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 .
Applicant’s response to restriction letter of 5/21/26 is acknowledged. Applicant elected Group I (claims 1-14, 16, 18-19) without traverse. Applicant additionally elected species (1), drawn to a recombinant yeast cell expressing 1,5-biophosphate carboxylase oxygenase (Rubisco) and species (B), a yeast cell comprising an ANB1 promoter, without traverse.
Claims 15 and 17 and all species beyond species (1) and species (B) are hereby withdrawn.
In response to applicant’s request for rejoinder of process claims with the instantly elected product claims, it should be noted that once the elected claims are deemed allowable, said request will be considered by the examiner.
DETAILED ACTION
In view of applicant’s election, claims 12-14 are also withdrawn.
Claims 1-10 and 18-19 and species (B) and species (1) only, are under examination on the merits.
Specification
The disclosure is objected for reciting hyperlink language (see for example, page 11, line 21. Applicant is advised to delete hyperlink language everywhere in the disclosure in compliance with 37 CFR section 1.57(d).
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, 18-19 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. Claim 1 and its dependent claims 2-10 and 18-19 are directed to a genus of recombinant yeast cells comprising a genera of DNA sequences, wherein said genus is adequately described in terms of structure.
With respect to the genus of DNA sequences encoding glycerol dehydrogenase (see claim 1), which could originate from any source or species including mammalian, plant, bacterial, fungal etc., the disclosure has merely provided 4 species (see table 1), which is totally inadequate to fully describe said genus.
Similarly, the broad genus of DNA sequences encoding dihydroxyacetone kinase, which can be from any source and species are merely represented by 3 species (again see table 1), namely Saccharomyces cerevisiae, Klebsiella pneumoniae, Schizosaccharomyces pombe, wherein said few species fail to fully describe the enormous family of said DNA sequences, which can be from mammalian, plant, bacterial, fungal and other sources.
This problem also exists with the genus of DNA encoding Rubisco enzymes recited in claim 1, wherein said DNA genus has merely been represented by a single species namely those from Thiobacillus source, which again is totally inadequate to fully describe said genus.
Finally, with respect to the genus of glycerol transporter encoding sequences, applicant has merely provided the following sources: S. pombe, Plasmodium falciparum Danio rerio, Xenopus tropicalis; and Z. rouxii, namely 5 species, which once again is insufficient to adequately structural characteristics of said genus.
Applicant is fully aware that for the combinations of claimed genus of DNA sequences, which can be homologous or heterologous, to be expressed together such that they retain function in the claimed recombinant yeast, some more structural information as to which promoters may be most appropriate to express said genes in yeast hosts and whether a single promoter or numerous promoters are necessary depending on the specific species of yeast host, and what structural changes are needed to successfully express each genus of DNA sequences in yeast host cells deems necessary, that is currently lacking in the disclosure.
Therefore, based on the information provided, one of skill in the art cannot reasonably conclude that applicant had full possession of the invention, before the effective filing of this application.
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.
Claims 1-9, 18-19 are rejected under 35 U.S.C. 103 as being obvious over Vugt-Van Lutz “Van Lutz” (US2022/0380813, 12/2022) applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Van Lutz in its abstract teaches the following:
The invention relates to a process for the production of ethanol, the process comprising fermenting of a carbon source composition with a recombinant yeast, wherein the carbon source composition comprises at least glucose and arabinose; and wherein the recombinant yeast comprises arabinose isomerase activity, ribulokinase activity, ribulose phosphate epimerase activity, glycerol uptake activity and glycerol conversion capacity; and wherein the recombinant yeast further comprises a genetic modification leading to the reduction, downregulation, inhibition and/or elimination of the activity of a homologous protein with glycerol-efflux activity; and wherein each of the glucose and the arabinose is converted into ethanol.
In addition, the invention relates to a recombinant yeast that can be used in such a process.
In [0029-0237], Van Lutz mentions:
preferably the invention provides a recombinant yeast comprising: [0230] a gene encoding for a heterologous protein having arabinose isomerase activity; [0231] a gene encoding for a protein having ribulokinase activity; [0232] a gene encoding for a protein having ribulose phosphate epimerase activity; [0233] a gene encoding for a protein having acetaldehyde dehydrogenase activity, preferably acetylating acetaldehyde dehydrogenase activity; [0234] a gene encoding for a protein having glycerol dehydrogenase activity; [0235] a, preferably glucose tolerant, gene encoding for a protein having glycerol-proton symporter activity, preferably an STL1 protein (which can be from Zygosaccharomyces rouxii, see [0012)];
[0236] a genetic modification causing overexpression of a nucleic acid sequence encoding for a homologous or heterologous protein having dihydroxyacetone kinase activity (see also [0189-1091]; and
[0237] a genetic modification causing deletion or disruption of a homologous protein with glycerol-efflux activity, preferably an fps1 protein native to the yeast.
In [0041], ANB1 is listed among the promoters helping optimal expression of genes incorporated into the recombinant yeast cell of Van Lutz.
Claim 14 of Van Lutz recites the following:
“14. A recombinant yeast comprising: a gene encoding a heterologous protein having arabinose isomerase activity; a gene encoding a heterologous protein having ribulokinase activity; a gene encoding a heterologous protein having ribulose phosphate epimerase activity; a gene encoding a heterologous protein having glycerol uptake activity; a gene encoding a heterologous protein having NAD+-dependent glycerol dehydrogenase activity; and a genetic modification leading to the reduction, downregulation, inhibition and/or elimination of the activity of a homologous protein with glycerol-efflux activity.”.
Therefore, given the teachings of Van Lutz, one of ordinary skill in the art can readily and reasonable envision a recombinant yeast cell that functionally expresses
- a nucleic acid sequence encoding a protein having glycerol dehydrogenase activity;
-a nucleic acid sequence encoding a protein having dihydroxyacetone kinase activity; and
- a nucleic acid sequence encoding a protein having glycerol transporter activity, wherein the expression of the nucleic acid sequence encoding the protein having glycerol transporter activity is under control of an ANB1 promoter inherently having an anaerobic/aerobic expression ratio for the glycerol transporter of 2 or more, rendering claim 1 (and its dependent claims 2-9, 16, and 18-19 obvious.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Van Lutz further in view of Picataggio et al., “Picataggio” (US 20110165661, 7/2011).
As mentioned above, Van Lutz teaches a recombinant yeast cell comprising a gene encoding for a protein having acetaldehyde dehydrogenase activity, preferably acetylating acetaldehyde dehydrogenase activity; [0234] a gene encoding for a protein having glycerol dehydrogenase activity; [0235] and a gene dihydroxyacetone kinase (see [0189-0191], and preferably a glucose tolerant gene encoding for a protein having glycerol-proton symporter activity attached to a promoter such as ANB1, wherein said symporter protein is an STL1 protein which has an anaerobic/aerobic expression ration of 2 or more, prior to this invention.
Said publication however, does not mention any yeast cells that express Rubisco.
Picataggio in [006] teaches microorganisms such as yeast (see [0011]) having enhanced fermentation activity. Said publication recites: in certain non-limiting embodiments, such microorganisms are capable of generating a target product with enhanced fermentation efficiency by, for example, (i) preferentially utilizing a particular glycolysis pathway, which increases yield of a target product, upon a change in fermentation conditions; (ii) reducing cell division rates upon a change in fermentation conditions, thereby diverting nutrients towards production of a target product; (iii) having the ability to readily metabolize five-carbon sugars; and/or (iv) having the ability to readily metabolize carbon dioxide; and combinations of the foregoing. In some embodiments, a target product is ethanol or succinic acid.
In [0071] according to Picataggio, photosynthetic organisms make use of atmospheric carbon by incorporating the carbon available in carbon dioxide into organic carbon compounds by a process known as carbon fixation. The activities responsible for a photosynthetic organism's ability to fix carbon dioxide include phosphoenolpyruvate carboxylase (e.g., PEP carboxylase) or ribulose 1,5-bis-phosphate carboxylase (e.g., Rubisco). PEP carboxylase catalyzes the addition of carbon dioxide to phosphoenolpyruvate to generate the four-carbon compound oxaloacetate. Oxaloacetate can be used in other cellular processes or be further converted to yield several industrially useful products (e.g., malate, succinate, citrate and the like). Rubisco catalyzes the addition of carbon dioxide and ribulose-1,5-bisphosphate to generate 2 molecules of 3-phosphoglycerate. 3-phosphoglycerate can be further converted to ethanol via cellular fermentation or used to produce other commercially useful products. Nucleic acid sequences encoding PEP carboxylase and Rubisco activities can be obtained from any suitable organism (e.g., plants, bacteria, and other microorganisms, for example) and any of these activities can be used herein with the proviso that the nucleic acid sequence is either naturally active in the chosen microorganism when expressed, or can be altered or modified to be active.
Before the effective filing of this application, to one of ordinary skill in the art when working on a method such an ethanol production under anaerobic fermentation conditions, it would have been obvious to start with the recombinant yeast cell of Van Lutz and incorporate Rubisco gene of Picataggio therein before utilizing said recombinant yeast for ethanol production. This is because anaerobic fermentation conditions using 5-6 carbon sources as substrates usually result in high levels of carbon dioxide in the fermenter and said gas can additionally be converted into ethanol when the recombinant yeast cell of Van Lutz in view of Picataggio is utilized resulting in higher yields of ethanol, rendering instant invention obvious.
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 1-10, 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of each of copending Application Nos. 18/578,590 and 18/030026, respectively. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of said claim 10 overlaps with the scope of instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARYAM MONSHIPOURI whose telephone number is (571)272-0932. The examiner can normally be reached full-flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L 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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/MARYAM MONSHIPOURI/Primary Examiner, Art Unit 1651
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