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 .
Claim Disposition
2. Claims 1-13 are pending. Claims 1-5 are under examination. Claims 6-13 are withdrawn from further consideration pursuant to 37 CFR 1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Restriction Requirement
3. Applicant’s election of Group I (claims 1-5, SEQ ID NO: 270) without traverse, on May 8, 2026 is acknowledged.
Specification
4. The specification is objected to because of the following informalities:
The specification is objected to because the priority information needs to be updated, Application No. 17/330,686 is now Patent No: 11,987,818.
Appropriate correction of the above is required.
Information Disclosure Statement
5. The Information Disclosure Statement filed on April 17, 2024, has 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 some references have been lined through because of improper date citations.
Claim Objection
6. Claims 1-5 are objected to because of the following informalities:
For clarity and precision of claim language, it is suggested that claim 1 is amended to read, ”An engineered polypeptide with imine reductase activity, comprising: an amino acid sequence that is at least 90% identical to the sequence set forth in SEQ ID NO: 270, and has an amino acid residue difference at positions selected from the group consisting of 169, 176, 178, 211, 214 and 217 of SEQ ID NO: 270”. The dependent claims hereto are also included.
For clarity a precision of claim language it is suggested that claim 2 is amended to recite “….claim 1, wherein the amino acid sequence further comprises amino acid residue differences at positions in the sequence of SEQ ID NO: 270 selected from the group consisting of: ”.
For clarity it is suggested that claim 3 is amended to read, “…..claim 1, wherein the amino acid residue difference is selected from the group consisting of A169N,……..”.
For clarity it is suggested that claim 4 is amended to read, “…..claim 2, wherein the amino acid residue difference is selected from the group consisting of:…..”.
For clarity it is suggested that claim 5 is amended to read, “…..claim 1, wherein the amino acid sequence is at least 90% identical to an even-numbered sequence of …...”.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 112
The following is a quotation of the first paragraph of 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.
7. Claims 1-5 are rejected under 35 U.S.C. 112, first paragraph, as containingsubject matter which was not described in the specification in such a way as to enableone skilled in the art to which it pertains, or with which it is most nearly connected, tomake and or use the invention.
The claimed invention is directed to an engineered polypeptide having imine reductase activity comprising an amino acid sequence with at least 80% sequence identity to a reference sequence of SEQ ID NO: 270 and comprising an amino acid residue difference at one or more positions numbered with reference to SEQ ID NO: 270 selected from: 169, 176, 178, 178, 211, 214 and 217. The claimed invention encompasses a large variable genus of polypeptide structures not adequately described (see also claim 5 which recites at least 90% identity to even numbered structures of SEQ ID NOs: 76 to 268). In addition, dependent claims 2 and 4 have a large number of residue differences that could all be encompassed in the structure. The art generally discloses that a single amino acid change can be detrimental to structure-function relationship, and the claimed invention encompasses an enormous amount of changes.
The specification fails to provide any additional representative species of 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.
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. The claimed genus of polypeptides could include non-functional proteins or proteins with a different function than the one described. Therefore, the genus of claimed polypeptides encompasses widely variant species. Based on the unlimited variations contemplated one skilled in the art would at best expect a protein that is different or at worst a protein that is not functional. Moreover, 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 of polypeptides, 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.
8. Claims 2 and 4 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 2 lacks clear antecedent basis because it recites residue differences not found in claim 1.
Claim 4 lacks clear antecedent basis for the recitation of residues not found in the independent claim and should properly depend from claim 2.
Conclusion
9. No claims are presently allowable, however SEQ ID NO: 270 with the mutations of claim 1, is free of the art.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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