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 .
Detailed Action
Applicant’s election of claims 1-12, and as sequences SEQ ID NOs: 1, 3, 11, 16, 17, 19, 21, 22, 24 and 28 (in claims 1-4 and 7-12); and as species (i) aromatic benzaldehydes; (ii) terephthalaldehyde; (iii) terephthalaldehyde; and (iv) terephthalaldehyde (in claims 8-11) without traverse in the reply filed on 08/24/2026 is acknowledged. Claims 1-20 are pending in this application; claims 1-5 and 7-12, the elected sequences (SEQ ID NOs) and the elected species reading on the elected invention is now under consideration for examination; claims 6 and 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Priority
Applicants’ claim for the benefit of priority under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a 371 of PCT/US2023/064643 filed on 03/17/2023, and claims the priority of Provisional Application 63/320,859 filed on 03/17/2022. However, note that the elected claims 1-5 and 7-12 are only granted the priority date 371 of PCT/US2023/064643 filed on 03/17/2023, as support for the elected sequences is found only in 371 of PCT/US2023/064643 filed on 03/17/2023.
Information disclosure statement
The information disclosure statements (IDS) submitted on 09/16/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statement is considered and initialed by the examiner.
Objections-Abstract/Specification
The Abstract of the disclosure is objected to because, Abstract should be on a separate sheet of paper. The abstract of the disclosure is objected to because the abstract is presented as part of the first page of a WO publication. The abstract should be presented as a single sheet apart from all other bibliographic material including the information included on the first page of a WO publication. If EFS is used to submit a replacement abstract, the appropriate abstract (ABST) document code should be used for the one-page document. Correction is required. See MPEP § 608.01 (b).
Claim Objections
Claims 1-4 and 7-12 are objected, as said claims recite non-elected subject-matter/SEQ ID NOs.
Claim Rejections: 35 USC § 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.
Claim 8 is 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 8 is indefinite in the recitation of “derived”. The metes and bounds of the term “derived” is not clear in the context of the claim. It is not clear to the examiner what are the structures encompassed in “derived”? or is a representative member of a genus/merely exemplary. Furthermore, in claim 8 is indefinite in the recitation of “derived”; as written, one cannot determine if the term refers to ‘functions of several real variables” or ‘structural variables’ of claimed “derived” aldehydes derived from pyrimidine nucleosides (unlimited structures or structurally undefined molecules or functionally variable molecules and the extent of variability is unclear). The metes and bounds of the claim is unclear. For examination purposes, no patentable weight will be given to the term. It is not clear to the examiner as to what the phrase “derived” means in the context of the above claim, is this synonymous with “obtained from specific source or having specific structures? or does it include natural and man-made variants of unlimited/undefined structures thereof from any source? Examiner suggests amending the claims to recite ”obtained from…”. Clarification and correction required.
Claim Rejections: 35 USC § 112(a)
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.
Written-Description
Claims 1-3, and 7-12 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 claims contain 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 inventors, at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The claimed method of claims 1-3, and 7-12, require a genus of L-threonine transaldolase (TTA), wherein said genus of TTA comprises an amino acid sequence having at least 90% identity to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-29 of undefined and unlimited structures including variants, mutants and homologs, whereby a beta-hydroxy non-standard amino acid (P-OH-nsAA) is produced; said method further comprises a genus of carboxylic acid reductases (CAR) of undefined and unlimited structures including variants, mutants and homologs, whereby the aldehyde is generated from the carboxylic acid (as in claim 12). The claims are not fully supported by the description. Again, a person skilled in the art would not know how to conduct the process/method according to the invention, since the description lacks information on which particular structure having 90% sequence identity to SEQ ID NOs: 1-29 are engaged in the process/method, i.e., structure correlated to function and there is no evidence of possession of the entire genus in the claimed process. What is more, the determination of which particular structure having 90% sequence identity to SEQ ID NOs: 1-29 for the claimed production of beta-hydroxy non-standard amino acid (P-OH-nsAA) fall within the scope of protection sought requires excessive effort and undue experimentation. There is no guidance in the specification and the skilled person should not be left in any doubt as to which subject matter is covered and which is not. The skilled person should be able to establish the demarcation of the scope of the claim (i.e. its extent of protection) without undue burden (also see 35 U.S.C. 112(b) rejection above for claims interpretation).
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. Applicants are directed to MPEP § 2163 for guidelines on compliance with the written description requirement.
The purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. For a broad generic claim, the specification must provide adequate written description to identify the genus of the claim.
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus.”). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
MPEP § 2163 further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the biomolecule, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed biomolecule.”
“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 . . ., reduction to drawings . . ., 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.” MPEP 2163.
Furthermore, 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. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure ‘indicates that the patentee has invented species sufficient to constitute the gen[us].’ See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (‘[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.’). ‘A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.’ In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).” MPEP 2163.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). See MPEP 2163(I).
The specification discloses and is limited to specific wild-type L-threonine transaldolases (TTAs) comprising the amino acid sequences of SEQ ID NOs: 1-29 (see Table 6, pages 45-54 of the specification) in the claimed process/method, which is insufficient to put one of skill in the art in possession of the attributes and features of all species within the claimed genus of L-threonine transaldolase (TTA), wherein said genus of TTA comprises an amino acid sequence having at least 90% identity to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-29 of undefined and unlimited structures including variants, mutants and homologs, whereby a beta-hydroxy non-standard amino acid (P-OH-nsAA) is produced; said method further comprises a genus of carboxylic acid reductases (CAR) of undefined and unlimited structures including variants, mutants and homologs, whereby the aldehyde is generated from the carboxylic acid, the structural and functional elements of the presently recited claims and in the instant method can vary substantially within the above given claimed recitations.
The prior art clearly teaches that there is wide variation in the ability of L-threonine transaldolase (TTA) to catalyze different substrates for the production of a beta-hydroxy non-standard amino acid (P-OH-nsAA), is challenging and requires optimization of various parameters and mutations affects the enzyme kinetics, substrate specificity, and the final product, beta-hydroxy non-standard amino acid (P-OH-nsAA); see Kumar P., (PhD., Thesis, 2022, Univ., of Wisconsin-Madison, pages 1-154) disclose via random mutagenesis studies of a single wild-type L-threonine transaldolase (wt-Obih) showed out of ~1600 variants screened only 15 variants showed any significant activity (see page 119, Chapter 4; Applicants are also directed to Introduction, pages 2-20; Figs. 7, 9, 10; Chapters 3-4, pages 61-136; and entire document).
Therefore, those of skill in the art would not accept that the inventor had been in possession of the full genus of L-threonine transaldolase (TTA), wherein said genus of TTA comprises an amino acid sequence having at least 90% identity to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-29 of undefined and unlimited structures including variants, mutants and homologs, whereby a beta-hydroxy non-standard amino acid (P-OH-nsAA) is produced; said method further comprises a genus of carboxylic acid reductases (CAR) of undefined and unlimited structures including variants, mutants and homologs, whereby the aldehyde is generated from the carboxylic acid as claimed in the instant claims. The specification does not provide accurate experimental conditions of the process and are not defined and it is not clear what is encompassed in the instant method claims.
Consequently, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus of L-threonine transaldolase (TTA), wherein said genus of TTA comprises an amino acid sequence having at least 90% identity to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-29 of undefined and unlimited structures including variants, mutants and homologs, whereby a beta-hydroxy non-standard amino acid (P-OH-nsAA) is produced; said method further comprises a genus of carboxylic acid reductases (CAR) of undefined and unlimited structures including variants, mutants and homologs, whereby the aldehyde is generated from the carboxylic acid encompassed by the claimed method would meet the limitations of the claims.
The skilled artisan cannot envision the detailed genus of L-threonine transaldolase (TTA), wherein said genus of TTA comprises an amino acid sequence having at least 90% identity to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-29 of undefined and unlimited structures including variants, mutants and homologs, whereby a beta-hydroxy non-standard amino acid (P-OH-nsAA) is produced; said method further comprises a genus of carboxylic acid reductases (CAR) of undefined and unlimited structures including variants, mutants and homologs, whereby the aldehyde is generated from the carboxylic acid in the claimed method.
Claim Rejections: 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1-4 and 7-12 are rejected under 35 U.S.C. 103(a) as being unpatentable Xiu et al., (Systems Biol., 2022, Vol. 2: 705-715, published online 05/02/2022; note the granted priority date of for instant claims is 03/17/2023) and further in view of Doyon et al., (ChemBioChem., 2002, Vol. 23, e202100577, pages 1-9), Wang et al., (Appl. Microbiol. Biochem., 2021, Vol. 105: 3507-3520, in IDS), Gradnigo et al., (UniProtKB/TrEMBL; Acc# A0A1E7N1Q8 disclosing a polypeptide having 99.4% sequence identity to SEQ ID NO: 1 of the instant invention and annotated as pyridoxal 5'-phosphate (PLP) amino acid methyltransferase), Nobary et al., (UniProtKB/TrEMBL; Acc# I0CBZ9 disclosing a polypeptide having 100% sequence identity to SEQ ID NO: 3; and disclosing a polypeptide having 99.6% sequence identity to SEQ ID NO: 11 of the instant invention and annotated and annotated as pyridoxal 5'-phosphate (PLP) amino acid methyltransferase), Graham et al., (UniProtKB/TrEMBL; Acc# A0A2N8PGK6 disclosing a polypeptide having 99.1% sequence identity to SEQ ID NO: 17 of the instant invention; and disclosing a polypeptide having 98% sequence identity to SEQ ID NO: 24 of the instant invention and annotated as pyridoxal 5'-phosphate (PLP) amino acid methyltransferase), and Malakhov et al., (J. Struct. Functional Genomics., 2004, Vol. 5: 75-89).
Regarding claims 1-4 and 8-12, Xiu et al., (Systems Biol., 2022, Vol. 2: 705-715, published online 05/02/2022; note the granted priority date of for instant claims is 03/17/2023), discloses an in vitro method for producing a beta-hydroxy non-standard amino acid (P-OH-nsAA), the method comprising: L-Threonine transaldolase catalyzing the transaldolation of L-threonine and aldehyde to generate β-hydroxy-α-amino acids with high diastereoselectivity and screening of various L-Threonine transaldolase including optimal biochemical properties (see Abstract; Fig. 1, page 708; Fig. 2, page 709; Fig. 3, page 710; Fig. 4, page 711; Fig. 5, page 712; Fig. 6, page 713; and entire document); said reference method includes to eliminate the inhibitory effect of aldehydes, an alcohol dehydrogenase (ADH) was employed to convert the byproduct acetaldehyde into ethanol; in addition, a carboxylic acid reductase (CAR) was introduced to catalyze the reduction of cheaper benzoic acid into benzaldehyde, which could be further utilized as substrate in LTTA-catalyzed reaction (col. 1, ¶ 2, page 706; Fig. 5, page 712; col. 1-2, page 712; Fig. 6, page 713; and Conclusions).
The disclosure of Xiu et al., is silent regarding wherein L-Threonine transaldolase (TAA) is selected from the group consisting of SEQ ID NOs: 1, 3, 11, 16, 17, 19, 21, 22, 24 and 28 (as in claims 1-4 and 7-12); and wherein the L-Threonine transaldolase (TAA) further comprises a small ubiquitin-like modifier motif (SUMO tag) (as in claim 7).
Regarding claims 1-4 and 8-11, Doyon et al., (ChemBioChem., 2002, Vol. 23, e202100577, pages 1-9) provide teaching, suggestion and motivation to a skilled artisan i.e., detail protocols regarding selection of various aldehydes/variety of aromatic, aliphatic and heterocyclic aldehydes as substrates and screening of various pyridoxal 5'-phosphate (PLP) dependent TAA with desirable activity (see Fig. 1-5; Conclusions; and entire document).
Regarding claims 1-4 and 8-11, Wang et al., (Appl. Microbiol. Biochem., 2021, Vol. 105: 3507-3520, in IDS) also provide teaching, suggestion and motivation to a skilled artisan i.e., detail protocols regarding selection of various aldehydes/variety of aromatic, aliphatic and heterocyclic aldehydes as substrates and screening of various pyridoxal 5'-phosphate (PLP) dependent TAA with desirable activity (see Abstract; Fig. 7-8, pages 3516-3517; Conclusion, pages 3517-3518). Wang et al., teaches a method of producing a beta-hydroxy non-standard amino acid (bHAA) using by mixing L-threonine, an aldehyde and a TTA enzyme, either in solution and in a recombinant cell that expresses a TTA in medium comprising an aldehyde and L-threonine and suggest "The discovery of the single-domain LTTAs L-threonine transaldolases in the biosynthesis of natural products facilitates a conserved genomic approach with the aim of identifying new LTTA homologues” (Discovery of LTTA homologues as biocatalyst, col 1, ¶ 1-2, page 3516).
Regarding claims 1-4 and 8-12, the following references provide the structural and functional elements of the instant invention: Gradnigo et al., (UniProtKB/TrEMBL; Acc# A0A1E7N1Q8 disclosing a polypeptide having 99.4% sequence identity to SEQ ID NO: 1 of the instant invention and annotated as pyridoxal 5'-phosphate (PLP) amino acid methyltransferase), Nobary et al., (UniProtKB/TrEMBL; Acc# I0CBZ9 disclosing a polypeptide having 100% sequence identity to SEQ ID NO: 3; and disclosing a polypeptide having 99.6% sequence identity to SEQ ID NO: 11 of the instant invention and annotated and annotated as pyridoxal 5'-phosphate (PLP) amino acid methyltransferase), Graham et al., (UniProtKB/TrEMBL; Acc# A0A2N8PGK6 disclosing a polypeptide having 99.1% sequence identity to SEQ ID NO: 17 of the instant invention; and disclosing a polypeptide having 98% sequence identity to SEQ ID NO: 24 of the instant invention and annotated as pyridoxal 5'-phosphate (PLP) amino acid methyltransferase).
Regarding claim 7, Malakhov et al., (J. Struct. Functional Genomics., 2004, Vol. 5: 75-89) provide teaching, suggestion and motivation to a skilled artisan for the use of SUMO fusions and SUMO-specific protease for efficient expression and purification of proteins and provide evidence that SUMO enhances expression and solubility of fused protein (see Abstract; Table 1, page 77; Results, pages 79-85).
As such, disclosure of strategy and methods including structural and functional elements for L-Threonine transaldolase of interest depending on the experimental need in the claimed method including the advantages of expression the L-Threonine transaldolases of interest as SUMO fusions, as suggested in the references of Gradnigo et al., (UniProtKB/TrEMBL; Acc# A0A1E7N1Q8 disclosing a polypeptide having 99.4% sequence identity to SEQ ID NO: 1 of the instant invention and annotated as pyridoxal 5'-phosphate (PLP) amino acid methyltransferase), Nobary et al., (UniProtKB/TrEMBL; Acc# I0CBZ9 disclosing a polypeptide having 100% sequence identity to SEQ ID NO: 3; and disclosing a polypeptide having 99.6% sequence identity to SEQ ID NO: 11 of the instant invention and annotated and annotated as pyridoxal 5'-phosphate (PLP) amino acid methyltransferase), Graham et al., (UniProtKB/TrEMBL; Acc# A0A2N8PGK6 disclosing a polypeptide having 99.1% sequence identity to SEQ ID NO: 17 of the instant invention; and disclosing a polypeptide having 98% sequence identity to SEQ ID NO: 24 of the instant invention and annotated as pyridoxal 5'-phosphate (PLP) amino acid methyltransferase), and Malakhov et al., (J. Struct. Functional Genomics., 2004, Vol. 5: 75-89) teaching the advantages of said modifications, clearly suggests to a skilled artisan to modify the teachings of Xiu et al., Doyon et al., and Wang et al., and incorporate the structural and functional elements of Gradnigo et al., Nobary et al., Graham et al., and Malakhov et al., and adopt the methods for obtaining desired L-Threonine transaldolases of interest in the claimed method for producing in vitro a beta-hydroxy non-standard amino acid (P-OH-nsAA), comprising incubating L-threonine, an aldehyde and an L-threonine transaldolase (TTA), as provided in the combined teachings of Xiu et al., Doyon et al., Wang et al., Gradnigo et al., Nobary et al., Graham et al., and Malakhov et al., and the combined references also provide teaching, suggestion and motivation including the structural and functional elements of the instant invention and are well known in the art (for details see the rejection above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claimed method, as suggested by the teachings of Doyon et al., and Wang et al., and incorporate the structural and functional elements of Gradnigo et al., Nobary et al., Graham et al., and Malakhov et al., and to modify the teachings of Xiu et al. A person of ordinary skill in the art is motivated to make such change depending on the experimental need, because a skilled artisan would realize such a modification would be useful to efficiently to produce a beta-hydroxy non-standard amino acid (P-OH-nsAA), comprising incubating L-threonine, an aldehyde and an L-threonine transaldolase (TTA) of interest in the claimed method of the instant invention. One of ordinary skill in the art has a reasonable expectation of success at adding the steps as suggested in the teachings of Doyon et al., and Wang et al., and incorporate the structural and functional elements of Gradnigo et al., Nobary et al., Graham et al., and Malakhov et al., and are well known in the art. Therefore, the invention as a whole lack an inventive step over the prior art. The expectation of success is high, because the combined teachings Xiu et al., Doyon et al., Wang et al., Gradnigo et al., Nobary et al., Graham et al., and Malakhov et al., also provide the structural and functional elements of the instant invention (Teaching, Suggestion and Motivation).
Regarding specific choice of an aldehyde and an L-threonine transaldolase (TTA) in the claimed method are also provided/suggested in the combination of references, and examiner also takes the position the following position; optimization of known variables, and the examiner finds support in: MPEP 2144.05 [R-5]: A. Optimization Within Prior Art Conditions or Through Routine Experimentation Generally, differences in choice of an aldehyde and an L-threonine transaldolase (TTA) in the claimed method will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation". As to optimization results, a patent will not be granted based upon the optimization of result effective variables when the optimization is obtained through routine experimentation unless there is a showing of unexpected results which properly rebuts the prima facie case of obviousness. See In re Boesch, 617 F.2d 272,276,205 USPQ 215,219 (CCPA 1980). See also In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936-37 (Fed. Cir. 1990), and In re Aller, 220 F2d 454,456,105 USPQ 233,235 (CCPA 1955). Furthermore, "it is prima facie obvious to combine two compositions or two methods each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition or third method to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)”. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
Therefore, claims 1-4 and 7-12 are rejected under 35 U.S.C. 103(a) as being unpatentable Xiu et al., (Systems Biol., 2022, Vol. 2: 705-715, published online 05/02/2022; note the granted priority date of for instant claims is 03/17/2023) and further in view of Doyon et al., (ChemBioChem., 2002, Vol. 23, e202100577, pages 1-9), Wang et al., (Appl. Microbiol. Biochem., 2021, Vol. 105: 3507-3520, in IDS) Gradnigo et al., (UniProtKB/TrEMBL; Acc# A0A1E7N1Q8 disclosing a polypeptide having 99.4% sequence identity to SEQ ID NO: 1 of the instant invention and annotated as pyridoxal 5'-phosphate (PLP) amino acid methyltransferase), Nobary et al., (UniProtKB/TrEMBL; Acc# I0CBZ9 disclosing a polypeptide having 100% sequence identity to SEQ ID NO: 3; and disclosing a polypeptide having 99.6% sequence identity to SEQ ID NO: 11 of the instant invention and annotated and annotated as pyridoxal 5'-phosphate (PLP) amino acid methyltransferase), Graham et al., (UniProtKB/TrEMBL; Acc# A0A2N8PGK6 disclosing a polypeptide having 99.1% sequence identity to SEQ ID NO: 17 of the instant invention; and disclosing a polypeptide having 98% sequence identity to SEQ ID NO: 24 of the instant invention and annotated as pyridoxal 5'-phosphate (PLP) amino acid methyltransferase), and Malakhov et al., (J. Struct. Functional Genomics., 2004, Vol. 5: 75-89).
Allowable Subject Matter/Conclusion
None of the claims are allowable. Claims 1-4 and 7-12 are rejected; and claim 5 is objected, as said claim 5 depends from rejected base claim 1.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
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