FERMENTALG et al.

Patent Trials and Appeals Board

Jan 20, 2022

2021003110 (P.T.A.B. Jan. 20, 2022)

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. 15/744,593 01/12/2018 Olivier CAGNAC 6927-0101PUS1 8381 2292 7590 01/20/2022 BIRCH STEWART KOLASCH & BIRCH, LLP 8110 Gatehouse Road Suite 100 East Falls Church, VA 22042-1248 EXAMINER SHEN, BIN ART UNIT PAPER NUMBER 1653 NOTIFICATION DATE DELIVERY MODE 01/20/2022 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): mailroom@bskb.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte OLIVIER CAGNAC, CYRIL ROLS, JULIEN PAGLIARDINI, PIERRE CALLEJA, CЀCILE GADY, and SABRINA VANDEPLAS Appeal 2021-003110 Application 15/744,593 Technology Center 1600 Before TAWEN CHANG, RACHEL H. TOWNSEND, and DAVID COTTA, 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 2, 3, 5-10, 20-24, 26, and 27. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 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 Fermentalg and Adisseo France SAS. Appeal Br. 1. Appeal 2021-003110 Application 15/744,593 2 STATEMENT OF THE CASE The Specification states that a goal of the invention is to provide a novel source of proteins for animal or human consumption that can be widely produced using economically-viable industrial methods, in order to replace sources such as soybean. Spec. 2:1-4. The Specification further states that, under certain culture conditions, thraustochytrids -- microalgae known to be useful “in the production of oils with high polyunsaturated fatty acid contents” - are “capable of producing a large amount of proteins, which can make them a source of dietary proteins similar to soybean, in particular for animal feed.” Id. at 1:4, 2:5-8. CLAIMED SUBJECT MATTER The claims are directed to a livestock feed. Claim 20 is illustrative: 20. A livestock feed, wherein it comprises 1% to 60% of a thraustochytrid biomass comprising at least 35% by weight of proteins relative to the weight of dry matter and less than 20% fat by weight relative to the weight of dry matter. Appeal Br. Claims App. 2. REJECTION(S) Claims 2, 3, 5-10, 20-24, 26, and 27 are rejected under 35 U.S.C. § 101 as being directed to a product of nature. OPINION A. Issue The Examiner notes that the claims recite “livestock feed compris[ing] thraustochytrid biomass with recited protein and fat contents Appeal 2021-003110 Application 15/744,593 3 which are all nature products that are not markedly different from their naturally occurring counterparts.” Ans. 4. The Examiner finds that “the recited composition with claimed dry weight percentages . . . does not recite any particular application” and thus does not “integrate the recited judicial exception into a practical application.” Id. The Examiner further finds that “the claimed biomass (comprising protein and fat) do not have markedly different characteristics from what occurs in nature” and thus “the claims do not amount to significantly more tha[n] nature products.” Id. Accordingly, the Examiner concludes that the claims are directed to a patent-ineligible judicial exception, without significantly more. Id. Citing to the Griffiths Declaration2 and Example 9 in Examples: Nature-Based Products from the Patent Office’s 2014 Interim Guidance on Patent Subject Matter Eligibility (“Nature-Based Product Examples”), Appellant contends that “the biomass as claimed is not naturally occurring and has structurally distinct, i.e. markedly different, features,” which are “present in both the relative amounts of the fat and proteins and in the thraustochytrid itself.” Appeal Br. 4. Appellant does not separately argue the claims. We therefore focus our analysis on claim 20 as representative. The issue with respect to this rejection is whether the livestock feed recited in claim 20 is directed to a product of nature, without significantly more. B. Claim Construction We begin our analysis with claim construction. “It is axiomatic that, in proceedings before the PTO, claims in an application are to be given their 2 Declaration of Hywel Griffiths (Oct. 15, 2020) (“Griffiths Decl.”). Appeal 2021-003110 Application 15/744,593 4 broadest reasonable interpretation consistent with the specification, and that claim language should be read in light of the specification as it would be interpreted by one of ordinary skill in the art.” In re Sneed, 710 F.2d 1544, 1548 (Fed. Cir. 1983) (citation omitted). In this case, the Examiner construes biomass to encompass biomass that is subsequently processed (e.g., “purified biomass in which all other constituents except the protein[] are removed” or “a purified thraustochy[t]rid biomass in which the fat is removed.”). Ans. 5. Appellant disputes that “biomass” encompasses such preparations. Reply Br. 4. We agree with the Examiner that the broadest reasonable interpretation of “thraustochytrid biomass,” in light of the Specification as it would be read by a skilled artisan, encompasses biomass that is processed after harvesting so as to alter the percentage weight of proteins or fat relative to the weight of the dry matter. In particular, the Specification states: According to the invention, the term “biomass” advantageously refers to a set of thraustochytrid cells produced by culturing . . . , and having the levels of proteins and, optionally, fatty acids described in the present text, cells which may or may not retain their physical integrity. It is thus understood that said biomass may comprise a quantity of degraded thraustochytrid cells ranging from 0% to 100%. The term “degraded” means that said thraustochytrid cells may have had their structure and/or composition modified. For example, they may have undergone a drying step or an oil harvesting step, the important thing being that the biomass Appeal 2021-003110 Application 15/744,593 5 comprising these cells has the levels of proteins and, optionally, of fatty acids described in the present text. Spec. 3:5-14 (emphasis added). A skilled artisan reading the passage above would understand that the term thraustochytrid biomass, as used in the claims, encompasses a set of thraustochytrid cells that are processed subsequent to harvesting, including by having their composition modified, so long as the percentage weights of proteins and fat of the processed biomass meet the requirements of the claims. Citing to page 3 of the Specification, Appellant contends that “[t]he specification explicitly and unequivocally states that the treatments of the biomass ‘do not alter the amino acid and fat composition’ and ‘In particular, the relative composition of amino acids in relation to fat remains substantially constant.’” Reply Br. 4. We acknowledge that the Specification states that: According to a preferred embodiment of the invention, the biomass has not undergone treatments that modify its amino acid composition during or after harvesting. That is, the treatments to which said biomass is subjected after harvesting do not alter the amino acid composition thereof. In particular, the biomass was not subjected to a step of enrichment in proteins and/or amino acids. That is, the proteins, peptides and amino acids contained in the biomass according to the invention derive only from the culture of thraustochytrids. . . . According to a more preferred embodiment of the invention, the biomass has not undergone treatments that modify the amino acid and fat composition thereof. That is, the treatments to which said biomass is subjected after harvesting do not alter the amino acid and fat composition thereof. In particular, the relative composition of amino acids in relation to fat remains substantially constant. Appeal 2021-003110 Application 15/744,593 6 . . . . One of the preferred forms of the invention is a biomass comprising a substantially predominant amount of non-degraded thraustochytrids. Spec. 3:15-34 (emphasis added). However, as the emphasized phrases from the Specification above indicate, biomass that has not undergone treatments modifying its amino acid composition during or after harvesting, or that retain a substantially constant relative composition of amino acid in relation to fat, are merely preferred embodiments. The definition of “biomass” from the Specification emphasized above expressly encompasses biomass that is degraded thraustochytrid cells that may have had their structure and/or composition modified. We will not “read into a claim a limitation from a preferred embodiment” where “that limitation is not present in the claim itself.” Bayer AG v. Biovail Corp., 279 F.3d 1340, 1348 (Fed. Cir. 2002). Accordingly, we construe thraustochytrid “biomass” as a set of thraustochytrid cells produced by culturing, including cells that are processed after harvesting. C. Eligibility Analysis Unless otherwise noted, we adopt the Examiner’s findings of fact and reasoning regarding the Examiner’s rejection of claim 20 under 35 U.S.C. § 101 (Final Act. 3-4; Ans. 3-6) and agree that claim 20 is unpatentable as being directed to a judicial exception without significantly more. Only those arguments timely made by Appellant in the briefs have been considered; arguments not so presented in the briefs are waived. See 37 C.F.R. § 41.37(c)(1)(iv) (2020); see also Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative) (“Any bases for asserting error, whether factual Appeal 2021-003110 Application 15/744,593 7 or legal, that are not raised in the principal brief are waived.”). We highlight the following points for emphasis. We analyze this case under the framework set forth by the Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), and applied by our reviewing court in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015). As the Ariosa court explained: In Mayo . . . , the Supreme Court set forth a framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts. First, we determine whether the claims at issue are directed to a patent-ineligible concept. . . . If the answer is yes, then we next consider the elements of each claim both individually and “as an ordered combination” to determine whether additional elements “transform the nature of the claim” into a patent-eligible application. . . . The Supreme Court has described the second step of this analysis as a search for an “inventive concept”-i.e., an element or combination of elements that is “sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.” Id. at 1375. Whether Claim 20 Is Directed to a Patent-Ineligible Concept We begin with the first step of the Mayo test, namely whether a claim is “directed to” a patent-ineligible concept. On January 7, 2019, the Director of the USPTO issued the “2019 Revised Patent Subject Matter Eligibility Guidance” (“Revised Guidance”),3 which provides further details regarding 3 In response to received public comments, the Office issued further guidance on October 17, 2019, clarifying the Revised Guidance. USPTO, October 2019 Update: Subject Matter Eligibility (the “October Appeal 2021-003110 Application 15/744,593 8 how the Patent Office analyzes patent-eligibility questions under 35 U.S.C. § 101. 84 Fed. Reg. 50-57 (Jan. 7, 2019). Under the Revised Guidance, the first step of the Mayo test (i.e., Step 2A of the Revised Guidance) is “a two- prong[ed] inquiry.” Id. at 54. In prong one, we evaluate whether the claim recites a judicial exception, such as laws of nature, natural phenomena, or abstract ideas. Id. If the claim recites a judicial exception, the claim is further analyzed under prong two, which requires “evaluat[ion of] whether the claim recites additional elements that integrate the exception into a practical application of that exception.” Id. The Revised Guidance explains that, “[i]f the recited exception is integrated into a practical application of the exception, then the claim is eligible at Prong Two of . . . Step 2A [of the Revised Guidance].” Id. Prong One of Step 2A of Revised Guidance We agree with the Examiner that claim 20 recites a judicial exception, namely, “a thraustochytrid biomass comprising at least 35% by weight of proteins relative to the weight of dry matter and less than 20% fat by weight relative to the weight of dry matter.” Thraustochytrids are naturally occurring organisms. Griffiths Decl. 2 (“The group collectively known as the Thraustochytrids are unicellular heterotrophic organisms that are mostly present in waters rich in sediments and organic matter, particularly in mangrove forests where they feed on decaying leaves.”). As explained in both case law and the Revised Guidance, natural phenomena, including naturally occurring organisms, are 2019 Update”) (available at https://www.uspto.gov/sites/default/files/ documents/peg_oct_2019_update.pdf) (last visited Jan. 13, 2022). Appeal 2021-003110 Application 15/744,593 9 not patentable. In re Roslin Inst. (Edinburgh), 750 F.3d 1333, 1335- 1336 (Fed. Cir. 2014). Citing to the Griffiths Declaration, Appellant asserts that “at all stages of the Thraustochytrid normal life cycle there is high level of lipid production” and that “[i]t took several years of research for the inventors to find the exact combinations of salinity, carbon to nitrogen ratio, oxygenation, growth rate, temperature, agitation and other parameters that allowed these cells to switch their metabolisms towards protein production for extended periods of time.” Appeal Br. 5. Appellant contends that these culture conditions do not occur in nature and that, accordingly, “[t]he biomass of the present invention in which high levels of protein are found across the entire population does not occur in nature.” Id. Appellant further asserts that the non-natural culture conditions “cause[s] structural changes in the Thraustochytrids,” - i.e., the operation of different groups of metabolic pathways than in naturally occurring Thraustochytrids, indicating “different genetic structures and levels and types of mRNA and expressed proteins” - “such that they are no longer a product of nature and are markedly different from naturally occurring Thraustochytrid biomasses.” Id. at 5-6 (emphasis omitted). We are not persuaded because, as discussed above, we construe thraustochytrid biomass in claim 20 to encompass biomass - including thraustochytrids cultured under conditions occurring in nature - that is processed after harvesting so as to alter the percentage weight of proteins or fat relative to the weight of the dry matter. Thus, claim 20 is not limited to thraustochytrids possessing “different groups of metabolic pathways,” Appeal 2021-003110 Application 15/744,593 10 “genetic structures,” or “levels and types of mRNA and expressed proteins” as compared to naturally occurring thraustochytrids. We further find that post-harvesting processing does not render the recited thraustochytrid biomass markedly different than a product of nature. The claim encompasses biomass subject to a post-harvesting step, which would concentrate or isolate the protein already present in the harvested biomass, e.g., by subjecting the harvested biomass to an oil harvesting step. After this post-harvesting step, the proteins that remain would be the same as are present in the naturally occurring thraustochytrid biomass. In this regard, we note that the Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), is instructive. In Myriad, the Supreme Court explained that a claim to an “isolated” DNA coding for a particular protein is not “saved [from patent ineligibility] by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule.” Id. at 593. In contrast, the Court held that cDNA, which is a DNA molecule that has its non-coding regions removed, is patent eligible because, while “cDNA retains the naturally occurring exons of DNA, . . . it is distinct from the DNA from which it was derived.” Id. at 594-595. The instant case is closer to the former scenario than the latter because, as discussed above, the proteins recited in claim 20 are chemically, structurally, and functionally identical to the proteins found in naturally occurring thraustochytrid biomass, even if the proteins may have been isolated from the naturally occurring biomass and/or be present in a concentrated form. For similar reasons, Appellant’s citation to Example 9 (Nature-Based Products), is inapposite. In that example, a claim to “[a]n isolated man- Appeal 2021-003110 Application 15/744,593 11 made human pacemaker cell expressing marker Z” was found to be patent eligible, because “[n]o human pacemaker cells expressing marker Z are naturally occurring,” and, although “the claimed cells are exact genetic replicas of naturally occurring pacemaker cells, . . . the claimed cells are phenotypically different than natural pacemaker cells, in that they express marker Z and have increased oxygen utilization efficiency.” Nature-Based Prod. Examples, Example 9 at 14. “These phenotypic differences were created by applicant’s efforts (e.g., by culturing the stem cells in a particular growth medium in the presence of growth factor A, at various temperatures), and were not the work of nature.” Id. In this case, as discussed above, the claim encompasses naturally occurring thraustochytrid biomass the protein content of which is increased relative to the dry weight of the biomass by, e.g., isolation or concentration. Such concentration or isolation of a component of a naturally occurring product does not rise to the level of a “marked” difference required to render the claim patent eligible. Prong Two of Step 2A of Revised Guidance With respect to the second prong of Step 2A of the Revised Guidance, we find that claim 20 does not recite sufficient additional elements that integrate the recited judicial exception (i.e., the product of nature) into a practical application of the exception. 84 Fed. Reg. at 54. In particular, the only element of claim 20 other than the recited thraustochytrid biomass discussed above is “[a] livestock feed.” Even assuming that the livestock feed itself does not encompass products of nature, this limitation “does no more than generally link the use of a judicial exception to a particular technological environment or field of use,” which does not suffice to integrate the product of nature (i.e., the thraustochytrid biomass having the Appeal 2021-003110 Application 15/744,593 12 specified relative amounts of proteins and fat) into a practical application. 84 Fed. Reg. at 55. Whether Claim 20 Amounts to Significantly More Having determined that claim 20 is directed to a patent-ineligible product of nature, we next consider whether claim 20 recites “an element or combination of elements that is ‘sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.’” Ariosa, 788 F.3d at 1375 (citation omitted). We agree with the Examiner that it does not. As discussed above, other than the recited thraustochytrid biomass, which we have determined to be a product of nature, the only additional element in claim 20 is “[a] livestock feed.” The Specification further states that “[t]he term ‘feed’ refers to anything that may be used to feed animals.” Spec. 11:26-27. Thus, the claim does no more than inform the skilled artisan to incorporate a product of nature into well-understood, routine, and conventional compositions (i.e., livestock feed). Accordingly, for the reasons stated above, we affirm the Examiner’s rejection of claim 20 as being directed to a patent-ineligible product of nature, without significantly more. Claims 2, 3, 5-10, 21-24, 26, and 27, which are not separately argued, fall within claim 20. Appeal 2021-003110 Application 15/744,593 13 CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 2, 3, 5-10, 20-24, 26, 27 101 Eligibility 2, 3, 5-10, 20-24, 26, 27 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED