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
Application Status
This application is 371 of PCT/JP2023/001336, filed on 07/17/2024.
Claims 1-20 are currently pending in the instant application.
The preliminary amendment filed on 07/17/2024, amending claims 6-8, 11-13, 16-18, and 19 is acknowledged.
Election/Restriction
Applicant's election without traverse of Group I, Claims 1-12, drawn to a glutamate oxidase mutant having a deleted region, wherein all or part of an inter-γ-β-region located between the γ and β-chain region of a wild type glutamate oxidase is deleted, 1 to 10 carboxy terminal amino acids of the γ chain region of the wild type glutamate oxidase are deleted or not deleted, 1 to 4 amino terminal amino acids of the β-chain region of the wild type glutamate oxidase are deleted or not deleted, wherein, the deleted region is one continuous deleted region, and the glutamate oxidase mutant comprises glutamate oxidase activity, and a composition comprising reagents, electrode, sensor or a kit comprising the same mutant polypeptide in the response filed on 07/24/2026 is acknowledged.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicants request for rejoinder is noted. However, current claims of elected Group I are not allowable at this time. When Group I would be allowable, rejoinder request would be evaluated at that time.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-12 are present for examination.
Priority
Acknowledgement is made of applicants claim for foreign priority under 35 U.S.C. 119(a)-(d) to a foreign patent application JAPAN 2022-005869, filed on 01/18/2022 without English translation.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 07/17/2024, and 02/04/2026 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are considered by the examiner. The signed copies of 1449 are enclosed herewith.
Specification objections
The disclosure is objected to because of the following informalities:
2422.01-.04 The Requirement for Exclusive Conformance; Sequences Presented
in Drawing Figures 37 CFR 1.821(b) requires….Any sequence more than 10 nucleotides or more than 3 amino acids, regardless of the format or the manner of presentation of that sequence in the Claims, Specification or Drawings the sequence must still be included in the Sequence Listing and the sequence identifier (“SEQ ID NO:X”) must be used (see, page 21-24 of the Specification). It should be noted, though, that when a sequence is presented in a drawing, regardless of the format or the manner of presentation of that sequence in the drawing, more than 10 nucleotides or more than 3 amino acids, regardless of the format or the manner of presentation of that sequence in the Claims, Specification or Drawing the sequence must still be included in the Sequence Listing and the sequence identifier (“SEQ ID NO:X”) must be used (see, page 21-24 of the Specification). Appropriate correction is required.
Drawings
There is no Drawing with this application.
Claim Objections
Claim 1 is objected to in the recitation “A glutamate oxidase mutant having …. wherein” at the beginning of independent claim 1. However, a claim generally presented in three parts, the preamble, a transition phrase (or words) and the body, but independent claim 1 does not follow normal claim construction guidelines of MPEP because there is no transitional phrase present in claim 1 of the instant application, such as "comprising", "consisting essentially of" or "consisting of" in the claim. Appropriate correction 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.
Claims 1-2, 6 and 12 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.
Claim 1 is indefinite in the recitation “part” in the context of an inter-γ-β region located between the γ-chain region of the glutamate oxidase enzyme, wherein the phrase “part” is a relative term, which renders the claim indefinite because there is no boundary of said phrase “part” of an inter-γ-β region”. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
Claims 1, 2, 6 and 12 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.
Claim 1 is indefinite and vague in the recitation “1 to 10 carboxy terminal amino acids” in the context of deletion of amino acid sequence of wild type glutamate oxidase, which is confusing because absent a reference to an wild type glutamate oxidase to which the amino acid numbering refers? What is the sequence of wild type glutamate oxidase? In the art, wild type glutamate oxidase can be multiple forms derived from many unknown sources as well as many mutants, variants and fragments thereof those are rendering the metes and bounds of the term confusing. Accordingly, claims 2-12 are also rejected, as claims 2, 6 and 12 depend on claim 1. Claim 2 is also rejected on the same ground. Clarification is required.
Claim 8 (depends on claim 1) is rejected under 35 U.S.C. 112(b), as being indefinite and vague for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 8 is indefinite and vague as it is unclear how claim 8 limits claim 1 because claim 8 recites “further composing …. SEQ ID NO: 1 or 58 and thus claim 8 is indefinite and confusing. Please, look at claim 9 and how claim 9 is further limiting claim 8. Clarification is required.
Claim 11 (depends on claim 1) is rejected under 35 U.S.C. 112(b), as being indefinite and vague for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 11 is indefinite and vague as it is unclear how claim 11 limits claim 1 because claim 11 recites “the amino acid sequence .... SEQ ID NO: 1 and thus claim 11 is indefinite and confusing. Please, look at claim 9 and how claim 9 is further limiting claim 8. Clarification is required
Claim Rejections - 35 USC § 112(a)
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.
A. Written Description
Claims 1-2, 6, and 12 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claim(s) 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 12 are directed to a variant of a glutamate oxidase mutant having a deleted region, wherein all or part of an inter-γ-β-region located between the γ and β-chain region of a wild type glutamate oxidase is deleted, 1 to 10 carboxy terminal amino acids of the γ chain region of the wild type glutamate oxidase are deleted or not deleted, 1 to 4 amino terminal amino acids of the β-chain region of the wild type glutamate oxidase are deleted or not deleted, wherein, the deleted region is one continuous deleted region, and the glutamate oxidase mutant comprises glutamate oxidase activity, and a composition comprising reagents, electrode, sensor or a kit comprising the same mutant polypeptide.
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.” University of California v. Eli Lilly and Co., 1997 U.S. App. LEXIS 18221, at *23, quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993). To fully describe a genus of genetic material, which is a chemical compound, applicants must (1) fully describe at least one species of the claimed genus sufficient to represent said genus whereby a skilled artisan, in view of the prior art, could predict the structure of other species encompassed by the claimed genus and (2) identify the common characteristics of the claimed molecules, e.g., structure, physical and/or chemical characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or a combination of these (paraphrased from Enzo Biochemical).
Thus, Claims are directed to any variant of any glutamate oxidase mutant having a deleted region, wherein all or part of an inter-γ-β-region located between the γ and β-chain region of a wild type glutamate oxidase is deleted, 1 to 10 carboxy terminal amino acids of the γ chain region of the wild type glutamate oxidase are deleted or not deleted, 1 to 4 amino terminal amino acids of the β-chain region of the wild type glutamate oxidase are deleted or not deleted, wherein, the deleted region is one continuous deleted region, and the glutamate oxidase mutant comprises glutamate oxidase activity, and a composition comprising reagents, electrode, sensor or a kit comprising the same mutant polypeptide, derived from any unknown sources any mutants, variants and fragments thereof having no structural feature, i.e., any variant of wild type glutamate oxidase encompasses many variant glutamate oxidase, and many mutants, variants, and fragments thereof, which can have wide variety of unknown structures, i.e. No Structure-Function correlation, which is required to fulfill the Written Description (WD) requirement.
As discussed in the written description guidelines 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 the applicant was in possession of the claimed genus. 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.
Furthermore, the genus of polypeptides required in the claimed invention is an extremely large structurally and functionally variable genus. While the argument can be made that the recited genius of polypeptides is adequately described by the disclosure of the structures of prior art. However, the art clearly teaches the “Practical Limits of Function Prediction”: Whisstock et al., (2003) highlight the difficulties associated with “Prediction of protein function from protein sequence and structure”; “To reason from sequence and structure to function is to step onto much shakier ground”, closely related proteins can change function, either through divergence to a related function or by recruitment for a very different function, in such cases, assignment of function on the basis of homology, in the absence of direct experimental evidence, will give the wrong answer, it is difficult to state criteria for successful prediction of function, since function is a vague concept. This finding is reinforced in the following scientific teachings for specific proteins in the art that suggest, even highly structurally homologous polypeptides do not necessarily share the same function, and many functionally similar proteins will have little or no structural homology to disclose proteins. For example, proteins having similar sstructureshave different activities (structure does not always correlate to function); Witkowski et al., (1999) teaches that one conservative amino acid substitution transforms a -ketoacyl synthase into a malonyl decarboxylase and eliminates -ketoacyl synthase activity. Similarly, the art also teaches that functionally similar molecules have different structures; Kisselev L. (2002) teaches that polypeptide release factors in prokaryotes and eukaryotes have same function but different structures.
Furthermore, the genus of polynucleotide encoding polypeptides or variants required in the claimed invention is an extremely large structurally and functionally variable genus. While the argument can be made that the recited genius of polypeptides is adequately described by the disclosure of the structures of prior art, i.e., lipase variant enzymes. However, the art clearly teaches the “Practical Limits of Function Prediction”: Whisstock et al., (2003) highlight the difficulties associated with “Prediction of protein function from protein sequence and structure”; “To reason from sequence and structure to function is to step onto much shakier ground”, closely related proteins can change function, either through divergence to a related function or by recruitment for a very different function, in such cases, assignment of function on the basis of homology, in the absence of direct experimental evidence, will give the wrong answer, it is difficult to state criteria for successful prediction of function, since function is in principle a fuzzy concept. This finding is reinforced in the following scientific teachings for specific proteins in the art that suggest, even highly structurally homologous polypeptides do not necessarily share the same function, and many functionally similar proteins will have little or no structural homology to disclose proteins. For example, proteins having similar sstructureshave different activities (structure does not always correlate to function); Witkowski et al., (1999) teaches that one conservative amino acid substitution transforms a -ketoacyl synthase into a malonyl decarboxylase and eliminates -ketoacyl synthase activity. Similarly, the art also teaches that functionally similar molecules have different structures; Kisselev L. (2002) teaches that polypeptide release factors in prokaryotes and eukaryotes have same function but different structures.
Claims are drawn to very broadly any mutant of any glutamate oxidase mutant having a deleted region, wherein all or part of an inter-γ-β-region located between the γ and β-chain region of a wild type glutamate oxidase is deleted, 1 to 10 carboxy terminal amino acids of the γ chain region of the wild type glutamate oxidase are deleted or not deleted, 1 to 4 amino terminal amino acids of the β-chain region of the wild type glutamate oxidase are deleted or not deleted, wherein, the deleted region is one continuous deleted region, and the glutamate oxidase mutant comprises glutamate oxidase activity, and a composition comprising reagents, electrode, sensor or a kit comprising the same mutant polypeptide, derived from any unknown sources any mutants, variants and fragments thereof having no structural feature, i.e., any variant of wild type glutamate oxidase encompasses many variant glutamate oxidase, and many mutants, variants, and fragments thereof, which can have wide variety of unknown structures, whose structures are not fully described in the specification. No information, beyond the characterization of variant of glutamate oxidase enzymes has been provided, which would indicate that applicants had possession of the claimed genus. The specification does not contain sufficient disclosure of the structure with function of all the variant lipase enzymes, within the scope of the claimed genus. The genus of polypeptides claimed is a large variable genus including many mutants, variant and fragments thereof, which can have wide variety of structures. Therefore, many structurally unrelated enzymes (variant glutamate oxidase) within the scope of these claims. The specification discloses the structure of only few representative species of the claimed genus, which is insufficient to put one of skill in the art in possession of the attributes and features of all species within the claimed genus. Therefore, one skilled in the art cannot reasonably conclude that applicant had possession of the claimed invention at the time the instant application was filed.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and available at www.uspto.gov.
Conclusion
Status of the claims:
Claims 1-2, 6, 8, 11-12-are rejected.
Allowable Subject Matter
Claims 3-5, 7, 9 and 10 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IQBAL H CHOWDHURY whose telephone number is (571)272-8137. The examiner can normally be reached on M-F, at 9:00-5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Iqbal H. Chowdhury, Ph.D.
Primary Patent Examiner
Art Unit 1656 (Recombinant Enzymes and Protein Crystallography)
US Patent and Trademark Office
Ph. (571)-272-8137 and Fax (571)-273-8137
/IQBAL H CHOWDHURY/
Primary Examiner, Art Unit 1656
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