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 .
This office action is in response to the application filed on April 17, 2023. The earliest effective filing date of the application is October 22, 2020.
Priority
The present application is a 371 National Stage Application of PCT/EP2021/079331 which has a filing date of October 22, 2021.
Election/Restrictions
Claims 3 – 11 and 19 – 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on January 26, 2026.
Applicant's election with traverse of Group I, claims 1, 2, and 14 – 18, in the reply filed on January 26, 2026 is acknowledged. The traversal is on the grounds that, as amended, Chen does not render obvious the shared technical feature linking the claims. This is not found persuasive because despite applicant’s amendments, Chen renders obvious the shared technical feature linking the claims as expounded upon below. Therefore the claims lack unity of invention, and restriction is proper.
The requirement is still deemed proper and is therefore made FINAL.
Status of Application
The amendment filed on January 26, 2026 with the Response to Restriction Requirement has been entered. The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1 – 11 and 14 – 21
Withdrawn claims: 3 – 11 and 19 – 21
New claims: 14 – 21
Claims currently under examination: 1, 2, and 14 – 18
Claim Objections
Claim 1 is objected to because of the following informalities:
- Claim 1 recites steps i) and ii) without an “and” or “then” linking them. Claim 1 should include “and” or “then” or some other appropriate linking conjunction at the end of step i):
“(b) a polypeptide comprising an amino acid sequence having at least 92% identity to the amino acid sequence set forth in SEQ ID NO: 1, […], 3-amino Deoxynivalenol; and
ii) applying one or more of (a)-(b) to a nutritive source or material suitable for production of foodstuff, intermediate foodstuff […]”
to make the claim a complete sentence.
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, 2, and 14 – 18 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.
Claim 1 uses improper Markush language to link group members. The list should link all group members by “and”. For example, the Markush language of claim 1 should be written as “3-keto Deoxynivalenol, 3-epi Deoxynivalenol, 15- Acetyldeoxynivalenol, Nivalenol, Fusarenon-X (4-acetylnivalenol), and 3-amino Deoxynivalenol” for each recitation in the claim (lines 8 – 10 and 18 – 20).
Claims 2 and 14 – 18 are rejected as dependent on a rejected base claim.
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.
Claims 1, 2, and 14 – 18 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (WO 2021027771 A1 – Provided with Requirement for Restriction filed on November 26, 2025 – WIPO Machine Translation).
Regarding claim 1, Chen teaches a method of reducing or deoxidizing the toxicity of deoxynivalenol (DON) or an acylated derivative thereof, comprising:
i) providing an SPG (i.e., providing a polypeptide – [0022]; [0068]; [0079]; [0088]); and
ii) applying the SPG as a detoxification preparation for the biological detoxification of food fungal toxins (i.e., applying a polypeptide to a nutritive food source or material suitable for production of foodstuff – [0022]; [0088]).
With respect to the capabilities of the SPG (i.e., polypeptide) of Chen, Chen teaches targeted modification of the detoxification binding sites of the natural glyoxalase SPG (i.e., polypeptide) from Gossypium hirsutum (cotton) enhances the detoxification properties of the glyoxalase SPG (i.e., polypeptide – [0089]). Chen further teaches the SPGs of the present invention modify the C7 carbon of a derivative of DON, 3- Acetyldeoxynivalenol ([0053]; Figure 3, (e)). Chen teaches the modification to the C7 carbon of the derivative of DON, 3- Acetyldeoxynivalenol converts the hydroxyl moiety at the C7 carbon to a carbonyl moiety ([0053]; Figure 3, (e)). Chen further states analogs, derivatives, or compounds having the same parent ring structure as those of these substrates in the above embodiments (i.e., the ring structure in the compounds presently claimed) can also be catalyzed by glyoxal enzyme SPG, and are also included in the scope of the present invention ([0084]). While Chen does not explicitly state that the mutant glyoxalase SPG (i.e., polypeptide) described above is capable of modifying the C7-atom of deoxynivalenol (DON) and/or DON derivative selected from the group consisting of: 3-keto Deoxynivalenol, 3-epi Deoxynivalenol, 15- Acetyldeoxynivalenol, Nivalenol, Fusarenon-X (4-acetylnivalenol), 3-amino Deoxynivalenol, as precisely claimed in the instant application, the targeted modifications made to the detoxification binding sites of the glyoxalase SPG (i.e., polypeptide) of Chen strongly suggest the mutant glyoxalase SPGs (i.e., polypeptides) of Chen are capable of the instantly claimed modifications.
With respect to the amino acid sequence of the SPG (i.e., polypeptide) of Chen, Chen teaches one of the modified glyoxalase SPGs (i.e., polypeptides) is a mutant derived from the Gossypium hirsutum (cotton) glyoxalase SPG sequence (which is SEQ ID No. 2 of Chen, and has 100% similarity with SEQ ID No. 2 of the instant application) comprising M69F/F101N/I121R mutation and 4 amino acids (GKMK) added between positions 153 and 154 as shown in [0089], [0090], and claim 16 (shown below). The mutant glyoxalase SPG (i.e., polypeptide) described above has a sequence identity of 89.8% with SEQ ID No. 1 of the instant application, 96.2% with SEQ ID No. 2 of the instant application, and 93.0% with SEQ ID No. 3 of the instant application.
Modified SEQ ID No. 2 of Chen as described above:
pend_SEQ1 1 MGSLDSKESPANNPGLHSPPDEATKGYIMQQTMFRIKDPKPTLEFYSRVLGMSLLNKVDV 60
| ||||||||||||||| |||||||||||||||||||||| |||||||||||:|||||||
mod_SEQ2_Chen 1 MASLDSKESPANNPGLHFPPDEATKGYIMQQTMFRIKDPKRTLEFYSRVLGMTLLNKVDV 60
pend_SEQ1 61 PYMKMTLYMMGYEDVSSAPSDPVEKTIWTFGRPATMELTHFWGTENDPEFKGYHDGNSEP 120
|||||||| ||||||||||:|||||||||||||||||||| |||||||||||||||||||
mod_SEQ2_Chen 61 PYMKMTLYFMGYEDVSSAPTDPVEKTIWTFGRPATMELTHNWGTENDPEFKGYHDGNSEP 120
pend_SEQ1 121 TGFGHIGITVDDMYKACERFESLGVEFVKKPGD----GYAFIKDPDGYWIEIFDLNGIRA 176
||||||:||||:|||||||||||||||||| | |:|||||||||||||||| |||
mod_SEQ2_Chen 121 RGFGHIGLTVDDLYKACERFESLGVEFVKKPSDGKMKGFAFIKDPDGYWIEIFDLKGIRQ 180
pend_SEQ1 177 IVNNLA 182
|||:||
mod_SEQ2_Chen 181 IVNSLA 186
While Chen does not teach the Modified SEQ ID No. 2 as shown above has a sequence with 92% identity to SEQ ID No. 1 of the instant application, MPEP § 2144.09 states prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In this case, because the modified SEQ ID No. 2 of Chen is capable of modifying the C7 carbon of a derivative of DON, 3- Acetyldeoxynivalenol in the precisely claimed way (i.e., converting a hydroxyl moiety to a carbonyl moiety – [0053]; Figure 3, (e)); and is therefore capable of modifying the C7-atom of deoxynivalenol (DON) and/or DON derivative selected from the group consisting of: 3-keto Deoxynivalenol, 3-epi Deoxynivalenol, 15- Acetyldeoxynivalenol, Nivalenol, Fusarenon-X (4-acetylnivalenol), 3-amino Deoxynivalenol, as claimed in the instant application, the precisely claimed sequence identity recited in claim 1 is rendered obvious by Chen due to the sequences having similar structure and utility.
In summary, the modified method of Chen as described above teaches a method for producing a foodstuff, said method comprising:
i) providing the following polypeptide, wherein said polypeptide is capable of modifying the C7-atom of deoxynivalenol (DON) and/or DON derivative selected from the group consisting of: 3-keto Deoxynivalenol, 3-epi Deoxynivalenol, 15- Acetyldeoxynivalenol, Nivalenol, Fusarenon-X (4-acetylnivalenol), and 3-amino Deoxynivalenol:
(b) a polypeptide comprising an amino acid sequence having at least 92% identity to the amino acid sequence set forth in SEQ ID NO: 1, but less than 100% sequence identity with the amino acid sequence set forth in SEQ ID NOs: 2 or 3, wherein said polypeptide is capable of modifying the C7-atom of deoxynivalenol (DON) and/or DON derivative selected from the group consisting of: 3-keto Deoxynivalenol, 3-epi Deoxynivalenol, 15- Acetyldeoxynivalenol, Nivalenol, Fusarenon-X (4-acetylnivalenol), and 3-amino Deoxynivalenol (i.e., the modified SPG of Chen); and
ii) applying (b) to a nutritive source or material suitable for production of foodstuff;
wherein said modifying the C7-atom comprising changing a hydroxyl-moiety to carbonyl moiety at C7-atom.
Regarding claim 2, Chen teaches the SPG is applied as a detoxification preparation to the biological detoxification of food fungal toxins (i.e., applying a polypeptide to a nutritive food source or material suitable for production of foodstuff – [0088]). Chen teaches the SPG catalyzes the reaction with DON and DON derivatives, for example, acetyl deoxynivalenol (3A-DON) as a substrate ([0134]). The phrase “incubating” in claim 2 is broadly interpreted to encompass the catalyzation reaction between SPG and 3A-DON as taught by Chen. Therefore, Chen renders obvious incubating a nutritive source or material with polypeptide (b) under conditions suitable for degrading DON and/or said DON derivative/s and/or altering toxicity of DON and/or said DON derivative/s, because Chen teaches applying the SPG to a nutritive food source, and that the application is a catalyzation reaction (i.e., incubation) between the SPG and DON/DON derivatives, which detoxifies the DON/ DON derivatives.
Regarding claims 14 – 18, while Chen does not teach the Modified SEQ ID No. 2 as shown above has a sequence with 95, 96, 97, 98, or 99% identity to SEQ ID No. 1 of the instant application, MPEP § 2144.09 states prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In this case, because the modified SEQ ID No. 2 of Chen is capable of modifying the C7 carbon of a derivative of DON, 3- Acetyldeoxynivalenol ([0053]; Figure 3, (e)); and is therefore capable of modifying the C7-atom of deoxynivalenol (DON) and/or DON derivative selected from the group consisting of: 3-keto Deoxynivalenol, 3-epi Deoxynivalenol, 15- Acetyldeoxynivalenol, Nivalenol, Fusarenon-X (4-acetylnivalenol), 3-amino Deoxynivalenol, as precisely claimed in the instant application, the precisely claimed sequence identity recited in claims 14 – 18 are rendered obvious by Chen due to the sequences having similar structure and utility.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure:
- Enguita et al. (Cross-Kingdom Enzymatic Strategies for Deoxynivalenol Detoxification: Computational Analysis of Structural Mechanisms and Evolutionary Adaptations. Microorganisms (2025)) discusses the functional structures in a naturally occurring protein family in cotton (Gossypum sp.) that is capable of degrading deoxynivalenol.
- Huang et al. (Aromatization of natural products by a specialized detoxification enzyme. Nature Chemical Biology. Vol 16. Pp. 250 - 256. (March 2020)) expounds upon the Chen reference relied upon above by providing more detail on the modified Seq No. 2 and its enzymatic activity on deoxynivalenol and its derivatives.
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/L.J.M./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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