ROY S. PAYNE, Magistrate Judge.
On February 20, 2019, the Court held a hearing to determine the proper construction of the disputed claim terms in United States Patent No. 8,961,476 ("the '476 Patent"). Having considered the arguments made by the parties at the hearing and in the parties' claim construction briefing (Dkt. Nos. 98, 101, and 102), having considered the intrinsic evidence, and having made subsidiary factual findings about the extrinsic evidence, the Court hereby issues this Claim Construction Memorandum and Order. See Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005); Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 841 (2015).
The '476 Patent was filed on March 21, 2014, issued on February 24, 2015, and is titled "Sharps Protector Device for Protecting a User From a Sharp Tip of a Medical Needle." The '476 Patent relates to a device that protects a person from a needle tip, which could be a "significant hazard" when it is "contaminated with blood or other fluids from the patient." '476 Patent at 1:32-33. Figure 10 illustrates an embodiment of the device that includes a central body portion 202 in fluid connection with a delivery tube 204, medical needle 206, and a pair of wings 216, 218. Id. at 4:62-5:5. The figure also illustrates a mechanical fastener "having a lip and a recessed portion configured to engage for attachment with one another, and with a groove sized to house the medical needle."
Claims 1, 8, and 9 of the '476 Patent recite the following elements (disputed term in italics)
"It is a `bedrock principle' of patent law that `the claims of a patent define the invention to which the patentee is entitled the right to exclude.'" Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (quoting Innova/Pure Water Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)). To determine the meaning of the claims, courts start by considering the intrinsic evidence. Id. at 1313; C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 861 (Fed. Cir. 2004); Bell Atl. Network Servs., Inc. v. Covad Commc'ns Group, Inc., 262 F.3d 1258, 1267 (Fed. Cir. 2001). The intrinsic evidence includes the claims themselves, the specification, and the prosecution history. Phillips, 415 F.3d at 1314; C.R. Bard, Inc., 388 F.3d at 861. The general rule—subject to certain specific exceptions discussed infra—is that each claim term is construed according to its ordinary and accustomed meaning as understood by one of ordinary skill in the art at the time of the invention in the context of the patent. Phillips, 415 F.3d at 1312-13; Alloc, Inc. v. Int'l Trade Comm'n, 342 F.3d 1361, 1368 (Fed. Cir. 2003); Azure Networks, LLC v. CSR PLC, 771 F.3d 1336, 1347 (Fed. Cir. 2014) ("There is a heavy presumption that claim terms carry their accustomed meaning in the relevant community at the relevant time.") (vacated on other grounds).
"The claim construction inquiry . . . begins and ends in all cases with the actual words of the claim." Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998). "[I]n all aspects of claim construction, `the name of the game is the claim.'" Apple Inc. v. Motorola, Inc., 757 F.3d 1286, 1298 (Fed. Cir. 2014) (quoting In re Hiniker Co., 150 F.3d 1362, 1369 (Fed. Cir. 1998)). First, a term's context in the asserted claim can be instructive. Phillips, 415 F.3d at 1314. Other asserted or unasserted claims can also aid in determining the claim's meaning, because claim terms are typically used consistently throughout the patent. Id. Differences among the claim terms can also assist in understanding a term's meaning. Id. For example, when a dependent claim adds a limitation to an independent claim, it is presumed that the independent claim does not include the limitation. Id. at 1314-15.
"[C]laims `must be read in view of the specification, of which they are a part.'" Id. (quoting Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995) (en banc)). "[T]he specification `is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.'" Id. (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)); Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002). But, "`[a]lthough the specification may aid the court in interpreting the meaning of disputed claim language, particular embodiments and examples appearing in the specification will not generally be read into the claims.'" Comark Commc'ns, Inc. v. Harris Corp., 156 F.3d 1182, 1187 (Fed. Cir. 1998) (quoting Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1571 (Fed. Cir. 1988)); see also Phillips, 415 F.3d at 1323. "[I]t is improper to read limitations from a preferred embodiment described in the specification—even if it is the only embodiment—into the claims absent a clear indication in the intrinsic record that the patentee intended the claims to be so limited." Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 913 (Fed. Cir. 2004).
The prosecution history is another tool to supply the proper context for claim construction because, like the specification, the prosecution history provides evidence of how the U.S. Patent and Trademark Office ("PTO") and the inventor understood the patent. Phillips, 415 F.3d at 1317. However, "because the prosecution history represents an ongoing negotiation between the PTO and the applicant, rather than the final product of that negotiation, it often lacks the clarity of the specification and thus is less useful for claim construction purposes." Id. at 1318; see also Athletic Alternatives, Inc. v. Prince Mfg., 73 F.3d 1573, 1580 (Fed. Cir. 1996) (ambiguous prosecution history may be "unhelpful as an interpretive resource").
Although extrinsic evidence can also be useful, it is "`less significant than the intrinsic record in determining the legally operative meaning of claim language.'" Phillips, 415 F.3d at 1317 (quoting C.R. Bard, Inc., 388 F.3d at 862). Technical dictionaries and treatises may help a court understand the underlying technology and the manner in which one skilled in the art might use claim terms, but technical dictionaries and treatises may provide definitions that are too broad or may not be indicative of how the term is used in the patent. Id. at 1318. Similarly, expert testimony may aid a court in understanding the underlying technology and determining the particular meaning of a term in the pertinent field, but an expert's conclusory, unsupported assertions as to a term's definition are entirely unhelpful to a court. Id. Generally, extrinsic evidence is "less reliable than the patent and its prosecution history in determining how to read claim terms." Id. The Supreme Court recently explained the role of extrinsic evidence in claim construction:
There are "only two exceptions to [the] general rule" that claim terms are construed according to their plain and ordinary meaning: "1) when a patentee sets out a definition and acts as his own lexicographer, or 2) when the patentee disavows the full scope of the claim term either in the specification or during prosecution."
To act as his own lexicographer, the patentee must "clearly set forth a definition of the disputed claim term," and "clearly express an intent to define the term." Id. (quoting Thorner, 669 F.3d at 1365); see also Renishaw, 158 F.3d at 1249. The patentee's lexicography must appear "with reasonable clarity, deliberateness, and precision." Renishaw, 158 F.3d at 1249.
To disavow or disclaim the full scope of a claim term, the patentee's statements in the specification or prosecution history must amount to a "clear and unmistakable" surrender. Cordis Corp. v. Boston Sci. Corp., 561 F.3d 1319, 1329 (Fed. Cir. 2009); see also Thorner, 669 F.3d at 1366 ("The patentee may demonstrate intent to deviate from the ordinary and accustomed meaning of a claim term by including in the specification expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope.") "Where an applicant's statements are amenable to multiple reasonable interpretations, they cannot be deemed clear and unmistakable." 3M Innovative Props. Co. v. Tredegar Corp., 725 F.3d 1315, 1326 (Fed. Cir. 2013); see also Avid Tech., Inc. v. Harmonic, Inc., 812 F.3d 1040, 1045 (Fed. Cir. 2016) ("When the prosecution history is used solely to support a conclusion of patentee disclaimer, the standard for justifying the conclusion is a high one.").
Although a statement of lexicography or disavowal must be exacting and clear, it need not be "explicit." See Trs. of Columbia Univ. v. Symantec Corp., 811 F.3d 1359, 1364 (Fed. Cir. 2016) ("a patent applicant need not expressly state `my invention does not include X' to indicate his exclusion of X from the scope of his patent"). Lexicography or disavowal can be implied where, e.g., the patentee makes clear statements characterizing the scope and purpose of the invention. See On Demand Mach. Corp. v. Ingram Indus., Inc., 442 F.3d 1331, 1340 (Fed. Cir. 2006) ("[W]hen the scope of the invention is clearly stated in the specification, and is described as the advantage and distinction of the invention, it is not necessary to disavow explicitly a different scope."). Nonetheless, the plain meaning governs "[a]bsent implied or explicit lexicography or disavowal." Trs. of Columbia Univ., 811 F.3d at 1364 n.2.
The parties agreed to the constructions of the following terms/phrases:
(Dkt. No. 104 at 2).
During the claim construction hearing, the parties agreed to the construction of the following terms/phrases:
Regarding the term
Regarding the phrase
Regarding the phrase
Regarding the phrase
Regarding the phrase
Regarding the phrase
Likewise, the specification states that "[t]he present invention relates to a device, system and method for protecting a user from a sharp tip of a medical needle." '476 Patent at 1:23-25. The specification further states that when the sharp tip "is contaminated with blood or other fluids from the patient, it is considered a significant hazard." Id. at 1:32-33. In describing Figure 10, the specification discloses that "[g]roove 1044 may be sized for housing medical needle 206 after the pair of wings 216, 218 are attached to one another," and that the "attachment of the wings 216, 218 protects a user from sharp tip 212 of medical needle 206." Id. at 6:39-39; see also, id. at 1:44, 1:55-3:20, 4:36-40, 4:57, 5:58. Thus, the patentee explicitly indicated that the goal of the invention is to protect the user from the tip of the needle. Indeed, the title of the '476 Patent is "Sharps Protection Device for Protecting a User From a Sharp Tip of a Medical Needle." As indicated in the intrinsic evidence, the device accomplishes this goal by housing at least the sharp tip of the medical needle within the recited groove.
The parties also previously disputed whether the "groove" houses the needle, as Plaintiffs propose, or if it encloses the needle, as Defendant proposes. Defendant argues that the patentee amended claim 1 during prosecution to distinguish "the protective role of the wings from that of the groove within the wings." (Dkt. No. 101 at 31) (citing Dkt. No. 101-18 at 8). According to Defendant, "[i]f the wings are the portion of the device that `covers' the needle, then the groove that is `housing' the needle must do something else, because [the patentee] used a different word." Id. The Court disagrees with Defendant's characterization of the prosecution history.
During prosecution, the patentee amended claim 1 of the '476 Patent to recite that when the wings are in the closed position they protect against accidental needle stick. The patentee argued that "amended claim 1 requires that
Contrary to Defendant's contention, the patentee did not distinguish the prior art based on "housing" meaning "enclosing." Indeed, claim 8 was not amended to include "housing." Instead, the patentee distinguished the prior art because it failed to cover the needle when in a closed position. This is not a clear or unmistakable disclaimer that requires construing "housing" to mean "enclosing." The extrinsic evidence cited by Defendant is also consistent with the intrinsic evidence, which defines "housing" as "something that covers or protects." (Dkt. No. 101 at 31 n. 37). Finally, Defendant's citation to the IPR and other patents does not compel redrafting the term "housing" as "enclosing." (Dkt. No. 101 at 33). Accordingly, the Court adopts the parties' agreed construction and construes the phrase
Regarding the phrase
The parties' dispute focuses on the meaning and scope of one term of the '476 Patent.
The parties agree that the recited "groove" is a "long narrow" something. The parties dispute whether the "groove" is a "cut," as Plaintiffs propose, or a "depression," as Defendant proposes. Plaintiffs argue that its construction more closely follows the term's ordinary meaning. (Dkt. No. 98 at 22). In the alternative, Plaintiffs contend that the term is a commonly-used term that can be readily understood and does not require construction. Id.
Defendant responds that its construction finds support in extrinsic evidence. (Dkt. No. 101 at 21-22). Defendant argues that Plaintiffs' construction is embodied in the prior art, and would prevent the groove from achieving its claimed form and purpose of being "configured for housing at least a portion of the medical needle." Id. at 26. Defendant contends that none of the small cuts illustrated in the Figure 1 prior art device is sufficient to qualify as a "groove" that is "configured for" or in any way corresponds to the size of the medical needle, as required by claim 8. Id. Defendant further contends that the "cuts" are also not capable of "housing at least a portion of the medical needle," as claim 8 also requires. Id. Defendant argues that a groove that is "configured" for "housing" a medical needle cannot be merely a "cut," as Plaintiffs propose. Id. at 27. According to Defendant, the size of the groove must at least approximate the size of the needle. Id. Defendant contends that "[a] minuscule `cut' cannot do what the patent language requires, while a wider and deeper `depression' is consistent with all evidence and the scope of the patent claim." Id.
Defendant further argues that its construction comports with the common usage of the term by those skilled in the art. Id. According to Defendant, the PTAB concluded that U.S. Patent No. 5,147,319 to Ishikawa et al. disclosed "grooves for housing at least a portion of the medical needle." (Dkt. No. 101 at 27) (citing Dkt. No. 55-1 at 29). Defendant also contends that its construction is consistent with the PTAB's interpretation of U.S. Patent 7,569,044 to Sasso. (Id. at 28) (citing Dkt. No. 55-1 at 31). Defendant further contends that the concept of a "groove" is also discussed in U.S. Patent No. 4,820,277 to Norelli. Id. (citing Dkt. No. 101-17). Finally, Defendant argues that "groove 1044" referenced by Plaintiffs in their claim construction chart is not shown in any figure or embodiment. Id. at 29. Defendant contends that a person of ordinary skill in the art would have to guess which "groove" in either wing is actually number 1044. Id.
Plaintiffs reply that "[t]he difference between a cut and a depression are small." (Dkt. No. 102 at 4). Plaintiffs contend that "a depression tends to connote a natural formation whereas a cut connoted a man (or woman) made article." Id. According to Plaintiffs, the groove that is formed in the wing is man-made. Id.
For the following reasons, the Court finds that the term
The term "groove" appears in claims 8 and 9 of the '476 Patent. The Court finds that the term is used consistently in the claims and is intended to have the same general meaning in each claim. The Court further finds that in the context of the surrounding claim language, both "cut" and "depression" accurately capture the meaning of "groove." Indeed, the extrinsic evidence cited by Defendant defines "groove" as "a long narrow cut or depression, especially one made to guide motion or receive a corresponding ridge." (Dkt. No. 101 at 26) (citing the Oxford Online English Dictionary (US)) (emphasis added). Moreover, neither party has provided a persuasive reason to reject the other side's construction. Accordingly, the Court construes "groove" to mean "a long narrow cut or depression."
Defendant argues that "[a] groove that is `configured' for `housing' a medical needle cannot be merely a `cut.'" (Dkt. No. 101 at 27). Defendant's argument, which quotes the claim language, indicates that the claim language itself defines the proper characteristics and requirements of the recited "groove." For example, claim 8 recites that the groove has "a size configured for housing at least a portion of the medical needle." If the recited groove is "merely a cut" that cannot house "at least a portion of the medical needle," as recited in the claim, then it would not fall within the scope of the claims. Thus, Defendant's concern with Plaintiffs' construction is addressed by the claim language itself.
The Court construes the term
The Court adopts the above constructions. The parties are ordered to not refer, directly or indirectly, to each other's claim construction positions in the presence of the jury. Likewise, the parties are ordered to refrain from mentioning any part of this opinion, other than the definitions adopted by the Court, in the presence of the jury. However, the parties are reminded that the testimony of any witness is bound by the Court's reasoning in this order but any reference to claim construction proceedings is limited to informing the jury of the definitions adopted by the Court.