American River Nutrition, LLC v. Beijing Gingko Group Biological Technology Co., LTD et al

Central District of California, cacd-8:2018-cv-02201

REPLY in Support of Defendants' NOTICE OF MOTION AND MOTION to Dismiss Case 54 filed by Defendants Beijing Gingko Group Biological Technology Co., Ltd, Jiangsu Xixin Vitamin Co., Ltd, Jinke Group USA Inc.

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1 Page ID #:505 1 GARY HNATH (admitted pro hac vice) ghnath@mayerbrown.com 2 BRYAN NESE (admitted pro hac vice) 3 bnese@mayerbrown.com MAYER BROWN LLP 4 1999 K Street NW 5 Washington, DC 20006 Telephone: (202) 263-3000 6 Facsimile: (202) 263-3001 7 EVAN M. WOOTEN (SBN 247340) 8 ewooten@mayerbrown.com 9 MAYER BROWN LLP 350 S. Grand Ave., 25th Floor 10 Los Angeles, CA 90071-1503 11 Telephone: (213) 229-9500 Facsimile: (213) 625-0248 12 13 Attorneys for Defendants Beijing Gingko Group Biological Technology Co., Ltd.; Jiangsu Xixin Vitamin Co., Ltd.; and Jinke 14 Group USA Inc. d/b/a Beijing Gingko Group North America 15 UNITED STATES DISTRICT COURT 16 CENTRAL DISTRICT OF CALIFORNIA 17 AMERICAN RIVER NUTRITION, Case No. 8:18-cv-02201-JLS (JDEx) 18 LLC, a Delaware limited liability REPLY IN SUPPORT OF 19 company, DEFENDANTS' MOTION TO DISMISS FIRST AMENDED 20 Plaintiff, COMPLAINT UNDER RULE 12(b)(6) 21 v. Date: May 31, 2019 22 BEIJING GINGKO GROUP Time: 10:30 a.m. 23 BIOLOGICAL TECHNOLOGY CO., Place: Courtroom 10A LTD., et al., Honorable Josephine L. Staton 24 Defendants. 25 Am. Complaint Filed: Mar. 4, 2019 26 27 28 REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEX) 1 Page ID #:506 1 TABLE OF CONTENTS 2 3 I. INTRODUCTION ......................................................................................... 1 4 II. ARGUMENT ................................................................................................. 2 5 A. ARN's Opposition Elevates Irrelevant Arguments and Ignores the 6 Key Issues. ............................................................................................ 2 7 B. Claims Reciting a "Byproduct Solution of Bixa orellana Seeds" Are 8 Still Directed to a Natural Phenomenon. .............................................. 6 9 C. The § 101 Case Law Supports Finding the Asserted Claims Invalid. 10 10 III. CONCLUSION ............................................................................................ 16 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 -i- REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx) 1 Page ID #:507 1 TABLE OF AUTHORITIES 2 Page(s) 3 Cases 4 Alice Corp. Pty. Ltd. v. CLS Bank Int'l., 5 573 U.S. 208 (2014) ......................................................................................... 4, 9 6 Ariosa Diagnostics, Inc. v. Sequenom, Inc., 7 788 F.3d 1371 (Fed. Cir. 2015) .................................................................... 10, 15 8 Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 9 569 U.S. 576 (2013) .......................................................................................... 10 10 In re Bhagat, 11 726 Fed. Appx. 772 (Fed. Cir. 2018) ................................................................... 8 12 Bilski v. Kappos, 561 U.S. 593 (2010) ............................................................................................. 4 13 14 In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) aff'd, Bilski v. Kappos, 561 U.S. 593 15 (2010).................................................................................................................... 3 16 Callwave Commc'ns, LLC v. AT&T Mobility, 17 207 F. Supp. 3d 405 (D. Del. 2016) ..................................................................... 4 18 CMG Fin. Serv., Inc., v. Pacific Trust Bank, F.S.B., 19 50 F. Supp. 3d 1306 (C.D. Cal. 2014), aff'd, 616 Fed. Appx. 420 (Fed. Cir. 2015) .................................................................................................... 4 20 Content Extraction and Transmission LLC v. Wells Fargo Bank, Nat. 21 Ass'n, 22 776 F.3d 1343 (Fed. Cir. 2014) ............................................................................ 7 23 CreAgri, Inc. v. Pinnaclife, Inc., 24 No. 11-CV-6635-LHK, 2013 WL 6673676 (N.D. Cal. Dec. 18, 2013) ..................................................................................................................... 9 25 Endo Pharms. Inc. v. Teva Pharms. USA, Inc., 26 919 F.3d 1347 (Fed. Cir. 2019) .......................................................................... 14 27 28 - ii - REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx) 1 Page ID #:508 1 Illumina, Inc. v. Ariosa Diagnostics, Inc., 2 356 F. Supp. 3d 925 (N.D. Cal. 2018), appeal docketed, No. 19- 1419 (Fed. Cir. Jan. 16, 2019) ............................................................................ 10 3 Kaneka Corp. v. Zhejiang Medicine Co., Ltd., 4 No. CV 11-02389-SJO, 2018 WL 2718036 (C.D. Cal. April 5, 5 2018) ............................................................................................................. 13, 14 6 Mayo Collaborative Serv. v. Prometheus Labs., Inc., 7 566 U.S. 66 (2012) ............................................................................................... 4 8 In re Method of Processing Ethanol Byproducts and Related Subsystems (ʼ858) Patent Lit., 9 303 F. Supp. 3d 791 (S.D. Ind. 2014) .................................................................. 9 10 Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 11 827 F.3d 1042 (Fed. Cir. 2016) .......................................................................... 12 12 Roche Molecular Sys., Inc. v. CEPHEID, 13 905 F.3d 1363 (Fed. Cir. 2018) .................................................................... 10, 11 14 Ex parte Tan, 15 No. 2017-001177, 2018 Pat. App. LEXIS 2394 (P.T.A.B. Mar. 6, 2018) ....................................................................................................... 4, 5, 9, 10 16 Two-Way Media, Ltd. v. Comcast Cable Commc'ns, LLC, 17 No. 14-1006-RGA, 2016 WL 4373698 (D. Del. Aug. 15, 2016) ........................ 3 18 United Cannabis Corp. v. Pure Hemp Collective Inc., 19 No. 18-cv-1922-WJM-NYW, 2019 WL 1651846 (D. Colo. April 20 17, 2019) ............................................................................................................. 11 21 Vanda Pharms. Inc. v. West-Ward Pharms. Int'l Ltd., 887 F.3d 1117 (Fed. Cir. 2018) .......................................................................... 14 22 23 Statutes 24 35 U.S.C. § 101.......................................................................................................... 1 25 26 27 28 - iii - REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx) 1 Page ID #:509 1 I. INTRODUCTION 2 Having been well aware of the natural phenomenon that tocotrienols and 3 geranylgeraniols exist in the seeds of the Bixa orellana plant,1 the named inventors of 4 the '453 patent drafted patent claims for using routine, well-known, and conventional 5 techniques for extracting and isolating those compositions. These techniques— 6 volatilization, distillation, and separation of these naturally occurring compounds from 7 byproduct solutions—are nothing new, and neither ARN nor the '453 patent itself 8 shows otherwise. The presence of these compositions in Bixa orellana seeds and 9 byproduct solutions thereof had nothing to do with the work of the inventors of the 10 ʼ453 patent—the tocotrienol and geranylgeraniol have been there all along. 11 Rather than deny this fatal fact, Plaintiff American River Nutrition, LLC 12 ("ARN") embraces it: "Inventors Tan and Foley do not claim to have invented 13 distillation and volatilization…." Opp. (ECF No. 62) at 23. ARN's admission 14 acknowledges that the methods used to form tocotrienol and geranylgeraniol 15 compositions in the asserted claims are routine, well-known, and conventional 16 techniques that the inventors cannot claim as their own. Nor can they claim that the 17 "discovery" of these compositions in nature was patentable subject matter. 18 As demonstrated by the case law detailed in Defendants' Motion to Dismiss, 35 19 U.S.C. § 101 serves as a check on inventors, like those here, who would claim 20 exclusive rights to such stumbled-upon "discoveries." 21 ARN's opposition ignores Defendants' arguments and does nothing to show 22 that the asserted claims are anything more than what they really are: a natural 23 24 1 For example, ARN admits that "in or about 1989, tocotrienols were discovered in 25 the seeds of Bixa orellana." Opp. (ECF No. 62) at 5. Likewise, ARN admits that "[i]t has been discovered that byproduct solutions of Bixa orellana seed 26 components contain tocotrienols, including delta-tocotrienols and gamma- 27 tocotrienols, and geranylgeraniol." Id. at 6 (quoting '453 patent at 3:31-33). 28 -1- REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx) 1 Page ID #:510 1 phenomenon devoid of any inventive concept. As such, these claims are invalid, and 2 the First Amended Complaint (FAC) should be dismissed in its entirety. 3 II. ARGUMENT 4 ARN's opposition consists mainly of irrelevant arguments, such as whether the 5 claims themselves are novel and whether the USPTO examiner ever rejected them. 6 Despite devoting page after page to these distractions, ARN overlooks many points 7 raised in Defendants' motion, such as ARN's admission in the FAC that its claims 8 supposedly cover any feasible method of making tocotrienols (FAC, ¶ 29), as well as 9 the Patent Trial and Appeal Board's recent decision finding claims of a similar ARN 10 patent invalid under § 101. 11 When reduced to its relevant points, ARN's opposition largely focuses on a 12 single argument: that the claims are subject matter eligible because they recite a 13 "byproduct solution" of Bixa orellana, as opposed to simply the seeds of the Bixa 14 orellana. But this argument overlooks that separating naturally occurring 15 compositions into byproduct solutions is also routine and conventional, as even the 16 '453 patent admits. 17 Finally, ARN's outdated and misapplied legal authority is unavailing. When the 18 two-step Alice test is applied properly in view of the Federal Circuit's guidance, 19 claims 1, 6, 7, and 10 of the '453 patent are subject matter ineligible, and dismissal at 20 this stage of the case is appropriate. Defendants should not be required to incur the 21 expense of defending against claims that are plainly unpatentable under Section 101. 22 A. ARN's Opposition Asserts Irrelevant Arguments and Ignores the 23 Key Issues. 24 ARN's opposition to Defendants' Motion to Dismiss never claims that any step 25 in the claimed process involves anything more than well-understood, long-known 26 techniques. For example, several pages of the brief are dedicated to highlighting prior 27 art uses of the Bixa orellana shrub to make colorant, the known benefits of delta- 28 -2- REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx) 1 Page ID #:511 1 tocotrienols and gamma-tocotrienols, and the "unexpected results" of obtaining these 2 compounds from Bixa orellana seeds. Opp. at 3-7; e.g., Opp. at 6 ("The Patent-in-Suit 3 denotes that the inventors were generally surprised by the success of their process — 4 as it resulted in four separate unexpected results" (emphasis in original).). In essence, 5 they argue that it was surprising that tocotrienols had unexpected health benefits. This 6 is the epitome of unpatentable "law of nature" subject matter. 7 Reading more like a rebuttal to an obviousness challenge than a targeted 8 response to Defendants' motion, this information also has no place in determining 9 patentability under §101. See In re Bilski, 545 F.3d 943, 958 (Fed. Cir. 2008) ("First, 10 the Court has held that whether a claimed process is novel or non-obvious is irrelevant 11 to the §101 analysis.") aff'd, Bilski v. Kappos, 561 U.S. 593, 604 (2010) (affirming 12 judgment but rejecting holding that machine-or-transformation test is the sole test for 13 deciding whether an invention is a patent-eligible process); see also Two-Way Media, 14 Ltd. v. Comcast Cable Commc'ns, LLC, No. 14-1006-RGA, 2016 WL 4373698, at *4 15 (D. Del. Aug. 15, 2016) (declining to consider materials that related to how inventors 16 solved specific technical problems and added inventive concepts over the prior art in 17 evaluating § 101 motion because the novelty and obviousness of the claims does not 18 bear on whether the claims are directed to patent-eligible subject matter). 19 ARN also appears to misunderstand which claims are at issue here. Although 20 the FAC asserts infringement of only claims 1, 6, 7, and 10, and although Defendants' 21 motion is similarly directed to these claims, ARN highlights several other claims in its 22 opposition, such as claims 11, 13-16, and 20-22. See Opp. at 22. As these claims have 23 not been asserted against Defendants,2 they are not part of this case. ARN's arguments 24 as to these claims are also irrelevant. 25 2 ARN's infringement contentions are currently due May 17—the same day as this 26 reply. See Scheduling Order (ECF No. 58) at 2. As of this filing, ARN has not 27 indicated that it intends to assert any claim of the '453 patent other than claims 1, 28 -3- REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx) 1 Page ID #:512 1 ARN further ignores the recent Patent Trial and Appeal Board's decision 2 affirming a § 101 rejection of ARN's claims for "a composition comprising annatto 3 seed oil extract and plant oil extract." See Ex parte Tan, No. 2017-001177, 2018 Pat. 4 App. LEXIS 2394, at *1 (P.T.A.B. Mar. 6, 2018); see also Mot. (ECF No. 54-2) at 6- 5 7. ARN does not even attempt to explain why this Court should reach a different 6 result. 7 Although it turns a blind eye to this USPTO authority, ARN seeks judicial 8 notice of an Office Action issued 18 years ago during prosecution of the '453 patent, 9 in which the examiner simply noted that "Claim 1 is allowable." See Request for 10 Judicial Notice (ECF No. 61), Exhibit 1. According to ARN, the examiner's 11 allowance of the claims without the need for further prosecution "is indicative of the 12 fact that the methods embodied in the Patent-in-Suit were not well-understood, 13 routine, and conventional to a skilled artisan" at the time of filing. Opp. at 23. 14 ARN offers no authority to support this proposition, and the authority that does 15 exist explicitly rejects it: an examiner's allowance of claims over the prior art is 16 "irrelevant to the § 101 inquiry." See Callwave Commc'ns, LLC v. AT&T Mobility, 17 207 F. Supp. 3d 405, 415 (D. Del. 2016) ("Plaintiff's repeated assertions that the 18 inventive concept is demonstrated by the fact that the PTO granted the claims over 19 certain prior art, both initially and after reexamination, are irrelevant to the §101 20 inquiry."). 21 That the '453 patent's examiner did not reject the claims on § 101 grounds here 22 is likewise irrelevant, particularly given that the law related to patentable subject 23 matter has fundamentally changed since that 2001 Office Action. See CMG Fin. Serv., 24 Inc., v. Pacific Trust Bank, F.S.B., 50 F. Supp. 3d 1306, 1327 (C.D. Cal. 2014) 25 ("Notably, the patent examiner evaluated and approved the Patent prior to Bilski, 26 27 6, 7, and 10. 28 -4- REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx) 1 Page ID #:513 1 Mayo, and Alice Corp., which explains why the patent examiner would have approved 2 the Patent at that time. Had this patent examiner had the benefit of these decisions. . . 3 he or she should not have approved it."), aff'd, 616 Fed. Appx. 420 (Fed. Cir. 2015). 4 When this Office Action issued in 2001, the Supreme Court's reworking of the 5 § 101 inquiry through Alice, Mayo, and Bilski were more than a decade from being 6 decided. See Alice Corp. Pty. Ltd. v. CLS Bank Int'l., 573 U.S. 208 (2014); Mayo 7 Collaborative Serv. v. Prometheus Labs., Inc., 566 U.S. 66 (2012); Bilski v. Kappos, 8 561 U.S. 593 (2010). When the USPTO encountered similar claims in another ARN 9 patent directed to tocotrienols after these decisions, both the examiner and the Patent 10 Trial and Appeal Board agreed that the claims were ineligible under § 101. See Ex 11 parte Tan, No. 2017-001177, 2018 Pat. App. LEXIS 2394, at *6 (P.T.A.B. Mar. 6, 12 2018). Thus, the Office Action presented in ARN's Request for Judicial Notice carries 13 no weight in deciding this issue. 14 Another example of ARN's attempts to ignore or gloss over Defendants' 15 Motion to Dismiss is the assertion that "Defendants do not argue that the Patent-in- 16 Suit asserts the only method by which to obtain the tocotrienol compositions from the 17 seed of the Bixa orellana." Opp. at 21. This is directly contrary to a point Defendants' 18 raised in their Motion to Dismiss: 19 The First Amended Complaint itself acknowledges that the ʼ453 patent 20 attempts to preempt any use of Bixa orellana seeds to produce 21 tocotrienols: "Upon information and belief, there is no scientific or 22 economically-feasible method of manufacturing Defendants' 23 TheraPrimeE® line of products without using Patented Processes." 24 Mot. at 5 (citing FAC, ¶ 29). ARN's opposition gives no indication that it considered 25 this argument, and it certainly does not address it. 26 27 28 -5- REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx) 1 Page ID #:514 1 ARN's ineffectual arguments cannot change the inescapable conclusion that the 2 '453 patent's claims are directed to no more than a natural phenomenon devoid of any 3 inventive concept. They fail the Alice inquiry and are thus invalid. 4 B. Claims Reciting a "Byproduct Solution of Bixa orellana Seeds" Are 5 Still Directed to a Natural Phenomenon. 6 Faced with a claim that recites no specific processing steps, equipment, or 7 specifications, ARN attempts to rewrite the claim language through the phrase "a 8 byproduct solution of Bixa orellana" seed components. Opp. at 7-10. 9 It was undisputedly well known that the seeds of Bixa orellana contain trace 10 amounts of delta-tocotrienols and gamma-tocotrienols, and that a byproduct solution, 11 still containing the tocotrienol components, is created during the widely used process 12 of extracting annatto colorant from Bixa orellana seeds. '453 patent at 1:34-38 and 13 3:8-33. Claim 1 of the '453 patent begins with this tocotrienol-containing byproduct 14 solution, and applies the well-known and conventional techniques of volatilization and 15 distillation to obtain tocotrienol compositions. Contrary to ARN's position, processing 16 of the seeds and the byproduct solution does not alter the underlying compounds. As 17 the patent admits, tocotrienols are contained as trace amount in the Bixa orellana 18 seeds, so all tocotrienol products are from byproducts. See id. at 1:34-38. 19 The '453 patent also admits that, since at least 1989, it was known that 20 tocotrienols naturally exist in the seeds of the Bixa orellana plant. Id. at 1:34-38. ARN 21 details the process by which annatto colorant has traditionally been extracted from 22 Bixa orellana seeds, and that a "slurry" waste, or oily phase, was generated during this 23 process. Opp. at 6-7.3 ARN then acknowledges that it was "discovered" that this slurry 24 waste (i.e., the byproduct) contained "tocotrienols, including delta-tocotrienols and 25 26 3 The '453 patent refers to this oily phase as "byproducts" of the process used to 27 extract annatto colorant. '453 patent at 3:28-33. 28 -6- REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx) 1 Page ID #:515 1 gamma-tocotrienols, and geranylgeraniol." Id. at 6 (citing '453 patent at 3:30-39). The 2 claimed process utilizes this byproduct solution to obtain tocotrienol and 3 geranylgeraniol compositions. Id. ARN did not create these "byproduct solution[s]" 4 nor can it claim them as an invention. 5 ARN leans heavily on the argument that because its method utilizes a byproduct 6 solution of Bixa orellana seeds that has been "chemically modified," the patent is not 7 directed to a natural phenomenon. Id. at 8-9. According to ARN, the byproduct 8 solution has a "chemically modified" lower amount of annatto colorant.4 Id. at 8. This 9 byproduct solution, ARN argues, is the result of "multiple rounds of processing, 10 including chemical treatment, precipitation, filtration and centrifugation." Id. at 15. 11 ARN's "chemical modification" argument fails for at least two reasons. First, 12 the language "chemically modified" does not appear in the claims—nor does any of 13 the other language ARN uses to make this point. The claims simply recite a 14 "byproduct solution" and do not claim any characteristics of that solution or of any 15 process to make it. Therefore, ARN cannot rely on the recitation of a "byproduct 16 solution" to contribute patentable subject matter. Second, even if the claims were 17 interpreted to cover something that was "chemically modified," this phrase alone 18 4 19 The '453 patent defines a byproduct solution of Bixa orellana seed components as "a solution derived from Bixa orellana seed components having a concentration 20 of annatto colorant significantly reduced" from the seeds themselves. ʼ453 patent 21 at 3:53-58. Applying ARN's own definition of a "byproduct solution of Bixa orellana" seeds to the present claims supports Defendants' position that what is 22 altered in the byproduct solution is the amount of annatto colorant, not the 23 underlying tocotrienol and geranylgeraniol compositions. The Court need not construe this term to find the claims § 101 ineligible. See Content Extraction and 24 Transmission LLC v. Wells Fargo Bank, Nat. Ass'n, 776 F.3d 1343 (Fed. Cir. 25 2014) ("[C]laim construction is not an inviolable prerequisite to a validity determination under § 101."). In any event, such a construction would not alter the 26 fact that ARN did not itself invent these byproduct solutions; they are a natural 27 consequence of the Bixa orellana seeds themselves. 28 -7- REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx) 1 Page ID #:516 1 cannot save them. Neither the specification nor the claims describe any specific type 2 of chemical modification, and therefore ARN's approach would preempt all such 3 byproduct solutions, regardless of how trivial such modification might be. 4 Moreover, ARN takes the specification's use of "chemically modified" out of 5 context. The full sentence from the specification states "[g]enerally, the concentration 6 of annatto colorant, which is defined as bixins and other carotenoids, chemically 7 modified, altered or esterified, in byproduct solution of Bixa orellana seed is less than 8 two percent, by weight." ʼ453 patent at 3:60-65. Neither the claims nor the 9 specification suggest that the tocotrienol or geranylgeraniol compounds found in the 10 seeds, or in the oily phase byproduct of Bixa orellana, have been chemically modified 11 or altered during any part of the claimed process. Instead, the chemical modifications, 12 precipitation, filtration, and centrifugation described in the patent specification, and 13 highlighted by ARN, relate to the process of obtaining the annatto colorant from Bixa 14 orellana seeds—a prerequisite before beginning the claimed process—not to the 15 underlying tocotrienol or geranylgeraniol compounds. See id. at 3:15-30, 3:50-65. 16 ARN also discusses the adding of a solvent to the byproduct solution, and 17 argues that this supports the proposition that the invention utilizes a non-naturally 18 occurring material. Opp. at 8-9. Again, however, there is no indication, either in the 19 ʼ453 patent or in ARN's opposition, that the addition of a solvent creates any changes 20 to the underlying tocotrienol and geranylgeraniol compounds. ARN's opposition 21 never suggests—nor could it—that the naturally-occurring tocotrienol and 22 geranylgeraniol compounds that are the subject of the claims at issue here are 23 chemically altered. The adding of caustic solution or organic solvent into the seeds 24 that ARN says chemically modifies the seeds (id. at 9) is only used to produce and 25 purify colorant, not change the structure of tocotrienols. 26 Thus, both ARN and the patent itself make plain that the tocotrienol and 27 geranylgeraniol compounds naturally occurring in Bixa orellana seeds remain 28 -8- REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx) 1 Page ID #:517 1 unchanged whether whole seeds or a byproduct of the seeds are utilized. Accordingly, 2 ARN's argument is inconsistent with how other courts interpret patentable subject 3 matter. See In re Bhagat, 726 Fed. Appx. 772, 777-79 (Fed. Cir. 2018) (finding claims 4 covering naturally occurring walnut oil and olive oil compositions unpatentable 5 because they were directed to natural products and the applicant failed to show how 6 properties of each were transformed as compared to how they exist in nature). 7 ARN's efforts to transform the challenged claims into something more complex 8 are also belied by the claims themselves. The claims are not, as ARN asserts, 9 "directed to" "processing undertaken in a lab that alters the underlying whole 10 dehusked annatto seeds." Id. at 15. Claim 1 does not mention "processing undertaken 11 in a lab," nor does it discuss "dehusked" seeds. 12 The specification contradicts ARN's assertions as well. It states that known 13 methods can be used to obtain the byproduct solution of Bixa orellana seed 14 components, plainly demonstrating that this step also cannot serve as the requisite 15 "inventive concept." See id. at 6:9-16; Alice, 573 U.S. at 217. For example, the 16 specification recognizes that there is nothing unique about forming the claimed 17 byproduct solution when it notes that "other methods can be employed" to produce the 18 byproduct solution. '453 patent at 6:9-16 (citing to 1990 reference). 19 In addition, the use of a byproduct solution to obtain desired product is also 20 well-known, routine, and conventional in this industry. See CreAgri, Inc. v. Pinnaclife, 21 Inc., No. 11-CV-6635-LHK, 2013 WL 6673676, at *1 (N.D. Cal. Dec. 18, 2013) 22 (discussing technology for obtaining particular chemical compositions from the 23 byproduct solution of olive oil production); In re Method of Processing Ethanol 24 Byproducts and Related Subsystems (ʼ858) Patent Lit., 303 F. Supp. 3d 791, 804 (S.D. 25 Ind. 2014) (discussing technology related to recovery of oil from thin stillage, which 26 is primarily a fluid made of water, oil and solids and is a byproduct of the corn to 27 ethanol production process). 28 -9- REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx) 1 Page ID #:518 1 At bottom, the challenged claims' use of a byproduct solution of Bixa orellana 2 seeds to obtain the underlying tocotrienol and geranylgeraniol compositions does not 3 remove them from the realm of natural phenomena. 4 C. The § 101 Case Law Supports Finding the Asserted Claims Invalid. 5 In arguing that the ʼ453 patent is not directed to a natural phenomenon, ARN 6 ignores or misconstrues relevant authority cited by Defendants, and its own cases are 7 easily distinguishable. 8 In its discussion of whether the '453 patent is directed to a natural phenomenon, 9 ARN ignores the § 101 decision involving claims most similar to those at issue here: 10 Ex parte Tan, No. 2017-001177, 2018 Pat. App. LEXIS 2394 (P.T.A.B. Mar. 6, 11 2018). In Tan, the Patent Trial and Appeal Board affirmed the rejection of ARN's 12 claims under § 101 in a patent application for a composition comprising "annatto seed 13 oil extract from an annatto seed, wherein the annatto seed oil extract comprises 14 tocotrienol" and plant oil extract that comprises tocotrienols as well. Id. at *2. Despite 15 prominent treatment of Tan throughout Defendants' opening brief (Mot. at 6-7, 13), 16 ARN simply ignores this case in its opposition, most likely because it cannot 17 distinguish it. 18 ARN also largely disregards Illumina, Inc. v. Ariosa Diagnostics, Inc., 356 F. 19 Supp. 3d 925 (N.D. Cal. 2018), appeal docketed, No. 19-1419 (Fed. Cir. Jan. 16, 20 2019). See Opp. at 17. Just like Illumina, the asserted claims here broadly recite the 21 use of general, well-known extraction techniques: volatilizing a solvent and distilling 22 components. See 356 F. Supp. 3d at 931-35. 23 The authority ARN does address receives only surface-level treatment; ARN 24 mostly just dismisses Defendants' authority as "detection" method cases. See Opp. at 25 16-17. Here again, ARN ignores that Defendants cited to non-"detection" cases as 26 well. See, e.g., Mot. at 6-7 (citing Ass'n for Molecular Pathology v. Myriad Genetics, 27 Inc., 569 U.S. 576, 580 (2013) (holding that a naturally occurring DNA segment is a 28 - 10 - REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx) 1 Page ID #:519 1 product of nature and not patent eligible merely because it has been isolated)). 2 But these so-called "detection" cases are still relevant. For example, in Ariosa, 3 the invention utilized a portion of "maternal blood samples that other researchers had 4 previously discarded as medical waste." Ariosa Diagnostics, Inc. v. Sequenom, Inc., 5 788 F.3d 1371, 1373 (Fed. Cir. 2015). Just as with the naturally occurring cffDNA in 6 Ariosa, the tocotrienol and geranylgeraniol compositions claimed by the '453 patent 7 are naturally occurring in the previously discarded byproduct of Bixa orellana seeds. 8 Id. at 1376. Just as in Ariosa, the '453 patent's claims employ nothing more than 9 routine and conventional steps: volatilization and distillation. 10 Similarly, in Roche Molecular Sys., Inc. v. CEPHEID, 905 F.3d 1363, 1371-72 11 (Fed. Cir. 2018), the method claims employed routine techniques and were directed to 12 a previously undiscovered naturally occurring phenomenon, i.e., that the presence of 13 eleven naturally occurring nucleotides indicated a diagnosis that the pathogenic 14 bacterium MTB was in a biological sample: "This relationship. . . is a phenomenon 15 that exists in nature apart from any human action, meaning the method claims are 16 directed to a natural phenomenon." Id. at 1371. The ʼ453 patent similarly is directed to 17 a discovery that tocotrienol and geranylgeraniol compounds are present in Bixa 18 orellana seeds, a natural phenomenon that exists apart from any human action. As in 19 Roche, the ʼ453 patent employs only routine techniques to utilize this discovery. 20 In addition to glossing over Defendants' cited case law, ARN's own authority is 21 distinguishable from the asserted claims here. For example, ARN mistakenly asserts 22 that the present case is analogous to United Cannabis Corp. v. Pure Hemp Collective 23 Inc., No. 18-cv-1922-WJM-NYW, 2019 WL 1651846 (D. Colo. April 17, 2019). 24 However, every independent claim in United Cannabis described "[a] liquid 25 cannabinoid formulation, wherein at least 95% of the total cannabinoids is a special 26 cannabinoid or combination of them." Id. at *2. The court there determined that the 27 "liquefied version of cannabinoids and related chemicals at the concentrations 28 - 11 - REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx) 1 Page ID #:520 1 specified" in the patent claims is not a natural phenomenon. Id. at *7. While ARN 2 copies language from this opinion in its opposition ("the claims are not the handiwork 3 of nature," Opp. at 16), ARN misses a key aspect of the court's reasoning: that the 4 claims in United Cannabis specified particular concentrations of the compounds. See, 5 2019 WL 1651846, at *2 (describing "an extract comprising a mixture of at least 95% 6 total cannabinoids, and at least one terpene/flavonoid"). ARN's claims lack these 7 details. 8 The United Cannabis court also noted that the claim there was more than just "a 9 process for extracting cannabinoids from cannabis plants." Id. at *6. Not so for the 10 asserted claims of the '453 patent, which simply recite methods for extracting 11 tocotrienols and geranylgeraniols from Bixa orellana seed byproducts. Moreover, the 12 "laboratory manipulation" ARN references (Opp. at 16) is nowhere in the plain 13 language of the asserted claims of the '453 patent. 14 ARN's next case fares no better. Opp. at 17. The method claims at issue in 15 CellzDirect call for multiple freezing cycles and have specific amounts of viable 16 hepatocytes needed in the product. See Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 17 827 F.3d 1042, 1047-48 (Fed. Cir. 2016). Not so for the '453 patent's claims. 18 The CellzDirect claim recited specific techniques ("density gradient 19 fractionation" and "cyropressing"), id., but the asserted claims of the '453 patent 20 recite only volatilization and distillation. The CellzDirect claim requires a specific 21 amount of viable compound ("wherein greater than 70% of the hepatocytes of said 22 preparation are viable after the final thaw"), id., but claim 1 of the ʼ453 patent broadly 23 recites forming any amount of tocotrienol composition. 24 As the following table shows, the differences between the CellzDirect claim and 25 the '453 patent's claim are readily apparent: 26 ʼ929 Patent, Claim 1 ʼ453 Patent, Claim 1 27 1. A method of producing a desired 1. A method of forming a tocotrienol 28 - 12 - REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx) 1 Page ID #:521 1 preparation of multi-cryopressed composition, comprising the step of hepatocytes, said hepatocytes being volatilizing a solvent from a byproduct 2 capable of being frozen and thawed solution of Bixa orellana seed 3 at least two times, and in which components to form thereby said greater than 70% of the hepatocytes tocotrienol composition. 4 of said preparation are viable after 5 the final thaw, said method comprising: 6 A) subjecting hepatocytes that have 7 been frozen and thawed to density gradient fractionation to separate 8 viable hepatocytes from nonviable 9 hepatocytes, B) recovering the separated 10 hepatocytes, and 11 C) cryopressing the recovered viable hepatocytes to thereby form 12 said desired preparation of 13 hepatocytes without requiring a 14 density gradient step after thawing the hepatocytes for the second time, 15 wherein the hepatocytes are not 16 plated between the first and second cryopreservations, and wherein 17 greater than 70% of the hepatocytes 18 of said preparation are viable after the final thaw. 19 20 ARN next relies on Kaneka Corp. v. Zhejiang Medicine Co., Ltd., No. CV 11- 21 02389-SJO, 2018 WL 2718036 (C.D. Cal. April 5, 2018). Here again, ARN attempts 22 to liken its broad claims to others that have much different, highly detailed language. 23 But the Kaneka claims are again readily distinguishable from those of the '453 patent. 24 Kaneka's claims recite specific steps such as culturing reduced CoQ10-producing 25 microorganisms in specific culture mediums, disrupting the microorganisms in a 26 specific way, and extracting the CoQ10 using specific equipment. See id. at *15. 27 Again, even a cursory comparison of the Kaneka claim to the '453 patent's claims 28 - 13 - REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx) 1 Page ID #:522 1 reveals just how different they are: 2 Kaneka Patent, Claim 22 ʼ453 Patent, Claim 1 22. A process for producing on an 1. A method of forming a tocotrienol 3 industrial scale the oxidized coenzyme composition, comprising the step of 4 Q10 represented by the following volatilizing a solvent from a byproduct formula… which comprises culturing solution of Bixa orellana seed 5 reduced coenzyme Q10-producing components to form thereby said 6 microorganisms in a culture medium tocotrienol composition. containing a carbon source, a nitrogen 7 source, a phosphorous source and a 8 micronutrient to obtain microbial cells containing reduced coenzyme Q10 at a 9 ratio of not less than 70 mole % among 10 the entire coenzymes Q10, 11 disrupting the microbial cells to obtain reduced coenzyme Q10; and 12 oxidizing thus-obtained reduced 13 coenzyme Q10 to oxidized coenzyme Q10 and then extracting the oxidized 14 coenzyme Q10 by an organic solvent in a 15 sealed tank. 16 In view of these specific method steps, the Kaneka court distinguished the 17 claims at issue—which were "a superior method of producing a certain end product … 18 efficiently creating oxidized CoQ10 on an industrial scale"—from "the inherent 19 properties of certain biological materials." Id. at *16. 20 This is not the case for ARN's claims. Kaneka's claims require particular 21 equipment ("a sealed tank"); ARN's do not. Kaneka's claims recite process steps with 22 specific requirements ("culturing coenzyme Q10-producing microorganisms in a 23 culture medium containing a carbon source, a nitrogen source, a phosphorous source 24 and a micronutrient"); ARN's do not. Kaneka's claims require specific results for the 25 processing steps ("obtain[ing] microbial cells containing reduced coenzyme Q10 at a 26 ratio of not less than 70 mole % among the entire coenzymes Q10"); ARN's do not. 27 28 - 14 - REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx) 1 Page ID #:523 1 Kaneka's claims and ARN's claims are plainly different. The outcomes should be 2 different as well. 3 Though it faults Defendants for citing to so-called "detection" case law, ARN 4 itself leans on two cases dealing with methods of treatment that look nothing like the 5 claims at issue here. Opp. at 18. Both cases deal with claims covering methods of 6 treating particular health conditions by administering particular drugs at particular 7 dosages. Endo Pharms. Inc. v. Teva Pharms. USA, Inc., 919 F.3d 1347, 1350-51 (Fed. 8 Cir. 2019); Vanda Pharms. Inc. v. West-Ward Pharms. Int'l Ltd., 887 F.3d 1117, 1121 9 (Fed. Cir. 2018). The claims were deemed patent eligible because they were "directed 10 to a specific method of treatment for specific patients using a specific compound at 11 specific doses to achieve a specific outcome." Endo, 919 F.3d at 1355 (citing Vanda, 12 887 F.3d at 1136). The challenged claims of the ʼ453 patent have no such specific 13 limitations or applications. Indeed, they are not methods of treatment at all. 14 In further arguing that the methods claimed in the ʼ453 patent contain an 15 "inventive concept," ARN accuses Defendants of not providing "case law teaching a 16 requirement that the methods used as part of the patent claims must be methods that 17 have never before been applied in the chemical or nutraceutical industry." Opp. at 23 18 (referring to claim 22 of the '453 patent). Again, ARN ignores the legal authority cited 19 throughout Defendants' opening brief, including Ariosa, which states that, "for 20 process claims that encompass natural phenomenon, the process steps are the 21 additional features that must be new and useful." 788 F.3d at 1377 (emphasis added). 22 ARN's attempt to use claim 22 to argue the subject matter eligibility of claims 23 1, 6, 7, and 10 also fails. See Opp. at 22-23. Defendants only challenge the validity of 24 the claims specifically asserted in the FAC: claims 1, 6, 7, and 10. Mot. at 1; see FAC, 25 ¶¶ 35, 45. ARN's reliance on claim 22 as supposedly showing a "complicated 26 27 28 - 15 - REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx) 1 Page ID #:524 1 process" is irrelevant for purposes of this motion.5 2 There is nothing complicated about the asserted claims here. They simply claim 3 "volatilizing a solvent" and "distilling" the tocotrienol and geranylgeraniol 4 compositions naturally residing therein. The claims don't require a specific type of 5 volatilization or distillation; they don't require any particular equipment; nor do they 6 recite any particular results. ARN has failed to show that the asserted claims of the 7 '453 patent recite more than just the presence of tocotrienol and geranylgeraniol 8 compositions in the byproduct of Bixa orellana seeds and ways to extract them. 9 The focus here is on claims 1, 6, 7, and 10, which each broadly covers 10 conventional, well-known volatilization and distillation techniques. ARN has failed to 11 show that these claims encompass any "inventive concept." 12 III. CONCLUSION 13 For the reasons set forth in Defendants' Memorandum in Support of its Motion 14 to Dismiss, and in this Reply, both claims for relief in the FAC should be dismissed. 15 16 Dated: May 17, 2019 MAYER BROWN LLP 17 By: /s/ Evan M. Wooten 18 Evan M. Wooten (SBN 247340) 19 ewooten@mayerbrown.com 20 MAYER BROWN LLP 350 S. Grand Ave., 25th Floor 21 Los Angeles, CA 90071-1503 22 Telephone: (213) 229-9500 23 Facsimile: (213) 625-0248 24 25 5 Should ARN seek to assert new claims other than those asserted in its amended 26 complaint, Defendants reserve the right to challenge the validity of those claims on 27 § 101 grounds. 28 - 16 - REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx) 1 Page ID #:525 1 Gary M. Hnath (admitted pro hac vice) 2 ghnath@mayerbrown.com Bryan Nese (admitted pro hac vice) 3 bnese@mayerbrown.com 4 Clark S. Bakewell (admitted pro hac vice) 5 cbakewell@mayerbrown.com MAYER BROWN LLP 6 1999 K Street NW 7 Washington, DC 20006 8 Telephone: (202) 263-3000 Facsimile: (202) 263-3001 9 10 Graham M. Buccigross (SBN 234558) 11 gbuccigross@mayerbrown.com MAYER BROWN LLP 12 Two Palo Alto Square, Suite 300 13 3000 El Camino Real 14 Palo Alto, CA 94306-2112 Telephone: (650) 331-2000 15 Facsimile: (650) 331-2060 16 Attorneys for Defendants Beijing Gingko 17 Group Biological Technology Co., Ltd.; 18 Jiangsu Xixin Vitamin Co., Ltd.; and Jinke 19 Group USA Inc. d/b/a Beijing Gingko Group North America 20 21 22 23 24 25 26 27 28 - 17 - REPLY IN SUPPORT OF DEFENDANTS' MOTION TO DISMISS UNDER RULE 12(b)(6) Case No. 8:18-cv-02201-JLS (JDEx)