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 2-8 are amended.
Claims 1-8 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/07/2024 is acknowledged. The submission is in compliance with the provision of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered.
Claim Objections
(previous objection, withdrawn) Claims 2-8 are objected to because of the following informalities:
With regards to claims 2-8, claim 1 is drawn to “a method for preparing (2S,3R)-p-methylsulfonylphenylserine”. Dependent claims 2-8 are drawn to “the method for preparing the (2S,3R)-p-methylsulfonylphenylserine to claim 1”. The presence of “the” in the dependent claims may lead to antecedent issues and is awkward. Consistency is requested. Appropriate correction is required.
Response to Arguments
Applicant’s arguments, see pg. 3, filed 07/31/2026, with respect to claims 2-8 have been fully considered and are persuasive. The objection of 05/27/2026 has been withdrawn.
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.
(previous rejection, maintained) Claims 1, 3, and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Fujian Changsheng Biotechnology Development Co. (CN110951799 A; published 04/03/2020; see English translation provided with From 892), hereinafter referred to as Fujian, in view of Uwajima et al., (EP 0091810 B1; published March 25, 1987), hereinafter referred to as Uwajima, and in further view of Heath et al. (Current Opinion in Green and Sustainable Chemistry; Vol. 38:100693, pg. 1-9; published December 2022), hereinafter referred to as Heath .
With regards to claims 1, 3, and 5-8, Fujian teaches a method for asymmetric synthesis of (2S, 3R)-p-methylsulfonyl phenylserine (see Abstract). Fujian teaches synthesizing (2S,3R)-p-methylsulfonylphenylserine in a whole cell asymmetric way by a recombinant expression plasmid which encodes L-threonine transaldolase, alcohol dehydrogenase and formate dehydrogenase. Step two of the reaction involves putting p-methylsulfonylbenzaldehyde, L-threonine, and pyridoxal phosphate in a reaction container and adding Tris-HCl buffer (aqueous) and adding the whole wet cells which encode the enzymes.
Fujian further teaches that method for whole cell asymmetric synthesis uses Tris-HCl at pH 7.0. This is followed by carrying out an oscillation reaction at 25-35o C. Fujian teaches that the synthesis principle is as follows: Synthesizing (2S,3R)-p-methylsulfonyphenylserine and acetaldehyde by asymmetrically catalyzing p-methylsulfonylbenzaldehyde and L-threonine through L-threonine transaldolase and removing acetaldehyde generated by the catalytic process of L-threonine aldolase by coupling of alcohol dehydrogenase and formate dehydrogenase to relieve the inhibitory effect of by-product acetaldehyde (see pg. 3). Fujian does not teach that anaerobic conditions are required thus it is inherent that the reaction is performed in the presence of air which inherently contains oxygen.
Fujian does not teach that the reaction is performed in the presence of an acetaldehyde oxidase as recited in the current instant application claim 1.
However, Uwajima teaches that aldehyde oxidase (EC 1.2.3.1) is known to catalyze the reaction represented by the following equation: RCHO + O2 [Wingdings font/0xE0] H2O2 (see line 5, pg. 3). Uwajima also teaches an aldehyde oxidase from Pseudomonas that exhibits activity against acetaldehyde (See Line 50, pg. 4 and Table 1 (Substrate Specificity), pg. 5).
Furthermore, Heath teaches that enzymatic oxidation reactions may offer “greener” alternatives to chemical oxidation processes (see Abstract, pg. 1). Heath teaches that unlike other enzymes which perform oxidation reactions, such as dehydrogenases, oxidases do not require expensive cofactors or cofactor regenerating systems. Furthermore, unlike dehydrogenases which catalyze the reverse reaction as well, oxidation by oxidases is essentially an irreversible reaction (see Introduction, pg. 1).
It would have been obvious to one of ordinary skill in the art of protein engineering and biocatalysis before the effective filing date of the current instant application to use an aldehyde (acetaldehyde) oxidase taught by Uwajima in place of the coupled alcohol dehydrogenase/formate dehydrogenase system taught by Fujian in the reaction mixture in order to remove the acetaldehyde generated by the transaldolase from the reaction mixture which Fujian teaches is necessary to remove the inhibitory effect of the acetaldehyde byproduct. One of ordinary skill in the art of protein engineering would be motivated to do so since Heath teaches that oxidases provide a greener alternative to dehydrogenases and do not require expensive cofactors such as NAD, which are required by dehydrogenases. Furthermore, using the aldehyde (acetaldehyde) oxidase to remove acetaldehyde would negate needing to use a coupled enzyme system of alcohol dehydrogenase/formate dehydrogenase to remove acetaldehyde. One of ordinary skill in the art would have expectations of success in doing so since Fujian, Uwajima and Heath provide the necessary teachings and guidance to do so.
With regards to claim 8, Fujima teaches putting 0.18-0.2 part by mass of p-methylsulfonylbenzaldehyde, 0.0013-0.0015 part of pyrodixal phosphate and 0.18-0.2 part of L-threonine into the reaction container with the cells (see claim 1, pg. 1). Fujima does not specifically teach the mass ratio of the p-methylsulfonylbenzaldehye to the L-threonine to the pyridoxal phosphate is 6.0: (4.0-5.0) : (0.1-0.3). However, Fujima recognizes the component proportions as variables affecting properties of the resulting composition. Optimization of such result-effective variables through routine experimentation would have been obvious to one of ordinary skill in the art. It would have therefore been obvious to one of ordinary skill in the art of protein engineering to modify the mass ratio taught by Fujima and arrive at the mass ratio of 6.0: (4.0-5.0) : (0.1-0.3) with expectation of success since this constitutes routine experimentation involving result-effective variables. (See In re Aller, 220 F.2d 454, 42 CCPA824, 105 USPQ 233 (C.C.P.A., 1955) and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)).
(previous rejection, maintained) Therefore, claims 1, 3, and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Fujian Changsheng Biotechnology Development Co. (CN110951799 A; published 04/03/2020), in view of Uwajima et al., (EP 0091810 B1; published March 25, 1987), and in further view of Heath et al. (Current Opinion in Green and Sustainable Chemistry; Vol. 38:100693, pg. 1-9; published December 2022).
Response to Arguments
Applicant's arguments filed 07/31/2026 have been fully considered but they are not persuasive.
With regards to claim 1, Applicant argues that Fujian only discloses that “L-threonine transaldolase asymmetrically catalyzes p-methylsulfonylbenzaldehyde and L-threonine to synthesize (2S, 3R)-p-methylsulfonylphenylserine and acetaldehyde, and the acetaldehyde generated is removed and the NADH cofactor is recycled through the coupling of alcohol dehydrogenase and formate dehydrogenase and that ApADH can catalyze the conversion of acetaldehyde into ethanol thereby relieving the inhibitory effect of acetaldehyde (see pg. 4). Applicant further argues the “oxygen-containing environment” in the present application does not merely refer to the passive presence of air in the reaction vessel, but rather refers to forced aerobic conditions in which air or oxygen is actively supplied/continuously introduced during the reaction and that Fujian does not disclose that the reaction of p-methylsulfonylbenzaldehyde, L-threonine, and pyridoxyal phosphate to produce (2S,3R)-p-methylsulfonylphenyserine is carried out under the combined action of transaldolase and an acetylaldehyde oxidase in an oxygen-containing environment (forced aerobic) ( see pg. 4).
The arguments have been fully considered but are not persuasive. With regards to Applicant’s argument that the present application does not merely refer to passive presence of air in the reaction vessel but rather forced aerobic conditions in which air or oxygen is actively supplied/continuously introduced in the reaction system during the reaction and that Fujian does not teach the need for an active oxygen supply to drive the reaction, the Examiner does not find the arguments persuasive. Fujian does not teach the requirement of anaerobic conditions thus the reaction is performed in the presence of air which inherently contains oxygen. Applicant’s argument that the “oxygen-containing environment” in the present application refers to “forced aerobic” conditions” which is not taught by Fujian is not found persuasive as claim 1 does not recite the requirement for an actively supplied/continuously supplied oxygen or forced aerobic conditions. Although the claims are examined in the light of the specification, the specification cannot be read into the claims, i.e., the limitation of the specification cannot be read into the claims (see MPEP 211 R-5). In response to Applicant’s argument that Fujian does not teach that the reaction is carried out under the combined action of a transaldolase and an acetaldehyde oxidase in an oxygen-containing environment (see pg. 4) and therefore Fujian does not anticipate claim 1, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). According the MPEP 2145 (IV), One cannot show nonobviousness by attacking references individually where the rejections are based on a combination of references. Uwajima teaches that aldehyde (acetaldehyde) oxidase has activity against aldehydes (acetaldehyde) and Heath teaches that oxidases provide a greener alternative to dehydrogenases and unlike dehydrogenases, oxidases do not require a cofactor such as NAD or a cofactor regeneration system. Given the teachings of Fujian that acetaldehyde is inhibitory against transaldolase and that the coupling of alcohol dehydrogenase and formate dehydrogenase is used to remove acetaldehyde, one of ordinary skill in the art would find it obvious to use an aldehyde (acetaldehyde) oxidase taught by Uwajima and Heath in place of the coupled alcohol dehydrogenase and formate dehydrogenase system taught by Fujian in order to achieve removal of inhibitory acetaldehyde without the need of a cofactor such as NAD or a cofactor regenerating system. Furthermore, as stated in the above rejection, Fujian does not teach the requirement of anaerobic conditions so it is inherent that the reaction is carried out in air which inherently contains oxygen.
With regards to Applicant’s argument that the technical problem to be solved is how to achieve a high conversion efficiency without the need to add a coenzyme NAD and that the aforementioned features are not obvious to a person skilled in the relevant art (see pg. 5), the Examiner has fully considered the arguments but does not find them persuasive. In response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
With regards to Applicant’s argument that Fujian provides a teaching away (see pg. 5), the Examiner does not find the argument persuasive. Applicant argues that Fujian discloses that alcohol dehydrogenase catalyzes the conversion of acetaldehyde into ethanol, thereby relieving the inhibitory effect of acetaldehyde on L-threonine transaldolase and that the reaction is carried out at pH 7.0. Applicant argues that replacing the alcohol dehydrogenase with acetaldehyde oxidase would produce the by-product of acetic acid which would consume buffer capacity and cause a pH decrease in the reaction system (see pg. 5). Thus, Applicant argues that one of ordinary skill in the art would have no motivation to select an enzyme that would disrupt the acid-base balance of the reaction system (see pg. 5). The Examiner does not find this argument persuasive as one of ordinary skill in the art would be well-skilled to monitor and maintain the proper pH of the system during the reaction and select a known buffer that has proper buffering capacity at pH 7.0. Applicant argues that Fujian “specifically selected pH 7.0 precisely to maintain the optimal activity of this enzyme” (see pg. 5). Applicant further argues that Fujian’s technical teaching is to teach away from using aldehyde oxidase, because its byproduct acetic acid is incompatible with the neutral pH reactions system of Fujian. The Examiner does not find this statement persuasive. Although Fujian teaches that the whole cell reaction solution was in Tris-HCl pH 7.0, Fujian does not teach or suggest that it must be precisely pH 7.0. Furthermore, one of ordinary skill in the art would be well-skilled to monitor and maintain the proper pH of the system during the reaction and select a known buffer that has proper buffering capacity at pH 7.0 to maintain the activity of the enzyme. According the MPEP 2145 (IV), One cannot show nonobviousness by attacking references individually where the rejections are based on a combination of references. As stated in the rejection above, Uwajima teaches that aldehyde (acetaldehyde) oxidase has activity against aldehyde and Heath teaches that oxidases provide a greener alternative to dehydrogenases and unlike dehydrogenases, oxidases do not require a cofactor such as NAD or a cofactor regeneration system. Given the teachings of Fujian that acetaldehyde is inhibitory against transaldolase and that the coupling of alcohol dehydrogenase and formate dehydrogenase is used to remove acetaldehyde, one of ordinary skill in the art would find it obvious to use an aldehyde (acetaldehyde) oxidase taught by Uwajima and Heath in place of the coupled alcohol dehydrogenase and formate dehydrogenase taught by Fujian in order to carry out removal of inhibitory acetaldehyde without the need of a cofactor such as NAD or a cofactor regenerating system.
With regards to the Applicant’s argument that Uwajima and Heath do not provide the teaching or suggestion to apply aldehyde oxidase to the present specific reaction system in Fujian (see pg. 5-6), the Examiner does not find the arguments persuasive. According the MPEP 2145 (IV), One cannot show nonobviousness by attacking references individually where the rejections are based on a combination of references. Furthermore, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Applicant argues that regarding the “oxygen-containing environment”, it was known in the art that forced aeration might cause oxidative inactivation of enzyme proteins and that neither Uwajima nor Heath teaches the compatibility of acetaldehyde oxidase with transaldolase or the stability of the reactions system under forced air conditions (see pg. 5-6). The Examiner does not find the argument persuasive. As stated earlier, claim 1 does not recite the requirement of a “forced aerobic condition”. Although the claims are examined in the light of the specification, the specification cannot be read into the claims, i.e., the limitation of the specification cannot be read into the claims (see MPEP 211 R-5). Furthermore, in the reactions taught by Fujian which contains alcohol dehydrogenase/formate dehydrogenase, the primary function of the alcohol dehydrogenase/formate dehydrogenase system is to remove acetaldehyde which is inhibitory against transaldolase and that removal of acetaldehyde is achieved by the coupling of alcohol dehydrogenase and formate dehydrogenase so as to realize the cyclic regeneration of coenzyme I in the catalytic process (see Fujian, pg.3). Applicant argues that Heath does not teach the application of aldehyde oxidase to a transaldolase-catalyzed system for producing (2S,3R)-p-methylsulfoneylphenylserine and that Uwajima does not teach that acetic acid would not inhibit the transaldolase-catalyzed reaction system nor does Uwajima teach that using aldehyde oxidase in the transaldolase catalyzed reaction system could efficiently produce (2S,3R)-p-methylsulfonylphenylserine (see pg. 6). The Examiner does not find this argument persuasive. The motivation to apply the combined teachings of Uwajima and Heath to the reaction taught by Fujian comes from the disclosure of Uwajima that aldehyde (acetaldehyde) dehydrogenase exhibits activity against acetaldehyde and the motivation to use the teachings from Heath come from the statement of Heath that unlike dehydrogenases, oxidases do not require expensive cofactors such as NAD or cofactor regenerating systems. Thus, the combination of the teachings of Uwajima and Heath would motivate one of ordinary skill in the art of protein engineering to use aldehyde (acetaldehyde) oxidase in place of the alcohol dehydrogenase/formate dehydrogenase system taught by Fujian in order to achieve removal of inhibitory acetaldehyde without the need of a cofactor such as NAD or a cofactor regenerating system such as alcohol dehydrogenase/formate dehydrogenase. One of ordinary skill in the art would have expectations of success in achieving removal of inhibitory acetaldehyde from the reaction system from the combined teachings of Fujian, Uwajima, and Heath who provide all the necessary teachings needed to do so. As stated earlier, Applicant argues that the byproduct acetic acid would disrupt the optimized pH conditions of Fujian and introduce a new problem of enzyme activity inhibition (see pg. 5). The Examiner does not find this argument persuasive as one of ordinary skill in the art would be able to properly monitor the pH of the reaction and make appropriate adjustments to the pH such as using a buffer with appropriate buffering conditions.
With regards to Applicant’s argument that none of D1, D2, D3 teaches or suggests that converting acetaldehyde into acetic acid under the combined action of a transaldolase and an acetaldehyde oxidase in an oxygen-containing (forced aerobic) environment could produce (2S, 3R)-p-methylsulfonylphenylserine more efficiently as compared to Fujian’s pathway, the Examiner does not find the argument persuasive. The Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). As stated earlier, claim 1 does not recite the requirement of a forced aerobic environment. Although Fujian does not teach the presence of an acetaldehyde oxidase, Fujian does teach the removal of acetaldehyde generated by the catalytic process of L-threonine aldolase by coupling of alcohol dehydrogenase and formate dehydrogenase to relieve the inhibitory effect of by-product acetaldehyde. It would have been obvious to one of ordinary skill in the art to modify the reaction taught by Fujian by replacing the alcohol dehydrogenase and formate dehydrogenase with an aldehyde (acetaldehyde oxidase) taught by Uwajima and Heath since Uwajima teaches an aldehyde oxidase that has activity against acetaldehyde and Heath teaches that unlike dehydrogenases, oxidases do not require a cofactor such as NAD or a cofactor regenerating system. The motivation to do so would come from the teachings of Uwajima and Heath, whose teachings show that the removal of inhibitory acetaldehyde by an aldehyde (acetaldehyde) oxidase would occur without the need of a cofactor such as NAD or a cofactor regenerating system.
With regards to Applicant’s argument that the technical effects achieved by the present application breaks away from the technical teachings of Fujian and the conventional perception that acids and oxygen can affect enzyme activity (see pg. 6-7), the Examiner does not find the arguments persuasive.
Applicant argues that the technical solution in the present application is not obvious and is capable of achieving a high conversion efficiency without the need to add a coenzyme NAD (see pg. 7). The Examiner does not find this argument persuasive. As summarized in the rejection above, Fujian teaches a method for synthesis of (2S, 3R)-p-methylsulfonyl phenylserine in a whole cell asymmetric way by a recombinant expression plasmid which encodes L-threonine transaldolase, alcohol dehydrogenase, and formate dehydrogenase. The second part of the reaction involves putting p-methylsulfonylbenzaldehyde, L-threoneine, and pyridoxal phosphate in a reaction container and adding the whole wet cells which encode the enzymes. As summarized in the above rejection, although Fujian, does not teach that the reaction comprises an acetaldehyde oxidase, Uwajima teaches that that aldehyde oxidase (EC 1.2.3.1) is known to catalyze the reaction of a substrate aldehyde (see line 5, pg. 3). Uwajima also teaches an aldehyde oxidase from Pseudomonas that exhibits activity against acetaldehyde (See Line 50, pg. 4 and Table 1 (Substrate Specificity), pg. 5). Furthermore, Heath teaches that enzymatic oxidation reactions may offer greener alternatives to chemical oxidation processes (see Heath, pg. 1) and that unlike other enzymes which perform oxidation reactions such as dehydrogenases, oxidases do not require expensive cofactors or cofactor regeneration systems (see Heath, pg. 1). Therefore, 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 use an aldehyde (acetaldehyde) oxidase as taught by Uwajima and Heath in place of the alcohol dehydrogenase/formate dehydrogenase coupling system taught by Fujian in order to remove the acetaldehyde byproduct without the need of a cofactor such as NAD or regenerating cofactor system. Furthermore, claim 1 does not recite a requirement for improved efficiency of the reaction. Although the claims are examined in the light of the specification, the specification cannot be read into the claims, i.e., the limitation of the specification cannot be read into the claims (see MPEP 211 R-5).
Thus, the above rejection is maintained.
(previous rejection, maintained) Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Fujian Changsheng Biotechnology Development Co. (CN110951799 A; published 04/03/2020), hereinafter referred to as Fujian, in view of Uwajima et al., (EP 0091810 B1; published March 25, 1987), hereinafter referred to as Uwajima, and in further view of Heath et al. (Current Opinion in Green and Sustainable Chemistry; Vol. 38:100693, pg. 1-9; published December 2022), hereinafter referred to as Heath as applied to claim 1 above, and further in view of Jessen et al. (US Patent Publication No: US20120135481A1; published 07/28/2015), hereinafter referred to as Jessen.
The teachings of Fuiian, Uwajima, and Heath as applied to claim 1 are summarized above.
With regards to claim 2, Fujian does not teach an acetaldehyde oxidase having the amino acid sequence shown in SEQ ID NO: 1.
However, Jessen teaches a polypeptide from Pseudomonas putida having the amino acid sequence of SEQ ID NO: 1 of the current instant application (see alignment below).
RESULT 2
US-13-301-556-31
(NOTE: this sequence has 12 duplicates in the database searched.
See complete list at the end of this report)
Sequence 31, US/13301556
Publication No. US20120135481A1
GENERAL INFORMATION
APPLICANT: Jessen, Holly
APPLICANT: Rush, Brian
APPLICANT: Huryta, Jeanette
APPLICANT: Mastel, Beth
APPLICANT: Berry, Alan
APPLICANT: Yaver, Debbie
TITLE OF INVENTION: Compositions and Methods for 3-Hydroxypropionic Acid Production
FILE REFERENCE: 12084-US-NP
CURRENT APPLICATION NUMBER: US/13/301,556
CURRENT FILING DATE: 2011-11-21
PRIOR APPLICATION NUMBER: US 61/416,199
PRIOR FILING DATE: 2010-11-22
PRIOR APPLICATION NUMBER: US 61/535,181
PRIOR FILING DATE: 2011-09-15
NUMBER OF SEQ ID NOS: 351
SEQ ID NO 31
LENGTH: 295
TYPE: PRT
ORGANISM: Pseudomonas putida
Query Match 94.2%; Score 1450; Length 295;
Best Local Similarity 96.3%;
Matches 283; Conservative 9; Mismatches 2; Indels 0; Gaps 0;
Qy 8 RIAFIGLGNMGAPMARNLIKAGHQLNLFDLNQTVLAELAELGGQVSASPKDAAASSELVI 67
|||||||||||||||||||||||||||||||:||||||||||||:| |||||||||||||
Db 2 RIAFIGLGNMGAPMARNLIKAGHQLNLFDLNKTVLAELAELGGQISPSPKDAAASSELVI 61
Qy 68 TMLPAAAHVRSVYLGDDGVLAGVRPGTPTVDCSTIDPQTAREVSKAAAAKGVDMGDAPVS 127
|||||||||||||| |||||||:||||||||||||||||||:||||||||||||||||||
Db 62 TMLPAAAHVRSVYLNDDGVLAGIRPGTPTVDCSTIDPQTARDVSKAAAAKGVDMGDAPVS 121
Qy 128 GGTGGAAAGTLTFMVGASAELFAALKPVLEQMGRNIVHCGEVGTGQIAKICNNLLLGISM 187
|||||||||||||||||||||||:||||||||||||||||||||||||||||||||||||
Db 122 GGTGGAAAGTLTFMVGASAELFASLKPVLEQMGRNIVHCGEVGTGQIAKICNNLLLGISM 181
Qy 188 IGVSEAMALGNALGIDTQVLAGIINSSTGRCWSSDTYNPWPGIIETAPASRGYTGGFGAE 247
|||||||||||||||||:||||||||||||||||||||||||||||||||||||||||||
Db 182 IGVSEAMALGNALGIDTKVLAGIINSSTGRCWSSDTYNPWPGIIETAPASRGYTGGFGAE 241
Qy 248 LMLKDLGLATEAARQAHQPVIMGALAQQLYQAMSLRGDGGKDFSAIVEGYRKKD 301
|||||||||||||||||||||:||:||||||||||||:||||||||||||||||
Db 242 LMLKDLGLATEAARQAHQPVILGAVAQQLYQAMSLRGEGGKDFSAIVEGYRKKD 295
It would have been obvious to one of ordinary skill in the art of protein engineering and biocatalysis before the effective filing date of the current instant application to use an acetaldehyde oxidase such as the polypeptide taught by Jessen (Note that the current instant application specification identifies SEQ ID NO:1 as an acetaldehyde oxidase, see paragraph 0036; also residues 1-7 in SEQ ID NO: 1 of the specification appear to be a His-tag), in place of the coupled alcohol dehydrogenase/formate dehydrogenase system taught by Fujian in the reaction mixture in order to remove the acetaldehyde generated by the transaldolase from the reaction mixture which Fujian teaches is necessary to remove the inhibitory effect of the acetaldehyde byproduct. One of ordinary skill in the art of protein engineering would be motivated to do so since Heath teaches that oxidases provide a greener alternative to dehydrogenases and do not require expensive cofactors such as NAD, which are required by dehydrogenases. Furthermore, using the acetaldehyde oxidase to remove acetaldehyde would negate needing to use a coupled enzyme system of alcohol dehydrogenase/formate dehydrogenase to remove acetaldehyde. One of ordinary skill in the art would have expectations of success in doing so since Fujian, Uwajima, Heath, and Jessen provide the necessary teachings and guidance to do so.
(previous rejection, maintained) Therefore, claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Fujian Changsheng Biotechnology Development Co. (CN110951799 A; published 04/03/2020), in view of Uwajima et al., (EP 0091810 B1; published March 25, 1987), and in further view of Heath et al. (Current Opinion in Green and Sustainable Chemistry; Vol. 38:100693, pg. 1-9; published December 2022), as applied to claim 1 above, and further in view of Jessen et al. (US Patent Publication No: US20120135481A1; published 07/28/2015).
(previous rejection, maintained) Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Fujian Changsheng Biotechnology Development Co. (CN110951799 A; published 04/03/2020), hereinafter referred to as Fujian, in view of Uwajima et al., (EP 0091810 B1; published March 25, 1987), hereinafter referred to as Uwajima, and in further view of Heath et al. (Current Opinion in Green and Sustainable Chemistry; Vol. 38:100693, pg. 1-9; published December 2022), hereinafter referred to as Heath as applied to claim 1 above, and further in view of Kaushal et al., (Biocatalysis and Agricultural Biotechnology, Vol. 16, pg. 192-199; published online August 04, 2018), hereinafter referred to as Kaushal.
The teachings of Fujian, Uwajima, and Heath as applied to claim 1 are summarized above.
With regards to claim 4, Fujian does not teach the addition of catalase.
However, Kaushal teaches that catalase is known to catalyze the breakdown of hydrogen peroxide into oxygen and water. Catalase has been used an important enzyme in many bioremediation in the removal of hydrogen peroxide where it is used to give out oxygen by breakdown of hydrogen peroxide (see Abstract, pg. 192).
One of ordinary skill in the art of protein engineering would be motivated to modify the method taught by Fujian and as further modified by the teachings of Uwajima and Heath as described above, by adding catalase to the reaction mixture in order to mediate removal of the reactive oxygen species, hydrogen peroxide, (which is a byproduct of aldehyde oxidase as taught by Uwajima, see line 5, pg. 3). One of ordinary skill in the art would be motivated to do so in order to avoid potential harms caused by reactive oxygen species but also this would provide additional O2 to the reaction mixture. One of ordinary skill in the art would be expected to have success in doing so since Fujian, Uwajma, Heath, and Kaushal provide all the necessary teaching and guidance to do so.
(previous rejection, maintained) Therefore, claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Fujian Changsheng Biotechnology Development Co. (CN110951799 A; published 04/03/2020), in view of Uwajima et al., (EP 0091810 B1; published March 25, 1987), and in further view of Heath et al. (Current Opinion in Green and Sustainable Chemistry; Vol. 38:100693, pg. 1-9; published December 2022), as applied to claim 1 above, and further in view of Kaushal et al., (Biocatalysis and Agricultural Biotechnology, Vol. 16, pg. 192-199; published online August 04, 2018).
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GEORGE THEMISTOCLIS LOUNTOS/ Examiner, Art Unit 1652
/ROBERT B MONDESI/ Supervisory Patent Examiner, Art Unit 1652
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