DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first-inventor-to-file provisions of the AIA .
Election/Restrictions
1. Claims 53-64 as filed 9 December 2022 were pending.
A restriction requirement was posted on 21 March 2025.
Applicant elected without traverse Invention II, claims 55-64 in the reply filed on 9 June 2025. The requirement is deemed proper and is therefore made FINAL.
Claims 55-64 are examined herein. Claims 53-54 are withdrawn as being drawn to a non-elected invention.
Applicant is reminded that upon the cancellation of claims, the inventorship should be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Claim Objections
2. Claim 62 and 64 are objected to for the following informalities.
Claim 62 is objected to because “the plurality of enzyme variants is EPSPS” is awkward in part because the verb “is” is singular but it follows “variants.” Further “is EPSPS” is also awkward. It appears that the intended meaning is that the variant has the activity of an ESPS synthase. Or at least that is how it was interpreted for examination.
Claim 64 is objected to because it recites the limitation “the enzyme and the substrate concentrations are the same.”
Applicant is requested to add “each” between “are” and “the.”
Appropriate correction is requested.
35 USC § 103-based Claim Rejections
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
§ 103. Conditions for patentability; non-obvious subject matter
A patent for a claimed invention may not be obtained, . . . . if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
3. Claims 55-54 are rejected under 35 U.S.C. 103 as being unpatentable over Heinrichs et al.; WO 2009/099906 A2; 13 August 2009.
.The factual inquiries set forth in Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-18, 148 USPQ 459, 467 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:a. Determining the scope and contents of the prior art.b. Ascertaining the differences between the prior art and the claims at issue.c. Resolving the level of ordinary skill in the pertinent art.d. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 55 is drawn to a method of rapidly assaying catalytic efficiency of a plurality of enzyme variants” where the enzyme substrate is in the presence of an inhibitor. First provide a plurality of enzyme variants together with an inhibitor and substrate. Compare two inhibitor concentrations and calculate Michaelis–Menten kinetics for the variants.
The Heinrichs et al. WO publication focuses on, in part, the directed evolution of EPSPS enzymes. (title) Heinrichs et al. teaches two such EPSPS polypeptides, SEQ ID NO:2 and SEQ ID NO:4 (p. 6, l.2). Heinrichs et al. also teaches the variants SEQ ID NO:7 to SEQ ID NO:28 (p. 5, ll. 4-5).
Claim 55 also requires
(d) performing a reaction involving the plurality of enzyme variants and the substrate, with two different inhibitor concentrations;
(e) measuring reaction rate at the two different inhibitor concentrations; and (f) calculating kcal/KM)*KI (Michaelis–Menten kinetics) of the plurality of enzyme variants.
Heinrichs et al. also teaches this. p. 8 (2nd full para.)(see also Example 4, p. 24 et seq.
Heinrichs et al. also teaches
Glyphosate inhibits the enzyme that converts phosphoenolpyruvic acid (PEP) and 3-phosphoshikimic acid (S3P) to 5-enolpyruvyl-3-phosphoshikimic acid. Inhibition of this enzyme (5-enolpyruvylshikimate-3-phosphate synthase; referred to 10 herein as "EPSP synthase", or "EPSPS") kills plant cells by shutting down the shikimate pathway, thereby inhibiting aromatic amino acid biosynthesis.
Id., p. 1, ll. 6-10.
Example 4 also teaches various concentrations of substrate. Id. p. 24. Ll. 14-15.
And inhibitor, glyphosate, one of which is zero. Id., p. 24, l. 12.
It would have been prima facie obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to practice the invention claimed in claims 55-57 in view of the teachings of Heinrichs et al.
Given the level of skill in the art as of the effective filing date of the claimed invention, one of ordinary skill in the art would have had a reasonable expectation of success.
Heinrichs et al. teaches glyphosate concentrations of 0, 1 and 2 mM. (p. 23, l. 22)
Thus claims 55-56 are obvious.
Claim 57 is sufficiently open-ended – “substantially similar” – that is merely a design choice available to an ordinary artisan and thus 57 is obvious.
Claim 62 (PEP/EPSPS/glyphosate as above) is also obvious.
Regarding claim 58, it is axiomatic that two points define a line. Additionally, given the glyphosate concentrations discussed above, and since Heinrichs et al. teaches a linear response (p. 33, l. 22) and thus claim 58 is obvious.
Heinrichs et al.’s Example 7 (pp. 25-26) teaches kinetic analysis and thus claim 61 is obvious.
Given, e.g., the list of percentages bridging pages 5-6 in Heinrichs et al., claim 59 is obvious as a design choice available to an ordinary artisan.
The number of clones / enzyme sequences taught at the beginning of Example 4 (p. 24) claim 60 is obvious.
Again, Heinrichs et al. teaches glyphosate concentrations of 0, 1 and 2 mM. (p. 23, l. 22) where one is zero and thus claim 63 is obvious.
Claim 64 represents a standard experimental design – holding all variables but one constant and varying the remaining variable, and thus claim 64 is obvious as a design choice available to an ordinary artisan.
Conclusion
No claim is allowed.
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/RUSSELL T BOGGS/Examiner, Art Unit 1663