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 .
Amendments Received
Amendments to the claims were received and entered on January 26, 2026.
Status of Claims
Claims 4-13 and 15-24 are currently pending.
Claims 4-5, 7-8, 11-13, 16-20, and 23-24 are under consideration as claims 6, 9-10, 15, and 21-22 are withdrawn.
Priority
The present application claims status as a 371 (National Stage) of PCT/EP2020/072142 filed on September 15, 2022 and claims priority to EP applications no. EP20169622.6 filed on April 15, 2020 and no. EP19190970.4 filed on August 9, 2019. Acknowledgment is made of applicant' s claim for foreign priority and papers submitted under 35 U.S.C. 119 (a)-(d). The present application and all claims are being examined with an effective filing date of August 9, 2019. In future actions, the effective filing date may change due to amendments or further review of priority documents.
Withdrawn Objections
In view of Applicant’s amendments, the objection to claim 13 is hereby withdrawn.
Withdrawn Rejections
In view of Applicant’s amendments, rejections of claims 4-5, 7, 11-12, 16-20 and 23-24 under 35 USC § 103 over Sasaki et al. and Adesogan et al. are hereby withdrawn.
In view of Applicant’s amendments, rejections of claims 8 and 13 under 35 USC § 103 over Sasaki et al. and Adesogan et al., further in view of Teo et al., are hereby withdrawn.
Modified Rejections Necessitated by Amendment
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4-5, 7-8, 11-13, 16-20 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Teo et al. (Inhibition of Clostridium perfringens by a Novel Strain of Bacillus subtilis Isolated from the Gastrointestinal Tracts of Healthy Chickens. Appl Environ Microbiol 71:8 (2005) p. 4185-4190, cited in a previous office action), Sasaki et al. (Acceleration of cellulose degradation and shift of product via methanogenic co-culture of a cellulolytic bacterium with a hydrogenotrophic methanogen, Journal of Bioscience and Bioengineering, Vol 114, Issue 4, Oct 2012, pg. 435-439, cited in a previous office action) and Adesogan et al. (A novel, wireless, automated system for measuring fermentation gas production kinetics of feeds and its application to feed characterization. Animal Feed Science and Technology 123–124 (2005), pg. 211–223, cited in a previous office action), as evidenced by Monteiro et al. (In Vitro Antimicrobial Activity and Probiotic Potential of Bifidobacterium and Lactobacillus against Species of Clostridium, Nutrients. 2019 Feb 21;11(2):448, cited in PTO-892).
It is noted that the subject matter of claim 19 is identical to the subject matter of claims 16-18, sharing the same limitations, and have therefore been grouped together below.
Regarding claims 16-19, Teo et al. teaches that a Bacillus subtilis strain, generally not known to be gas-producing, exhibits inhibitory activity against pathogenic Clostridium strains, including Clostridium perfringens, a well-known gas producing strain. Teo et al. further teaches cultivating the Bacillus subtilis strain and Clostridium perfringens together on a common culture medium in antagonism assays to evaluate the inhibitory effect of Bacillus subtilis on Clostridium perfringens (Abstract, pg. 4186-4187, and Table 1). Thus, Teo et al. teaches cultivating a first bacterial strain (that produces no or only negligible volumes of gas) with a second gas-producing bacterial strain and determining the inhibitory effect of the first strain on the second strain. However, Teo et al. does not teach cultivating the strains within a closed gas-impermeable culture system, measuring gas pressure produced during cultivation using an automated measuring device, comparing gas pressure produced by the co-culture to gas pressure produced by the second bacterial strain alone, or calculating a percentage of inhibition based upon gas production measurements.
Sasaki et al. teaches a method comprising cultivating microorganisms within a closed culture system, including both a co-culture and a corresponding monoculture control. Specifically, Sasaki et al. teaches cultivating Clostridium clariflavum strain CL1 together with Methanothermobacter thermautotrophicus and additionally cultivating the Clostridium clariflavum strain alone as a monoculture control. Sasaki et al. further teaches measuring gases produced under the co-culture and monoculture conditions and comparing the gas production results between the two culture systems (see Abstract, Fig. 1 showing sealed bottles fitted with tubing to a gas bag, and pg. 436, “analytical procedures”, noting that gases were collected in gas bags). Accordingly, Sasaki et al. teaches measuring gas production from a co-culture and comparing the measured gas production to gas production from a culture of one of the microorganisms alone. Sasaki et al. also teaches that both the co-culture and monoculture were incubated for the same period of time (60 hours) prior to comparison of the measured gas production. Therefore, Sasaki et al. teaches comparing cumulative gas production generated over equal periods of time.
Adesogan et al. teaches an automated method of measuring fermentation gas production using pressure sensors that intermittently monitor pressure within closed culture vessels and relay the measurements to a server for collection and analysis (pg. 213). Adesogan et al. further teaches that the culture vessels are maintained airtight during monitoring and that software may be used to analyze gas-production data, including cumulative gas production over time. Adesogan et al. teaches the use of software to perform analysis of gas-production measurements, including determination of cumulative gas production over time (pg. 215). Accordingly, Adesogan et al. teaches measuring gas pressure produced during cultivation using an automated measuring device and performing calculations based upon the collected gas-production data. It would have been obvious to a person of ordinary skill in the art to calculate a percentage of inhibition from the measured gas-production values because such calculation merely represents routine mathematical analysis of the collected experimental data in order to quantify the degree of inhibition exhibited by the first bacterial strain.
Furthermore, it was known in the art to evaluate inhibitory effects of probiotic microorganisms upon Clostridium species by assessing inhibition of gas production, as evidenced by Monteiro et al. Specifically, Monteiro et al. teaches evaluating antimicrobial activity of probiotic strains against Clostridium species using inhibition of gas production as an indicator of inhibitory activity (Abstract and pg. 3 “Inhibition of Gas production”). Thus, a person of ordinary skill in the art would have recognized gas production as a useful and informative parameter for assessing the effect of one microorganism upon another and would have been motivated to evaluate the effect of the Bacillus subtilis/Clostridium perfringens interaction taught by Teo et al. on gas production using the gas-monitoring systems taught by Sasaki et al. and Adesogan et al.
Before the effective filing date of the claimed invention, given Teo et al.’s demonstration that Bacillus subtilis inhibits Clostridium perfringens and alters the metabolic activity of the Clostridium strain, a person of ordinary skill in the art would have been motivated to further quantify the effect of such inhibition. Sasaki et al. teaches a comparative methodology in which gas production from a co-culture is measured and compared with gas production from a monoculture control, thereby providing a means for evaluating the effect of one microorganism upon another. Because gas production constitutes a measurable indicator of microbial metabolic activity, a person of ordinary skill in the art would have found it obvious to apply the comparative co-culture and gas-production methodology of Sasaki et al. to the inhibitory Bacillus subtilis/Clostridium perfringens interaction taught by Teo et al. in order to quantify the effect of inhibition on microbial activity, including gas production. Furthermore, in view of Adesogan et al.’s teachings of an automated system for measuring fermentation gas production in closed culture vessels, a person of ordinary skill in the art would have been motivated to incorporate Adesogan et al.’s automated pressure-monitoring system into the method made obvious by Teo et al. and Sasaki et al., to facilitate more accurate, efficient, and comprehensive collection and analysis of gas-production data, with a reasonable expectation of success. Therefore, the invention as a whole would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 4, Sasaki et al. teaches cultivating strains in sealed culture bottles connected to gas bags that prevent external gas exchange (Fig. 1). Sasaki et al. explicitly teaches an anaerobic culture system, i.e., “the head space in the serum vial was replaced with anaerobic and axenic N2-CO2 (80:20) gas” (pg. 436, “media”). Therefore, Sasaki et al. teaches that the closed gas-impermeable culture system is an anaerobic culture system.
Regarding claims 5, 7-8, and 20, as indicated above, the “at least one first bacterial or yeast strain” is one bacterial strain and of the genus Bacillus.
Regarding claims 11-13, 23-24, as indicated above, the “second gas-producing bacterial or yeast strain” is a bacterial strain of the genus Clostridium, specifically C. perfringens.
Response to Arguments for Prior Art Rejections
In the response filed on 12/10/2025, Applicant argued, inter alia, that the rejection failed to satisfy the recited limitation requiring a first bacterial or yeast strain and further failed to satisfy the limitation requiring a first strain that produces no or only negligible volumes of gas. Applicant additionally argued that one of ordinary skill in the art would not have been motivated to modify the teachings of Sasaki et al. in the manner proposed by the Office. Applicant’s arguments have been considered, and the rejections set forth in the previous Office action have been withdrawn. The present rejection has been modified in view of Applicant’s amendment requiring a first bacterial or yeast strain that produces no or only negligible volumes of gas and further relies upon Teo et al. for teaching an inhibitory Bacillus subtilis/Clostridium perfringens interaction. The present rejection no longer relies upon Methanothermobacter thermautotrophicus as the claimed first bacterial or yeast strain and does not rely upon substitution of Bacillus subtilis into the methanogenic co-culture system of Sasaki et al. Accordingly, Applicant’s arguments directed to the previous rejection are not persuasive with respect to the rejection presently of record.
Applicant’s arguments regarding the relative simplicity of Sasaki et al. compared to Adesogan et al. have also been considered but are not persuasive with respect to the rejection presently of record. The current rejection does not rely upon modifying Sasaki et al. for the purpose of improving the methanogenic co-culture system disclosed therein. Rather, Teo et al. provides the motivation to investigate the inhibitory interaction between Bacillus subtilis and Clostridium perfringens, while Sasaki et al. and Adesogan et al. provide known systems for measuring and evaluating gas production in microbial cultures. The fact that Adesogan et al. utilizes a more automated measurement system does not outweigh the recognized benefit of obtaining automated gas-production data when evaluating microbial interactions affecting gas production.
Conclusion
No claim is in condition for allowance.
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 NAGHMEH NINA MOAZZAMI whose telephone number is (703)756-4770. The examiner can normally be reached Monday-Friday, 9:00-5:00.
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, Robert Mondesi can be reached at 408-918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NAGHMEH NINA MOAZZAMI/ Examiner, Art Unit 1652
/ROBERT B MONDESI/ Supervisory Patent Examiner, Art Unit 1652
Prosecution Insights