Primus Group, Inc. v. Institute for Environmental Health, Inc., No. 3:2018cv00005 - Document 90 (N.D. Cal. 2019)

Court Description: ORDER DENYING PRIMUS'S 64 MOTION FOR SUMMARY JUDGMENT OF INVALIDITY; GRANTING INSTITUTE FOR ENVIRONMENTAL HEALTH, INC.S 63 MOTION FOR PARTIAL SUMMARY JUDGMENT; MOTIONS TO SEAL by Judge William H. Orrick. (jmdS, COURT STAFF) (Filed on 8/19/2019)

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1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 7 PRIMUS GROUP, INC., Plaintiff, 8 United States District Court Northern District of California 9 v. 10 INSTITUTE FOR ENVIRONMENTAL HEALTH, INC., 11 Defendant. 12 Case No. 18-cv-00005-WHO ORDER DENYING PRIMUS’S MOTION FOR SUMMARY JUDGMENT OF INVALIDITY; GRANTING INSTITUTE FOR ENVIRONMENTAL HEALTH, INC.’S MOTION FOR PARTIAL SUMMARY JUDGMENT; MOTIONS TO SEAL Re: Dkt. Nos. 62, 63, 64, 65, 66, 72, 74, 80 13 14 In this action, plaintiff and counter-defendant Primus Group Inc. (“Primus”) seeks 15 declaratory judgment of patent invalidity and of patent non-infringement related to two patents 16 owned by defendant and counterclaimant Institute for Environmental Health, Inc. (“IEH”), and 17 IEH asserts a counterclaim contending that Primus infringes on the same two patents. [Dkt. Nos. 18 23 and 25]. The patents in suit, Patent No. 8,822,143 (‘143 Patent) and Patent No. 9,637,771 19 (‘771 Patent), relate to testing for microbial contamination. Now Primus moves for summary 20 judgment to invalidate the patents in suit as being obvious (Primus Motion for Summary Judgment 21 of Invalidity (“Primus MSJ”) [Dkt. No. 66]) and IEH seeks partial summary judgment asserting 22 that Primus has infringed on its patents. Defendant Institute for Environmental Health, Inc.’s 23 Notice of Motion and Motion for Partial Summary Judgment (“IEH MSJ”) [Dkt. No. 62-4]. 24 Primus’s pooled testing method infringes IEH’s patented method 99.99% of the time, and IEH 25 does not claim infringement on the other .01%. For the reasons discussed, below Primus’s motion 26 for summary judgment is denied and IEH’s motion for partial summary judgment is granted. 27 28 BACKGROUND 1 2 Food Testing Primus and IEH are competitors in the field of testing for microbial contaminants in the United States District Court Northern District of California 3 4 food industry. In order to prevent foodborne illnesses, food is tested for the presence of pathogens 5 such as E. coli, Salmonella, and Listeria. Declaration of Dr. Bruce Applegate in Support of 6 Institute for Environmental Health, Inc.’s Opposition to Primus Motion for Summary Judgment of 7 Invalidity (“Applegate Decl.”) at ¶ 79 [Dkt. No. 74-10]. Notable outbreaks in the past include the 8 1993 outbreak of E. coli, which was traced to hamburgers at Jack-in-the-Box, and the 1996 E. coli 9 outbreak traced to Odwalla apple juice. Id.1 According to the Centers for Disease Control, 10 between 1998 and 2002, there were 6,647 reported outbreaks of foodborne disease, causing 11 128,370 persons to become ill. Id. (Michael Lynch, et al., Surveillance for Foodborne-Disease 12 Outbreaks – United States, 1998-2000, CDC (Nov. 10, 2006), 13 https://www.cdc.gov/mmwr/preview/mmwrhtml/ss5510a1.htm). Traditionally, the food industry approached pathogen testing as if contamination was 14 15 distributed uniformly through production “lots”; producers maximized the size of their lots to 16 reduce the number of pathogen tests that needed to be performed. Id. at ¶ 3. The downside to this 17 approach is that once a pathogen was detected, producers often had to destroy the entire large lot 18 of food. Id. But if producers instead used smaller lots, it would drive up costs by requiring 19 additional sampling and assays (tests) of each lot. Id. IEH’s founder, CEO, and President, 20 Mansour Samadpour, patented a method to test for pathogens that is meant to be faster and more 21 cost effective than testing either large lots or smaller lots individually. Id. at ¶ 3. 22 The Patents at Issue 23 The patents at issue describe a method for screening test lots for the presence or absence of 24 microorganisms. ‘143 Patent and ‘771 Patent attached as Exs. D-F to Declaration of Scott J. Allen 25 26 27 28 Dr. Applegate cites to Food Safety News, Jack in the Box E. coli Outbreak – 25th Anniversary (Dec. 27, 2017), https://www.foodsafetynews.com/2017/12/jack-in-the-box-e-coli-outbreak-25thanniversary/ and Pam Belluck, Juice-Poisoning Case Brings Guilty Plea and a Huge Fine, N.Y. Times (July 24, 1998), https://www.nytimes.com/1998/07/24/us/juice-poisoning-case-brings-guilty-plea-and-a-hugefine.html). 2 1 1 in Support of Motion for Summary Judgment (“Allen Decl.”) [Dkt. No. 66-1]. They are both 2 titled “Modular Compositing-Multiple Lot Screening Protocols for Detection of Pathogens, 3 Microbial Contaminants and/or Constituents.” Id. The invention claimed involves the following 4 steps: a) separately collecting multiple independent samples from each of multiple separate lots,2 wherein each separate lot is separately sampled by taking said multiple independent samples thereof; 5 6 b) separately compositing the collected multiple independent samples from each of the separate lots to provide a corresponding set of separate composited lot samples, wherein each of the separate composited lot samples is attributed to a particular corresponding separate lot; 7 8 9 c) enriching each of the separate composited lot samples to provide a set of separate composited lot samples enriched for the target microbe(s); 10 United States District Court Northern District of California 11 d) removing portions of each separate enriched composited lot sample, and combining the removed portions to provide a pooled modular composite sample; and 12 13 e) testing of the pooled modular composite sample, using a suitable detection assay, for the target microbe(s), wherein when such testing is negative all of said samples that were composited to form the separate composited lot samples are deemed negative for the target microbe(s) and each of the multiple separate lots is validated, and wherein when such testing is positive, each of the individual separate composited lot samples that were used to form the pooled modular composite sample are individually tested to determine which of the separate composited lot samples is positive for the target microbe(s), wherein the lots corresponding to any negatively testing composited lot samples are validated. 14 15 16 17 18 19 ‘771 Patent at 15:30-60; ‘143 Patent at 15:7-38. 20 Put more simply, step A involves collecting samples, step B involves combining those 21 samples (pooling/dry compositing), step C involves enriching the pooled samples to allow the 22 targeted bacteria (if present) to grow, step D involves taking portions of each enriched composited 23 sample (pooling again/wet compositing) into a pooled modular composited sample, and step E 24 involves testing that pooled modular composited sample for the presence of the target bacteria. If 25 the test is negative, step E validates all the lots from which the samples were drawn. If the test is 26 27 28 In my Claim Construction Order I construed this claim term as “Collecting multiple samples from different, non-contiguous locations from each of multiple separate lots.” [Dkt. No. 50]. 3 2 United States District Court Northern District of California 1 positive, step E requires testing of the enriched pooled samples, validating the lots for samples 2 which test negative. Primus characterizes steps A and B together as “dry compositing” and step C 3 as enrichment of the dry composited sample. Id. at 2-4. Step D is characterized as wet 4 compositing, with pre-enrichment (after the first of a two-step enrichment process) wet 5 compositing allegedly taught by the USDA and Price references and post-enrichment wet pooling 6 as taught by the Gombas reference. Id. at 4-5. 7 The enriching process described in step C is meant to make contamination easier to detect. 8 Applegate Decl. at ¶ 8. The composite samples are collected into a warm liquid in order to create 9 a condition that encourages bacteria to grow and multiply, akin to how leaving warm food outside 10 the refrigerator causes it to go bad more easily. Id. It is easier to detect bacteria in a sample when 11 there is more of it. Id. Conversely, pooling dilutes samples and makes contamination harder to 12 detect. Id. at ¶ 9. As a result, conventional wisdom taught that dilution should be avoided in 13 testing methods intended to locate small amounts of contaminants. Id. The testing method 14 described in the patent is meant to remain accurate despite the pooling, and to make it easier to 15 trace contamination to the correct lot when present. 16 According to Primus, each of these steps is taught by prior art. Primus MSJ at 2-7. 17 LEGAL STANDARD 18 A party is entitled to summary judgment where it “shows that there is no genuine dispute 19 as to any material fact and [it] is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). A 20 dispute is genuine if it could reasonably be resolved in favor of the nonmoving party. Anderson v. 21 Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A fact is material where it could affect the 22 outcome of the case. Id. 23 The moving party has the initial burden of informing the court of the basis for its motion 24 and identifying those portions of the record that demonstrate the absence of a genuine dispute of 25 material fact. See Celotex Corp. v. Catrett, 477 U.S. 317, 323-24 (1986). Once the movant has 26 made this showing, the burden shifts to the nonmoving party to identify specific evidence showing 27 that a material factual issue remains for trial. Id. The nonmoving party may not rest on mere 28 allegations or denials from its pleadings, but must “cit[e] to particular parts of materials in the 4 1 record” demonstrating the presence of a material factual dispute. Fed. R. Civ. P. 56(c)(1)(A); see 2 also Liberty Lobby, 477 U.S. at 248. The nonmoving party need not show that the issue will be 3 conclusively resolved in its favor. Id. at 24-49. All that is required is the identification of 4 sufficient evidence to create a genuine dispute of material fact, thereby “requir[ing] a jury or judge 5 to resolve the parties’ differing versions of the truth at trial.” Id. (internal quotation marks 6 omitted). If the nonmoving party cannot produce such evidence, the movant “is entitled to . . . 7 judgment as a matter of law because the nonmoving party has failed to make a sufficient showing 8 on an essential element of her case.” Celotex, 477 U.S. at 323. On summary judgment, the court draws all reasonable factual inferences in favor of the United States District Court Northern District of California 9 10 nonmoving party. Liberty Lobby, 477 U.S. at 255. “Credibility determinations, the weighing of 11 the evidence, and the drawing of legitimate inferences from the facts are jury functions, not those 12 of a judge.” Id. However, conclusory and speculative testimony does not raise a genuine factual 13 dispute and is insufficient to defeat summary judgment. See Thornhill Publ'g Co., Inc. v. GTE 14 Corp., 594 F.2d 730, 738-39 (9th Cir. 1979). DISCUSSION 15 16 17 I. PRIMUS’S MOTION FOR SUMMARY JUDGMENT Primus moves for summary judgment that the patents in suit are obvious because they are 18 composed entirely of techniques that were already known and well-understood in the field. 19 Primus MSJ at 1. It argues that IEH’s patents’ parent only survived re-examination by the USPTO 20 by a thin distinction between the method claimed and prior art. Id. That distinction is filled by 21 prior art not considered by the USPTO, according to Primus, and so the elements of the patents 22 would have been obvious to a microbiologist of ordinary skill. Id. 23 24 25 A. The Admissibility of Dr. Applegate’s Opinions 1. Striking Primus’s Counsel’s Declaration IEH’s opposition relies heavily on the opinions of its expert, Dr. Bruce Applegate. See 26 generally Defendant Institute for Environmental Health, Inc.’s Opposition to Primus’s Motion for 27 Summary Judgment of Invalidity (“Primus MSJ Oppo.”) [Dkt. No. 74-6]. Primus argues that IEH 28 cannot raise factual disputes based on Dr. Applegate’s testimony because he lacks any specialized 5 1 expertise in compositing methods or in many of the other topics on which he offers expert 2 opinions. Primus Reply in Support of its Motion for Summary Judgment Invalidity (“Primus MSJ 3 Reply”) at 1-2 [Dkt. No. 82]. Because the admissibility of Dr. Applegate’s declaration is key to 4 this motion, I will address that issue first. United States District Court Northern District of California 5 Preliminarily, Primus attached to its reply a declaration by its attorney, Scott Allen, which 6 is full of legal argument. Scott Allen Declaration in Support of Reply Memorandum, Motion for 7 Summary Judgment (“Allen Reply Decl.”) [Dkt 82-1]. IEH objects to portions of it and seeks to 8 have paragraphs 2-14 and Exhibits A-D struck because they contain improper argument and 9 conclusions that amount to a Daubert motion to which IEH has not had an opportunity to respond. 10 Defendant Institute for Environmental Health, Inc.’s Objection to Reply Evidence (“IEH 11 Objection”) [Dkt. No. 83]. 12 IEH is correct. Under Civil Local Rule 7-5(b), a declaration may only contain facts and 13 must avoid conclusions and argument. Non-compliant declarations may be struck in whole or in 14 part. As IEH argued, Primus attempted to exceed its reply brief page limit by embedding a 15 Daubert motion in the Allen Reply Decl. IEH Objection at 1. Its argument should have been in 16 Primus’s reply brief, yet its brief provides only a single conclusory statement that Dr. Applegate is 17 not qualified as an expert on a range of topics. Id. Otherwise, the reply relies on broad citations to 18 paragraphs 2-14 of the Allen Reply Decl. to provide its actual arguments. Id. Argument in a 19 declaration, by Primus’s counsel no less, violates Civil Local Rule 7-5(b). 20 21 22 Accordingly, I strike paragraphs 2-14 of the Allen Reply Decl. I will not strike the attachments because they do not contain improper attorney argument. 2. Dr. Applegate’s Qualifications 23 Turning to whether Dr. Applegate’s report and declaration should be considered to 24 evaluate Primus’s motion for summary judgment, Rule 702 allows a qualified expert to testify “in 25 the form of an opinion or otherwise” where: (a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; 26 27 28 (b) the testimony is based on sufficient facts or data; 6 1 2 3 4 (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case. Fed.R.Evid. 702. Expert testimony is admissible under Rule 702 “if it is both relevant and reliable.” Cooper v. Brown, 510 F.3d 870, 942 (9th Cir. 2007). “[R]elevance means that the 5 evidence will assist the trier of fact to understand or determine a fact in issue.” Id. Under the 6 7 8 reliability requirement, expert testimony must “relate to scientific, technical, or other specialized knowledge, which does not include unsubstantiated speculation and subjective beliefs.” Id. “Importantly, there must be a recognized body of knowledge, learning, or expertise upon which 9 the witness relies. Where there is no field of expertise, nobody will qualify as an expert witness on 10 the subject.” Perez v. Seafood Peddler of San Rafael, Inc., No. 12-cv-00116-WHO, 2014 WL 11 United States District Court Northern District of California 2810144, at *2 (N.D. Cal. June 20, 2014) (internal quotation marks omitted). The burden is on the 12 proponent of the expert testimony to show, by a preponderance of the evidence, that the 13 14 admissibility requirements are satisfied. Fed.R.Evid. 702 advisory committee’s note. The relevance of Dr. Applegate’s testimony is undisputed, so the question is whether it is 15 reliable. Dr. Applegate is a Professor in the Departments of Food and Biological Sciences at 16 Purdue University and has been associated with the Department of Food Science since 1999. CV 17 of Dr. Bruce M Applegate Ph.D. attached as Exhibit A to Applegate Decl. [Dkt. No. 75-4]. He 18 has knowledge about how beef and lettuce are tested from attending food safety workshops, 19 working with the Agricultural Research Service, and in pursuit of his own research developing 20 methods for the detection of pathogens. Deposition of Bruce Applegate at 17:22-25, 18:1-6, 21 18:22-19:3, 19:18-21, 20:2-9, 126:13-127:17 attached as Ex. A to Declaration of Jennifer K. 22 Chung in Support of Institute for Environmental Health, Inc.’s Objection to Reply Evidence [Dkt. 23 No. 83-1]. This is sufficient to qualify him as an expert on food testing, despite the testimony 24 identified by Primus that he does not research wet pooling or engage in compositing and 25 noncontiguous sampling specifically. Deposition of Bruce Applegate at 26:11-14, 27:19-24, 34:726 9, 35:8-11 attached as Ex. A to Allen Reply Decl. [Dkt. 82-1]. 27 Dr. Applegate admits that he lacks sufficient independent knowledge to determine whether 28 7 United States District Court Northern District of California 1 or not IEH’s invention would meet a long felt but unsatisfied need in the pathogen testing industry 2 in 2004. See Id. at 120:8-121:5. His testimony also shows that he is not qualified to provide an 3 analysis of the supply and demand factors in the pathogen testing industry or how those factors 4 might change over time. Id. at 192:3-193:12. He may not testify on either of these topics at trial. 5 B. Obviousness 6 The crux of Primus’s motion is that every step of the patents-in-suit has been taught by 7 prior art and that IEH’s patent should in invalidated due to obviousness. 35 U.S.C. § 103(a) 8 prohibits the issuance of a patent when “the differences between the subject matter sought to be 9 patented and the prior art are such that the subject matter as a whole would have been obvious at 10 the time the invention was made to a person having ordinary skill in the art to which said subject 11 matter pertains.” 35 U.S.C. § 103(a). Obviousness is a question of law based on underlying factual determinations. Insite Vision 12 13 Inc. v. Sandoz, Inc., 783 F.3d 853, 858 (Fed. Cir. 2015). The underlying factual inquires include: 14 (i) “the scope and the content of the prior art;” (ii) “the level of ordinary skill in the art;” and (iii) 15 “the differences between the claimed invention and the prior art.” Graham v. John Deere Co. of 16 Kansas City, 383 U.S. 1, 17 (1966). Secondary indicators such as “commercial success, long felt 17 but unsolved needs, [and] failure of others,” that can “give light to the circumstances surrounding 18 the origin of the subject matter sought to be patented” should also be considered. KSR Int'l Co. v. 19 Teleflex Inc., 550 U.S. 398, 399 (2007) (internal citations and quotation marks omitted). Evidence 20 of secondary considerations “may often be the most probative and cogent evidence [of 21 nonobviousness] in the record.” Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538 (Fed. Cir. 22 1983). 23 Each claim in an issued patent is presumed valid. 35 U.S.C. § 282. To invalidate a patent 24 on the basis of obviousness, the moving party must prove obviousness by clear and convincing 25 evidence. Oakley, Inc. v. Sunglass Hut Int’l, 316 F.3d 1331, 1339 (Fed. Cir. 2003). Summary 26 judgment of obviousness is appropriate if “the content of the prior art, the scope of the patent 27 claim, and the level of ordinary skill in the art are not in dispute, and the obviousness of the claim 28 is apparent in light of these factors.” KSR Int’l Co., 550 U.S. at 427. A factual dispute as to any 8 1 one of the elements will defeat a motion for summary judgment. See Helifix Ltd. v. Blok–Lok, 2 Ltd., 208 F.3d 1339, 1346 (Fed. Cir. 2000). Primus argues that the subject matter of the patents in suit are obvious when considering United States District Court Northern District of California 3 4 three academic papers, referred to by the parties as the Davies, Siragusa, and Gombas references, 5 in combination. Primus MSJ at 2-7, 10-11. According to Primus, it is undisputed that the Davies 6 reference teaches steps A (collecting multiple samples from multiple lots), B (dry compositing), 7 and C (enrichment of the dry composites). MSJ at 10; Expert Report of Michael Doyle (“Doyle 8 Report”) attached as Exhibit B to Declaration of Michael Doyle, Ph.D. in Support of Motion for 9 Summary Judgment (“Doyle Decl.”) at ¶ 37 [Dkt. No. 64-2]. IEH’s expert, Dr. Applegate does 10 not dispute that the Davies reference teaches steps A, B, and C.3 Applegate Decl. at ¶ 27; 11 Applegate Depo at 91:16-92:5, 99:11-25 attached as Ex. Q to Allen Decl. [Dkt. No. 66-1]. In 12 opposition, IEH argues that Primus misrepresents the Gombas reference and that a person of 13 ordinary skill in the art (“POSITA”) would not have been motivated to combine dry compositing 14 and enrichment in the Davies reference with the allegedly post-enrichment wet pooling and testing 15 in the Gombas reference. Primus MSJ Oppo. at 8-10. 1. The Scope and Content of Prior Art 16 a. 17 The Gombas Reference IEH argues that Primus incorrectly describes the scope and content of the prior art as 18 19 teaching that combining multiple levels of pooling would be obvious. Primus MSJ Oppo. at 8-12. 20 IEH contends that the Gombas reference does not teach the claimed enrichment process by 21 enriching a non-composite sample. Id. at 8. It asserts that this goes to the heart of Primus’s 22 obviousness theory. Id. It states that to minimize the problematic effects of the dilution inherent 23 in pooling, the Gombas reference teaches two countermeasures: (i) enriching the sample in two 24 stages for a total of 48 hours (instead of the typical 24 hours) and (ii) enriching more of the 25 product by dividing the sample in half and using the first half for pooling and the second half for 26 27 28 3 The parties somewhat puzzlingly dispute whether the Siragusa, Siliker, Price, and Jarvis references teach steps A, B, and C since it is undisputed that the Davies reference teaches these steps. Primus MSJ Oppo. at 10-12. 9 United States District Court Northern District of California 1 follow-up testing. Id. at 8-9; Applegate Decl. ¶¶ 75-76 [Dkt. No. 75-4]. But unlike the patents-in- 2 suit, IEH contends that the Gombas reference did not teach enriching non-contiguous samples as 3 its patents require. Applegate Decl. at ¶ 76. 4 According to Dr. Applegate, this difference exists because a POSITA would have been 5 concerned that enriching small portions of non-contiguous samples would lead to dilution and 6 therefore enriching the largest possible sample would be critical. Id. Additionally, Dr. Applegate 7 notes that the Gombas reference involved a two-stage testing process where a portion of the 8 enrichment process served as the first stage. Id. at ¶ 77. In the first stage, the Gombas reference 9 used a specialized enrichment medium that made any contamination visible by changing color. Id. 10 If the media indicated that the sample might be positive, the Gombas reference would teach that 11 further testing to confirm the presence of contamination should be conducted. Id. But if the 12 sample was not presumptively positive, the Gombas reference did not teach conducting any 13 additional testing. Id. Dr. Applegate states that although researchers such as the ones in the 14 Gombas reference may skip additional testing to lower costs, a business would not skip additional 15 testing of food that will be released into commerce. Id. IEH has not created a dispute of material fact with regard to whether Primus has 16 17 misrepresented the scope of the Gombas reference. As Primus argues in reply, the Gombas 18 reference did not involve a two-stage testing process. Instead, it consisted of two separate 19 analyses: screening, where pooling was used, and enumeration, which involved the color 20 changing specialized enrichment medium. Primus MSJ Reply at 3; Gombas at 563-564. There is 21 nothing within the text of the Gombas reference that suggests that any less than all of the enriched 22 samples were subjected to pooled testing during the screening analysis. Id. Looking at the 23 reference itself, it does not appear that any additional testing was skipped.4 Gombas at 563-64. 24 25 26 27 28 “After incubation, individual Maryland sample enrichments were swabbed onto two plates of modified lithium chloride-ceftazidime agar (mLCA). . . . Cell growth was collected from one of the plates with a cotton swab for composite screening with Gene-Trak, and the other plate was held for individual screening if needed. For each California sample, 0.1 ml of the demi-Fraser enrichment culture was transferred to 10 ml of morpholinepropanesulfonic acid-Listeria enrichment broth and incubated. . . . After the secondary enrichment, 1ml of the broth culture was used for screening with BAX assay as described below.” Gombas at 564. 10 4 1 Additionally, that the samples used in the reference were not from non-contiguous samples is not 2 relevant to whether it teaches steps D and E of the patents in suit, because the collection and 3 compositing of non-contiguous samples is not alleged to have been taught by the Gombas 4 reference. 5 United States District Court Northern District of California 6 b. The Siragusa Reference IEH argues that Primus has misrepresented the scope of the Siragusa reference. Primus 7 MSJ Oppo. at 10-11. The Siragusa reference involves a research study that analyzed multiple 8 herds of cows to determine how many herds were contaminated by testing each cow’s feces. 9 According to IEH, the reference does not teach sampling, compositing, and enriching the 10 composite because a POSITA would not consider that testing the entire herd was “sampling,” 11 which inherently requires testing less than the entire herd. Applegate Decl. at ¶¶ 32-34, 37-40. . 12 Primus counters that IEH is erroneously treating the cows as the samples, rather than the 10 gram 13 portion of their feces. Primus MSJ Reply at 6. 14 I largely agree with IEH. The purpose of the study was to detect listeria in the cows, not 15 just to study what percentage of cow feces contains listeria. Cow feces are not the product, the 16 cows are. Testing each cow does not teach representative sampling and pooling because it does 17 not allow one to extrapolate something probative about the presence of listeria in one cow to the 18 rest of herd. The method of testing each cow cannot be said teach step A in the patents in suit. 19 20 c. The Silliker Reference IEH and Primus reach opposite conclusions on the scope of the Silliker reference. Primus 21 claims that the reference “conclude[d] that Salmonella could be detected with ‘equal facility’ in 22 composite samples as individual samples” and this provided a motivation to combine the Gombas 23 reference with either the Siragusa or Davies references. Primus MSJ at 2-3 n.5. Dr. Applegate 24 opines the opposite, stating that the Silliker reference found that compositing samples decreased 25 accuracy and was apt to lead to false negatives. Applegate Decl. at ¶ 121. The parties also 26 disagree if the Silliker reference describes collecting multiple subsamples across multiple lots, or 27 two levels of compositing. Primus MSJ at 3 n.7, 7; Applegate Decl. ¶ 26. Primus notes that the 28 authors of the Silliker reference write that “[a]nalytical results from 26 samples of naturally 11 1 contaminated dried foods indicate that Salmonella-positive samples may be detected with equal 2 facility by analyzing sixty 25-g subsamples, fifteen 100-g subsamples, or three 500-g subsamples. 3 Pooling sixty 25-g or fifteen 100-g pre-enrichment cultures into groups of five (wet compositing) 4 followed by selective enrichment of the composites apparently results in the same assurance of 5 detection of positive lots as the analysis of individual samples.” Primus MSJ Reply at 5; Silliker 6 478. But this statement could be interpreted in two ways: as either proof that pooling works or 7 that pooling only works with sufficiently large subsamples to overcome the effects of dilution. 8 Whether a POSITA would interpret it in one way or the other is a disputed issue. d. 9 Primus cites the Price and Jarvis references to support its theory that multiple levels of 10 United States District Court Northern District of California The Price and Jarvis References 11 compositing is obvious, Primus MSJ at 7, 13-14, while IEH counters that Primus’s theory is based 12 on an incorrect description of the scope and content of both references. Primus MSJ Oppo. at 12. 13 Dr. Applegate opines that the Price reference does not describe the claimed sampling across lots, 14 the claimed dry compositing across lots, the claimed enrichment of multiple composite samples, 15 the claimed wet compositing, and the claimed validation process. Applegate Decl. ¶¶ 43-50. 16 According to Dr. Applegate, the Price reference teaches pre-enriching individual samples—not 17 composites—and that compositing should be avoided because “if many food samples are pooled at 18 the pre-enrichment stage, the target organism . . . face competition from the flora of all the 19 samples in the pool.” Applegate Decl. ¶ 49. He also contends that the reference uses only a single 20 level of pooling and teaches away from adding a second level as claimed by the patents in suit. Id. 21 at ¶ 50. 22 Primus quotes the Price reference in response: “These studies support the conclusion that 23 Salmonella pre-enrichment broths can be pooled for analysis without loss in sensitivity to 24 Salmonella in the individual samples.” Primus MSJ at 5-6; Price at 679. It argues that Dr. 25 Applegate’s quotation of the Price reference is out of context and merely refers to the superiority 26 of wet compositing over dry compositing. Id. The Price reference states: “If, on the other hand, 27 the samples are individually preenriched, the actively growing salmonellae might be expected to 28 compete more favorably with organisms introduced from other samples when pooled at the 12 1 enrichment stage.” Price at 681. Unlike the reference’s unequivocal statements that pooling can 2 be done “without a loss in sensitivity,” according to Primus, nothing within the reference’s actual 3 text indicates a conclusion on how many “levels” of compositing a method should have. Primus 4 MSJ at 5-6; Price at 681. 5 6 based on the appropriate level of abstraction. According to IEH, it teaches that one should pool 7 samples after they have been pre-enriched, otherwise it can lead to inaccurate results because the 8 target organism will have less competition. But according to Primus, it teaches that pooling is 9 possible generally if done correctly. This creates a dispute of fact about whether it supports 10 11 United States District Court Northern District of California As with the Silliker reference, there is a dispute about what the Price reference teaches Primus’s argument that multiple levels of compositing was obvious. Similarly, IEH contests Primus’s citation to the Jarvis reference as an alternative example 12 of two levels of dilution. Primus MSJ Oppo. at 12. Dr. Applegate opines that it also fails to 13 describe pooling of composites. Applegate Decl. at ¶¶ 51-65. This dispute is also material. 14 Relatedly, IEH notes that Primus’s definition of “enrichment” in its motion differs from 15 their agreed upon definition during claim construction. Primus MSJ Oppo. at 13-14. In the claim 16 construction order, “enrichment” was defined as “incubating a sample under conditions suitable to 17 allow levels of a target agent/organism that is present to reach detectable levels and become 18 uniform or substantially uniform.” Claim Construction Order at 4. But in its motion, Primus now 19 states that: 20 21 22 23 24 Enrichment typically involves incubating samples in enrichment media (often a liquid broth) in order to increase the numbers of the target microbe and facilitate detection. Sometimes the enrichment process is conducted in two parts—the first part, referred to as "preenrichment," is designed to allow injured bacteria to recover and start to multiply, and the second part, referred to as "secondary enrichment" or "selective enrichment" is then designed to allow bacteria to multiply to detectable levels. Primus MSJ at 3-4; Doyle Report. at ¶ 28. IEH contends that by expanding the term “enrichment” 25 to include pre-enrichment, Primus is attempting to show that the Silliker and Jarvis references 26 teach step C when both references teach pre-enrichment and not the parties’ agreed upon 27 definition of enrichment. Primus MSJ Oppo. at 13-14; Applegate Decl. at ¶¶ 51, 60, 122. IEH 28 13 1 asserts that the Silliker and Jarvis references do not provide a motivation to combine the collection 2 process of the Siragusa or Davies references with the post-enrichment compositing of the Gombas 3 reference. Id. Whether a POSITA would learn that the Silliker and Jarvis references teach step C 4 when they involve pre-enrichment rather than enrichment is a disputed issue of fact. 5 United States District Court Northern District of California 6 2. Who is a POSITA? The parties dispute the qualifications of a POSITA in this case. According to Primus’s 7 expert, Dr. Michael Doyle, a POSITA would likely have at least a bachelor’s degree in the field 8 and either an advanced degree or equivalent professional experience. Doyle Report at ¶ 18. This 9 person would be familiar with a variety of sampling, enrichment, and testing techniques, including 10 the pooling technique discussed in the Gombas reference and the sampling technique discussed in 11 the Davies reference. Id. 12 IEH’s expert, Dr. Applegate, asserts that a POSITA would have either an associate’s 13 degree and at least one year of experience in the field, or a bachelor’s degree in biology (or other 14 closely related subject and some experience in the field). Applegate Decl. at ¶ 10. In support of 15 this position, IEH notes that when Primus hires laboratory technicians it requires some relevant 16 class work, but no degree. See Deposition of Gosia Myers at 11:6-12 attached as Ex. D to 17 Declaration of Jennifer K. Chung in Support of Institute for Environmental Health, Inc.’s 18 Opposition to Primus Motion for Summary Judgment of Invalidity (“Chung Decl.”) [Dkt. No. 75- 19 3]. When Primus hires microbiologists, it requires no more than a bachelor’s degree. Id. at 12:3- 20 10.8. IEH also points out that Primus’s Director of Microbiology holds a bachelor’s degree in 21 microbiology and a master’s degree in an unrelated field. See Deposition of Adam Hughes at 22 16:3-17 attached as Ex. C to Chung Decl. [Dkt. No. 75-3]. 23 24 25 26 27 28 This conflicting evidence is sufficient to raise a disputed issue of fact regarding the qualifications of a POSITA in this case. 3. Does the Combination of the Davies/Siragusa References and the Gombas Reference Yield Predictable Results? With the above questions of fact in mind, I must determine if it would be obvious to a POSITA to combine the Davies/Siragusa and Gombas references. “[A] patent composed of several 14 1 elements is not proved obvious merely by demonstrating that each of its elements was, 2 independently, known in the prior art.” KSR Int’l Co., 550 U.S. at 418. In determining 3 obviousness, a court must avoid hindsight bias and ex-post facto reasoning. Id. at 421. “[A] judge 4 must not pick and choose isolated elements from the prior art and combine them so as to yield the 5 invention in question if such a combination would not have been obvious at the time of the 6 invention.” Dennison Mfg. Co. v. Panduit Corp., 475 U.S. 809, 810 (1986). In this regard, 7 “knowledge of a problem and motivation to solve it are entirely different from motivation to 8 combine particular references to reach the particular claimed method.” Innogenetics, N.V. v. 9 Abbott Labs., 512 F.3d 1363, 1373 (Fed. Cir. 2008). United States District Court Northern District of California 10 Identifying a motivation to combine is important because “inventions in most, if not all, 11 instances rely upon building blocks since uncovered, and claimed discoveries almost of necessity 12 will be combinations of what, in some sense, is already known.” KSR In’'l Co., 550 U.S. at 418- 13 19. When a POSITA is faced with “a finite number of identified, predictable solutions” to a 14 problem and pursues “the known options within his or her technical grasp,” the resulting discovery 15 “is likely the product not of innovation but of ordinary skill and common sense.” Id. at 402-03. 16 But if researchers can only “vary all parameters or try each of numerous possible choices until one 17 possibly arrives at a successful result, where the prior art gives either no indication of which 18 parameters are critical or no direction as to which of many possible choices is likely to be 19 successful,” then a finding of obviousness is not warranted. Procter & Gamble Co. v. Teva 20 Pharm. USA, Inc., 566 F.3d 989, 997-98 (Fed. Cir. 2009). 21 Primus argues that the method claimed is obvious because all the steps of the claimed 22 method perform exactly the same functions that they do in the prior art and the patents’ 23 combination of steps A-C with steps D-E simply represents application of a known sampling 24 technique to the prior-art pooling method of the Gombas reference. Primus MSJ at 13-14. IEH 25 makes two persuasive arguments to show that the undisputed evidence does not support this 26 factual contention. Primus MSJ at 14-19. 27 28 a. The Uncertain Nature of Pathogen Testing First, IEH argues that a POSITA would not find it obvious to combine the methods 15 1 described in the different references to teach every step of the patent-in-suit because the references 2 studied different types of pathogens and products. Primus MSJ Oppo. at 14-16. IEH cites facts 3 that show that different types of foods require different tests in order to determine the presence of 4 pathogens because some food have natural inhibitors, like spices or chocolates, that interfere with 5 the testing method and prevent predictable results when attempting to apply a method of testing 6 one food to another. Id.; Deposition of Dr. Michael P. Doyle at 146:1-6, 147:3-12, 148:12-22, 7 148:23-149:4, 149:6-22 attached as Exhibit A to Chung Decl. [Dkt. No. 74-12]. IEH also refers to two emails from Primus employees to support its argument. The first 8 9 comes from microbiologist Kenna Smith, who stated: 10 Produce is a complicated matrix with many factors to consider (organic residues, pesticides, soil particles, etc) that can cause a test not to function the way it is intended. Many of these challenges are unique to produce, and are not present in the beef or dairy side of the food industry. United States District Court Northern District of California 11 12 13 Id.; Exhibit L attached to Chung Decl. [Dkt. No. 74-12]. The second is from microbiologist 14 Roberto Guzman, who wrote that “[m]ost of the wet pooled research is made on feces from pigs, 15 turkeys, chicken and carcass but not on fresh produce or matrices more closely similar to the 16 received in our lab.” Exhibit M, attached to Chung Decl. [Dkt. No. 74-12]. He also said that “the 17 pool protocol is more viable on meat product.” Id. This means that a POSITA would not assume 18 that sampling and testing methods used for animal feces or ready-to-eat food would make sense to 19 combine without further expensive and time consuming validation studies and would therefore be 20 nonobvious. Id. at 16; Applegate Decl. at ¶ 110. 21 In reply, Primus argues that that IEH has mischaracterized Dr. Doyle’s testimony and that 22 he was actually discussing the reliability of assay methods and not the reliability or predictability 23 compositing techniques.5 Primus MSJ Reply at 8-10 (to “validate” means to “determine that a 24 particular sample tests negative using the detection assay”). But a close reading of Dr. Doyle’s 25 deposition is more ambiguous than Primus suggests. Dr. Doyle is asked why a worker should not 26 select an assay or a testing method absent additional data. Doyle Depo. at 145:3-5 attached as Ex. 27 28 5 In the patents-in-suit, the assay is the validation test run to determine the presence of the pathogen after compositing and enrichment. Claim Construction Order at 4. 16 1 2 3 4 5 6 7 E to Allen Reply Decl. [Dkt. No. 82-1]. Dr. Doyle responds that: Well, when—when a assay is developed that—for example, a shortened assay, and it’s done with the idea that you can run this assay in a very short period of time without comparing it to standard protocols where we know it takes longer to detect injured cells, as an example, those comparisons need to be made because if—you miss those, if you have gross contamination, you can likely pick it up. And if the cells aren’t injured, you can likely pick it up, and you can make that assay look really good to AOAC, but in real life—in real life, in reality, its very misleading to the—to whoever you are doing the testing for as to the validity of the results. Doyle Depo. at 145:10-22. The question asked, this response, and its reference to the effects of 8 injured bacterial cells and “real life” conditions, suggests a connection between the method of 9 sampling, dilution, and enrichment to the effect of different assays. 10 Further, when responding to a question about whether a POSITA would require additional 11 United States District Court Northern District of California data to confirm that an assay shown to work in one scenario would work in another, Dr. Doyle 12 answered that additional data would be required since “evidence to show that if [the assay] works 13 for one food under certain conditions that are defined by the manufacturer, . . . it may not be 14 translatable to . . . another food. Doyle Depo. at 148:12-22. Dr. Doyle then noted how in the 15 context of Salmonella testing, the FDA prescribes different enrichment protocols because certain 16 foods, such as spice and chocolate, have natural inhibitors that require particular enrichment 17 procedures. Doyle Depo. at 148:23-149:4. Dr. Doyle gives a similar answer in response to a 18 question about whether a POSITA could look at an assay or testing methodology and inherently 19 know the different contexts that it would work in. Id. at 149:6-22. 20 I agree with IEH that this is sufficient to create a dispute of material fact over whether a 21 POSITA would find it obvious to combine references related to different foods and pathogens to 22 create the method claimed by the patents in suit. My conclusion is not undermined by Primus’s 23 three other counterarguments that (i) the BAM reference teaches that sample collection and dry 24 compositing in the Siragusa/Davies references can be applied to a wide variety of food products, 25 (ii) a POSITA would only need to understand that combining the references might be viable in 26 some scenarios and (iii) that validation is simply part of the scientific process and does not create a 27 shroud of unpredictability. Primus MSJ Reply at 9-10. While those arguments may have some 28 17 1 merit, they speak to the weight of the evidence and do not eliminate the dispute of material fact. b. 2 3 IEH’s second argument is that the combination of the method taught by the Davies and 4 Gombas references would add another layer of dilution and multiply the unpredictability of the 5 results, and that a POSITA would understand that there is a cost in terms of accuracy to combining 6 samples and using fewer assays. Primus MSJ Oppo. at 16-17; Applegate Decl. at ¶ 109. IEH 7 notes that numerous references have described the dilution problem that comes with pooling. 8 Primus MSJ Oppo. at 16-17; Applegate Decl. at ¶ 121. Therefore, IEH argues, a POSITA would 9 have known that combining two levels of pooling would yield unpredictable results and would not 10 assume that doing so would be obviously successful. Id.; Applegate Decl. at ¶ 109. Primus responds that IEH fails to explain how its patent solved the dilution problem or 11 United States District Court Northern District of California Concerns About Dilution 12 improved the accuracy of microbial detection. Primus MSJ Reply at 7-8. Instead, Primus states 13 that “the patents simply claim a combination of dry compositing and wet compositing, with 14 apparent confidence that accuracy will not be compromised.” Id. It contends that this confidence 15 exists because it is grounded both in the Silliker and Jarvis references.6 Id. But as discussed 16 above, the meaning of those references is disputed and citing to them is not enough to eliminate a 17 material dispute of fact over whether a POSITA would find the results of combining the references 18 predictable in light of fears over dilution. Although the patents-in-suit do not purport to solve the 19 issues presented by dilution, this counter argument does not address whether a POSITA would 20 find the combination obvious. Because there is a material dispute of fact concerning whether a POSITA would find the 21 22 combination of prior art obvious, I deny Primus’s motion for summary judgment. I need not 23 consider the parties’ arguments related to objective indicia of nonobviousness in light of that 24 25 26 27 28 6 Primus also cites to a statement by the USDA in 2008 advising the mead industry that as long as care was taken “to ensure that the enrichment procedure (time and temperature of incubation) is adequate,” it “believe[d] that the testing of pooled samples from 5 individual enriched samples can be made without losing sensitivity” Exhibit K to Allen Decl. [Dkt. No. 64-1]. But the patents in suit were continuations of an application filed in 2005 so that statement is not relevant. See the ‘771 Patent and the ‘143 Patent. 18 1 ruling.7 2 II. IEH moves for partial summary judgment against Primus for infringing the same patents- 3 4 in-suit just discussed. IEH MSJ at 1. Primus and IEH compete in the microbiological testing 5 market. Deposition of Adam Hughes (“Hughes Depo.”) at 130:21-131:20 attached as Ex. C to 6 Declaration of Benjamin J. Byer in Support of Institute for Environmental Health, Inc.’s Motion 7 for Partial Summary Judgment (“Byer Decl.”) [Dkt. No. 63-1]. The parties have won and lost 8 customers from each other and come across each other regularly in the marketplace. Id. Primus had used a pooling testing method in 2007 but stopped in 2008, not restarting it 9 United States District Court Northern District of California IEH’S MOTION FOR PARTIAL SUMMARY JUDGMENT 10 until they were asked to do so by a client.8 Deposition of Gosia Myers (“Myers Depo”) attached 11 as Ex. E to Byer Decl. [Dkt. No. 63-1]. Now it offers pooled testing services to test for four 12 pathogenic bacteria: Salmonella; Shigatoxin producing E. coli (STEC) serotypes including E. Coli 13 O157:H7; Listeria monocytogenes; and Listeria spp. Declaration of Dr. Bruce Applegate in 14 Support of Institute for Environmental Health, Inc.’s Motion for Partial Summary Judgment 15 (“Applegate MPSJ Decl.”) at ¶ 8 [Dkt. No. 62-6]. 16 IEH accuses Primus’s pooled testing services of infringing claims 1, 2, 5, 18, 19, 22, 29, 17 35, and 36 of the ’143 patent and claims 1, 2, 4, 6, 22, 23, 26, 36, 37, 38, 47, and 48 of the ’771 18 patent. See Applegate MPSJ Decl. ¶ 43; Infringement Table attached as Ex. B. to Applegate 19 MPSJ Decl. [Dkt. No. 62-7]. Using claim 1 of the ‘143 patent as an example IEH states that: 20 Method of sampling and testing: The pooled testing services offered by Primus are a method “of sampling and testing for microbes in multiple separate test lots.” [Applegate MPSJ Decl. at] ¶¶ 16-17. 21 22 Step A: Primus begins by separately collecting multiple independent samples from multiple separate test lots. Id. ¶¶ 8-9, 18-22. Primus either conducts this step itself or instructs its customers to conduct this step on its behalf. Id. ¶ 22; see Travel Sentry, Inc. v. Tropp, 877 23 24 25 26 27 28 7 The evidence here also creates the same issues of material fact with regards to the dependent claims in the patents-in-suit that are more focused on specific industrial applications. Primus MSJ Oppo. at 24-25. Primus’s arguments to the contrary are wholly conclusory. Primus MSJ at 2 n.4. 8 The parties dispute whether this customer provided Primus with the IEH pooling recipe, but it is not material. Myer Depo at 22:22-25; Primus Opposition to IEH’s Motion for Partial Summary Judgment (“IEH MSJ Oppo.”) at 6-7 [Dkt. No. 73]. 19 1 2 3 4 5 6 7 8 9 10 United States District Court Northern District of California 11 12 13 14 F.3d 1370, 1381 (Fed. Cir. 2017) (“[T]he restrictive view of when the acts of a third party can be attributable to another . . . is no longer the governing law. In other words, [Akamai V] ‘broaden[ed] the circumstances in which others’ acts may be attributed to an accused infringer to support direct-infringement liability for divided infringement . . . .’”) (third alteration in original) (citation omitted). Step B: Primus then separately combines the samples from each of the test lots to create a set of separate composited test lot samples. Applegate Decl. ¶¶ 8-9, 23-29. Step C: Primus enriches each of the composited test lot samples for the target microbe to create a set of enriched composited test lot samples. Id. ¶¶ 10, 30-31. Step D: Primus removes portions of each enriched composited test lot sample, and combines the portions together to create a pooled sample. Id. ¶¶ 11, 32-34. Step E: Primus then uses a suitable detection assay to test the pool for the target microbe. When that test is negative, Primus validates all of the test lots. But when that test is positive, Primus individually tests each of the enriched composite samples to identify those contaminated with the target microbe. At that point, Primus validates the test lots corresponding to any negatively testing composite. See id. ¶¶ 12-13, 35-42. IEH MSJ at 12-13. 15 Primus only disputes whether it practices step E. IEH MSJ Oppo. Primus characterizes 16 step E of having two sub-steps: (E1) testing a pooled sample, wherein when the pooled sample 17 tests negative, the individual samples are deemed negative; (E2) when the pooled sample tests 18 positive, testing the individual samples wherein the lots corresponding to any negatively testing 19 composited lot samples are validated. Id. at 1-2 (internal quotation marks omitted); ‘771 Patent. 20 Primus states that its pooled testing protocols do not practice step E2. Id. at 2. “Instead, when a 21 pooled sample tests positive, Primus performs testing of the individual samples, wherein 22 negatively testing samples are validated only if at least one other sample in the pool tests 23 positive.” Id.; Declaration of Adam Hughes in Support of Primus’s Opposition to Motion for 24 Partial Summary Judgment (“Hughes Decl.”) at ¶ 3 [Dkt. No. 72-5]. If none of the individual 25 samples test positive, all individual samples are deemed presumptively positive and Primus will 26 generally retest the pooled sample using a cultural confirmation assay. Hughes Decl. at ¶ 4. If the 27 cultural confirmation result is negative, the individual samples are then validated, but if the result 28 is positive, under Primus’s error protocol the individual samples are deemed positive, despite 20 United States District Court Northern District of California 1 having tested negative. Id. In other words, according to Primus, under its protocol, one of the 2 following conditions must be met: (i) the pooled sample tests negative; (ii) the individual sample 3 tests negative and at least one of the other samples making up the pooled sample tests positive; or 4 (iii) the pooled sample tests negative upon cultural confirmation. IEH MSJ Oppo.; Hughes Decl. 5 at ¶ 4. 6 IEH states that Primus’s “error protocol” is used exceedingly rarely; according to Primus, 7 this scenario occurs less than .01% of the time. Hughes Depo. at 90:2-22. Dr. Applegate opines 8 that the error protocol is likely only used when something has gone wrong, such as a Primus 9 employee unintentionally contaminating the pool after forming it from uncontaminated samples. 10 Applegate MPSJ Decl. at ¶ 41. IEH is not asserting its patents against instances where Primus 11 follows its error protocol and does not validate lots; therefore, the error protocol should have no 12 relevance to whether Primus infringes the other 99.99% of the time. IEH MSJ at 15. 13 IEH argues that the patents’ claims do not exclude additional testing of the pool or 14 individual samples, so the additional confirmation test in Primus’s error protocol does not mean 15 that its standard protocol does not satisfy the validation step in the patents. Id. It contends that 16 because the invention claimed is “[a] method of sampling and testing for microbes in multiple 17 separate test lots, comprising” the claim elements, the use of the term “comprising” indicates that 18 it covers methods that include additional steps. Id. at 15-16. It also argues that “[u]nder the 19 principles of claim differentiation, the independent claims are presumed to be broader” than a 20 patent’s dependent claims. Id. (citing Hill-Rom Servs., Inc. v. Stryker Corp., 755 F.3d 1367, 1376 21 (Fed. Cir. 2014). It points out that both patents-in-suit include dependent claims requiring 22 additional testing “to enhance confidence in the negative testing results.” Id.; Claims 28, 38 of the 23 ’143 patent; Claims 35 and 40 of the ’771 patent. Thus, according to IEH, Primus’s additional 24 testing does not affect its infringement. Id. 25 Primus responds that use of the word “comprising” cannot abrogate claim limitations and 26 that the steps must still all be practiced as recited in the claim for a process to infringe. IEH MSJ 27 Oppo. at 3-4 (citing Dippin’Dots, Inc. v. Mosey, 476 F. 3d 1337, 1343 (Fed. Cir. 2007); FlatWorld 28 Interactives LLC v. Apple Inc., No. 12-cv-01956-WHO, 2014 WL 31392 (N.D. Cal. Jan. 3, 2014)). 21 1 It contends that the claims asserted by IEH do not say that “the lots corresponding to any 2 negatively testing composited lot samples may be validated” or that “the lots corresponding to 3 some negatively testing composited lot samples are validated”; they say that “the lots 4 corresponding to any negatively testing composited lot samples are validated.” Id. at 4 (emphasis 5 in original). Therefore, Primus argues, it does not practice this limitation and its services do not 6 infringe IEH’s patents. Id. United States District Court Northern District of California 7 Primus’s argument is unconvincing. As IEH noted in its reply, Primus’s assertion is 8 contrary to FlatWorld and to the well-understood meaning of “comprising.” Reply in Support of 9 Institute for Environmental Health, Inc.’s Motion for Partial Summary Judgment (“IEH MSJ 10 Reply”) at 4-7 [Dkt. No. 80-4]. IEH’s other dependent claims confirm that step E2 is broad 11 enough to include additional confirmation tests, such as Primus’s error protocol, prior to 12 validation. Id. at 6. 13 As the Federal Circuit stated in Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., other 14 claims in a patent can be “valuable sources of enlightenment as to the meaning of a claim term” 15 and that courts should strive to reach a “claim construction that does not render claim language in 16 dependent claims meaningless.” 520 F.3d 1358, 1362 (Fed. Cir. 2008) (internal citations and 17 quotation marks omitted). In the ‘143 Patent, dependent claims 28 and 35 both require testing “to 18 enhance confidence in the negative testing results” and show the patentee intended the 19 independent claims to allow for additional testing. If step E2 did not allow for additional tests 20 prior to validation, these dependent claims would be meaningless. Primus’s error protocol does 21 not put its pooled testing services outside of the claims in the Patents-in-Suit. 22 I also agree with IEH that Primus has misinterpreted Flatworld. In that case, Apple and 23 FlatWorld disagreed whether exceeding the threshold velocity was a necessary, as opposed to a 24 sufficient, condition for “throwing” of an image (or removal) to occur. FlatWorld, 2014 WL 25 31392, at *4. I adopted Apple’s construction and found that exceeding the threshold velocity was 26 sufficient to cause an image to be removed and that there was no indication in the claims that 27 anything additional was necessary. Id. I rejected FlatWorld’s argument that “comprising” meant 28 that the “threshold velocity” condition was not, by itself, enough to trigger removal because the 22 1 argument made “an unwarranted leap of logic from the proposition that the recited elements are 2 not exclusive to the conclusion that they are insufficient for some previously disclosed result to 3 take place.” Id. at *5. As IEH argues, here “comprising” means that step E2 does not exclude 4 additional conditions, such as Primus’s error protocol, prior to validation. IEH MSJ Reply at 5. Dippin’Dots also does not support Primus’s stance. There, the parties disputed whether the United States District Court Northern District of California 5 6 claim was limited to a process that produced beads or if it also included a process that produced 7 beads and irregular particles. 476 F.3d at 1343. The Federal Circuit upheld the district court’s 8 refusal to construe “comprising” as including both beads and irregular particles because the 9 patentee had “narrowly defined the claim term it now seeks to have broadened.” Id. But here, 10 IEH has not narrowly defined step E2, as shown by the dependent claims, to exclude Primus’s 11 error protocol. Primus separately argues that it never performs the validation step as recited in the claims 12 13 because the error protocol is always a part of its process, even if it is not used in a way that 14 diverges from IEH’s patented method 99.99% of the time. IEH MSJ Oppo. at 4-6. Although this 15 argument fails for the reasons discussed above, it also lacks merit for other reasons that I discuss 16 below. 17 Primus relies heavily on UltimatePointer, L.L.C. v. Nintendo Co., 816 F.3d 816 (Fed. Cir. 18 2016), where the patent in suit described a handheld pointing device that could be used to control 19 the cursor on a projected computer screen through measuring its location and orientation relative 20 to the projected image, and use that measurement to determine where on the image to display the 21 cursor. Id. at 818-19. UltimatePointer characterized its product as a direct-pointing device where 22 the physical point-of-aim coincides with the item being pointed at. Id. This was in contrast to the 23 remote on Nintendo’s Wii gaming console, which could control an on-screen cursor through the 24 interaction of the remote and a sensor bar. Id. at 820. UltimatePointer sued Nintendo and Wii 25 retailers, alleging that the Wii gaming console infringed several of its patent’s claims. Id. The 26 court construed UltimatePointer’s claims to require a direct pointing device and concluded that the 27 Wii remote was an indirect pointing device because it interacted solely with the sensor and not the 28 screen. Id. at 824-25. The court then reasoned that although the rule that “imperfect practice of an 23 1 invention does not avoid infringement,” and that “an accused device that ‘sometimes, but not 2 always, embodies a claim[ ] nonetheless infringes’” was still good law, it was not applicable in 3 that case. Id. at 825 (citing Paper Converting Mach. Co. v. Magna–Graphics Corp., 745 F.2d 11, 4 20 (Fed. Cir. 1984), Broadcom Corp. v. Emulex Corp., 732 F.3d 1325, 1333 (Fed. Cir. 2013), and 5 Bell Commc'ns Research, Inc. v. Vitalink Commc'ns Corp., 55 F.3d 615, 622–23 (Fed.Cir.1995)). 6 This was because the Wii remote, in any arrangement, could never infringe on UltimatePointer’s 7 patent because it could never act as a direct pointing device. Id. It could only perform indirect 8 pointing. Id. This case does not help Primus. Even if I ignore the effect of the dependent claims, United States District Court Northern District of California 9 10 Primus’s pooled testing method always infringes on the independent claims in the 99.99% of 11 instances where it does not engage in the error protocol. Additionally, as IEH notes “[i]f the 12 condition for performing a contingent step is not satisfied, the performance recited by the step 13 need not be carried out in order for the claimed method to be performed.” Cybersettle, Inc. v. 14 Nat'l Arbitration Forum, Inc., 243 F. App'x 603, 607 (Fed. Cir. 2007). Because step E2 is 15 contingent on step E1, Primus infringes the independent claims whenever the pooled sample tests 16 negative and the lots are validated or the pooled sample tests positive and the contamination is 17 traced back to a particular subsample (as occurs 99.99% of the time). There is a broader absurdity to Primus’s argument. According to Primus, anyone could 18 19 copy a patented method without infringing as long as it introduced some sort of step at the end that 20 is effectively never performed. For a method patent to have any usefulness, this cannot be the 21 case. For these reasons, I find that there is no dispute of material fact that Primus practices step 22 23 E of the patents in suit. IEH’s motion for partial summary judgment is granted. 24 III. MOTIONS TO SEAL 25 The parties filed five motions to seal in conjunction with their motions for summary 26 judgment. [Dkt. Nos. 62, 65, 72, 74, 80]. Courts have long recognized a “general right to inspect 27 and copy public records and documents, including judicial records and documents.” Nixon v. 28 Warner Commc’s Inc., 435 U.S. 589, 597 (1978). A party seeking to seal judicial records attached 24 United States District Court Northern District of California 1 to a dispositive motion must “articulate[ ] compelling reasons supported by specific factual 2 findings that outweigh the general history of access and the public policies favoring disclosure.” 3 Kamakana v. City & Cty. of Honolulu, 447 F.3d 1172, 1178-79 (9th Cir. 2006) (alteration in 4 original) (internal quotation marks and citations omitted). Examples of compelling reasons 5 include when court records are used for “improper purposes,” such as “to gratify private spite, 6 promote public scandal, circulate libelous statements, or release trade secrets.” Id. at 1179 (citing 7 Nixon, 435 U.S. at 598). Similarly, “sources of business information that might harm a litigant’s 8 competitive standing” may also constitute a compelling reason to seal, see Nixon, 435 U.S. at 598, 9 as may a company’s confidential profit, cost, and pricing information that if publicly disclosed 10 could put the company at a competitive disadvantage, see Apple Inc. v. Samsung Elecs. Co., 727 11 F.3d 1214, 1225 (Fed. Cir. 2013). The court must balance the competing interests of the public’s 12 right of inspection against litigants’ need for confidentiality, and “if the court decides to seal 13 certain judicial records, it must base its decision on a compelling reason and articulate the factual 14 basis for its ruling, without relying on hypothesis or conjecture.” Kamakana, 447 F.3d at 1179. 15 A. 16 In the first motion to seal, IEH moves to seal portions of its motion for partial summary The First Motion to Seal 17 judgment and portions of the attached declaration of Dr. Bruce Applegate because Primus has 18 designated certain information confidential under the interim protective order. [Dkt. No. 62]. 19 Primus submits a declaration in support of the motion stating that the redacted portions of exhibit 20 B [Dkt. No. 62-7] contain detailed discussion of the field and laboratory protocols used by Primus 21 based on Dr. Applegate’s review of Primus’s confidential standard operating procedure 22 documents. [Dkt. No. 68]. Primus argues that if this information were filed publicly, competitors 23 could use it to Primus’s disadvantage to develop their own protocols without investing similar 24 time and resources. Id. I do not find that Primus’s characterization of its methods as confidential 25 to be the equivalent of arguing that they are a trade secret or that its reasons to keep exhibit B 26 under seal outweigh the public’s right of inspection. This is particularly true because the specifics 27 of Primus’s method are the subject of IEH’s motion for summary judgment, which I granted. The 28 motion to seal exhibit B to the declaration of Dr. Applegate is denied. 25 United States District Court Northern District of California 1 The redacted portions of exhibits D, G, and J contain internal Primus emails discussing 2 Primus’s costs and pricing practices that are not generally known to Primus’s customers and 3 competitors. Id. If they were filed publicly, Primus claims that competitors could use this 4 information to Primus’s disadvantage by adjusting their own pricing to compete more effectively. 5 Id. Similarly customers and potential customers could use this information in price negotiations to 6 demand more favorable terms. Id. Here, I find Primus’s reason to seal to be compelling and I do 7 not use any of the sealed information to decide IEH’s motion for summary judgment. The motion 8 to seal as to exhibits D, G, and J is granted. 9 Finally, exhibits F, G, H, and I contain internal Primus emails revealing the identity of and 10 information about specific customers. Id. If filed publicly, competitors could use this information 11 to effectively target their marketing efforts without expending similar time and resources to learn 12 about the product testing needs of particular companies. I find Primus’s reasoning compelling 13 here as well, find Primus’s redactions to be narrowly tailored, and do not rely on this information 14 in deciding the above motions. The motion to seal exhibits F, G, H, and I is granted. 15 B. 16 In the second motion, Primus seeks to seal portions of its motion for summary judgment The Second Motion to Seal 17 and certain exhibits because either IEH marked them confidential under the protective order or 18 because they relate to Primus’s sales volumes from 1998-2018. [Dkt. No. 65]. Primus argues that 19 it derives value from the continued confidentiality of this data during its price negotiations with 20 clients and vendors, and disclosure would hurt its competitive standing. Id. Primus has not 21 provided compelling reasons to justify sealing the information related to its sales data. Its sales 22 data only states the number and types of tests performed. Primus’s conclusory argument that its 23 disclosure would damage its competitive standing is unpersuasive and conclusory. Primus MSJ at 24 19. This is true of the declaration of Robert Stovicek and the attachments to Stovicek’s 25 declaration as well. [Dkt. No. 66-2]. 26 Turning to the arguments in favor of sealing by IEH, Mansour Samadpour submits a 27 declaration in support of Primus’s motion to seal stating that IEH seeks to seal documents attached 28 to the declaration of Scott Allen because they contain sensitive and proprietary trade secrets, 26 1 including the confidential identities of clients and other confidential client information, IEH’s non- 2 public market share, IEH’s revenue, details of IEH’s business methods, and the technical operation 3 of IEH”s services. [Dkt. No. 69]. As an initial matter, IEH’s declaration only identifies and seeks 4 to seal certain portions of each exhibit, constituting 261 out of 497 pages of the Allen declaration. 5 But the entirety of the Allen declaration and the accompanying exhibits have been filed under seal. 6 IEH’s request is not narrowly tailored and its sealed filing contains numerous public documents 7 such as the Gombas reference and a PTAB decision. 8 United States District Court Northern District of California 9 As for the exhibits identified by IEH, the portions of exhibit A containing Dr. Samadpour’s deposition (pages 6-12) and Exhibit N containing a response by Washington Beef, LLC to a FSIS 10 Notice of Intended Enforcement Action (NOIE) dated July 5, 2006 (pages 428-465) contain 11 confidential client information. There is a compelling reason to grant the motion to seal on this 12 information. As to the other exhibits, pages 24-192 contain a slideshow used in the deposition of 13 Dr. Samadpour. IEH argues that it should be sealed because it contains proprietary information 14 about IEH's processes, including trade secret information regarding molecular targets and how 15 IEH applies its proprietary processes over time. Having reviewed the slideshow, I am persuaded 16 that it contains trade secret information beyond the methods taught in IEH’s patents or relied upon 17 in my order on Primus’s motion for summary judgment. The motion to seal exhibits A and N is 18 granted. 19 IEH argues that the remaining exhibits contain confidential information pertaining to 20 IEH’s business practices, revenue, and business strategy. This includes exhibit B, which contains 21 portions of the deposition of Dr. Mohammad Koohmaraie (pages 207-252); Exhibit C, which 22 contains a selected page from Dr. Applegate’s report (page 270); and exhibit P which contains a 23 letter from the Food Safety and Inspection Service (page 485-489). IEH’s argument that 24 disclosure of these exhibits would hurt its competitive standing is unpersuasive and does not raise 25 a compelling reason to seal these documents that outweighs the public’s right of access. Some of 26 the information IEH seeks to seal is also well known to the public and is not confidential. For 27 example pages 213 to 217 in the attachment to Dr. Koohmaraie deposition describes a well-known 28 E. coli outbreak. The motion to seal these exhibits is denied. 27 United States District Court Northern District of California 1 Because all the exhibits have been filed under seal together, Dkt. No. 66-1 will remain 2 under seal. IEH is directed to refile exhibits A and N under seal and to also refile unsealed 3 versions of the other exhibits. Primus’s unredacted version of its motion for summary judgment 4 [Dkt. No. 66] shall also be unsealed because the redactions relate to exhibits that I have ordered to 5 be unsealed. 6 C. 7 In the third motion to seal, in connection with its opposition to IEH’s motion for summary 8 judgment, Primus moves to seal portions of an exhibit that contains confidential communications 9 between Primus and its clients regarding the clients’ test results and information marked The Third Motion to Seal 10 confidential by IEH. [Dkt. No. 72]. With regards to its own communications, Primus argues that 11 they contain confidential business information concerning Primus’s customers and the results of 12 microbiological testing performed for those customers. Id. It states that revealing the identity of 13 customers and the specific services provided to them would harm its competitive standing because 14 competitors would more effectively be able to target their marketing efforts without expending the 15 time and resources that it has invested in learning about the product testing needs of these 16 particular companies. Id. It also claims that disclosure would provide its competitors and its 17 customers’ competitors with valuable insights into the prevalence of particular microbes in 18 particular product categories without conducting similar tests themselves. Id. It contends that 19 there is a public interest in sealing these documents because public exposure of test results would 20 undermine food producers’ confidence in the confidentiality of such tests and discourage further 21 testing. Id. Primus has provided a compelling reason to seal the client emails attached to the 22 declaration of Adam Hughes. [Dkt. No. 72-5]. 23 IEH also submits a declaration in support of Primus’s motion stating that exhibit A to the 24 declaration of Gosia Myers contains sensitive and proprietary trade secrets, including confidential 25 identities of clients and other confidential client information, and details of IEH’s business 26 methods and the technical operation of IEH’s services and that disclosure would hurt IEH’s 27 competitive standing. [Dkt. No. 78]. Exhibit A is titled IEH Laboratories Standard Operating 28 Procedure and does not appear to contain any confidential client information. [Dkt. No. 72-6]. 28 1 Additionally, I am not persuaded by IEH that the methods described differ significantly from the 2 claimed invention such that they constitute a trade secret or that there is otherwise a compelling 3 reason to seal this document. The motion to seal exhibit A to the declaration of Gosia Myers is 4 denied. 5 D. 6 The fourth motion to seal is in connection with IEH’s opposition to Primus’s motion for 7 summary judgment. [Dkt. No. 74]. IEH seeks to seal portions of its opposition, portions of the 8 declaration of Dr. Bruce Applegate filed in support, limited portions of the declaration of Drew E. 9 Voth filed in support, and certain exhibits attached to the declaration of Jennifer K. Chung filed in 10 United States District Court Northern District of California 11 The Fourth Motion to Seal support because both it and Primus have designated some of the information confidential. Id. With respect to information IEH has designated confidential, it seeks to keep under seal 12 portions of the depositions of Dr. Samadpour and Dr. Koohmaraie attached as Exhibits O and P to 13 the declaration of Jennifer K Chung and [Dkt. No 74-12] and one paragraph of Dr. Applegate’s 14 report [Dkt. No. 74-10]. It argues that the portions of those documents should be sealed because 15 they contain sensitive and proprietary trade secrets, including confidential identities of clients and 16 other confidential client information including include IEH’s non-public market share, IEH’s 17 revenue, and details of IEH’s business methods and the technical operation of IEH’s services. Id. 18 It claims that disclosure of this information would hurt its competitive standing. Id. As to the two 19 declarations, I am unable to identify any confidential client information. The other information 20 IEH seeks to seal in the declarations relate to public information about previous outbreaks of food 21 related pathogens and IEH’s patented testing method. I am unpersuaded that IEH’s allegations of 22 competitive harm here outweigh the public’s right of access. I am similarly unpersuaded by IEH’s 23 conclusory allegations of harm related to the paragraph in Dr. Applegate’s report that describes 24 IEH’s sales of its pooled vs. non-pooled pathogen tests between 2008-2018. IEH has not met is 25 burden under the compelling reasons standard and the motion to seal these documents is denied. 26 Primus also submits a declaration in support of IEH’s motion, arguing that the information 27 it has designated as confidential should remain under seal. [Dkt. No. 79]. As an initial matter, 28 Primus does not discuss exhibit A to the Chung declaration, and it shall be unsealed. Primus does 29 1 state that exhibits D, E, and G of the Chung declaration, as well as the corresponding redacted 2 portions of its opposition to IEH’s motion for summary judgment should remain under seal 3 because they contain emails discussing Primus’s costs and pricing practices, which are not 4 generally known to its customers and competitors. It argues that if they were filed publicly, its 5 competitors could use this information to its disadvantage by adjusting their own pricing to 6 compete more effectively. Additionally, Primus claims that this would allow customers and 7 potential customers to disadvantage it in price negotiations by leveraging knowledge of Primus’s 8 cost and past pricing practices to demand more favorable terms. These exhibits do not contain any 9 specific information about Primus’s costs and pricing practices; the motion to seal them is denied. Primus next argues that the emails contained in exhibits E, G, H, I, J, L, and M should be United States District Court Northern District of California 10 11 sealed because they contain the identity of and information about specific customers. It states that 12 it has invested time and resources developing its knowledge of customers and potential customers 13 of food safety testing services. If filed publicly, Primus contends that its competitors could use 14 this information to its disadvantage by more effectively targeting their marketing efforts without 15 expending similar time or resources. This is not a compelling reason to seal these emails and the 16 motion to seal them is denied. Nothing in these exhibits contains any particularized pricing 17 information as to any particular Primus customer. Primus seeks to have exhibit M and K remain under seal because they contain emails 18 19 between Primus and its vendors discussing its confidential laboratory protocols and a confidential 20 study prepared for Primus by its vendor. Primus argues that it has invested time and resources 21 developing the protocols revealed in these exhibits and takes steps to maintain their 22 confidentiality. Primus claims that if its methods were disclosed, competitors could disadvantage 23 it by developing their own protocols without investing similar time and resources. This argument 24 is largely conclusory and the information in exhibit M is relied on in my order. Primus has not 25 shown that there is a compelling reason to seal these exhibits that outweighs the public’s right of 26 access. 27 Finally, Primus seeks to file the declaration of Drew E. Voth under seal because it contains 28 its annual revenue in connection with its pooled sample testing services. It argues that it considers 30 1 this data a trade secret and public disclosure would hurt its competitive standing. Specifically, it 2 claims that competitors would be able to use this information about Primus’s market share to its 3 disadvantage by more effectively targeting their marketing and business development efforts. 4 This argument is also wholly conclusory and insufficient to justify sealing. The fourth motion to seal is denied. The sealed exhibits and IEH’s unredacted opposition 5 6 7 E. 8 The fifth motion to seal is filed by IEH in connection with its reply in support of its motion 9 United States District Court Northern District of California to Primus’s motion for summary judgment shall be unsealed. The Fifth Motion to Seal for summary judgment. [Dkt. No. 80]. The motion is based on Primus’s confidentiality 10 designations. Id. Primus has yet to submit a declaration stating why the portions of IEH’s reply 11 and exhibit A to the Declaration of Jennifer K. Chung in Support of Reply in Support of IEH’s 12 Motion for Partial Summary Judgment should remain under seal. If Primus does not file a 13 declaration and provide compelling reasons to seal within two weeks of the date of this order, the 14 motion will be denied, and the relevant documents will be unsealed. CONCLUSION 15 For the reasons above, Primus’s motion for summary judgment is denied. IEH’s motion 16 17 for partial summary judgment is granted. The motions to seal are granted in part and denied in 18 part. 19 20 IT IS SO ORDERED. Dated: August 19, 2019 21 22 William H. Orrick United States District Judge 23 24 25 26 27 28 31

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