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 .
Claim Objections
Claim 11 is objected to because of the following informalities: the claim lacks proper punctuation. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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.
Claim(s) 1-5 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (US 10,364,446) in view of da Silva et al. (Chemical Engineering Research and Design, 2009).
The instant claims are drawn to a process for purifying a fermentation must obtained by a biotechnological process, comprising biomass and vanillin or derivatives thereof, the purification process comprising:
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Zhao et al. teach the production of vanillin from a biotechnological process, specifically from fermentation of a bacterial strain. The vanillin is extracted, i.e., purified by first filtering the fermented medium using a ceramic membrane to remove any biomass present; further treating the filtrate by ultrafiltration (stabilizing step), followed by reverse osmosis (concentration); the concentrate is then adjusted to pH 5-6 and allowed to cool for crystallization (col. 5, lines 6 to 42).
Zhao et al. do not expressly teach liquid-liquid extraction of an aqueous stream comprising vanillin or derivatives thereof; however, da Silva et al. teach that vanillin obtained by a biotechnological process, e.g., oxidation of kraft lignin, can be purified using multiple crystallization steps from water-methanol solutions. The vanillin obtained from lignin oxidation may be dissolved in a solvent mixture of water and alcohol, e.g., 40% methanol in water, followed by stirring and cooling to 23 to 25°C to crystallize the vanillin (page 1285, 3rd paragraph). da Silva et al. also teach that in known methods, vanillin may be extracted from a reaction medium resulting from sulfite lignin oxidation (biomass) by liquid-liquid extraction with suitable solvents (page 1282, sect. 4.3).
In view of the combined reference teachings, it would have been obvious to a person having ordinary skill in the art that liquid-liquid extraction may be used to separate an aqueous stream from an organic stream comprising vanillin or derivatives thereof, as taught by da Silva, prior to purification of the vanillin according to the purification steps taught by Zhao et al., such that any vanillate salts present in the reaction medium are removed prior to vanillin purification.
While the reference(s) does not teach the use of the solvents recited in the instant claims, e.g., methyl ethyl ketone, ethyl acetate, cyclohexane, etc., it would have been obvious to a person having ordinary skill in the art to use any solvent that it known to be capable of dissolving vanillin.
Claim(s) 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. in view of da Silva et al. as applied to claims 1-4 and 11-13 above, and further in view of Gayet et al. (US 10,017,444).
The instant claims further limit the process of the present invention, such that the concentration (step c) of the organic stream and separation of compounds with a higher boiling point than that of vanillin or derivatives thereof (step d), are accomplished using tray or packed distillation columns, falling film or scraped film evaporators, or baffle columns; and, wherein vanillin or derivatives thereof have a color in ethanolic solution at 10% by weight of less than or equal to 150 Hazen. Neither Zhao et al. nor da Silva et al. teach these parameters.
Gayet et al. teach a process for the purification of natural vanillin, wherein the vanillin may be produced by a biotechnological process, including fermentation of a microorganism. Gayet et al. further teach that natural vanillin is typically purified by extraction followed by crystallization. More specifically, the reference teaches that a stream comprising natural vanillin may undergo distillation in order to separate “heavies”, i.e., compounds having a higher boiling point, and “ultralights”, i.e., compounds having a lower boiling point than vanillin. Gayet et al. also teach the desirability of natural vanillin having a color, in ethanolic solution at 10% by weight, of less than or equal to 200 Hazen, preferably less than or equal to 100 Hazen (abstract; col. 2, line 37 to col. 5, line 44). Low color vanillin ensures purity, stability, and aesthetic consistency across a wide range of applications.
In view of the combined reference teachings, it would have been obvious to a person having ordinary skill in the art using the methods for purifying vanillin taught by Zhao et al. and/or da Silva et al., to include a distillation step of the vanillin-containing organic phase, in order to remove “ultralight” or “heavy” by-products, prior to the purification taught by Zhao et al. and/or da Silver et al., and, to provide a vanillin having a low Hazen color value, since, as taught by Gayet et al., vanillin having a color, in ethanolic solution at 10% by weight, of less than or equal to 200 Hazen, preferably less than or equal to 100 Hazen is desirable, as it ensures purity, stability, and aesthetic consistency of the purified vanillin product.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5-11, and 13-18 of copending Application No. 18/550,931 in view of Zhao et al. and da Silva et al. Both sets of claims are drawn to a process for purifying a fermentation must comprising biomass and vanillin via a series of steps. The claims of the ‘931 application do not recite all of the steps recited by the instant claims, e.g., liquid/liquid extraction, concentration, and distillation; however, a person having ordinary skill in the art may look to Zhao et al. and da Silva for teachings of liquid/liquid extraction, concentration, etc., in processes for producing a high purity crystallized vanillin product. Therefore, the instant claims are rendered obvious over the claims of the ‘931 application and the cited references.
This is a provisional nonstatutory double patenting rejection.
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/SIKARL A WITHERSPOON/Primary Examiner, Art Unit 1692