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 .
Status of the Application
Claims 1-23 filed on 1/25/2024 are pending in the application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/15/2025, 1/25/2024,10/4/2024 were filed before the first Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
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 1,8,16 and dependent claims 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.
Claims 1, 8 and 16 recite a system comprising a fermentation tank and a programmed processor to monitor “conversion of plant-based nitrates to nitrites.”
In claim 1,8 and 16, it is not clear whether the system is designed to operate continuously, intermittently or in fed-batch mode. It is generally known that in a continuous process, feed is added and product is removed at a constant rate (see Mears pg. 35 column 1 paragraph 3 in the record).
Further, the claims recite “when nitrites in the source material liquid reaches a desired concentration” with no limit on initial nitrate content in the source liquid, the composition of the source liquid, or a range for “a desired concentration.” The claims recite “cause a first harvest volume of the source material liquid to be harvested at a harvest rate, and cause the source material liquid to be replenished with the source material liquid comprising additional plant -based nitrates at a feed rate, wherein the harvest rate is higher than the feed rate.” Claim 1 provides no limits on the first harvest volume, or feed rate, and “higher” is a relative term. Claim 8 provides a broad range for “higher” and Claim 16 provides indirect limitation for harvest volume based on a broad “at least 30% of the bacterial culture remains in the source liquid.” A continuous operation of the system in claims 8 and 16 is not clearly established. One of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Appropriate correction is required.
Potentially Allowable Subject Matter
The claims are potentially free of the art. However, a definite determination of patentability can be made only after the indefiniteness issues are resolved.
The closest identified prior art is Kerry Group Services International (US20080305213A1) (US2014/0242217A1) , Dziewinski (US6,030,520) , Genomatica, WO2014/089025A1, Chr. Hansen (WO2013/186348A1), Korea Food Research Institute (KR20180031438A), in view of Mears et al. (Journal of Biotechnology 245 (2017) 34-46), all cited in an IDS.
Processes for continuous production of chemical compounds are well established in the art, however, a continuous process for producing nitrites from nitrate containing plant materials by microbial conversion as claimed is not disclosed in the art. Systems for continuous automated operation of bioreactors, comprising fermentation tanks and suitably programmed processors are well known, but have not been used for the continuous production of nitrites from plant-based nitrates.
Kerry discloses the production of the curing agent (abstract) by microbial conversion of nitrate from plant materials to nitrite, but Kerry does not disclose a continuous production system. Specifically, Kerry for example in the ‘213 reference [0018] discloses that when the predetermined level of nitrite is reached, the bacterial culture can be inactivated using methods known to those of ordinary skill in the art such as filter sterilization, heat treatment such as pasteurization, sterilization, or centrifugation. When the predetermined level of nitrite is reached, the organism can be inactivated and remain in the curing agent, or inactivated and removed from the curing agent.
In the present system, when nitrites in the fed source material liquid reach a desired concentration, a first harvest volume of the source material liquid is harvested at a harvest rate and the harvested volume is replenished with the source material liquid feed material comprising additional plant based nitrates at a feed rate wherein the harvest rate is higher than the feed rate. Active bacterial culture remains in the unharvested portion of the source liquid in the fermentation tank, facilitating fermentation after replenishment of source material liquid.
Dziewinski directed to purification of waste streams discloses conversion of nitrates to nitrites using a continuous process in which a metal reactant is employed for conversion of nitrates to nitrites.
Genomatica discloses converting nitrate to nitrite using a continuous process wherein the reduction of nitrate to nitrite is a part of a process directed towards producing biosynthesized chemicals.
Chr. Hansen discloses a continuous feed of nitrates to produce a composition comprising nitrites, in a fermentation process. However, the process has continuous nitrate feed but is processed as a batch.
Korea Food Research discloses a fermentation batch for converting a natural nitrate source onto a nitrite to prepare a food coloring agent.
Mears discloses feed rate as an important factor in optimizing fermentation processes, and that the feed rate which will achieve an optimal point based monitored process conditions and product output, is constantly changing, making any control implementation challenging in fed-batch processes (page 35, column 2, 1.2).
As multiple variables are involved, a system as claimed, to effect efficient production of nitrites from a plant-based source liquid is not disclosed in, or rendered obvious by the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Subbalakshmi Prakash whose telephone number is (571)270-3685. The examiner can normally be reached Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at (571) 272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUBBALAKSHMI PRAKASH/ Primary Examiner, Art Unit 1793
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