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 .
Claim Status
Claims 1-8, 11-22, 30, 36-40 & 44-46 are under examination on the merits.
Claims 9-10, 23-29, 31-35 & 47-52 are canceled.
Priority
Claims 1-8, 11-22, 30, 36-40 & 44-46 receive the U.S. effective filing date of 08/14/2023
The previous rejection of Claims 1-9, 11-22, 30, 36-40 & 44-46 under 35 U.S.C. 112(a) for failing to comply with written description is withdrawn due to Applicant’s amendment to the claims.
The previous rejection of Claims 1-9, 11-22, 30, 36-40 & 44-46 under 35 U.S.C. 112(a) for failing to provide enablement for the full scope of the claims is withdrawn due to Applicant’s amendment to the claims.
Claim Objections
Claim 46 is objected to because of the following informalities:
Improper use of article(s); the claim reads “…an antifungal composition…” when referring to claim 45 but should state, “…the antifungal composition…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8, 11-22, 30, 36-40 & 44-46 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for SEQ ID NO.2, does not reasonably provide enablement for SEQ ID NO 3-8. 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.
Claims 1, 21 & 30 from which all other claims depend, require polypeptides of 95% sequence identity to SEQ ID NO.2-8 derived from Serratia. Thus, the claims are broad and read on numerous unspecified polypeptides.
A review of sequence search information reveals that several polypeptides of Serratia have been reported with sequence similarity as low as 88% to SEQ ID NO.2. Thus, prior art provides such polypeptides of 95% or more similarity. However, there appear to be no reports of polypeptides of less than 99.5% identity to the claimed polypeptides, derived from Serratia, for SEQ ID NO.3-8. For SEQ ID NO.2, the only sequences with 88% similarity were in the databases before filing of the instant application, and for SEQ ID NO.3-8, the only sequences with 25.9-57% similarity were in the databases before the filing of the instant application. The sequences which are 25.9-57% similar to SEQ ID NO.3-8 are not derived from Serratia, but from other microorganisms.
Proteins with 95% identity to the 95-residue long SEQ ID NO.3 encompass polypeptides with approximately 4 random amino acid substitutions. Describing a genus of polypeptides with all possible single amino acid substitutions relative to the 95-amino-acids-long polypeptide of SEQ ID NO.3 would require describing 420 polypeptide sequences derived from Serratia; a representative number of which were not described by Applicant at the time of filing.
Proteins with 95% identity to the 63-residue long SEQ ID NO.5 encompass polypeptides with approximately 3 random amino acid substitutions. Describing a genus of polypeptides with all possible single amino acid substitutions relative to the 63-amino-acids-long polypeptide of SEQ ID NO.5 would require describing 320 polypeptide sequences derived from Serratia; a representative number of which were not described by Applicant at the time of filing.
Proteins with 95% identity to the 299-residue long SEQ ID NO.6 encompass polypeptides with approximately 15 random amino acid substitutions. Describing a genus of polypeptides with all possible single amino acid substitutions relative to the 299-amino-acids-long polypeptide of SEQ ID NO.6 would require describing 1520 polypeptide sequences derived from Serratia; a representative number of which were not described by Applicant at the time of filing.
Proteins with 95% identity to the 389-residue long SEQ ID NO.7 encompass polypeptides with approximately 19 random amino acid substitutions. Describing a genus of polypeptides with all possible single amino acid substitutions relative to the 389-amino-acids-long polypeptide of SEQ ID NO.7 would require describing 1920 polypeptide sequences derived from Serratia; a representative number of which were not described by Applicant at the time of filing.
Proteins with 95% identity to the 479-residue long SEQ ID NO.8 encompass polypeptides with approximately 24 random amino acid substitutions. Describing a genus of polypeptides with all possible single amino acid substitutions relative to the 479-amino-acids-long polypeptide of SEQ ID NO.8 would require describing 2420 polypeptide sequences derived from Serratia; a representative number of which were not described by Applicant at the time of filing.
Applicant is claiming a broad range of structurally variable proteins as a result of only requiring 95% identity to any of their recited polypeptides. No structural information is described beyond that of the seven SEQ ID NO.2-8. Without further guidance in the written description, such structural modifications would amount to making random mutational changes in proteins derived from Serratia. Making random changes in proteins is unpredictable, and thus one would not be enabled to isolate or derive from Serratia spp. or use such proteins with less than 100% identity to SEQ ID NO.2-8 with any reasonable certainty that it would function properly, or reduce mycotoxins.
Because of this, claims 1, 21 & 30 and their dependents are rejected as not having been fully enabled, as such Serratia proteins are not described in the specification, nor taught by the existing art. Even with 664 Serratia genomes having been sequenced [see Williams et al. Nat Commun 13, 5195 (2022); Published 3 Sep 2022] no Serratia proteins with 95% identity to SEQ ID NO:3-8 have been found. Therefore, without guidance from the specification as to which Serratia strains and species have proteins with 95% identity to SEQ ID NO:3 & 5-8, it would require undue experimentation to find these proteins, if it is even possible to do so.
With respect to claim 45; the claim is drawn to use of the polynucleotide construct as an antifungal composition. This claim is not enabled because while the specification describes fungicidal activity of a protein encoded by the claimed nucleic acids, the nucleic acids themselves are not insecticidal. The specification does not describe that applying an extract of DNA, without protein, is fungicidal. Only when the DNA is incorporated into a biological system capable of producing the encoded protein(s), is pesticidal activity conferred by the protein.
Because the specification only discloses the fungicidal polypeptide, and does not describe fungicidal nucleic acids per se, the scope of such claim is not enabled by the specification and claim 45 is rejected.
Claims 1-8, 11-22, 30, 36-40 & 44-46 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 21 & 30 from which all other claims depend, require polypeptides of 95% sequence identity to SEQ ID NO.2-8 derived from Serratia. Thus, the claims are broad and read on numerous unspecified polypeptides.
A review of sequence search information reveals that several polypeptides of Serratia have been reported with sequence similarity as low as 88% to SEQ ID NO.2. Thus, prior art provides such polypeptides of 95% or more similarity. However, there appear to be no reports of polypeptides of less than 99.5% identity to the claimed polypeptides, derived from Serratia, for SEQ ID NO.3-8. For SEQ ID NO.2, the only sequences with 100% were in the databases before filing of the instant application, and for SEQ ID NO.3-8, the only sequences with 25.9-57% similarity were in the databases before the filing of the instant application. Additionally, the sequences which are 25.9-57% similar to SEQ ID NO.3-8 are not derived from Serratia, but from other microorganisms.
Proteins with 95% identity to the 95-residue long SEQ ID NO.3 encompass polypeptides with approximately 4 random amino acid substitutions. Describing a genus of polypeptides with all possible single amino acid substitutions relative to the 95-amino-acids-long polypeptide of SEQ ID NO.3 would require describing 420 polypeptide sequences derived from Serratia; a representative number of which were not in possession of the Applicant at the time of filing.
Proteins with 95% identity to the 63-residue long SEQ ID NO.5 encompass polypeptides with approximately 3 random amino acid substitutions. Describing a genus of polypeptides with all possible single amino acid substitutions relative to the 63-amino-acids-long polypeptide of SEQ ID NO.5 would require describing 320 polypeptide sequences derived from Serratia; a representative number of which were not in possession of the Applicant at the time of filing.
Proteins with 95% identity to the 299-residue long SEQ ID NO.6 encompass polypeptides with approximately 15 random amino acid substitutions. Describing a genus of polypeptides with all possible single amino acid substitutions relative to the 299-amino-acids-long polypeptide of SEQ ID NO.6 would require describing 1520 polypeptide sequences derived from Serratia; a representative number of which were not in possession of the Applicant at the time of filing.
Proteins with 95% identity to the 389-residue long SEQ ID NO.7 encompass polypeptides with approximately 19 random amino acid substitutions. Describing a genus of polypeptides with all possible single amino acid substitutions relative to the 389-amino-acids-long polypeptide of SEQ ID NO.7 would require describing 1920 polypeptide sequences derived from Serratia; a representative number of which were not in possession of the Applicant at the time of filing.
Proteins with 95% identity to the 479-residue long SEQ ID NO.8 encompass polypeptides with approximately 24 random amino acid substitutions. Describing a genus of polypeptides with all possible single amino acid substitutions relative to the 479-amino-acids-long polypeptide of SEQ ID NO.8 would require describing 2420 polypeptide sequences derived from Serratia; a representative number of which were not in possession of the Applicant at the time of filing.
Applicant is claiming a broad range of structurally variable proteins as a result of only requiring 95% identity to any of their recited polypeptides. Looking to the specification for structural description of the numerous proteins encompassed, one finds only description of generic methods of modifying polypeptides [par.44, 48-50, 65-73]. No structural information is described beyond that of the seven SEQ ID NO.2-8. Without further guidance in the written description, such structural modifications would amount to making random mutational changes in proteins derived from Serratia. One skilled in the art would not consider the Applicant to be in possession of the claimed protein variants, lacking further sequence or structural information.
Because of this, claims 1, 21 & 30 and their dependents are rejected because the specification does not convey to one skilled in the relevant art that the inventor, at the time the application was filed, had possession of such protein variants with less than 100% sequence similarity to SEQ ID NO.3-8, derived from Serratia.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 16 & 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. EPA [White Paper on The Possible Presence of Cry9c Protein in Processed Human Foods Made From Food Fractions Produced Through The Wet Milling Of Corn; Published 13 Oct 2001].
The claim is drawn to commodity plant products derived from maize, including oil.
The U.S. EPA teaches the making of corn oil [p.4-5, Figure 2; p.10, par.2]. They also teach that expressed oil from transgenic corn products is free of transgenic protein(s) [p.2, par.2-3; p.7, Table 1].
Therefore, the corn oil taught by Applicant is indistinguishable from the corn oil taught by EPA, and EPA’s corn oil thus anticipates the instantly claimed corn oil.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEITH R WILLIAMS whose telephone number is (571)272-3911. The examiner can normally be reached Mon - Fri, 9:30 - 5:30 EST.
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/KEITH R. WILLIAMS/Examiner, Art Unit 1663
/Anne Kubelik/Primary Examiner, Art Unit 1663
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