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File Like an Eagle: ANDA pH Specification Rules Infringement Inquiry

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding of noninfringement in a Hatch-Waxman case under 35 U.S.C. § 271(e)(2) and § 271(a)-(b). The Court found that the alleged infringer’s abbreviated new drug application (ANDA) specification controlled the § 271(e)(2) infringement inquiry, and that there were no clear errors by the district court that would warrant reconsideration of the § 271(a)-(b) ruling. Par Pharmaceutical, Inc. et al. v. Eagle Pharmaceuticals, Inc., Case No. 21-2342 (Fed. Cir. Aug. 18, 2022) (Moore, Prost, Hughes, JJ.)

Par is the maker of Vasostrict®, a vasopressin injection product used to treat patients with critically low blood pressure. Par sued Eagle, an ANDA filer seeking to market a generic version of Vasostrict®, asserting infringement of two Orange Book-listed patents. The claims of both asserted patents required a vasopressin composition with a rounded pH between 3.7 and 3.9 (i.e., a pH between 3.65 and 3.94 before rounding). Par argued that Eagle infringed because Eagle’s ANDA sought approval for a product with a pH of 3.64, just 0.01 beneath the claimed range, and because “real-world” evidence purportedly showed that the pH of Eagle’s product drifts up over time. Accordingly, Par asserted infringement under § 271(e)(2), based on the filing of Eagle’s ANDA, and also sought a declaratory judgment that Eagle’s planned generic product would infringe under § 271(a)-(b). The district court disagreed. Par appealed.

Turning first to the issue of infringement under § 271(e)(2), the Federal Circuit explained that because drug manufacturers are bound by strict statutory provisions to sell only those products that comport with their ANDAs, if an ANDA defines a proposed generic drug in a manner that directly addresses the issue of infringement, the ANDA controls the infringement inquiry. The Court stated, however, that if an ANDA specification does not speak clearly and directly to the question of infringement, courts may look to other relevant evidence, such as data or samples the ANDA filer has submitted to the US Food & Drug Administration (FDA), to assess whether a proposed product will infringe.

The Federal Circuit found that in Eagle’s case, “the inquiry begins and ends with Eagle’s ANDA specification.” Eagle’s ANDA contained both a release specification, requiring the generic product to have a pH range of 3.4–3.6 (i.e., up to 3.64 before rounding) at the time of distribution, and a stability specification, requiring that same pH range throughout the entirety of the product’s shelf life. Par argued that the stability specification was irrelevant to the infringement inquiry because the FDA cannot ensure that every product Eagle sells complies with the stability specification. The Court disagreed, finding that the district court did not clearly err in ruling that Eagle’s ANDA defined a product outside the scope of Par’s claims.

As to Par’s declaratory judgment claim under § 271(a)-(b), the Federal Circuit found that the district court did not commit clear error in its consideration of Par’s infringement arguments. The district court considered but did not find compelling Par’s evidence of an upward pH drift in Eagle’s post-release pH data [...]

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Fifth Circuit Affirms Dismissal of Walker Process Claim, Disagrees with Federal Circuit Transfer of Action

The US Court of Appeals for the Fifth Circuit affirmed a summary judgment order dismissing a Walker Process monopolization action brought by Ronald Chandler and his oilfield service company Chandler Manufacturing (collectively, Chandler). The Fifth Circuit affirmed the lower court’s tossing of the action, holding that the alleged claims lacked a nexus to antitrust injury and were time barred under the four-year statute of limitations. Ronald Chandler et al. v. Phoenix Services, LLC, Case No. 21-10626 (5th Cir. Aug. 15, 2022) (Wiener, Graves, Duncan, JJ.)

A Walker Process monopolization action involves antitrust claims regarding fraudulently obtained patents. Chandler alleged that even though Phoenix Services’ patent for fracking technology was declared unenforceable in separate federal litigation in 2018, Phoenix Services continued to enforce the patent to exclude competitors from the market (for example, by sending cease-and-desist letters to Chandler’s clients that attempted to utilize the technology). A Walker Process claim requires a showing of the following:

  • The defendant obtained its patent by “knowing and willful fraud on the patent office and maintained and enforced the patent with knowledge of the fraudulent procurement.”
  • The plaintiff can satisfy all other elements of a Sherman Act monopolization claim.

In the district court, a Texas federal judge granted summary judgment to Phoenix Services, finding that Chandler filed the lawsuit too late and that the defendants involved ultimately could not be held liable. Chandler appealed.

The Fifth Circuit first addressed its appellate jurisdiction. The Court made it clear that it did not agree with the Federal Circuit’s transfer of this Walker Process case (on the basis that it did “not present a substantial issue of patent law” since the underlying patent had already been declared unenforceable in earlier litigation), but that under the Supreme Court’s 1988 decision in Christianson v. Colt Indus. Operating Corp. it did not find the transfer “implausible.” It therefore accepted jurisdiction but noted that its acceptance did not mean that it found the Federal Circuit’s decision correct.

The Fifth Circuit acknowledged that unlike the situation in Xitronix v. KLA-Tencor, where it and the Federal Circuit debated the appellate jurisdiction issue of Walker Process claims, the patent involved here had already been declared unenforceable. However, the Fifth Circuit pointedly noted its position that Walker Process claims should fall under the appellate purview of the Federal Circuit.

On the merits, the Fifth Circuit agreed with the Texas district court that Chandler did not sufficiently demonstrate that its alleged lost profits were caused by Phoenix Services’ alleged antitrust behavior. The Court found that Chandler failed to present substantial evidence that the cease-and-desist letters materially harmed Chandler’s business.

Antitrust plaintiffs must show the following:

  • Injury-in-fact, e., an injury to the plaintiff proximately caused by the defendants’ conduct
  • Antitrust injury
  • Proper plaintiff status, which ensures that other parties are not better situated to bring suit.

Only injury-in-fact was analyzed in the appeal. Chandler argued that the cease-and-desist letter sent to its clients eventually drove the client out of business. However, the Fifth Circuit [...]

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Claim Cancelation Limits but Doesn’t Prohibit Assignor Estoppel Defense

On remand from the Supreme Court, the US Court of Appeals for the Federal Circuit reconsidered the boundaries of the doctrine of assignor estoppel. The Federal Circuit found that the patent assignor was estopped from challenging the validity of an asserted patent because the asserted claim was not materially broader than the specific claims assigned to the patent owner. Hologic, Inc. v. Minerva Surgical, Inc., Case Nos. 2019-2054; -2081 (Fed. Cir. Aug. 11, 2022) (Stoll, Clevenger, Wallach, JJ.)

Csaba Truckai filed a patent application for a device that was designed with a moisture-permeable head to treat abnormal uterine bleeding while avoiding unintended burning or ablation. Truckai assigned the pending patent application to his company, Novacept, which was later acquired by Hologic. Truckai then founded a new company, Minerva Surgical, and developed a new device that used moisture impermeability to avoid the unwanted ablation. Hologic subsequently filed a continuation application to expand the scope of its claims to encompass applicator heads in general, regardless of moisture permeability. The US Patent & Trademark Office issued a patent on the expanded claims in 2015, and Hologic subsequently sued Minerva for patent infringement.

Hologic argued that doctrine of assignor estoppel barred Minerva from challenging the validity of the patent claims. The district court agreed and granted summary judgment of infringement. On appeal, the Federal Circuit affirmed the summary judgment of no invalidity. The Supreme Court granted certiorari and declined Minerva’s request to discard the doctrine of assignor estoppel but clarified that it comes with limits, holding that “assignor estoppel applies only when an inventor says one thing (explicitly or implicitly) in assigning a patent and the opposite in litigation against the patent’s owner.” The Supreme Court remanded to the Federal Circuit to address whether Hologic’s claim was materially broader than the one Truckai assigned. The Supreme Court explained that if the asserted claim was materially broader than the assigned claim, “then Truckai could not have warranted its validity in making the assignment and without such a prior inconsistent representation, there is no basis for estoppel.”

On remand, the Federal Circuit considered whether Truckai warranted the assigned claim’s validity at the time of assignment and whether the assigned claim was materially broader than the asserted claim.

The Federal Circuit concluded that Truckai had represented that the assigned claim was valid. The Court explained that the assigned claim was initially rejected as being anticipated, but Truckai successfully argued for its allowance. The claim was then canceled in response to a restriction requirement, but such cancellation did not speak to the claim’s patentability because an assignee would understand that it could later prosecute the claim’s subject matter under standard patent practice. Therefore, cancelation did not nullify the claim, and it “remained viable for further prosecution.” Additionally, the assignment was not just to the rights to the application, but to the rights to any continuation, continuation-in-part or divisional patent applications not yet filed. When presenting the application, Truckai signed [...]

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Not “Use It or Lose It”: Even if Unexercised, Director’s Authority over Institution Decisions Remains

The US Court of Appeals for the Federal Circuit denied mandamus relief, finding that a party is not entitled to petition the director for review of a Patent Trial & Appeal Board (Board) decision denying institution of an inter partes review (IPR) or post-grant review (PGR) proceeding. This ruling reflects the Court’s ongoing consideration of the Supreme Court’s decision in United States v. Arthrex, Inc., which held that Board judges cannot constitutionally render final decisions in IPRs without US Patent & Trademark Office (PTO) Director oversight. Click here for our discussion of the case on remand, for which the Federal Circuit just denied en banc rehearing. In re Palo Alto Networks, Inc., Case No. 22-145 (Fed. Cir. Aug. 16, 2022) (Dyk, Chen, JJ.) (Reyna, J., concurring).

After being sued by Centripetal Systems for patent infringement, Palo Alto Networks filed petitions for IPR and PGR of some of the asserted patents. The Board denied institution, and Palo Alto Networks filed requests for Director rehearing. Although the PTO acknowledged receipt of the request, it informed Palo Alto Networks that the Director was not considering requests for rehearing of institution decisions “at this time.” Thereafter, Palo Alto Networks sought a writ of mandamus from the Federal Circuit. Between the request for mandamus and the Court’s decision, the PTO issued guidance explaining that although the PTO was not considering requests for rehearing, “the Director has always retained and continues to retain the authority to review such decisions sua sponte after issuance (at the Director’s discretion),” and indeed, exercised its authority to initiate sua sponte review since.

The Federal Circuit rejected Palo Alto Networks’ claim that the Director’s refusal to consider petitions for rehearing of institution decisions amounted to an abdication of authority prohibited by the Appointments Clause. Even assuming that institution decisions were “final decisions on how to exercise executive power” implicating the Appointments Clause, the Court found that the Director maintains statutory and regulatory authority to review institution decisions (unlike in Arthrex), and that the Board renders such decisions only based on the Director’s delegation of authority (also unlike Arthrex). Accordingly, the structural authority maintained by the Director is sufficient, even if such authority goes unexercised, according to the Court.

Writing separately, Judge Reyna agreed that no Appointments Clause violation had occurred but on different grounds. Although Judge Reyna noted that a categorical rejection of requests for rehearing by the Director might raise constitutional concerns, he concluded that mandamus was inappropriate for several reasons. First, the Director’s caveat that she refused to accept requests “at this time” did not constitute a categorical refusal but rather an exercise of discretion. Second, the Director’s invocation of her sua sponte authority to review belied a lack of exercise of discretion. The Director did in fact exercise sua sponte authority to consider Palo Alto Networks’ request, even though briefing in the Federal Circuit was pending, and thus a writ of mandamus was inappropriate.




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Not a Well-Crafted Housing: Product-by-Process Claim Element Isn’t Limiting

The US Court of Appeals for the Federal Circuit affirmed a ruling that certain claims reciting a “housing . . . being cast in one piece” should be construed as a product-by-process claim element and affirmed the subsequent finding of invalidity of all challenged claims. Kamstrup A/S v. Axioma Metering UAB, Case No. 21-1923 (Aug. 12, 2022) (Reyna, Mayer, Cunningham, JJ.)

Kamstrup owns a patent directed to an ultrasonic flow meter housing in the form of a monolithic polymer structure that is cast in one piece. The patent specification explains that the invention can be fabricated with fewer steps compared to existing meters, since only a single step is used to form the monolithic polymer structure. Axioma petitioned for inter partes review of all claims of the patent, and the Patent Trial & Appeal Board (Board) found each claim unpatentable as either obvious or anticipated.

The Board construed the claim term “being cast in one piece” to be a product-by-process claim element. Kamstrup did not present any evidence showing that this claim element provided structural or functional differences distinguishing the housing itself from the prior art, and therefore the Board determined that the housing element was not entitled to patentable weight. The Board subsequently invalidated the independent claim and various dependent claims based on a prior art meter having a housing. The Board also found the remaining dependent claims to be invalid based on two additional references, which the Board determined were sufficiently analogous to flow meter technology to merit consideration in its obviousness analysis.

On appeal, Kamstrup challenged the Board’s product-by-process construction. The Federal Circuit explained that product-by-process claiming is designed to enable an applicant to claim an otherwise patentable product that resists definition other than by the process by which it is made. Where a product-by-process claim element is implicated, structural and functional differences distinguishing the claimed product from the prior art must be shown in order for that claim element to be relevant (limiting) to the anticipation or obviousness inquiry. If no structural or functional differences are shown, the element is given no patentable weight. Turning to the claim element at issue, the Court found that the plain meaning of the term “housing . . . being cast in one piece” implicated a product-by-process interpretation since it described the structure “being” cast in a particular way. The Court also affirmed the Board’s finding of invalidity because Kamstrup failed to identify any disclosure in the specification, prosecution history or extrinsic evidence of any structural or functional differences between the housing element as claimed and the prior art.

Kamstrup also argued that the two secondary prior art references were not analogous prior art because they fell within the field of “medical devices for thermodilution,” and therefore they should not be included in an obviousness analysis. The Federal Circuit disagreed, finding that the references were directed to “sensing or measuring fluid flow and fluid flow characteristics such as temperature,” which is related to “flow meters that include different types of sensors.”




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Prior Art Citation to Inventors’ Report Not “By Another” for § 102(e)

The US Court of Appeals for the Federal Circuit found that a prior art patent’s summarization of a report authored by the inventors of a patent challenged under inter partes review (IPR) did not constitute a disclosure “by another” under pre-America Invents Act § 102(e). LSI Corp. v. Regents of Univ. of Minnesota, Case No. 21-2057 (Fed. Cir. Aug. 11, 2022) (Dyk, Reyna, Hughes, JJ.)

The Regents of the University of Minnesota (UMN) sued LSI Corporation and Avago Technologies (collectively, LSI) for infringement of a patent related to methods for reducing errors in binary data sequences. LSI petitioned for IPR, challenging several claims of the asserted patent and arguing that they were anticipated by two prior art references, Okada and Tsang. Tsang made reference to a “Seagate Annual Report” that was published by the inventors of the asserted patent, and which was later embodied in the patent’s application.

The Patent Trial & Appeal Board (Board) found that one of the challenged claims was anticipated by Okada. The Board also found that LSI had not shown that the other challenged claims were rendered unpatentable by either Okada or Tsang and further rejected an invalidity (anticipation) theory first raised by LSI during oral arguments as untimely (while noting that the argument failed even if timely raised). The Board determined that the Tsang reference was not “by another” under § 102(e) because LSI’s petition relied solely on material that was originally disclosed in the inventor’s Seagate Annual Report. LSI appealed the Board’s determinations relating to invalidity based on Okada or Tsang.

The Federal Circuit noted that LSI did not challenge the Board’s untimeliness determination and rejected LSI’s argument that it did not need to because the Board nevertheless reached a merits decision on the argument. The Court cited to its 2016 decision in Intelligent Bio-Systems v. Illumina Cambridge, which held that “the Board’s rejection of arguments on the ground that they were newly raised in a reply brief was not an abuse of discretion even though the Board went on to address the merits.”

Turning to the § 102(e) issue, the Federal Circuit first explained that an invention is anticipated under § 102(e) if the invention is described in a patent application filed “by another,” but a patent owner may overcome such anticipation by establishing that the relevant prior art disclosure describes the owner’s invention. Describing the history of the Tsang reference and the patent under review, the Court explained that the inventors originally submitted a Seagate Annual Report to Seagate, a UMN collaborator. Tsang, a Seagate employee, received the report and quickly filed a patent application for an improvement on the methods described in the report. This application listed only Tsang as inventor and made direct reference to the Seagate Annual Report.

The Federal Circuit then addressed whether LSI’s IPR petition relied on Tsang’s improvement to the inventors’ report or simply on Tsang’s summary of the inventors’ report. The Court explained that while LSI’s petition relied on both Tsang’s summary of the [...]

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Recapture Rule Applies to Subject Matter Surrendered to Overcome § 101 Rejection

Affirming a Patent Trial & Appeal Board (Board) decision, the US Court of Appeals for the Federal Circuit held, for the first time, that the rule prohibiting recapture of subject matter surrendered during prosecution applies to subject matter surrendered to overcome a § 101 patent eligibility rejection. In re McDonald, Case No. 21-1697 (Fed. Cir. Aug. 10, 2022) (Newman, Stoll, Cunningham, JJ.)

During prosecution of a parent patent application relating to displaying search results, the inventor, John McDonald, added a “processor” limitation to certain claims to overcome a § 101 rejection. McDonald subsequently filed a continuation application, which was eventually issued. McDonald then filed a reissue application seeking to broaden the claims of the continuation patent by striking all of the originally added “processor” claim language. With the reissue application, he included a declaration that the processor language was unnecessary to the patentability and operability of the relevant claims. The examiner rejected the claims as obvious, and McDonald appealed. On appeal, the Board affirmed the obviousness rejection and also rejected the reissue claims as being based on a defective declaration lacking a correctable error. The Board found that McDonald was impermissibly attempting to recapture surrendered subject matter. McDonald appealed.

Exercising de novo review, the Federal Circuit first recounted more than a century of caselaw relating to patent reissue and recapture. The Court explained that a patent may be reissued if the inventor erroneously claimed less than they had a right to claim in the original patent, but that the recapture rule bars a patentee from regaining that which was surrendered during prosecution. The Court then turned to its three-step recapture analysis in which it considers the following:

  1. Whether, and in what aspect, the reissue claims are broader than the patent claims
  2. If broader, whether those broader aspects of the reissue claim relate to the surrendered subject matter
  3. If they do, whether the surrendered subject matter has crept into the reissue claim.

Applying this test, the Court concluded that McDonald sought to broaden his claims and that the surrendered subject matter crept into those broadened claims. The Court also held that McDonald did not meet the reissue statute’s “error” requirement, finding that his actions were deliberate as opposed to inadvertent or by mistake.

The Federal Circuit then addressed McDonald’s arguments that the recapture rule does not apply to subject matter surrendered to overcome a § 101 rejection. The Court conceded that its previous decisions centered on prior art rejections under § 102 and § 103 but found that the public’s reliance interest on a patent’s public record must also apply to subject matter surrendered under § 101. The Court also reiterated that it “reviews a patent family’s entire prosecution history when applying both the rule against recapture and prosecution history estoppel.” The Court thus affirmed the Board’s decision barring McDonald from reclaiming subject matter previously surrendered during prosecution.




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Rage against the Machine: Inventors Must Be Human

The US Court of Appeals for the Federal Circuit found that an artificial intelligence (AI) software system cannot be listed as an inventor on a patent application because the Patent Act requires an “inventor” to be a natural person. Thaler v. Vidal, Case No. 21-2347 (Fed. Cir. Aug. 5, 2022) (Moore, Taranto, Stark, JJ.)

Stephen Thaler develops and runs AI systems that generate patentable inventions, including a system that he calls his “Device for the Autonomous Bootstrapping of Unified Science” (DABUS). In 2019, Thaler sought patent protection for two of DABUS’s putative inventions by filing patent applications with the US Patent & Trademark Office (PTO). Thaler listed DABUS as the sole inventor on both applications. The PTO found that the patent applications lacked valid inventorship and sent a Notice of Missing Parts requesting that Thaler identify a valid inventor. Thaler petitioned the director to vacate the notices. The PTO denied the petitions, explaining that a machine does not qualify as an inventor and that inventors on patent applications must be natural persons. Thaler then pursued judicial review in the district court. The district court agreed with the PTO, concluding that an “inventor” under the Patent Act must be an “individual,” and that the plain meaning of “individual” is a natural person. Thaler appealed.

The sole issue on appeal was whether an AI software system can be an “inventor” under the Patent Act. The Federal Circuit started with the statutory language of the Patent Act, finding that it expressly provides that inventors are “individuals.” The Court noted that while the Patent Act does not define “individual,” the Supreme Court has explained that the term “individual” refers to a human being unless there is some indication that Congress intended a different reading. The Federal Circuit also found that this result was consistent with its own precedent, which found that neither corporations nor sovereigns can be inventors; instead only natural persons can be inventors.

The Federal Circuit rejected Thaler’s policy argument that inventions generated by AI should be patentable to encourage innovation and public disclosure. The Court found that these policy arguments were speculative, lacked any basis in the text of the Patent Act, and were contrary to the unambiguous text of the Patent Act. The Court also rejected Thaler’s reliance on the fact that South Africa has granted a patent with DABUS as an inventor, explaining that the South African Patent Office was not interpreting the US Patent Act. The Court concluded that since Congress has determined that only a natural person can be an inventor, AI cannot be an inventor.

Practice Note: The Federal Circuit’s decision comes on the heels of a decision from the US Copyright Office Review Board finding that a work must be created by a human being to obtain a copyright. The Federal Circuit also noted that it was not confronted with the question of whether inventions made by human beings with the assistance of AI are eligible for patent protection.




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Argument Forfeit in Remand Notwithstanding Modified Claim Construction

In the second appeal arising from an inter partes review (IPR), the US Court of Appeals for the Federal Circuit found that its revised claim construction from the first appeal did not permit the patent challenger to raise a new argument in a remand proceeding at the Patent Trial & Appeal Board (Board) since the patent owner’s response in the original proceeding had sufficiently put the challenger on notice of the claim construction that was adopted in the first appeal. Wireless Protocol Innovations, Inc. v. TCT Mobile, Inc., Case No. 21-2112 (Fed. Cir. July 19, 2022) (Prost, Taranto, Chen, JJ.)

Wireless Protocol Innovations (WPI) owns a patent related to controlling data flow in a point-to-multipoint communications system. WPI filed a district court complaint in 2015 asserting the patent against TCT. In response, TCT filed IPR petitions challenging certain claims of the patent. The petition presented three grounds of unpatentability, one of which relied on a reference by Sen. TCT’s petition did not propose constructions for any claim terms and argued that Sen taught the “grant pending absent state” limitation of the challenged patent. WPI argued that Sen failed to disclose “transitioning” between the “grant pending absent” and “grant pending” states after a “subsequent bandwidth grant,” as required by the claims. In its reply, TCT maintained that Sen taught the limitation but never argued that Sen could be readily modified to include a “grant pending absent state.” The Board found all of the challenged claims to be unpatentable on two grounds, one of which relied on Sen. WPI appealed.

The Federal Circuit reversed the Board’s decision with respect to the first ground, vacated the Board’s decision relying on Sen because the Board applied a flawed claim construction of “grant pending absent state,” and remanded the IPR for the Board to reconsider in view of the Court’s new claim construction. The Court also specifically declined to “prejudge what arguments TCT has properly preserved or should now be permitted to advance or what determinations as to Sen, Rydnell, and admitted prior art are supported by the evidence.”

On remand, the Board allowed the parties to submit additional briefing and expert testimony limited to the issue of whether Sen described operating a consumer premises equipment (CPE) in a “grant pending absent state” as interpreted by the Federal Circuit. TCT maintained its argument that Sen disclosed a grant pending absent state and argued for the first time that, in the alternative, it would have been obvious to a person skilled in the art to modify Sen to meet the limitation. The Board issued a remand decision finding the challenged claims unpatentable. Again, WPI appealed.

The Federal Circuit found that TCT had failed to preserve its new claim construction and obviousness argument and that “failure to timely assert a right or raise an argument constitutes forfeiture.” The Court explained that TCT acknowledged that it understood, prior to its reply, that WPI sought to distinguish the claimed “grant pending absent state” from Sen because Sen involved some [...]

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Claim Construction Error Fuels Remand

The US Court of Appeals for the Federal Circuit vacated and remanded a district court’s noninfringement decision, finding that the district court improperly construed the asserted claims as requiring a dual-fuel system. Ethanol Boosting Sys., LLC v. Ford Motor Co., Case No. 21-1949 (Fed. Cir. July 18, 2022) (Moore, Hughes, JJ.) (Newman, J., dissenting) (non-precedential).

Ethanol Boosting Systems (EBS) filed suit against Ford for infringement of three patents relating to fuel management systems for spark ignition engines that include both a direct injection and a port fuel injection fueling system. During claim construction, Ford argued that the direct injection fuel system required “a fuel that contains an anti-knock agent . . . that is different from the fuel used for port injection.” The district court agreed with Ford, relying on the patents’ titles, figures and background sections. The district court noted that no figures depicted a single fuel engine, and that the specification repeatedly referenced direct injection of a non-gasoline fuel, such as ethanol, into a gasoline engine. The district court acknowledged that the specification made a singular reference to a 100% ethanol embodiment but found that this disclosure did not teach a single fuel engine and that it was in the context of a dual-fuel engine. In view of this construction, the parties stipulated to judgment of noninfringement. EBS appealed.

Reviewing claim construction de novo, the Federal Circuit found that nothing in the asserted claim language required the use of different fuels in the direct-injection and port-injection systems. The Court also found that the specification imposed no such requirement, relying on one embodiment that disclosed “100% of the fuel . . . come[s] from ethanol with a smaller fraction being port injected.” The Court rejected Ford’s citation to multiple passages requiring the use of two fuels, finding that those statements could not describe the invention as a whole because they did not describe all embodiments (namely, the aforementioned 100% ethanol embodiment). Ford also cited to an earlier Federal Circuit decision in which family members of the asserted patents were construed to require dual fuels. The Court disagreed, concluding that those patents had different specifications that did not disclose the 100% ethanol embodiment. The Court finally turned to the prosecution history of a different patent family member that has the same specification as the asserted patents. In that application’s prosecution history, the patent holder distinguished a prior art reference on the ground that it only used a single fuel type. The Court declined to import such a limitation from a statement made in that prosecution history because it did not reflect the claim language. The Court concluded that the district court erred in construing the claims to require a dual-fuel system and remanded the case for further proceedings.

Judge Newman issued a stinging dissent, taking the panel majority to task for departing from what she regarded as settled claim construction law. She agreed with the district court that the 100% ethanol example, considered in context, was “merely discussing how this [...]

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