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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/21/2025 has been entered.
Election/Restrictions
Applicant’s previous election of Group I (i.e., claims 1, 9, 18, 22, 24, 32, 53, 55, 57, 115, and 124, 126 and 128-131, drawn to methods of culturing anaerobic bacteria comprising culturing the anaerobic bacteria in a bioreactor under an anaerobic atmosphere comprising greater than 1% CO2) in the reply filed on 08/01/2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election was treated as an election without traverse (MPEP § 818.01(a)).
Claims 75, 84, 106 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Election was made without traverse in the reply filed on 08/01/2024.
Amendments Received
Amendments to the claims were received and entered on October 21, 2025.
Status of Claims
Claims 123, 125, and 127 have been cancelled; claims 129-131 are newly added.
Claims 1, 9, 18, 22, 24, 32, 53, 55, 57, 75, 84, 106, 115, and 124, 126 and 128-131 are currently pending.
Claims 1, 9, 18, 22, 24, 32, 53, 55, 57, 115, and 124, 126 and 128-131 are under consideration, as claims 75, 84, and 106 are withdrawn.
Priority
The present application claims status as a 371 (National Stage) of PCT/US20/33927 filed on 05/21/2020. Acknowledgment is made of applicant’s claim for benefit under 35 U.S.C. 119(e) of Provisional application No. 62/952,798, filed on 12/23/2019 and Provisional application No. 62/850,726, filed on 05/21/2019. The present application and all claims are being examined with an effective filing date of 05/21/2019. In future actions, the effective filing date may change due to amendments or further review of priority documents.
Withdrawn Rejections
In view of Applicant’s cancellation of claims 123, 125, and 127, all rejections of claims 123, 125, and 127 are hereby withdrawn.
Maintained/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 1, 9, 18, 22, 24, 53, 115, and 129-131 are rejected under 35 U.S.C. 103 as being unpatentable over Makoto, K. (EP0120111, cited in the IDS), Vuillermin et al. (WO2018112553 A1, cited in a previous office action), and Downes et al. (Prevotella histicola sp. nov., isolated from the human oral cavity, International Journal of Systematic and Evolutionary Microbiology (2008), 58, 1788–1791, cited in PTO-892), as evidenced by Reilly, S. (The Carbon Dioxide Requirements of Anaerobic Bacteria, Microbiol Society, Vol 13, Iss 4, Nov 1980, Abstract only, cited in PTO-892) and Shah and Collins (Prevotella, a New Genus To Include Bacteroides melaninogenicus and Related Species Formerly Classified in the Genus Bacteroides, INTERNATIONAL JOURNAL OF SYSTEMATIC BACTERIOLOGY, Apr. 1990, p. 205-208, cited in PTO-892).
Regarding claims 1, 9, 115, and 129-131, Makato teaches a process for culturing anaerobic bacteria wherein an agent enclosed in a gas-permeable inner bag is put in an airtightly closed culture vessel, wherein said agent is put in an amount sufficient to bring the interior atmosphere in the culture vessel to a substantially oxygen-free state, the resultant state being maintained at the carbon dioxide concentration of 10 + 2 % by volume (claims 1-2). With respect to the anaerobic bacteria, Makato discloses observations of growth in the conditions described above using 30 strains from Bacteroides, Fusobacterium, Clostridium, Propionibacterium, Lactobacillus, Peptococcus, Peptostreptococcus, and Veillonella (Specification, pg. 12, Example 1). In a comparative test where cultivation was carried out in an atmosphere of 20% carbon dioxide, Makato teaches that “most of strains could not be detected because of their poor growth” (pg. 12, Comparative test 2). By the recitation of “most of strains”, and not all, Makato suggests that at least one strain could be detected in 20% carbon dioxide. It is noted that at the time of publication (1983), the genus Prevotella had not yet been formally described. As evidenced by Shah and Collins in 1990, numerous moderately saccharolytic oral Bacteroides species—including Bacteroides melaninogenicus and related organisms—were subsequently reclassified into the newly established genus Prevotella (Abstract). Therefore, Bacteroides melaninogenicus and Prevotella melaninogenica may be used interchangeably and understood as referring to the same microorganism. Accordingly, Makoto’s disclosure of Bacteroides strains reasonably encompasses microorganisms that would today be recognized as members of Prevotella Makoto therefore provides relevant evidence regarding anaerobic atmospheric conditions and CO₂ tolerance among organisms belonging to, or related to, Prevotella. However, Makoto does not specify the identity of the strain that exhibited detectable growth at 20% CO₂ and thus does not expressly teach Prevotella histicola, nor does it teach culturing P. histicola at CO₂ concentrations of 25% or greater.
Vuillermin et al. teaches the successful culturing of another member of the genus Prevotella, Prevotella copri, in a 100% CO₂ atmosphere at 37°C under anaerobic conditions (pg. 29, lines 24-28 and pg. 30, lines 14-16). Vuillermin et al. therefore demonstrates that Prevotella species are capable of growth across a very broad CO₂ range—from at least 10% to 100%—and provides motivation to adjust or optimize CO₂ concentration when culturing Prevotella microorganisms to improve growth characteristics.
Downes et al. teaches the isolation, characterization, and culturing of Prevotella histicola. Downes et al. discloses that strains, including the type strain P. histicola T05-04, were grown at 37°C on fastidious anaerobe agar supplemented with horse blood under an atmosphere composed of 80% N₂, 10% H₂, and 10% CO₂, and that broth cultures of P. histicola were incubated for 18 hours (pg. 1788). Downes et al. therefore discloses explicit species-level support that P. histicola is successfully cultured under CO₂-supplemented anaerobic conditions.
As further evidenced by Reilly, the organism identified at the time (1980) as Bacteroides melaninogenicus—now recognized as Prevotella melaninogenica, per Shah and Collins, exhibits optimal growth at CO₂ concentrations ranging from 10% to 40%. Importantly, Downes et al. identifies P. melaninogenica as one of two of the closest known phylogenetic relatives of P. histicola (Abstract). Accordingly, the CO₂ requirements reported by Reilly for P. melaninogenica provide strong evidence that moderately elevated CO₂ concentrations (e.g., 10%–40%) are expected to be compatible with, and potentially beneficial for, the growth of P. histicola. This evidentiary relationship supports that atmospheric CO₂ concentration is a result-effective variable for organisms within the Prevotella lineage and that P. histicola would be expected to grow successfully at CO₂ concentrations falling within this known workable range, which encompasses the claimed 25% CO₂.
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to combine prior art reference teachings to arrive at the claimed invention. Before the effective filing date of the claimed invention, , the teachings of Makoto, a method of culturing anaerobic bacteria under CO₂-supplemented anaerobic conditions—together with the teachings of Vuillermin et al. that the Prevotella species P. copri can be successfully cultured in a 100% CO₂ atmosphere, the species-specific teachings of Downes et al. that P. histicola itself is cultured under 10% CO₂ at 37°C, and the evidentiary disclosure of Reilly establishing that the most closely related species to P. histicola (P. melaninogenica) exhibits optimal growth at CO₂ concentrations of 10% to 40%, would have led a person of ordinary skill in the art to adjust or optimize the CO₂ concentration to at least 25% when culturing Prevotella histicola. There is a reasonable expectation of success in doing so because Reilly explicitly teaches that the closest known relative of P. histicola grows optimally within the very CO₂ range that encompasses the claimed 25%, and other species within Prevotella (e.g., P. copri) have demonstrated the ability to grow under a broad CO₂ range above 25%. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claims 18 and 22, Makoto teaches that “the cultivation proceeds in an atmosphere containing not exceeding 0.1 % by volume (% refers to % by volume hereinafter) of oxygen and 10 + 2 % of carbon dioxide during 24 - 48 hours at shortest after inoculation…” (pg. 4, last para). As indicated above, Downes et al. explicitly teaches inoculation of P. histicola into broth cultures incubated for 18 hours and Vuillermin et al. additionally teaches inoculating media to culture Prevotella copri (pg. 30, lines 24–28). Pursuant to MPEP 2144.05, where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Additionally, the combined teachings demonstrate that inoculation prior to cultivation is a standard and inherent step in anaerobic bacterial culture, and thus it would have been prima facie obvious to perform the inoculation step before culturing P. histicola at the claimed CO₂ level.
Regarding claim 24, Makoto teaches the successful inoculation and culturing of several anaerobic bacterial strains, on GAM agar, in the method described above (pg. 12, Example 1). As indicated above, Downes et al. teaches inoculating several Prevotella strains, including P. histicola, on fastidious anaerobe agar supplemented with 5 % horse blood, as well as peptone/yeast/glucose broth (pg. 1788, right column). Vuillermin et al. teaches the successful inoculation of P. copri using 0.5 g of a fecal sample diluted in buffer to 50ml on medium comprising glucose and other nutrients required for growth, and subculture on Eggerth Gagnon agar supplemented with horse blood (pg. 30, lines 28-33 and pg. 31, lines 1-3). While specific volumes of bacteria and/or media are not disclosed, 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. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. "[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. It would have been customary for an artisan of ordinary skill to determine the optimal concentration of cultured bacteria in a growth medium to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the cultured bacteria in growth media would have been obvious at the time of applicant's invention. Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention, because the combined teachings of the prior art are fairly suggestive of the claimed invention.
Regarding claim 53, as described above, Makoto teaches culturing anaerobic bacteria, including Bacteroides/Prevotella at a temperature of 37°C. Also described above, Vuillermin et al. teaches culturing P. copri at a temperature of 37°C and Downes et al. explicitly teaches culturing P. histicola at 37°C.
Thus, claims 1, 9, 18, 22, 24, 53, 115, and 129-131 are rejected under 35 U.S.C. 103 over Makato, Vuillermin et al. and Downes et al., as evidenced by Reilly and Shah & Collins.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Makoto, Vuillermin et al., and Downes et al., as applied to claims 9 and 18 above, further in view of Kim et al. (US20220154133A1, cited in a previous office action), Zigha et al. (US20150004664A1, cited in a previous office action), and Formanek et al. (Enhanced Butanol Production by Clostridium beijerinckii BA101Grown in Semidefined P2 Medium Containing 6 Percent Maltodextrin or Glucose, APPLIED AND ENVIRONMENTAL MICROBIOLOGY, June 1997, p. 2306–2310, cited in a previous office action), as evidenced by HyServe (GAM Agar, product brochure, date unknown, cited in a previous office action).
The combined teachings of Makato, Vuillermin et al. and Downes et al. as they apply to claims 9 and 18 have already been discussed above. Briefly, Makoto teaches a process for culturing anaerobic bacteria, including Bacteroides, which also encompassed Prevotella at the time, at a carbon dioxide concentration of 10 + 2 % by volume, for 24 - 48 hours after inoculation, with at least one (unknown) strain growing at a carbon dioxide concentration of 20%. Vuillermin et al. teaches media for inoculating and growing Prevotella copri, further teaching that P. copri can be cultured in 100% carbon dioxide;. Downes et al. teaches culturing P. histicola at a concentration of 10% carbon dioxide. As evidenced by Reilly, Bacteroides melaninogenicus—now recognized as Prevotella melaninogenica, per Shah and Collins, exhibits optimal growth at CO₂ concentrations ranging from 10% to 40%, thereby leading a person of ordinary skill in the art to optimize the carbon dioxide concentration during the culture and growth of P. histicola.
Regarding the growth media components recited in the instant claim, Makato specifically teaches culturing bacteria on GAM agar, and as evidenced by HyServe, GAM agar comprises soy peptone, yeast extract, and L-cysteine hydrochloride (see GAM Agar brochure, “Formula”). Vuillermin et al. teaches culturing Prevotella copri on media comprising glucose and hemoglobin (from horse blood). Downes et al. also teaches culturing P. histicola on fastidious agar supplemented with horse blood. However, neither Downes et al., Makato, nor Vuillermin et al. teach wherein the growth media comprises soy peptone A2SC, soy peptone E110, dipotassium phosphate, monophosphate potassium, ammonium chloride, and maltodextrin.
Zigha et al. teach a process for producing n-butanol by culturing a Clostridium species in “an appropriate culture medium” (Specification, para 0007). An “appropriate culture medium”, as taught by Zigha et al., comprises nitrogen sources such as ammonium chloride, and phosphate sources, such as dipotassium phosphate and monopotassium phosphate (Specification, para 0038).
Kim et al. teach a medium composition for culturing the anaerobe Clostridium botulinum comprising soy peptone A2SC and soy peptone E110 (Specification, Example 1, para 0040, 0049-0051).
Formanek et al. teach the fermentation of the anaerobe Clostridium beijerinckii in medium containing 6% maltodextrin as the carbon source (Abstract). As shown by the increase in optical density, Formanek et al. teach that C. beijerinckii is successfully grown in medium comprising maltodextrin (pg. 2308, Fig. 2, bottom left graph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine these known media components—carbon sources (glucose, maltodextrin), nitrogen sources (peptones, ammonium chloride), reducing agents (L-cysteine), phosphate buffers, and hemoglobin—to create an enriched growth medium suitable for fastidious anaerobes such as P. histicola. Such combinations represent routine media optimization familiar in the anaerobic culture arts and would have been expected to succeed, because they are components known to provide benefit and result in the successful growth of a variety of anaerobic bacteria, as demonstrated by the prior art. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Thus, claim 32 is rejected under 35 U.S.C. 103 over Makato, Vuillermin et al. and Downes et al., further in view of Kim et al., Zigha et al. and Formanek et al., as evidenced by HyServe.
Claims 55 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Makoto, K., Vuillermin et al., and Downes et al., as applied to claim 9 above, and further in view of Pybus, V. and Onderdonk, A.B. (The Effect of pH on Growth and Succinate Production by Prevotella bivia, Microbial Ecology in Health and Disease, 9:1, 19-25, herein “Pybus”, cited in PTO-892).
The combined teachings of Makato, Vuillermin et al., and Downes et al. as they apply to claim 9 have already been discussed above. Briefly, Makoto teaches a process for culturing anaerobic bacteria, including Bacteroides, which also encompassed Prevotella at the time, at a carbon dioxide concentration of 10 + 2 % by volume, for 24 - 48 hours after inoculation, with at least one (unknown) strain growing at a carbon dioxide concentration of 20%. Vuillermin et al. teaches media for inoculating and growing Prevotella copri, further teaching that P. copri can be cultured in 100% carbon dioxide;. Downes et al. teaches culturing P. histicola at a concentration of 10% carbon dioxide. As evidenced by Reilly, Bacteroides melaninogenicus—now recognized as Prevotella melaninogenica, per Shah and Collins, exhibits optimal growth at CO₂ concentrations ranging from 10% to 40%, thereby leading a person of ordinary skill in the art to optimize the carbon dioxide concentration during the culture and growth of P. histicola. Neither Makato, Vuillermin et al., nor Downes et al. explicitly disclose culture conditions comprising a pH of 5.5 to 7.5, and wherein the culturing comprises agitating at an RPM of 50 to 300.
Regarding claim 55, Pybus teaches suitable pH conditions for culturing a Prevotella species. Specifically, Pybus discloses culturing P. bivia in continuous culture at pH 6.0, and further examines bacterial growth at pH 4.5-5.5 (pg. 20-21, Materials and Methods). Pybus additionally reports that cultures maintained at pH 6.0 exhibit stable viable counts throughout the experiment. It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01). Adjusting pH within a known workable range for anaerobic bacterial culture is routine optimization and obvious to persons of ordinary skill in the art.
Regarding claim 57, Pybus teaches culturing P. bivia under anaerobic conditions with agitation at 200 rpm (pg. 20, Materials and Methods), which falls within the claimed range (see MPEP 2144.05.01). Optimizing agitation to maintain mixing, gas transfer, and dispersion in anaerobic cultures is routine, and adjusting RPM within the broad 50–300 RPM range would have been obvious to persons of ordinary skill in the art.
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to combine prior art reference teachings to arrive at the claimed invention. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the pH of media for culturing P. histicola to 5.5. or 6 and agitate (i.e., stir) the culture at a speed of 200 rpm, in view of Pybus’ teachings. Given that pH and agitation speed are common parameters that are routinely optimized when culturing bacteria, and given that Pybus demonstrates a successful method of culturing a Prevotella species at a pH of 5.5-6.0 and stirring speed of 200 rpm, said practitioner would have readily predicted that the combination of teachings would successfully result in a method of culturing anaerobic bacteria, with a reasonable expectation of success. Furthermore, pursuant to MPEP 2144.05 II., it is not inventive to discover the optimum or workable ranges by routine experimentation. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Thus, claims 55 and 57 are rejected under 35 U.S.C. 103 over Makato, Vuillermin et al. and Downes et al., further in view of Pybus.
Claims 124, 126, and 128 are rejected under 35 U.S.C. 103 as being unpatentable over Makoto, Vuillermin et al. and Downes et al., as applied to claims 1, 9 and 115 above, further in view of Mettler Toledo (In-line Control of CO2 Accumulation for Improved Cell Culture Processes, White Paper, Mettler Toledo Group, Process Analytics, author unknown, 2017, cited in a previous office action).
The combined teachings of Makato, Vuillermin et al., and Downes et al. as they apply to claim 9 have already been discussed above. Briefly, Makoto teaches a process for culturing anaerobic bacteria, including Bacteroides, which also encompassed Prevotella at the time, at a carbon dioxide concentration of 10 + 2 % by volume, for 24 - 48 hours after inoculation, with at least one (unknown) strain growing at a carbon dioxide concentration of 20%. Vuillermin et al. teaches media for inoculating and growing Prevotella copri, further teaching that P. copri can be cultured in 100% carbon dioxide;. Downes et al. teaches culturing P. histicola at a concentration of 10% carbon dioxide. As evidenced by Reilly, Bacteroides melaninogenicus—now recognized as Prevotella melaninogenica, per Shah and Collins, exhibits optimal growth at CO₂ concentrations ranging from 10% to 40%, thereby leading a person of ordinary skill in the art to optimize the carbon dioxide concentration during the culture and growth of P. histicola. Neither Makato, Vuillermin et al. nor Downes et al. teach how the disclosed level of carbon dioxide is maintained (e.g., sparging).
Mettler Toledo teaches common ways to increase and decrease carbon dioxide in bioreactors, which include sparging (e.g., CO2 sparge to increase CO2; and air, O2 or N2 sparge to decrease CO2) (pg. 3, Table 2). Specifically, with respect to increasing carbon dioxide levels during culture, Mettler Toledo teaches “dCO2 should be kept within the required range throughout culturing. Low dCO2 can be elevated by CO2 sparging or via a supplemental feed” (pg. 2, right column).
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to combine prior art reference teachings to arrive at the claimed invention. Before the effective filing date of the claimed invention, the teachings of Mettler Toledo, that sparging is a commonly used and effective way to control carbon dioxide levels, would have led said practitioner to use sparging strategies to optimize and maintain the carbon dioxide levels when culturing P. histicola in the method taught by Makato. Given that Mettler Toledo teaches that CO2 sparging increases CO2 levels and air/O2/N2 sparging decreases CO2 levels, said practitioner would have a reasonable expectation of success that the combination of teachings would successfully result in a method for culturing Prevotella in an atmosphere having at least 25% CO2, maintained by sparging. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Thus, claims 124, 126, and 128 are rejected under 35 U.S.C. 103 over Makato, Vuillermin et al. and Downes et al., further in view of Mettler Toledo.
Response to Arguments for Rejections under 35 USC § 103
In the response filed on 10/21/025, Applicant argues that the cited references do not teach culturing Prevotella histicola under at least 25% CO₂, that the references allegedly teach away from such concentrations, and that the data of record demonstrate unexpected results. With respect to the argument that none of the cited references teach P. histicola, it is noted that the rejections above have been modified, as necessitated by amendment, to consider and address the added limitation requiring the anaerobic bacteria to comprise Prevotella histicola. As set forth in the updated rejections, Downes et al. expressly isolate and culture P. histicola at 10% CO₂, and the combination with Reilly and Shah & Collins establishes that the closest phylogenetic relatives of P. histicola exhibit optimal growth in 10–40% CO₂. Accordingly, the updated rejections now expressly incorporate the required species-level limitation.
With respect to applicant’s assertion that Makoto “teaches away” because most strains grew poorly at 20% CO₂, this argument is not persuasive. As noted in the rejection, Makoto discloses that most strains could not be detected at 20% CO₂, which necessarily implies that at least one strain did exhibit detectable growth. Makoto also includes Bacteroides among the strains evaluated, and as evidenced by Shah and Collins, Bacteroides, at that time, encompassed organisms now classified as Prevotella. Thus, Makoto cannot be considered to teach away from the claimed CO₂ range, as it allows for the possibility that Prevotella (e.g., P. histicola) may have grown at 20% CO₂. Moreover, Makoto’s experiment was directed to general anaerobes and does not counter the combined teachings of Vuillermin et al. (showing successful growth of Prevotella at 100% CO₂) and Reilly (showing optimal growth of the species most closely related to P. histicola at 10–40% CO₂, which consequently was, at the time, Bacteroides, later classified as Prevotella).
Regarding applicant’s allegations of unexpected results, the disclosed data does not provide a comparison to the closest prior art, namely Downes et al.’s culture of P. histicola at 10% CO₂, and therefore does not demonstrate any improvement over the most relevant baseline. The observed increase in growth at 25% CO₂ represents a predictable dose-dependent response, consistent with Reilly’s disclosure that the closest relative of P. histicola grows optimally within 10–40% CO₂. The decreased growth observed at 100% CO₂ is likewise expected, as excessively high CO₂ levels are known to reduce anaerobic growth. Accordingly, the data does not demonstrate unexpected results sufficient to overcome the prima facie case of obviousness.
Applicant’s arguments have been considered in full and have not been found to be persuasive, and do not overcome the rejections, which are therefore maintained.
Conclusion
No claim is in condition for allowance.
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/NAGHMEH NINA MOAZZAMI/Examiner, Art Unit 1652
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652