First, there is no evidence that the "matrix" needs to be a discrete structure. To the contrary, during the prosecution of the '499, '520, '667, '052, and '056 patents, applicants submitted a definition of matrix which defined it as a "substance containing something: a substance in which something is embedded or enclosed." Matrix Definition, Microsoft Encarta 2006. The '783 patent also describes the invention as "a tablet comprising a matrix of drug and controlled release material, and optionally other pharmaceutically desirable ingredients (e.g., diluents, binders, colorants, lubricants, etc.)." The patent and the prosecution history make no mention that the matrix must be separate from other pharmaceutical ingredients. Additionally, Defendants offer no explanation of what they mean by "discrete" except to say that "discrete just means it has to be distinct. It has to occupy some sort of contiguous identifiable space." Markman Hr'g Tr. 41:4-5. The court finds that Defendants' construction imports unwarranted and unnecessary confusion into the claims. Accordingly, the court finds no reason to import the term "discrete" into the construction of matrix.

To further support inclusion of the word "discrete," Defendants allege that a POSA must be able to identify individual matrices because claim 17 of the '401 patent discloses "a plurality of pharmaceutically acceptable matrices." '401 patent, col. 26 ll. 30-31. According to Defendants, the matrix must occupy some discrete, identifiable space because that is the only way to determine whether a dosage form has multiple matrices; therefore, satisfying the limitation of claim 17. Markman Hr'g Tr. 41:5. Defendants posed a question to the court during the Markman Hearing: "[h]ow is one to know if a dosage form with an active ingredient and say half a dozen excipients has one matrix or two matrices or six matrices if there [does not] . . . have to be any special distinction between them." Id. 41 :24-42:2. The court is not persuaded by Defendants' argument because the claims do not require a certain number of matrices. Defendants admit that "examples of dosage forms . . . include a core, and then another layer, or a shell," implying multiple matrices. Tr. 42:6-7. Just because examples of dosage forms require the matrices to be discrete, that does not mean that every dosage form has to have discrete matrices. Accordingly, the court finds Plaintiff's position persuasive-the term "matrices" is just the plural of the term "matrix."

Second, outside of preferred embodiments discussed in the '783 patent, there is no evidence supporting the inclusion of "solid" in the construction of "matrix." Defendants argue that the specification solely provides examples of a solid dosage forms, which would inherently require solid matrices. (D.I. 102 at 4). That does not convince the court that it must adopt Defendants' construction, however. The Federal Circuit has repeatedly cautioned against importing limitations from the specification into the claims. See ComarkCommc'ns, Inc. v. Harris Corp., 156 F.3d 1182, 1186 (Fed. Cir. 1998); Phillips v. AWHCorp., 415 F.3d 1303, 1323 (Fed. Cir. 2005); Computer Docking Station Corp. v. Dell, Inc., 519 F.3d 1366, 1374 (Fed. Cir. 2008). The court also sees a distinction between a solid dosage form and a solid matrix. The patents with the term matrix in their claim language do refer to solid dosages forms, but the court does not take that to mean that a solid matrix is also required. Defendants admit that the '060 patent refers to matrix materials that could exist in a semi-solid form, such as wax. Markman Hr'g Tr. 39: 14-40:2. They contend, however, that the '060 patent requires a breaking strength of 500 N, so it does not make sense to have a dosage form with a very high breaking strength if the dosage form has a liquid matrix. Id No scientific evidence was presented on that point, though. The fact that the patent mentions a semi-solid used in forming the matrix is enough to persuade the court it cannot adopt Defendants' construction. There is simply nothing in the asserted patents that convinces the court that the "matrix" must be a solid structure.

In the '740 patent, regardless of whether polyethylene oxide is a matrix material or a controlled release material, it is still "in" the matrix. The patent provides a "non-limiting list of suitable controlled release materials," '740 patent, col. 14 ll.65-67, and then explains that "[c]ertain embodiments utilize mixtures of two or more of the foregoing controlled release materials in the matrix of the core." Id. col. 15 ll.11-12. When the patent describes polyethylene oxide as a matrix material it states that in certain embodiments, the first and second matrix material "comprise[] polyethylene oxide." '740 patent, col. 6 l. 3. Further, the patent states that "polyethylene oxide is contained in both components," where "both components" refers to the first and second matrix materials. Accordingly, requiring the controlled release matrix material to be "in a matrix" does not remove the option of forming the matrix out of the claimed material itself, as evidenced by the patents example of forming the matrix out of polyethylene oxide. The court finds that Defendants' proposed construction of "controlled release matrix material" is consistent with the usage of that phrase and related phrases throughout the '740 patent.

The court also declines to adopt Defendants' proposed construction because of the phrase "at controlled rates." The court is unsure of the meaning of "controlled rates." The court agrees with Plaintiffs that the phrase implies a rate comparison to an immediate release dosage form when the patent and the prosecution history do not necessitate such a comparison. (D.I. 147 at 2). In the prosecution history, the applicants told the Examiner that "in dosage forms according to the subject invention the high molecular weight polyalkylene oxide serves as a controlled-release matrix thereby retarding the release profile of the drug." (D.I. 116, Ex. 31, Response to Dec. 28. 2006 Office Action at 12). Based on the inventor's statement to the Examiner, it seems that no comparison to an immediate release dosage form is necessary to explain the purpose of controlled-release matrix materials-to retard the release of the active pharmaceutical ingredient from the dosage form. For those reasons, the court adopts Plaintiffs' proposed construction.

Plaintiff's main argument is that Defendants ignore the sentence that comes after the specification's definition of steady-states—"Thus, at `steady-state,' the patient's body eliminates the drug at approximately the same rate that the drug becomes available to the patient's system through absorption into the blood." '667, col. 4 ll. 49-52. Plaintiffs contend that "the blood stream (i.e. blood serum) is the [relevant] "system" for "steady-state." (D.I. 101 at 15). Plaintiffs thus maintain that the proper construction of "steady state" is "[a] state in which the amount of drug reaching blood serum is approximately the same as the amount of drug leaving blood serum." Id. The court does not find Plaintiffs' argument persuasive. The court sees no reason to import the limitation "blood serum" into the patentees' explicit definition in the specification.

The court in Combined Sys., Inc. v. Def Tech. Corp. ofAm., 350 F.3d 1207 (Fed. Cir. 2003), found that the term "forming" required "deliberate and systematic creation of folds. In the comi's analysis, it explained that the district court was instructed by not only the gerund form of the term, but also by the American Heritage Dictionary definition of the term and the term's use in the specification. Id at 1210. Here, while the American Heritage Dictionary and the gerund form of the word might counsel against Plaintiff's proposed construction, the specification and the claim itself make clear that "obtaining a serum plasma profile" is actually a passive consequence of administering the drug.

First, claim 20 of the '940 patent discloses "[a] method of providing effective pain relief to a patient in need thereof comprising: obtaining a serum profile," having a specific plasma level, "by administering orally on a once-a-day basis a controlled release formulation of the hydrocodone." From that language, it appears that the desired serum profile is "obtained" by administering the drug. The specification supports the courts understanding.

According to the patentees, the novelty of the invention—improving the efficiency and quality of pain management in patients experiencing moderate pain—follows from providing the controlled release opioid formulation. See '940 patent, col. 1 ll. 38-40. Once the drug is administered, because of the release profile, there is "an early onset of therapeutic effect," and then "after rising to a maximum concentration during the dosage interval,'' the controlled release opioid formulation "provide[s] a relatively flat serum plasma profile, meaning that the plasma level of the opioid provides a C24/Cmax ratio of about 0.55 to about 1.0." Id. ll. 50-58. The word "assaying," in Defendants' construction is never used in the patent and the specification, neither implicitly nor explicitly, requires regular blood sampling. While the court understands how "obtaining" could imply an active assaying step in other contexts, the word, as used in the context of this patent, seems to rather clearly imply a passive occmTence that is the result of administering the controlled release formulation. For that reason, the court adopts Plaintiff's proposed construction.

Defendants propose a construction of "thermoforming" that excludes dosage forms made using pressure and subsequent exposure to heat. The asserted claim, claim 1 of the '060 patent, does not mention a heating step. Instead, it just discloses a "thermoformed dosage form comprising one or more active ingredients with abuse potential." Col. 21 ll. 6-7. Claim 25 describes "[a] process for the production of a dosage form according to claim 1, comprising" mixing a number of components and then "press-forming the resultant mixture . . . to yield the dosage form with preceding, simultaneous, or subsequent exposure to heat." '060 patent, col. 23 II. 1-8. There are only two steps in claim 25: (1) mixing the components; and (2) press-forming the resultant mixture. There is no implication that the mixture is thermoformed and then, at some later point, exposed to heat. The claim explicitly links "yield[ing] the dosage form" with the "preceding, simultaneous, or subsequent exposure to heat."

The specification is also replete with examples of subsequent applications of heat. The use of heat, subsequent to the application of pressure, is mentioned four separate times in the specification. '060 patent, col. 11 ll. 19, 27, 33, 44. Defendants attempt to undermine the disclosure of subsequent heating by pointing to one line in the specification: "[i]n direct tableting with subsequent exposure to heat, the formed tablets are briefly heated at least to the softening temperature (glass transition temperature, melting temperature, sintering temperature) of component (C) and cooled again." Defendants contend that the reference to "cooled again" implies that the dosage form was exposed to heat, then cooled, then heated again, and then "cooled again." In that scenario, Defendants argue, the dosage form is "thermoformed" using preceding or simultaneous heat, and then later, only after thermoforming is complete, is the dosage form exposed to heat again. "[C]ool[ing] again" is only discussed in the context of "direct tableting." '060 patent, col. 11 ll. 28-40. Direct tableting is explicitly labeled as one example by which the mixture can be formed into tablets. Id. For that reason, the specification's disclosure of a formed tablet being "cooled again" does not alter the court's conclusion that a thermoformed dosage form can be created with pressure and the subsequent application of heat.

Plaintiffs contend that the claims and the intrinsic record do not exclude polymer (C) from serving as the viscosity-increasing agent. The court disagrees. Claim 9 discloses "[a] dosage form according to claim 1, which additionally comprises at least one of the following components a)-f): . . . (b) at least one viscosity-increasing agent." '060 patent, col. 21 ll. 37-42. The phrase "additionally comprises" leads the court to believe that the viscosity-increasing agent must be a component distinct from the components disclosed in claim 1. The specification confirms the court's reading of the plain language ofclaim 9.

The specification explains that dosage forms according to the invention cannot be crushed into a powder, effectively nullifying the possibility of intravenous or nasal abuse. '060 patent, col. 6 ll. 24-26. Polymer (C)-a component listed in claim 1—is included to increase the hardness of the dosage form and ensure that it cannot be easily pulverized or crushed. Id. col. 6 ll. 20-23. The specification goes on to explain that in order to prevent any abuse if a dosage form is somehow pulverized, the dosage form may "contain further agents which complicate or prevent abuse as auxiliary substances (B)." Id. ll. 28-34. The viscosity-increasing agent is listed as an auxiliary substance that can be included in the dosage form. Id. ll. 40-43. The fact that the auxiliary substance (B) is different from polymer (C) in claim 1, and the fact that the specification classifies auxiliary substances as "further agents," confirm the court's finding that the viscosity-increasing agent is distinct from polymer (C).

'060 patent, col. 8 ll. 55-62. The meaning of "a necessary minimum quantity of an aqueous liquid" cannot be derived from the specification test because of key differences between it and the gelling test explained in claim 9. Claim 9 requires that a gel form from the mixture of the "viscosity-increasing agent," a "necessary minimum quantity of an aqueous liquid," and "the extract obtained from the dosage form." '060 col. 21 ll. 41-56. As recognized in OxyContin, the claim 9 test "applies to the dosage form as a whole," whereas the specification test "is designed to assess whether a particular viscosity-increasing agent is suitable for use in the invention." 2014 WL 2198590, at *13.

Another key difference between the two tests is that the specification test calls for the mixture of the active-ingredient and the viscosity-increasing agent. The claim 9 test, by contrast, calls for a mixture of the viscosity-increasing agent and "the extract obtained from the dosage form." '060 patent, col. 211. 43. It is clear from claim 1 that the dosage form comprises components other than the active ingredient. Id. col. 21 ll. 6-14. Those additional components could affect gel formation. Accordingly, the example 3 test cannot inform the court's construction of "an aqueous liquid in a necessary minimum quantity."

Because the court finds that the patent does not provide a meaning for the claimed phrase, the court adopts Defendants' proposed plain meaning construction. The possible indefiniteness of the claim phrase is a matter that the parties can explore at trial.

Claim 1 of the '615 patent discloses a "cured shaped tablet" comprising "an opioid . . ., at least one low molecular weight polyethylene oxide . . ., at least one high molecular weight polyethylene oxide . . .; and at least one additive." '615 patent, col. 166 ll. 13-23. Claim 1 also discloses the process by which the tablet is prepared, which requires:

Id. ll. 26-31 (emphasis added). As Defendants point out, the plain and ordinary meaning of the language in claim 1 of the '615 patent requires all three ingredients to be present in the blend. (D.I. 102 at 13). The court finds that combining the opioid with "each of' the different-weight polyethylene oxides—where the claim uses the conjunctive "and"—means that the opioid must be combined with both the high and low molecular weight polyethylene oxides. Plaintiffs do not seriously dispute that the plain language of claim 1 of the patents appears to require all three ingredients in a single blend. Instead, they instruct the court to consider claim 21. (D.I. 101 at 14).

Claim 21 of the '615 patent then requires a "cured shaped tablet" according to claim 1, where "said low molecular weight polyethylene oxide comprises a first blend and said high molecular weight polyethylene oxide comprises a second blend, wherein at least one said blend further comprises said at least one additive." Col. 168 ll. 16-20. Plaintiffs contend that, if the court adopts Defendants' proposed construction, claim 21 is broader than claim 1, in violation of a cannon of claim construction. (D.I. 111 at 13). The court does not agree with Plaintiffs' contention. Claim 1 states the requirements when the cured shaped tablet comprises one blend. Claim 1 explicitly allows for the possibility of more than one blend, however. '615 patent, col. 166 I. 29. Claim 21 discloses a cured shaped tablet of claim 1 that comprises more than one blend, making claim 21 narrower than claim 1. Id. col 168 II. 16-19. Claim 21 makes clear that when the tablet has more than one blend, those additional blends can be different from each other— one blend can have a mixture of opioid and a low molecular weight polyethylene oxide, and the other blend can have a mixture of opioid and high molecular weight polyethylene oxide. Claim 21 does nothing to negate the requirement that at least one blend comprises the opioid, a high molecular weight polyethylene oxide, and a low molecular weight polyethylene oxide.

Plaintiffs also contend that claim 23 of the '615 patent supports their construction because it discloses "[a] cured tablet as defined in claim 21, wherein at least one blend is compressed by direct compression." Id. col. 168 ll. 26-27. Similar to claim 21, claim 23 only states a requirement for one of the blends. The court does not read claim 23 as contradicting the language of claim 1. Claim 1 discloses "applying each said blend to form a shaped tablet." Id. col. 1661. 32. Claim 23 is an example of applying one of the blends, via direct compression, to form a shaped tablet.

The prosecution history of the '948 patent does not persuade the court to adopt Plaintiffs' construction. Plaintiffs argue that during the prosecution of the'948 patent, they pointed the Examiner to example 3 in the specification to "support the significance of the viscosity of at least 10 cP." (D .I. 115, Ex. 20 at 7). The applicants' statements only demonstrated that example 3 was one way to support the significance of the viscosity of at least 10 cP. It appears that the Examiner agreed during the interview that the Kao reference is totally "silent as to the dosage forms . . . achieving a viscosity of at least 10 cp when tampered." Id The court agrees with Defendants that such a statement cannot amount to the necessary clear disavowal that would be required to limit the viscosity test of the '948 patent to xample 3. See Digital-Vending Servs. Int'l, LLC v. Univ. of Phoenix, Inc., 672 F.3d 1270, 1276 (Fed. Cir. 2012) (explaining the importance of not limiting the claim scope based on statements made during prosecution unless there is a clear disavowal or different definition). The court finds that the statements the applicants made during prosecution do nothing to limit the construction of the claim phrase at issue.

'614 patent, col. 7 l. 61-col. 8 l. 1. The specification also goes on to define the meaning of other weights of polyethylene oxide. The specification's definition of "rheological measurements" is not found in a preferred embodiment or example, but instead, in the section where definitions of other terms are laid out. Because the court finds that the patentees essentially acted as their own lexicographers with regard to the meaning of "molecular weight . . . based on rheological measurements," the court declines to construe the term any more precisely than the patent warrants. In their briefing, Defendants took issue with the fact that Plaintiffs offered no construction for the phrase "rheological measurement." (D.I. 102 at 19). The court finds that the meaning of that phrase is defined by way of the specific test outlined in the specification. Accordingly, the court sees no need to be any more specific in its construction of the disputed phrases.

Lastly, Plaintiffs' proposed that the phrases be construed to mean "a measurement of the mass of a molecule [based on] correlation of molecular weight to viscosity according to rheological measurements." The specification states that the "polyethylene oxide is considered to have an approximate molecular when the "Brookfield viscometer Model RVF, spindle No. 1, at 10 rpm, at 25° C. shows a [specific] viscosity range." The court declines to infer a correlation between molecular weight and viscosity from that disclosure. '614 patent, col. 7 l. 61-col. 8 l. 1.

Further, the patents do not just use the terms "average molecular weight" and "weight-average molecular weight." The '863 and the '948 patents mention both weight-average and number-average molecular weights. '948 patent, col. 24 11. 55-57 (number-average), col. 23 ll. 35-37 (weight-average); '863 patent, col. 9 ll. 12-15 (number-average), col. 16 11.34-37 (weight-average). The '740 mentions neither weight-average nor number-average molecular weight, and, instead, explains approximate molecular weight as a number determined by a viscosity range. '740 patent, col. 15 1.30-col.16 l. 3. Plaintiffs admit that "there are different ways to characterize molecular weight for polymers, the tWo most well-known being weight-average and number-average." (D.I. 101 at 9) (internal quotation marks omitted). Defendants' Expert, Dr. Ryu, also stated in his declaration that "there are different kinds of `average molecular weights' that can be used to characterize a polydisperse polymer such as PEO." (D.I. 105 at 7). Accordingly, the court adopts Defendants' proposed constructions, which follows from the plain and ordinary meaning of both terms, and reserves ruling on indefiniteness until trial.

The '060 patent never mentions "weight-average molecular weight." Plaintiffs point to the prosecution history of the parent application, now U.S. Patent No. 8,114,383, as evidence that when the applicant's used the word "molecular weight" they meant "weight-average molecular weight." It is true that the applicants described component (C) in Example 3 as having an "average molecular weight Mw of 100,000 g/mol." (D.I. 116, Ex. 31, Aug. 25, 2008 Bartholomaus Decl. at 5). There does not appear to be a disagreement between Plaintiffs and Defendants that Mw is a symbol commonly used in scientific literature to denote weight-average molecular weight. See (D.I. 101 at 12); (D.I. 105 at 7). Still, the court is not persuaded that "average molecular weight" should be limited to weight-average molecular weight in the '060 patent. The court does not find it proper to limit the scope of "average molecular weight" when the only evidence in support of such a limitation comes from the prosecution history of a related patent. There is nothing in the specification or claims of the '060 patent that counsels in favor oflimiting the scope of "average molecular weight."

The court also declines to limit the term "rheological measurement" to "measurements based on the change in form and the flow of matter." Again, the '060 patent does not support that construction. The '060 patent indicates what it means by "rheological measurements." The specification of the '060 patent discloses:

'060 patent, col. 5 l.66-col.6 l. 4. Accordingly, the court construes "rheological measurements" to have its plain and ordinary meaning to a person skilled in the art, in the context of the entire patent. Eon Corp. IP Holdings v. Silver Spring Networks, 815 F.3d 1314, 1320 (Fed. Cir. 2016) (explaining that the plain and ordinary meaning "of a claim term is its meaning to the ordinary artisan after reading the entire patent").

The specification uses two different definitions to describe the layer that "encase[es] the core" and comprises "a second portion of the opioid analgesic," '740 patent, col. 4711. 38-40, depending on the layer's location. When that layer is the outermost layer, the specification refers to it as "the shell." See id. col. 28 ll. 17—41. When that layer is the interior layer, the specification refers to it as the "dry coat." See id col. 32 l. 43-col. 33 l. 48. It is clear from the patent that the inventors wanted to refer to the layers differently despite the fact that they have close to the same composition. The necessary implication is that when the dosage form includes a cosmetic coat, the layer previously described as "the shell" becomes the "dry coat" because it is no longer the outermost layer.

Plaintiffs argue that construing the "shell" to be the "outer layer of the dosage form," somehow makes it so that the cosmetic layer becomes the "shell" in examples 7-12 and 14-20. Markman Hr'g Tr. 115:14-19. The court disagrees. Defendants admitted during the Markman Hearing that examples 7-20 and 14-20 do not disclose a shell. Id 116:3-14. There is no dispute that the cosmetic coat disclosed in examples 7-12 and 14-20 cannot be the "shell" discussed in the asserted claims. It simply does not meet the claim requirements for a "shell." '740 patent, col. 4711. 38-40. Further, there seems to be no issue with the fact the examples 7-12 and 14-20 do not disclose a shell because claims 91-95 do not require a shell. Id. col. 52 l. 38-col. 54 l. 19. Therefore, examples 7-12 and 14-20 do not fall outside of the scope of all of the claims. The court thus adopts Defendants' proposed construction for "a shell encasing the core."