author: LOURIE, Circuit Judge.

text:
    SONIX TECHNOLOGY CO., LTD., Plaintiff-Appellant v. PUBLICATIONS INTERNATIONAL, LTD., SD-X Interactive, Inc., Encyclopedia Brittannica, Inc., Herff Jones, Inc., Defendants-Appellees
    2016-1449
    United States Court of Appeals, Federal Circuit.
    Decided: January 5, 2017

      JONATHAN HangaRTNER, X-Patents, APC, La Jolla, CA, argued for plaintiff-appellant. Also represented by Steven P. Fal-lon, Greer, Burns & Crain, Ltd., Chicago, IL.
    Jaoob Daniel Koering, Miller, Canfield, Paddock, & Stone, PLC, Chicago, IL, argued for defendants-appellees. Also represented by Terrence Joseph Sheahan, Freeborn & Peters, LLP, Chicago, IL.
    Before LOURIE, O’MALLEY, and TARANTO, Circuit Judges.
   LOURIE, Circuit Judge.

Sonix Technology Co., Ltd. (“Sonix”) appeals from the district court’s grant of summary judgment following its determination that claims 9, 25, 35-36, 52-55, 57-60, 62-64, 66, 68, 71-77, 79-82, and 85-90 (“the asserted claims”) of Sonix’s U.S. Patent 7,328,845 (“the ’845 patent”) are invalid as indefinite. See Sonix Tech. Co. v. Publ’ns. Int’l, Ltd., No. 13-cv-2082, 2015 WL 8153600, at *9-17 (N.D. Ill. Dec. 8. 2015) (“Opinion”). Specifically, the district court concluded that the term “visually negligible” rendered the asserted claims indefinite under 35 U.S.C. § 112 ¶ 2. For the reasons that follow, we reverse the determination of indefiniteness and hence the summary judgment of invalidity.

Background

Sonix owns the ’845 patent, which describes a system and method for using a “graphical indicator” (e.g., a matrix of small dots) to encode information on the surface of an object. See ’845 patent, col. 3 11. 6-43. The surface may feature additional information as well; for example, illustrations or icons in a children’s book. Id. col. 7 11. 1-6. The invention also includes an “optical device” that can read the graphical indicator and output further information. Id. col. 7 11. 18-32. Figure 5 illustrates an example:

Id. fig.5. In this example, an icon showing a person riding a horse (511) is printed on the page of a book (51). Id. col. 7 11. 1-10. The graphical indicator (512) is printed in the same area as the icon. Id. col. 7 11. 18-21, The optical device (311) captures an image that includes the graphical indica-toi\ Id. col. 7 11. 21-24. The processing device (312) retrieves the indicator from the image and outputs additional information. Id. In this particular example, holding the optical device over the horse icon could cause the device to output “audio information, such as pronunciations of horse in English.” Id. col. 7 11. 27-32.

Of course, encoding information on the surface of an object is not new. The ’845 patent admits that information has been recorded on the surface of objects “[d]at-ing back to ancient time[s],” id. col. 1 11. 15-16, and lists a bar code as a “conventional” example of a graphical indicator, id. col. 9 11. 46-57. The ’845 patent purports to improve on conventional methods by rendering the graphical indicator “visually negligible.” Id. col. 3 11. 5-11. The patent uses a book cover to illustrate, the difference between a conventional bar code and the claimed indicator:

Id. fígs.l2(A) & 12(B). The graphical indicator (10002) in figure 12(B) stores the same information as the bar code (10001) in figure 12(A), but in a manner that does not “interfere with the other main informar tion on the surface.” Id. col. 9 11. 47-57.

The “[e]xemplary [d]esign,” id. col. 3 1. 5, of the claimed indicator “includes multiple graphical micro-units arranged in a layout.” Id. col, 3 11. 14-15. In one embodiment the micro-units are dots, arranged in a matrix. Id. col. 3 11. 15-25. Each cell in the matrix either contains or does not contain a dot, resulting in a unique pattern that can store information. Id. col. 3 11. 38-30, col. 411.13-41.

The written description also discloses differentiability, brightness, and homogeneity “requirements for the graphical indicators being negligible to human eyes.” Id. col. 4 11. 60-61. First, the indicator must be so small that “human eyes cannot differentiate one graphical indicator from others.” Id. col. 4 11. 61-63. The patent indicates that “[f]or best result, the graphical micro-unit must be so tiny that only a microscope apparatus can detect it.” Id. col. 3 11. 24-25. Second, the patent advises that the number of micro-units should be reduced based on “the size of the graphical micro-unit, the pitch between micro-unit, and the desired visual effect,” so that they “have little influence on the brightness of the surface of the object.” Id. col. 4 1. 67-col. 5 1. 1. Finally, the “number of graphical micro-units of each graphical indicator” should be “substantially equal to each other,” so that “the graphical indicators look more homogenous to human eyes and become invisible to human eyes.” Id. col. 5 11. 1-5.

The written description also gives two examples of visually-negligible indicators. In the first, each square centimeter contains 3,000 matrix cells, of which less than 70% contain graphical micro-units, and where each micro-unit occupies less than 80% of the cell. Id. col. 5 11. 6-10. The second is similar, but requires each square centimeter to include 6,000 cells. Id. col. 5 11.11-15.

In 2010, Sonix alleged that children’s books using dot pattern technology produced by GeneralPlus, a Taiwanese company, infringed the ’845 patent. In response, SunPlus Technology Co. Ltd. (“SunPlus”), GeneralPlus’s parent company, requested ex parte reexamination of the ’845 patent (“the first reexamination”) by the U.S. Patent and Trademark Office (“USPTO”). On December 27, 2011, the USPTO confirmed the patentability of, inter alia, asserted claims 9, 25, and 35-86, and allowed new, and now asserted, claims 52-55, 57-60, 62-64, 66, 68, 71-77, 79-82, and 85-90, among others. J.A. 94-96.

Less than one month later, GeneralPlus requested another ex parte reexamination (“the second reexamination”). J.A. 1937. One of the central disputed issues during this second reexamination was whether the combination of U.S. Patent 5,416,312 (“La-moure”) and U.S. Patent 5,329,107 (“Prid-dy”) would have led to a visually-negligible indicator, as the examiner initially rejected all pending claims over that combination. See, e.g., J.A. 2328-31. Sonix responded to that rejection with a declaration from Ser-jer Serjersen (“Serjersen”), an expert with more than thirty years of experience. J.A, 2337, Serjersen declared that he created graphical indicators using the processes described by the ’845 patent and by the cited references, and determined that only the indicator produced using the process of the ’845 patent was visually negligible. J.A. 2338-44, 5313-25. The examiner confirmed the patentability of the asserted claims on the basis of Serjersen’s declaration, specifically indicating that the combination of cited references did not disclose a visually-negligible graphical indicator. J.A. 2362-65.

In 2013, Sonix alleged that Publications International, Ltd., SD-X Interactive, Inc., Encyclopedia Brittannica, Inc., and Herff Jones, Inc. (collectively, “Appellees”) infringed the asserted claims. Appellees’ initial invalidity contentions identified twenty-six claim limitations that they believed to be indefinite; however, that list did not include the term “visually negligible.” See J.A. 2637-41. In their final invalidity contentions, Appellees contended that two additional claim limitations were indefinite, but again did not question “visually negligible.” J.A. 3031.

During claim construction, Appellees initially asked the district court to construe “visually negligible,” J.A. 2430, but, when they retained new counsel, proposed that the term be given its ordinary meaning, J.A. 2434-36. Sonix agreed with an ordinary-meaning construction, and so the district court did not construe “visually negligible.”

Even so, “visually negligible” was used repeatedly in the expert reports. For example, Sonix’s expert, Dr. Ashok, opined that the accused products included visually-negligible indicators, J.A. 3087-88, and that the cited prior art did not, J.A. 3539-41, 3547. Appellees’ expert, Dr. Engels, also applied “visually negligible” throughout his reports, and even ‘agreed that “the dot patterns in the specific products reviewed by Dr. Ashok in his Report are visually negligible_”. J.A. 4210-11, On validity, Dr. Engels repeatedly opined that the indicators disclosed in Lamoure and Priddy—the same references' at issue in the second reexamination—were visually negligible. See J.A. 5348-49, 5355-56, 5418, 5430-31. But Dr. Engels did not opine that “visually negligible” was indefinite. See id. Elsewhere in his report, Dr. Engels contended that alternatives to the claimed invention would have been available because “it would be a simple matter to ensure that any pattern being used would be printed in a manner that would be visually negligible compared to the main information on a page.” J.A. 4228.

At Dr. Ashok’s deposition, after the close of fact discovery and after the parties agreed to an ordinary meaning for “visually negligible,” he was asked to explain “what does [‘visually negligible’] mean to you?” J.A. 4755 at 46:25-17:1. Dr. Ashok indicated that he understood it “to mean that if these dot patterns are imprinted on a surface, with a cursory look, I will not notice that.” Id. at 47:2-7. Dr, Ashok was then asked whether there was “any sort of objective standard” for visual negligibility. J.A. 4756 at 49:11. Dr. Ashok explained that visibility depended on the ink used, the printing pattern, and the size of the dot, but that there “is not a universal standard by any means because it depends on the visual acuity of the observer.” Id. at 50:24-51:4. Even so, Dr. Ashok indicated that his “method of determining visual negligibility would be [to] print at' the magnification desired and look at it,” because he “would imagine that would be representative of most people looking at it.” Id. at 51:5-8.

In response, Dr. Engels asserted at his deposition that “visually negligible” was subjective because “there is no objective test to define the boundary between visually negligible and visually non-negligible,” Dr. Engels did not analyze the intrinsic evidence, and did not provide any detail explaining his conclusion. J.A. 3709. On the basis of the two expert depositions, Appel-lees amended their invalidity contentions and moved for summary judgment of indefiniteness.

The district court ultimately held that the claims are invalid as indefinite. Opinion, 2015 WL 8153600, at *9-17. Reasoning that “visually negligible” is “purely subjective” and that the claim language does not provide guidance on its meaning, the court turned to the other intrinsic evidence. Id. at *13. The court determined that the written description does not provide a person of ordinary skill in the art “with a meaning that is reasonably certain and defines objective boundaries” of the claim scope. Id. The court rejected Sonix’s argument that “visually negligible” means “something that may be visible, but does not interfere with the user’s perception of other visual information on-a surface,” concluding that defining the term “as reliant on the user’s perception provides no objective standard by which to measure the scope of the term'—the user’s perception becomes the measure and this is insufficient.” Id. (citing Datamize, LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1351 (Fed. Cir. 2005)).

The district court also rejected Sonix’s attempts to rely on other portions of the written description. For example, the court determined that the instruction that the graphical micro-units “must be so tiny that only a' microscope apparatus can detect it,” ’845 patent, col. 3 11. 24-25, failed to provide reasonáble certainty because the written description “contains no information ... regarding what type of microscope apparatus or what level of magnification the user would need.” Opinion, 2015 WL 8153600, at *14. The court similarly rejected Sonix’s reliance on the differentiability, brightness, and homogeneity requirements because they lacked “the necessary detail to make [them] meaningful.” Id. Finally, the court rejected the prosecution and reexamination history as not providing additional guidance. Id. at *15.

Although the district court determined that it was “not necessary” to consult the extrinsic evidence, it nonetheless concluded that the extrinsic evidence “highlights the problem with the subjective nature of the ‘visually negligible’ claim term.” Id. The court noted, for example, that although the experts applied the term to the prior art, they did not provide any standard by which to measure negligibility aside from their “subjective belief.” Id.

The district court then reviewed recent cases from the Supreme Court and this court, and determined that the present case was more similar to those concluding that claims were invalid as indefinite than to those holding, otherwise. See id. at *15-17- (citing Nautilus v. Biosig Instruments, Inc., — U.S. -, 134 S.Ct. 2120, 2129, 189 L.Ed.2d 37 (2014); Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1368-74 (Fed. Cir. 2014); Enzo Biochem, Inc. v. Applera Corp., 599 F.3d 1325, 1336 (Fed. Cir. 2010); Datamize, 417 F.3d at 1349-54).

The district court therefore entered judgment against Sonix and for Appellees on December 8, 2015. J.A. 1-2. Sonix timely appealed. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).

Discussion

At the outset, there is a dispute relating to the standard of review to be applied to the present case. Sonix argues that our review is entirely de novo, because the district court indicated that it was unnecessary to address the extrinsic evidence and did not make any factual findings based thereon. Appellees respond that the district court made underlying findings that “visually negligible” is subjective and that it lacks an objectively-measurable standard.

We agree with Sonix that we review a district court’s determination that a claim is invalid as indefinite under 35 U.S.C. § 112 ¶ 2 de novo, although, as with claim construction, any factual findings by the district court based on extrinsic evidence are reviewed for clear error. Cox Commc’ns, Inc. v. Sprint Commc’n Co., 838 F.3d 1224, 1228 (Fed. Cir. 2016) (citing Teva Pharm. USA, Inc. v. Sandoz, Inc., — U.S. -, 135 S.Ct. 831, 840-42, — L.Ed.2d -(2015) (“Teva /”)). To trigger clear error review, “it is not enough that the district court may have heard extrinsic evidence during a claim construction proceeding—rather, the district court must have actually made a factual finding.... ” CardSoft, LLC v. VeriFone, Inc., 807 F.3d 1346, 1350 (Fed. Cir. 2015) (citations omitted). Moreover, “[a] party cannot transform into a factual matter the internal coherence and context assessment of the patent simply by having an expert offer an opinion on it. The internal coherence and context assessment of the patent, and whether it conveys claim meaning with reasonable certainty, are questions of law.” Teva Pharm. USA Inc. v. Sandoz, Inc., 789 F.3d 1335, 1342 (Fed. Cir. 2015) (“Teva IP).

The district court expressly explained that the extrinsic evidence was “not necessary for [its] consideration” of the indefiniteness issue. Opinion, 2015 WL 8153600, at *15. Moreover, the district court’s conclusions of subjectivity and lack of an objective standard are not findings subject to clear error review; instead, they are conclusions relating to the meaning. of the intrinsic evidence, and whether it conveys claim meaning with reasonable certainty. See Teva II, 789 F.3d at 1342. Such conclusions cannot be transformed into factual matters “simply by having an expert offer an opinion on [them].” Id.

I. Indefiniteness

Sonix argues that the district court erred in concluding that “visually negligible” renders the asserted claims invalid as indefinite. Specifically, Sonix argues that the requirements and examples in the written description would have allowed a skilled artisan to know the scope of the claimed invention with reasonable certainty. and establish that the term depends on human perception, not opinion. This conclusion is supported, Sonix contends, by the consistent manner in which “visually negligible” has been applied during initial examination, both reexaminations, and the majority of the district court litigation.

Appellees respond that visual negligibility does not have an objective standard because it depends on the “vagaries of any one person’s opinion,” Datamize, 417 F.3d at 1350, and is therefore indefinite. Appel-lees contend that the written description would not allow a skilled artisan to understand the scope of the claims with reasonable certainty, and that the ability of experts to apply the term does not provide an objective standard.

We agree with Sonix that á skilled artisan would understand, with reasonable certainty, what it means for an indicator in the claimed invention to be “visually negligible.” The intrinsic evidence supports, and the extrinsic evidence is consistent with, this conclusion.

Section 112 requires that a patent specification “conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.” The Supreme Court has read this provision to require that “a patent’s claims, viewed in light of the specification and prosecution history, inform those skilled in the art about the scope of the invention with reasonable certainty.” Nautilus, 134 S.Ct. at 2129. Indefiniteness must be proven by clear and convincing evidence. See Tevall, 789 F.3d at 1345.

The § 112 ¶ 2 requirement strikes a “delicate balance” between “the inherent limitations of language” and providing “clear notice of what is claimed.” Nautilus, 134 S.Ct. at 2129 (internal citations omitted). Even so, the Supreme Court has recognized that “absolute precision is unattainable.” Id. “[T]he certainty which the law requires in patents is not greater than is reasonable, having regard to their subject-matter.” Id. (quoting Minerals Separation, Ltd. v. Hyde, 242 Ú.S. 261, 270, 37 S.Ct. 82, 61 L.Ed. 286 (1916) (internal quotation marks omitted)).

Because language is limited, we have rejected the proposition that claims involving terms of degree are inherently indefinite. Interval Licensing, 766 F.3d at 1370. Thus, “a patentee need not define his invention with mathematical precision in order to comply with the definiteness requirement.” Invitrogen Carp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1384 (Fed. Cir. 2005) (citation omitted). Indeed, “[cjlaim language employing terms of degree has long been found definite where it provided enough certainty to one of skill in the art when read in the context of the invention.” Interval Licensing, 766 F.3d at 1370 (citing Libel Process Co. v. Minn. & Ont. Paper Co., 261 U.S. 45, 65-66, 43 S.Ct. 322, 67 L.Ed. 523 (1923)).

Accordingly, we have held that the clause “not interfering substantially” did not render a claim invalid as indefinite. Enzo, 599 F.3d at 1336. In that case, we reasoned that the intrinsic evidence provided guidance as to the scope of the claims, including, inter alia, examples of noninterfering structures and criteria for their selection. Id. at 1334-35. This guidance allowed a skilled artisan to compare a potentially infringing product “with the examples in the specification to determine whether interference ... is substantial.” Id. at 1336.

We have found terms of degree indefinite, however, when such guidance is lacking. For example, Datamize involved claims to an “aesthetically pleasing” look and feel for interface screens. 417 F.3d at 1348-49. We determined that such language rendered the claim indefinite because, although the written description did detail various elements that might affect whether a screen was aesthetically pleasing (such as button styles and sizes), it “provide[d] no guidance to a person making aesthetic choices such that their choices' will result in an ‘aesthetically pleasing’ look and feel of an interface screen.” Id. at 1352. Without such guidance, the claim did “not just include a subjective element, it [wa]s completely dependent on a person’s subjective opinion.” Id.

Similarly, Interval Licensing involved a claim related to displaying content “in an unobtrusive manner that does not distract a user.” 766 F.3d at 1368. We observed that the term was “a term of degree,” id. at 1370, “purely subjective,” id. at 1371, and that the claim language offered “no objective indication of the manner in which content images are to be displayed to the user,” id. We refused to limit the “facially subjective claim term” to the single example in. the written description because, without more information, “a skilled artisan is still left to wonder what other forms of display are unobtrusive and non-distracting ... thus leaving the skilled artisan to consult the ‘unpredictable vagaries of any one person’s opinion.’ ” Id. at 1373-74 (quoting Datamize, 417 F.3d at 1350).

As indefiniteness analysis involves general claim construction principles, we begin with the language of the claims of the ’845 patent. See Enzo, 599 F.3d 1332. We do agree with the district court that the claim language itself does not unmistakably make clear the scope of “visually negligible”; however, we disagree with the conclusion, and Appellees’ argument, that the term is “purely subjective,” Opinion, 2015 WL 8153600, at *13, in the same manner as' “aesthetically pleasing” in Datamize and “iii an unobtrusive manner that does not distract a user” in Interval Licensing.

Datamize and Interval Licensing in: volved terms that were subjective in the sense that they turned on a person’s tastes or opinion. “Aesthetically pleasing” implicates matters of taste or preference; whether something is aesthetically pleasing is a value judgment that inherently varies from person to person. “In an unobtrusive manner that does not distract” similarly implicates a person’s individual focus, concentration, attentiveness, or similar mental state at a given moment, or even -opinions, affecting what is or is not distracting. The question whether something is “visually negligible” or whether it interferes with a user’s perception, however, involves what can be seen by the normal human eye. This provides an objective baseline through which to interpret the claims. See Warsaw Orthopedic, Inc. v. NuVasive, Inc., 778 F.3d 1365, 1371 (Fed. Cir. 2015), cert. granted, judgment vacated sub nom. Medtronic Sofamor Danek USA, Inc. v. NuVasive, Inc., — U.S. -, 136 S.Ct. 893, 193 L.Ed.2d 785 (2016), and opinion reinstated in relevant part, 824 F.3d 1344, 1346 (Fed. Cir. 2016). Thus, although the term may be a term of degree, it is not “purely subjective.”

We turn next to the written description, to determine whether there is some standard- in the written description for measuring visual negligibility. See Enzo, 599 F.3d at 1332. Our prior eases establish that the written description is key to determining whether a term of degree is indefinite. In Enzo, for example, the written description included examples of noninterfering structures and the procedures for selecting them; we reasoned that the examples and procedures provided guidance and points of comparison for skilled artisans. Id. at 1335-36. The one example provided in the written description at issue in Interval Licensing, in contrast, was not accompanied by sufficient detail to render the claim scope reasonably certain. 766 F.3d at 1372. In’ Datamize, the written description did not contain any examples of an “aesthetically pleasing” interface, nor did it “explain what factors a person should consider when selecting a feature” to lead to an aesthetically pleasing result. 417 F.3d at 1352.

On the other hand, the ’845 patent contains considerably more detail than Da-tamize or Interval Licensing. As explained previously, the written description of the ’845 patent'includes: (1) a general exemplary design for a visually-negligible indicator, ’845 patent, col. 3 11. 13-20; (2) “requirements for the graphical indicators being negligible to human eyes,” id. col. 4 1. 60-col. 5 1. 5;- and (3) two specific examples of visually-negligible indicators, id. col. 5 11. 6-15. That there are examples at all distinguishes this -case from Datamitie, and that the written description contains an additional example and specific requirements distances this case .from Interval Licensing. Instead, the level of detail provided in the written description is closer to that provided in Enzo: These are statements that , provide guidance on how to create visually-negligible indicators, and specific examples that provide points of comparison for the result. . -

Appellees criticize what they see as the written description’s low level of detail. Specifically, they argue that the examples and requirements in the written' description cannot be translated to an objective standard for the claim’s scope because they, too, are subjective. We disagree. Just as the patent in Enzo included “examples of suitable linkage groups,” 599 F.3d at 1334, the ’845 patent includes examples of visually-negligible indicators, ’845 patent, col. 5 11. 6-15. Just as the patent in Enzo provided “some criteria for selecting [linkage groups that did not substantially interfere],” 599 F.3d at 1334, the ’845 patent includes the differentiability, brightness, and homogeneity “requirements for the graphical indicators being negligible to human eyes,” ’845 patent, col. 4 1. 60-col. 5 1. 5. The guidance in Enzo allowed a skilled artisan to compare a potentially infringing product “with the examples in the specification to determine whether interference ... is substantial,” 599 F.3d- at 1336; similarly, an accused infringer could compare the examples and criteria from the written description of the ’845 patent to determine whether an indicator is visually negligible. Moreover, Appellees have not provided evidence that human perception varies so significantly that reliance on' it as a standard renders the claims indefinite. See Warsaw, 778 F.3d at 1371. Thus, as in .Enzo, thé written description .of the. ’845 patent supports the conclusion that a skilled artisan would have understood the .term with reasonable certainty.

Other aspects 'of this case also make reversal compelling. The prosecution history of'the ’845 patent, which includes the reexamination history, see Info-Hold, Inc. v. Applied Media Techs. Corp., 783 F.3d 1262, 1266 (Fed. Cir. 2015), supports that conclusion. No one involved in either the first or the-second reexamination had any apparent difficulty in determining the scope of “visually negligible.” During- the first reexamination, SunPlus repeatedly argued that the prior art disclosed visually-negligible graphical indicators without any apparent uncertainty as-to the meaning or scope of the term, and no apparent difficulty applying it to the- references at issue. See, e.g., J.A. 795, 800, 801, 811, 823, 835, 844, 849-50, 854, 864, 876. During the second reexamination, the examiner was able to understand and apply the term in performing a search for. prior art and make an initial rejection. See J.A. 2312-13. Moreover, Serjersen was able to understand both the claims and written description with sufficient certainty to (1) replicate the claimed indicator; and (2) opine regarding whether it, and the indicators of Lamoure and Priddy, were visually negligible. See J.A. 2338-44, 5313-25. Thus, he was readily able to differentiate between which indicators were and which were not visually negligible. Finally, the- examiner understood the import of Serjersen’s results well enough to withdraw the rejections in response, indicating that he was able to differentiate between indicators as well. J.A. 2363-65. Again, GeneralPlus, So-nix, and the USPTO did not express any uncertainty as to the scope of “visually negligible,” or encounter any apparent difficulty in applying the term to the references. '

Appellees challenge this evidence as well, arguing that the fact that the experts applied the term does not mean that they used or could determine an objective standard. Although Appellees are correct that application by the examiner and an expert do not, on .their own, , establish an objective standard, they nevertheless provide evidence that a skilled artisan did understand the scope of this invention with reasonable certainty.

The extrinsic evidence, to the extent that it is necessary in this case, does not counsel otherwise. Appellees apparently understood the meaning of “visually negligible” from the" beginning of the litigation. Their initial invalidity contentions did not argue that the “visually negligible” was indefinite, and neither did their final contentions. Indeed, at no point before Dr. Ashok’s deposition did they contend that “visually negligible” was indefinite, even though they' contended that twenty-eight other terms were indefinite. That Appel-lees themselves did not question the clarity of “visually negligible” in the first several years of litigation supports the conclusion that the,term could be understood with reasonable certainty.

Appellees’ other actions during litigation also reflect -that they understood “visually negligible.” They initially argued for a specific construction of the term, but later abandoned their attempt in favor of an ordinary-meaning construction. The parties’ experts also had no difficulty in applying “visually negligible.” Dr. Ashok and Dr. Engels repeatedly applied the term to the references and the accused products. Although Appellees again argue that this does not establish an objective standard, continued application by the experts in this case further supports the conclusion that a skilled artisan did understand the term with reasonable certainty.

Appellees’ repeatedly cite Dr. Ashok’s responses during his deposition. Appellees asked Dr. Ashok to define “visually negligible,” a term for which he had given no previous definition, and which Appellees had previously agreed did not need a construction. But it is unsurprising that Dr. Ashok indicated that he was unaware of a “technical standard” for the term, J.A. 4756 at 51:9-11; as Appellees- had agreed to an ordinary-meaning construction, there was no reason for him to attempt to determine one. Even so, Dr. Ashok did not opine that a skilled artisan would have any trouble understanding the term or that the claims were indefinite, and he observed that he thought that his assessment of what was visually negligible would likely be representative. See J.A. 4755-56. Dr. Engels, Appellees’ own expert, also did not opine that the claims were indefinite or that a skilled artisan would not have understood the term; instead, he provided a one-sentence statement that “visually negligible” is subjective and that there was no objective test to define it. See J.A. 3709. Dr. Engels did not detail any basis for this conclusion, instead simply stating that it was “based on Dr. Ashok’s testimony.” Id. In light of the intrinsic evidence, this ambiguous testimony is not persuasive.

Our holding in this case- does not mean that the existence of examples in the written description will always render a claim definite, or that listing requirements always provide sufficient certainty. Neither does the fact that an expert has applied a contested claim term without difficulty render a claim immune from an indefiniteness challenge. As always, whether a claim is indefinite must be judged “in light of the specification and prosecution history” of the patent in which it appears. Interval Licensing, 766 F.3d at 1369. We simply hold that “visually negligible” is not a purely subjective term and that, on this record, the written description and prosecution history provide sufficient support to inform with reasonable certainty those skilled in the art of the scope of the invention. The examiner’s knowing allowance of claims based on the term that is now questioned, plus the acceptance of the term by both parties’ experts, force us to the conclusion that the term “visually negligible” is not indefinite. Accordingly, we reverse the district court’s conclusion that the asserted claims are invalid as indefinite.

Because we hold that the district court erred in concluding that the asserted claims are indefinite, we need not, and do not, reach Sonix’s alternative arguments for reversal.

CONCLUSION

We have considered the remaining arguments, but find them unpersuasive. For the foregoing reasons, the decision of the district court is reversed.

REVERSED

      . Because the ’845 patent was filed before the enactment of the Leahy-Smith America Invents Act, Pub. L. No. 112-29, § 3, 125 Stat. 284, 285-93 (2011), the prior version of § 112 governs. See Fleming v. Escort, Inc., 774 F.3d 1371, 1374 n.1 (Fed. Cir. 2014).

      . Although Enzo was decided before the introduction of the "reasonable certainty” standard, we have relied on it in our post-Nautilus decisions. See, e.g., Interval Licensing, 766 F.3d at 1370.


source: Caselaw Access Project

author: KAYATTA, Circuit Judge.

license: Public Domain

text:
    Jeffrey D’AGOSTINO, Plaintiff, Appellant, State of California; State of Connecticut; District of Columbia; State of Florida; State of Georgia; State of Hawaii; State of Illinois; State of Indiana; State of Louisiana; State of Maryland; Commonwealth of Massachusetts; State of Michigan; State of Montana; State of Nevada; State of New Hampshire; State of New Jersey; State of New Mexico; State of New York; State of North Carolina; State of Oklahoma; State of Rhode Island; State of Tennessee; State of Texas; Commonwealth of Virginia; State of Wisconsin; John Doe; United States; State of Delaware; State of Minnesota, Plaintiffs, v. EV3, INC.; Microtherapeutics, Inc., Defendants, Appellees, John Cubelic; Vitas J. Sipelis; John Hardin; Brett Wall, Defendants.
    No. 16-1126
    United States Court of Appeals, First Circuit.
    December 23, 2016

      Daniel Robert Miller, with whom Susan Schneider Thomas, Philadelphia, PA, Berger & Montague PC, Lynn G. Weissberg, Jonathan Shapiro, and Shapiro, Weissberg & Garin LLP, Boston, MA, were on brief, for appellant.
    Joshua S. Levy, with whom Mitchell Stromberg, Rebecca C. Ellis, Boston, MA, Bryan Alexander Pennington, Chicago, IL, Jeremy E. Kanarek, and Ropes & Gray LLP were on brief, for appellees.
    Tara S. Morrissey, Attorney, Department of Justice, Civil Division, with whom Michael S. Raab, Attorney, Civil Division, Benjamin C. Mizer, Principal Deputy Assistant Attorney General, Civil Division, and Carmen M. Ortiz, United States Attorney, were on brief, for amicus curiae the United States of America.
    Before HOWARD, Chief Judge, SELYA and KAYATTA, Circuit Judges.
   KAYATTA, Circuit Judge.

This qui tam action makes its second appearance before us. Last year, we held that the district court should have evaluated Jeffrey D’Agostino’s request for leave to file his fourth amended complaint under the standard set forth in Federal Rule of Civil Procedure 15(a). United States ex rel. D’Agostino v. ev3, Inc. (D’Agostino I), 802 F.3d 188, 193-96 (1st Cir. 2015). On remand, the district court found that D’Agostino’s desired amendment failed under that standard because, even as proposed to be amended, the complaint did not allege claims upon which the court could grant relief. United States ex rel. D’Agostino v. ev3, Inc., 153 F.Supp.3d 519, 538 (D. Mass. 2015). For the following reasons, we agree.

I. Background

A. Factual Allegations

Defendant ev3, Inc. (“ev3”) discovers, develops, manufactures, and markets medical devices. Defendant Micro Therapeutics, Inc. (“MTI”), ev3’s subsidiary since 2006, likewise manufactures and markets medical devices. D’Agostino’s original and proposed complaints against these companies focus on two devices, the Onyx Liquid Embolic System (“Onyx”) and the Axium Detachable Coil System (“Axium”). We recite the relevant facts concerning each device as they are alleged by D’Agostino in his proposed complaint, assuming them to be true unless they are merely conclusory. See Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009).

1. Onyx

Onyx is an artificial liquid material developed by MTI to treat malformed blood vessels in the brain. In plain terms, it is injected into blood vessels near the brain, and then forms a mass blocking the flow of blood to facilitate subsequent surgery. In the early 2000s, MTI licensed the Onyx molecule to a company named Enteric. Enteric used the molecule to develop another medical device, Enteryx, which went to market first, after gaining Food and Drug Administration (“FDA”) approval in April 2003 for the treatment of gastroeso-phageal reflux disease. A series of adverse events involving Enteryx followed, prompting a patient safety alert in October 2004, and culminating in a complete recall of the device in September 2005.

It was during this timeframe — between Enteryx’s approval and recall — that MTI sought approval for Onyx. The FDA’s regulations require a premarket approval (“PMA”) process for medical devices like Onyx. See 21 C.F.R, § 814.1(c). During that process, the device manufacturer supplies the FDA with extensive information regarding the device — including its design, manufacturing, packing, labeling, and testing — to satisfy the agency that the device is safe and effective. IdL § 814.20. A “sufficiently complete” application proceeds to substantive review. Id. § 814.42(a). That review is performed by FDA personnel and, at the FDA’s election as in this instance, by an advisory panel of outside experts. Id. § 814.44(a). The panel holds a public meeting to review the PMA before making a recommendation to the FDA. Id. § 814.44(b). The FDA then considers the PMA application, together with any advisory panel report and recommendation, before issuing a decision on approval. Id § 814.44(c).

MTI’s PMA application identified a narrow indication for Onyx: “use in the treatment of brain arteriovenous malformations (‘BAVM’s’), when embolization is indicated to minimize blood loss to reduce the BAVM size prior to surgery.” While seeking approval, MTI emphasized the narrow scope of the indication as well as the rigorous nature of the training program required for physicians using Onyx. According to the testimony of MTI’s Vice President before the FDA advisory panel, that training program would include an instructional session, a hands-on workshop, a case review, and observations. According to another MTI witness, any physician who completed this training would receive the assistance of an experienced proctor the first time he or she used Onyx. The advisory panel members placed great weight on these training requirements, describing them as “critically important” and “a very big component of getting [Onyx] into safe use.”

The panel ultimately recommended approval of Onyx. However, several of its members explained that it was a “cautious approval,” and others warned that they would advise the FDA to rescind approval if MTI disregarded their suggestions for carefully monitoring Onyx cases.

The FDA adopted the panel’s recommendation, granting approval to Onyx in July 2005. The Onyx label authorized by the FDA restricted the device’s use to “physicians with neurointerventional training and a thorough knowledge of the pathology to be treated, angiographic techniques, and super-selective embolization.” It stated, “Contact your Micro Therapeutics Inc. sales representative for information on training courses.”

Enter D’Agostino, a sales representative who worked at ev3 from January 2005 until his termination in January 2010. After ev3 acquired MTI in 2006, D’Agostino became familiar with the manner in which the defendants promoted and sold Onyx. He says that he observed physician trainings that lasted as little as four hours and proctored surgeries that involved off-label procedures. He also alleges that the defendants instituted a “Site Certification Process” whereby they certified and sold Onyx to any site where a single neurosurgeon who had completed their training enjoyed privileges. As a result, he says that Onyx fell into the hands of physicians at those sites with inadequate training or no training at all. Additionally, the defendants encouraged off-label marketing by setting sales quotas for their representatives that anticipated such sales, educating their sales force on “peripheral applications,” and providing off-label training to physicians during all-expenses-paid retreats. All in all, it became clear, alleges D’Agostino, that the defendants never intended to hon- or the commitments that MTI had made to the FDA.

2. Axium

Because clinical trials involving Onyx in the treatment of aneurysms evinced numerous complications, the defendants in 2007 launched a new medical device, Axi-um. Put simply, Axium provides another means of generating an embolism to facilitate the surgical treatment of anomalies in blood vessels in the brain. Surgeons use the device to place a small, detachable coil at a desired spot to generate a blockage of blood flow to an abnormality such as an aneurysm. Following the initial launch in 2007, the defendants redesigned the device several times in response to reports that it malfunctioned during procedures. They did not, however, recall earlier generations or relabel any devices. Problems persisted, notwithstanding frequent modifications. On top of these design challenges, irregularities during manufacturing resulted in defective lots of the devices that the defendants nonetheless sold. D’Agostino, who also promoted Axium, attended a February 2009 meeting where top brass admonished the sales force to keep quiet about defects in hopes of dodging FDA scrutiny.

3. Qui Tam Action

Approximately one year later, the defendants terminated D’Agostino’s employment. In October 2010, he brought this qui tarn action as a “relator” on behalf of the United States under the False Claims Act (“FCA”), 31 U.S.C. §§ 3729-3733, and on behalf of numerous states under similar state statutes. The relevant provisions of the FCA are those imposing liability on anyone who “knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval,” id. § 3729(a)(1)(A), or “knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim,” id. § 3729(a)(1)(B). D’Agostino’s proposed complaint accuses ev3 and MTI of violating those provisions in selling Onyx and Axium to hospitals that seek reimbursement from the federal government through, for example, the Centers for Medicare and Medicaid Services (“CMS”).

B. Procedural History

Our opinion in D’Agostino I provides a full recitation of the suit’s early procedural history, 802 F.3d at 190-91, which we repeat only briefly here, D’Agostino filed his original complaint under seal in October 2010 and amended the complaint as a matter of course in February 2011. Through two subsequent amendments, both with permission of the court, D’Agostino added several defendants and retooled his claims. In October 2013, the United States declined to intervene, and the court lifted the seal and authorized service. The parties then submitted a joint briefing schedule to the court for the defendants’ motion to dismiss. The court endorsed the schedule and the defendants timely filed their motion.

A few days before his opposition was due, D’Agostino filed a fourth amended complaint (i.e., his fifth version of the complaint). The defendants immediately moved to strike, insisting that D’Agostino had used up his right to amend as a matter of course back in February 2011. The court agreed but construed D’Agostino’s filing as a request for leave to amend. It applied to that request the “good cause” standard from Rule 16(b) of the Federal Rules of Civil Procedure and-struck the amended complaint for want of good cause. His fourth amended complaint rejected, D’Agostino opposed the motion to dismiss his third amended complaint. The district court sided with the defendants, ruling that certain claims were subject to the FCA’s public disclosure bar, 31 U.S.C. § 3730(e)(4), and that the remaining claims failed to satisfy the pleading requirements of Rules 9(b) and 12(b)(6). See United States ex rel. D’Agostino v. ev3, Inc., No. 10-CV-11822, 2014 WL 4926369, at *5-9 (D. Mass. Sept. 30, 2014).

In the appeal that followed, we held that the district court erred by applying Rule 16(b)’s standard rather than Rule 15(a)’s more lenient standard. D'Agostino I, 802 F.3d at 194. We therefore remanded the case to the district court to evaluate under Rule 15(a) D’Agostino’s request to file a fourth amended complaint. Id. at 195-96. After briefing and argument on the proposed amendment, the district court once again denied D’Agostino’s request to file a fourth amended complaint. See D’Agostino, 153 F.Supp.3d at 525. As before, the district court determined that certain claims were subject to the FCA’s public disclosure bar. Id. at 530-32. Others, it found, lacked particularity per Rule 9(b), id. at 533-38, or otherwise failed to state a claim upon which relief can be granted per Rule 12(b)(6), id. at 538-39. It therefore deemed the motion to amend futile.

In addition to finding the proposed amendment futile, the district court expressed the “tentative view that permitting a further amendment would substantially prejudice the individual defendants,” id. at 539, but decided it was “not necessary for the court to definitively resolve the issue," id. at 540. The court finally noted that it was “inclined to agree” with undue delay arguments advanced by the defendants, which faulted D’Agostino for labeling as “new evidence” information that he could have obtained through reasonable diligence before filing the third amended complaint. Id.

This appeal followed.

II. Discussion

A district court’s ruling under Rule 15(a) that amendment would be futile “means that the complaint, as amended, would fail to state a claim upon which relief could be granted.” Glassman v. Computervision Corp., 90 F.3d 617, 623 (1st Cir. 1996) (citing 3 Moore’s Federal Practice ¶ 15.08[4], at 15-80 (2d ed. 1993)). While we review Rule 15(a) rulings for abuse of discretion, see, e.g., Nikitine v. Wilmington Trust Co., 715 F.3d 388, 389 (1st Cir. 2013), a material error of law constitutes such an abuse, and the question whether a motion to amend is futile because the amended complaint fails to state a claim upon which relief can be granted is a question of law, see Ouch v. Fed. Nat’l Mortg. Ass’n, 799 F.3d 62, 65 (1st Cir. 2015). Hence, our review in this case is actually de novo.

In performing this review, we, like the district court, confront a proposed complaint that covers 123 pages and features extensive single-spaced excerpts. D’Agosti-no devotes most of his pleading to establishing in excessive detail that the defendants said and did things that they knew were false or improper, and to critiquing the Onyx and Axium devices. At the same time, the pleading offers hints of numerous theories for tying the alleged improprieties and defects to false claims. D’Agostino’s briefs on appeal call for us to consider two of those theories for his claims concerning Onyx, and two for his. claims concerning Axium.

A. Onyx Fraudulent Inducement Claims

D’Agostino’s principal claim relating to the government’s payment for the use of MTI’s Onyx device rests on an allegation that MTI made three fraudulent representations to the FDA in seeking approval to market Onyx. Specifically, the defendants disclaimed uses for the device they later pursued, overstated the training they later provided, and omitted critical safety information about the molecule, including its failure in the Enteryx device. The FDA, however, made none of the payments at issue in this lawsuit. Rather, CMS made the payments by reimbursing physicians who performed procedures using Onyx and hospitals where such procedures took place. “FCA liability attaches to a ‘false or fraudulent claim for payment or approval’ or to a ‘false record or statement material to a false or fraudulent claim.’” United States ex rel. Kelly v. Novartis Pharm. Corp., 827 F.3d 5, 14 (1st Cir. 2016) (quoting 81 U.S.C. § 3729(a)(1)(A)-(B)). To link those CMS payments to the fraudulent representations allegedly made to the FDA, DAgostino notes that FDA approval is a precondition to CMS reimbursement for use of a medical device, and argues that the fraudulent representations allegedly made by MTI to the FDA “could have” influenced the FDA to grant that approval.

We reject this argument because alleging that the fraudulent representations “could have” influenced the FDA to approve Onyx falls short of pleading a causal link between the representations made to the FDA and the payments made by CMS. If the representations did not actually cause the FDA to grant approval it otherwise would not have granted, CMS would still have paid the claims. In this respect, DAgostino’s fraudulent inducement theory is like a kick shot in billiards where the cue ball “could have” but did not in fact bounce off the rail, much less hit the targeted ball.

D’Agostino tries to rebut this conclusion by relying on the FCA’s materiality standard. Under that standard, a representation made to secure a payment is material if it has “a natural tendency to influence, or [is] capable of influencing, the payment or receipt of money or property.” 31 U.S.C. § 3729(b)(4). He reasons that as long as MTI’s representations at issue “could have” influenced the FDA to grant approval, the representations were material.

This argument may well misconstrue the FCA’s materiality standard. It is a “demanding” standard. Universal Health Servs., Inc. v. United States, — U.S. —, 136 S.Ct. 1989, 2003,195 L.Ed.2d 348 (2016). Moreover, the FCA requires that the fraudulent representation be material to the government’s payment decision itself. Id at 2002-04. The fact that CMS has not denied reimbursement for Onyx in the wake of D’Agostino’s allegations casts serious doubt on the materiality of the fraudulent representations that D’Agostino alleges. Id. at 2003-04 (“[I]f the Government regularly pays a particular type of claim in full despite actual knowledge that certain requirements were violated, and has signaled no change in position, that is strong evidence that the requirements are not material.”).

In any event, even if the alleged fraudulent representations were material as defined by the FCA, the elements of D’Agostino’s fraudulent inducement claims include not just materiality but also causation; the defendant’s conduct must cause the government to make a payment or to forfeit money owed. See United States ex rel. Westrick v. Second Chance Body Armor Inc., 128 F.Supp.3d 1, 18 (D.D.C. 2015) (holding that a plaintiff asserting fraudulent inducement claims must demonstrate “not only that the omitted information was material but also that the government was induced by, or relied on, the fraudulent statement or omission” (quoting United States ex rel. Thomas v. Siemens AG, 991 F.Supp.2d 540, 569 (E.D. Pa. 2014))), reconsideration granted in part on other grounds sub nom. United States v. Second Chance Body Armor Inc., No. 04-CV-280, 2016 WL 3033937 (D.D.C. Feb. 11, 2016); see also, e.g., United States ex rel. Main v. Oakland City Univ., 426 F.3d 914, 916 (7th Cir. 2005) (“The [FCA] requires a causal rather than a temporal connection between fraud and payment.”). See generally 1 John T. Boese, Civil False Claims and Qui Tam Actions §§ 2.01[A][3], 2.05 (4th ed. 2016). If the FDA would have approved Onyx notwithstanding the alleged fraudulent representations, then the connection between those representations to the FDA and a payment by CMS relying on FDA approval disappears.

The defect in D’Agostino’s claim is not a mere flaw in the complaint’s choice of words. In the six years since D’Agostino surfaced the alleged fraud, the FDA has apparently demanded neither recall nor relabeling of Onyx — this notwithstanding the agency’s option to impose postapproval requirements, 21 C.F.R. § 814.82(a), its clear prerogative to suspend approval temporarily, id. § 814.47(a), and its broad authority to withdraw approval, id. § 814.46(a). In particular, when the FDA concludes that it has been misled because an “application contained or was accompanied by an untrue statement of a material fact,” it can commence an “informal” hearing and withdraw its approval allowing the marketing of a device. See 21 U.S.C. § 360e(e). In such an instance, it acts with the benefit, where appropriate, of “advice on scientific matters from a panel or panels [of experts] under section 360c.” Id.

The FDA’s failure actually to withdraw its approval of Onyx in the face of D’Agostino’s allegations precludes D’Agos-tino from resting his claims on a contention that the FDA’s approval was fraudulently obtained. To rule otherwise would be to turn the FCA into a tool with which a jury of six people could retroactively eliminate the value of FDA approval and effectively require that a product largely be withdrawn from the market even when the FDA itself sees no reason to do so. The FCA exists to protect the government from paying fraudulent claims, not to second-guess agencies’ judgments about whether to rescind regulatory rulings. See D’Agostino, 153 F.Supp.3d at 539 (“Surely, where the FDA was authorized to render the expert decision on ... use and labeling, it, and not some jury or judge, is best suited to determine the factual issues and what their effect would have been on its original conclusions.” (quoting King v. Collagen Corp., 983 F.2d 1130, 1140 (1st Cir. 1993) (Aldrich, J., concurring))).

The collateral effects of allowing juries in qui tam actions to find causation by determining the judgment of the FDA when the FDA itself has not spoken are akin to those practical effects that counsel in favor of not allowing state-law fraud-on-the-FDA claims. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349-51, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). If jurors in a single qui tam case could determine precisely what representations were essential to approval, which experts to believe, and how the FDA interpreted submissions made to it, some potential applicants who would otherwise seek approval for new products might be deterred, others might swamp the FDA with more data than it wants, and the “FDA’s responsibility to police fraud consistently with the Administration’s judgment and objectives” might be undercut. Id. at 350, 121 S.Ct. 1012.

Practical problems of proof also inform our conclusion. How would a relator prove that the FDA would not have granted approval but for the fraudulent representations made by the applicant? Would competing experts read someone’s mind? Whose? What if former officials no longer in government were of one view, and current officials of another? These and similar questions all support our position that the absence of some official agency action confirming its position and judgment in accordance with the law renders D’Agostino’s fraud-on-the-FDA theory futile.

The United States as amicus curiae agrees that D’Agostino’s fraudulent inducement theory “necessarily asks whether [the] FDA would have made a different decision absent the fraud.” The United States does request that we reject any reading of the district court’s opinion as implying that a fraudulent inducement claim would not lie even if fraudulent representations “actually caused [the] FDA to approve or clear the device.”

We do not read the district court’s carefully crafted opinion that way. Its holding does not, in our view, hinge on rejecting or accepting the position of the United States, and neither does ours. Nor are we saying that the FCA is in this context preempted by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-399f. We hold only that causation is an element of the fraudulent inducement claims D’Agostino alleges and that the absence of official action by the FDA establishing such causation leaves a fatal gap in this particular proposed complaint. Certainly some official action by the FDA confirming that its approval was actually procured by the alleged fraudulent representations would fill that particular gap in the proposed complaint. Whether it would suffice to sustain the proposed complaint we need not decide.

We do recognize that, should a valid FCA claim exist if the FDA withdrew its approval for a product upon discovering fraud, our ruling today would pose a theoretical risk that the whistleblowing relator might be deprived of his or her bounty by a government intent on doing so. This is because the relator would need to alert the FDA — to secure withdrawal of approval— before the relator could allege causation. In theory, the government in such an instance might first file an FCA action itself, thereby arguably precluding the whistle-blower from qualifying for a share of the recovery under 31 U.S.C. § 3730(d). As a practical matter, though, this risk is small, and it does not warrant eliminating causation as an element of the claim. As the United States notes, instances in which fraudulent representations “masked problems that are so serious that [the] FDA would have (for example) withheld or withdrawn its approval” are “likely rare.” Moreover, if such a case actually arises, there is no logical reason why the government itself (in a case involving what the FDA finds to be the fraudulent procural of approval) would want to proceed in a manner that deprives the whistleblower of a bounty, thereby reducing the incentive for future potential whistleblowers aware of fraud on the FDA.

In any event, the FDA approved Onyx, and has never withdrawn that approval. D’Agostino therefore cannot establish a causal link between the alleged fraudulent representations made to the FDA and the payment of claims for reimbursement by the government.

B. Onyx “Training Program” Claims

That leaves, with respect to Onyx, D’Agostino’s theory that the defendants caused the submission of false claims by encouraging medically unnecessary and dangerous uses of Onyx by physicians who did not attend the training program offered by the defendants. Undergirding this theory is the fact that Medicare excludes from coverage claims involving procedures that “are not reasonable and necessary for the diagnosis or treatment of illness or injury.” 42 U.S.C. § 1395y(a)(l)(A). D’Agostino’s proposed complaint incorporates the statement of a neurosurgeon and leading Onyx user, who opines that it is never “medically reasonable or medically necessary for an untrained physician to use Onyx in procedure [sic] involving a live human being,” as such use “creates an exceedingly dangerous situation for the patient.” According to D’Agostino, the defendants therefore caused the submission of false claims by “failing] to provide the physician training that the FDA required as a condition of approved usage, and subsequently inducting] those untrained doctors to use Onyx anyway.” This theory, rather than targeting every Onyx claim, attacks the subset of claims seeking reimbursement for procedures performed by physicians whom the defendants did not train.

We evaluate the sufficiency of these allegations under Federal Rule of Civil Procedure 9(b), which provides that, “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.” Fed. R. Civ. P. 9(b). More precisely, Rule 9(b) requires a relator to allege with particularity the who, what, when, where, and how of the fraud. United States ex rel. Ge v. Takeda Pharm. Co., 737 F.3d 116, 123 (1st Cir. 2013). Furthermore, allegations limited to describing the defendant’s scheme and intent are insufficient, “[because FCA liability attaches only to false claims.” Id. at 124 (citing United States ex rel. Karvelas v. Melrose-Wakefield Hosp., 360 F.3d 220, 225 (1st Cir. 2004), abrogated on other grounds by United States ex rel. Gagne v. City of Worcester, 565 F.3d 40 (1st Cir. 2009)). Thus, the allegations must also establish that the fraudulent conduct actually caused the submission of false claims to the government for payment. Id. (citing United States ex rel. Rost v. Pfizer, Inc., 507 F.3d 720, 732-33 (1st Cir. 2007), overruled in part by Allison Engine Co. v. United States ex rel. Sanders, 553 U.S. 662, 128 S.Ct. 2123, 170 L.Ed.2d 1030 (2008)). As a general matter, a relator does this by alleging with particularity examples of actual false claims submitted to the government. Karvelas, 360 F.3d at 232-33. By doing so, the relator conveys that if the facts alleged are true, the filing of a false claim is not merely a possibility, but rather, necessarily occurred. Alternatively, in appropriate circumstances, a relator may instead allege “factual or statistical evidence to strengthen the inference of fraud beyond possibility.” United States ex rel. Duxbury v. Ortho Biotech Prod., L.P., 579 F.3d 13, 29 (1st Cir. 2009) (quoting Rost, 507 F.3d at 733). See, e.g., United States ex rel. Escobar v. Universal Health Servs., Inc., 780 F.3d 504, 515 (1st Cir. 2015), overruled on other grounds by — U.S. —, 136 S.Ct. 1989, 195 L.Ed.2d 348 (2016) (holding that particular allegations concerning one patient were sufficient because they arose from a “systematic failure” that necessarily “infected” other claims with fraud).

Applying these rules, the district court found the proposed complaint’s allegations insufficient, citing their failure to identify any specific false claim submitted to the government for reimbursement. D’Agostino, 153 F.Supp.3d at 536 n.38. In response, D’Agostino repeats the argument he made to the district court, pointing to allegations in his proposed complaint that two physicians who did not attend the defendants’ training program performed a total of approximately seventy procedures using Onyx, and that “well over 50%” of these physicians’ patients were insured under government health plans. So, reasons D’Agostino, the odds are very high that at least some bills were submitted to and paid by the government for use of Onyx by untrained physicians. And since the device label calls for use only by trained physicians, the use by untrained physicians was both off-label and, in the opinion of an expert retained by D’Agostino, not medically necessary.

There are several problems with this line of reasoning. First, and most simply, while the FDA-approved label for Onyx does indeed restrict use to “physicians with neurointerventional training,” and refers users to MTI “for information on training courses,” it contains no requirement that the physician must obtain the training from MTI or ev3. Therefore, D’Agostino’s allegation that the defendants did not train these two physicians falls materially short of alleging facts showing that they were not trained at all. And if they were indeed otherwise trained, the use of Onyx would not have been off-label. For this reason alone, D’Agostino’s “training program” claims fail.

Additionally, even if we were to overlook this gap in the allegations, the assumption that physicians submitted claims for reimbursement merely because many of their patients in general were insured under government programs is faulty. The district court noted as much, explaining the distinction between alleging that a certain percentage of patients carried government insurance and alleging that any patient carrying government insurance underwent a procedure involving the device that resulted in a claim for government reimbursement. D’Agostino, 153 F.Supp.3d at 536 n.38. D’Agostino’s assumption is particularly faulty because seeking reimbursement here would have required the physicians knowingly to submit off-label claims if they did indeed lack the training the label plainly required. See Rost, 507 F.3d at 732-34.

For each of these reasons, we agree with the district court that D’Agostino’s “training program” version of his Onyx claim fails because it does not sufficiently allege the submission of a false claim nor does it advance a theory and facts that together create a “strong inference” that false claims were actually filed. Id. at 732.

C. Axium Manufacturing Defect Claims

D’Agostino describes various alleged defects in the manufacture of Axium. Instead of identifying specific false claims to CMS involving Axium, the proposed complaint seeks to rely on what D’Agostino calls a “complete falsity” theory. This theory applies, he argues, when every device is defective, rendering each claim for reimbursement involving the product false, and thereby “logically obviatpng] the need for identification of specific false claims, because their submission is a virtual certainty.”

This case presents no need to decide whether such a theory is tenable. The proposed complaint simply does not allege facts making it plausible that all Axium devices — or even most-were defective. It alleges only that “certain lots of Axium” contained manufacturing defects that caused the device to malfunction when the surgeon tried to use it. The proposed complaint does not give the number or percentage of Axium devices that suffered these manufacturing defects. It does identify by hospital, surgeon, date, and (sometimes) Axium generation and lot number a dozen or so surgeries during which the surgeon encountered difficulty or failure in trying to deploy the Axium coil. Only certain of those instances are said to involve defectively manufactured devices, and none are alleged to have resulted in any particular false claims paid by the government. See, e.g., Hagerty ex rel. United States v. Cyberonics, Inc., No. 16-1304, 2016 WL 7321224, at *4-5 (1st Cir. Dec. 16, 2016) (holding that identifying doctors and hospitals whose patients had device replacement surgeries does not establish that any medical provider actually submitted claims for government reimbursement). Importantly, there is no claim here of a latent manufacturing defect that manifested itself only after the surgery was completed and the claim for reimbursement submitted. To the contrary, the allegation is that the defect caused the device to fail as the surgeons tried to use it, and thus before any claim for reimbursement might have been submitted. We are therefore left with a proposed complaint that neither alleges any specific false claims involving Axium devices with manufacturing defects nor demonstrates beyond possibility that claims of the type said to be false were actually submitted.

D. Axium Design Defect Claims

The proposed complaint also seeks to advance a design defect claim. To do so, it first asserts that Axium was modified and improved over time. It then calls “defective” all earlier versions of the device that predated such improvements. Even by their own conclusory terms, these allegations do not make all devices defective; for example, any device featuring the most recent modifications when sold would not be “defective.” More importantly, we agree with the district court that a product (much less an FDA-approved medical device) cannot be called defective for purposes of establishing falsity in a qui tam case merely because new versions of the product contain design improvements. See D’Agostino, 153 F.Supp.3d at 537. Indeed, by that standard, most every car sold to the government would be per se defective.

III. Conclusion

None of the claims in D’Agostino’s fourth amended complaint is adequately pled, so his request for leave to file that complaint was properly denied as futile. A fortiori, the lesser included factual recitation set forth in the third amended complaint fails as well. We therefore have no need to consider the district court’s alternative reasons for rejecting D’Agostino’s claims. The district court’s order denying D’Agostino’s motion to amend the complaint is affirmed.

      . The proposed complaint does not allege that Axium was not FDA-approved.

      . The defendants named in the fourth amended complaint are ev3, MTI, and two individuals: John H. Hardin II, a Vice President of Sales at ev3 who oversaw Onyx and Axium, and Brett Wall, a Director at MTI who joined ev3 to serve as a Vice President of Marketing. During the pendency of this appeal, D’Agosti-no voluntarily dismissed with prejudice his appeal as to those individual defendants.

      . To be more precise, a futility finding could also mean that the proposed complaint would require dismissal for other reasons, such as lack of subject-matter jurisdiction under Rule 12(b)(1).

      . The whistleblower in such a scenario, as an original source of the information, would trump any copycats who tried to first file suit after the FDA publicly disclosed its actions. See 31 U.S.C. § 3730(e)(4)(A)(i)-(ii).

      . The proposed complaint alleges that the defendants trained at least one physician at each medical facility, including presumably the facilities at which each of these two physicians worked.