author: STOLL, Circuit Judge.

text:
    TINNUS ENTERPRISES, LLC, Zuru Ltd., Plaintiffs-Appellees v. TELEBRANDS CORPORATION, Bed Bath & Beyond, Inc., Defendants-Appellants
    2016-1410
    United States Court of Appeals, Federal Circuit.
    Decided: January 24, 2017

      Thomas Mansfield Dunlap, Dunlap Bennett & Ludwig PLLC, Leesburg, VA, argued for plaintiffs-appellees. Also represented by David Ludwig, Erio Lorenz Olavson, Robert D. Spendlove; Cortland Christopher Putbrese, Richmond, VA.
    David Miohael Underhill, Boies, Schiller & Flexner, LLP, Washington, DC, argued for defendant-appellant Telebrands Corporation. Also represented by Staoey K. Grigsby, AMY Lynn Neuhardt; David Boies, Armonk, NY; Elana Araj, Cooper & Dunham, LLP, New York, NY.
    Robert Thomas Maldonado, Elana Araj, Cooper & Dunham, LLP, New York, NY, appeared for defendant-appellant Bed Bath & Beyond, Inc.
    Before MOORE, WALLACH, and STOLL, Circuit Judges.
   STOLL, Circuit Judge.

This is an appeal from the grant of a preliminary injunction. The United States District Court for the Eastern District of Texas ruled for the patentee, Tinnus Enterprises, LLC, and entered a preliminary injunction barring Telebrands Corporation from selling its accused product, Balloon Bonanza, or any colorable imitation thereof. Telebrands alleges that the district court abused its discretion by concluding that (1) the asserted claims were likely infringed; (2) the claims were not vulnerable on indefiniteness or obviousness grounds; and (3) Tinnus made a showing of irreparable harm. For the reasons stated below, we disagree with Telebrands and affirm the district court’s grant of a preliminary injunction.

Background

Tinnus Enterprises, LLC produces a toy for filling water balloons covered by U.S. Patent No. 9,051,066, which it calls “Bunch 0 Balloons.” Telebrands Corporation sells a competing product, “Balloon Bonanza.” Both products attach to a hose and fill multiple water balloons at once by channeling the water into the balloons through a set of hollow tubes. A side-by-side comparison of the rival products is shown below:

Bunch Q Balloons

Balloon Bonanza

Appellee Br. 11.

Tinnus and ZURU Ltd. (collectively, “Tinnus”) sued Telebrands and Bed Bath & Beyond, Inc. (collectively, “Telebrands”) for infringement of the ’066 patent and subsequently moved for a preliminary injunction. The Magistrate Judge issued a Report and Recommendation (“R & R”) in which he recommended granting Tinnus’s motion. Tinnus Enters., LLC v. Telebrands Corp., No. 15-00551, 2015 WL 11089479 (E.D. Tex. Sept. 11, 2015) (Magistrate Op.). The district court overruled Telebrands’ objections to the R & R, adopted the R & R’s findings, and granted Tinnus’s motion. Tinnus Enters., LLC v. Telebrands Corp., No. 15-00551, 2015 WL 11089480 (E.D. Tex. Dec. 2, 2015). Shortly thereafter, the Patent Trial and Appeal Board instituted a Post-Grant Review proceeding for the ’066 patent, finding all claims were more likely than not invalid based on the same arguments considered by the district court.

I. The ’066 Patent

The ’066 patent relates to a system and method for simultaneously filling multiple containers with fluid. ’066 patent col. 1 11. 19-21. One application of the ’066 patent is the mass-filling of water balloons, as shown in the embodiment depicted in Figure 1:

This embodiment includes a housing 12 with two ends: end A is removably attached to a fluid source, e.g., hose 14, and end B is attached to a plurality of hollow tubes 16. Id. col. 2 11. 36-37. A plurality of containers 18—in this instance, balloons— are clamped to the tubes 16 using elastic valves 20, which can include elastic fasteners, such as O-rings. Id. col. 2 11. 51-69. The patent refers to the force applied by the elastic valves to keep the containers attached to the tubes as the “connecting force.” Id. col. 3 11. 52-64. Once the fluid source is turned on, multiple balloons are filled simultaneously: fluid flows from hose 14, through the housing 12, and into the containers 18 through the tubes 16. Id. col. 3 11. 41-42.

The ’066 patent teaches three ways to overcome the connecting force such that the containers detach from the tubes. These include: (1) pulling the containers away from the tubes, id. col. 3 11. 48-51; (2) shaking the device to overcome the connecting force holding the containers to the tubes, id. col. 3 11. 52-57; and (3) allowing the containers to fall off due to gravity, id. col. 3 11. 65-67. After being detached from the tubes using any of the above-described methods, the elastic valve constricts and seals the balloon. Id. col. 411. 64-67.

Independent claim 1 is illustrative, and it recites:

1. An apparatus comprising:
a housing comprising an opening at a first end, and a plurality of holes extending through a common face of the housing at a second end;
a plurality of flexible hollow tubes, each hollow tube attached to the housing at a respective one of the holes at the second end of the housing;
a plurality of containers, each container removably attached to a respective one of the hollow tubes; and
a plurality of elastic fasteners, each elastic fastener clamping a respective one of the plurality of containers to a corresponding hollow tube, and each elastic fastener configured to provide a connecting force that is not less than a weight of one of the containers when substantially filled with water, and to automatically seal its respective one of the plurality of containers upon detaching the container from its corresponding hollow tube, such that shaking the hollow tubes in a state in which the containers are substantially filled with water overcomes the connecting force and causes the containers to detach from the hollow tubes thereby causing the elastic fasteners to automatically seal the containers,
wherein the apparatus is configured to fill the containers substantially simultaneously with a fluid.

Id. col. 6 11. 30-53 (emphasis added to indicate disputed limitations).

II. District Court Proceedings

Tinnus filed its patent infringement suit against Telebrands on the day the ’066 patent issued and filed a motion for a preliminary injunction nine days later. The Magistrate Judge reviewed the briefing and held a hearing to evaluate evidence on the preliminary injunction factors before recommending that Tinnus’s motion be granted.

In his infringement analysis, the Magistrate Judge reviewed Tinnus’s claim chart, which mapped the claim limitations onto the Balloon Bonanza product. The claim chart explained why each limitation was met and included photographs of the allegedly infringing product, images from the product instruction manual, screenshots of the product, and related product videos. Telebrands countered that its product did not infringe because its tubes can slide in and out of the housing and therefore are not “attached” to the housing, as required by the claims. Relying on the plain and ordinary meaning of “attached”—“connected or joined to something”—the Magistrate Judge concluded that the “tubes of the Balloon Bonanza product are connected to the housing holes in order for the product to function properly.” Magistrate Op., 2015 WL 11089479, at *4. Telebrands also asserted that disputes over the meaning of “not less than” in conjunction with the term “connecting force” meant that the elastic fastener limitation was not met. The Magistrate Judge, however, found that this argument was actually premised on Telebrands’ contention that shaking is not required to detach the balloons from the tubes in the Balloon Bonanza product. Because the Balloon Bonanza manual instructs the user to “[t]urn off water and give balloons a shake to release,” id. (alteration in original) (quoting J.A. 447), the Magistrate Judge concluded that Balloon Bonanza likely met the disputed limitation, regardless of how it construed “connecting force” or “not less than.”

The Magistrate Judge also found that Telebrands’ indefiniteness and enablement arguments failed to raise a substantial question of validity. First, Telebrands contended that the term “substantially filled” was indefinite because it required subjectivity in determining when the container had become substantially filled. The Magistrate Judge disagreed, noting that there is no per se rule that the term “substantially” is indefinite. The Magistrate Judge further identified “specific parameters” in the claims describing how to determine whether a container is substantially filled—for example, “when the ‘water overcomes the connecting force and causes the containers to detach from the hollow tubes.’ ” Id. at *5 (quoting ’066 patent col. 6 11. 48-52). Second, Telebrands alleged that the term “connecting force” was not enabled because the ’066 patent never describes the type of force where the connecting force is not less than the weight of the container, i.e., when the container will not detach from the tube. The Magistrate Judge disagreed because claim 1 itself recites a shaking limitation for detaching the containers when the connecting force is not less than the weight of the containers when substantially filled with water, which was consistent with the teachings in the specification.

Next, Telebrands argued that claim 1 was obvious over U.S. Patent No. 5,826,803 (“Cooper”) in view of U.S. Patent Publication No. 2013/0118640 (“Saggio”), as well as Cooper in view of Saggio and U.S. Patent Publication No. 2005/0004430 (“Lee”). Cooper discloses a garden sprinkler, as shown in Figure 4 below, that attaches to a garden hose and has multiple bendable tubes 18. ’803 patent col. 2 11. 22-28, col. 3 11.19-23.

Saggio teaches a system, shown in Figure 7 below, that fills multiple tie-less water balloons simultaneously using a one-way valve, as depicted in Figure 5 reproduced below. When water flows into the balloon through channel 20, the water pressure pushes seal 16 and inner membrane 18 up against the outer wall of the balloon 12, thereby locking in the water and preventing it from escaping. J.A. 741.

Lee discloses a method and apparatus for endoscopically inserting a balloon into a person’s stomach to treat obesity. J.A. 753. As shown in Figure 6, a balloon is attached to the inner guide pipe 3 using a rubber band 2 with a high elastic force that stably binds the balloon to the inner guide pipe when it is expanded. J.A. 754. The outer guide pipe 4 can slide forward towards the balloon once the endoscope and balloon are properly placed inside the stomach, which pushes the rubber band off of inner guide pipe 3 and seals the balloon. Id.

FIG. 6

The Magistrate Judge found the combination of Cooper and Saggio deficient because neither reference disclosed the required “elastic fasteners.” The combination of Cooper and Saggio with Lee fared no better because the Magistrate Judge found no evidence that Lee’s rubber band would provide the claimed connecting force. Moreover, the Magistrate Judge was not convinced that a person of ordinary skill in the art (“POSA”) would have been motivated to combine Lee with Cooper and Saggio because the references come from diverse fields: endoscopic balloon insertion devices for obesity treatment, garden sprinklers, and water balloon filling systems, respectively. Finally, even if Teleb-rands were able to establish a prima facie case of obviousness, the Magistrate Judge noted that secondary considerations, such as commercial success and copying, would be relevant because the Balloon Bonanza product appeared to be “a near identical replica” of the patented Bunch 0 Balloons product. Magistrate Op., 2015 WL 11089479, at *7.

With respect to irreparable harm, the Magistrate Judge found evidence of price erosion, consumer confusion, reputational harm, and loss of goodwill based on customer calls, emails, and online reviews. As evidence of price erosion, the Magistrate Judge explained that, while ZURU initially sold Bunch 0 Balloons for $17 in August 2014, in response to direct competition from Balloon Bonanza, ZURU reduced the price of Bunch O Balloons to $12.99, and eventually to $9.99 by mid-2015. According to the Magistrate Judge, the “market entry and continually reduced sale prices of Telebrands’ allegedly infringing product has driven down the price at which the Bunch O Balloons product has sold,” leading to the “harm that is ultimately irreparable here” in the form of the “now lowered price of sale for the present monopoly right.” Id. at *8 (citing Douglas Dynamics, LLC v. Buyers Prods. Co., 717 F.3d 1336, 1345 (Fed. Cir. 2013) (“Where two companies are in competition against one another, the patentee suffers the harm—often irreparable—of being forced to compete against products that incorporate and infringe its own patented inventions,”)).

To establish consumer confusion, reputa-tional harm, and loss of good will, Tinnus provided evidence of conversations and reviews from confused customers. For example, the Magistrate Judge cited evidence that one customer called ZURU to inquire about her product order when, in fact, the customer had purchased Balloon Bonanza instead and that another customer left a review online stating “the inventor of the Balloon Bonanza who invented this product was formerly called Bunch 0 Balloons.” Id. Customers also sent emails to Tinnus asking whether Balloon Bonanza was invented by Mr. Malone, Tinnus’s founder, and wondering whether he had licensed his invention to Telebrands. This evidence convinced the Magistrate Judge that consumers were confused about which product is sold by which company and that the patented Bunch 0 Balloons product had “been diluted in the minds of the consuming public.” Id. Aside from the consumer confusion, the false association between the products harmed Tinnus because Bunch 0 Balloons received better ratings than Balloon Bonanza on Amazon.com and ToysRUs.com. Even though most of these examples pre-dated the issuance of the ’066 patent, the Magistrate Judge found that several of the harms, including customer confusion, were ongoing.

The Magistrate Judge also concluded that the balance of hardships and public interest factors weighed in Tinnus’s favor due to the relative size of the parties and the strong public interest in enforcing valid patents. Because Tinnus established all four factors required for a preliminary injunction, the Magistrate Judge recommended granting Tinnus’s motion.

Telebrands timely filed its objections to the Magistrate Judge’s R & R, alleging that it erred (1) by failing to provide a claim construction for the “attached,” “connecting force,” “elastic fastener,” and “shaking” limitations; (2) by improperly shifting the burden of proof to Telebrands on infringement and invalidity; and (3) by relying on insufficient evidence to support findings of commercial success and copying. Notably, Telebrands did not object to the Magistrate Judge’s indefiniteness ruling or its rejection of Telebrands’ obviousness arguments. The district court overruled each of the objections, adopted the R & R’s findings, and entered a preliminary injunction.

III. PTAB Proceedings

Operating in parallel to the district court proceeding was Telebrands’ PGR petition seeking to invalidate the ’066 patent. The PTAB, relying on the same evidence and arguments before the district court, instituted review on all claims of the ’066 patent shortly after the district court granted Tinnus’s request for a preliminary injunction.

The PTAB found that claim l’s “shake-to-detach” feature was likely indefinite because the specification and prior art both fail to provide “any objective standard for measuring the scope of ‘filled’ or ‘substantially filled,’ ” and the specification sets forth no limit on the amount of shaking needed to detach a filled container from the tube. Institution Decision, 2016 WL 270152, at *7-8. The PTAB also found that a combination of Cooper, Sag-gio, and Lee would likely render claim 1 obvious. Id. at *14. According to the PTAB, a POSA would have combined Sag-gio with Cooper to create a multi-balloon filling assembly by “attach[ing] balloons to the ends of the flexible tubes of Cooper’s sprinkler” and would have added Lee’s mechanism for clamping and sealing the balloons once filled because it was “reasonably pertinent to a particular problem the inventor of the ’066 patent was trying to solve.” Id. at *13.

Telebrands appeals the preliminary injunction entered by the district court. We have jurisdiction pursuant to 28 U.S.C. § 1292(a)(1) and (c)(1).

DISCUSSION

On appeal, Telebrands challenges the district court’s conclusions on likelihood of success on the merits—including its findings on infringement and invalidity—as well as its conclusions on irreparable harm, which we address in turn.

“A decision to grant or deny a preliminary injunction is within the sound discretion of the district court, based upon its assessment of four factors: (1) the likelihood of the patentee’s success on the merits; (2) irreparable harm if the injunction is not granted; (3) the balance of hardships between the parties; and (4) the public interest.” Procter & Gamble Co. v. Kraft Foods Glob., Inc., 549 F.3d 842, 847 (Fed. Cir. 2008) (quoting Oakley, Inc. v. Sunglass Hut Int’l, 316 F.3d 1331, 1338-39 (Fed. Cir. 2003)). With respect to establishing a likelihood of success on the merits, “the patentee seeking a preliminary injunction in a patent infringement suit must show that it will likely prove infringement, and that it will likely withstand challenges, if any, to the validity of the patent.” Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372, 1376 (Fed. Cir. 2009). An accused infringer “can defeat a showing of likelihood of success on the merits by demonstrating a substantial question of validity or infringement.” Trebro Mfg., Inc. v. Firefly Equip., LLC, 748 F.3d 1159, 1165 (Fed. Cir. 2014) (citing Aria Diagnostics, Inc. v. Sequenom, Inc., 726 F.3d 1296, 1304 (Fed. Cir. 2013)).

In general, we review preliminary injunctions using the law of the regional circuit—here, the Fifth Circuit— because “[t]he grant, denial, or modification of a preliminary injunction ... is not unique to patent law.” Id. (alteration in original) (quoting Aevoe Corp. v. AE Tech Co., 727 F.3d 1375, 1381 (Fed. Cir. 2013)). “However, the Federal Circuit has itself built a body of precedent applying the general preliminary injunction considerations to a large number of factually variant patent cases, and gives dominant effect to Federal Circuit precedent insofar as it reflects considerations specific to patent issues.” Murata Mach. USA v. Daifuku Co., 830 F.3d 1357, 1363 (Fed. Cir. 2016) (quoting Trebro, 748 F.3d at 1165). Both the Fifth Circuit and the Federal Circuit review preliminary injunctions for an abuse of discretion. See Sepulvado v. Jindal, 729 F.3d 413, 417 (5th Cir. 2013); see also Procter & Gamble, 549 F.3d at 845. A party can establish an abuse of discretion in the preliminary injunction context “by showing that the court made a clear error of judgment in weighing relevant factors or exercised its discretion based upon an error of law or clearly erroneous factual findings.” Abbott Labs. v. Andrx Pharm., Inc., 452 F.3d 1331, 1335 (Fed. Cir. 2006) (quoting Polymer Techs., Inc. v. Bridwell, 103 F.3d 970, 973 (Fed. Cir. 1996)).

Under Fifth Circuit law, where a party fails to object to a magistrate judge’s findings of fact, conclusions of law, or recommendation to the district court, plain error review applies to those unob-jected-to factual findings and legal conclusions adopted by the district court. Douglass v. United Sens. Auto. Ass’n, 79 F.3d 1415, 1430 (5th Cir. 1996) (en banc), superseded by statute on other grounds, 28 U.S.C. § 636(b)(1) (extending time to file objections from ten to fourteen days). “To prevail under [the plain error] standard, the appellant ‘must show (1) that an error occurred; (2) that the error was plain, which means clear or obvious; (3) the plain error must affect substantial rights; and (4) not correcting the error would seriously impact the fairness, integrity, or public reputation of judicial proceedings.’ ” Ortiz v. City of San Antonio Fire Dep’t, 806 F.3d 822, 825-26 (5th Cir. 2015) (quoting Septimus v. Univ. of Hous., 399 F.3d 601, 607 (5th Cir. 2005)). “When the nature of the claimed error is a question of fact, however, the possibility that such a finding could rise to the level of obvious error required to meet part of the standard for plain error is remote.” Casas v. Aduddell, 404 Fed.Appx. 879, 881 (5th Cir. 2010).

I. Patent Infringement

On appeal, Telebrands first faults the district court for failing to construe the terms “not less than” and “connecting force.” Telebrands also alleges clear error in the district court’s conclusions that the Balloon Bonanza tubes are “attached” to the housing and meet the shake to detach limitation. For the reasons explained below, none of these arguments are persuasive.

An infringement analysis involves the two-step process of “construing the claims and comparing the properly construed claims to the accused product.” Advanced Steel Recovery, LLC v. X-Body Equip., Inc., 808 F.3d 1313, 1316 (Fed. Cir. 2015). Infringement is a question of fact, which we review on appeal for clear error. See AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1056 (Fed. Cir. 2010).

Contrary to Telebrands’ argument, the R & R, which was adopted by the district court, did not refuse to construe the terms “not less than” and “connecting force.” Instead, the R & R acknowledged Telebrands’ disagreement regarding those terms but concluded that Tinnus was likely to succeed on its infringement claim “irrespective of the interpretation of these claim terms.” Magistrate Op., 2015 WL 11089479, at *4. The R & R reached this conclusion because it found that Telebrands’ claim construction argument hinged on the contention that shaking is not required to detach the balloons from the tubes. Because the Balloon Bonanza instruction manual tells users to “[t]urn off water and give balloons a shake to release,” id. (alteration in original), the Magistrate Judge determined that Telebrands’ position conflicted with the record evidence and failed to demonstrate that Tinnus was unlikely to succeed on its infringement claim. It was not clear error for the district court to adopt this finding.

Next, Telebrands challenges the district court’s application of the claim term “attached” to the Balloon Bonanza product because its tubes allegedly “do not connect or join to the housing, but rather slide in and out of the holes in the common face of the housing.” Appellant Br. 24-25. The R & R applied the plain and ordinary meaning for the term “attached,” i.e., “connected or joined to something,” and found that the Balloon Bonanza product’s tubes must be “connected to” the housing’s holes in order for it to function properly. Magistrate Op., 2015 WL 11089479, at *4 (citing Merriam-Webster Dictionary, https://www. merriam-webster.com/dictionary/attached (last visited Dec. 19, 2016)). This must be so, according to the R & R, because the housing accepts water from the hose at one end and sends the water through the holes at the other end, which are connected to hollow tubes for filling the balloons. The R & R’s analysis of the “attached” limitation is reasonable, and the district court’s adoption of it does not constitute clear error.

Finally, Telebrands alleges that each claim limitation must be found in the accused product itself, and that it was clear error for the Magistrate Judge to rely on Balloon Bonanza’s instruction manual to satisfy the shaking limitation. We disagree. The instructions for the Balloon Bonanza product are at least circumstantial evidence of infringement for any claim elements taught by those materials. A pat-entee is entitled to rely on circumstantial evidence to establish infringement: “If [Defendant] is arguing that proof of inducing infringement or direct infringement requires direct, as opposed to circumstantial evidence, we must disagree. It is hornbook law that direct evidence of a fact is not necessary.” Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 1272 (Fed. Cir. 1986), abrogated on other grounds by Egyptian Goddess, Inc. v. Swisa, Inc., 543 F.3d 665 (Fed. Cir. 2008) (en banc), as recognized in VirtualAgility Inc. v. Salesforce.com, Inc., 759 F.3d 1307, 1318 (Fed. Cir. 2014). Indeed, this court has previously approved of the use of instruction manuals to demonstrate direct infringement by customers in the context of induced infringement. Golden Blount, Inc. v. Robert H. Peterson Co., 438 F.3d 1354, 1362-63 (Fed. Cir. 2006) (“We reject [Defendant's argument that [the patentee] could not rely on the instruction sheets to prove acts of direct infringement by end-users.”); see also Moleculon, 793 F.2d at 1272 (affirming district court’s finding of induced infringement based, in part, on instruction sheet).

The cases Telebrands cites to the contrary are not persuasive. MicroStrategy stands for the unremarkable proposition that every claim limitation must be met to establish literal infringement and says nothing about product instructions. MicroStrategy Inc. v. Bus. Objects, S.A., 429 F.3d 1344, 1352-53 (Fed. Cir. 2005). The pertinent portion of the Vita-Mix case relates to an induced infringement analysis where the Plaintiff attempted to use the accused infringer’s instructions to establish an intent to induce infringement. Vita-Mix Corp. v. Basic Holding, Inc., 581 F.3d 1317, 1328 (Fed. Cir. 2009). There, we disregarded the instructions because they did not support the inference of intent to infringe, not because reliance on the instructions would be legally improper. Id. at 1328-29. We are aware of no case law prohibiting a court from relying on product instructions to find direct infringement. Accordingly, the district court did not clearly err in relying on Telebrands’ instruction manual as part of its infringement analysis.

II. Patent Validity

“The burden on the accused infringer to show a substantial question of invalidity at [the preliminary injunction] stage is lower than what is required to prove invalidity at trial.” Altana Pharma AG v. Teva Pharm. USA, Inc., 566 F.3d 999, 1006 (Fed. Cir. 2009). “Vulnerability is the issue at the preliminary injunction stage, while validity is the issue at trial.” Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1359 (Fed. Cir. 2001). Telebrands contends that the Magistrate Judge improperly shifted the burden of proving invalidity to Telebrands, rather than requiring Tinnus to establish a likelihood of success in proving the patent’s validity. This argument is not compelling.

Each issued patent carries with it a presumption of validity under 35 U.S.C. § 282. Titan Tire, 566 F.3d at 1376-77. This presumption is sufficient to establish a likelihood of success on the validity issue, absent a challenge by the accused infringer. Id. at 1377. Where the alleged infringer attacks the validity of the patent, “the burden is on the challenger to come forward with evidence of invalidity,” which the patentee must then rebut. Id. at 1377-78. “[I]f the trial court concludes there is a ‘substantial question’ concerning the validity of the patent, meaning that the alleged infringer has presented an invalidity defense that the patentee has not shown lacks substantial merit, it necessarily follows that the patentee has not succeeded in showing it is likely to succeed at trial on the merits of the validity issue.” Id. at 1379. The district court properly applied this analytical framework.

A. Indefiniteness

Telebrands contends that the claim term “substantially filled” is indefinite because a POSA would not be able to determine whether an expandable container meets this limitation.

“[A] patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., — U.S. -, 134 S.Ct. 2120, 2124, 189 L.Ed.2d 37 (2014). Because Telebrands did not object to the R & R’s indefiniteness determination, we review the district court’s determination on indefiniteness for plain error. Douglass, 79 F.3d at 1430.

Telebrands attempts to circumvent this deferential standard of review by arguing that objecting to the R & R’s claim construction, or lack thereof, put the Magistrate Judge on notice that it was contesting the definiteness of “substantially filled.” We disagree. Nowhere in its objections to the R & R does Telebrands mention the word “indefinite,” J.A. 1986-88, and “substantially filled” is not even among the terms flagged by Telebrands— “attached,” “connecting force,” “elastic fastener,” and the “shaking” limitation—as requiring construction. Id. We fail to see how seeking the construction of different, albeit related, claim terms would put the district court on notice of Telebrands’ objection to the R & R’s conclusion that “substantially filled” was not indefinite.

Turning to the merits, Telebrands argues on appeal that the ’066 patent creates a subjective standard for determining whether a container is “substantially filled” because the specification makes frequent references to detaching the containers when they reach a “desired size.” Appellant Br. 13-14. The specification, however, does not define or equate “substantially filled” with “desired size.” And the claims themselves teach that shaking causes the containers to detach from the hollow tubes when they are “substantially filled” with water, ’066 patent col. 6 11. 46-51, meaning that shaking will not detach the containers if they are not “substantially filled.” To put a finer point on it, if the balloons detach after shaking, then they are “substantially filled.” The R & R cited a portion of this claim language to support its conclusion that the ’066 patent provided “specific parameters” for determining when the containers are “substantially filled.” Magistrate Op., 2015 WL 11089479, at *5.

Telebrands alleges that the R & R’s reliance on a portion of this claim language for determining when a container is “substantially filled” was based on a truncated and incorrect reading of the claim. The R & R says, “containers are substantially filled with water when the ‘water overcomes the connecting force and causes the containers to detach from the hollow tubes.’ ” Id. (quoting ’066 patent col. 6 11. 48-52). According to Telebrands, shaking, not the water, overcomes the connecting force. Although shaking does contribute to the detachment, as discussed above, the claims specifically call for detachment by shaking when the container is “substantially filled” with water. Thus, we do not find this argument persuasive.

In addition to the reasons set forth in the R & R, the level of ordinary skill in the art plays an important role in an indefiniteness analysis. Telebrands asserts that a POSA has “a general knowledge about and experience with expandable containers, including without limitation balloons, and at least an associate’s degree in science or engineering.” J.A. 835-36 ¶¶ 10-13. We find it difficult to believe that a person with an associate’s degree in a science or engineering discipline who had read the specification and relevant prosecution history would be unable to determine with reasonable certainty when a water balloon is “substantially filled.”

For these reasons, the district court’s conclusion that Telebrands’ indefiniteness argument failed to raise a substantial question of validity does not suffer from a “clear or obvious” error, Ortiz, 806 F.3d at 825-26, requiring reversal under plain error review. Because we find no clear or obvious error, we need not address the other plain error factors articulated by the Fifth Circuit in Ortiz.

B. Obviousness

On appeal, Telebrands advances several arguments relating to the combination of the Cooper, Saggio, and Lee references. Because Telebrands did not object to the factual findings and legal conclusions in the R & R relating to obviousness, we review the district court’s obviousness analysis for plain error.

A claim is unpatentable as obvious “if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art.” 35 U.S.C. § 103. The law is clear, however, that “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR Int'l, Co. v. Teleflex Inc., 550 U.S. 398, 418, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007). Indeed, “it can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” Id.

Telebrands argues that the district court erred because it found there was no motivation to combine the prior art references without first considering whether Lee was reasonably pertinent to the particular problem the inventor solved. More specifically, Telebrands alleges that Cooper, Saggio, and Lee each relate to the same problem addressed by the ’066 patent: “automatically sealing a balloon or multiple balloons at one time.” Appellant Br. 17-18. A prior art reference is analogous and thus can be used in an obviousness combination if it “is from the same field of endeavor, regardless of the problem addressed” or “is reasonably pertinent to the particular problem with which the inventor is involved,” even if it is not within the inventor’s field of endeavor. Unwired Planet, LLC v. Google Inc., 841 F.3d 995, 1000-01 (Fed. Cir. 2016) (quoting In re Clay, 966 F.2d 656, 658-59 (Fed. Cir. 1992)). The particular problem confronting the inventor here was how to rapidly fill multiple containers with fluid. This is far removed from the problems associated with an endoscopic balloon insertion device for treating obesity, and Telebrands has not demonstrated that Lee is reasonably pertinent to the problem addressed in the ’066 patent. Therefore, under a plain error review, we cannot say that the district court committed a clear or obvious error when it found insufficient motivation to combine these disparate references. Absent a motivation to combine, Telebrands’ remaining obviousness arguments are unavailing.

III. Irreparable Harm

Finally, Telebrands alleges that it was clear error for the Magistrate Judge to rely on evidence pre-dating the ’066 patent’s issuance in support of its finding of irreparable harm. Citing GAF Building Materials Corp. v. Elk Corp. of Dallas, 90 F.3d 479 (Fed. Cir. 1996), Telebrands asserts that irreparable harm must be measured from the date the patent issues because that is the date on which the right to exclude others arises. The GAF case is inapposite, however, because it addresses the dismissal for lack of jurisdiction of an action for declaratory judgment of invalidity and noninfringement of a design patent that had not yet issued. Id. at 481-83. And Telebrands cites no case prohibiting reliance on evidence of irreparable harm predating the patent’s issuance.

Evidence of consumer confusion, harm to reputation, and loss of goodwill predating the patent is, at the very least, circumstantial evidence demonstrating the possibility of identical harms once the patent issues. Neither party has suggested that the issuance of a patent would somehow mitigate or otherwise eliminate those harms. Similarly, the pre-issuance price erosion evidence may be relevant to show what would happen if Balloon Bonanza was no longer on the market. For example, it might support an argument that, absent competition, Tinnus could raise its price back to the original price point, but would not be able to do so as long as competition from Balloon Bonanza remains.

Nonetheless, the irreparable harm analysis does not depend solely on evidence pre-dating the patent. The record contains additional evidence of harm after the ’066 patent’s issuance that is sufficient to support a finding of irreparable harm. For example, a review for Tinnus’s Bunch 0 Balloons product on Amazon—dated a few weeks after the patent issued—states that the customer liked the “off brand” Bunch 0 Balloons product better than the “name brand” Balloon Bonanza. J.A. 1436. This establishes persisting harm to Tinnus’s reputation and tarnishes its status as the innovator in this market. See Celsis In Vitro, Inc. v. CellzDirect, Inc., 664 F.3d 922, 930 (Fed. Cir. 2012) (“Price erosion, loss of goodwill, damage to reputation, and loss of business opportunities are all valid grounds for finding irreparable harm.”). Although the post-issuance evidence is thinner, we are unable to find any clear error in the district court’s conclusion that Tinnus had demonstrated irreparable harm.

CONCLUSION

For the reasons stated above, the district court did not abuse its discretion in granting the preliminary injunction. Accordingly, we affirm the district court’s judgment.

AFFIRMED

Costs

Costs to Appellees.

      . ZURU is the exclusive licensee of all present and future patent rights owned by Tinnus that relate to the Bunch O Balloons product,

      . This limitation requires "each elastic fastener configured to provide a connecting force that is not less than a weight of one of the containers when substantially filled with water.” Magistrate Op., 2015 WL 11089479, at *4 (quoting '066 patent col. 6 11. 41-44).

      . Telebrands offered additional obviousness combinations based on other references at the district court level, but it does not raise them on appeal.

      . Telebrands also objected to the R & R’s findings with respect to irreparable harm, but this portion of its objections was not included in the appellate record. See Defendants’ Objections to the Report and Recommendation Regarding Plaintiffs’ Motion for Preliminary Injunction (Dkt. No. 9) at 4-5, Tinnus Enters., LLC v. Telebrands Corp., No. 15-00551 (E.D. Tex. Sept. 25, 2015), ECF No. 70.

      . The PTAB instituted review for claims 1-6, 8, and 10-14. Tinnus disclaimed claims 7 and 9. Telebrands Corp. v. Tinnus Enters., LLC, PGR2015-18, 2016 WL 270152, at *1 n.1 (PTAB Jan. 4, 2016) (Institution Decision).

      . The PTAB defined the following italicized claim language as the shake-to-detach feature: "each elastic fastener configured to provide a connecting force that is not less than a weight of one of the containers when substantially filled with water, ... such that shaking the hollow tubes in a state in which the containers are substantially filled with water overcomes the connecting force and causes the containers to detach from the hollow tubes.” Id. at *7 (alteration in original).

      . We are aware that the PTAB issued a Final Written Decision on December 30, 2016, concluding that the claims of the '066 patent are indefinite. The PTAB's decision is not binding on this court, and based on the record before us and the applicable standard of review, it does not persuade us that the district court abused its discretion in granting the preliminary injunction. The parties are, of course, free to ask the district court to reconsider its preliminary injunction in light of the PTAB’s Decision.

      . Telebrands also argues that "connecting force” is indefinite, but its argument turns on the indefiniteness of "substantially filled.” See Appellant Br. 14 ("Without knowing what volume of water constitutes ‘substantially filled,’ one skilled in the art cannot know its weight, thus rendering the 'connecting force’ indefinite.”).

      . Telebrands conceded that plain error review applies during oral argument. See Oral Arg. at 6:10-6:30, http://oralarguments.cafc.uscourts. gov/default.aspx?fl=2016-1410.mp3.


source: Caselaw Access Project

author: HUGHES, Circuit Judge.

license: Public Domain

text:
    Charles L. KAYS, Jr., Claimant-Appellant v. Robert D. SNYDER, Acting Secretary of Veterans Affairs, Respondent-Appellee
    2016-1314
    United States Court of Appeals, Federal Circuit.
    Decided: January 25, 2017

      Kenneth M. CaRpenter, Law Offices of Carpenter Chartered, Topeka, KS, argued for claimant-appellant.
    Martin M. Tomlinson, Commercial Litigation Branch, Civil Division, United States Department of Justice, Washington, DC, argued for defendant-appellee. Also represented by Benjamin C. MizeR, RobeRT E. Kirschman, Jr., Soott D. Austin; Y. Ken Lee, Martie Ajdelman, Office of General Counsel, Department of Veterans Affairs, Washington, DC.
    Before REYNA, TARANTO, and HUGHES, Circuit Judges.
   HUGHES, Circuit Judge.

Charles L. Kays appeals from a final judgment of the United States Court of Appeals for Veterans Claims. The Veterans Court affirmed a Board of Veterans’ Appeals decision denying Mr. Kays’s claim for disability compensation for post-traumatic stress disorder because he failed to establish credible evidence of the in-service stressor necessary to support a PTSD claim. On appeal, Mr. Kays challenges the Veterans Court’s decision regarding the in-service stressor and, particularly, the standard of review it applied to the Board’s finding regarding the claimed stressor. Because the Veterans Court applied the correct standard of review, and because it correctly determined that the regulations require credible supporting evidence that the claimed in-service stressor occurred to the veteran, we affirm.

I

Mr. Kays served in the United States Navy from August 1972 to August 1976. In 2005, he filed a claim with the Department of Veterans Affairs for benefits for disability caused by PTSD. He alleged that two non-combat stressors during his service caused his PTSD. First, he claims that he was stabbed during a fight as he left an Enlisted Men’s Club. Second, he claims that while he was off-duty and taking diving lessons, he was asked to help with the recovery effort of a downed civilian helicopter. When he dove into the water, he was separated from the group and became stressed and scared.

To establish that the alleged in-service stressors occurred, Mr. Kays submitted statements, records, and in-person testimony about the events surrounding the stabbing and the helicopter incident. Mr. Kays also submitted a newspaper article entitled “Fatal ’Copter Crash Probed” and dated Monday, January 12, 1976. J.A. 192. The article describes how the Maryland state and marine police investigated a helicopter crash that occurred the preceding Friday. The pilot died three hours after the accident and a helicopter mechanic was treated for exposure and later released from a local hospital. The article did not mention that any civilian diving students were involved with rescue efforts.

In 2005, the Regional Office denied Mr. Kays’s claim for service connection for PTSD, and in 2007, the Board of Veterans Appeals (Board) remanded for further development of the record. The Regional Office again denied the PTSD claim and, in 2010, the Board affirmed that decision. While this case was pending appeal at the Veterans Court, the pertinent regulation, 38 C.F.R. § 3.304(f), was amended and the Veterans Court issued a decision holding that the amendments to § 3.304(f) were retroactive. See Ervin v. Shinsehi, 24 Vet. App. 318 (2011). At the parties’ request, the Veterans Court remanded this case to the Board.

The Board subsequently denied Mr. Kays’s claim for compensation because he did not present credible evidence establishing that the claimed stressors occurred. Specifically, the Board found that statements by Mr. Elays and his former spouse about the alleged stabbing were not credible because they were unsupported and contradicted by other evidence in the record. The Board also found that Mr. Kays’s testimony about his involvement in a traumatizing search and rescue was not credible because of the lack of supporting detail in the article, his delay in reporting the event, and his changing and inconsistent story.

Mr. Kays appealed to the Veterans Court, arguing' that it should review de novo the Board’s decision on whether a veteran has submitted credible supporting evidence that a claimed in-service stressor occurred. The Veterans Court disagreed and found the Board’s decision to be a question of fact reviewed under the clearly erroneous standard. Mr. Kays appeals. We have jurisdiction pursuant to 38 U.S.C. §§ 7292(a), (c), (d)(1).

II

We review questions of statutory and regulatory interpretation de novo. Blubaugh v. McDonald, 773 F.3d 1310, 1312 (Fed. Cir. 2014). A non-combat veteran seeking to establish service connection for PTSD must establish (1) a current medical diagnosis of PTSD; (2) a link between the current symptoms and an in-service stressor; and (3) “credible supporting evidence that the claimed in-service stressor occurred.” 38 C.F.R. § 3.304(f). At issue here is the third requirement— whether there is credible supporting evidence that the claimed stressor actually occurred. That is a factual determination, to be made in the first instance by the Board, and reviewed by the Veterans Court under a clearly erroneous standard. See, e.g., Sizemore v. Principi, 18 Vet.App. 264, 270 (2004) (‘Whether a veteran has submitted sufficient corroborative evidence of his or her claimed in-service stressors is also a factual determination that is reviewed under th[e] [clearly erroneous] standard.”). Mr. Kays argues, however, that rather than a factual determination reviewed for clear error, the credible supporting evidence requirement is an “evi-dentiary burden” that should be reviewed de novo by the Veterans Court. See, e.g., Appellant’s Br. 7; Appellant’s Reply Br. 2-10. We disagree.

As an initial matter, the language of the regulation makes clear that the credible supporting evidence requirement imposes a burden on the veteran to demonstrate that the claimed stressor occurred—a quintessential factual inquiry. In similar cases, we have rejected the argument that a veteran meets this burden by pointing to any evidence. Instead, we have recognized that when a statute or regulation requires a veteran to demonstrate proof of an injury or event, the veteran must put forth sufficient evidence to show that “it was at least as likely as not that” the event or injury occurred. Holton v. Shinseki, 557 F.3d 1362, 1370 (Fed. Cir. 2009). Further, we have held that once such evidence is submitted, it is incumbent on the Board to “evaluate the weight of the evidence.” Id. That evaluation and subsequent determination of whether an event occurred is precisely the type of factual determination that the Board is tasked with making. And that the Veterans Court reviews for clear error. Sizemore, 18 Vet.App. at 270.

Likewise, in Lennox v. Principi, 353 F.3d 941, 945 (Fed. Cir. 2003), we rejected a similar argument that the Veterans Court should always review de novo a finding of no service connection. We explained that de novo review may be performed by the Veterans Court only when the Board (1) has explicitly interpreted a statute or regulation “concerning the correct standard for service connection,” id. or (2) is “establishing a legal rule to be applied to similar fact situations in future cases,” id. at 946. When the Board is deciding disputed facts or applying established law to the facts of a case, we held that those decisions are “subject to review by the [Veterans Court] under the clearly erroneous standard....” Id. at 945.

In this case, the Board did not explicitly interpret a statute or regulation concerning the correct standard for service connection or make a legal rule to apply in future cases on the amount of evidence necessary for there to be “credible supporting evidence.” Rather, it applied established law to the specific facts of this case to find Mr. Kays had not provided “credible supporting evidence.” In other words, the Board made quintessential factual determinations regarding Mr. Kays’s evidence, statements, and credibility, and found that he was not entitled to service connection. J.A. 164-75. The Veterans Court appropriately reviewed these factual determinations under the clearly erroneous standard.

At oral argument, Mr. Kays appeared to raise a slightly different argument relating to why the Veterans Court’s decision affirming the Board should be reversed. See, e.g., Oral Argument at 5:51-6:03, available at http://oralarguments. cafc.uscourts.gov/default.aspx?fl=2016-1314.mp3. According to Mr. Kays, § 3.304(f)’s requirement to provide “credible supporting evidence that the claimed in-service stressor occurred” requires only evidence that the “stressor occurred,” not that it occurred to the veteran. Mr. Kays argues that § 3.304(f)’s requirement that there be “a current medical diagnosis of PTSD” ensures a nexus between the stres-sor and the veteran. Thus, under Mr. Kays’s view of § 3.304(f), he needed to provide evidence only that a helicopter crash occurred, but did not need to provide any evidence that he got lost participating in search and rescue activities.

We find Mr. Kays’s interpretation of § 3.304(f) unpersuasive. The regulation requires “credible supporting evidence that the claimed in-service stressor occurred.” 38 C.F.R. § 3.304(f) (emphasis added). Here, Mr. Kays claimed that his in-service stressor was getting lost while participating in search and rescue activities after a civilian helicopter crash. Accordingly, § 3.304(f) required Mr. Kays to submit credible evidence that he was involved in search and rescue activities and not simply that a civilian helicopter crash occurred.

Furthermore, Mr. Kays’s argument— that “a current medical diagnosis of PTSD” assures that the in-service stressor occurred to the veteran—misunderstands the ordinary role of a physician diagnosing PTSD. A physician is not expected to do a detailed investigation of a veteran’s claimed in-service stressors. And a physician’s diagnosis of PTSD does not necessarily identify what stressor caused it. Indeed, PTSD could result from an event not identified by the veteran. That is why the regulation requires the veteran to separately submit credible supporting evidence that the claimed in-service stressor occurred.

Accordingly, because the Veterans Court applied the proper standard of review, and because § 3.304(f) requires credible supporting evidence that the claimed in-service stressor occurred as claimed by the veteran, we affirm.

AFFIRMED

No costs.


author: TARANTO, Circuit Judge.

text:
    CUMBERLAND PHARMACEUTICALS INC., Plaintiff-Appellee v. MYLAN INSTITUTIONAL LLC, Mylan Inc., Defendants-Appellants
    2016-1155, 2016-1259
    United States Court of Appeals, Federal Circuit.
    Decided: January 26, 2017

      Laura PollaRD Masurovsky, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC, argued for plaintiff-appellee. Also represented by Danielle Andrea Duszczyszyn, Mark J. Feld-stein, Jason Lee Romrell.
    Nioole W. Stafford, Wilson, Sonsini, Goodrich & Rosati, PC, Austin, TX, argued for defendants-appellants. Also represented by Robert Delafield; Adam William Burrowbridge, Washington, DC; Elham Firouzi Steiner, San Diego, CA; Nanoy L. Zhang, Palo Alto, CA.
    Before MOORE, REYNA, and TARANTO, Circuit Judges.
   TARANTO, Circuit Judge.

Cumberland Pharmaceuticals, Inc. owns U.S. Patent No. 8,399,445, which describes and claims acetylcysteine compositions substantially free of chelating agents. It is listed in the Food and Drug Administration’s Approved, Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) as covering Cumberland’s ehelating-agent-free formulation of Aceta-dote®, an intravenous antidote for overdoses of acetaminophen. When Mylan Institutional LLC filed an abbreviated new drug application to market its own chelating-agent-free acetylcysteine formulation, Cumberland brought this patent-infringement action in the Northern District of Illinois against Mylan Institutional LLC and Mylan Inc. (hereafter “Mylan,” individually or jointly). Mylan stipulated to infringement but asserted invalidity on two grounds: derivation of the claimed invention from someone at the FDA and obviousness. The district court rejected both challenges after a bench trial. In particular, the court found that Mylan proved neither (1) that anyone at the FDA conceived of the claimed invention before the patent-named inventor nor (2) that there was a reasonable expectation that the claimed formulations, without any chelat-ing agents, would succeed. Cumberland Pharm., Inc. v. Mylan Institutional LLC, 137 F.Supp.3d 1108, 1121-22, 1127 (N.D. Ill. 2015). We affirm.

I

A

At the priority date relevant here (August 24, 2005), acetylcysteine was known in the art as an antidote for acetaminophen overdoses. ’445 patent, col. 1, lines 20-34. It also was known to have a stability problem: heavy metal ions, whether inherent in the formulation or found as contaminants, catalyze the oxidation of acetylcysteine in solution, causing it to degrade. Id., col. 1, lines 39-40; see Cumberland, 137 F.Supp.3d at 1112 n.2. A prior-art response to the stability problem was to include edetate disodium (EDTA or ede-tate) in an acetylcysteine formulation. ’445 patent, col. 1, line 45, through col. 2, line 4. EDTA, a chelating agent, surrounds and binds to heavy metal ions, preventing them from acting as catalysts that oxidize ace-tylcysteine. Id. Such EDTA-eontaining formulations of acetylcysteine were considered safe, despite potential negative side effects. Id., col. 2, lines 14-27.

Cumberland’s ’445 patent declares: “It has been surprisingly found that an aqueous composition containing acetylcysteine, sterilized water, and a pH-adjusting agent, is stable without the addition of a chelating agent.” Id., col. 2, lines 48-50. The patent claims such compositions. Every claim in the patent requires a “stable” composition that is “free of chelating agents,” id., col. 9, line 16, through col. 10, line 53, and the district court construed the term to mean “[blacking one or more chelating agents,” Cumberland, 137 F.Supp.3d at 1112.

B

The facts central to the dispute over the ’445 patent’s validity date from 2002, when the FDA was considering Cumberland’s application for permission to market the original EDTA-containing formulation of Acetadote®, a formulation previously approved in other countries. On December 10, 2002, the FDA sent Cumberland a letter, in which the FDA gave Cumberland the following instructions (among others): “[2c.] Provide scientific and regulatory justification for the inclusion of Edetate as a component in the drug product. In addition, provide a description of the pharmacological properties for Edetate in this drug product.” J.A. 12837. Six days later, representatives of the FDA and Cumberland spoke by telephone. Notes of the call state: “Regarding item 2(c), the Division explained that data should be provided to support any justification for the inclusion of Edetate, since a non-trivial amount is included in the formulation.” J.A. 12899.

On December 20, 2002, Cumberland formally responded to the FDA in a letter written by Leo Pavliv, who was the Cumberland official responsible for Acetadote® and who is the named inventor on the ’445 patent. The letter explained that EDTA was included to stabilize the formulation and stated: “If no or lower concentrations of edetate are capable of ensuring product stability, lowering or removing edetate would raise questions of how the safety and efficacy of the product would be effected.” J.A. 14783. Mr. Pavliv ultimately testified at trial that, shortly after writing this letter, he had the idea of testing the stability of an acetylcysteine formulation without EDTA.

On March 5, 2003, Cumberland asked the PDA to schedule a call for further discussion of its December 20, 2002 response. With respect to question 2c, Cumberland proposed to discuss the following: “Cumberland believes the use of Edetate as a component in the drug product is justified both from a scientific as well as a regulatory point of view. Does FDA agree?” J.A, 11343. There is no written record of the occurrence or content of the requested call. At trial, however, Mr. Pav-liv testified that the call took place; that FDA representatives indicated on the call that they were not prepared to say whether they considered EDTA’s inclusion justified; and that Mr. Pavliv then stated his idea to perform a stability study. According to Mr. Pavliv, at least one FDA representative on the call approved of his idea to do a study and asked him to put the proposal in writing.

Cumberland did so in a July 21, 2003 letter, stating: “As requested by FDA, upon product approval \ie., upon FDA approval of the EDTA-containing formulation], Cumberland Pharmaceuticals intends to initiate studies to determine the impact on product stability of both decreasing and completely removing edetate disodium from the formulation.” J.A. 14916. The FDA issued its Chemistry Review of the EDTA-containing formulation on January 9, 2004. That document states: “The sponsor reported that, as requested by the FDA upon drug approval, an independent study will be initiated to determine the impact on drug product stability of both decreasing and completely removing the amount of edetate sodium.” J.Á. 12968; see id. at 12969 (referring twice more to Cumberland’s commitment to a post-approval study). The FDA approved the EDTA-containing product on January 23, 2004, J.A. 11334-37, with the approval letter reminding Cumberland of its commitment to “evaluate the potential benefit of Edetate disodium on the stability of the drug product,” the study to “include a comparison of the current concentration of Edetate to a formulation with a lower concentration and no concentration of Edetate.” Id. at 11336.

Cumberland then arranged by contract for testing to be done by Bioniche Pharma Group, “Mylan’s predecessor company.” Cumberland, 137 F.Supp.3d at 1116. The protocol, proposed by Mr. Pavliv and approved by the FDA without change, included testing a formulation that turned out to be the claimed invention, i.e., a formulation containing neither EDTA nor any other chelating agent. On November 18, 2004, three months into the study, Mr. Pavliv received encouraging stability data. On August 24, 2005, having received further encouraging stability data (for a longer period), Cumberland filed its application for what became U.S. Patent No. 8,148,-356, the parent of the ’445 patent at issue here.

Cumberland gave the FDA the final results of the stability study, containing data for thirty-six months, on August 13, 2008. It then set about securing approval to market an EDTA-free version of Aceta-dote®. The FDA approved that product in January 2011.

C

On December 19, 2011, Mylan filed an abbreviated new drug application seeking permission to market a generic version of Cumberland’s EDTA-free acetylcysteine product. Shortly thereafter, on February 27, 2012, Cumberland filed the divisional application that became the ’445 patent. When the ’356 patent issued on April 3, 2012, Mylan sent Cumberland a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) that the ’356 patent was either invalid or not infringed by My-lan’s proposed product.

On May 17, 2012, Cumberland sued My-lan for infringement of the ’356 patent pursuant to 35 U.S.C. § 271(e)(2)(A). The ’445 patent issued on March 19, 2013, and Cumberland then amended its complaint to add allegations of infringement of the ’445 patent. On August 4, 2014, Mylan stipulated to infringement of claims 1-14 of the ’445 patent should they be held valid and enforceable. Cumberland withdrew its claims regarding the ’356 patent on September 28,2014.

At the bench trial, Mylan argued that (1) the ’445 patent had been derived from someone at the FDA, on the theory that it was someone at the FDA, not Mr. Pavliv, who first had the idea to remove EDTA from the prior-art formulation, and (2) the invention would have been obvious in light of certain prior-art communications from the FDA. The district court held that (1) Mylan had not proved that anyone at the FDA conceived of the invention before Cumberland’s inventor did, Cumberland, 137 F.Supp.3d at 1121-22, and (2) there was no reasonable expectation that a formulation without any chelating agents would be successful, given the prevailing skilled-artisan view that chelating agents were necessary to prevent degradation of acetylcysteine, id. at 1127. The court entered a final judgment of validity and infringement on November 17, 2015. We have jurisdiction under 28 U.S.C. § 1295(a)(1).

II

“While the ultimate question of whether a patentee derived an invention from another is one of fact, the determination of whether there was a prior conception is a question of law, which is based upon subsidiary factual findings.” Price v. Symsek, 988 F.2d 1187, 1190 (Fed. Cir. 1993) (citations omitted). Obviousness is a question of law based on underlying questions of fact. Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1290 (Fed. Cir. 2013). We review the district court’s conclusions of law de novo and its findings of fact for clear error. Id.

A

Mylan’s derivation challenge invokes the rule that an applicant is not entitled to a patent if “he did not himself invent the subject matter sought to be patented.” 35 U.S.C. § 102(f) (2006). More specifically, it invokes the familiar requirement that a challenger asserting this ground show that there was a “prior conception of the claimed subject matter and communication of the conception” to the named inventor. Price, 988 F.2d at 1190; see Creative Compounds, LLC v. Starmark Labs., 651 F.3d 1303, 1313 (Fed. Cir. 2011); Eaton Corp. v. Rockwell Int'l Corp., 323 F.3d 1332,1344 (Fed. Cir. 2003); Gambro Lundia AB v. Baxter Healthcare Corp., 110 F.3d 1573, 1576 (Fed. Cir. 1997) (“To show derivation, the party asserting invalidity must prove both prior conception of the invention by another and communication of that conception to the patentee.”). The conception requirement of derivation borrows from the conception standard for prior invention. Creative Compounds, 651 F.3d at 1313 (relying on the conception analysis from a discussion of priority earlier in the opinion as sufficient in the discussion of derivation). Conception is keyed to the claimed invention; “A conception must encompass all limitations of the claimed invention.” Singh v. Brake, 317 F.3d 1334, 1340 (Fed. Cir. 2003); see Taurus IP, LLC v. DaimlerChrysler Corp., 726 F.3d 1306, 1323 (Fed. Cir. 2013); Slip Track Sys., Inc. v. Metal-Lite, Inc., 304 F.3d 1256, 1263 (Fed. Cir. 2002); Brown v. Barbacid, 276 F.3d 1327, 1336 (Fed. Cir. 2002). Conception requires more than “a general goal or research plan”; it requires a “definite and permanent,” “specific, settled idea,” namely, the idea defined by the claim at issue. Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994); see REG Synthetic Fuels, LLC v. Neste Oil Oyj, 841 F.3d 954, 962 (Fed. Cir. 2016).

In inventorship disputes, “the inventors named on the issued patent are presumed to be correct” and “a person seeking to add his name ‘must meet the heavy burden of proving its case by clear and convincing evidence.’” Shum v. Intel Corp., 633 F.3d 1067, 1083 (Fed. Cir. 2010) (quoting Eli Lilly & Co. v. Aradigm Corp., 376 F.3d 1352, 1358 (Fed. Cir. 2004)). We apply the same approach in the derivation context here. Amax Fly Ash Corp. v. United States, 514 F.2d 1041, 1047-48 (Ct. Cl. 1975), cited with approval in Hess v. Advanced Cardiovascular Sys., Inc., 106 F.3d 976, 980 (Fed. Cir. 1997).

In this case, as the derivation issue was litigated, it suffices to focus on the fact that the required complete conception had to include the specific idea to remove EDTA from Acetadote® (or a similar product that met all the other ’445 claim elements) and not add another chelating agent. It was that idea which Mylan had to show, by clear and convincing evidence, was conceived by someone at the FDA and communicated to Mr. Pavliv. See Amax Fly Ash Corp., 514 F.2d at 1048.

The district court found that Mylan did not carry that burden. After considering the “surprising paucity of direct evidence,” Cumberland, 137 F.Supp.3d at 1120, the district court concluded that while “the evidence does not establish a precise date of conception by Pavliv,” “Mylan has failed to persuade the court that anyone other than Pavliv ever conceived of a ‘definite and permanent idea’ of an EDTA-free Ace-tadote formulation,” id. at 1121-22. Given the claim language requiring that the product be “free of chelating agents,” ’445 patent, col. 9, lines 20-21, not just EDTA, and the district court’s several references to that particular claim requirement, Cumberland, 137 F.Supp.3d at 1112-13 (discussing the claim limitation “free of chelat-ing agents”); id. at 1123-24 (same), we think it clear that the district court’s finding refers to a formulation of Acetadote® that simply removes EDTA, without adding another chelating agent in its place. The court thus found that Mylan did not prove that an FDA person conceived of that formulation, or communicated it to Cumberland, before Mr. Pavliv thought of it.

The evidence supports the finding. The court could properly view the FDA’s December 10, 2002 letter, which simply requested justification for the inclusion of EDTA in the drug product, as not showing the prior conception needed here. J.A. 12887 (“[2(c):] Provide scientific and regulatory justification for the inclusion of Ede-tate as a component in the drug product. In addition, provide a description of the pharmacological properties for Edetate in this drug product.”). A different view is not required by the notes of the December 16, 2002 call, which add only that the FDA wanted data to support the justification. J.A. 12899 (“Regarding item 2(c), the Division explained that data should be provided to support any justification for the inclusion of Edetate, since a non-trivial amount is included in the formulation.”). A request for justification of the inclusion of EDTA, supported by data, is not the same as a suggestion to remove it, let alone to remove it and not replace it with another chelating agent.

Mylan argues that the request for data to support the inclusion of EDTA required Cumberland to undertake research that would have inevitably led it to the invention. That is not enough for derivation. We have held that derivation is not proved by showing conception and communication of an idea different from the claimed invention even where that idea would make the claimed idea obvious. Gambro Lundia, 110 F.3d at 1577-78. We also have made clear that a “general goal or research plan” does not constitute the “definite and permanent idea” required for conception, Burroughs Wellcome, 40 F.3d at 1228, and that a “bare hope” of a result “never before ... achieved” (here, the claimed “stable” compound) is not sufficient for conception, Hitzeman v. Rutter, 243 F.3d 1345, 1356-57 (Fed. Cir. 2001). See Cumberland, 137 F.Supp.3d at 1121. The kind of general research suggestion at issue here, whatever its role in an obviousness analysis, does not establish the conception required for derivation.

The evidence dating from after December 2002 likewise does not compel a finding contrary to the district court’s. In particular, even when documents go beyond discussing a study of whether EDTA’s inclusion is justified and mention removing EDTA, they do not make clear either that all chelating agents were to be avoided or that even the EDTA-removal idea (whether or not a substitute was to be added) came from someone other than Mr. Pavliv. All of those documents postdate the conversation Mr. Pavliv had with FDA representatives, in which, he testified, he was the one who introduced the idea of testing an EDTA-free product.

Thus, several Cumberland documents, starting with the July 21, 2003 letter quoted above, J.A. 14916, refer to the FDA as having “requested” the study. But that language can be read as focusing on the FDA’s request for a study implementing the idea already suggested by Mr. Pavliv. See J.A. 11263 (Cumberland’s Apr. 19, 2004 proposed study protocol) (“As part of a post approval marketing commitment, the FDA requested Cumberland investigate whether EDTA has a beneficial impact on stability and if so whether the level could be reduced.”); J.A. 11311 (Cumberland’s Aug. 13, 2008 final report from stability study) (“The FDA expressed a potential safety concern with EDTA in the formulation and as such, requested Cumberland investigate whether EDTA provided a stability benefit or could be reduced or removed from the product.”); J.A. 11360 (Cumberland’s May 10, 2011 draft clinical study protocol for EDTA-free Acetadote®) (“The FDA expressed a potential safety concern with EDTA in the formulation of Acetadote and requested that the manufacturer investigate whether EDTA provided a stability benefit or could be reduced or removed from the product.”); J.A. 11693 (Cumberland’s May 18, 2012 citizen petition) (“From the outset, FDA wanted Cumberland to investigate reducing or removing EDTA from Acetadote® because the agency was concerned with the safety of EDTA. The agency should not now approve an ANDA for Acetadote® that relies on the discontinued formulation that is less safe than the EDTA-free formulation that FDA specifically requested Cumberland investigate developing, and that is currently on the market.”).

Indeed, the FDA’s January 9, 2004 Chemistry Review, after stating that “[t]he sponsor reported that, as requested by FDA ..., an independent study will be initiated to determine the impact on drug product stability of both decreasing and completely removing the amount of ede-tate sodium,” J.A. 12968, adds that the study was “applicant proposed,” J.A. 12969. As that document confirms, it is entirely possible for Cumberland to have first proposed the idea of studying EDTA removal, as Mr. Pavliv testified, and for the FDA to have “requested” that Cumberland actually perform that study. And, as with the December 2002 communications, none of these documents establish that the FDA specifically conceived of removing EDTA from the prior-art Aceta-dote® without adding any other chelating agents, as required by the claim language.

Mylan gets no further help in reversing the district court’s finding from the FDA’s reliance on Cumberland’s commitment to perform the study in approving the EDTA-containing product in 2004. It simply does not follow from the fact that the study ultimately became a commitment recited in the 2004 FDA approval that it was someone at the FDA who originally proposed the study, let alone conceived of the invention eventually claimed in the ’445 patent. The district court could properly find that the study requirement in the Approval Letter did not specify that Cumberland must test an EDTA-free formulation of acetylcysteine without adding any other chelating agents. Cumberland, 137 F.Supp.3d at 1123 (“Most importantly, the reference to Cumberland’s commitment to study the removal of EDTA from Aceta-dote nowhere specifies that the exact same drug formulation without EDTA must be used.”). The study requirement, in total, reads:

Commit to evaluate the potential benefit of Edetate disodium on the stability of the drug product. The study shall include a comparison of the current concentration of Edetate to a formulation with a lower concentration and no concentration of Edetate. Generate stability data from the new proposed formulations including compatibility stability with infusion bags.

J.A. 11336. As the district court explained: “ ‘A formulation’ could contain, for instance, a chelating agent other than EDTA. This composition would be free of EDTA and satisfy the study requirement, but would not be ‘free of chelating agents,’ ... which every claim of the ’445 patent requires.” Cumberland, 137 F.Supp.3d at 1123-24 (citation omitted). Consistent with this conclusion, Cumberland provided testimony that there were many possible ways to meet this commitment, including adding other chelating agents or testing without the claimed “airtight container” containing inert gas, and there was documentary evidence that it was Mr. Pavliv who came up with the precise protocol that amounted to a reduction to practice of the ’445 patent’s invention.

Mylan does not contend that anyone at the FDA, rather than Mr. Pavliv, drafted the study protocol that resulted in the claimed invention (though it does point out that the protocol Mr. Pavliv chose was the same protocol used to confirm the stability of EDTA-containing Acetadote®). Instead, Mylan takes the position that the communications between the FDA and Cumberland, which all require “removing or reducing” EDTA from “the” formulation or “the” drug product, must refer to the approved EDTA-containing product; thus, according to Mylan, the study requirement is not open to an interpretation that would allow a relevant skilled artisan to do anything other than arrive at the claimed invention, free of chelating agents. But the use of the definite article need not do so much work as to direct a skilled artisan to remove EDTA, add nothing else, and test the resulting formulation in exactly the manner to lead to the invention. Indeed, Mylan’s theory would appear to prove too much: Cumberland’s December 20, 2002 letter referred to the effect on “the product” if it turned out that “no or lower concentrations of edetate are capable of ensuring product stability,” and Cumberland’s July 21, 2003 letter also refers to “completely removing edetate disodium from the formulation.” J.A. 14783, 14916 (emphases added). If reference to removing EDTA from “the” formulation is enough, we do not see why Cumberland’s evidence would not suffice to show that Mr. Pavliv, the author of the December 20, 2002 and July 21, 2003 letters, first conceived of the invention.

For those reasons, we affirm the district court’s determination that Mylan did not clearly and convincingly show that Mr. Pavliv derived the invention of the ’445 patent from someone at the FDA.

B

We also affirm the district court’s rejection of Mylan’s obviousness challenge. Mylan relies for this challenge on the EDTA-containing Acetadote® and its package insert—which, Mylan asserts, include or teach all of the elements of the invention except the removal of EDTA—together with several references that allegedly bridge the gap to reach the claimed chelat-ing-agent-free version of an acetylcysteine product. Specifically, Mylan relies on (a) the FDA’s January 9, 2004 Chemistry Review and January 23, 2004 Approval Letter, each of which, it asserts, motivates removal of EDTA by stating Cumberland’s commitment to study EDTA’s role; and (b) U.S. Patent Pub. No. 2004/0022873 to Guil-ford, which describes intravenous acetylcy-steine formulations for treating bioterror exposures. Those contentions, we conclude, do not undermine the district court’s rejection of Mylan’s obviousness challenge.

“A party seeking to invalidate a patent on the basis of obviousness must demonstrate by clear and convincing evidence that a skilled artisan would' have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Kinetic Con cepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1360 (Fed. Cir. 2012) (internal quotation marks and citations omitted). The presence or absence of a reasonable expectation of success is a question of fact. See Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1366 (Fed. Cir. 2016); PAR Phann., Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1196 (Fed. Cir. 2014); Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006).

“The reasonable expectation of success requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Systems, 821 F.3d at 1367. Here, stability is an express claim requirement. The district court in this case wrote: “the coui't’s review of the evidence supports the conclusion that persons of ordinary skill in the art would have assumed that EDTA, or some other chelat-ing agent, was necessary to maintain stability in an acetylcysteine formulation.” Cumberland, 137 F.Supp.3d at 1125. It added: “Given that all prior acetylcysteine formulations contained EDTA, and given that the prior art taught that EDTA or another chelating agent was necessary to stabilize the formulation, the court rejects the argument that the Approval Letter or Chemistry Review, which contained the EDTA study commitments, would reasonably lead to a stable acetylcysteine formulation.” Id. at 1126. Though not using the exact phrase, “reasonable expectation of success,” the court thus found that the hypothetical relevant skilled artisan would not have reasonably expected a chelating-agent-free intravenous acetylcysteine formulation to succeed in being stable, a claim requirement. Id. at 1125.

That finding is not clearly erroneous. Considerable evidence supports the finding that relevant skilled artisans believed that chelating agents were necessary to sequester metal contaminants and prevent oxida-tive degradation of acetylcysteine and that such artisans had no reasonable expectation of stability without such an agent. J.A. 14507 (U.S. Patent No. 5,700,653 to Lu, explaining how EDTA can alleviate acetyl-cysteine’s “notorious instability in solution”); J.A. 14509 (Lu patent, referring to an experiment “carried out to confirm that, as known in the art, [acetylcysteine] in a solution of creatine kinase buffer will become unstable in the buffer solution, but that the presence of EDTA can provide some limited stability”); J.A. 8666, 8723 (Dr. Kent, expert for Mylan, testifying that acetylcysteine’s thiol groups are prone to oxidation); J.A. 9298, 9304, 9323-25 (Dr. Bym, expert for Cumberland, testifying that a person of ordinary skill would understand that EDTA was necessary to prevent oxidation and would be concerned about removing it); see also J.A. 13324 (Hamlow, observing that “data show that acetylcysteine solution containing the che-lating agent EDTA is well protected from oxidative degradation”). As late as 2011, Mylan’s own scientists expressed concern that the removal of EDTA would make the product more vulnerable to oxidation. E.g., J.A. 14346 (email noting the “risk” that “removing EDTA will open up sensitivity to heavy metals at low ppm levels in solution” and proposing experiments to determine sources and effects of heavy metals in the proposed product); J.A. 14487-88 (email to vial supplier requesting data for how much iron could leech from the glass into solution because of concern that the “product may be sensitive to oxidation”); J.A. 14562 (meeting agenda stating: “Iron in Glass may cause an issue with EDTA removal. Set up tests to confirm glass being chosen is acceptable.”).

Mylan offered evidence tending to show that there is no need to chelate trace metal ions because degradation may be effectively avoided by an inert vial atmosphere together with modern manufacturing practices that leave very low levels of metal contaminants. But Mylan’s evidence did not compel a finding that relevant skilled artisans would have reasonably expected success for those reasons in 2005. The district court had sufficient evidence to find otherwise. In addition to the already-cited evidence, we note the pre-2005 references indicating that even very small amounts of metal and oxygen could result in degradation. J.A. 13574 (Kasraian et al. stating: “In many' cases, minimizing oxygen alone is not sufficient to prevent au-toxidation, because trace levels of oxygen may be enough to initiate this reaction”); J.A. 13459 (Waterman stating: “Trace metals are almost ubiquitous in dosage forms, and since they are often catalysts rather than consumed, they can affect rates even at low levels”).

Finally, there is no clear error in the district court’s finding that Guilford did not provide either a motivation to remove EDTA or a reasonable expectation of success. Cumberland, 137 F.Supp.3d at 1126. Although Guilford did not disclose a che-lating agent in its formulation of acetylcy-steine, it also did not publish stability data. To the extent that a person of ordinary skill could infer that the Guilford formulation was stable, there was testimony explaining that a person of ordinary skill would not expect it to remain stable as the concentration of acetylcysteine was raised to the level required by the ’445 patent. See id.

Ill

For the foregoing reasons, we affirm the district court’s judgment.

AFFIRMED

      . Although the letter is signed by Amy Rock of Cumberland’s department of regulatory affairs, both Mr. Pavliv and Dr. Rock testified that it was Mr. Pavliv who drafted the December 20th response and Cumberland’s Aceta-dote® correspondence to the FDA more generally. See Cumberland, 137 F.Supp.3d at 1114 n.3.

      . Although several patent claims are at issue in this case, the issues have been litigated in such a way as to make it appropriate to use the singular “invention,”

      . The quoted version of 35 U.S.C. § 102 applies to this case. The application that became the ’445 patent was filed on February 27, 2012, and claims priority to August 2005. The application has never contained a claim having an effective filing date on or after March 16, 2013 (the effective date of the statutory changes enacted in 2011), or a reference under 35 U.S.C. §§ 120, 121, of 365(c) to any patent or application that ever contained such a claim. See Leahy-Smith America Invents Act, Pub. L. No. 112-29, § 3(n)(1), 125 Stat. 284, 293 (2011); Fleming v. Escort Inc., 774 F.3d 1371, 1374 n.1 (Fed. Cir. 2014).

      . The parties have stipulated that the Approval Letter and package insert were publicly available no later than February 2, 2004, and that the Chemistry Review was publicly available as of October 1, 2004. J.A. 14923. The parties accept that the priority date for the '445 patent is August 24, 2005.

      . Kasra Kasraian et al., Developing an Injecta-ble Formula Containing an Oxygen-Sensitive Drug: A case Study of Danofloxacin Injectable, 4 Pharmaceutical Dev. & Tech. 475 (1999).

      . Kenneth C. Waterman et al., Stabilization of Pharmaceuticals to Oxidative Degradation, 7 Pharmaceutical Dev. & Tech. 1 (2002).