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 .
Election/Restrictions
Claims 1, 2, and 6-10, 12 and 13 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected methods, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/25/2026.
Drawings
The drawings are objected to because the x- and y-axis are not labeled. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
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 3-5, 11 and 14 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 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. Claim 3 provides for a composition comprising a CYP716A53v2 mutant, wherein the mutants are one of four options. The first option, which does possess adequate written description is option a), which is a specifically claimed mutant of the wild-type protein; however, options b) though d) do not provide for adequate written description. Option b) is any protein that is “derived from” the wild-type, wherein any amino acid can be mutated, with the provision that the mutations provided in option a) must also be included, this protein must have the function of the mutant of option a). With option c), the protein can be mutated as much as 80% from the wild-type, with the provision that is behaves like protein a) and possesses the mutations disclosed in option a). Option d) is a derivative of options b) and c), wherein anything described regarding options b) and c) would equally apply to option d).
These options do not have adequate written description because there does not appear to be a reasonable cross section of proteins disclosed in the specification to suggest that the Applicant was in possession of the claimed scope. For example, option c) requires the behavior of option a), but does not state what portions of the wild-type must remain for any amount of functionality that is consistent with that of option a). By instructing the skilled artisan that up to 20% of the sequence can be mutated (80% homology), nearly 100 amino acids can be added, deleted, or mutated into any number of natural or unnatural amino acids. This means that the skilled artisan must test innumerable combinations of mutants in order to determine what has the same properties as option a), and as such, what the Applicant has invented.
When looking towards the instant specification, the only CYP716A53v2 sequence that is disclosed in the wild-type sequence, SEQ ID No 1. Option a) has adequate written description, because it would be clear to the skilled artisan what can be mutated, and the options for mutation are exceptionally limited. Options b)-d), however, present with a tremendous burden on the skilled artisan in order to make proteins that present with properties that are consistent with option a), and within the mutation framework defined within the claim. While the amino acid mutations of option a) do provide for some clarity towards options b)-d), there is nothing in the specification to suggest what other portions can be mutated and provide for the claimed functionality. Since it does not appear as though the Applicant provides for a reasonable number of mutants that would fulfill the limitations of options b)-d), the Applicant does not appear to be in possession of an adequate number of variants to suggest possession of the whole claim.
When looking to claims 4 and 5, which explicitly define the position and type of mutation, since these claims do not describe the variable portion of options b)-d), and only further define the expressly claimed mutations of option a), these claims are also ineligible under 35 USC 112(a).
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.
Claims 3-5, 11 and 14 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 3 is indefinite because it is drawn to mutants of CYP716A53v2 at positions 167, 451, 117, and/or 208, but the claim does not provide for a sequence to compare these mutations to. Although CYP716A53v2 is a known protein, any claims drawn to mutations at particular residues should include, at least, the wild-type sequence. In order to eliminate any ambiguity, the Applicant should claim SEQ ID No 1 in the claim, as this appears to be the sequence of the wild-type CYP716A53v2.
Claims 4, 5, 11, and 14 are indefinite insofar as they claim dependence on claim 3, but are not recited SEQ ID No 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Han, et al (Plant & Cell Physiology, 53, 1535-1545, 2012).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
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