MARA RENEWABLES CORPORATIONDownload PDFPatent Trials and Appeals BoardOct 25, 20212021000179 (P.T.A.B. Oct. 25, 2021) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 15/079,735 03/24/2016 Laura Purdue 095523-0972126-011US1 8898 23370 7590 10/25/2021 Kilpatrick Townsend & Stockton LLP - East Coast MAILSTOP: IP DOCKETING - 22 1100 PEACHTREE STREET SUITE 2800 ATLANTA, GA 30309 EXAMINER AFREMOVA, VERA ART UNIT PAPER NUMBER 1653 NOTIFICATION DATE DELIVERY MODE 10/25/2021 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): KTSDocketing2@kilpatrick.foundationip.com ipefiling@kilpatricktownsend.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte LAURA PURDUE, MICHAEL MILWAY, KEVIN BERRYMAN, MERCIA VALENTINE, ZHIYONG SUN, and ROBERTO E. ARMENTA Appeal 2021-000179 Application 15/079,735 Technology Center 1600 Before DONALD E. ADAMS, TAWEN CHANG, and RYAN H. FLAX, Administrative Patent Judges. CHANG, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–21 and 33–40. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Mara Renewables Corporation. Appeal Br. 2. Appeal 2021-000179 Application 15/079,735 2 STATEMENT OF THE CASE “Heterotrophic fermentations of microorganisms” provide an “efficient way of generating high value oil and biomass products.” Spec. 1:10–11. According to the Specification, however, heterotrophic fermentation requires high energy and feedstock — including carbon feedstock — consumption, and “[e]xisting microorganism fermentations use mainly expensive carbohydrates, such as glucose, as the carbon source.” Id. at 1:16–20. Further according to the Specification, although glycerol is a “natural carbon substrate[] for microorganisms,” “highly purified glycerol costs more than glucose.” Id. at 1:20–23. The invention relates to a method of culturing microorganisms in a medium comprising crude glycerol to achieve a desired microorganism cell density is achieved. Id. at 1:25–31. CLAIMED SUBJECT MATTER The claims are directed to a method of producing a population of microorganisms having a selected cell density. Claim 1, the only independent claim, is illustrative: 1. (Previously presented) A method of producing a population of microorganisms having a selected cell density, comprising: (a) culturing one or more microorganisms in a medium comprising crude glycerol at a first concentration level and a nitrogen source; (b) feeding to the medium an additional amount of crude glycerol, once the first concentration of glycerol is reduced to a first threshold level, at a concentration sufficient to achieve the first concentration level, wherein a nitrogen source is not added to the medium during the feeding step; Appeal 2021-000179 Application 15/079,735 3 (c) monitoring the crude glycerol concentration until the first concentration level of the crude glycerol is reduced to the first threshold level; and (d) repeating steps (b) and (c) until the selected microorganism cell density is achieved. Appeal Br. 26 (Claims App.). REJECTION(S) A. Claims 1, 2, 4–9, 11–21, 33, and 34 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Chi.2 Ans. 3. B. Claims 1–18, 21, and 33–40 are rejected under 35 U.S.C. § 103 as being unpatentable over Chi and Burja.3 Ans. 7. C. Claims 1–21 and 33–40 are rejected under 35 U.S.C. § 103 as being unpatentable over Chi, Burja, and Pyle.4 Ans. 12. OPINION A. Issue The Examiner finds that Chi teaches “a method of culturing microorganisms of the genera Thraustochytriales including Schizochytrium in a medium with crude glycerol by a fed-batch or continuous mode,” which the Examiner finds to meet all of the method steps of independent claim 1. Ans. 3–4. 2 Chi et al., US 7,989,195 B2, issued Aug. 2, 2011. 3 Burja et al., US 8,163,515 B2, issued Apr. 24, 2012. 4 Denver J. Pyle et al., Producing Docosahexaenoic Acid (DHA)-Rich Algae from Biodiesel-Derived Crude Glycerol: Effects of Impurities on DHA Production and Algal Biomass Composition, 56 J. AGRIC. & FOOD CHEMISTRY 3933 (2008). Appeal 2021-000179 Application 15/079,735 4 Appellant contends among other things that Chi feeds glycerol at the controlled rate of 30g/L and does not disclose “monitor[ing] crude glycerol concentrations until reduced to a first threshold level” as required by independent claim 1. Appeal Br. 10–11. The dispositive issue with respect to all the rejections is whether a preponderance of the evidence of record supports the Examiner’s finding that Chi discloses the steps of “monitoring the crude glycerol concentration until the first concentration level of the crude glycerol is reduced to the first threshold level” and “feeding to the medium an additional amount of crude glycerol[] once the first concentration of glycerol is reduced to a first threshold level,” as recited in independent claim 1. B. Analysis On balance, we agree with Appellant that the Examiner has not established a prima facie case that Chi teaches a method wherein an additional amount of crude glycerol is fed to the medium “once [a] first concentration of glycerol is reduced to a first threshold level,” or monitoring the crude glycerol concentration until “[a] first concentration level of the crude glycerol is reduced to the first threshold level,” as recited in independent claim 1. As an initial matter, we construe the term “first concentration level of the crude glycerol is reduced to the first threshold level” to require a decrease in the level of crude glycerol to a value below the first concentration level and not merely the maintenance of a steady state concentration level. We conclude such a construction is the broadest reasonable construction consistent with the Specification. In particular, pertinent dictionary definitions of “reduce” and “threshold” are, Appeal 2021-000179 Application 15/079,735 5 respectively, “to diminish in size, amount, extent, or number,”5 and “a level, point, or value above which something is true or will take place and below which it is not or will not.”6 These definitions illuminate what the ordinarily skilled artisan would have understood to have been the ordinary and customary meaning of the claim language. The Specification is also consistent with our construction. For example, the Specification describes an example method in which the fermentations were “operated in fed-batch mode,” with “initial fermentation medium contain[ing] (per liter): glycerol 60 g,” wherein, “[a]t the appropriate time, a dose of crude glycerol was automatically pumped into the fermentor to bring the in-medium glycerol concentration up to 60 g/L (for 2L runs).” Spec. 13:13–15. The Examiner cites to column 14, lines 60–62 of Chi as teaching step (b) of claim 1 (i.e., “feeding to the medium an additional amount of crude glycerol, once the first concentration of glycerol is reduced to a first threshold level, at a concentration sufficient to achieve the first concentration level, wherein a nitrogen source is not added to the medium during the feeding step”). Ans. 3. The Examiner further cites to column 8, line(s) 49 and/or 55 of Chi as teaching “the use of a fed-batch mode” and 5 “reduce.” MERRIAM-WEBSTER, https://www.merriam- webster.com/dictionary/reduce (last visited Oct. 12, 2021). Although this dictionary definition is dated 2021, we understand that the definition of the term would not have changed since the filing of the claims. 6 “threshold.” MERRIAM-WEBSTER, https://www.merriam- webster.com/dictionary/threshold (last visited Oct. 12, 2021). Again, the late date of this definition does not suggest the definition of the term has changed since the filing of the claims and we understand it has not. Appeal 2021-000179 Application 15/079,735 6 asserts that, “thus, the steps (b) and (c) are repeated in the cited method in the same manner as it is encompassed for claimed step (d).” Id. at 4. We are not persuaded. Chi teaches a multi-stage fermentation process wherein the first stage is the “cell number increasing stage”; the second stage, in which fatty acids are accumulated, begins after the cell number has stopped increasing; and the third stage, which further accumulates fatty acids and provides for an improved polyunsaturated fatty acid profile, begins after the dry cell weight has stopped increasing. Chi 14:40–67. Column 14, lines 60–62 of Chi, cited by the Examiner, indeed teaches part of claimed step (b), namely “feeding to the medium an additional amount of crude glycerol . . . wherein a nitrogen source is not added to the medium during the feeding step,” because it teaches that “nitrogen feeding will be stopped while glycerol is still fed and controlled at 30 g/L” in the third stage of Chi’s process. Chi 14:60–62. However, the Examiner does not explain how this disclosure teaches that a “first concentration of glycerol is reduced to a first threshold level” before such an additional amount of crude glycerol is fed to the medium. Instead, Chi teaches that in the second stage the glycerol and nitrogen concentrations are controlled at, respectively, 30–50 g/L and 0.5–1.0 g/L and that, in the third stage when nitrogen feeding is stopped, “the glycerol is still fed and controlled at 30 g/L.” Id. at 14:52–62. In short, this portion of Chi teaches maintaining the level of glycerol at the steady state of 30 g/L rather than letting it be reduced to a value (i.e., “first threshold level”) below the initial concentration (i.e., “first concentration level”) before adding more glycerol into the medium. Given the above, the Examiner’s citation to Chi’s use of the “fed-batch mode” also does not explain why Chi teaches repeating Appeal 2021-000179 Application 15/079,735 7 a step wherein additional amount of crude glycerol is fed to the medium, without nitrogen, “once first concentration of glycerol is reduced to a first threshold level,” even if fed-batch mode suggests repeated addition of nutrients. In rejecting claims 8 and 9, which depend from claim 1 and further recite, respectively, that “the first concentration level is between 1 and 60 g/L” and “the first threshold level is between 0 and 5 g/L,” the Examiner asserts that the cited method comprises the use of first or star[t]ing concentration such as about 40 g/L (col.[]14, line 44) and within the range of claim 8. Further, the glycerol level fall down to nearly zero within first 12-24 hours because the cell number has stopped increased (col.[]14, line 54) and all 40 g/L of original glycerol was consumed. See table 4 which describes that glycerol consumption was about 4 g/L/hr. Thus, about 12–24 hours are enough for the culture to consume at least 40 g/L of glycerol. Further during culturing under additional feeding of glycerol (30 g/L) when the additional nitrogen feeding totally stopped (after 60-80 hours), glycerol consumption rates remains at about 2-4 g/L/hr (70–120[]hours, see table 4). Thus, the continuing consumption of glycerol by the culture means that each added 30g/L glycerol amount is still consumed within intervals of 12–24 hours to the undesired low “threshold” including claimed “threshold” range 0-5 g/L when another 30g/L would be needed to provide for accumulation (“polishing” as described) of a desired product (fatty acids, PUFA). Ans. 5; see also id. at 15. We are not persuaded by the Examiner’s interpretation of Chi’s Example 2 as allowing glycerol in the third stage to be almost entirely consumed (i.e., reduced to a range of 0–5 g/L) before 30 g/L of glycerol would be added. First, as discussed above, Chi teaches that, in the second Appeal 2021-000179 Application 15/079,735 8 stage, where fatty acids are accumulated, “the glycerol . . . concentration [is] controlled at 30–50 g/L” and that, in the third (i.e., “polishing”) stage, “nitrogen feeding will be stopped while glycerol is still fed and controlled at 30 g/L.” Chi 14:53–62 (emphasis added); see also id. at 15:48–60 (Table 3, describing glycerol concentration as 30 g/L during hours 80–120 of fermentation). The Examiner’s interpretation above would appear to contradict Chi’s teaching that the glycerol concentration be “controlled at,” i.e., maintained at, a particular level in the third stage of its process. Even if Chi may be read as the Examiner suggests, “if a reference is ambiguous and can be interpreted so that it may or may no[t] constitute an anticipation of an appellant’s claims, an anticipation rejection under 35 U.S.C. § 102 based upon the ambiguous reference is improper.” In re Brink, 419 F.2d 914, 917 (CCPA 1970). In response to Appellant’s arguments in the Appeal Brief, the Examiner further responds that [i]n the cited method during the final stage 3 the [concentration] of glycerol is monitored in order to provide and to maintain a sufficient level of glycerol for microbial fermentation, which is evidenced by disclosure of glycerol consumption rates during fermentation; for example: see table [4], wherein several values for glycerol consumption rates are estimated during fermentation including period between hours 81 and 120. The period of fermentation after 80 hours corresponds to the final third stage in the cited method when nitrogen feeding has been stopped (see example 2 at col. 14, lines 59–63; see also table 3). Thus, the cited method by Chi comprises same manipulations as required by the claimed step (c). Ans. 14. Appeal 2021-000179 Application 15/079,735 9 We are not persuaded for the same reasons discussed above, namely that the Examiner has cited no persuasive evidence that monitoring of glycerol concentration necessarily indicates feeding additional glycerol in the third stage only when the initial glycerol concentration has been reduced to a threshold amount, rather than, e.g., maintaining glycerol at a steady concentration. As our reviewing court has explained, although a reference may anticipate inherently even if it does not expressly disclose a claim limitation, “[i]nherency may not be established by probabilities or possibilities.” Scaltech Inc. v. Retec/Tetra L.L.C., 178 F.3d 1378, 1384 (Fed. Cir. 1999). Accordingly, we reverse the Examiner’s rejection of claim 1 as anticipated by Chi. For the same reasons, we reverse the Examiner’s rejection of claims 2, 4–9, 11–21, 33, 34, which all depend from claim 1, as anticipated by Chi. Furthermore, the Examiner has not pointed to any disclosure in Burja or Pyle that makes up for the deficiency of Chi discussed above. We therefore also reverse the Examiner’s rejections of claims 1–18, 21, and 33–40 as obvious over Chi and Burja and claims 1–21 and 33–40 as obvious over Chi, Burja, and Pyle. Appeal 2021-000179 Application 15/079,735 10 CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 2, 4–9, 11–21, 33, 34 102(a)(1) Chi 1, 2, 4–9, 11–21, 33, 34 1–18, 21, 33–40 103 Chi, Burja 1–18, 21, 33–40 1–21, 33–40 103 Chi, Burja, Pyle 1–21, 33–40 Overall Outcome 1–21, 33–40 REVERSED Copy with citationCopy as parenthetical citation