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
Claims 1-13 and 17-21 are pending.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-8, 10, 12 and 17-21 and the species of SEQ ID NO: 1, l308V+V355L, and motif SEQ ID NO: 4 in the reply filed on 7/13/2026 is acknowledged. The traversal is on the grounds that A0A7X3FZM9_9BURK is 90.7% identical to SEQ ID NO: 1 and that there is no evidence provided that A0A 7X3FZM9 9BURK is capable of detoxifying mycotoxin of Formula (I). This is not found persuasive because independent claim 1 only requires at least 70% identity to SEQ ID NO: 1. In addition, SEQ ID NO: 370 is 100% identical to the sequence of WP_197065214.1 (2020, website), which is a bacterial ochrotaxinase from the genus Massilia (OA Appendix B). Therefore, the technical feature of the polypeptide having at least 70% identity to SEQ ID NO: 1 is also not a special technical feature because it does not make a contribution over the prior art of WP_197065214.1.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9, 11, and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/13/2026.
Claims 1-8, 10, 12 and 17-21 are examined herein.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See [00135], [00137]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 1, 3-4, and 12 are objected to because of the following informalities:
In claim 1 parts i) and ii), claim 3, and claim 12 part (i): wherein X is selected from the group consisting of 9, 4, 5, 7, 12, 17, 18, 19, 20, 21, 22, 23. The list should be in ascending numerical order rather than beginning with 9.
Claim 1 also recites i), ii), (iii), (iv), (v), which is inconsistent nomenclature.
In claim 1 part ii) and claims 3-4, SEQ ID NO: 1, 2, 16-21, 22, 23-34 can be simplified to SEQ ID NO: 1-2 and 16-34.
Claim 12 (iv) and (v) include additional extraneous indents.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-8, 10, 12 and 17-21 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the following phrases in the preamble and part (i) render the claim indefinite because it is unclear whether the limitations following the phrase e.g. and in parentheses are part of the claimed invention: (e.g., in vitro, ex vivo, in vivo or manufacturing method), (e.g., modifying or hydrolyzing), (e.g. at least 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or 100%), (e.g., Ochratoxin A, Ochratoxin Band/or Ochratoxin C), and (e.g. conservative motifs). 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) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 part (i) recites the broad recitation “wherein said one or more polypeptide are capable of detoxifying at least one mycotoxin having said Formula I,” and the claim also recites “preferably said polypeptide having peptidase activity having E.C. 3.4.13.X,” “further preferably said polypeptide having a peptidase activity having E.C. 3.4.13.9,” and “most preferably said on or more polypeptide comprising one or more of the following amin acid sequences” which are the narrower statements of the limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 1 is further indefinite for “polypeptide/s,” since it is unclear whether a single polypeptide is required or multiple polypeptides.
Claim 1 is further indefinite in (i) for the limitation “selected from the group consisting of: SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 22, SEQ ID NO: 318, SEQ ID NO: 336, SEQ ID NO: 348, SEQ ID NOs: 16-359, 368-370;” which does not include the conjunction “and” leading to confusion as to whether the list is complete.
Claim 1 is further indefinite for the limitation wherein X is selected from the group consisting of 9, 4, 5, 7, 12, 17, 18, 19, 20, 21, 22, 23. There is no conjunction “and” separating 22 from 23, leading to confusion as to whether the list is complete.
Claim 1 is further indefinite for its reference to enzyme commission (EC) numbers, which are variable objects subject to revision.
Claim 1 also recites i’) preferably said SEQ ID NO: 3 is comprised at amino acid positions corresponding to positions 87-95 of SEQ ID NO: 1 (e.g., using the numbering of SEQ ID NO: 1). Each of these limitations further renders claim 1 indefinite because it is unclear whether the claim is limited to the narrower scope and it is further unclear whether the limitation “(e.g., using the numbering of SEQ ID NO: 1)” is an example or a required claim limitation. In addition, “is comprised at” is grammatically incorrect and leads to further ambiguity in the claim scope due to multiple reasonable interpretations of the claim. In one interpretation, the polypeptide comprises at least 70% identity to SEQ ID NO: 1 and residues 87-95 of the polypeptide are SEQ ID NO: 3. In a second interpretation, the polypeptide comprises SEQ ID NO: 3 (which is the residues 87-95 of SEQ ID NO: 1) at any position of the polypeptide. Similar limitations are recited in ii’) to xxi’) and further render the claim indefinite.
Regarding claim 1 in (ii), the phrases (e.g., a substitution, deletion and/or insertion), (e.g. at least 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91 %, 92%, 93%, 94%, 95%, 96%, 97%, 98% or 99% ), (e.g., modifying or hydrolyzing), (e.g., Ochratoxin A, Ochratoxin Band/or Ochratoxin C), and (e.g., conservative motifs) render the claim indefinite because it is unclear whether the limitations following the phrase e.g. and in parentheses are part of the claimed invention. See MPEP § 2173.05(d).
Claim 1 is further indefinite in (ii) for the limitation “selected from the group consisting of: SEQ ID NOs 1, 2, 16-21, 22, 23-34, 317-318, 326-335, 336-337, 348-349, 368-370,” which does not include the conjunction “and” leading to confusion as to whether the list is complete.
Claim 1 is further indefinite in (ii) for the limitation “wherein X is selected from the group consisting of: 9, 4, 5, 7, 12, 17, 18, 19, 20, 21, 22, 23.” There is no conjunction “and” separating 22 from 23, leading to confusion as to whether the list is complete.
Claim 1 is further indefinite in (ii) for its reference to enzyme commission (EC) numbers, which are variable objects subject to revision.
In claim 1 part (ii), the claim recites “variant/s,” leading to ambiguity as to whether a variant of variants is required.
Claim 1 is further indefinite in part (ii) for reciting the limitations following preferably, further preferably, most preferably, and further most preferably. These limitations render the claim indefinite because it is unclear whether the claim is limited to these narrower scopes. In addition, the limitation following “further most preferably” appears to be redundant.
In addition, claim 1 part (ii) recites said variants comprising one or more of the following amino acid sequences: (i')-(xxi') according to (i). The amino acid sequences (i) (i')-(xxi') do not follow this limitation, leading to ambiguity in the amino acid sequences. Applicant may consider amending the claim to recite “comprising one or more of the amino acid sequences set forth in (i')-(xxi').”
In claim 1 part (v), the claim recites “mixture/s,” leading to ambiguity as to whether a mixture of mixtures is required.
In claim 1 part (v), the claim recites the limitations (e.g., foodstuff, fodder or feed additive) and (e.g., foodstuff, fodder or feed intermediate additive). It is unclear whether these are required claim features.
Claim 1 also recites (b) applying (a) to said mycotoxin having Formula I. However, (a) refers to the step of providing (i), (ii), (iii), (iv), and/or (v). Thus, it is unclear what is applied. Applicant may consider amending to (b) applying (i), (ii), (iii), (iv), and/or (v) to said mycotoxin having Formula I.
Claim 2 is indefinite for the limitation wherein step (b), (a) is applied to a foodstuff. The designation (a) refers to the step of providing (i), (ii), (iii), (iv), and/or (v). Thus, it is unclear what is applied. Applicant may consider amending to “wherein in step (b), (i), (ii), (iii), (iv), and/or (v) are applied to a foodstuff…”
Regarding claim 2, the phrases (e.g., foodstuff, fodder or feed additive) and (e.g., foodstuff, fodder or feed intermediate additive) render the claim indefinite because it is unclear whether the limitations following the phrase e.g. and in parentheses are part of the claimed invention. See MPEP § 2173.05(d).
Claim 2 is also indefinite for “mixture/s” since it is unclear whether a single mixture of multiple mixtures are required.
Claim 3 recites wherein a) ii) said one or more variants of a parent polypeptide are applied to said mycotoxin. There are at least two different reasonable interpretations of this claim, rendering the claim indefinite. In one interpretation, step a) ii) further comprises applying the one or more variants to the mycotoxin. In a second interpretation, the claim further limits step b) to applying the one or more variant of a parent polypeptide to the mycotoxin.
Regarding claim 3, the phrases (e.g., a substitution, deletion and/or insertion), (e.g. at least 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% or 99%), and (e.g., conservative motifs) render the claim indefinite because it is unclear whether the limitations following the phrase e.g. and in parentheses are part of the claimed invention. See MPEP § 2173.05(d).
Claim 3 is also indefinite for “variant/s” since it is unclear whether a single variant of multiple variants are required.
Claim 3 recites enzyme commission (EC) numbers, which are variable objects subject to revision.
Claim 3 presents two different Markush groups (sequence and EC numbers) which do not include a conjunction separating the final two members of the group. Thus, it is unclear whether these groups are complete. Claim 3 recites limitations preceded by “preferably,” further preferably,” and “most preferably,” which further renders claim 3 indefinite since it leads to ambiguity in the claim scope since it is unclear whether the scope of the claim is limited to these narrower limitations.
Claim 3 also recites i’) preferably said SEQ ID NO: 3 is comprised at amino acid positions corresponding to positions 87-95 of SEQ ID NO: 1 (e.g., using the numbering of SEQ ID NO: 1). Similar limitations are recited in ii’) to xxi’). Each of these limitations further renders claim 1 indefinite because it is unclear whether the claim is limited to the narrower scope and it is further unclear whether the limitation (e.g., using the numbering of SEQ ID NO: 1) is an example or a required claim limitation. In addition, “is comprised at” is grammatically incorrect and leads to further ambiguity in the claim scope due to multiple reasonable interpretations of the claim. In one interpretation, the polypeptide comprises at least 70% identity to SEQ ID NO: 1 and residues 87-95 of the polypeptide are SEQ ID NO: 3. In a second interpretation, the polypeptide comprises SEQ ID NO: 3, which are the residues 87-95 of SEQ ID NO: 1.
Claim 4 recites an enzyme commission (EC) number, which is variable object subject to change. Therefore, claim 4 is indefinite.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation “said polypeptide and/or variant having a TIM barrel structure comprising 8 α-helices and 8 parallel β-strands alternating along the polypeptide backbone,” and the claim also recites “wherein preferably said TIM barrel further comprising a phosphate binding site” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 4 part (v) also recites a broad limitation “said polypeptide and/or variant having a T50 value of more than 80°C” and a narrower limitation in parenthesis “(e.g. more than 85°C).” The parentheses and e.g. lead to further ambiguity in the claim scope.
Claim 4 parts (vi) and (vii) each recite a Markush group without the conjunction “and,” thus it is unclear whether the lists are complete.
Regarding claim 5, the phrases (e.g., a substitution, deletion and/or insertion) render the claim indefinite because it is unclear whether the limitations following the phrase e.g. and in parentheses are part of the claimed invention. See MPEP § 2173.05(d).
Claim 5 is further indefinite for the limitation “preferably using the numbering of SEQ ID NO: 2” since it is unclear whether this is a required claim limitation.
Claim 6 recites a list of substitutions and also recites “equivalent amino acid substitutions thereof.” It is unclear what constitutes an equivalent amino acid substitution.
Claim 7 is indefinite for the limitations (e.g., a substitution, deletion and/or insertion) and the limitations preceded by “preferably” and “further preferably.” These limitations render claim 7 indefinite because it is unclear whether the claim scope is limited to these narrower limitations.
Claim 8 recites a list of substitutions and also recites “equivalent amino acid substitutions thereof.” It is unclear what constitutes an equivalent amino acid substitution.
Claim 10 is indefinite for (e.g., an isolated recombinant host cell) because it is unclear whether this limitation is a required claim feature due to the parentheses and the exemplary language. Claim 10 is further indefinite because step a) ii) recites providing rather than applying the recombinant host cell. It is unclear whether claim 10 is further limiting step b) or step a).
Claim 12 is indefinite for the limitations (e.g., foodstuff, fodder or feed additive), (e.g., foodstuff fodder or feed intermediate additive), (e.g. at least 71 %, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or 100%), ( e.g., modifying or hydrolyzing), (e.g., Ochratoxin A, Ochratoxin Band/or Ochratoxin C): and (e.g., conservative motifs) because it is unclear whether this limitation is a required claim feature due to the parentheses and the exemplary language.
Claim 12 is further indefinite for “mixture/s” and “polypeptide/s” since it is unclear whether the singular or plural are required.
Claim 12 is further indefinite for the limitation selected from the group consisting of: SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 22, SEQ ID NO: 318, SEQ ID NO: 336, SEQ ID NO: 348, SEQ ID NOs: 16-359, 368-370. It is unclear whether the Markush is complete because there is no “and” conjunction separating the final two members of the list. Similarly, it is unclear whether the limitation wherein X is selected from the group consisting of: 9, 4, 5, 7, 12, 17, 18, 19, 20, 21, 22, 23 is complete because of the lack of a conjunction separating the final two members of the list.
Claim 12 is indefinite for the use of enzyme commission (EC) numbers, which are variable objects subject to revision.
Claim 12 is further indefinite for the limitations following “preferably,” “further preferably,” and “most preferably” because it is unclear whether the claim scope is limited to these narrower limitations.
Claim 12 also recites i’) preferably said SEQ ID NO: 3 is comprised at amino acid positions corresponding to positions 87-95 of SEQ ID NO: 1 (e.g., using the numbering of SEQ ID NO: 1). Similar limitations are recited in ii’) to xxi’). Each of these limitations further renders claim 1 indefinite because it is unclear whether the claim is limited to the narrower scope and it is further unclear whether the limitation “(e.g., using the numbering of SEQ ID NO: 1)” is an example or a required claim limitation. In addition, “is comprised at” is grammatically incorrect and leads to further ambiguity in the claim scope due to multiple reasonable interpretations of the claim. In one interpretation, the polypeptide comprises at least 70% identity to SEQ ID NO: 1 and residues 87-95 of the polypeptide are SEQ ID NO: 3. In a second interpretation, the polypeptide comprises SEQ ID NO: 3, which are the residues 87-95 of SEQ ID NO: 1.
Claim 12 also recites (b) applying (a) to a nutritive source or material suitable for production of foodstuff. However, (a) refers to the step of providing (i), (ii), (iii), (iv), and/or (v). Thus, it is unclear what is applied. Applicant may consider amending to (b) applying (i), (ii), (iii), (iv), and/or (v) to a nutritive source or material suitable for production of foodstuff.
Claims 17-21 are indefinite for the limitation “selected from the group consisting of: SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 22, SEQ ID NO: 318, SEQ ID NO: 336, SEQ ID NO: 348, and SEQ ID NOs: 16-359, 368-370,” which is missing the conjunction “and” separating the final two members of the group, thus it is unclear whether the Markush group is complete. Applicant may consider amending to: “selected from the group consisting of: SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 22, SEQ ID NO: 318, SEQ ID NO: 336, SEQ ID NO: 348, and 368-370.”
Claims 2-8, 10, 12, and 17-21 are also rejected for depending from a rejected based claim and not rectifying the source of indefiniteness discussed above.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 and 12 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites “wherein step (b), (a) is applied to a foodstuff, intermediate foodstuff, fodder…” However, step (b) of claim 1 recites applying (a) to said mycotoxin having Formula I. Therefore, claim 2 fails to include all the limitations of the claim upon which it depends.
Claim 12 appears to be an independent method, but requires “variants of claim 3” in (a)(ii). Claim 12 depends from claim 3, which depends from claim 1. Claim 12 fails to include all of the limitations of claim 1 and also fails to further limit the subject matter of claim 1.
Applicant may cancel the claims, amend the claims to place the claim in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-8, 10, 12 and 17-21 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
Claims 1 and 12 recite a genus of polypeptides having at least 70% sequence identity to the amino acid sequence selected from the group consisting of SEQ ID NO: 1-2, 22, 318, 336, 348, 16-359, and 368-370, wherein the polypeptides are capable of detoxifying at least one mycotoxin of Formula I. Claims 1 and 12 also recite a genus of polypeptide variants comprising a substitution, deletion, and/or insertion at one or more positions corresponding to positions of the parent polypeptide, wherein the variant has at least 70% but less than 100% sequence identity to a parent amino acid sequence selected from SEQ ID NOs 1-2, 16-34, 317-318, 326-335, 336-337, 348-349, and 368-370, wherein the variant is capable of detoxifying at least one mycotoxin having Formula I. The person of ordinary skill in the art would not have recognized that the inventors, at the time the application was filed, had possession of the claimed genus of variants.
Claims 17-21 further limit the method of claim 1 by requiring at least 80%, at least 90%, at least 92%, at least 95%, or at least 98% identity to the amino acid sequence selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 22, SEQ ID NO: 318, SEQ ID NO: 336, SEQ ID NO: 348, and SEQ ID NOs: 16-359, 368-370. However, these claims depend from claim 1, which recites variants comprising amino acid insertions or deletions as well as variants with amino acid substitutions.
SEQ ID NO: 16-370 are all at least at least 80% identical to SEQ ID NO: 1 (Table 3 on pages 45-46). SEQ ID NO: 22-34 are at least 98% identical to SEQ ID NO: 2 (00131]). SEQ ID NO: 23-34 are at least 70% identical to SEQ ID NO: 22 ([00132]). SEQ ID NO: 338-347 are at least 90% identical to SEQ ID NO; 336. ([00133]). SEQ ID NO: 350-359 are at least 90% identical to SEQ ID NO: 348 ([00134]).
SEQ ID NO: 1 is a mature, processed species (i.e. a fragment) of SEQ ID NO: 318 lacking N-terminal residues 1-24 ([00141]). SEQ ID NO: 16-21 and 48-316 are processed species (fragments) of SEQ ID NO; 318. SEQ ID NO; 326-327 are processed species of SEQ ID NO: 17 ([00141]). SEQ ID NO; 328-329 are processed species of SEQ ID NO: 18 ([00141]). SEQ ID NO; 330 331 are processed species of SEQ ID NO: 19 ([00141]). SEQ ID NO: 332 and 333 are processed species of SEQ ID NO: 20 ([00141]). SEQ ID NO: 334-335 are processed species of 21. SEQ ID NO: 336 and 348 are mature, processed species of SEQ ID NO: 337 and 349 respectively ([00141]).
The specification discloses in Table 8 ([00147] the specific OTA detoxification activities of SEQ ID NO: 12, 17-22 and 368-369. Table 9 ([00151]) presents SEQ ID NO: 48-316, which are variants of SEQ ID NO: 318. SEQ ID NO: 316 has 77 amino acid substitutions relative to SEQ ID NO: 318 (i.e. 82.% sequence identity to SEQ ID NO: 318). Table 10 ([00153]) presents SEQ ID NO: 35-47, which are variants of SEQ ID NO: 2 comprising up to eight amino acid substitutions. Table 11 ([00156]) presents the OTA detoxication activities of SEQ ID NO: 35-47. Table 12 in [00158] presents the specific OTA detoxification activities of SEQ ID NO; 48-316 compared to SEQ ID NO: 1. Table 13 in [00160] presents SEQ ID NO: 338-347, which are variants of SEQ ID NO: 337 comprising approximately 42 amino acid substitutions relative to SEQ ID NO: 337. Table 14 in [00162] presents SEQ ID NO: 350-359, which are variants of SEQ ID NO: 349 comprising approximately 42 amino acid substitutions.
Although the specification discloses several amino acid motifs (SEQ ID NO; 3-15), there is no structure-function correlation disclosed between the motifs and the activity of modifying or hydrolyzing a compound of Formula I.
In summary, although the specification discloses a large number of variants, these variants are limited to variants comprising substitutions or N-terminal deletions (fragments). No variants are disclosed with insertions or internal deletions. There are also no variants disclosed for some of the sequences. For example, SEQ ID NO: 370 is only 83.67% identical to SEQ ID NO: 1 ([00130]) but the specification does not disclose any variants of SEQ ID NO: 370. Furthermore, there is no structure-function correlation between the amino acid sequence motifs and the function of hydrolyzing a compound of Formula I.
Dobritzsch et al. (Biochemical Journal 462.3 (2014): 441-452) teaches the crystal structure of a 480 amino acid ochratoxinase from Aspergillus niger (Abstract and Figure 2). The subunit of the homo-octameric enzyme folds into a two-domain structure characteristic of a metal dependent amidohydrolase, with a twisted TIM (triosephosphateisomerase)-barrel and a smaller β-sandwich domain (Abstract). The active site contains an aspartate residue for acid–base catalysis, and a carboxylated lysine and four histidine residues for binding of a binuclear metal center (Abstract). The fold of the ochratoxinase subunit resembles that of other members of the amidohydrolase superfamily (page 447, right column, bottom paragraph). The subunit comprises a core catalytic domain and a smaller β-sandwich domain (page 447, right column, bottom paragraph and Figure 2A). The catalytic domain comprises residues 107–425 (page 447, right column, bottom paragraph). However, Dobritzsch does not teach any variants of the ochratoxinase. Furthermore, Dobritzsch’s ochrotaxinase is of fungal origin, whereas instant SEQ ID NO: 1 is 92% identical to a bacterial ochrotaxinase from the genus Massilia (OA Appendix A; WP_157202021.1, 2019 website, see Organism) and SEQ ID NO: 370 is 100% identical to a bacterial ochrotaxinase WP_197065214.1 (2020, website) from the genus Massilia (OA Appendix B).
SEQ ID NO: 22 is 100% identical to a metal-dependent hydrolase WP_152939286.1 (2019, website) from Acidianus ambivalens (OA Appendix E). SEQ ID NO: 338-347 are variants of SEQ ID NO: 337, which is 100% identical to an amidohydrolase SPE56482.1 (2018, website) from Verrucomicrobiota (OA Appendix C). SEQ ID NO: 350-359 are variants of SEQ ID NO: 349, which is 100% identical to an amidohydrolase RMF12292.1 (2018, website) from Alphaproteobacteria (OA Appendix D). However, WP_152939286.1, SPE56482.1, and RMF12292.1 do not teach any activity of these proteins in hydrolyzing compounds of Formula I (ochratoxins).
Based on the above analysis, the person of ordinary skill in the art would not have recognized that the inventors, at the time the application was filed, had possession of the claimed genus of polypeptides having at least 70% sequence identity to the amino acid sequence selected from the group consisting of SEQ ID NO: 1, 2, 22, 318, 336, 348, 16-359, and 368-370, wherein the polypeptides are capable of detoxifying at least one mycotoxin of Formula I, or the claimed genus of variants having at least 70% sequence identity to SEQ ID NOs 1, 2, 16-21, 22, 23-34, 317-318, 326-335, 336-337, 348-349, and 368-370 capable of modifying or hydrolyzing at least one mycotoxin having said Formula I.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CANDICE LEE SWIFT whose telephone number is (571)272-0177. The examiner can normally be reached M-F 8:00 AM-4:30 PM (Eastern).
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/CANDICE LEE SWIFT/Examiner, Art Unit 1657
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