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
Amended Claims 1-19 (dated 03/28/2024) are pending and now under consideration.
Priority
Acknowledgment is made of applicants’ claim for foreign priority under 35 U.S.C. 119(a)-(d). This application is a 371 of PCT/CN2021/127138 filed on 10/28/2021 and claims the priority date of China application 202111146751.0 filed on 09/28/2021; however, no English translation of said foreign priority application has been provided. Therefore, the priority date for instant claims under consideration is deemed to be the filing date of 371 of PCT/CN2021/127138 filed on 10/28/2021.
Information disclosure statement
The information disclosure statement (IDS) submitted on 03/28/2024 and 04/25/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statements are considered and initialed by the examiner.
Objections-Specification
I. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. The specification contains hyperlinks to various site domains, for example, page 14 of the instant application. Applicants’ are required to thoroughly scrutinize the specification and delete all embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01. Appropriate correction is required.
II. The use of trademarks throughout the specification and in claims has been noted in this application, for example, pages 5-7 of specification and claims 8-9, 15-16 and 18-19 i.e., NKA9, LXEP120,AB-8, ECR8806, XAD-7 or D3520;… Septet® LXHFA001 or LifetechTM ECR8285… . It should be capitalized wherever it appears and be accompanied by the generic terminology. Although the use of trademarks is permissible in patent applications, the proprietary nature of the trademarks should be respected and every effort made to prevent their use in any manner, which might adversely affect their validity as trademarks. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. The above mentioned term is only one example and not necessarily all-inclusive. Applicant is encouraged to inspect the entire disclosure for other improperly cited trademarks/names.
Claim Objections
I. Claim 1 and claims 2-19 depending therefrom are objected to because of the following informalities: Claim 1 has two periods (“.”) in the claim i.e., in line 16 and at the end of the claim. Appropriate correction is required.
II. Claims 8-9, 15-16 and 18-19 are objected to because of the following informalities; due to the recitation of Trademarks in claims.
2173.05(u) Trademarks or Trade Names in a Claim [R-07.2022]
The presence of a trademark or trade name in a claim is not, per se, improper under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, but the claim should be carefully analyzed to determine how the mark or name is used in the claim. It is important to recognize that a trademark or trade name is used to identify a source of goods, and is not the name of the goods themselves. Thus a trademark or trade name does not define or describe the goods associated with the trademark or trade name. See definitions of trademark and trade name in MPEP § 608.01(v).
If the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). See also Eli Lilly & Co. v. Apotex, Inc., 837 Fed. Appx. 780, 784-85, 2020 USPQ2d 11531 (Fed. Cir. 2020) ("Following Patent Office procedure, the Examiner in this case rejected the claims of the '821 application as indefinite because they improperly used the trade name 'ALIMTA.' In response to the rejection, Lilly canceled its claims reciting the trade name and pursued claims using the generic name for the same substance, which mooted the rejection. Additionally, as the district court observed, the Examiner 'explicitly noted that pemetrexed disodium was 'also known by the trade name ALIMTA' ' in the contemporaneous obviousness rejection."). The claim scope is uncertain since the trademark or trade name cannot be used properly to describe any particular material or product. In fact, the value of a trademark would be lost to the extent that it became the generic name of a product, rather than used as an identification of a source or origin of a product. Thus, the use of a trademark or trade name in a claim to describe a material or product would not only render a claim indefinite, but would also constitute an improper use of the trademark or trade name. If the applicant responds to such a rejection by replacing the trademark or trade name with a generic term, the examiner should determine whether there is sufficient support in the application for use of a generic term. See MPEP § 2163, subsection II.A.3(b).
If a trademark or trade name appears in a claim and is not intended as a limitation in the claim, the question of why it is in the claim should be addressed. If its presence in the claim causes confusion as to the scope of the claim, then the claim should be rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
II. PROPRIETARY NATURE OF MARKS USED IN COMMERCE
Although the use of marks having definite meanings is permissible in patent applications, the proprietary nature of the marks should be respected. Marks should be identified by capitalizing each letter of the mark (in the case of word or letter marks) or otherwise indicating the description of the mark (in the case of marks in the form of a symbol or device or other nontextual form). Every effort should be made to prevent their use in any manner which might adversely affect their validity as marks.
Claims Objections/MULTIPLE DEPENDENT CLAIMS
35 U.S.C. 112 Specification.
REFERENCE IN MULTIPLE DEPENDENT FORM.-A claim in multiple dependent form shall contain a reference, in the alternative only, to more than one claim previously set forth and then specify a further limitation of the subject matter claimed. A multiple dependent claim shall not serve as a basis for any other multiple dependent claim. A multiple dependent claim shall be construed to incorporate by reference all the limitations of the particular claim in relation to which it is being considered.
IV. Claim 11 and claim 12 depending therefrom are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims 11-12 not been further treated on the merits. Claim 11 depends from claim 10 and also claims 6-9.
V. Claims 7, 14 and 17 are objected to, due to the following informality: Claims 7, 14 and 17 recite abbreviation "PEI" in the claims. Examiner suggests expanding the abbreviations to recite the full form of what the abbreviation stands for at least in the first recitation. Appropriate correction is required. For examination purposes "PEI" is interpreted as "polyetherimide (PEI)".
VI. Claim 11 is objected, due to the following informality: Claim 11 recites “any one od…” is a spelling/typographical error; should read as “any one of…”. Correction and clarification is required.
Claim Rejections: 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
I. Claims 2, 7-9, 11-12 and 14-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claims 2, 7-9, 11-12 and 14-19, the phrase “preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
In the present instance, claims 2, 7-9, 11-12 and 14-19 recite the broad recitation “… mutant has more than 90% …resin carrier” and the claims also recite “…preferably more than 99% … epoxy resin sphere… NKA9, LXEP120,AB-8, ECR8806, XAD-7 or D3520;… Septet® LXHFA001 or LifetechTM ECR8285…”, which is the narrower statement of the range/limitation (range within range). It is not clear what the applicants’ intend to encompass in the rejected claims and the metes and bounds of the claims are unclear and as being indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. Correction and clarification is required. Examiner suggests for the following range “…preferably more than 99% … epoxy resin sphere… NKA9, LXEP120,AB-8, ECR8806, XAD-7 or D3520;… Septet® LXHFA001 or LifetechTM ECR8285…” applicants’ consider writing additional new claims as dependent claims.
II. Claim 3 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 3 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 3 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” genes/encoded polypeptides (unlimited structures or structurally undefined molecules or functionally variable molecules and the extent of variability is unclear). The metes and bounds of the claims are unclear. For examination purposes, no patentable weight will be given to the terms. It is not clear to the examiner as to what the phrase “derived” means in the context of the above claims, 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.
Trademarks in the claims
III. Claims 8-9, 15-16 and 18-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 8-9, 15-16 and 18-19 recite the phrase/Trademark in the claims “NKA9, LXEP120,AB-8, ECR8806, XAD-7 or D3520;… Septet® LXHFA001 or LifetechTM ECR8285…”, as the metes and bounds of the claims are unclear for the following reasons: although the Trademark name may remain the same, the contents/components of the product or the system may vary periodically. Thus, the scope of the claim is unclear. Clarification and correction is required. For examination purposes “NKA9, LXEP120,AB-8, ECR8806, XAD-7 or D3520;… Septet® LXHFA001 or LifetechTM ECR8285…” are interpreted to encompass “resin spheres”. As set forth in MPEP § 2173.05(u), if a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 USC § 112(b) or pre-AIA 35 USC § 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used to properly identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. In fact, the value of a trademark would be lost to the extent that it became descriptive of a product, rather than used as an identification of a source or origin of a product. The use of a trademark or a trade name in a claim to identify or describe a material or product would not only render a claim indefinite, but would also constitute an improper use of the trademark or trade name. Correction is required.
Claim Rejections: 35 USC § 112(a)
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 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
I. Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-19 as interpreted is directed to encompass: any transaminase mutant, wherein the transaminase mutant comprising: a protein having the amino acid sequence of SEQ ID NO: 1 with a mutation of one or more amino acids, wherein the mutation comprises any one or more of the group consisting of: C418Q, C418W, W60Y, Y168A,… alternatively, the amino acid sequence of the transaminase mutant has a mutation site in the mutated amino acid sequence, and has more than 85% of identity with the mutated amino acid sequence, and has the transaminase activity (genera of polypeptides, as in claims 1-3 and 6-9); encoding polynucleotides (as in claim 4-5); method of making and method of use (as in claims 10-19; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation).
In University of California v. Eli Lilly & Co., 43 USPQ2d 1938, the Court of Appeals for the Federal Circuit has held that “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”. As indicated in MPEP § 2163, 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 that Applicant was in possession of the claimed genus. In addition, MPEP § 2163 states that 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.
In the instant case the scope of the instant claims encompass a and a genus of structures for polypeptides and the encoding polynucleotides of interest with associated function, i.e., any transaminase mutant, wherein the transaminase mutant comprising: a protein having the amino acid sequence of SEQ ID NO: 1 with a mutation of one or more amino acids, wherein the mutation comprises any one or more of the group consisting of: C418Q, C418W, W60Y, Y168A,… alternatively, the amino acid sequence of the transaminase mutant has a mutation site in the mutated amino acid sequence, and has more than 85% of identity with the mutated amino acid sequence, and has the transaminase activity (genera of polypeptides, as in claims 1-3 and 6-9); encoding polynucleotides (as in claim 4-5); method of making and method of use (as in claims 10-19; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation).
No information, beyond the characterization of specific mutants of parental wild-type transaminase comprising the amino acid sequence of SEQ ID NO: 1 and said mutant of SEQ ID NO: 1 comprising specific amino acid reside substitutions, wherein the mutation comprises any one or more of the group consisting of: C418Q, C418W, W60Y, Y168A, V379W, V379L, V379M, W60Y+Y168A, W60Y+V379W,… method of making and method of use (see pages 15-31 of specification), has been provided by the applicants’, which would indicate that they had possession of the claimed genus of structures for polypeptides and the encoding polynucleotides of interest with associated function, i.e., any transaminase mutant, wherein the transaminase mutant comprising: a protein having the amino acid sequence of SEQ ID NO: 1 with a mutation of one or more amino acids, wherein the mutation comprises any one or more of the group consisting of: C418Q, C418W, W60Y, Y168A,… alternatively, the amino acid sequence of the transaminase mutant has a mutation site in the mutated amino acid sequence, and has more than 85% of identity with the mutated amino acid sequence, and has the transaminase activity (genera of polypeptides, as in claims 1-3 and 6-9); encoding polynucleotides (as in claim 4-5); method of making and method of use (as in claims 10-19; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation).
The art also teaches, even highly structurally homologous polypeptides do not necessarily share the same function and conversely functionally similar molecules do not necessarily have similar structures. For example proteins having similar structure have different activities; Witkowski et al., (Biochemistry 38:11643-11650, 1999) teaches that one conservative amino acid substitution transforms a b-ketoacyl synthase into a malonyl decarboxylase and completely eliminates b-ketoacyl synthase activity. Similarly, Wishart et al., (J. Biol. Chem., 1995, Vol. 270(10): 26782-26785) teach that a single mutation converts a novel phosphotyrosine binding domain into a dual-specificity phosphatase.
Specifically regarding transaminases, the art teaches the following structural changes correlate strongly with transaminase substrate specificity and enzyme kinetics and random mutations affect the activity. Applicants’ are directed to the following references: (i) Deszcz et al., (FEBS J., 2015, Vol. 282: 2512-2526), see Abstract; Fig. 4-5, pages 2518-2519; Table 2, page 2521; Conclusions; and entire document; and (ii) Voss et al., (ACS Catal., 2018, Vol. 8: 11524-11533), provide evidence regarding mutagenesis of amino acid residues forming the substrate entry tunnel in transaminases can have profound impact on activity and selectivity, see Abstract; Conclusions; and entire document.
Hence, the recited genera of polypeptides and the encoding polynucleotides are interpreted to have widely variable structures, since minor changes may result in changes affecting function and no additional information correlating structure with function has been provided.
Therefore, given the lack of description of representative species encompassed by the genus of polypeptides, encoding polynucleotides and modifications, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that applicants’ were in possession of the claimed invention. Applicants’ are referred to the revised guidelines concerning compliance with the written description requirement of 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Enablement
II. Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, because the specification, while being enabling for characterization of specific mutants of parental wild-type transaminase comprising the amino acid sequence of SEQ ID NO: 1 and said mutant of SEQ ID NO: 1 comprising specific amino acid reside substitutions, wherein the mutation comprises any one or more of the group consisting of: C418Q, C418W, W60Y, Y168A, V379W, V379L, V379M, W60Y+Y168A, W60Y+V379W,… method of making and method of use (see pages 15-31 of specification), does not reasonably provide enablement for a genus of structures for polypeptides and the encoding polynucleotides of interest with associated function, i.e., any transaminase mutant, wherein the transaminase mutant comprising: a protein having the amino acid sequence of SEQ ID NO: 1 with a mutation of one or more amino acids, wherein the mutation comprises any one or more of the group consisting of: C418Q, C418W, W60Y, Y168A,… alternatively, the amino acid sequence of the transaminase mutant has a mutation site in the mutated amino acid sequence, and has more than 85% of identity with the mutated amino acid sequence, and has the transaminase activity (genera of polypeptides, as in claims 1-3 and 6-9); encoding polynucleotides (as in claim 4-5); method of making and method of use (as in claims 10-19; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation). 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 the claim.
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).
Claims 1-19 are so broad as to encompass: a genus of structures for polypeptides and the encoding polynucleotides of interest with associated function, i.e., any transaminase mutant, wherein the transaminase mutant comprising: a protein having the amino acid sequence of SEQ ID NO: 1 with a mutation of one or more amino acids, wherein the mutation comprises any one or more of the group consisting of: C418Q, C418W, W60Y, Y168A,… alternatively, the amino acid sequence of the transaminase mutant has a mutation site in the mutated amino acid sequence, and has more than 85% of identity with the mutated amino acid sequence, and has the transaminase activity (genera of polypeptides, as in claims 1-3 and 6-9); encoding polynucleotides (as in claim 4-5); method of making and method of use (as in claims 10-19; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation). The scope of the claims is not commensurate with the enablement provided by the disclosure with regard to the extremely large number polypeptides and encoding polynucleotides broadly encompassed by the claims. Since the amino acid sequence of a protein encoded by a polynucleotide 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 knowledge and guidance with regard to which amino acids in the protein's sequence and the respective codons in its polynucleotide, 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 encoded proteins' structure relates to its function. In view of the broad breadth of the claims, the amount of experimentation required to determine the structure of all the polypeptides or the encoding polynucleotides from any plant source including variants, mutants and recombinants, the lack of guidance, working examples, and unpredictability of the art in predicting function from a polypeptide primary structure (e.g., see Whisstock et al., Q Rev Biophys. 2003 Aug; 36(3): 307-340), practicing the claimed invention would require undue experimentation. As such, the specification fails to enable the entire scope of the claimed invention.
However, in this case the disclosure is limited to characterization of specific mutants of parental wild-type transaminase comprising the amino acid sequence of SEQ ID NO: 1 and said mutant of SEQ ID NO: 1 comprising specific amino acid reside substitutions, wherein the mutation comprises any one or more of the group consisting of: C418Q, C418W, W60Y, Y168A, V379W, V379L, V379M, W60Y+Y168A, W60Y+V379W,… method of making and method of use (see pages 15-31 of specification), but provides no guidance with regard to the making and using of a genus of structures for polypeptides and the encoding polynucleotides of interest with associated function, i.e., any transaminase mutant, wherein the transaminase mutant comprising: a protein having the amino acid sequence of SEQ ID NO: 1 with a mutation of one or more amino acids, wherein the mutation comprises any one or more of the group consisting of: C418Q, C418W, W60Y, Y168A,… alternatively, the amino acid sequence of the transaminase mutant has a mutation site in the mutated amino acid sequence, and has more than 85% of identity with the mutated amino acid sequence, and has the transaminase activity (genera of polypeptides, as in claims 1-3 and 6-9); encoding polynucleotides (as in claim 4-5); method of making and method of use (as in claims 10-19; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation) or with regard to other uses. In view of the great breadth of the claims, amount of experimentation required to make the claimed polypeptides and encoding polynucleotides, the lack of guidance, working examples, and unpredictability of the art in predicting function from a polypeptide primary structure (e.g., see Whisstock et al., Q Rev Biophys. 2003 Aug; 36(3): 307-340), the claimed invention would require undue experimentation. As such, the specification fails to teach one of ordinary skill how to make and use the full scope of polypeptides and encoding polynucleotides encompassed by the claims.
While enzyme isolation techniques, recombinant and mutagenesis techniques are known, and it is not routine in the art to screen for multiple substitutions or multiple modifications as encompassed by the instant claim, the specific amino acid 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 or deletions.
The specification does not support the broad scope of the claims which encompass: a genus of structures for polypeptides and the encoding polynucleotides of interest with associated function, i.e., any transaminase mutant, wherein the transaminase mutant comprising: a protein having the amino acid sequence of SEQ ID NO: 1 with a mutation of one or more amino acids, wherein the mutation comprises any one or more of the group consisting of: C418Q, C418W, W60Y, Y168A,… alternatively, the amino acid sequence of the transaminase mutant has a mutation site in the mutated amino acid sequence, and has more than 85% of identity with the mutated amino acid sequence, and has the transaminase activity (genera of polypeptides, as in claims 1-3 and 6-9); encoding polynucleotides (as in claim 4-5); method of making and method of use (as in claims 10-19; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation), because the specification does not establish: (A) encodes an enzyme comprising an amino acid sequence that is at least 85% identical to the amino acid sequence of SEQ ID NO: 1 including variants, mutants and recombinants and regions of the protein/polynucleotide structure which may be modified without affecting the activity of the encoded enzyme/transaminase (B) the general tolerance of the polypeptide and the polynucleotide encoding claimed enzymes to modification and extent of such tolerance; (C) a rational and predictable scheme for modifying any amino acid residue or the respective codon in the polynucleotide 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.
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 claim broadly including polypeptides and encoding polynucleotides with an enormous number of modifications including variants, mutants and recombinants of undefined structure with the associated function. The scope of the claim must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of polypeptides having the desired biological characteristics 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).
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 use the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The Court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or 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 claims. While all of these factors are considered, a sufficient amount for a prima facie case are discussed below.
The breadth of claims includes overly broad genus, applicants’ disclose no direction or guidance on how to design and make any polypeptide and the encoding polynucleotide of undefined structure having desired activity as noted in the breadth above. Thus, instant specification and prior art failed to describe how to make and use the claimed genus of polypeptides and encoding polynucleotides sufficiently. Although, it is possible to display and create any protein structure in computer (in silico) and manipulate in any possible way, such as inserting any amino acid(s) into preexisting three-dimensional scaffold; the creation of desired catalytic/biologic activity in a solution is highly unpredictable.
According to MPEP § 2164.02: “All questions of enablement are evaluated against the claimed subject matter. The focus of the examination inquiry is whether everything within the scope of the claim is enabled.”; “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). Nevertheless, not everything necessary to practice the invention need be disclosed. In fact, what is well-known is best omitted. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991). All that is necessary is that one skilled in the art be able to practice the claimed invention, given the level of knowledge and skill in the art. Further the scope of enablement must only bear a “reasonable correlation” to the scope of the claims. See, e.g., In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).”; and “As concerns the breadth of a claim relevant to enablement, the only relevant concern should be whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims. > AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244, 68 USPQ2d 1280, 1287 (Fed. Cir. 2003); < In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971). See also Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339, 65 USPQ2d 1452, 1455 (Fed. Cir. 2003) (alleged “pioneer status” of invention irrelevant to enablement determination).”
Instant claims are so broad such that, instant disclosure of instant specification and a general knowledge in the art are not commensurate with the scope of instant claims for one skilled in the art to make and use claimed invention without undue experimentation. As noted above, the breadth of instant claims encompass an overly broad genus of undefined structure including variants, mutants and homologs.
Therefore, taking into consideration the extremely broad scope of the claims, the lack of guidance, the amount of information provided, the lack of knowledge about a correlation between structure and the desired function, and the high degree of unpredictability of the prior art in regard to structural variability and its effect on function, one of ordinary skill in the art would have to go through the burden of undue experimentation in order to practice the claimed invention. 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. The scope of the claim must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of genus of structures for polypeptides and the encoding polynucleotides of interest with associated function, i.e., any transaminase mutant, wherein the transaminase mutant comprising: a protein having the amino acid sequence of SEQ ID NO: 1 with a mutation of one or more amino acids, wherein the mutation comprises any one or more of the group consisting of: C418Q, C418W, W60Y, Y168A,… alternatively, the amino acid sequence of the transaminase mutant has a mutation site in the mutated amino acid sequence, and has more than 85% of identity with the mutated amino acid sequence, and has the transaminase activity (genera of polypeptides, as in claims 1-3 and 6-9); encoding polynucleotides (as in claim 4-5); method of making and method of use (as in claims 10-19; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation), 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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title
Claims 1-4 and 6-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-4 and 6-9 are directed to a law of nature or a natural phenomenon: non-naturally occurring variant/mutant transaminase enzyme comprising an amino acid sequence that is at least 85% identical to the amino acid sequence of SEQ ID NO: 1 and comprising a substitution V379L (also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation).The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons stated below.
The “2014 Interim Guidance on Patent Subject Matter Eligibility” 79 FR 74618 (Dec. 16, 2014) directs that claims drawn to 1) a composition of matter, 2) a law of nature or a natural phenomenon and 3) lacking recitation of additional elements that make the claims directed to significantly more than a judicial exception are ineligible for patenting under 35 U.S.C. 101. See, 79 FR, page 74621 (flow chart). Nature-based compositions of matter are not directed to significantly more than a judicial exception when the claimed "naturally occurring products and some man-made products ... are essentially no different from a naturally occurring product ... that fall under the laws of nature or natural phenomena exception.” 79 FR, page 74623, left column. That is, a patent-eligible composition of matter must be "markedly different" in terms of the "product's structure, function, and/or other properties." 79 FR, page 74623, center column. Further, processes directly to isolating nature-based compositions of matter have also been found to be directed to nothing more than a judicial exception when only routine purification techniques are employed. 79 FR, page 74622, center column (e.g. isolating DNA or other nature-based products).
Claims 1-4 and 6-9 are directed to naturally-occurring protein(s) or composition thereof, whether isolated, synthetic or recombinant or not, that are not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 106 USPQ2d 1972 (June 13, 2013), as they are not markedly different than the naturally-occurring protein(s), or composition thereof protein of SEQ ID NO: 1 and comprising a substitution V379L obtained from bacterial source. Examiner would like to point out that bacteria/Pseudomonas endogenously comprises a transaminase protein having 92.9% sequence identity to SEQ ID NO: 1 and comprising a substitution V379L (UniProtKB/TrEMBL database; Accession # A0A2K4MJ43, priority 03/28/2018; see provided sequence alignment; see, the recent Office Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products, available from http://www.uspto.gov/patents/law/exam/examguide.jsp). Although claims 6-9 recites that the composition is “immobilized transaminase” the variant polypeptide of SEQ ID NO: 1, the polypeptide of UniProtKB/TrEMBL database; Accession # A0A2K4MJ43 disclose a naturally occurring variant transaminase having 92.9% sequence identity to SEQ ID NO:1, having the following amino acid substitution V379L and further comprising multiple substitutions (see provided sequence alignment) alone without anything else clearly meets the recitation of “immobilized transaminase”. As such, the claims recite patent ineligible subject matter for the reasons stated. The courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 133 S. Ct. at 2111, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.” MPEP 2106(c)(II)(C). Here, there is no evidence of record that indicates that placement of the naturally-occurring transaminase of UniProtKB/TrEMBL database; Accession # A0A2K4MJ43 or any natural transaminase into a “immobilized” composition as recited in claims 6-9 introduces any specific characteristic that is not an inherent or innate characteristic of the naturally-occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart transaminase of UniProtKB/TrEMBL database; Accession # A0A2K4MJ43 (e.g., physical form as “immobilized composition” on a resin, paste, gel, etc., is an incidental change in characteristic). As such, regarding claims 6-9, the recited “immobilized” compositions do not appear to possess a marked difference such that Step 2A is answered as the compositions of claims 6-9 not being markedly different. Here, as stated, the claims encompass naturally-occurring variant transaminases having the same structure, and therefore biological activity, chemical and physical properties, as a naturally-occurring product. As such, the claims appear to be directed towards nothing more than a judicial exception for the reasons stated. The claims recite ineligible subject matter for the reasons stated.
Claim Rejections: 35 USC § 102 (AIA )
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.
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 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.
I. Claims 1-6 and 10-13 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Hong1 et al., (US 11,952,575 B2; priority 11/15/2017) and disclose wild-type/parental transaminase comprising an amino acid sequence having 100% sequence identity to SEQ ID NO: 1 of the instant application obtained from Chromobacterium violaceum and mutants of said wild-type/parental transaminase comprising the following amino acid residue substitutions V379L, V379M, C418Q (see Abstract; col. 3, lines 16-28; col. 6, lines 46-56; and entire document), including immobilized enzyme (col. 5, lines 47-67); method of synthesizing chiral amine (col. 4, lines 14-62; reproduced below):
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Therefore, the reference of Hong1 et al., (US 11,952,575 B2; priority 11/15/2017) is deemed to anticipate claims 1-6 and 10-13 as written and when given the broadest reasonable interpretation.
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 1-19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hong1 et al., (US 11,952,575 B2; priority 11/15/2017) as applied to claims 1-6 and 10-13 see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) above) and further in view Hong2 et al., (US 11,359,219 B2; priority 02/05/2018).
Regarding claims 1-6 and 10-13, the disclosure of Hong1 et al., (US 11,952,575 B2; priority 11/15/2017) disclose wild-type/parental transaminase comprising an amino acid sequence having 100% sequence identity to SEQ ID NO: 1 of the instant application obtained from Chromobacterium violaceum and mutants of said wild-type/parental transaminase comprising the following amino acid residue substitutions V379L, V379M, C418Q (see Abstract; col. 3, lines 16-28; col. 6, lines 46-56; and entire document), including immobilized enzyme (col. 5, lines 47-67); method of synthesizing chiral amine.
However, Hong1 et al., is silent regarding wherein the immobilized transaminase is a cross-linked immobilized enzyme aggregate of the transaminase mutant; preferably, the cross-linked immobilized enzyme aggregate is an immobilized enzyme aggregate cross-linked by glutaraldehyde… wherein the immobilized transaminase is an immobilized enzyme formed by binding the transaminase mutant to a carrier; preferably, the carrier is a cross-linked polymer resin carrier; preferably, the resin carrier comprises a macroporous adsorption resin sphere, an amino resin sphere or an epoxy resin sphere; preferably, the macroporous adsorption resin sphere has a matrix of polystyrene; more preferably, the macroporous adsorption resin sphere comprises NKA9, LXEP120,AB-8, ECR8806 (as in claims 7-9 and 14-19).
Regarding claims 7-9 and 14-19, Hong2 et al., (US 11,359,219 B2; priority 02/05/2018) provide structural and functional elements of the instant invention; said reference discloses disclose wild-type/parental transaminase comprising an amino acid sequence having 100% sequence identity to SEQ ID NO: 1 of the instant application obtained from Chromobacterium violaceum and mutants of said wild-type/parental transaminase (see provided sequence alignment) and wherein the immobilized transaminase is a cross-linked immobilized enzyme aggregate of the transaminase mutant; preferably, the cross-linked immobilized enzyme aggregate is an immobilized enzyme aggregate cross-linked by glutaraldehyde… (col. 3, lines 26-67 to col. 4, lines 1-10; col. 14, lines 44-55); wherein the immobilized transaminase is an immobilized enzyme formed by binding the transaminase mutant to a carrier; preferably, the carrier is a cross-linked polymer resin carrier; preferably, the resin carrier comprises a macroporous adsorption resin sphere, an amino resin sphere or an epoxy resin sphere; preferably, the macroporous adsorption resin sphere has a matrix of polystyrene; more preferably, the macroporous adsorption resin sphere comprises NKA9, LXEP120,AB-8, ECR8806 (col. 5, lines 5-15; col. 16, Adsorption Immobilization Method of Transaminase; col. 18-19, Metal Ion Chelating Immobilization Method and TABLE 11; and entire document).
Therefore, using the indications of Hong2 et al., as a reference, it would have been easy for a person skilled in the art to immobilize transaminase and is a cross-linked immobilized enzyme aggregate of the transaminase mutant; preferably, the cross-linked immobilized enzyme aggregate is an immobilized enzyme aggregate cross-linked by glutaraldehyde… wherein the immobilized transaminase is an immobilized enzyme formed by binding the transaminase mutant to a carrier; preferably, the carrier is a cross-linked polymer resin carrier; preferably, the resin carrier comprises a macroporous adsorption resin sphere, an amino resin sphere or an epoxy resin sphere; preferably, the macroporous adsorption resin sphere has a matrix of polystyrene; more preferably, the macroporous adsorption resin sphere comprises NKA9, LXEP120,AB-8, ECR8806 as and modify the teachings of Hong1 et al., and to generate a immobilized transaminase and is a cross-linked immobilized enzyme aggregate of the transaminase mutant; preferably, the cross-linked immobilized enzyme aggregate is an immobilized enzyme aggregate cross-linked by glutaraldehyde, depending on the experimental need. As such, disclosures of Hong1 et al., and Hong2 et al., provide the structural and functional elements in the claimed compositions of mutant transaminases and method of use as claimed in the instant invention. One of ordinary skill in the art would have a reasonable expectation of success, since basic strategy for immobilizing mutant transaminases and a method of use are well known in the art. Therefore, the above reference renders claims 1-19 prima facie obvious to one of ordinary skill in the art.
Therefore, claims 1-19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hong1 et al., (US 11,952,575 B2; priority 11/15/2017) as applied to claims 1-6 and 10-13 see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) above) and further in view Hong2 et al., (US 11,359,219 B2; priority 02/05/2018).
Double patenting rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-19 of the instant application are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 and 3-6 of reference patent Hong1 et al., (US 11,952,575 B2; priority 11/15/2017) and in view of Hong2 et al., (US 11,359,219 B2; priority 02/05/2018). An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claims are not patentably distinct from the reference claims, because the examined claims are either anticipated by, or would have been obvious over reference claims. See, e.g., In re Berg, 140 F.3d 1428,46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir.1993); In re Longi 759 F.2d 887,225 USPQ 645 (Fed. Cir. 1985).
Although the conflicting claims are not identical, they are not patentably distinct from each other. Claims 1-19 of the instant application as interpreted are directed to “any transaminase mutant, wherein the transaminase mutant comprising: a protein having the amino acid sequence of SEQ ID NO: 1 with a mutation of one or more amino acids, wherein the mutation comprises any one or more of the group consisting of: C418Q, C418W, W60Y, Y168A,… alternatively, the amino acid sequence of the transaminase mutant has a mutation site in the mutated amino acid sequence, and has more than 85% of identity with the mutated amino acid sequence, and has the transaminase activity (genera of polypeptides, as in claims 1-3 and 6-9); encoding polynucleotides (as in claim 4-5); method of making and method of use (as in claims 10-19; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation)”.
Claims 1 and 3-6 of reference patent Hong1 et al., (US 11,952,575 B2; priority 11/15/2017) are directed to “a transaminase mutant, wherein the amino acid sequence of the transaminase mutant is the mutated amino acid sequence of SEQ ID NO: 1, and wherein the mutated amino acid sequence comprises mutations at one or more of amino acids selected from a group consisting of P243E, F89Y/W, K193E, V234I, I262V, Q280K, V379L/M/T, R416A/C/H/Q/T/S, A417S and C418A/Q/S, wherein “/” stands for “or”, and wherein the mutations at one or more of amino acids must comprise V379 and a method for synthesizing a chiral amine, comprising a step of performing a catalytic transamination reaction on a ketone compound and an amino donor with a transaminase, wherein the transaminase is the transaminase mutant”. Furthermore, the preferred embodiment in said reference patent Hong1 et al., (US 11,952,575 B2; priority 11/15/2017) is also directed to the following method:
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Additionally regarding claims 7-9 and 14-19, the following reference Hong2 et al., (US 11,359,219 B2; priority 02/05/2018) provides teaching, suggestion and motivation to modify the allowed claims 1 and 3-6 of reference patent Hong1 et al., (US 11,952,575 B2; priority 11/15/2017), for details see 35 U.S.C. 103(a) rejection above.
Hence, examiner also takes the position that the instant claims 1-19 are obvious variation of allowed claims 1 and 3-6 of reference patent Hong1 et al., (US 11,952,575 B2; priority 11/15/2017) and in view of reference patent Hong2 et al., (US 11,359,219 B2; priority 02/05/2018).
Therefore, claims 1-19 of the of the instant application cannot be considered patentably distinct over 1 and 3-6 of reference patent Hong1 et al., (US 11,952,575 B2; priority 11/15/2017) and in view of Hong2 et al., (US 11,359,219 B2; priority 02/05/2018) when there is specifically disclosed embodiment in the reference patent Hong1 et al., (US 11,952,575 B2) that supports claims 1 and 3-6 of that patent and falls within the scope of the claims 1-19 herein i.e., “any transaminase mutant, wherein the transaminase mutant comprising: a protein having the amino acid sequence of SEQ ID NO: 1 with a mutation of one or more amino acids, wherein the mutation comprises any one or more of the group consisting of: C418Q, C418W, W60Y, Y168A,… alternatively, the amino acid sequence of the transaminase mutant has a mutation site in the mutated amino acid sequence, and has more than 85% of identity with the mutated amino acid sequence, and has the transaminase activity (genera of polypeptides, as in claims 1-3 and 6-9); encoding polynucleotides (as in claim 4-5); method of making and method of use (as in claims 10-19; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation)”, because it would have been obvious to one having ordinary skill in the art to modify claims 1 and 3-6 of reference patent Hong1 et al., (US 11,952,575 B2; priority 11/15/2017) and in view of Hong2 et al., (US 11,359,219 B2; priority 02/05/2018) by selecting a specifically disclosed embodiment that supports those claims of the reference patent. One of ordinary skill in the art would have been motivated to do this because that embodiment is disclosed as being preferred embodiment within claims 1 and 3-6 of the allowed patent and hence 1-19 of the instant application are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 and 3-6 of reference patent Hong1 et al., (US 11,952,575 B2; priority 11/15/2017) and in view of Hong2 et al., (US 11,359,219 B2; priority 02/05/2018)
Allowable Subject Matter/Conclusion
None of the claims are allowable.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652