DETAILED ACTION
All objections and rejections raised in prior Office Actions are withdrawn unless restated below.
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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “one or more genes selected from . . . OMT, PPTase, ACAR, EAO, and UGT.” The under lined are not genes but are abbreviation for enzymes: OMT (O-methyltransferase), UDP-glycosyltransferase (UGT), aromatic carboxylic acid reductase (CAR), eugenol alcohol oxidase (EAO), etc. Claim 1 should be corrected to indicate that the genes encode the recited enzymes and the full name of the enzyme (not just an abbreviation) should be recited.
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.
Claims 1, 4-7, 14, 15 and 17-23 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.
“New or amended claims which introduce elements or limitations that are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (an adequate description of a genus may not support claims to a subgenus or species within the genus)”; MPEP 2163(I)(B). “While there is no in haec verba requirement, newly added claims or claim limitations must be supported in the specification through express, implicit, or inherent disclosure.” MPEP 2163(I)(B).
“With respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims. See, e.g., Hyatt v. Dudas, 492 F.3d 1365, 1370, n.4 (Fed. Cir. 2007) (citing MPEP § 2163.04 which provides that a "simple statement such as ‘applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the claim limitation ‘___’ in the application as filed’ may be sufficient where the claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported."); see also MPEP §§ 714.02 and 2163.06 ("Applicant should ... specifically point out the support for any amendments made to the disclosure."); and MPEP § 2163.04.” MPEP 2163(II)(A).
In amendment dated 12/17/2025, independent claim 1 was amended to recite “about 15 to about 50 mg/L p-aminobenozic acid.” Applicant states:
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Applicant does not state specifically how the newly recited range of “about 15 to about 50 mg/L p-aminobenozic acid” is supported. However, it is noted that:
Original claims 2, 8, 9, 13 and 16 have no mention of a value of 15 mg/L p-aminobenozic acid. Only original claim 2 has any mention of a concentration range for p-aminobenzoic acid.
Paragraph [0059] of the specification has no mention of value of about 15 mg/L p-aminobenozic acid.
“The failure to meet the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, commonly arises when the claims are changed after filing to either broaden or narrow the breadth of the claim limitations, or to alter a numerical range limitation or to use claim language which is not synonymous with the terminology used in the original disclosure.” MPEP 2163.05. “With respect to changing numerical range limitations, the analysis must take into account which ranges one skilled in the art would consider inherently supported by the discussion in the original disclosure. In the decision in In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), the ranges described in the original specification included a range of "25%- 60%" and specific examples of "36%" and "50%." A corresponding new claim limitation to "at least 35%" did not meet the description requirement because the phrase "at least" had no upper limit and caused the claim to read literally on embodiments outside the "25% to 60%" range, however a limitation to "between 35% and 60%" did meet the description requirement.” MPEP 2163.05(III).
Paragraph [0059] of the specification (nor any other part of the specification) does not describe a value of 15 mg/L for concentration of p-aminobenzoic acid. As such, there is no basis for one skilled in the art to consider any range of p-aminobutyric acid define with a limit of 15 mg/L to be inherently nor explicitly supported by the as-filed specification. Applicant has not pointed out where the amended claim limitation is supported, nor does there appear to be a written description of the claim limitation “about 15 to about 50 mg/L p-aminobenozic acid” in the application and support for the limitation is not apparent.
Allowable Subject Matter
Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
As discussed in the rejections under 35 USC 103 in the prior Office Action, Sunrise Science Products teaches an SC medium for culturing of S. cerevisiae with 8.6 mg/L p-aminobenzoic acid.
“Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP 2144.05(II)(A).
The prior art of record does not suggest that the concentration of p-aminobenzoic acid requires optimization, or in the alternative recited concentrations of 15 or 24 mg/L p-aminobenzoic acid is above concentrations that would routinely be explored by a skilled artisan within the scope of routine optimization. Both vanillin and p-aminobenzoic acids are products of the shikimate pathway; however, p-aminobenzoic acid is not understood to be an intermediate to vanillin. See Averesch et al. (Production of para‑aminobenzoic acid from different carbon‑sources in engineered Saccharomyces cerevisiae, Microb. Cell Fact. 15, 2016, 89), Fig. 1, for synthesis pathway for p-aminobutyric acid.
Culturing in S. cerevisiae in the presence of high amounts of p-aminobutyric acid is known in the prior art. Gientka et al. (p-Aminobenzoic acid (PABA) changes folate content in cell biomass of Saccharomyces cerevisiae, Polish J. Food Nutrition Sci. 60, 2010, 13-17) explores the ability of p-aminobutyric acid to increase folic acid production of S. cerevisiae with particularly high concentrations of p-aminobutyric acid reported in Table 1. However, there is no clear connection to affecting folate production and motivation to optimize p-aminobutyric acid concentration in a fermentation containing a yeast cell specific for vanillin or glucovanillin.
It is noted that yeasts are often cultured in undefined or rich media wherein the p-aminobenzoic acid concentration thereof is not openly discussed in the prior art and the concentration of p-aminobenzoic acid in such media can only be speculated. However, Stokes et al. (J. Bacteriology 47, 1944: 293-9) as discussed in the prior Office Action indicates that yeast extract as common used to make rich media is unlikely to provide more than 15 or 24 mg/L of p-aminobenzoic acid to a rich media.
It is noted that the above further applies to any potential non-statutory double patenting rejection.
Response to arguments
Applicant’s arguments are noted. However, the rejections above are necessitated by applicant’s amendment.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD M EPSTEIN whose telephone number is (571)272-5141. The examiner can normally be reached Mon-Fri 9:00a-5:30p.
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/TODD M EPSTEIN/Primary Examiner, Art Unit 1652