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 June 18, 2026 and December 30, 2024, have been received and entered.
Restriction Requirement
3. Applicant’s election of Group I with traverse, on June 18, 2026, is acknowledged. The traversal is on the grounds that unity of invention is present as the groups have the same technical feature. Applicant states that Riley reference has an oxidoreductase NRRL Y-366-8 which is identical to SEQ ID NO:2, this argument is not persuasive because SEQ ID NO:2 is at least 99% identical to SEQ ID NO:4 which is substantial in view of the fact the SEQ ID NO:4 is recited as being mutated (and the claim does not define a specific mutation). The application recites different oxidoreductase which represent separate products and under PCT Rule 13.1, applicant is entitled to the first product, method of making and using the same. Note that several method claims are ‘use’ claims which is not eligible for consideration and mostly directed to the another product in the application, the gene. Thus, the lack of unity is proper and is made final.
Claim Disposition
4. Claims 1-12 are canceled. Claims 13-30 are pending. Claim 20 is under examination. Claims 13-19 and 21-30 are withdrawn from further consideration pursuant to 37 CFR1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
5. The Information Disclosure Statement filed on June 13, 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 a reference has been lined through based on an improper citation of the date.
Drawing
6. The Drawings filed on June 13, 2024, are accepted by the examiner.
Abstract Objection
7. The abstract is objected to for the following informalities:
(a)The abstract is objected to for having “FIG.1” with no figure displayed.
(b) Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Specification Objection
8. The specification is objected to for the following informalities:
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The following is suggested: "Oxidoreductase Mutant and Use in Biosynthesis of Nootkatone" (see page 1).
The specification is objected to for the following typographical error of not having enough spacing, see “……amino acid of SEQ ID No.2from the glycine G…..”, see page 4.
The specification is objected to because the organism name is not italicized ‘Arabidopsis thaliana’, see page 6, line 2.
The specification is objected to because trademarks are disclosed and they are not capitalized. The use of the trademark such as Triton-100, has been noted in this application (see page 6, for example). It should be capitalized wherever it appears and be accompanied by the generic terminology. Although the use of trademarks is permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner, which might adversely affect their validity as trademarks (see page 12).
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 page14, for example. It is suggested that http:// is deleted.
The specification is objected to because the sequence notation is improper, see “SEQ ID NO.2”, which should be “SEQ ID NO: 2” on page 18 and throughout the specification.
Appropriate correction is required.
Claim objection
9. Claim 20 is objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 20 is amended to recite, “An oxidoreductase mutant having the sequence of SEQ ID NO: 4 and wherein the oxidoreductase mutant catalyzes nootkatol”.
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.
10. Claim 20 is 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 “an oxidoreductase mutant having the sequence of SEQ ID NO: 4”, the claimed invention is devoid of any functional limitations. The claimed invention is not adequately described because there’s no assertion that the mutant retains the native activity or has acquired a new activity and what the mutation is or its effects.
The claimed invention is overly broad and not commensurate in scope with the disclosure in the specification which discloses that the oxidoreductase catalyzes nootkatol. The art generally acknowledges that a single amino acid change can be detrimental to protein’s structure-function relationship and the claim does not have any functional limitations. Thus the claimed invention is not adequately described.
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.
Conclusion
11. No claims are presently allowable, however, SEQ ID NO:4 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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