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extrinsic evidence
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Resorting to Extrinsic Evidence Is Necessary When Intrinsic Evidence Is Muddied

by | Nov 16, 2023 |

The US Court of Appeals for the Federal Circuit determined that the limitation “a pH of 13 or higher” could not be construed using the asserted patents’ intrinsic evidence and therefore remanded to the district court with instructions to consider the extrinsic evidence and its impact on claim construction. Actelion Pharms. Ltd v. Mylan Pharms. Inc., Case No. 22-1889 (Fed. Cir. Nov. 6, 2023) (Reyna, Stoll, Stark, JJ.)

Mylan Pharmaceuticals sought market entry for its generic epoprostenol—a small molecule hypertension drug—via an abbreviated new drug application (ANDA). Mylan certified under Paragraph IV with respect to two Orange Book-listed patents that Actelion Pharmaceuticals owned. Actelion timely asserted both patents and achieved a favorable claim construction for the term “a pH of 13 or higher.” This limitation is central to the pharmaceutical breakthrough that the asserted patents disclose, which is stably solubilizing the otherwise unstable epoprostenol. The asserted patents teach that epoprostenol bulk solutions’ pH should preferably be adjusted to about 12.5 to 13.5. Mylan contended that this language meant the claim should not encompass anything below pH 13 (i.e., leaving only a fraction of the disclosure’s preferred range within the scope of the issued claims). The district court disagreed, adopting Actelion’s position that the limitation encompassed values that “rounded” to pH 13 (i.e., pH 12.5 and above). This prompted a stipulated infringement judgment. Mylan appealed.

The Federal Circuit reviewed the district court’s construction de novo, explaining that the district court’s construction was a ruling as a matter of law because no extrinsic evidence was considered. The Court then examined the claim language, specifications and prosecution histories in turn.

Regarding the claim language, the Federal Circuit rejected the parties’ invitations to acknowledge certain prior decisions as articulating bright-line rules. Instead, the Court appeared to endorse analyzing the intrinsic evidence on a case-by-case basis when construing similar range limitations. For example, the Court explained that “there is no blanket rule that ranges, or specifically open-ended ranges, must foreclose rounding.” The Court also rejected the following rules concerning range precision:

  • Avoiding rounding requires terms of precision, such as “precisely” or “exactly.”
  • The absence of approximation language dictates a precise value.

In contrast, the Federal Circuit signaled that district courts should properly account for a range’s technical implications (or at least ranges concerning the pH scale) even if that means looking to extrinsic evidence.

Regarding the specifications and prosecution histories, the Federal Circuit disagreed with the district court’s finding that both were inconsistent with Mylan’s position that the disputed limitation reflected a higher degree of precision. The Court concluded that there was little to glean from either, finding that the specifications were as clear as “muddied water” and the prosecution histories provided no insight into the relevant pH range—between pH 12 and pH 13.

The Federal Circuit ultimately concluded that this was an instance in which properly construing a claim limitation required the aid of extrinsic evidence, invoking the Supreme Court of the United States’ guidance from Teva v. Sandoz that extrinsic evidence [...]

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Weeded Out: Mark for Drug Paraphernalia Described as “Essential Oil Dispenser” Refused Registration

by | May 18, 2023 |

Addressing the registrability of marks for cannabis-related products, the Trademark Trial & Appeal Board upheld an Examiner’s refusal to register marks for an “essential oil dispenser” based on extrinsic evidence that the dispenser was primarily used with cannabis extract. In re National Concessions Group, Inc., Ser. Nos. 87168058 and 87183434 (TTAB May 3, 2023) (Thurmon, Greenbaum, English, ATJs) (precedential).

National Concessions sought registration of the word mark BAKKED and a stylized drop logo for an “essential oil dispenser, sold empty, for domestic use” on the Principal Register. The specimen provided by National Concessions illustrated the two marks on an oil dispensing pen identified as “THE DABARATUS.” After reviewing National Concessions’ website—where THE DABARATUS was touted as “THE ALL-IN-ONE TOOL FOR DABBING” that delivers “THE PERFECT DOSE OF CANNABIS EXTRACT”—the Examiner concluded that THE DABARATUS was unlawful drug paraphernalia under the Controlled Substances Act (CSA) and refused registration of the marks. National Concessions appealed on the following three grounds:

  1. The goods are not drug paraphernalia because they are used to dispense essential oil.
  2. The exemption in Section 863(f)(1) of the CSA applies because National Concessions was permitted to sell the goods under Colorado state law.
  3. The exemption in Section 863(f)(2) of the CSA applies because the goods are traditionally intended for tobacco products.

After briefing, the Board suspended the appeal and remanded the applications to the Examiner to request information from National Concessions concerning the legislative histories of Sections 863(f)(1) and (2) of the CSA and the relevant provisions of Colorado state law. The Examiner then issued a Supplemental Final Office Action maintaining the refusal of both marks, and the Board continued proceedings.

The Board began its analysis by outlining the relevant provisions of the CSA, explaining that for a mark to be eligible for registration, the goods must be legal under federal law. Under Section 863(a) of the CSA, it is unlawful to sell “drug paraphernalia,” which is defined as “any equipment, product, or material of any kind which is primarily intended or designed for use in … introducing into the human body a controlled substance, possession of which is unlawful under [the CSA],” including marijuana and marijuana-based preparations. The CSA includes exemptions for any person authorized by local, state or federal law to distribute such items (Section 863(f)(1)) or any item that is traditionally intended for use with tobacco products (Section 863(f)(2)).

The Board first found that National Concessions’ “essential oil dispenser” was prohibited drug paraphernalia under the CSA, even though the product was not unlawful as described in the application. The Board noted that extrinsic evidence, such as an applicant’s marketing materials or product instructions, can be used to show a violation of the CSA even if the application does not reveal a per se violation. After considering National Concessions’ website as well as third-party websites and articles, the Board agreed with the Examiner that National Concessions’ “essential oil dispenser” was primarily intended to dispense cannabis oil for “dabbing”—a method of inhaling superheated cannabis concentrates. The [...]

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Dictionaries Don’t Know Best: The Intrinsic Record Prevails (Again)

by | Jan 19, 2023 |

The US Court of Appeals for the Federal Circuit addressed the tension between the intrinsic and extrinsic record in claim construction, holding that the intrinsic record should be relied on first. The Court therefore reversed a district court finding of indefiniteness based on dictionary definitions and expert testimony. Grace Instrument Industries, LLC v. Chandler Instruments Company, LLC, Case Nos. 21-2370; -2370 (Fed. Cir. Jan. 12, 2023) (Chen, Cunningham, Stark, JJ.)

Grace owns a patent for a liquid pressurized viscometer used commonly to test the viscosity of drilling fluid that is used to drill oil wells. Grace’s viscometer uses an “enlarged chamber” between a lower chamber and a pressurization fluid inlet. According to the patent specification, this enlarged chamber was designed to reduce the measurement error in prior viscometer models that was caused by the mixing of sample fluid and pressurization fluid or by friction emanating from a seal in the viscometer. Within the lower chamber of the patented viscometer, there is a rotor having a “means for driving said rotor to rotate.”

Grace sued Chandler, claiming that Chandler infringed Grace’s viscometer patent. During claim construction, the district court found that the term “enlarged chamber” was indefinite, and that because it was a “term of degree,” it must be compared against something objective. The district court entered its final judgment in favor of Chandler. Grace appealed.

The Federal Circuit reversed, explaining that the “enlarged chamber[’s]” size did not need to be compared against any baseline object, but rather needed to be “large enough to accomplish a particular function.” The Court relied on the specification, which explained that the viscometer described in the patent reduced the mixing of sample fluid and pressurization fluid that was common in older viscometer models by using an “enlarged chamber.” The Court also cited the prosecution history, where the applicant explained that the invention solved a “long lasting problem” by reducing the measurement error caused by the friction of the seal or mixing of the fluids in older viscometer designs. Thus, the Court reasoned that a person of ordinary skill in the art would understand that the “enlarged chamber” must be large enough to prevent the mixing of the pressurization fluid and sample fluid to avoid the measurement errors associated with prior art viscometers.

Chandler argued that the term “enlarged chamber” was not a term of art. The Federal Circuit agreed but explained that “the intrinsic record sufficiently guides a skilled artisan as to the meaning of the term” as used in the patent. The Federal Circuit found that the district court erred in relying on a dictionary definition (extrinsic evidence) to contradict the meaning of the term found within the intrinsic record. The specification’s instructions for the meaning of a claim term should prevail over extrinsic evidence. Rebuffing Chandler’s argument, the Court explained that the specification does not need to explicitly define the claim term to govern the interpretation of that term.

The Federal Circuit remanded the case to the district court to reconsider indefiniteness in [...]

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Bad Connection: Claim Construction Argument without Explanation Given No Weight

by | Dec 22, 2022 |

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) obviousness decision after finding that the patent owner failed to explain how its cited extrinsic evidence supported its proposed claim construction. Uniloc 2017 LLC v. Netflix, Inc., Case No. 21-2085 (Fed. Cir. Dec. 15, 2022) (Dyk, Taranto, Hughes, JJ.) (nonprecedential).

Uniloc owns a patent directed to a “more efficient” method for encoding videos by only coding at the pixel level when necessary and, where possible, reusing code for macroblocks in the background area. Netflix petitioned for inter partes review of several claims in Uniloc’s patent. The Board ultimately found the claims unpatentable as obvious. Uniloc appealed.

Uniloc argued that the Board erred in its claim construction of a limitation that required “dividing the stationary background region and the object region from an inputted video in a macroblock-by-macroblock basis by using a difference between the previous frame and the current frame.” The dispute before the Federal Circuit was whether the “macroblock-by-macroblock basis” required that the act of dividing be done macroblock-by-macroblock, as urged by Uniloc, or whether the dividing resulted in separate macroblock-based regions, as urged by Netflix and found by the Board. The Court concluded that Netflix and the Board were correct.

The Federal Circuit first addressed the intrinsic record, finding that it was ambiguous as to the meaning of “macroblock-by-macroblock basis.” Although the claim language supported either interpretation, Uniloc’s argument would require the Court to read language into the claim that was “simply not there.” The specification did not clarify the claim construction issue either. Although Uniloc pointed to one example where the dividing step occurred one macroblock at a time, the Court stated that it did not limit claim language to examples used in the specification. Lastly, the Court explained that the portions of the specification describing the purpose of the invention and avoiding problems in the prior art also failed to clarify the meaning of the macroblock-by-macroblock basis. Because the purpose was merely to make coding more efficient and avoid dividing at the pixel level, either interpretation could apply.

Relatedly, the Federal Circuit rejected Netflix’s argument that Uniloc forfeited the arguments on appeal related to the portions of the specification explaining the purpose of the claimed invention and how it purportedly solved problems in the prior art. The Court explained that the forfeiture doctrine does not “preclude a party from proffering additional or new supporting arguments, based on evidence record, for its claim construction.” Here, Uniloc “merely cited additional support in the specification to support the same argument it had always made” related to the macroblock-by-macroblock basis.

The Federal Circuit next addressed the extrinsic evidence and agreed with the Board’s decision that a “macroblock-by-macroblock basis” required dividing results in separate macroblock-based regions. Uniloc’s only extrinsic evidence was a dictionary definition of “basis,” and Uniloc offered no additional expert evidence to explain technological facts or usage in the field that would support its interpretation. In contrast, Netflix provided expert testimony and [...]

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Terms of Degree Not Always Indefinite

by | Apr 21, 2022 |

The US Court of Appeals for the Federal Circuit overturned a district court determination that the claim terms “resilient” and “pliable” were indefinite. The Federal Circuit found that the claims, while broad, were sufficiently definite in view of both intrinsic and extrinsic evidence. The Federal Circuit also upheld the district court’s findings of no induced infringement, finding zero evidence of predicate direct infringement of the properly construed method claims. Niazi Licensing Corp. v. St. Jude Medical S.C., Inc., Case No. 21-1864 (Fed. Cir. Apr. 11, 2022) (Taranto, Bryson, Stoll, JJ.) The Federal Circuit also affirmed entry of sanctions excluding portions of the plaintiff’s technical and damages expert reports for failing to disclose predicate facts during discovery and also affirmed exclusion of portions of plaintiff’s damages expert report as unreliable for being conclusory and legally insufficient.

In reaching its decision on indefiniteness, the Federal Circuit focused on the terms “resilient” and “pliable” as used in a claim directed to a double catheter structure. Citing the 2014 Supreme Court decision in Nautilus v. Biosig Instruments, the Federal Circuit explained that language has “inherent limitations,” and stated that a “delicate balance” must be struck to provide “clear notice of what is claimed” and avoid the “zone of uncertainty” relating to infringement. The Court noted that under Nautilus, claims must provide “objective boundaries,” but the Court distinguished the present case from those in which “subjective boundaries” created uncertainty and rendered the claim indefinite. The Court pointed to its 2005 decision in Datamize v. Plumtree Software as a “classic example” of subjectivity where the term “aesthetically pleasing” was deemed indefinite because the patent provided no way to provide “some standard for measuring the scope of the phrase.” The Court also noted that a patent’s claims, written description and prosecution history—along with any relevant extrinsic evidence—can provide or help identify the necessary objective boundaries for claim scope

The Federal Circuit concluded that there was sufficient support in the intrinsic evidence, both in the claims themselves and the written description, to allow a skilled artisan to determine the scope of the claims with reasonable certainty. The Court explained that the claim at issue recited “an outer, resilient catheter having shape memory” that “itself provides guidance on what this term means—the outer catheter must have ‘shape memory,’ and ‘sufficient stiffness.’” The Court also cited to “[n]umerous dependent claims [that] further inform the meaning of this term by providing exemplary resilient materials of which the outer catheter could be made. . . . The written description provides similar guidance . . . . Thus, a person of ordinary skill reading the claims and written description would know of exemplary materials that can be used to make a resilient outer catheter, i.e., one that has shape memory and stiffness such that it can return to its original shape.”

The Federal Circuit distinguished this case from Datamize, where the claim scope depended on the eye of each observer, finding it more akin to its 2017 decision in Sonix Technologies. In that [...]

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Game Reset: Extrinsic Evidence Can’t Limit Claim Scope Beyond Scope Based on Unambiguous Intrinsic Evidence

by | Apr 7, 2022 |

The US Court of Appeals for the Federal Circuit reversed a district court’s grant of summary judgment of noninfringement after concluding that the district court erred by relying on expert testimony to construe a claim term in a manner not contemplated by the intrinsic evidence. Genuine Enabling Tech. LLC v. Nintendo Co., Ltd., et al., Case No. 20-2167 (Fed. Cir. Apr. 1, 2022) (Newman, Reyna, Stoll, JJ.)

Genuine owns a patent directed to a user interface device (UID) that, in the process of synchronizing and merging data streams into a combined data stream, directly receives microphone speech input and transmits speech output via a speaker. During prosecution, the inventor distinguished “slow varying” physiological response signals discussed in a prior art reference from the “signals containing audio or higher frequencies” in his invention, arguing that the latter posed a signal “collision” problem that his invention solved. In distinguishing the prior art, the inventor explained that his invention “describes, in its representative embodiments, how to combine the data from a UID (mouse) and from a high-frequency signal, via a framer, which is unique and novel.”

Genuine subsequently filed a lawsuit against Nintendo, accusing Nintendo’s Wii Remote, Wii Remote Plus, Nunchuk, WiiU GamePad, Switch Joy-Con Controller and Switch Pro Controller of infringing the patent. During claim construction, the parties asked the district court to construe the term “input signal.” Genuine proposed the construction of the disputed claim term to be “a signal having an audio or higher frequency,” whereas Nintendo proposed the narrower construction of “[a] signal containing audio or higher frequencies.” Relying on expert testimony, Nintendo also argued that the inventor “disclaimed signals that are 500 [Hz] or less . . . generated from positional change information, user selection information, physiological response information, and other slow-varying information.”

The district court found that the inventor’s arguments amounted to a disclaimer. Crediting Nintendo’s expert testimony, the district court construed “input signal” as “signals above 500 Hz and excluding signals generated from positional change information, user selection information, physiological response information, and other slow-varying information.” The district court subsequently granted summary judgment of noninfringement, finding that the accused controllers produced the types of slow-varying signals that the inventor had disclaimed during prosecution. Genuine appealed.

Genuine argued that the district court erred in construing “input signal” by improperly relying on extrinsic evidence and improperly finding that the inventor disclaimed certain claim scope during prosecution. The Federal Circuit agreed, reiterating that although extrinsic evidence can be helpful in claim construction, “the intrinsic record ‘must be considered and where clear must be followed,’” such that “where the patent documents are unambiguous, expert testimony regarding the meaning of a claim is entitled to no weight.” In this case, although the parties agreed that the inventor had disavowed claim scope during prosecution, there was a dispute as to the scope of the disclaimer beyond signals below the audio frequency spectrum.

The Federal Circuit explained that for a statement made during prosecution to qualify as a disavowal of claim scope, it [...]

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If Intrinsic Evidence Provides a Clear Meaning, Just Stop

by | Aug 19, 2021 |

The US Court of Appeals for the Federal Circuit vacated a final written decision of the Patent Trial & Appeal Board (Board) based on its finding that the Board erred in its ultimate claim construction by relying on extrinsic evidence that was inconsistent with the intrinsic evidence. Seabed Geosolutions (US) Inc. v. Magseis FF LLC, Case No. 20-1237 (Fed. Cir. Aug. 11, 2021) (Moore, C.J.)

In April 2018, Seabed Geosolutions petitioned for inter partes review of a patent owned by Magseis directed to “seismometers for use in seismic exploration.” Every claim recited a “geophone internally fixed within” either a “housing” or an “internal compartment” of a seismometer. The Board construed this limitation to require a non-gimbaled geophone based entirely on extrinsic evidence. The Board found that the term “fixed” had a special meaning of “non-gimbaled” at the time of the invention. Based on this finding, the Board determined that Seabed had failed to prove that the challenged claims were unpatentable because the cited prior art did not disclose a non-gimbaled geophone. Seabed appealed.

The Federal Circuit reversed the Board’s claim construction of the term “fixed” because it relied on extrinsic evidence that was inconsistent with the intrinsic evidence and unnecessary to consider given the clarity of the intrinsic evidence. The Court reminded the Board that it “resort[s] to extrinsic evidence to construe claims only if it is consistent with the intrinsic evidence,” and that “[i]f the meaning of a claim term is clear from the intrinsic evidence, there is no reason to resort to extrinsic evidence,” citing prior Federal Circuit decisions.

Contrary to the special meaning found by the Board, the Federal Circuit determined that the term “fixed” carried its ordinary meaning (i.e., attached or fastened). The Court found that the term “specifies the geophone’s relationship with the housing, not the type of geophone.” As an initial matter, the specification was silent as to whether the geophone was gimbaled or not. “That silence does not support reading the claims to exclude gimbaled geophones,” in part because the specification used the term gimbaled when describing other aspects of the invention. Had the applicant intended to limit the claimed geophone, it would have done so.

Furthermore, the specification described the internal mounting of the geophone as a key feature to overcome issues with the then-conventional method of separating the geophone from the seismometer’s other components. The specification reiterated that by internally mounting the geophone, the invention was “self-contained.” The prosecution history also revealed that both the applicant and examiner understood the term to carry its plain and ordinary meaning, equating “internally fixed within” with “disposed, and electrically connected, within.” That equivalence indicates that the term was intended to describe the relationship of the geophone with the seismometer, rather than to limit the type of geophone as contemplated by the Board. Accordingly, the Court found that the intrinsic record was clear, and that the Board’s reliance on extrinsic evidence—much less extrinsic evidence that was inconsistent with the specification itself—was improper and remanded for [...]

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