10, 12-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9, 10, 12-15, 21 of Application Serial No. 18553810, claims 9-15 of Application Serial No. 18553801. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims are broad and widely varying and encompass any process for producing any fermentation product from any cellulosic material, which process comprises a) hydrolysing the cellulosic material with any enzyme composition to obtain any sugar, b) fermenting the obtained sugar by contacting the obtained sugar with any fermenting microorganism to produce the fermentation product, and c) optionally, recovering the fermentation product,
wherein the enzyme composition comprises any glucoamylase comprising the amino acid sequence of any mature polypeptide of SEQ ID NO: 2, any cellobiohydrolase I comprising the amino acid sequence of any mature polypeptide of SEQ ID NO: 4, and any beta-glucosidase.
The claims and/or specification of the copending applications teach the claimed process for producing a fermentation product from a cellulosic material, which process comprises a) hydrolysing the cellulosic material with an enzyme composition to obtain a sugar, b) fermenting the obtained sugar by contacting the obtained sugar with a fermenting microorganism to produce the fermentation product, and c) optionally, recovering the fermentation product. Thus, the teachings anticipate the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652