DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Preliminary Amendment filed on April 18, 2024 and November 29, 2024, have been received and entered.
3. Applicant’s election with traverse of Group II (with species) on November 11, 2025, is acknowledged. The traversal is on the grounds that the species election is not proper nor burdensome. This argument is not persuasive because with each mutation, a different structure exists. The search burden exists with the multiple search that has to be done with each single mutation for example claim 13 has more than 31 mutations. Thus the Restriction Requirement of record is maintained and is final.
Claim Disposition
4. Claims 1-25 are pending. Claims 13-21 are under examination. Claims 1-12 and 22-25 are withdrawn from further consideration pursuant to 37 CFR 1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
5. The Information Disclosure Statements filed on March 29, 2023, April 18, 2025 and November 29, 2024, have been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action. Note that a reference has been lined through based on an incomplete date.
Drawing
6. The drawings filed on March 29, 2023, have been accepted by the examiner.
Specification Objection
7. The specification is objected to for the following informalities:
The specification is also objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01. See pages 42 and 45, for example. It is suggested that http:// is deleted.
The specification is objected to because paragraph [0293] has an improper sequence notation, see ‘SEQ ID NOS:’ which should be “SEQ ID NOs:”.
Appropriate correction is required.
Claim objection
8. Claims 13-21 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that 13 recite the sequence where the mutation is found.
For clarity it is suggested that claim 13 is amended to read, “….solely selected; and (B1) the specific……” The dependent claims hereto are also included.
For clarity it is suggested that claims 14-21 are amended to delete ‘according to’ and instead recite ‘of’.
For clarity and precision of claim language it is suggested that claim 13 is amended to delete the phrase ‘the mutation”, “following” and “shown below”, for example, “…..or the mutation (B)[[ shown below]]:
[[the mutation]] (A): mutation (s) at one or more amino acid residues selected from the [[followings]] group consisting of: G275…..”. See the dependent claims with similar language.
For clarity it is suggested that claim 21 is amended to delete the phrase “including”.
For clarity and precision of claim language it is suggested that claim 21 is amended to read, “is any of [[the following proteins]]:
a protein comprising the amino acid sequence of SEQ ID NO: 2;
a protein comprising the amino acid sequence of SEQ ID NO: 2….”.
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.
9. Claims 13-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), first paragraph, 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 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.
The claimed invention is directed to “a mutant transglutaminase having a specific mutation in the amino acid sequence of a wildtype transglutaminase and having a transglutaminase activity…” (see claim 13 in its entirety). However, there is no reference sequence provided for the wildtype to know where the mutations are found. In addition, item A provides 25 residues that could be mutated in some fashion and only provides R48I and S246N as specific mutations, although the language in the claim is directed to a “specific mutation”. Thus the claimed invention is not adequately described. The claimed embodiments encompasses 25 mutations in item A and 16 in item B and asserts that the mutant has a transglutaminase activity (see claim 13). The art generally recognizes that transglutaminase can catalyze acyl transfer reactions as a primary function but also functions to catalyze protein modification, specifically cross-linking glutamine and lysine residues, thus not clear which activity is asserted as being retained in the mutant. The claimed invention is not adequately described because the specification discloses a limited set of mutations and the claims require one but is limitless as to the amount of mutations and modification. The claimed invention also encompasses a large variable genus of enzymes bearing the limitless mutations/modifications.
The claimed invention is not commensurate in scope with the disclosure and no correlation is made between structure and function (see for example no activity is provided for the modified enzyme. The specification fails to provide a representative number of species for the claimed genus to show that 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.
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, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, 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. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
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.
10. Claims 13-20 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.
Claims 13 and the dependent claims hereto are rejected as being indefinite because they recite mutations with positions, however, no reference structure is provided where to find them, the recitation of ‘wildtype’ is not sufficient.
Claim Rejections - 35 USC § 102
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.
11. Claim(s) 13-15 and 20-21 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by WO 2019/107288 (2019, of record in the application).
The primary reference is directed to improving Streptomyces mobaraensis derived transglutaminase by an amino acid substitution and identified a plurality of substitutions effective for changes in its properties, for example, reduction in temperature stability, improvement in heat resistance, improvement in oxidation resistance, improvement in reactivity, or conversion into deamidase [0005]-[0007]; FIG 1-1 to FIG 6-9; claims 1-13). Further the reference suggests that modified enzymes with altered temperature stability are highly useful in applications such as production of yogurt and cheese (see par. [0016]). The reference also discloses in particular the Streptomyces mobaraensis transglutaminase mutant G275A (GSP:BGK02275;FIG. 6-6). The reference discloses a structure that is 99.70% identical to the instant SEQ ID NO:2 with the mutation of G275A that accounts for the mismatch in the sequence. Therefore, the limitations of the claims are met by the reference.
Conclusion
12. No claims are presently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652