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 .
Claims Status
Claims 1-17 are pending.
Claim 1 is amended.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-2) in the reply filed on 07/06/2026 is acknowledged. The traversal is on the ground(s) that in claim 1, the transaminase mutant has an amino acid sequence obtained by the mutation of the amino acid of SEQ ID NO. 1, and the mutation comprises V242W and that Claims 1,3,4,6,and 9 have corresponding specific distinguishing technical features. This is not found persuasive because even in view of the amended claim 1, Pannuri et al. (WIPO International Publication Number: WO 2006/063336 A2; published June 15, 2006) teaches an omega-transaminase sequence, SEQ ID NO. 2 (94.6 % identical to instant application SEQ ID NO. 1; see paragraph 08, pg. 2 and sequence listings, pg. 2, SEQ ID NO.2), having a mutation of the amino acid sequence in SEQ ID NO: 1 of instant application (see sequence alignment below). Pannuri also teaches that the thermostable omega transaminase of the invention comprises an amino acid sequence which differs from the amino acid sequence shown in SEQ ID NO. 2 at position 242 and that a preferred mutation at position 242 is a Trp (W) substitution (V242W) (see Table 1, pg. 4).
RESULT 14
PCT-US05-44883-2
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
Sequence 2, PC/TUS0544883
GENERAL INFORMATION
APPLICANT: Pannuri, Sachin
APPLICANT: Kamat, Sanjay
APPLICANT: Garcia, Abraham Rogelio Martin
TITLE OF INVENTION: Thermostable Transaminases
FILE REFERENCE: 014730.00003
CURRENT APPLICATION NUMBER: PCT/US05,44883
CURRENT FILING DATE: 2005-12-16
PRIOR APPLICATION NUMBER: US 60/634,526
PRIOR FILING DATE: 2004-12-10
NUMBER OF SEQ ID NOS: 18
SEQ ID NO 2
LENGTH: 476
TYPE: PRT
ORGANISM: Arthrobacter citreus
FEATURE:
OTHER INFORMATION: Cel9611
Query Match 94.6%; Score 2405; Length 476;
Best Local Similarity 96.6%;
Matches 460; Conservative 5; Mismatches 11; Indels 0; Gaps 0;
Qy 1 MGLTVQKINWEQVKEWDRKYLMRTFSTQNEYQPVPIESTEGDYLITPGGTRLLDFFNQLY 60
||||||||||||||||||||||||||||||||||||||||||||| | ||||||||||||
Db 1 MGLTVQKINWEQVKEWDRKYLMRTFSTQNEYQPVPIESTEGDYLIMPDGTRLLDFFNQLY 60
Qy 61 CVNLGQKNQKVNAAIKEALDRYGFVWDTYATDYKAKAAKIIIEDILGDEDWPGKVRFVST 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 CVNLGQKNQKVNAAIKEALDRYGFVWDTYATDYKAKAAKIIIEDILGDEDWPGKVRFVST 120
Qy 121 GSEAVETALNIARLYTNRPLVVTREHDYHGWTGGAATVTRLRSFRSGLVGENSESFSAQI 180
|||||||||||||||||||||||||||||||||||||||||||:||||||||||||||||
Db 121 GSEAVETALNIARLYTNRPLVVTREHDYHGWTGGAATVTRLRSYRSGLVGENSESFSAQI 180
Qy 181 PGSSCSSAVLMAPSSNTFQDSNGNYLKDENGELLSVKYTRRMIENYGPEQVAAVITEVSQ 240
|||| :|||||||| | ||||||| |||||||||||||||||||||||||||||||||||
Db 181 PGSSYNSAVLMAPSPNMFQDSNGNCLKDENGELLSVKYTRRMIENYGPEQVAAVITEVSQ 240
Qy 241 GVGSTMPPYEYVPQIRKMTKELGVLWISDEVLTGFGRTGKWFGYQHYGVQPDIITMGKGL 300
| || ||||||:|| ||||||||||||:||||||||||||||||||||||||||||||||
Db 241 GAGSAMPPYEYIPQFRKMTKELGVLWINDEVLTGFGRTGKWFGYQHYGVQPDIITMGKGL 300
Qy 301 SSSSLPAGAVVVSKEIAAFMDKHRWESVSTYAGHPVAMAAVCANLEVMMEENLVEQAKNS 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 SSSSLPAGAVVVSKEIAAFMDKHRWESVSTYAGHPVAMAAVCANLEVMMEENLVEQAKNS 360
Qy 361 GEYIRSKLELLQEKHKSIGNFDGYGLLWIVDIVNAKTKTPYVKLDRNFRHGMNPNQIPTQ 420
|||||||||||||||||||||||||||||||||||||||||||||||| |||||||||||
Db 361 GEYIRSKLELLQEKHKSIGNFDGYGLLWIVDIVNAKTKTPYVKLDRNFTHGMNPNQIPTQ 420
Qy 421 IIMEKALEKGVLIGGAMPNTMRIGASLNVSRGDIDKAMDALDYALDYLESGEWQQS 476
|||:||||||||||| ||||||||||||||||||||||||||||||||||||||||
Db 421 IIMKKALEKGVLIGGVMPNTMRIGASLNVSRGDIDKAMDALDYALDYLESGEWQQS 476
Applicant’s election of:
Species Group 1: (V242W + F164Q + V328I+R442T+S194P + V252I + G48D)
Species Group 2: Each cell listed in claim 7: 1) a prokaryotic cell, 2) a eukaryotic cell, is a distinct species. Applicants should elect one. Applicants did not elect a single species.
Species Group 3: Each recombinant plasmid listed in claim 6 is a distinct species. Applicants should elect one. Applicants did not elect a single species.
in the reply filed on 07/06/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 3-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected non-elected subject matter, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/06/2026.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/04/2024, 05/07/2024, 03/03/2025 and 12/02/2025 is acknowledged. The submission is in compliance with the provision of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered.
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 1-2 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 is directed to all possible transaminase mutants, wherein the transaminase mutants have an amino acid sequence obtained by the mutation of the amino acid sequence shown in SEQ ID NO: 1 and the mutation comprises V242W. There is no disclosure of any particular structure to function/activity relationship in the disclosed species.
Claim 2 is directed to all possible transaminase mutants, wherein the transaminase mutants have an amino acid sequence obtained by the mutation of the amino acid sequence shown in SEQ ID NO: 1 and the mutation comprises V242W and comprises the following mutation site combination: V242W + F164Q + V328I + R442T + S194P + V252I + G48D. There is no disclosure of any particular structure to function/activity relationship in the disclosed species.
The art teaches that transaminases are highly selective toward their natural substrates which makes them of key interest in biocatalysis for industrial application. Besides a-amino acid transaminases, which are ubiquitous in all organisms, a smaller group of amine transaminases exists Vos et al. (ACS Catalysis, Vol. 8, pg. 11524-11533; published October 25, 2018, see Introduction, pg. 11524). Voss et al. also teach that mutagenesis of residues forming the substrate entry tunnel in transaminases can have a profound impact on activity and selectivity (see Abstract, Pg. 11524).
Regarding the level of skill and knowledge in the art of amino acid mutation, the reference of Singh et al., (Curr. Protein Pept. Sci. 18:1-11, 2017; cited on the attached PTO0-892) reviews various protein engineering methods and discloses that despite the availability of an ever-growing database of protein structures and highly sophisticated computational algorithms, protein engineering is still limited by the incomplete understanding of protein functions, folding, flexibility, and conformational changes (see pg. 7, column 1, top). Also, the unpredictability associated with amino acid mutations is exemplified by the reference of Zhang et al. (Structure 26: 1474-1485, 2018, cited on the attached Form PTO-82) which discloses that even a mutation of a surface residue that was predicted to be benign caused significant structural changes and unexpected effects on the function of a polypeptide (p. 1475, column 1).
Given this lack of additional representative species as encompassed by the claims, Applicants have failed to sufficiently describe the claimed invention, in such full, clear, concise, and exact terms that a skilled artisan would recognize Applicants were in possession of the claimed invention.
Claims 1-2 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a transaminase mutant having a mutation in SEQ ID NO: 1 , V242W (claim 1) or a transaminase mutant of SEQ ID NO. 1 having any one of mutations site combinations of V242W+L59Q , V242W+F164C, V242W+F164Q, V242W+F164W , V242W+F164Y , V242W+L272G, V242W+L272I, V242W+L272K, V242W+L272M, V242W+L272P, V242W+L272V, V242W+L272Y, V242W+V328C, V242W+V328I, V242W+V328L, V242W+V328M, V242W+V328Q, V242W+V328S, V242W+V328T, V242W+V328W, V242W+T330F, V242W+T330I, V242W+T330S, V242W+A436H, V242W+A436K, V242W+A436L, V242W+A436N, V242W+A436P, V242W+A436Q, V242W+A436S, V242W+A436Y, V242W+R442A, V242W+R442C, V242W+R442F, V242W+R442G, V242W+R442H, V242W+R442N, V242W+R442Q, V242W+R442S, V242W+R442T, V242W+F164Q+V328A, V242W+F164Q+V328C, V242W+F164Q+V328D, V242W+F164Q+V328E, V242W+F164Q+V328F, V242W+F164Q+V328G, V242W+F164Q+V328H, V242W+F164Q+V328I, V242W+F164Q+V328L, V242W+F164Q+V328M, V242W+F164Q+V328P, V242W+F164Q+V328Q, V242W+F164Q+V328R, V242W+F164Q+V328S, V242W+F164Q+V328W, V242W+F164Q+V328T, V242W+F164Q+V328Y, V242W+F164Q+R442T, V242W+F164Q+V328I+G2S, V242W+F164Q+V328I+T46M, V242W+F164Q+V328I+G48D, V242W+F164Q+V328I+C185Y, V242W+F164Q+V328I+S186N, V242W+F164Q+V328I+S194P, V242W+F164Q+V328I+T197M, V242W+F164Q+V328I+N202D, V242W+F164Q+V328I+Y205L , V242W+F164Q+V328I+T245A, V242W+F164Q+V328I+V252I, V242W+F164Q+V328I+S268N, V242W+F164Q+V328I+L353F, V242W+F164Q+V328I+N359D, V242W+F164Q+V328I+R409T, V242W+F164Q+V328I+E424K, V242W+F164Q+V328I+A436V, V242W+F164Q+V328I+R442T, V242W+F164Q+V328I+R442T+G48D, V242W+F164Q+V328I+R442T+S194P, V242W+F164Q+V328I+R442T+V252I, V242W+F 164Q+V328I+R442T+S 194P+V252I, V242W+F164Q+V328I+R442T+V252I+G48D, V242W+F164Q+V328I+R442T+S194P+G48D or V242W+F 164Q+V328I+R442T+S 194P+V252I+G48D and mutations listed in specification Tables 1-5 (claim 2) , does not reasonably provide enablement for
(claim 1) to all possible transaminase mutants, wherein the transaminase mutants have an amino acid sequence obtained by the mutation of the amino acid sequence shown in SEQ ID NO: 1 and the mutation comprises V242W
(Claim 2) to all possible transaminase mutants, wherein the transaminase mutants have an amino acid sequence obtained by the mutation of the amino acid sequence shown in SEQ ID NO: 1 and the mutation comprises V242W and comprises the following mutation site combination: V242W + F164Q + V328I + R442T + S194P + V252I + G48D. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required, are summarized in In re Wands (858 F.2d 731, 8 USPQ 2nd 1400 (Fed. Cir. 1988)) as follows: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claim(s).
Claim 1 is so broad as to encompass all possible transaminase mutants, wherein the transaminase mutants have an amino acid sequence obtained by the mutation of the amino acid sequence shown in SEQ ID NO: 1 and the mutation comprises V242W.
Claim 2 is so broad as to encompass all possible transaminase mutants, wherein the transaminase mutants have an amino acid sequence obtained by the mutation of the amino acid sequence shown in SEQ ID NO: 1 and the mutation comprises V242W and comprises the following mutation site combination: V242W + F164Q + V328I + R442T + S194P + V252I + G48D.
The claims rejected under this section of U.S.C. 112, first paragraph, place minimal structural limits on the required variant polypeptides encompassed by the claims. Since the amino acid sequence of a protein determines its structural and functional properties, predictability of which changes can be tolerated in a protein's amino acid sequence and obtain the desired activity requires a knowledge of and guidance with regard to which amino acids in the protein's sequence, if any, are tolerant of modification and which are conserved (i.e. expectedly intolerant to modification), and detailed knowledge of the ways in which the proteins' structure relates to its function. However, in this case the disclosure is limited to:
(claim 1) a transaminase mutant having a mutation in SEQ ID NO: 1, V242W.
(claim 2) or a transaminase mutant of SEQ ID NO. 1 having any one of mutations site combinations of V242W+L59Q , V242W+F164C, V242W+F164Q, V242W+F164W , V242W+F164Y , V242W+L272G, V242W+L272I, V242W+L272K, V242W+L272M, V242W+L272P, V242W+L272V, V242W+L272Y, V242W+V328C, V242W+V328I, V242W+V328L, V242W+V328M, V242W+V328Q, V242W+V328S, V242W+V328T, V242W+V328W, V242W+T330F, V242W+T330I, V242W+T330S, V242W+A436H, V242W+A436K, V242W+A436L, V242W+A436N, V242W+A436P, V242W+A436Q, V242W+A436S, V242W+A436Y, V242W+R442A, V242W+R442C, V242W+R442F, V242W+R442G, V242W+R442H, V242W+R442N, V242W+R442Q, V242W+R442S, V242W+R442T, V242W+F164Q+V328A, V242W+F164Q+V328C, V242W+F164Q+V328D, V242W+F164Q+V328E, V242W+F164Q+V328F, V242W+F164Q+V328G, V242W+F164Q+V328H, V242W+F164Q+V328I, V242W+F164Q+V328L, V242W+F164Q+V328M, V242W+F164Q+V328P, V242W+F164Q+V328Q, V242W+F164Q+V328R, V242W+F164Q+V328S, V242W+F164Q+V328W, V242W+F164Q+V328T, V242W+F164Q+V328Y, V242W+F164Q+R442T, V242W+F164Q+V328I+G2S, V242W+F164Q+V328I+T46M, V242W+F164Q+V328I+G48D, V242W+F164Q+V328I+C185Y, V242W+F164Q+V328I+S186N, V242W+F164Q+V328I+S194P, V242W+F164Q+V328I+T197M, V242W+F164Q+V328I+N202D, V242W+F164Q+V328I+Y205L , V242W+F164Q+V328I+T245A, V242W+F164Q+V328I+V252I, V242W+F164Q+V328I+S268N, V242W+F164Q+V328I+L353F, V242W+F164Q+V328I+N359D, V242W+F164Q+V328I+R409T, V242W+F164Q+V328I+E424K, V242W+F164Q+V328I+A436V, V242W+F164Q+V328I+R442T, V242W+F164Q+V328I+R442T+G48D, V242W+F164Q+V328I+R442T+S194P, V242W+F164Q+V328I+R442T+V252I, V242W+F 164Q+V328I+R442T+S 194P+V252I, V242W+F164Q+V328I+R442T+V252I+G48D, V242W+F164Q+V328I+R442T+S194P+G48D or V242W+F 164Q+V328I+R442T+S 194P+V252I+G48D and mutations listed in specification Tables 1-5.
While recombinant and mutagenesis techniques are known, it is not routine in the art to screen for multiple substitutions or multiple modifications, as encompassed by the instant claims, and the positions within a protein's sequence where amino acid modifications can be made with a reasonable expectation of success in obtaining the desired activity/utility are limited in any protein and the result of such modifications is unpredictable. In addition, one skilled in the art would expect any tolerance to modification for a given protein to diminish with each further and additional modification, e.g. multiple substitutions.
The specification does not support the broad scope of the claims which encompass any possible:
(claim 1) transaminase mutants, wherein the transaminase mutants have an amino acid sequence obtained by the mutation of the amino acid sequence shown in SEQ ID NO: 1 and the mutation comprises V242W
(claim 2) transaminase mutants, wherein the transaminase mutants have an amino acid sequence obtained by the mutation of the amino acid sequence shown in SEQ ID NO: 1 and the mutation comprises V242W and comprises the following mutation site combination: V242W + F164Q + V328I + R442T + S194P + V252I + G48D because the specification does not establish: (A) regions of the polypeptide which may be modified affecting the transaminase activity of the polypeptide of claims 1-2; (B) the general tolerance of enzymes with transaminase activity to modification and extent of such tolerance; (C) a rational and predictable scheme for modifying any amino acid residue of a protein with transaminase activity with an expectation of obtaining the desired biological function; and (D) the specification provides insufficient guidance as to which of the essentially infinite possible choices is likely to be successful. Because of this lack of guidance, the extended experimentation that would be required to determine which substitutions would be acceptable to retain the required functions of the transaminase activity of the polypeptide of claims 1-2 and the fact that the relationship between the sequence of a peptide and its tertiary structure (i.e. its activity) are not well understood and are not predictable (e.g., see Ngo et al. in The Protein Folding Problem and Tertiary Structure Prediction, 1994, Merz et al. (ed.), Birkhauser, Boston, MA, pp. 433 and 492-495; Franceus et al., J. Ind. Microbiol. Biotechnol. Vol 44, pp 687-695, 2017), it would require undue experimentation for one skilled in the art to arrive at the majority of polypeptides having the transaminase activity function of the polypeptide of claims 1-2 of the claimed genus.
Thus, applicants have not provided sufficient guidance to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims broadly including any:
(claim 1) transaminase mutants, wherein the transaminase mutants have an amino acid sequence obtained by the mutation of the amino acid sequence shown in SEQ ID NO: 1 and the mutation comprises V242W
(claim 2) transaminase mutants, wherein the transaminase mutants have an amino acid sequence obtained by the mutation of the amino acid sequence shown in SEQ ID NO: 1 and the mutation comprises V242W and comprises the following mutation site combination: V242W + F164Q + V328I + R442T + S194P + V252I + G48D
The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of:
(claim 1) all possible transaminase mutants, wherein the transaminase mutants have an amino acid sequence obtained by the mutation of the amino acid sequence shown in SEQ ID NO: 1 and the mutation comprises V242W
(claim 2) all possible transaminase mutants, wherein the transaminase mutants have an amino acid sequence obtained by the mutation of the amino acid sequence shown in SEQ ID NO: 1 and the mutation comprises V242W and comprises the following mutation site combination: V242W + F164Q + V328I + R442T + S194P + V252I + G48D
is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1)( and 102(a)(2) as being anticipated by Pannuri et al. (WIPO International Publication Number: WO 2006/063336 A2; published June 15, 2006), hereinafter referred to as Pannuri.
With regards to claim 1, Pannuri teaches an omega-transaminase sequence, SEQ ID NO. 2 (94.6 % identical to instant application SEQ ID NO. 1; see paragraph 08, pg. 2 and sequence listings, pg. 2, SEQ ID NO.2), having a mutation of the amino acid sequence in SEQ ID NO: 1 of instant application (see sequence alignment below). Pannuri also teaches that the thermostable omega transaminase of the invention comprises an amino acid sequence which differs from the amino acid sequence shown in SEQ ID NO. 2 at position 242 and that a preferred mutation at position 242 is a Trp (W) substitution (V242W) (see Table 1, pg. 4).
RESULT 14
PCT-US05-44883-2
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
Sequence 2, PC/TUS0544883
GENERAL INFORMATION
APPLICANT: Pannuri, Sachin
APPLICANT: Kamat, Sanjay
APPLICANT: Garcia, Abraham Rogelio Martin
TITLE OF INVENTION: Thermostable Transaminases
FILE REFERENCE: 014730.00003
CURRENT APPLICATION NUMBER: PCT/US05,44883
CURRENT FILING DATE: 2005-12-16
PRIOR APPLICATION NUMBER: US 60/634,526
PRIOR FILING DATE: 2004-12-10
NUMBER OF SEQ ID NOS: 18
SEQ ID NO 2
LENGTH: 476
TYPE: PRT
ORGANISM: Arthrobacter citreus
FEATURE:
OTHER INFORMATION: Cel9611
Query Match 94.6%; Score 2405; Length 476;
Best Local Similarity 96.6%;
Matches 460; Conservative 5; Mismatches 11; Indels 0; Gaps 0;
Qy 1 MGLTVQKINWEQVKEWDRKYLMRTFSTQNEYQPVPIESTEGDYLITPGGTRLLDFFNQLY 60
||||||||||||||||||||||||||||||||||||||||||||| | ||||||||||||
Db 1 MGLTVQKINWEQVKEWDRKYLMRTFSTQNEYQPVPIESTEGDYLIMPDGTRLLDFFNQLY 60
Qy 61 CVNLGQKNQKVNAAIKEALDRYGFVWDTYATDYKAKAAKIIIEDILGDEDWPGKVRFVST 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 CVNLGQKNQKVNAAIKEALDRYGFVWDTYATDYKAKAAKIIIEDILGDEDWPGKVRFVST 120
Qy 121 GSEAVETALNIARLYTNRPLVVTREHDYHGWTGGAATVTRLRSFRSGLVGENSESFSAQI 180
|||||||||||||||||||||||||||||||||||||||||||:||||||||||||||||
Db 121 GSEAVETALNIARLYTNRPLVVTREHDYHGWTGGAATVTRLRSYRSGLVGENSESFSAQI 180
Qy 181 PGSSCSSAVLMAPSSNTFQDSNGNYLKDENGELLSVKYTRRMIENYGPEQVAAVITEVSQ 240
|||| :|||||||| | ||||||| |||||||||||||||||||||||||||||||||||
Db 181 PGSSYNSAVLMAPSPNMFQDSNGNCLKDENGELLSVKYTRRMIENYGPEQVAAVITEVSQ 240
Qy 241 GVGSTMPPYEYVPQIRKMTKELGVLWISDEVLTGFGRTGKWFGYQHYGVQPDIITMGKGL 300
| || ||||||:|| ||||||||||||:||||||||||||||||||||||||||||||||
Db 241 GAGSAMPPYEYIPQFRKMTKELGVLWINDEVLTGFGRTGKWFGYQHYGVQPDIITMGKGL 300
Qy 301 SSSSLPAGAVVVSKEIAAFMDKHRWESVSTYAGHPVAMAAVCANLEVMMEENLVEQAKNS 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 SSSSLPAGAVVVSKEIAAFMDKHRWESVSTYAGHPVAMAAVCANLEVMMEENLVEQAKNS 360
Qy 361 GEYIRSKLELLQEKHKSIGNFDGYGLLWIVDIVNAKTKTPYVKLDRNFRHGMNPNQIPTQ 420
|||||||||||||||||||||||||||||||||||||||||||||||| |||||||||||
Db 361 GEYIRSKLELLQEKHKSIGNFDGYGLLWIVDIVNAKTKTPYVKLDRNFTHGMNPNQIPTQ 420
Qy 421 IIMEKALEKGVLIGGAMPNTMRIGASLNVSRGDIDKAMDALDYALDYLESGEWQQS 476
|||:||||||||||| ||||||||||||||||||||||||||||||||||||||||
Db 421 IIMKKALEKGVLIGGVMPNTMRIGASLNVSRGDIDKAMDALDYALDYLESGEWQQS 476
Therefore, claim 1 is rejected under 35 U.S.C. 102(a)(1)( and 102(a)(2) as being anticipated by Pannuri et al. (WIPO International Publication Number: WO 2006/063336 A2; published June 15, 2006).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Pannuri et al. (WIPO International Publication Number: WO 2006/063336 A2; published June 15, 2006), hereinafter referred to Pannuri, as applied to claim 1 above, and further in view of Asymchem Life Science Tianjin Co Ltd. (CN110205310A; published 09/06/2019), hereinafter referred to as Asymchem.
The teachings of Pannuri as applied to claim 1 are summarized above.
With regards to claim 2, Pannuri does not teach a suggested mutation of V242W+A436N to the transaminase.
However, Asymchem teaches a transaminase mutant represented by SEQ ID NO.1 that has 94.4% sequence identity to SEQ ID NO. 1 of the current instant application and differs at position 60 (see sequence alignment below). Asymchem also teaches that the amino acid sequence of the transaminase mutant is an amino acid sequence obtained by mutation of the amino acid sequence of SEQ ID NO. 1 and the mutation includes at least one of the following mutation sites: position 242 and position 436 (see claim 1) among others. Asymchem does not specifically teach a mutation of V242W but does teach a mutation at position 436 of SEQ ID NO.1, A436N (see claim 1) to improve the activity of transaminase (see contents of invention, pg. 3 of translated patent).
Title: US-18-707-998-1
Perfect score: 2543
Sequence: 1 MGLTVQKINWEQVKEWDRKY..........LDYLESGEWQQSLEHHHHHH 484
Scoring table: BLOSUM62
Gapop 10.0 , Gapext 0.5
Searched: 1 seqs, 465 residues
Total number of hits satisfying chosen parameters: 1
Minimum DB seq length: 0
Maximum DB seq length: inf
Post-processing: Minimum Match 0%
Maximum Match 100%
Listing first 50 summaries
Database : AASEQ2_07222026_153612.fasta:*
SUMMARIES
%
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 2400.5 94.4 465 1 AASEQ2_07222026_153612
ALIGNMENTS
RESULT 1
AASEQ2_07222026_153612
Query Match 94.4%; Score 2400.5; DB 1; Length 465;
Best Local Similarity 99.6%;
Matches 463; Conservative 0; Mismatches 1; Indels 1; Gaps 1;
Qy 1 MGLTVQKINWEQVKEWDRKYLMRTFSTQNEYQPVPIESTEGDYLITPGGTRLLDFFNQLY 60
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MGLTVQKINWEQVKEWDRKYLMRTFSTQNEYQPVPIESTEGDYLITPGGTRLLDFFNQLC 60
Qy 61 CVNLGQKNQKVNAAIKEALDRYGFVWDTYATDYKAKAAKIIIEDILGDEDWPGKVRFVST 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 CVNLGQKNQKVNAAIKEALDRYGFVWDTYATDYKAKAAKIIIEDILGDEDWPGKVRFVST 120
Qy 121 GSEAVETALNIARLYTNRPLVVTREHDYHGWTGGAATVTRLRSFRSGLVGENSESFSAQI 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 GSEAVETALNIARLYTNRPLVVTREHDYHGWTGGAATVTRLRSFRSGLVGENSESFSAQI 180
Qy 181 PGSSCSSAVLMAPSSNTFQDSNGNYLKDENGELLSVKYTRRMIENYGPEQVAAVITEVSQ 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 PGSSCSSAVLMAPSSNTFQDSNGNYLKDENGELLSVKYTRRMIENYGPEQVAAVITEVSQ 240
Qy 241 GVGSTMPPYEYVPQIRKMTKELGVLWISDEVLTGFGRTGKWFGYQHYGVQPDIITMGKGL 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 GVGSTMPPYEYVPQIRKMTKELGVLWISDEVLTGFGRTGKWFGYQHYGVQPDIITMGKGL 300
Qy 301 -SSSSLPAGAVVVSKEIAAFMDKHRWESVSTYAGHPVAMAAVCANLEVMMEENLVEQAKN 359
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 SSSSSLPAGAVVVSKEIAAFMDKHRWESVSTYAGHPVAMAAVCANLEVMMEENLVEQAKN 360
Qy 360 SGEYIRSKLELLQEKHKSIGNFDGYGLLWIVDIVNAKTKTPYVKLDRNFRHGMNPNQIPT 419
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 SGEYIRSKLELLQEKHKSIGNFDGYGLLWIVDIVNAKTKTPYVKLDRNFRHGMNPNQIPT 420
Qy 420 QIIMEKALEKGVLIGGAMPNTMRIGASLNVSRGDIDKAMDALDYA 464
|||||||||||||||||||||||||||||||||||||||||||||
Db 421 QIIMEKALEKGVLIGGAMPNTMRIGASLNVSRGDIDKAMDALDYA 465
It would have been obvious to one of ordinary skill in the art of protein engineering before the effective filing date of the current instant application to combine the A436N mutation with V242W mutation applied to omega-transaminase sequence, SEQ ID NO. 2, taught by Pannuri to arrive at a mutation comprising of V242W+A4356N to the transaminase mutant taught by Pannuri. One of ordinary skill in the art of protein engineering would be motivated to do so by the teachings of Asymchem who teach suggested mutations at positions 242 and 436 of the transaminase mutant in order to improve transaminase activity. One of ordinary skill in the art of protein engineering would have expectations of success in doing so from the combined teachings of Asymchem and Pannuri who provide all the teachings and guidance needed to do so.
Therefore, claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Pannuri et al. (WIPO International Publication Number: WO 2006/063336 A2; published June 15, 2006) as applied to claim 1 above, and further in view of Asymchem Life Science Tianjin Co Ltd. (CN110205310A; published 09/06/2019).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE T LOUNTOS whose telephone number is (571)272-0502. The examiner can normally be reached Monday-Friday 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached at 408-918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GEORGE THEMISTOCLIS LOUNTOS/ Examiner, Art Unit 1652
/ROBERT B MONDESI/ Supervisory Patent Examiner, Art Unit 1652
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